sqfi audit report edition 8 - mount franklin foods...1) the product formula for fondant was...

Company Number: 3325Audit Number: 2084230

ConfidentialAudit# - Visit#: 2084230 - 1658021 of 92

SQFI Audit Report Edition 8

I. Company Information

Company Name Mount Franklin Foods, LLC dba Sunrise Confections - Planta Norte Company # 3325

Address Magneto 1810, Parque Industrial Fernandez

City Ciudad Juarez State Chihuahua Zip Code 32270

Country México Phone # +52 656 649 6963

Primary Contact Oscar Moreno Email [email protected]

Food Sector Categories

000 - Quality 17 - Confectionary Manufacturing

Modules Audited Module 2 (Manufacturing), Module 2 (Quality), Module 11

Certified Products Gummies, jellies, jelly beans, hard candy, soft candy, mellow crèmes

II. Certification Body

Certifying Body NSF Certification LLC CB # NSF

Address 789 N. Dixboro Rd.

City Ann Arbor State MI Zip Code 48105

Country United States of America Phone # (734) 769-8010

Accreditation Body

ANSI Accreditation Program

Accreditation Number

1181

III. Audit Schedule

Certification Type Recertification Audit Level HACCP-Based Food Safety and Quality

Start Date 20/May/2019 08:30:00 AM End Date 24/May/2019 04:30:00 PM

Scope of Certification

Exclusions: Scope: Confection Candy

IV. Audit Team

First Name Last Name Person # RoleJose Flores Luna 9379 Lead Auditor

V. Audit Duration

Actual Start Date 20/May/2019 08:30:00 AM Actual End Date 24/May/2019 04:30:00 PM

Hours Spent at Facility

41Hours Spent Writing Report

30

VI. Certification Decision



Certificate Decision Date

21/Jun/2019Certificate Issue Date

25/JUN/2019

Audit Score 93% Audit Rating Good

Certification # C0232069-SQF3

Re-certification Date

13/MAY/2020 Expiration Date 27/JUL/2020

Surveillance Audit Due Date

Certification Decision

Certify



VII.Non-ConformitiesElement Description Primary Response Evidence

M2 (MANU) - 2.5.2.3

Records of the verification of monitoring activities shall be maintained.

Minor(1) Records of cleaning and sanitation and allergen management programs identified as preventive controls have not been verified by the preventive control qualified individual (PCQI). 2) Records of metal detector monitoring do not include the specific name plant name, as required by FSMA.

M2 (QUAL) - 2.2.3.1

The methods and responsibility for authorization, accessibility, retention and storage of quality records shall be the same as those required for SQF Food Safety System records.

Minor

Record 60.PRO.CP.04.10 Control de lotes para preparacion de cremas – FONDANT had three issues: temperature of preparation was out of required range 190 degrees Fahrenheit outside required range of175 to 180 degrees Fahrenheit, did not include the person that filled the record, and recorded first shift where it seemed to be recorded in the third shift.

M2 (QUAL) - 2.3.5.1

Finished product specifications shall be documented, current, approved by the site and their customer, accessible to relevant staff and shall include product quality attributes, service deliveryrequirements, and labeling and packaging requirements.

Minor

Formula and process parameters for Moguls 60.R&D.SB.PC.001 updated on 2019.04.26 specify a 78%to 79% solid concentration to prepare gummies; however it was known by production and quality staff that the actual valid concentration was 77%, since the specified concentration is only valid for the Planta Sur facility.

M2 (QUAL) - 2.4.3.14

The food quality team shall develop and document deviation procedures that identify the disposition of affected product when monitoring indicates a loss of control at a CQP. The procedures shall also prescribe actions to correct the process step to prevent recurrence of the quality failure.

Minor Corrective actions of CQP does not describe that nonconforming product is identified and segregated tobe inspected and disposed since last good check, although it was observed implemented on site.

11.2.2.1

Floors shall be constructed of smooth, dense impact resistant material that can be effectively graded, drained, impervious to liquid and easily cleaned.

Minor Some spots on the floors of curing rooms #4 and #5 were observed with aggregate exposed.

11.2.7.1All external windows, ventilation openings, doors and other openings shall be effectively

Minor External door 1D was observed not effectively sealed when closed, leaving a space of less than 1 cm along the door.



sealed when closed and proofed against dust, vermin and other pests.

11.2.9.5

Waste and overflow water from tubs, tanks and other equipment shall be discharged direct to the floor drainage system, and to meet local regulatory requirements.

Minor Water spill from the "mazeta" preparation tank was observed on the floor of the Mogul III kitchen platform due to a defective pipe connection.

11.6.1.4

Equipment storage rooms shall be designed and constructed to allow for the hygienic and efficient storage of equipment and containers.

Minor Maintenance storage room located aside the hazardous chemical room were observed not clean with items directly above the floor.

11.7.5.1

The responsibility and methods used to prevent foreign matter contamination of the product shall be documented, implemented and communicated to all staff.

Minor

Work in progress in reinforced plastic trays with slots in the lower part stacked on plastic pallets and stored in racks of four levels in the Mogul 4 warehouse and each stacking is protected with an empty tray with grooves. It was observed that the product in process are not completely protected from the foreign matter that could come from the pallet stored in the upper level.

11.7.6.3

Records shall be maintained of the inspection of foreign object detection devices and of any products rejected or removed by them. Records shall include any corrective actions resulting from the inspections.

Minor There is no record of inspection of the magnetic grid of the kitchen continuous line #3 and the filter of the preparation tank of the hard candy continuous line #3.

VIII.Root Cause Analysis (To be completed by supplier)Element Description Primary Response Root Cause

M2 (MANU) - 2.5.2.3

Records of the verification of monitoring activities shall be maintained.

Minor

Root cause analysis 1) The plant is assigned to a PCQI 2) The PCQI was trained by FSMA 3) The PQCI was trained by AIB International Root cause Omission by the PCQI for not including the logo andaddress of the company in the metal detector records and for not signing the sanitation records for allergens.

M2 (QUAL) - 2.2.3.1

The methods and responsibility for authorization, accessibility, retention and storage of quality

Minor1) The product formula for Fondant was evaluated, no parameter change was found. It has established 175 to 180 degrees Fahrenheit.2) The registration for the preparation of fondant was evaluated, the registration parameter is equal to



records shall be the same as those required for SQF Food Safety System records.

that established in the formula 175 to 180 degrees Fahrenheit.3) The verifications of the thermometers used were evaluated. No deviation was found in the thermometers used.4) The parameter for the preparation of Mazeta (another syrup) is 190 degrees fahrenheit. 5) The employee recorded the data in the incorrect report. The employee registered the result of the mazeta syrup in the Fondant syrup register.6) At the beginning of each preparation, the record of the change is made for the fondant preparation; however, the employee still did not sign the document and assigned the shift.7) The list of attendance of use and filling of record sheets is evaluated, the worker did not attend the training.

Based on the investigation, it was determined that the root cause is caused by insufficient instructions for the use and filling of records in specific the fondant preparation procedures and records.

M2 (QUAL) - 2.3.5.1

Finished product specifications shall be documented, current, approved by the site and their customer, accessible to relevant staff and shall include product quality attributes, service deliveryrequirements, and labeling and packaging requirements.

Minor Based on the investigation it was determined that the root cause was related with omitting the validationof the formula the spice drops

M2 (QUAL) - 2.4.3.14


Minor Omission of the HACCP team for not documenting the criteria for non conforming product with the PCQ in the quality master plan.

11.2.2.1

Floors shall be constructed of smooth, dense impact resistant material that can be effectively graded, drained, impervious to liquid and easily cleaned.

MinorBased on the investigation, the corrective action team determines that the root cause is Omission for not including in the orders of preventive maintenance for the curing rooms the revision of the conditions of the floor

11.2.7.1

All external windows, ventilation openings, doors and other openings shall be effectively sealed when closed and proofed against dust, vermin and other

Minor

1) The preventive maintenance records of the dock door metal curtains were evaluated; it was observed that the preventive maintenance in the dock door 1D was made 4 weeks before.2) The maintenance program of the metallic curtains of the dock doors was evaluated; the frequency of the preventive maintenance for the manual metallic curtain is for every two months. The frequency for electric metal curtain is for every 3 months.



pests.

3) The records of the dock door maintenance prevention program were evaluated, the established maintenance program has been followed.4) The use of ramps was evaluated on the site; it is observed that the flow of use is continuous with a large flow of forklifts.5) The preventive records of metal curtains were evaluated, in case of having light filtration, it is not registered in the order of preventive maintenance.

Based on the investigation, it was determined that the root cause was caused by an insufficient established frequency in the preventive maintenance program for the metallic curtains since the use of ramps is continuous and the preventive maintenance activity is long.

11.2.9.5

Waste and overflow water from tubs, tanks and other equipment shall be discharged direct to the floor drainage system, and to meet local regulatory requirements.

Minor

1) The preventive maintenance of mogul 3 was evaluated, no problems were observed in the records.2) The last record of preventive maintenance of mogul 3 was evaluated, the maintenance was carried out normally and without problems.3)When the joints of the pipe were checked, a bad positioning between pipes was detected, generating wear and damage in the o-ring.

Based on the information reviewed, it was determined that the root cause was caused by not following the established controls for the application of pipe and rubber o-ring maintenance.

11.6.1.4

Equipment storage rooms shall be designed and constructed to allow for the hygienic and efficient storage of equipment and containers.

Minor

1) The building maintenance preventive program was reviewed finding that the maintenance rooom area does not have a cleaning plan.

Based on the investigation, the corrective action team determined that the root cause was due to managerial omission for not considering the maintenance storage room was not considered in the cleaning plan.

11.7.5.1

The responsibility and methods used to prevent foreign matter contamination of the product shall be documented, implemented and communicated to all staff.

Minor

1) The available inventory of trays and lids is inspected, it was observed that the current quantity is sufficient for the production plan.2) The execution of the operation was evaluated, it is observed that operators occasionally place tray with slots as top trays.3) The training of Good Practices of mogul personnel who carry out the storage of the trays was evaluated, the personnel complied with the established program.

Based on the analysis, it was determined that the root cause was an insufficient instructions since thereis no established requirement on the use of top trays to protect the product .

11.7.6.3

Records shall be maintained of the inspection of foreign object detection devices and of any products rejected or removed by them. Records shall include any corrective actions resulting from the inspections.

Minor Based on the analysis, it was determined that the root cause was due to an omission in not generating the magnets inspection record for the Hard Candy area.



IX. Corrective Actions

Clause Primary Response Corrective Action(Supplier)

Verification of Closeout(Certification Body)

Required Completion Date

Close Out (CB)

M2 (MANU) - 2.5.2.3 Records of the verification of monitoring activities shall be maintained.

Minor

1 Evaluation by the PCQI of the cleaning and sanitation records2 Self training of the PCQI to refresh the guidance of the implementation ofpreventive controls.3 Add the company logo and the address to the metal detector report4 Add the company logo and address, and the signature of the PCQI in the cleaning for allergens.

Root cause analysis, Corrective and preventive action plans were reviewed and approved.

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M2 (QUAL) - 2.2.3.1 The methods and responsibility for authorization, accessibility, retention and storage of quality records shall be the same as those required for SQF Food Safety System records.

Minor

1 Corrected the report of the day observed by the Auditor that was incorrectly filled.2 Training was provided on the use and on how to fill out records.3 Establish an evaluation of records in the beginning of the season to produce mellowcrems (Control de lotes para preparacion de cremas – FONDANT )4 Refresher training was provided to enforce the Fondant preparation parameters Control de lotes para preparacion de cremas – FONDANT

Root cause analysis, corrective and preventive actin plans were reviewed and approved.

23/Jun/2019 19/Jun/2019

M2 (QUAL) - 2.3.5.1 Finished product specifications shall be documented, current, approved by the site and their customer, accessible to relevant staff and shall include product quality attributes, service delivery requirements, and labeling and packaging requirements.

Minor

1 Changed the percent of solids in the formula of spice drops2 Training was given to the Production and Quality workers on the formula change3 Changed the percent of solids specifications in quality and production records4 Training was given to the Production and Quality workers on

Root cause analysis, corrective and preventive action plans were reviewed and approved.

23/Jun/2019 19/Jun/2019



the change of percent of solids in the Production and Quality records5 Conducted a validation of the SpiceDrops formula

M2 (QUAL) - 2.4.3.14 The food quality team shall develop and document deviation procedures that identify the disposition of affected product when monitoring indicates a loss of control at a CQP. The procedures shall also prescribe actions to correct the process step to prevent recurrence of the quality failure.

Minor

1 The corrective action was updated in the Quality Master Plan 2 Notified the Quality team of the changes in the format3 HACCP team received refresher training on the change of the quality master plan


23/Jun/2019 19/Jun/2019

11.2.2.1 Floors shall be constructed of smooth, dense impact resistant material that can be effectively graded, drained, impervious to liquid and easily cleaned.

Minor

1 Repaired the floors on the curing rooms 4 and 5 on Mogul 32 Training was provided for the Maintenance personnel in the floor specification3 Added the floor inspection to the preventive maintenance program for curing rooms Mogul 34 Training was given to the Maintenance personnel in the new inspection task


23/Jun/2019 19/Jun/2019

11.2.7.1 All external windows, ventilation openings, doors and other openings shall be effectively sealed when closed and proofed against dust, vermin and other pests.

Minor

1 Repaired the dock door 1D metal curtain2 Changed the frequency of the preventive maintenance activity on the metallic curtain from every two months to monthly (manual closing)3 Training was given on the new established frequency of the preventive maintenance of metallic curtain dock doors.4 A new task was added in the preventive maintenance program: "Inspection of the correct sealing in metal curtain"5 Training was given to the Maintenance personnel in the new metal curtain sealing inspection task


23/Jun/2019 19/Jun/2019



11.2.9.5 Waste and overflow water from tubs, tanks and other equipment shall be discharged direct to the floor drainage system, and to meet local regulatory requirements.

Minor

1 The rubber ring was replaced in theMazeta pipe in the mogul 3 kitchen2 Refresher training was given to the Maintance personnel on the inspection of the tasks mentioned in the preventive maintenance program.3 Added a task to the preventive maintenance the rubber o ring inspection after making a replacement or maintenance.4 Training was given to the Maintenance personnel in the new established maintenance task.


23/Jun/2019 19/Jun/2019

11.6.1.4 Equipment storage rooms shall be designed and constructed to allow for the hygienic and efficient storage of equipment and containers.

Minor

1 Cleaning was done on the maintenance storage room 2 The cleaning master plan was revised to include the maintenance storage room.3 Training was given to the Maintenance personnel on the new cleaning program


23/Jun/2019 19/Jun/2019

11.7.5.1 The responsibility and methods used to prevent foreign matter contamination of the product shall be documented, implemented and communicated to all staff.

Minor

1 Ensured that all the products located in the mogul 4 room were protected.2 The instructions for the protection ofproduct in the storage warehouse were added to the Mogul quality control procedure.3 Training to the Quality and Production personnel in the revised procedure instructions.4 Visual aids were created for productprotection.5 Product protection was added to the daily GMPs inspection report6 Training was given to the Quality personnel to the added requirement on product protection in the GMPs inspection report


23/Jun/2019 19/Jun/2019



11.7.6.3 Records shall be maintained of the inspection of foreign object detection devices and of any products rejected or removed by them. Records shall include any corrective actions resulting from the inspections.

Minor

1 Created a format for magnets inspection2 Training was given to the Production personnel on the use of the magnets inspection form for Hard Candy area.3 The inspection of the condition of magnets was added to the quality control procedure4 Training was provided to the Production and Quality personnel on the revision of the procedure


23/Jun/2019 19/Jun/2019

Audit Statement

Header Item Evidence

Opening Meeting People Present at the Opening Meeting (Please list names and roles in the following format Name: Role separated by commas)

Oscar Moreno: Vice President of Quality, Francisco Andrade: Quality Manager, Saul Valdivia: Plant Manager, Oswaldo Solorio: Maintenance Manager, Plutarco Gonzalez: Production Manager, Rocio Rangel: Packaging Manager.

Closing Meeting People Present at the Closing Meeting (Please list names and roles in the following format Name: Role separated by commas)

Oscar Moreno: Vice President of Quality, Francisco Andrade: Quality Manager, Saul Valdivia: Plant Manager, Oswaldo Solorio: Maintenance Manager, Plutarco Gonzalez: Production Manager, Rocio Rangel: Packaging Manager.

Facility DescriptionAuditor Description of Facility (Please provide facility description include # of employees, size, production schedule, general layout, and any additional pertinent details

The recertification audit of Sunrise Confections – Planta Norte was performed based on SQF Edition 8, under FSC 17 - Confectionery Manufacturing and 00 – Quality. Sunrise Confections - North corporate is part of Mount Franklin Foods and manufactures candies distributed mainly inthe US. The site is located in the metropolitan area of Juarez, Chihuahua, Mexico and manufactures gummies, jellies, jellybeans, hard candy, soft candy, and crèmes mellow. It started operations on 1988. Sunrise Confections – Planta Norte has a total area of 41700 square feet, with 1020 employees working 3 shifts in continuous production 5 day a week. The manufacturing process of Sunrise has the following facilities: general services, water, air, storage, packaging, raw materials storage, finished product storage, reception of bulk materials, refrigerated warehouse, and multiple processing and packaging rooms. The plant has 4 HACCP plans



and handles egg and soy allergens. Process are low risk due to the low water activity of products.

Auditor Recommendation Auditor Recommendation Issue of Certification of Registration recommended once deficiencies rectified



2.1.1 Food Safety Policy Module 2 (Manufacturing)

Element Description Primary Response

Evidence

2.1.1.1

Senior site management shall prepare and implement a policy statement that outlines as a minimum the: i. The site's commitment to supply safe food; ii. Methods used to comply with its customer and regulatory requirements and continually improve its food safety management system; and iii. The site's commitment to establish and review food safety objectives.

Compliant

2.1.1.2 The policy statement shall be: i. Signed by senior site management; ii. Made available in language understood by all staff; and iii. Displayed in a prominent position and effectively communicated to all staff.

Compliant

2.1.1 Summary

The site has a corporate food safety commitment statement, called "Food safety and quality policy" code 10.ACP.00.FS.001 dated 2018.05, that the Chief Operation Officer (COO) has signed and implemented. The Policy statement covers customer and regulatory requirements, the use of continuous improvement of the system and the review of food safety objectives. The policy is communicated to the facility's staff by way of training to the new employees as well as yearly refresh training and is in languages used in the site. The policy was observed posted in several locations in the food processing areas.

2.1.1 Quality Policy Module 2 (Quality)

Element Description Primary Response Evidence

2.1.1.1

The policy statement prepared and implemented by senior site management to communicate their commitment to food safety shall also include at a minimum: i. The site's commitment to establish quality objectives; ii. The site's commitment to comply with customers' quality requirements; iii. Themethods used to measure the site's quality objectives, and iv. The site's commitment to continually improve its quality performance.

Compliant

2.1.1.2 The site's vision and mission statement shall also be displayed in a prominent position and communicated to all staff. The vision and mission statement may be included in, or separate from, the organization's food safety policy.

Compliant

2.1.1 Summary

The site has a quality commitment statement, called Food Safety and Quality Commitment Statement that senior management has implemented. It is signed by the COO. The Policy statement covers customer and regulatory requirements, the use of continuous improvement of the system for quality and the review of food safety and quality objectives. The policy is communicated to the facility's staff by way of training to the new employees as well as yearly refresh training and is in languages used in the site. The policy was observed posted in the food processing areas. The site's vision and mission statement are included in the food safety and quality statement.



2.1.2 Management Responsibility Module 2 (Quality)


Evidence

2.1.2.1 The reporting structure shall identify personnel performing key process steps and responsible for achieving quality requirements. Compliant

2.1.2.10 Sites that are certified to the SQF Quality Code may use the SQF quality shield. Use of the SQF quality shield shall follow the requirements outlined in Appendix 5: SQF Quality Shield Rules of Use.

N/A The site is not using the SQF Quality Shield.

2.1.2.2 The senior site management shall develop quality objectives and a process by which quality performance is measured. Compliant

2.1.2.3

The senior site management shall ensure adequate resources are available to achieve quality objectives and customer quality requirements, and to support thedevelopment, implementation, maintenance and ongoing improvement of the SQF Quality System.

Compliant

2.1.2.4

Senior site management shall designate an SQF quality practitioner for each sitewith responsibility and authority to: i. Oversee the development, implementation,review and maintenance of the SQF Quality System including quality fundamentals outlined in 2.4.2, and the quality plan outlined in 2.4.3; ii. Take appropriate action to ensure the integrity of the SQF Quality System; iii. Communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF Quality System; and iv. Ensure that site personnel have the required competencies to carry out those functions affecting product quality.

Compliant

2.1.2.5

In addition to the SQF Food Safety Code requirements, the SQF quality practitioner shall: i. Be competent to implement and maintain HACCP-based food quality plans; ii. Understand the SQF Quality Code and the requirements toimplement and maintain a quality management system; and iii. Be competent in statistical process control (SPC) and/or other quality tools to reduce process variation and drive root cause analysis of non-conformities.

Compliant

2.1.2.6

Senior site management shall ensure site personnel responsible for performing key process steps and meeting customer requirements, and corporate quality requirements where applicable, have the required competencies to carry out those functions.

Compliant

2.1.2.7

Senior site management shall develop and implement a quality communication program to ensure that all staff are informed of their quality responsibilities, are aware of their role in meeting the requirements of the SQF Quality Code, and areinformed of the organization's performance against quality objectives. The program shall include: i. the defined vision and mission statement of the site; ii.

Compliant



the site's quality objectives and the process by which quality performance is measured, and iii. The methods by which customer quality requirements, and corporate quality requirements where applicable, are met.

2.1.2.8 Job descriptions for personnel performing key process steps and responsible for achieving quality requirements shall be documented and include provision to cover for the absence of key personnel.

Compliant

2.1.2.9

Senior site management shall establish a process to trend progress in quality performance against agreed measures. Benchmarking shall be part of this process and the performance data shall be reported at least annually to demonstrate effectiveness of the quality management System, and communicated to all staff.

Compliant

2.1.2 Summary

An organizational chart COR-FCH-001 Corporate Quality Organizational Flow, dated 2019.03.07 outlines the structure of staff having responsibility for quality and food safety. Clear, measured, quality objectives for 2019, including •No loss of customer caused by quality issues, •<= 0.5 customer complaints per million pounds manufactured; •Continuous improvement CpK >= 1.33. The results are reviewed monthly by the corporate. Senior management has communicated this to the organization and provides the resources for implementation of the quality systems. The QC manager who is the designated SQF Practitioner for food safety, is also the SQF Quality Practitioner. He received training in SQF Quality Systems on 2018.07.19. The SQF Quality Practitioner has duties including the development and maintenance of quality fundamentals and HACCP-based food quality plans and has shown competency in the operation of statistical process control SPC designed to reduce process variation and products deviating from specifications. He received training in SPC from Qteam on 2019.03.29 – 30. The training program is resourced, implemented and meets requirements outline in system element 2.9. Job descriptions are written for staff responsible for quality, with coverage for absenteeism assigned. Job descriptions for QC manager 60.HRD.SB.HR.028, 2019.04.17 were reviewed and contained quality responsibilities and the provision to cover personnel during absences. A quality communication plan has been implemented, in which plant staff is informed of the site's quality objectives and quality performance trends. Personnel were aware of the site's requirement to report quality issues to management, as evidenced by interviews with packaging operator, QC technician and QC inspector. Senior site management has processes in place to demonstrate continuous improvement, to ensure the integrity of the quality systems and personnel are in place with the competency and resourcesfor achieving the quality objectives. Trending and benchmarking of the site's quality performance in Slide show dated 2019.05.17 were reviewed and found to be conducted annually. The site is not using the SQF Quality Shield.

2.1.2 Management Responsibility Module 2 (Manufacturing)


2.1.2.1 The reporting structure describing those who have responsibility for food safety shall be identified and communicated within the site. Compliant

2.1.2.10 Senior site management shall ensure the integrity and continued operation of thefood safety system in the event of organizational or personnel changes within thecompany or associated facilities.

Compliant

2.1.2.11

Senior site management shall designate defined blackout periods that prevent unannounced re-certification audits from occurring out of season or when the site is not operating for legitimate business reasons. The list of blackout dates and their justification shall be submitted to the certification body a minimum of

N/A This was an announced audit.



one (1) month before the sixty (60) day re-certification window for the agreed upon unannounced audit.

2.1.2.2 The senior site management shall make provision to ensure food safety practices and all applicable requirements of the SQF System are adopted and maintained.

Compliant

2.1.2.3 The senior site management shall ensure adequate resources are available to achieve food safety objectives and support the development, implementation, maintenance and ongoing improvement of the SQF System.

Compliant

2.1.2.4

Senior site management shall designate an SQF practitioner for each site with responsibility and authority to: i. Oversee the development, implementation, review and maintenance of the SQF System, including food safety fundamentals outlined in 2.4.2, and the food safety plan outlined in 2.4.3. ii. Take appropriate action to ensure the integrity of the SQF System; and iii. Communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF System.

Compliant

2.1.2.5

The SQF practitioner shall: i. Be employed by the site as a company employee on a full-time basis; ii. Hold a position of responsibility in relation to the management of the site's SQF System; iii. Have completed a HACCP training course; iv. Be competent to implement and maintain HACCP based food safety plans; and v. Have an understanding of the SQF Food Safety Code for Manufacturing and the requirements to implement and maintain an SQF System relevant to the site's scope of certification.

Compliant

2.1.2.6

Senior site management shall ensure the training needs of the site are resourced, implemented and meet the requirements outlined in system elements2.9, and that site personnel have met the required competencies to carry out those functions affecting the legality and safety of food products.

Compliant

2.1.2.7

Senior site management shall ensure that all staff are informed of their food safety and regulatory responsibilities, are aware of their role in meeting the requirements of the SQF Food Safety Code for Manufacturing, and are informed of their responsibility to report food safety problems to personnel with authority toinitiate action.

Compliant

2.1.2.8 Job descriptions for those responsible for food safety shall be documented and include provision to cover for the absence of key personnel. Compliant

2.1.2.9 Senior site management shall establish processes to improve the effectiveness of the SQF System to demonstrate continuous improvement. Compliant

2.1.2 Summary

An organizational chart COR-FCH-001 of the Corporate Quality Organizational Flow, dated 2019.03.07 and 50.QCD.BB.FS.002, dated 2019.04.15 outline the corporate and plant structureof staff having responsibility for food safety. VP quality management has communicated this to the Corporate staff and provides the resources for implementation of the food safety systems. Clear and measured, food safety objectives, including: •Zero recalls or market withdrawals; •No loss of customer caused by food safety issues, •Excellent rating SQF audits,



•Superior score on customers audits rate; •<= 0.09 customer complaints due to foreign mater per million pounds manufactured; Senior management has communicated this to the organization and provides resources to achieve food safety objectives and ensure the development, implementation, maintenance and on going improvement of the SQF System. The results are reviewed monthly by the corporate office. Last revision was made on 2019.05.17 and it shows that results are achieved. An annual budget is prepared, and monthly reviews areheld to discuss areas where additional resources are necessary. The QC manager is the designated SQF Practitioner with responsibilities to the development, implementation and maintenance of the SQF System. The QC manager is a full-time employee of the facility and has a HACCP food safety training course, as evidenced by (certificate from AIB, HACCP II. Validation and Verification, 2018.010.02 – 04) and understands the SQF Food Safety Code for Manufacturing and its requirement. The training program is resourced, implemented and meets requirements outline in system element 2.9. Plant staff is required to report food safety issues to management, as evidenced on Job descriptions and interviews with 15 employees in hard candy, mogul 1, 3, 4, and 5 and packaging areas A and B. Job descriptions are written for staff responsible for quality, with coverage for absenteeism assigned. Job descriptions for QC manager 60.HRD.SB.HR.028, 2019.04.17 were reviewed and contained quality responsibilities and the provision to cover personnel during absences. Senior site management has processes in place documented in Responsabilidades del Sistema 30.QCD.BB.FS.026 dated 2018.09.14 to demonstrate continuous improvement and to ensure the integrity of the food safety systems when there are organizational or personnel changes.

2.1.3 Management Review Module 2 (Manufacturing)


2.1.3.1

The senior site management shall be responsible for reviewing the SQF System and documenting the review procedure. Reviews shall include: i. The policy manual; ii. Internal and external audit findings; iii. Corrective actions and their investigations and resolution; iv. Customer complaints and their resolution and investigation; v. Hazard and risk management system; and vi. Follow-up action items from previous management review.

Compliant

2.1.3.2

The SQF practitioner (s) shall update senior site management on a (minimum) monthly basis on matters impacting the implementation and maintenance of the SQF System. The updates and management responses shall be documented. The SQF System in its entirety shall be reviewed at least annually.

Compliant

2.1.3.3 Food safety plans, Good Manufacturing Practices and other aspects of the SQF System shall be reviewed and updated as needed when any potential changes implemented have an impact on the site's ability to deliver safe food.

Compliant

2.1.3.4 Records of all management reviews and updates shall be maintained. Compliant

2.1.3 Summary

The entire SQF System is reviewed annually by the site's senior manage team with the last review documented and completed on 2019.05.17. The review includes the food safety manual,internal and external audit findings, the investigations and resolutions of corrective actions and customer complaints with investigations and trends, hazard and risk management system, and follow up actions items from previous management review. The SQF Practitioner has updated VP Quality, Plant manager and department manager on a weekly basis, on any mattersthat impact the site's SQF System. Attendance sheets of the Quality and Operations meetings dated 2019.03.01, 2019.04.11 and 2019.05.09 were reviewed. Food safety plans, Good Manufacturing Practices and the rest of the SQF system are reviewed by management when any potential changes are made in products and processes.



2.1.3 Management Review Module 2 (Quality)

Element DescriptionPrimary

Response Evidence

2.1.3.1

The senior site management shall be responsible for reviewing the SQF Quality Code. Reviews shall include actions required to: i. Monitor specification compliance and corrective actions taken; ii. Reduce process and product variation; iii. Meet customer requirements; iv. Ensure sufficient resources are allocated to maintain, and improve the performance of the Quality System.

Compliant

2.1.3.2 The senior site management and SQF quality practitioner shall meet to review the implementation and maintenance of the Quality System at least monthly, andthe SQF Quality System in its entirety shall be reviewed at least annually.

Compliant

2.1.3.3 The Quality System, including food quality plans, shall be reviewed when any changes are implemented that have an impact on the site's ability to meet customer requirements and corporate quality requirements where applicable.

Compliant

2.1.3.4 Senior site management shall ensure the integrity and continued operation of theQuality System in the event of organizational or personnel changes within the company or associated facilities.

Compliant

2.1.3.5

The senior site management shall document and implement a change management process that details how changes in specifications, materials, equipment or resources are evaluated for their impact on quality, communicated to customers and effectively implemented.

Compliant

2.1.3.6

Records of all Quality System reviews and reasons for amending documents, and changes to the SQF Quality System shall be maintained. Records shall include decisions for actions related to improvement of the Quality System and process effectiveness.

Compliant

2.1.3 Summary

The entire SQF Quality System is reviewed annually by site's senior manage team with the last review documented and completed on 2019.05.17. The review includes specification compliance and corrective actions taken, performance to reduce process and product variation. Steps taken to ensure sufficient resources are allocated to maintain and improve the performance of the Quality System and customer requirements and quality resource needs. Quality plans, Good Manufacturing Practices, specifications and the rest of the SQF system are reviewed by management when any potential changes are made in products and processes. The SQF Quality Practitioner has updated senior site management, i.e. VP. Quality, Plant manager and department manager on a weekly basis, on any matter impacting the site's SQF Quality System.

2.1.4 Complaint Management Module 2 (Quality)


Response Evidence

2.1.4.1 The complaint management process shall include a requirement to identify and resolve the cause of all quality complaints resulting from activities at the site. Compliant



2.1.4.2 Trends in quality complaints shall be included in the performance measures established for the Quality System.

Compliant

2.1.4.3 Corrective action shall be implemented based on the seriousness of the incident and as outlined in 2.5.3. Compliant

2.1.4.4 Records of quality complaints, their investigation and resolution (if applicable) shall be maintained.

Compliant

2.1.4 Summary

The written Corporate quality complaint procedure is found in the document CORP-PRC-005. It defines the methods and responsibilities for handling customer complaints and has been implemented. The customer service area receives the complaint which is entered in an electronic log. The site quality alerts team is notified as well as the corporate quality vice-president and quality director. The investigation of each complaint is carried out, using various tools such as root cause investigation for the Sunrise plants and 8'D for Azor Nut. All root cause investigations and their action plans are approved by the Vice President of Corporate Quality. If the client requires it, a formal letter is sent with the conclusion of the complaint. They have deadlines to respond to complaints regarding quality in 72 hours. Records of quality complaints and their resolution were reviewed for SUN-CR-2019-02-01 and SUN-CR-2019-02-03 dated 2019.02.08 and 2019.02.11 showed that investigation and corrective actions of the complaints had been put into place. Trending graphs of complaints for the time period 2018 to 2019.04 were also reviewed and it was observed compliance with KPI.

2.1.4 Complaint Management Module 2 (Manufacturing)


2.1.4.1 The methods and responsibility for handling and investigating the cause and resolution of complaints from customers and authorities, arising from products manufactured or handled on site, shall be documented and implemented.

Compliant

2.1.4.2 Trends of customer complaint data shall be investigated and analyzed by personnel knowledgeable about the incidents.

Compliant

2.1.4.3 Corrective action shall be implemented based on the seriousness of the incident and as outlined in 2.5.5. Compliant

2.1.4.4 Records of customer complaints and their investigations shall be maintained. Compliant

2.1.4 Summary

The written Corporate quality complaint procedure is found in the document CORP-PRC-005. It defines the methods and responsibilities for handling customer complaints and has been implemented. The customer service area receives the complaint which is entered in an electronic log. The site quality alert team is notified as well as the corporate quality vice-president and quality director. The investigation of each complaint is carried out, using various tools such as root cause investigation for the Sunrise plants. All root cause investigations and their action plans are approved by the Vice President of Corporate Quality. If the client requires it, a formal letter is sent with the conclusion of the complaint. They have deadlines to respond to complaints regarding food safety in 24 hours. Records of complaints reviewed indicate that there was no food safety / foreign matter complaint. Trending graphs of complaints for the time period 2018 to 2019.04 were reviewed.

2.1.5 Crisis Management Planning Module 2 (Quality)




Evidence

2.1.5.1 The crisis management plan prepared by senior management shall include the methods by which the site shall, in the event of a crisis, maintain continuity of supply that meets the customers' product and service quality requirements.

Compliant

2.1.5.2 The site shall contact their customers in the event of a crisis that impacts their ability to supply quality product. Compliant

2.1.5 Summary

The site's written Crisis Management Plan is found in the COR-PRC-017 Rev A Business continuity and crisis management plan and COR-FMS-025 Crisis alert contact list USA and COR-FMS-026 crisis alert contact list Sunrise. The Plan has been implemented and addresses serious disaster threats to the extended interruption of the business. The team leader is the operations vice president has oversight of the Plan., and it contains a provision to contact customers when a crisis occurs that affects the site's ability to supply quality products.

2.1.5 Crisis Management Planning Module 2 (Manufacturing)


2.1.5.1

A crisis management plan that is based on the understanding of known potential dangers (e.g. flood, drought, fire, tsunami, or other severe weather or regional events such as warfare or civil unrest) that can impact the site's ability to deliver safe food, shall be documented by senior management outlining the methods and responsibility the site shall implement to cope with such a business crisis.

Compliant

2.1.5.2

The crisis management plan shall include as a minimum: i. A senior manager responsible for decision making, oversight and initiating actions arising from a crisis management incident; ii. The nomination and training of a crisis management team; iii. The controls implemented to ensure a response does not compromise product safety; iv. The measures to isolate and identify product affected by a response to a crisis; v. The measures taken to verify the acceptability of food prior to release; vi. The preparation and maintenance of a current crisis alert contact list, including supply chain customers; vii. Sources of legal and expert advice; and viii. The responsibility for internal communications and communicating with authorities, external organizations and media.

Compliant

2.1.5.3 The crisis management plan shall be reviewed, tested and verified at least annually. Compliant

2.1.5.4 Records of reviews of the crisis management plan shall be maintained. Compliant

2.1.5 Summary



The site's written Crisis Management Plan is found in the COR-PRC-017 Rev A Business Continuity and Crisis Management Plan and COR-FMS-025, Crisis Alert Contact List USA, and COR- FMS-026 Crisis Alert Contact List Sunrise. The Plan has been implemented and addresses serious disaster threats to the extended interruption of the business. The team leader is the operations vice president has oversight of the Plan. BCP & Crisis Management team has been identified as was observed on the document Corporate procedure. The Plan includes responses to a business interruption, isolating and identifying affected product and a current crisis alert list. The Crisis Management Plan includes internal/external communications and sources of legal and expert advice. A test of the plan was conducted on 2019.03.06 involving a disaster scenario of fire in the Mogul 3 curing room that affected the food safety of the site's products. Records are maintained in QC manager office, including follow-up corrective actions of this review and annual test of the Crisis Management Plan.

2.2.1 Quality Management System Module 2 (Quality)


ResponseEvidence

2.2.1.1

A quality manual shall be documented and maintained in either electronic and/or hard copy form. It shall outline the methods the site uses to meet the requirements of the SQF Quality Code, be made available to staff, and include: i. A summary of the organization's quality policies and the methods it will apply tomeet the requirements of the SQF Quality Code; ii. The policy statement and site organization chart; iii. A list of the products covered under the scope of certification; iv. Finished product specifications agreed with customers' or corporate quality requirements where applicable; and v. Statistical process control methods and other quality tools that are used to control and reduce process variation. The quality manual may be incorporated into, or independent from the SQF food safety manual, and shall be signed by senior management.

Compliant

2.2.1 Summary

A food and quality safety manual has been developed and is maintained in hard copy and electronic form called Manual de Inocuidad y Calidad 50.QCD.BB.FS.002. It is dated 2019.05.16 and maintained by the SQF practitioner. The Food Safety and Quality Manual contains the scope of the certification, a list of products in the scope, finished product specifications, the organizational chart; and the food safety and quality policies, programs and procedures, including SPC and other quality tools the site uses to reduce process variation that are part of the site's SQF Quality System. It is made available to all relevant staff by means of hard copy in quality workstations.

2.2.1 Food Safety Management System Module 2 (Manufacturing)


2.2.1.1

A food safety management system shall be documented and maintained in either electronic and/or hard copy form. It shall outline the methods the organization will use to meet the requirements of the SQF Food Safety Code for Manufacturing, be made available to relevant staff and include: i. A summary of the organization's food safety policies and the methods it will apply to meet the requirements of this standard; ii. The food safety policy statement and

Compliant



organization chart; iii. The scope of certification; iv. A list of the products coveredunder the scope of certification; v. Food safety procedures, pre-requisite programs, food safety plans; and vi. Other documentation necessary to support the development and the implementation, maintenance and control of the SQF System.

2.2.1.2 All changes made to food safety plans, Good Manufacturing Practices and other aspects of the SQF System shall be validated or justified. Compliant

2.2.1 Summary

A food safety manual has been developed and is maintained in hard copy and electronic form called Manual de Inocuidad y Calidad 50.QCD.BB.FS.002. It is dated 2019.05.16 and maintained by the SQF practitioner. The food safety manual contains the scope of the certification, a list of products in the scope (Gummies, jellies, hard candy, soft candy, sour candy, crèmes mellow), the organizational chart and food safety policies, programs and procedures that make up the site's SQF System. It is made available to all relevant staff by means of hardcopy in the quality workstations.

2.2.2 Document Control Module 2 (Quality)


2.2.2.1 The methods and responsibility for maintenance, storage, and distribution of quality documents shall be the same as those required for SQF Food Safety System documentation.

Compliant

2.2.2 Summary

The site has implemented its procedure called Control de Documentos 30.QCD.BB.DL.002, 2018.06.15, defining the methods and responsibilities for document control of quality records. The procedures for maintenance, storage, and distribution of quality documents were observed to be equivalent to those required for SQF Food Safety System documentation.

2.2.2 Document Control Module 2 (Manufacturing)


2.2.2.1 The methods and responsibility for maintaining document control and ensuring staff have access to current documents shall be documented and implemented. Compliant

2.2.2.2 A register of current SQF System documents and amendments to documents shall be maintained. Compliant

2.2.2.3 Documents shall be safely stored and readily accessible. Compliant

2.2.2 Summary



The site has implemented its procedure called Control de Documentos 30.QCD.BB.DL.002, 2018.06.15, defining the methods and responsibilities for document control. Documents were found during the audit to be readily accessible and properly stored. A current list of all SQF documents is maintained by the Document control technician and documents were observed to be stored securely and are accessible. The register of SQF documents is called Lista Maestra de Documentos 60.QCD.BB.DL.001 and Lista Maestra de Registros 60.QCD.BB.DL.001 dated 201905.20 and are found in the site share point.

2.2.3 Records Module 2 (Manufacturing)


Evidence

2.2.3.1 The methods and responsibility for undertaking monitoring activities, verifying, maintaining and retaining records shall be documented and implemented. Compliant

2.2.3.2 All records shall be legible and suitably authorized by those undertaking monitoring activities that demonstrate inspections, analyses and other essential activities have been completed.

Compliant

2.2.3.3 Records shall be readily accessible, retrievable, securely stored to prevent damage and deterioration and shall be retained in accordance with periods specified by a customer or regulations.

Compliant

2.2.3 Summary

The site has implemented its policy for verifying and retaining records found in the document called Control de Registos 30.QCD.BB.DL.003, dated 2019.03.07. The facility has documented procedures for recording production as well as the proper correcting and initialing of errors. These are based on company and regulatory requirements. Records were observed to be readily accessible, legibly filled out, securely stored to prevent damage and have documented retention times. Records are retained in the warehouse for two years.

2.2.3 Records Module 2 (Quality)


2.2.3.1 The methods and responsibility for authorization, accessibility, retention and storage of quality records shall be the same as those required for SQF Food Safety System records.

Minor

Record 60.PRO.CP.04.10 Control de lotes para preparacion de cremas – FONDANT had three issues: temperature of preparation was out of required range 190 degrees Fahrenheit outside required range of 175 to 180 degrees Fahrenheit, did not include the person that filled the record, and recorded first shift where it seemed to be recorded in the third shift.

2.2.3 Summary

The site has implemented its policy for verifying and retaining quality records found in the document called Control de Registos 30.QCD.BB.DL.003, dated 2019.03.07. The procedures for authorization, accessibility, retention and storage of quality records were observed to be equivalent to those required for SQF Food Safety System records. Quality records are retained in



the warehouse for two years. Minor NC – 2.2.3.1 Record 60.PRO.CP.04.10 Control de lotes para preparacion de cremas – FONDANT had three issues: temperature of preparation was out of required range 190 degrees Fahrenheit outside required range of 175 to 180 degrees Fahrenheit, did not include the person that filled the record, and recorded first shift where it seemed to be recorded in the third shift.

2.3.1 Product Development and Realization Module 2 (Manufacturing)


Evidence

2.3.1.1 The methods and responsibility for designing, developing and converting productconcepts to commercial realization shall be documented and implemented. Compliant

2.3.1.2 Product formulation, manufacturing processes and the fulfillment of product requirements shall be validated by site trials, shelf life trials and product testing. Compliant

2.3.1.3

Shelf life trials where necessary shall be conducted to establish and validate a product's: i. Handling, storage requirements including the establishment of "use by" or "best before dates"; ii. Microbiological criteria; and iii. Consumer preparation, storage and handling requirements.

Compliant

2.3.1.4

A food safety plan shall be validated and verified for each new product and its associated process through conversion to commercial production and distribution, or where a change to ingredients, process, or packaging occurs that may impact food safety.

Compliant

2.3.1.5 Records of all product design, process development, shelf life trials and approvals shall be maintained. Compliant

2.3.1 Summary

Part of this requirement was included in the Corporate audit conducted on 2019.03.11. The policy defining the methods and responsibilities for commercialization of new products, called R&D.SB.DD.010 Development of new products has been implemented. Procedures conducted at the facility include checking formulations and processes with production trials, shelf-life trials and product testing. Product tests on the floor are documented at 60.R & D.BB.DD.005 "Floor test notification". Shelf-life trials are conducted to establish "best by" dates and handling& storage requirements. The food safety plan is validated and verified for each new product and process by approval of the first production trial by the corporate and site Food safety personnel (quality VP and SQF practitioner). This review includes changes to distribution and ingredients. The facility maintains records of all steps of the product development cycle including process development, shelf-life trials and facility trials. The records for development of new product called "SC Sour neon worn nat CRF 6/5 on January, 2018, were reviewed and found to contain production scale trials, the product shelf life studies was customer responsibility due that the recipe is customer property as was observed on the customer plant trial request record.

2.3.1 Product Development and Realization Module 2 (Quality)


Evidence

2.3.1.1 The methods for designing, developing and converting product concepts to commercial realization shall include a process capability analysis to ensure that Compliant



processes are able to consistently supply products that meet customer specifications.

2.3.1.2 Product formulation, manufacturing processes and the fulfillment of product quality requirements shall be validated by facility trials and product testing. Compliant

2.3.1.3 Shelf life trials shall be conducted to establish and validate a product's packaging, handling, storage and customer use requirements through to the end of its commercial life and consumer use.

Compliant

2.3.1.4

A food quality plan shall be validated and verified for each new product and its associated process from conversion to commercial production and distribution, or where a change to ingredients, process, or packaging occurs that may impact food quality.

Compliant

2.3.1.5 Records of all quality tests, product design, process development, and shelf life trials associated with product changes or new product development shall be maintained.

Compliant

2.3.1 Summary

This requirement was included in the Corporate audit conducted on 2019.03.11. The policy defining the methods and responsibilities for commercialization of new products, called R&D.SB.DD.010 Development of new products has been implemented.

2.3.2 Raw and Packaging Materials Module 2 (Quality)


2.3.2.1 Specifications for all raw and packaging materials, including, but not limited to ingredients, additives, hazardous chemicals and processing aids that impact on finished product quality shall be documented and kept current.

Compliant

2.3.2.2 Raw and packaging materials and ingredients shall be validated to ensure product quality is not compromised and the material is fit for its intended purpose.

Compliant

2.3.2.3 Product labels that are designed or specified by customers shall be approved by those customers. Records shall be maintained of customer approvals. Compliant

2.3.2.4 The register of current raw and packaging material specifications shall include those raw and packaging materials impacting product quality and customer labels.

Compliant

2.3.2 Summary

Specifications for raw materials, packaging, ingredients, additives, chemicals and processing aids that have an impact on product quality have been documented. Current registers were reviewed for raw materials, packaging materials and labels. All applicable raw and packaging materials are verified to ensure product quality and regulatory requirements are met, and the material is fit for its intended purpose. Product labels that are designed or specified by customers have been approved by those customers. Product labels for own branded products are



designed and proved by the packaging engineering department with approval from the marketing, R & D, purchasing and quality departments. There is a register of raw material, ingredients and packaging specifications affecting product quality.

2.3.2 Raw and Packaging Materials Module 2 (Manufacturing)


Evidence

2.3.2.1 Specifications for all raw and packaging materials, including, but not limited to ingredients, additives, hazardous chemicals and processing aids that impact on finished product safety shall be documented and kept current.

Compliant

2.3.2.2 All raw and packaging materials and ingredients shall comply with the relevant legislation in the country of manufacture and country of destination, if known. Compliant

2.3.2.3 The methods and responsibility for developing and approving detailed raw material, ingredient, and packaging specifications shall be documented. Compliant

2.3.2.4

Raw and packaging materials and ingredients shall be validated to ensure product safety is not compromised and the material is fit for its intended purpose.Verification of raw materials and ingredients shall include certificates of conformance, or certificate of analysis, or sampling and testing.

Compliant

2.3.2.5

Verification of packaging materials shall include: i. Certification that all packagingthat comes into direct contact with food meets either regulatory acceptance or approval criteria. Documentation shall either be in the form of a declaration of continued guarantee of compliance, a certificate of conformance, or a certificate from the applicable regulatory agency. ii. In the absence of a certificate of conformance, certificate of analysis, or letter of guarantee, tests and analyses to confirm the absence of potential chemical migration from the packaging to the food contents shall be conducted and records maintained.

Compliant

2.3.2.6 Finished product labels shall be accurate, comply with the relevant legislation and be approved by qualified company personnel. Compliant

2.3.2.7 A register of raw and packaging material specifications and labels shall be maintained and kept current. Compliant

2.3.2 Summary

Specifications for raw materials, packaging, ingredients, additives, chemicals and processing aids have been documented. Specification were reviewed and found to be current. A policy defining the methods and responsibilities for developing and maintaining specifications has been documented in R&D.SB.DD.010. Raw and packaging materials are validated to ensure product safety and regulatory requirements are met by means of the receipt of Letters of Guarantee, Certificates of Compliance or Certificates of Analysis. Food contact packaging is verified to not present chemical migration by letter of conformance. Product labels are approved by the packaging engineering department with approval from the marketing, R & D, purchasing and quality departments. There are current registers in place for raw materials, packaging materials and labels.



2.3.3 Contract Service Providers Module 2 (Manufacturing)


Response Evidence

2.3.3.1 Specifications for contract services that have an impact on product safety shall be documented, current, include a full description of the service to be provided and detail relevant training requirements of all contract personnel.

Compliant

2.3.3.2 A register of all contract service specifications shall be maintained. Compliant

2.3.3 Summary

Descriptions of requirements for services provided by contract providers having an impact on food safety are documented in Requerimientos Generales de Prestadores de Servicios 30.QCD.BB.FS.020, dated 2019.01.08. A list of current contract service providers is maintained in QCD.BB.FS.020 and found to include providers of services such as including Pest Control Rentokil, Laboratory Analysis CDM 1698.06, SPC / CARPERMORE, VRC Transports, VRP, Techmaster de México AC-1342, Systems and scales 3063.01, Gracida L18-41. Contract arrangements for Pest Control was reviewed during the audit and found to be satisfactory.

2.3.3 Contract Service Providers Module 2 (Quality)


2.3.3.1

Specifications for contract services that have an impact on in-process or finishedproduct quality shall be documented, current, include a full description of the service to be provided and detail relevant training requirements of contract personnel.

Compliant

2.3.3.2 The register of contract service specifications shall include those services impacting product quality. Compliant

2.3.3 Summary

Descriptions of requirements for services provided by contract providers having an impact on food safety are documented in Requerimientos Generales de Prestadores de Servicios 30.QCD.BB.FS.020, dated 2019.01.08. A list of current contract service providers is maintained in QCD.BB.FS.020 and found to include providers of services such as including Pest Control Rentokil, Laboratory Analysis CDM 1698.06, SPC / CARPERMORE, VRC Transports, VRP, Techmaster de México AC-1342, Systems and scales 3063.01, Gracida L18-41. Contract arrangements for Pest Control was reviewed during the audit and found to be satisfactory.

2.3.4 Contract Manufacturers Module 2 (Quality)


2.3.4.1 The methods and responsibility for ensuring all agreements relating to food safety and customer product requirements and its realization and delivery are

N/A The site does not use contract manufacturers.



specified and agreed shall be documented and implemented.

2.3.4.2

The site shall: i. Ensure that the processes in place at the contract manufacturerare capable of consistently meeting customer requirements, or corporate quality requirements where applicable; ii. Verify compliance with the SQF Quality Code and that all customer requirements are being met at all times; iii. Audit the contract manufacturer annually at a minimum to confirm compliance to the SQF Quality Code and agreed arrangements, or accept the manufacturer's certification to the SQF Quality Code or equivalent; and iv. Ensure changes to contractual agreements are approved by both parties, agreed with customers where necessary, and communicated to relevant personnel.

N/A The site does not use contract manufacturers.

2.3.4.3 Records of all contract reviews and changes to contractual agreements and theirapprovals extend to quality records. N/A The site does not use contract manufacturers.

2.3.4 Summary

The site does not use contract manufacturers.

2.3.4 Contract Manufacturers Module 2 (Manufacturing)


2.3.4.1 The methods and responsibility for ensuring all agreements relating to food safety and customer product requirements and its realization and delivery are specified and agreed shall be documented and implemented.

N/A The supplier does not use contract manufacturers.

2.3.4.2

The site shall: i. Verify compliance with the SQF Food Safety Code for Manufacturing and that all customer requirements are being met at all times. Products and/or processes of co-manufacturers that are considered high risk shall be required to undergo an audit by the site or other third party agency to confirm compliance to the SQF Food Safety Code for Manufacturing and agreed arrangements; and ii. Ensure changes to contractual agreements are approved by both parties and communicated to relevant personnel.

N/A The supplier does not use contract manufacturers.

2.3.4.3 Records of all contract reviews and changes to contractual agreements and theirapprovals shall be maintained. N/A The supplier does not use contract manufacturers.

2.3.4 Summary

The supplier does not use contract manufacturers.

2.3.5 Finished Product Specifications Module 2 (Quality)




Evidence

2.3.5.1

Finished product specifications shall be documented, current, approved by the site and their customer, accessible to relevant staff and shall include product quality attributes, service delivery requirements, and labeling and packaging requirements.

Minor

Formula and process parameters for Moguls 60.R&D.SB.PC.001 updated on 2019.04.26 specify a 78%to 79% solid concentration to prepare gummies; however it was known by production and quality staff that the actual valid concentration was 77%, since the specified concentration is only valid for the Planta Sur facility.

2.3.5.2 Customer product specifications and delivery requirements shall be communicated to appropriate departments and staff within the site. Compliant

2.3.5 Summary

Finished product specifications are current, documented, available to relevant site personnel and approved by the site's customers. Specifications include labeling and packaging attributes. A register of all current finished product specifications is maintained in the EPR system. Finished product specifications for Blue Shark – Sunrise were reviewed during the auditand contained the required information. Minor NC - 2.3.5.1 Formula and process parameters for Moguls 60.R&D.SB.PC.001 updated on 2019.04.26 specify a 78% to 79% solid concentration to prepare gummies; however it was known by production and quality staff that the actual valid concentration was 77%, since the specified concentration is only valid for the Planta Sur facility.

2.3.5 Finished Product Specifications Module 2 (Manufacturing)


2.3.5.1 Finished product specifications shall be documented, current, approved by the site and their customer, accessible to relevant staff and may include: i. Microbiological and chemical limits; and ii. Labeling and packaging requirements.

Compliant

2.3.5.2 A register of finished product specifications shall be maintained. Compliant

2.3.5 Summary

Finished product specifications are current, documented and approved by I&D, Quality and supplier's customers. Specifications include microbiological and chemical limits, labeling and packaging requirements. The plant maintains a list of approved specifications. Finished product specifications are included in the ERP system and printed in the Operation Note by authorized personal, such as QC technician to control finished product. Finished product specifications for Blue Shark – Sunrise was reviewed during the audit and found to be complete.

2.4.1 Customer Requirements Module 2 (Quality)


Evidence



2.4.1.1

The requirements and expectations of customers and final consumers shall be continually reviewed to ensure the accuracy of specifications and the ability to supply to customer needs. A full review of customers' expectations for product and delivery shall occur at least annually.

Compliant

2.4.1.2 The site shall have a procedure in place to notify essential customers where theirability to supply product that meets customer specifications is temporarily suspended or halted.

Compliant

2.4.1.3 Where customer products, materials or equipment are used within the facility, the site shall have measures in place to safeguard customer property and ensure its correct and proper use.

N/ACustomer products, materials or equipment are not used within the facility.

2.4.1 Summary

The site was observed to review the requirements and expectations of its customers and final consumers on a demand basis. The accuracy of specifications and the ability to supply to customer needs are part of this review. Primary responsibility for ensuring that the site is up to date on the requirements of customers and consumers and for notifying essential customersof temporary quality issues is held by the Business Unit Manager. Specifications for customer products are uploaded in the Product System database in share point that together with the ERP system used in the facility provides Bills of Materials, label and packaging requirements to production and packaging staff. Customer products, materials or equipment are not used within the facility.

2.4.1 Food Legislation Module 2 (Manufacturing)


2.4.1.1

The site shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of use or sale. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, packaging, product description, net weights, nutritional, allergen and additive labeling, labeling of identify preserved foods, any other criteria listed under food legislation, and to relevant established industry codes of practice.

Compliant

2.4.1.2

The methods and responsibility for ensuring the site is kept informed of changes to relevant legislation, scientific and technical developments, emerging food safety issues, and relevant industry codes of practice shall be documented and implemented.

Compliant

2.4.1.3 SQFI and the certification body shall be notified in writing within twenty-four (24) hours in the event of a regulatory warning. Notification to SQFI shall be by emailto [email protected].

Compliant

2.4.1 Summary

This requirement was audited in the Corporate audit. The supplier has ensured that product delivered to their customers complies with regulatory requirements. Regulatory compliance for



this operation includes packaging, product description, net weights, nutritional, allergen and additive labeling, and labeling of identify preserved foods, among others. The corporate manager is the Senior quality manager (Sunrise facilities) and Marketing director (Azor Nut). They took the training Food labeling compliance review seminar on 2015.09. Each facility has an FDA bioterrorism registration. The supplier keeps updated about changes in relevant legislation, technical developments and industry codes of practice in their specific industry, by means Food Legislation Policy 30.QCD.SB.FS.004. The supplier has documented in the policy mentioned that the certification body and SQF will be notified within 24 hours if a food safety event requiring public notification occurs.

2.4.2 Quality Fundamentals Module 2 (Quality)


ResponseEvidence

2.4.2.1 The buildings and equipment shall be constructed, designed and maintained to facilitate the manufacture, handling, storage and/or delivery of food that meets customer specifications or corporate quality requirements.

Compliant

2.4.2.2

The methods and responsibility for the calibration of measuring, test and inspection equipment used for quality testing of raw materials, work-in-progress, and finished product, food quality plans and other process controls, or to demonstrate compliance with customer specifications shall be documented and implemented. Software used for such activities shall be validated as appropriate.

Compliant

2.4.2.3 Storage and transport of raw materials, work-in progress, and finished product shall be suitable to maintain the integrity of the product without loss, waste or damage.

Compliant

2.4.2 Summary

The property, buildings and equipment are located, constructed and designed to ensure food meets specifications and is manufactured, stored and transported to meet customer and corporate quality requirements. Calibration of measuring, inspection and test equipment used to monitor compliance to customer specifications is documented in Procedimientos de Calibracion 30.QCD.BB.QC.008, 2019.04.29.

2.4.2 Good Manufacturing Practices Module 2 (Manufacturing)


2.4.2.1

The site shall ensure the Good Manufacturing Practices described in modules 3, 4, 9, 10 or 11 (as applicable) of this Food Safety Code are applied, or exempted according to a written risk analysis outlining the justification for exemption or evidence of the effectiveness of alternative control measures to ensure that food safety is not compromised.

Compliant

2.4.2.2 Those Good Manufacturing Practices applicable to the scope of certification that outline how food safety is controlled and assured shall be documented and

Compliant



implemented.

2.4.2 Summary

The property, buildings and equipment are located, constructed and designed to ensure food is manufactured in a safe, hygienic environment. The site has written and implemented those Good Manufacturing Practices applicable to the scope of this certification. The effectiveness of the prerequisite programs has been verified based on a schedule, which is found in Validation of prerequisite programs, i.e., physical contamination, training, water, transportation and loading, pest control, among others, dated 2019.01.25.

2.4.3 Food Safety Plan Module 2 (Manufacturing)


2.4.3.1

A food safety plan shall be prepared in accordance with the twelve steps identified in the Codex Alimentarius Commission HACCP guidelines. Feed manufacturers may utilize a HACCP-based reference food safety plan developedby a responsible authority.

Compliant

2.4.3.10

The food safety team shall determine and document the control measures that must be applied to all significant hazards. More than one control measure may be required to control an identified hazard, and more than one significant hazard may be controlled by a specific control measure.

Compliant

2.4.3.11

Based on the results of the hazard analysis (refer to 2.4.3.9), the food safety team shall identify the steps in the process where control must be applied to eliminate a significant hazard or reduce it to an acceptable level (i.e. a critical control point, or CCP). In instances where a significant hazard has been identified at a step in the process, but no control measure exists, the food safety team shall modify the process to include an appropriate control measure.

Compliant

2.4.3.12

For each identified CCP, the food safety team shall identify and document the limits that separate safe from unsafe product. The food safety team shall validate the critical limits to ensure the designated level of control of the identified food safety hazard (s); and that all critical limits and control measures individually or in combination effectively provide the level of control required (refer to 2.5.2.1).

Compliant

2.4.3.13

The food safety team shall develop and document procedures to monitor CCPs to ensure they remain within the established limits (refer to 2.4.3.12). Monitoringprocedures shall identify the personnel assigned to conduct testing, the samplingand test methods, and the test frequency.

Compliant

2.4.3.14

The food safety team shall develop and document deviation procedures that identify the disposition of affected product when monitoring indicates a loss of control at a CCP. The procedures shall also prescribe actions to correct the process step to prevent recurrence of the safety failure.

Compliant



2.4.3.15

The documented and approved food safety plan (s) shall be implemented in full.The effective implementation shall be monitored by the food safety team, and a full review of the documented and implemented plans shall be conducted at leastannually, or when changes to the process, equipment, inputs or other changes affecting product safety occur.

Compliant

2.4.3.16 Implemented food safety plans shall be verified as part of SQF System verification (refer to 2.5) Compliant

2.4.3.17

Where food safety regulations in the country of production and destination (if known) prescribe a food safety control methodology other than the Codex Alimentarius Commission HACCP guidelines, the food safety team shall implement food safety plans that meet both Codex and food regulatory requirements.

Compliant

2.4.3.2

The food safety plan shall be effectively implemented and maintained and outlinethe means by which the site controls and assures food safety of the products or product groups included in the scope of the SQF certification and their associated processes. More than one HACCP food safety plan may be required to cover all products included in the scope of certification.

Compliant

2.4.3.3

The food safety plan or plans shall be developed and maintained by a multidisciplinary team that includes the SQF practitioner and those site personnel with technical, production, and engineering knowledge of the relevant products and associated processes. Where the relevant expertise is not available on site, advice may be obtained from other sources to assist the food safety team.

Compliant

2.4.3.4 The scope of each food safety plan shall be developed and documented including the start and end-point of the processes under consideration and all relevant inputs and outputs.

Compliant

2.4.3.5

Product descriptions shall be developed and documented for all products included in the scope of the food safety plans. This shall reference the finished product specifications (refer to 2.3.5.1) plus any additional information relevant toproduct safety, such as pH, water activity, and/or composition.

Compliant

2.4.3.6

The intended use of each product shall be determined and documented by the food safety team. This shall include target consumer groups, the potential for consumption by vulnerable groups of the population, requirements for further processing if applicable, and potential alternative use of the product.

Compliant

2.4.3.7

The food safety team shall develop and document a flow diagram covering the scope of each food safety plan. The flow diagram shall include every step in the process, all raw material, packaging material, and service inputs (e.g. water, steam, gasses as appropriate), scheduled process delays, and all process outputs including waste and rework. Each flow diagram shall be confirmed by the food safety team during all stages and hours of operation.

Compliant



2.4.3.8 The food safety team shall identify and document all food safety hazards that can reasonably be expected to occur at each step in the processes, including raw materials and other inputs.

Compliant

2.4.3.9

The food safety team shall conduct a hazard analysis for every identified hazard,to identify which hazards are significant, i.e. their elimination or reduction to an acceptable level is necessary to ensure food safety. The methodology for determining hazard significance shall be documented and used consistently to assess all potential hazards.

Compliant

2.4.3 Summary

The site has developed and implemented one food safety plan with four subplans, which includes: Mogul 5 (Gummies), Mogul 1 (jellies), Hard candy (included soft candy and sour candy), and Mogul 3 (crèmes mellow). The food safety plan is based on the steps outlined by the Codex Alimentarius Commission. A multi-disciplinary Food Safety Team (8) has been identified and trained, with documentation found in records of AIB International training, HACCP II: Validation and Verification, 2018.10.02-04. Developed HACCP plans include the manufactured products and associated processes. Identification of product characteristics and its intended use, the identification of raw materials, ingredients and materials in contact with the product and the description of the characteristics of the final product are developed and well supported. Flow´s charts were developed considering every stage and process operations identifying for each technology. Hard candy LC1 – Empaque 20.QCD.BB.FS.019. Rev B and Mogul 1, Mogul 3 and Packaging 20.QCD.BB.FS.001. Rev J. were reviewed. The flow charts were verified in the field by the HACCP team on 2019.03.11 to 15. The food safety team has analyzed all hazards reasonably likely to occur including physical (metal foreign matter, glass, plastic, buttons, personal items and dust); chemical (allergens cross contact, sanitizers, boiler additive, and heavy metals); and microbiological hazards (coliforms) for each process step, ingredient and packaging. Control measures are in place to eliminate or reduce the food safety risk to acceptable levels. The plant presented data / references supporting the possibility of occurrence, information on the severity of the health effects and the acceptable level in the finished product. The decision and rationale of the assessment for each risk, is documented. The selection and categorization of control measures for significant hazards are carried out using a decision tree which allows the plant to establish measures to control CCP's. The PCC control of foreign matter was determined: Fe, No Fe, SS for each packing line. Critical Limit for the CCP were developed, including CCP Horizontal metal detectors Non Fe 1.5, SS 2.0 and Fe 1.2 and CCP Vertical metal detectors Non Fe 1.5, SS 2.0 and Fe 1.5. These are monitored and verified every hour, product changeover, beginning and end of shift by QC technicians and once per shift by the QC supervisor, respectively. Any deviations found in monitoring of established control limits are documented and investigated, with proper disposal of involved products. The plan is verified as part of the SQF System and reviewed annually or when changes occur, by the food safety team with the last review date on 2019.03.11 to 15. Federal regulatory requirements for the site also require a Preventive Control FSMA Food Safety Plan 60.QCD.BB.FS.031 and 60.QCD.BB.FS.011 for Mogul 5 (Gummies), Mogul 1 (jellies), Hard candy (included soft candy and sour candy), Mogul 3 (crèmes mellow)., which was observed documented. Preventive controls determined were metal detectors (CCP), supplier approval and monitoring, cleaning and sanitation and allergen management prerequisite programs.

2.4.3 Food Quality Plan Module 2 (Quality)


2.4.3.1

A food quality plan shall be developed, effectively implemented, and maintained in accordance with the Codex Alimentarius Commission HACCP method. The food quality plan may be combined with, or independent from, the food safety plan, but must separately identify quality threats and their controls, and critical quality points.

Compliant

2.4.3.10 The food quality team shall determine and document the control measures that must be applied to all significant quality threats. More than one control measure Compliant



may be required to control an identified threat, and more than one significant threat may be controlled by a specific control measure.

2.4.3.11

Based on the results of the threat analysis (refer to 2.4.3.9), the food quality team shall identify the steps in the process where control must be applied to eliminate a significant threat or reduce it to an acceptable level. These steps shall be identified as Critical Quality Points or CQPs.

Compliant

2.4.3.12

For each identified CQP, the food quality team shall identify and document the quality limits that separate acceptable from unacceptable product. The food quality team shall validate the critical quality limits to ensure the designated levelof control of the identified quality threat (s); and that all critical quality limits and control measures individually or in combination effectively provide the level of control required.

Compliant

2.4.3.13

The food quality team shall develop and document procedures to monitor CQPs to ensure they remain within the established limits (refer to 2.4.3.12). Monitoringprocedures shall identify the personnel assigned to conduct testing, the samplingand test methods, and the test frequency.

Compliant

2.4.3.14


Minor

Corrective actions of CQP does not describe that nonconforming product is identified and segregated to be inspected and disposed since last good check, although it was observed implemented on site.

2.4.3.15

The documented and approved food quality plan shall be fully implemented. Theeffective implementation shall be monitored by the food quality team, and a full review of the documented and implemented plans shall be conducted at least annually, or when changes to the process, equipment, specifications or inputs occur which may affect product quality.

Compliant

2.4.3.16 Implemented food quality plans shall be verified as part of SQF Quality System verification (refer to 2.5).

Compliant

2.4.3.2 The food quality plan shall outline the means by which the site controls and assures the quality attributes of the products or product groups and their associated processes.

Compliant

2.4.3.3

The food quality plan shall be developed and maintained by a multidisciplinary team that includes the SQF practitioner and those site personnel with technical, production, and marketing knowledge of the relevant products and associated processes. Where the relevant expertise is not available on site, advice may be obtained from other sources to assist the food quality team. The composition of the food quality team may be different from the food safety team.

Compliant

2.4.3.4 The scope of the food quality plan shall be developed and documented includingthe start and end-point of the process under consideration and all relevant inputsand outputs.

Compliant



2.4.3.5

Product descriptions shall be developed and documented for all products included in the scope of the food quality plan. This shall include information in the finished product specifications (refer to 2.3.5.1) plus any additional quality or service attributes established by agreement with the customers.

Compliant

2.4.3.6

The intended use of each product shall be determined and documented by the food quality team. This shall include as appropriate target consumer groups, ease of use by consumers, consumer instructions, tamper evidence, and other applicable information affecting product quality.

Compliant

2.4.3.7 The food quality team shall review the flow diagram developed and confirmed aspart of the food safety plan, and ensure process steps, process delays, and inputs that impact product quality are included.

Compliant

2.4.3.8 The food quality team shall identify and document all quality threats that can reasonably be expected to occur at each step in the processes, including raw materials and other inputs.

Compliant

2.4.3.9

The food quality team shall conduct a quality threat analysis for every identified quality threat, to identify which threats are significant, i.e. their elimination or reduction to an acceptable level is necessary to ensure or maintain product quality. The methodology for determining threat significance shall be documented and used consistently to assess all potential quality threats.

Compliant

2.4.3 Summary

A Food Quality Plan with four subplans, which includes: Mogul 5 (Gummies), Mogul 1 (jellies), Hard candy (included soft candy and sour candy), and Mogul 3 (crèmes mellow) has been developed, implemented and maintained by the site. It is kept on file and maintained by the SQF practitioner. The Food Quality Plan has been prepared in accordance with the 12 steps identified in the Codex Alimentarius Commission HACCP guidelines and outlines the means by which the site controls and assures its quality. The Food Quality Team is the same as the Food Safety Team. The Plan includes a list of all products in the scope of the certification, a product description (including relevant specification information), intended product use (including target consumer group) and flow diagrams for each process step. The process flow has been verified by the site per site inspection. The Food Quality Team has analyzed all quality threats reasonably likely to occur at each process step, raw material and ingredient input. Control measures are in place to eliminate or reduce the quality threats to acceptable levels. The following Critical Quality Points have been identified: CQP1 – low weight Mogul 5 (Gummies), Mogul 1 (jellies), Hard candy (included soft candy and sour candy), and Mogul 3 (crèmes mellow) and CQP2 – broken product (Hard candy) and Mogul 3 (crèmes mellow). As a result, the following Critical Quality Limits were identified: CQP1 – packed finished product above minimum legal weight and CQP2 broken product less than 4% of packed finished product. Control limit compliance is monitored and verified by the site's Food Quality Plan. CQP are three bags of finished product monitored every hour. Any deviation found in the monitoring of established control limits is documented and investigated, with proper disposal of involvedproducts. Minor NC – 2.4.3.14 Corrective actions of CQP does not describe that nonconforming product is identified and segregated to be inspected and disposed since last good check, although it was observed implemented on site. The Food Quality Plan is verified as part of the SQF System and reviewed annually or when changes occur, by the Food Quality Team with the last review date on 2019.03.11 to 15.

2.4.4 Approved Supplier Program Module 2 (Quality)


Response Evidence



2.4.4.1 Raw materials, ingredients, packaging materials, and services that impact on finished product quality shall be supplied by an approved supplier.

Compliant

2.4.4.2

Material suppliers shall be selected and approved based on their ability to supplymaterials that meet quality specifications. The evaluation program shall require suppliers to: i. Maintain controlled and current copies of specifications; ii. Have processes that are capable of consistently supplying materials that meet specification and other defined quality metrics (e.g. delivery. service, adherence to specifications, etc.); iii. Be certified to a second or third party quality management system; and iv. Have a complaints and corrective action process in place.

Compliant

2.4.4.3

Material suppliers shall only be accepted into the facility based on either certificates of analysis for every lot received, or inspection at receipt to ensure materials comply with specification. All receipts shall be visually inspected for damage and product integrity.

Compliant

2.4.4.4 The approved supplier program shall include an agreement with suppliers for thereturn or disposal of materials that fail to meet specifications or are damaged or contaminated.

Compliant

2.4.4 Summary

The site has a written supplier approval procedure Corporate standard operation procedure COR-PRC-014 Rev A, that impact on product quality. Material supplies are only accepted into the facility based on either certificate of analysis for every lot received and inspection at receipt to ensure materials comply with specification. The approved supplier program contains an agreement with suppliers for the return or disposal of materials that fail to meet specifications or are damaged or contaminated. The policy includes a review of products and testing applicable to each supplier. Approval requires material suppliers to maintain controlled and current specifications for the site, to have a quality complaint corrective action program in place and for quality-related suppliers to be certified to a second or third-party quality system. GFSI certificates were reviewed in the Mount Franklin Foods – Corporate audit of 2019.03.11

2.4.4 Approved Supplier Program Module 2 (Manufacturing)


2.4.4.1 Raw materials, ingredients, packaging materials, and services that impact on finished product safety shall meet the agreed specification (refer to 2.3.2) and besupplied by an approved supplier.

Compliant

2.4.4.10 A register of approved supplier and records of inspections and audits of approved suppliers shall be maintained. Compliant

2.4.4.2 The receipt of raw materials, ingredients, and packaging materials received from non-approved suppliers shall be acceptable only in an emergency situation, and provided they are inspected or analyzed before use.

Compliant

2.4.4.3 The responsibility and procedure for selecting, evaluating, approving and monitoring an approved supplier shall be documented and implemented. Compliant



2.4.4.4 The site's food defense plan (refer to 2.7.1.1) shall include measures to secure incoming materials and ingredients and protect them from deliberate act of sabotage or terrorist-like incidents.

Compliant

2.4.4.5 The site's food fraud vulnerability assessment (refer to 2.7.2.1) shall include the site's susceptibility to raw material or ingredient substitution, mislabeling, dilution and counterfeiting which may adversely impact food safety.

Compliant

2.4.4.6 The food fraud mitigation plan (refer to 2.7.2.2) shall include methods by which the identified food safety vulnerabilities from ingredients and materials shall be controlled.

Compliant

2.4.4.7

Raw materials, ingredients, and packaging materials received from other facilities under the same corporate ownership, shall be subject to the same specification requirements (refer to 2.3.2) and approved supplier requirements as all other material providers.

N/A There is no incoming materials from sister facilities.

2.4.4.8

The approved supplier program shall be based on the prior performance of a supplier and the risk level of the raw materials ingredients, packaging materials, and services supplied, and shall contain as a minimum: i. Agreed specifications (refer to 2.3.2); ii. Reference to the rating of the level of risk applied to a raw material ingredients, packaging materials and services and the approved supplier; iii. A summary of the food safety controls implemented by the approved supplier; iv. Methods for granting approved supplier status; v. Methods and frequency of monitoring approved suppliers; vi. Details of the certificates of conformance if required; and vii. Methods and frequency of reviewing approved supplier performance and status.

Compliant

2.4.4.9 Supplier audits shall be based on risk and shall be conducted by individuals knowledgeable of applicable regulatory and food safety requirements and trainedin auditing techniques.

Compliant

2.4.4 Summary

Raw materials, ingredients, packaging materials, and services that impact on finished product safety are supplied by an approved supplier The receipt of raw materials, ingredients, and packaging materials received from non-approved suppliers could be acceptable only in an emergency situation, and provided they are inspected and analyzed before use. The site has a written supplier approval procedure Corporate standard operation procedure COR-PRC-014 Rev A, which has been implemented and covers the procedures for approving suppliers of rawmaterials, ingredients, packaging materials and services. It was observed that the food defense plan contains methods to secure incoming products from sabotage (the site is C-TPAT register, (incoming trailers and tanks are inspected and checks are recorded in 60.SEC.SB.SP.013 and 60.SEC.SB.SP.004), the food fraud vulnerability assessment identifies threats to incoming product substitution, mislabeling and dilution, and the food fraud mitigation plan demonstrates these threats are controlled. The policy includes a review of the specifications of products, the supplier's food safety controls, procedures for granting and monitoring approved suppliers, the level of risk of products to the site and details of requirements for Certificate of Conformance, Certificates of Analysis and testing. Approved supplier performance and status is reviewed using an annual assessment of quality, service, performance, existence of deviations (shipment and receiving issues). The annual assessment of 2019 was reviewed. A register is maintained of all current approved suppliers Sunrise approved suppliers 2019 60.QCD.SR.FS.047, which was reviewed during the audit and found to be acceptable. Raw materials such as colors, flavors, corn syrup, finishing agents (class I) and film (class II), found in the storage warehouse and involved in the vertical traceability challenge were verified to have come from suppliers on the Approved Supplier List. Supplier audits are based on risk; audits were on file for approved suppliers of ingredients/components and reviewed in the corporate audit to Mount Franklin audit. There is no incoming materials from sister facilities.



2.4.5 Non-conforming Product or Equipment Module 2 (Quality)


Evidence

2.4.5.1 Non-conforming product shall include products that fail to meet quality specifications. Compliant

2.4.5.2 Non-conforming equipment shall include equipment that is not suitable for use, and is not capable of producing products that meet quality specifications. Compliant

2.4.5.3

The site shall document and implement a procedure to accept returned product that does not meet finished product specifications. The procedure shall include handling of returned goods to prevent redistribution or contamination of other products.

Compliant

2.4.5 Summary

The site has written procedures for withholding non-conforming products, raw materials, work-in-progress, ingredients, packaging and equipment in document Detencion y Disposicion de Producto No Conforme 30.QCD.BB.NC.001, 2019.04.24 and Detencion y Disposicion de Equipo No Conforme 30.MNT.BB.SS.008 dated 2019.03.24, which were found to be properly implemented in the facility. The site has not documented the policy to accept products returned by customers that do not meet finished product specifications and methods to segregate, identify, handle and dispose of nonconforming and returned product documented in Detencion y Disposicion de Producto No Conforme 30.QCD.BB.NC.001 include inspection, segregation, validation, and if applicable, repackaging were observed to minimize any inadvertent use.

2.4.5 Non-conforming Product or Equipment Module 2 (Manufacturing)


2.4.5.1

The responsibility and methods outlining how non-conforming product, raw material, ingredient, work-in-progress, packaging or equipment detected during receipt, storage, processing, handling or delivery is handled shall be documented and implemented. The methods applied shall ensure: i. Non-conforming product is quarantined, identified, handled and disposed of in a manner that minimizes the risk of inadvertent use, improper use or risk to the integrity of finished product; ii. Non-conforming equipment is effectively repaired or disposed of in a manner that minimizes the risk of inadvertent use, improper use or risk to the integrity of finished product; and iii. All relevant staff are aware of the organization's quarantine and release requirements applicable to equipment or product placed under quarantine status.

Compliant

2.4.5.2 Quarantine records, and records of the handling, corrective action, or disposal ofnon-conforming product or equipment shall be maintained. Compliant

2.4.5 Summary



The site has written procedures for withholding non-conforming products, raw materials, work-in-progress, ingredients, packaging and equipment in document Detencion y Disposicion de Producto No Conforme 30.QCD.BB.NC.001, 2019.04.24 and Detencion y Disposicion de Equipo No Conforme 30.MNT.BB.SS.008 dated 2019.03.24, which were found to be properly implemented in the facility. Methods to segregate, identify, handle and dispose of product include labeling and position and identification in an ERP system, and were observed to minimizeany inadvertent use. Nonconforming products or equipment is identified, segregated or disposed of, with records maintained by QC supervisor and maintenance SV, respectively. This wasobserved during the audit by a review of the Hold Log "Detenciones y Disposiciones" for items: Candy corn file 3455-4 and scrap, part no. 54HC0060801, production order 936415 "STR REG", lot 190520050. Relevant staff is aware of the site's Hold policy, as evidenced by interviews with warehouse QC technician and maintenance supervisor.

2.4.6 Product Rework Module 2 (Manufacturing)


ResponseEvidence

2.4.6.1

The responsibility and methods outlining how ingredients, packaging materials, or products are reworked shall be documented and implemented. The methods applied shall ensure: i. Reworking operations are supervised by qualified personnel; ii. Reworked product is clearly identified and traceable; iii. Each batchof reworked product is inspected or analyzed as required before release; iv. Inspections and analyses shall conform to the requirements outlined in element 2.5.6; and v. Release of reworked product shall conform to element 2.4.7

Compliant

2.4.6.2 Records of all reworking operations shall be maintained. Compliant

2.4.6 Summary

The site's policy for recouped product documented in Detencion y Disposicion de Producto No Conforme 30.QCD.BB.NC.001, 2019.04.24 has been implemented. Reworked product is clearly identified, traceable, inspected and analyzed before release. Rework operations were observed to be supervised by qualified personnel. Records are maintained for all reworked product.

2.4.6 Product Rework Module 2 (Quality)


2.4.6.1 Procedures shall be documented and implemented to ensure product quality or formulation is not compromised by the rework process. Compliant

2.4.6 Summary

The site's policy for reworked and recouped product has been implemented. Procedures are documented and in place to ensure product quality is not compromised by the site's rework process. These records were reviewed during the audit for hard candy, part no. 54MC060800, production order 936413, dated 2019.05.20 first shift recorded in 60.PRO.BB.TR.009.

2.4.7 Product Release Module 2 (Manufacturing)




Evidence

2.4.7.1

The responsibility and methods for releasing products shall be documented and implemented. The methods applied shall ensure the product is released: i. By authorized personnel; and ii. Once all inspections and analyses are successfully completed and documented to verify legislative and other established food safetycontrols have been met.

Compliant

2.4.7.2 Records of all product release shall be maintained. Compliant

2.4.7 Summary

The site has written procedures Liberacion Positiva 30.QCD.BB.FS.018, 2019.03.14, implemented for releasing finished products. These release procedures include ensuring that all product inspections and metal detector have been verified and documented by authorized personnel to show that all food safety and quality controls have been met. A review of records for product releases of SC Key Lime disks 31 # Bulk "Bitacora de liberacion positive 60.QCD.BB.FS.030 dated 2019.01.31 during the audit showed they had been conducted per procedures.

2.4.7 Product Release Module 2 (Quality)


2.4.7.1

The site shall document and implement a positive product release procedure to ensure that, at the time of delivery to its customer, the food supplied complies with all agreed customer requirements including, but not limited to, product specifications, sensory, packaging and package integrity, labeling, delivery and service requirements.

Compliant

2.4.7.2 Records of all product release shall be maintained. Compliant

2.4.7 Summary

The site has written procedures Liberacion Positiva 30.QCD.BB.FS.018, 2019.03.14, implemented for the positive release of finished products. These positive release procedures include ensuring that all product inspections and analyses have been verified and documented by authorized personnel to show that all quality controls, labeling, weight, sensory analysis, and product specification have been met. A review of records for product releases of SC Key Lime disks 31 # Bulk "Bitacora de liberacion positive 60.QCD.BB.FS.030 dated 2019.01.31 during the audit showed they had been conducted per procedures.

2.4.8 Environmental Monitoring Module 2 (Manufacturing)




2.4.8.1 A risk-based environmental monitoring program shall be in place for all food and pet food manufacturing processes.

Compliant

2.4.8.2 The responsibility and methods for the environmental monitoring program shall be documented and implemented. Compliant

2.4.8.3 An environmental sampling and testing schedule shall be prepared, detailing the applicable pathogens or indicator organisms to test for that industry, the number of samples to be taken and the frequency of sampling.

Compliant

2.4.8.4 Environmental testing results shall be monitored and corrective actions (refer to 2.5.3.1) implemented where unsatisfactory trends are observed. Compliant

2.4.8 Summary

The site has implemented a risk based environmental monitoring program. The sampling and testing program include E. coli and Salmonella spp. The results of the environmental analyzes are reviewed by the Quality Manager, the results show no deviations nor the presence of pathogens in the operations and sampling sites of the plant. In case of a positive sampling of pathogens the plant has developed a plan of corrective actions, and containment actions.

2.5.1 Validation and Effectiveness Module 2 (Quality)


2.5.1.1 Validation activities shall include those necessary to authenticate critical quality limits, process controls, and other quality tests established to meet customer requirements.

Compliant

2.5.1.2 Records of validation of quality criteria shall be maintained. Compliant

2.5.1 Summary

The site has written validation activities that authenticate critical quality limits, process controls, and other quality tests to ensure customer requirements are met. These methods are in Monitoring and verification activities 60.QCD.BB.FS.039 and were found to ensure that each has been implemented effectively. Methods to ensure that procedure or process changes are still effective in controlling quality requirements are in place. PCQ1 validation is based in the analysis of customer complaints trends and PCQ2 validation is based in the customer complaints trends and sampling programs for hard candy. Critical quality limits are re-validated at least annually by the QC manager. Records of all verifications of effectiveness and validations such as PCQ 1 low weight and PCQ 2 broken product dated 2019.01.25 are maintained by the SQF Practitioner.

2.5.1 Validation and Effectiveness Module 2 (Manufacturing)


2.5.1.1 The methods, responsibility and criteria for ensuring the effectiveness of all applicable elements of the SQF Program shall be documented and implemented.The methods applied shall ensure that: i. Good Manufacturing Practices are

Compliant



confirmed to ensure they achieve the required result; ii. Critical food safety limitsare validated, and re-validated annually; iii. Changes to the processes or procedures are assessed to ensure controls are still effective; and iv. All applicable elements of the SQF Program are implemented and effective.

2.5.1.2 Records of all validation activities shall be maintained. Compliant

2.5.1 Summary

The methods, responsibilities and criteria for ensuring the effectiveness of Good Manufacturing Practices, critical food safety limits and all other applicable elements of the SQF System have been documented and implemented. These methods are for CCP validation were customer complaints due to metallic foreign matter, challenge test to metal detectors (35) and calibration and maintenance of metal detectors twice a year by a contracted supplier were found to ensure that each has been implemented effectively. Methods to ensure that procedure or process changes are still effective in controlling food safety are in place and documented in Verification schedule, dated 2019. Records of verification of effectiveness of prerequisite programs (BPM, water quality, transportation and delivery, foreign matter, pest management, training and sanitation dated) dated 2019.01.25 were reviewed. Critical food safety limits are re-validated at least annually. Records of all verifications of effectiveness and validations dated 2019.01.25 are maintained by the QC manager/SQF practitioner.

2.5.2 Verification Activities Module 2 (Manufacturing)


2.5.2.1 A verification schedule outlining the verification activities, their frequency of completion and the person responsible for each activity shall be prepared and implemented.

Compliant

2.5.2.2

The methods, responsibility and criteria for verifying monitoring of Good Manufacturing Practices, critical control points and other food safety controls, and the legality of certified products, shall be documented and implemented. The methods applied shall ensure that personnel with responsibility for verifying monitoring activities authorize each verified record.

Compliant

2.5.2.3 Records of the verification of monitoring activities shall be maintained. Minor

(1) Records of cleaning and sanitation and allergen management programs identified as preventive controls have not been verified by the preventive control qualified individual (PCQI). 2) Records of metal detector monitoringdo not include the specific name plant name, as required by FSMA.

2.5.2 Summary

The site has established a Verification schedule, dated 2019.01 and Monitoring and verification activities 60.QCD.BB.FS.039, outlining the verification steps, procedures and responsibilities for each verification activity maintained by the QC manager. The procedures for verifying Good Manufacturing Practices, critical control points, and all SQF requirements include utilizing authorized personnel to verify all monitoring activities. Minor NC – 2.5.2.3 (1) Records of cleaning and sanitation and allergen management programs identified as preventive controls have not been verified by the preventive control qualified individual (PCQI); (2) Records of metal detector monitoring do not include the specific name plant name, as



required by FSMA.

2.5.2 Verification Activities Module 2 (Quality)


ResponseEvidence

2.5.2.1 The verification schedule shall include activities designed to ensure the effectiveness of process controls and quality tests. Compliant

2.5.2.2

The methods, responsibility and criteria for verifying the effectiveness of monitoring critical quality points and other process and quality controls shall be documented and implemented. The methods applied shall ensure that personnel with responsibility for verifying monitoring activities authorize each record.

Compliant

2.5.2.3 Records of the verification of quality activities shall be maintained. Compliant

2.5.2 Summary

The site has established a Verification schedule, dated 2019.01 and Monitoring and verification activities 60.QCD.BB.FS.039, outlining the verification steps, procedures and responsibilities for each verification activity maintained by the QC manager. The procedures for verifying Critical Quality Points, process controls, and other quality tests include utilizing authorized personnel to verify all monitoring activities. Records of verification of monitoring activities including Quality-related verification activities were found to include comparison of process control limits (+/- 3σ) with specification limits to ensure alignment and appropriate process control correction as needed. Packaging weight; starch humidity in mogul 1, 3 and 5; starch temperature in mogul 1, 3 and 5; syrup deposit weight in mogul 1, 3, and 5; syrup brix in mogul 1 and 3; in hard candy syrup temperature in the pre cooker; and flavor and color volume were reviewed and found to meet requirements.

2.5.3 Corrective and Preventative Action Module 2 (Quality)


2.5.3.1 Corrective and preventative action methods shall include the identification of the root cause and resolution of non-compliance of critical quality limits and deviations from quality requirements.

Compliant

2.5.3.2 Verification activities shall include a comparison of process control limits (+/- 3σ) with specification limits to ensure alignment and appropriate process control corrections.

Compliant

2.5.3 Summary

The site's Corrective and Preventative Action program is written in Acciones Preventiva y Correctivas 30.QCD.SB.QC.005, 2019.04.01. It describes the methods and responsibilities for investigating, resolving and managing corrective actions, including the identification of root causes and resolutions to deviations of critical limits and deviation from quality requirements.



Records of investigations and corrective actions were reviewed for deviations of CQP1 broken product larger than 3% on 2019.01.17 and CQP2 low weight below minimum allowable limit on 2019.01.17. These were found to have reviews, investigations, corrective and preventative actions and resolutions documented. Quality-related verification activities were found to include comparison of process control limits (+/- 3σ) with specification limits to ensure alignment and appropriate process control correction as needed.

2.5.3 Corrective and Preventative Action Module 2 (Manufacturing)


Evidence

2.5.3.1

The responsibility and methods outlining how corrections and corrective actions are determined, implemented and verified, including the identification of the root cause and resolution of non-compliance of critical food safety limits, and deviations from food safety requirements, shall be documented and implemented.

Compliant

2.5.3.2 Records of all investigation and resolution of non-conformities including their corrections and corrective action shall be maintained. Compliant

2.5.3 Summary

The site's Corrective and Preventative Action program is written in Acciones Preventiva y Correctivas 30.QCD.SB.QC.005, 2019.04.01. It describes the methods and responsibilities for investigating, resolving and managing corrective actions from deviations of audits, customer complaints, deviations of critical limits. The identification of root causes and resolutions to deviations of critical control limits are documented. Records of investigations and corrective actions were reviewed for metal detector false positive rejections larger than 5% dated 2019.02.15 and metal detector failure to detect a tablet with metal dated 2019.04.21. These were found to have reviews, investigations, corrective and preventative actions and resolutionsdocumented.

2.5.4 Product Sampling, Inspection and Analysis Module 2 (Quality)


2.5.4.1 Processing parameters or in-process measurements shall be established, validated, and verified at a determined frequency to meet all customer requirements.

Compliant

2.5.4.2 On-site laboratories and inspection stations shall be equipped and resourced to enable testing of in-process and finished products to meet customer expectations and meet quality objectives.

Compliant

2.5.4.3

Statistical process control methods shall be used to effectively control and optimize production processes to improve process efficiency and product quality and reduced waste. Control charts shall be in use for control of key processes and have defined upper and lower (process) control limits (+/- 3σ).

Compliant

2.5.4.4 A sensory evaluation program shall be in place to ensure alignment with agreed customer requirements. Sensory evaluation results shall be communicated with Compliant



relevant staff and with customers where appropriate.

2.5.4.5 Records of all quality inspections and analyses, and statistical analyses, shall bemaintained. Compliant

2.5.4 Summary

The site's procedures and criteria for sampling, inspecting and analyzing quality attributes of raw materials, work-in-progress and finished product have been documented and implemented. The program includes sensory evaluations and scheduled verifications of process parameters at suitably equipped locations, to ensure compliance with process specifications. Statistical process control methods are in use to effectively control and optimize production processes that improve process efficiency, product quality and reduce waste. For example. Control charts were reviewed for packaging weight; starch humidity in mogul 1, 3 and 5; starch temperature in mogul 1, 3 and 5; syrup deposit weight in mogul 1, 3, and 5; syrup brix in mogul 1 and 3; in hard candy syrup temperature in the pre cooker; and flavor and color volume and had upper and lower process control limits (+/- 3σ). Product evaluation and testing records of water activity for incoming gelatin and starch; Brix for gummies in "Calidad de proceso en mogul" 60.QCO.BB.IT.084 and "Calidad del desmolde de Mogul" 60.QCD.BB.IT.014 were found to be conducted to ensure customer expectations and specifications were met.

2.5.4 Product Sampling, Inspection and Analysis Module 2 (Manufacturing)


2.5.4.1

The methods, responsibility and criteria for sampling, inspecting and/or analyzingraw materials, finished product and work in progress shall be documented and implemented. The methods applied shall ensure: i. Inspections and analyses are completed at regular intervals as required and to agreed specification and legal requirements; ii. Inspections are conducted to ensure raw materials, work in process and finished products comply with the relevant specification, regulatory requirements and are true to label; and iii. All analyses are conducted to nationally recognized methods or alternative methods which are validated as equivalent to the nationally recognized methods.

Compliant

2.5.4.2 On-site personnel that conduct environmental or product testing shall participate in an applicable proficiency testing program at least annually to ensure accuracy of results.

Compliant

2.5.4.3

Where external laboratories are utilized to conduct input or product analysis, the laboratories shall be accredited to ISO 17025 or an equivalent national standard,and shall be included on the site's contract service specifications register (refer to 2.3.3.1).

Compliant

2.5.4.4 Records of all inspections and analyses shall be maintained. Compliant

2.5.4 Summary

The plant procedures and criteria for sampling, inspecting and analyzing raw materials, work-in-progress and finished product have been documented and implemented. Certificates of Analysis are required for all ingredients in the distribution center of El Paso, TX, where all products are received. From there all raw materials and packaging materials are supplied to the site. Inspections and analyses of WIP and finished products are scheduled at regular intervals to agreed specifications, true to label, and weight requirements. All analyses are conducted



to nationally recognized standards or by an equivalent validated method. Records of inspection of ingredients "Inspeccion de ingredientes" 60.PRO.BD.IT.643 reviewed during the onsite audit; and finished product test for microbiological indicators, S. aureus and lead performed by a third party laboratory accredited by a2LA dated 2019.31.01 were reviewed.

2.5.5 Internal Audits Module 2 (Quality)


Evidence

2.5.5.1 Internal audit plans and methods shall include food quality plans, process controls, quality tests, and other activities implemented to meet finished product specifications and customer requirements.

Compliant

2.5.5.2 Staff conducting the quality internal audits shall be trained and assessed in internal audit procedures and have knowledge and experience in the quality process and process control methods as they relate to the scope of certification.

Compliant

2.5.5 Summary

The site's procedure for scheduling and conducting internal audits to assess the effectiveness of the SQF Quality system has been documented and implemented per document Auditoriasdel Sistema 30.QCD.SB.FS.003, 2019.04.01. The Internal Audit Program is maintained by the SQF practitioner. Process controls, quality plans, quality tests and all applicable SQF Quality Code requirements, are part of the internal audit program. Personnel auditing quality functions, e.g. Senior QC manager, were seen to have knowledge of the quality process and process control methods for the activities audited.

2.5.5 Internal Audits and Inspections Module 2 (Manufacturing)


2.5.5.1

The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted at least annually. The methodsapplied shall ensure: i. All applicable requirements of the SQF Food Safety Codefor Manufacturing are audited as per the SQF audit checklist or similar tool; ii. Correction and corrective action of deficiencies identified during the internal audits are undertaken; iii. Audit results are communicated to relevant management personnel and staff responsible for implementing and verifying corrective actions.

Compliant

2.5.5.2 Staff conducting internal audits shall be trained and competent in internal audit procedures.

Compliant

2.5.5.3

Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing Practices and building/equipment maintenance is compliant to the SQF Food Safety Code for Manufacturing. The site shall: i. Takecorrections or corrective and preventative action; and ii. Maintain records of

Compliant



inspections and any corrective action taken.

2.5.5.4 Where practical staff conducting internal audits shall be independent of the function being audited. Compliant

2.5.5.5 Records of internal audits and inspections and any corrections and corrective action taken as a result of internal audits shall be maintained.

Compliant

2.5.5 Summary

The site's procedure for scheduling and conducting internal audits to assess the effectiveness of the SQF system has been documented and implemented per document Auditorias del Sistema 30.QCD.SB.FS.003, 2019.04.01. The Internal Audit Program is maintained by the SQF Practitioner. Facility and equipment inspections are conducted regularly to ensure Good Manufacturing Practices are followed, which is documented in Auditorias Internas de Buenas Practicas de Manufactura 30.QCD.BB.FS.009, 2019.03.10. All applicable SQF Code requirements, using the SQF checklist are part of the internal audit program. The frequency of the audits is communicated to management. The SQF practitioner is responsible to see that corrective actions are implemented and verified. Personnel conducting audits have been properly trained and where practical, audit areas independent of their function. Records of internalaudits in the facility conducted on 2019.04.30, 2019.05.03, and 2019.05.07 and records of GMP inspections per area dated 2018.07.18, 2018.08.13, 2018.09.26, and 2018.10.17 were sampled and reviewed during the audit.

2.6.1 Product Identification Module 2 (Manufacturing)


2.6.1.1

The methods and responsibility for identifying raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products during all stages of production and storage shall be documented and implemented. The product identification system shall be implemented to ensure:i. Raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products are clearly identified during all stages of receipt, production, storage and dispatch; and ii. Finished product is labeled to the customer specification and/or regulatory requirements.

Compliant

2.6.1.2 Product identification records shall be maintained. Compliant

2.6.1.3

Product start up and changeover procedures during packing shall be documented and implemented to ensure that the correct product is in the correct package and with the correct label, and that the changeover is inspected and approved by an authorized person.

Compliant

2.6.1 Summary

A policy defining how products are identified from receipt through production and shipping has been documented in Identificacion de Producto 30.QCD.BB.QC.011, 2019.03.31. The site's identification system ensures all raw materials, ingredients, packaging materials, work-in-progress, process inputs and finished goods are clearly identified at all stages of their process. Items are marked at receipt by warehouse staff. Product identification records were reviewed during the audit for raw materials, packaging materials, and process aids (Tally Sheets), WIP, rework product and scrap (Identification sheets), and labeling of finished product (individual bags, cases, and pallets) reviewed and demonstrated the products were properly identified throughout the process. Product startup/changeover procedures during packing Procedimiento de Control de Calidad de Empaque 30.QCD.BB.QC.005, 2019.03.09 ensure that



the correct product goes into the correct package with the correct label. A changeover was observed on the plant floor and was approved and signed off by the QC technician person, as reviewed in "Calidad de primera caja y producto terminado" 60.QCD.BB.IT.036.

2.6.1 Product Identification Module 2 (Quality)


Evidence

2.6.1.1 Finished product shall be labeled to the agreed customer, company or corporate requirements. Compliant

2.6.1.2 Product changeover procedures shall include quality attributes required to meet finished product specifications and customer requirements. Compliant

2.6.1 Summary

Instructions defining how finished product are labeled to the agreed customer, company or corporate requirements is found in Mount Franklin Foods share point. Product system for each product and bill of materials are written to include quality attributes required to meet finished product specifications and customer requirements. Product startup/changeover procedures Procedimiento de Control de Calidad de Empaque 30.QCD.BB.QC.005 include those quality attributes required to meet customer requirements as well as finished product specifications.

2.6.2 Product Trace Module 2 (Quality)


2.6.2.1 Finished product shall be traceable forward to the final customer, such as the retailer, distributor, or manufacturer. Compliant

2.6.2.2

All raw materials, ingredients, and packaging materials used in manufacturing a finished product, and processing aids associated with the product, shall be identified with the finished product lot number and traceable back to the supplier (one back).

Compliant

2.6.2 Summary

A policy defines the methods and responsibilities for tracing finished product one step forward to the final customer, such as the retailer, distributor, or manufacturer. This is written in Procedimiento de Recoleccion y Retiro de Producto 30.QCD.SB.QC.007, dated 2018.06.15. All raw materials, ingredients, and packaging materials used in manufacturing a finished product, and processing aids associated with the product, are identified with the lot number and traceable back to the supplier (one step back).

2.6.2 Product Trace Module 2 (Manufacturing)




2.6.2.1

The responsibility and methods used to trace product shall be documented and implemented to ensure: i. Finished product is traceable to the customer (one up) and provides traceability through the process to the manufacturing supplier and date of receipt of raw materials, food contact packaging and materials and other inputs (one back); ii. Traceability is maintained where product is reworked; and iii. The effectiveness of the product trace system shall be reviewed at least annually as part of the product recall and withdrawal review (refer to 2.6.3.3)

Compliant

2.6.2.2 Records of raw and packaging material receipt and use, and finished product dispatch and destination shall be maintained. Compliant

2.6.2 Summary

A policy defines the methods and responsibilities for tracing product to the customer (one up) and from vendors of raw materials and packaging (one back). This is written in Product Traceability Procedure COR-PRC-016, dated 2019.03.08. Rework was observed to be identified to ensure traceability in Produccion de dulce duro LC#1 60.QCD.BB.IT.005, dated 2019.05.21 in which rework was same into same. Three traceability exercises were performed in the past twelve months, two of them carried out as part of the product recall exercise: S8001801 Peppermint Starlight, lot no 30B83133 on 2018.12.07, lasting 89 minutes and 58687107 Gummi Worms, lot no 1990071 on 2019.03.04, lasting 1 hour and 25 minutes. Additionally, the third trace exercise was 58180707J, Mini Gummi Bears, lot no 1691233 on 2019.05.07, lasted 110 minutes and achieved 100% recovery. Records of the receipt, use and dispatch of finished product are maintained.

2.6.3 Product Withdrawal and Recall Module 2 (Quality)


2.6.3.1 The site's recall and withdrawal procedures shall apply to product recalled or withdrawn due to failure to meet customer specifications or corporate quality requirements.

Compliant

2.6.3 Summary

The site's Recall Plan Procedimiento de Recoleccion y Retiro de Producto 30.QCD.SB.QC.007, dated 2018.06.15 includes recall and withdrawal procedures for products recalled or withdrawn from the marketplace due to failure to meet customer specifications or corporate quality requirements.

2.6.3 Product Withdrawal and Recall Module 2 (Manufacturing)


2.6.3.1

The responsibility and methods used to withdraw or recall product shall be documented and implemented. The procedure shall: i. Identify those responsiblefor initiating, managing and investigating a product withdrawal or recall; ii. Describe the management procedures to be implemented including sources of legal, regulatory and expert advice and essential traceability information; and iii.

Compliant



Outline a communication plan to inform customers, consumers, authorities and other essential bodies in a timely manner appropriate to the nature of the incident; iv. SQFI, the certification body, and the appropriate regulatory authority shall be listed as an essential body and notified in instances of a food safety incident of a public nature, or product recall for any reason.

2.6.3.2 Investigation shall be undertaken to determine the root cause of a withdrawal, mock recall or recall and details of investigations and any action taken shall be documented.

Compliant

2.6.3.3 The product withdrawal and recall system shall be reviewed, tested and verified as effective at least annually. Testing shall include incoming materials (one back)and finished product (one up).

Compliant

2.6.3.4 SQFI and the certification body shall be notified in writing within twenty-four (24) hours upon identification of a food safety event that requires public notification. SQFI shall be notified at [email protected].

Compliant

2.6.3.5 Records of all product withdrawals, recalls and mock recalls shall be maintained. Compliant

2.6.3 Summary

The site has a Recall Plan documented in Product Recall Procedure COR-PRC-015, 2019.03.08 defining the methods and responsibilities for withdrawing and recalling product if necessary. A recall team has been designated and is led by the corporate quality VP. The withdrawal policy includes the requirement to investigate a recall and determine the root cause ofa recall/withdrawal with a corrective action. It also includes a communication plan to notify customers, consumers, regulatory authorities and other essential bodies. This includes SQFI andNSF, the Certification Body, who must be notified within 24 hours in writing of any food safety event requiring public notification. Investigation into the root cause of any product recall, mock recall or product withdrawal, with actions taken, was observed to be documented. Mock trace exercises are completed annually, one step forward and one step back, to verify the effectiveness of the system. Records were reviewed of the recall plan and summaries of the trace exercises performed for S8001801 Peppermint Starlight, lot no 30B83133 on 2018.12.07and 58687107 Gummi Worms, lot no 1990071 on 2019.03.04. The mock trace exercise records reviewed showed the Product Withdrawal and Recall procedures were tested back one step and forward one step with acceptable accountability.

2.7.1 Food Defense Plan Module 2 (Manufacturing)


2.7.1.1 The methods, responsibility and criteria for preventing food adulteration caused by a deliberate act of sabotage or terrorist-like incident shall be documented, implemented and maintained.

Compliant

2.7.1.2

A food defense plan shall include: i. The name of the senior site management person responsible for food defense; ii. The methods implemented to ensure only authorized personnel have access to production equipment and vehicles, manufacturing and storage areas through designated access points; iii. The methods implemented to protect sensitive processing points from intentional adulteration; iv. The measures taken to ensure the secure receipt and storage of

Compliant



raw materials, packaging, equipment and hazardous chemicals; v. The measures implemented to ensure raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products are held under secure storage and transportation conditions; and vi. The methods implemented to record and control access to the premises by employees, contractors, and visitors.

2.7.1.3 The food defense plan shall be reviewed and challenged at least annually. Compliant

2.7.1.4 Records of reviews of the food defense plan shall be maintained. Compliant

2.7.1 Summary

The site has a Food Defense Policy documented in Programa de Defensa de los Alimentos 30.ADM.BB.FD.001, 2019.02.23 and Programa de Auditorias e Inspecciones Internas de Defensa de los Alimentos 30.ADM.BB.FD.002, 2019.02.23, in which the procedures, responsibilities and criteria for preventing deliberate food adulteration have been documented and implemented. A food defense protocol includes the name of the senior manager responsible for food defense (the plant manager), methods to allow access to the site only for authorized personnel, designated access points, the secured storage of materials and hazardous chemicals and the control of access to contractors and visitors. The Food Defense Plan was audited on 2019.04.19 by the QC manager of the Sunrise Planta Oeste. The program was tested and challenged on 2019.04.30 with the input of an unauthorized package in the shipping area with records reviewed.

2.7.1 Food Fraud Vulnerability Assessment Module 2 (Quality)


2.7.1.1 The food fraud vulnerability assessment shall include the site's susceptibility to ingredient or product substitution, mislabeling, dilution and counterfeiting that could adversely impact food quality.

Compliant

2.7.1.2 A food fraud mitigation plan shall be developed and implemented which specifiesthe methods by which the identified food fraud vulnerabilities that could adversely impact food quality shall be controlled.

Compliant

2.7.1 Summary

The site has conducted a Food Fraud Vulnerability Assessment, found in document CORP-PRC-004 which includes the site's susceptibility to fraudulent economic gain, including product substitution, mislabeling, counterfeiting and dilution that could impact product quality. The site has developed a Food Fraud Mitigation Plan for honey, based on purchase of honey from Mexican suppliers and the turmeric color based on all requirements of the supplier approval program to address the control of the identified food fraud vulnerabilities to product quality.

2.7.2 Food Fraud Module 2 (Manufacturing)


Evidence



2.7.2.1

The methods, responsibility and criteria for identifying the site's vulnerability to food fraud shall be documented, implemented and maintained. The food fraud vulnerability assessment shall include the site's susceptibility to product substitution, mislabeling, dilution, counterfeiting or stolen goods which may adversely impact food safety.

Compliant

2.7.2.2 A food fraud mitigation plan shall be developed and implemented which specifiesthe methods by which the identified food fraud vulnerabilities shall be controlled. Compliant

2.7.2.3 The food fraud vulnerability assessment and mitigation plan shall be reviewed and verified at least annually. Compliant

2.7.2.4 Records of reviews of the food fraud vulnerability assessment and mitigation plan shall be maintained. Compliant

2.7.2 Summary

Part of this requirement was audited during the Corporate audit. The site has conducted a Food Fraud Vulnerability Assessment, found in document CORP-PRC-004 which includes the site's susceptibility to fraudulent economic gain, including product substitution, mislabeling, counterfeiting and dilution that could impact food safety. The site has developed a Food Fraud Mitigation Plan documented in CORP-PRC-004 to address the control of the identified food fraud vulnerabilities. The person in charge of the program is the corporate supplier engineer. A team has been structured where the purchasing managers, the QA manager and the QA supervisor are included. There is a list of ingredients where a level of risk has been established according to its vulnerability to fraud. The honey color and turmeric color used by Sunrise Planta Norte have a high-risk level. The Planta Norte Vulnerability Assessment the Mitigation Plan was last reviewed on 2019.05.15. The reviews of the Vulnerability Assessment and the Mitigation Plan are on file in corporate quality supplier engineer.

2.8.1 General Requirements for Identity Preserved Foods Module 2 (Quality)


2.8.1.1

The methods and responsibility for the identification and processing of food and other products requiring the preservation of their identity preserved status (e.g. Kosher, HALAL, organic, GMO-free, regional provenance, free from, free trade etc.) shall be documented and implemented.

Compliant

2.8.1.2 Identification shall include a statement of the product's identity preserved status of all ingredients, including additives, preservatives, processing aids and flavorings.

Compliant

2.8.1.3 Raw material and ingredient specifications to identity preserved foods shall include requirements for their handling, transport, storage and delivery prior to use.

Compliant

2.8.1.4 Assurances concerning the raw material or ingredient's identity preserved status shall be by agreement with the supplier of the material. Compliant

2.8.1.5 The process description shall allow for a product's identity preserved status to bemaintained during manufacturing. Compliant

2.8.1.6 The processing of identity preserved foods shall be conducted under controlled conditions such that: i. Ingredients are physically separated from ingredients Compliant



identified as incompatible with the identity preserved food; ii. Processing is completed in separate rooms; or scheduled as the first production run; or carried out after the completion of a thorough sanitation of the area and equipment; andiii. Finished product is stored and transported in separate units or isolated by a physical barrier from non- specialty product.

2.8.1.7 The identity preserved status shall be declared in accordance with legal requirements. Compliant

2.8.1.8 Additional customer-specific requirements concerning identity preserved foods shall be included in the finished product specification described in 2.3.5, or label register, and implemented by the site.

Compliant

2.8.1 Summary

The site's policy for the identification and processing of products requiring preservation of their status is included in the Programa de Control de Alimentos de Identidad Preservada 30.QCD.BB.FS.022, 2019.03.30. Identity Preserved Foods produced by this site include: Kosher preserved and Organic preserved. The Kosher preserved identity covers all products manufactured in the facility, except product containing gelatin and grape juice (gummies). Organic preserved identity covers organic candy corn manufactured in Mogul 3 and packed on Packaging B. Process observed during the audit showed that procedures adequately address the status of all ingredients, preservatives, processing aids and flavorings; that specifications include handling, transport, storage and delivery of inputs prior to use, and agreements with the suppliers of relevant input materials. Processing controls implemented included: •Physicalseparation from incompatible materials during storage •Processing in separate locations •Scheduling and cleaning controls to prevent cross contamination of materials •Implementation of customer specific requirements Orthodox Union certificate issued on 2019.05.23 and valid thorough 2010.05.31 and the USDA Organic issued on 2019.05.16 valid through 2010.03.31 were on file.

2.8.1 Allergen Management for Food Manufacturing Module 2 (Manufacturing)


2.8.1.1

The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented.The allergen management program shall include: i. A risk analysis of those raw materials, ingredients and processing aids, including food grade lubricants, that contain food allergens; ii. An assessment of workplace-related food allergens from locker rooms, vending machines, lunch rooms, visitors; iii. A register of allergens which is applicable in the country of manufacture and the country (ies) of destination if known; iv. A list of allergens which is accessible by relevant staff.v. The hazards associated with allergens and their control incorporated into the food safety plan. vi. A management plan for control of identified allergens. The allergen management program shall include the identification, management, andlabelling of products containing gluten, where applicable.

Compliant

2.8.1.10 Re-working of product containing food allergens shall be conducted under conditions that ensure product safety and integrity is maintained. Re-worked product containing allergens shall be clearly identified and traceable.

Compliant



2.8.1.11

Sites that do not handle allergenic materials or produce allergenic products shall document, implement and maintain an allergen management program addressing at a minimum the mitigation of introducing unintended allergens through supplier, contract manufacturer, employee and visitor activities.

Compliant

2.8.1.2 Instructions shall be provided to all relevant staff involved in the receipt or handling of raw materials, work-in progress, rework or finished product on how toidentify, handle, store and segregate raw materials containing allergens.

Compliant

2.8.1.3 Provision shall be made to clearly identify and segregate foods that contain allergens. Segregation procedures shall be implemented and continually monitored.

Compliant

2.8.1.4

Where allergenic material may be intentionally or unintentionally present, cleaning and sanitation of product contact surfaces between line changeovers shall be effective, appropriate to the risk and legal requirements, and sufficient toremove all potential target allergens from product contact surfaces, including aerosols as appropriate, to prevent cross contact. Separate handling and production equipment shall be provided where satisfactory line hygiene and clean-up or segregation is not possible.

Compliant

2.8.1.5 Based on risk assessment, procedures for validation and verification of the effectiveness of the cleaning and sanitation of areas and equipment in which allergens are used shall be effectively implemented.

Compliant

2.8.1.6 Where allergenic material may be present, product changeover procedures shall be documented and implemented to eliminate the risk of cross-contact. Compliant

2.8.1.7

The product identification system shall make provision for clear identification andlabeling in accordance with regulatory requirements of those products produced on production lines and equipment on which foods containing allergens were manufactured.

Compliant

2.8.1.8

The site shall document and implement methods to control the accuracy of finished product labels (or consumer information where applicable) and assure work in progress and finished product is true to label with regard to allergens. Such measures may include label approvals at receipt, label reconciliations during production, destruction of obsolete labels and verification of labels on finished product as appropriate and product change over procedures.

Compliant

2.8.1.9 The product trace system shall take into consideration the conditions under which allergen containing foods are manufactured and ensure full trace back of all ingredients and processing aids used.

Compliant

2.8.1 Summary

The site's Allergen Management Policy to control allergens and prevent contamination of other products has been documented and implemented. It is found in document Gestion de Alergenos 30.QCD.BB.FS.003, 2019.01.08 and is the responsibility of quality, production, warehouse, training and all staff. Allergens of concern in this operation were observed to be soyprotein and egg white. The site awarded a GFCO (gluten free) certificate based on an audit performed on 2018.06.25. The hazard analysis in the food safety plan includes the hazards



associated with allergens. The list of allergens ingredients 60.QCD.BB.FS.026 and allergenic finished products 60.QCD.BB.FS.028 are accessible by relevant staff and instructions to staffinvolved in the receipt or handling of raw materials, WIP, rework or finished product on how to identify, handle, store and segregate products containing allergens are provided by QC manager. Allergenic products in storage were observed during the audit to be properly labeled and stored separately to prevent cross- contact. Procedures for cleaning of food contact surfaces are documented including regular verification of cleaning methods by protein test and validation of cleaning methods by protein-specific testing after the weekly deep cleaning where allergenic materials have been involved. Procedure for Mogul 1 and 3 Sanitizacion 30.SAN.BB.FS.005 and 30.SAN.BB.FS.003, respectively were reviewed. Product changeover procedures are documented and implemented in line mogul 1 and mogul 3, where products with soy and egg allergenic material are processed. Records of preoperational inspection of Mogul 3 60.QCD.BB.FS.0018 dated 2019.05.20 were reviewed. The operation was found to have a product identification system that includes clear identification of product produced on production lines and which equipment was used with allergens. Procedure to control the accuracy of finished product labels at receipt is documented Procedimiento de Aprobacion de Etiqueta y Film 30.QCD.SB.QC.001, 2019.05.29 and Procedimiento de Control de Calidad de Almacen 30.QCD.BB.QC.006, 2019.03.06. The procedure to assure work in progress and finished product is true to label with regards to allergens is documented in Procedimiento de Control de Calidad de Empaque 30.QCD.BB.QC.005, 2019.03.09. The procedure is implemented through visual inspection on the first product manufactured. The product trace system ensures the complete trace of allergen ingredients including any recouping… containing allergens. The allergen management program addresses mitigation measures to prevent the unintended introduction of allergens.

2.8.2 Allergen Management for Pet Food Manufacturing Module 2 (Manufacturing)


2.8.2.1

The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented.The allergen management program shall include: i. A risk analysis of those inputs and processing aids, including food grade lubricants, that contain food allergens; ii. An assessment of workplace-related food allergens from locker rooms, vending machines, lunch rooms, visitors; iii. A list of allergens which is accessible by relevant staff. iv. The hazards associated with allergens and their control incorporated into the food safety plan.

N/A The site does not manufacture any pet food product.

2.8.2.2 Product labeling, in accordance with regulatory requirements, shall include allergens where risks from cross contact have been identified. N/A The site does not manufacture any pet food product.

2.8.2 Summary

The site does not manufacture any pet food product.

2.8.3 Allergen Management for Manufacturers of Animal Feed Module 2 (Manufacturing)


2.8.3.1 Sites that exclusively manufacture animal feed and do not manufacture, handle or store food or pet food products are not required to implement an allergen management plan unless required by regulation or customer requirement.

N/A The site does not manufacture animal feed.



2.8.3.2 Where an allergen management plan is required by regulation or customer specification, the requirements of 2.8.2 shall apply.

N/A The site does not manufacture animal feed.

2.8.3 Summary

The site does not manufacture animal feed.

2.9.1 Training Requirements Module 2 (Quality)


ResponseEvidence

2.9.1.1 Appropriate training shall be provided for personnel carrying out the tasks criticalto the effective implementation of the SQF Quality System and the maintenance and improvement of quality requirements.

Compliant

2.9.1 Summary

Appropriate training is provided for all plant personnel for all tasks to ensure the effective implementation of the SQF Quality system and the maintenance and improvement of quality requirements. This training program is administered by the human resources manager.

2.9.1 Training Requirements Module 2 (Manufacturing)


2.9.1.1

The responsibility for establishing and implementing the training needs of the organization's personnel to ensure they have the required competencies to carryout those functions affecting products, legality, and safety shall be defined and documented.

Compliant

2.9.1.2 Appropriate training shall be provided for personnel carrying out the tasks essential to the effective implementation of the SQF System and the maintenance of food safety and regulatory requirements.

Compliant

2.9.1 Summary

Appropriate training is provided for all plant personnel for all tasks to ensure the effective implementation of the SQF system and the maintenance and improvement of quality requirements. This training program is administered by the human resources manager. The effectiveness of the facility's training program was evidenced by interviews with plant employees cooker of hard candy, QC technicians, packaging supervisors, variations supervisor, cooker assistant, color and flavor cooker, storage supervisor, shipper clerk, and guard, among others.

2.9.2 Training Program Module 2 (Quality)




Evidence

2.9.2.1

The employee training program shall include the necessary competencies for specific duties and the training methods to be applied for those staff carrying out tasks associated with: i. Process control and monitoring of critical quality points (CQPs); ii. Steps identified as critical to effective implementation of the food quality plan and the maintenance of food quality, and iii. Product inspection and testing.

Compliant

2.9.2.2 The employee training program shall include applicable statistical process control training for line operators, quality inspectors and supervisory staff responsible for operating and inspecting key manufacturing processes.

Compliant

2.9.2.3 The training program shall include training, calibration and proficiency testing of internal laboratory personnel. Compliant

2.9.2 Summary

The site has implemented a training program, entitled 2019 Programa Annual de Entrenamiento, which covers competencies including Quality, SPC control graphs, and HACCP/SQF identified as critical to effective implementation and maintenance of the food quality plan and product inspection and testing.

2.9.2 Training Program Module 2 (Manufacturing)


2.9.2.1

An employee training program shall be documented and implemented. It shall outline the necessary competencies for specific duties and the training methods to be applied for those staff carrying out tasks associated with: i. Developing andapplying Good Manufacturing Practices; ii. Applying food regulatory requirements; iii. Steps identified by the hazard analysis and/or other instructionsas critical to effective implementation of the food safety plan and the maintenance of food safety; and iv. Tasks identified as critical to meeting the effective implementation and maintenance of the SQF System.

Compliant

2.9.2 Summary

Appropriate training is provided for all plant personnel for all tasks to ensure the effective implementation of the SQF system and the maintenance and improvement of quality requirements. This training program is administered by the human resources manager. The effectiveness of the facility's training program was evidenced by interviews with plant employees cooker of hard candy, QC technicians, packaging supervisors, variations supervisor, cooker assistant, color and flavor cooker, storage supervisor, shipper clerk, and guard, among others.

2.9.3 Quality Instructions Module 2 (Quality)




Evidence

2.9.3.1 Instructions shall be available explaining how all tasks critical to meeting customer specifications, and quality and process efficiency are to be performed. Compliant

2.9.3 Summary

Work instructions have been written explaining how tasks critical to meeting customer specifications, and how quality and process efficiency are to be performed.

2.9.3 Instructions Module 2 (Manufacturing)


Evidence

2.9.3.1 Instructions shall be available in the languages relevant to the staff, explaining how all tasks critical to meeting regulatory compliance, the maintenance of food safety and process efficiency are to be performed.

Compliant

2.9.3 Summary

Work instructions have been written explaining how tasks critical to maintaining food safety are performed.

2.9.4 HACCP for Quality Training Requirements Module 2 (Quality)


2.9.4.1 Training in the application of HACCP principles for the identification and control of quality threats shall be provided to staff involved in development and maintenance of the food quality plan.

Compliant

2.9.4 Summary

Training in the application of HACCP principles for the identification and control of quality threats has been conducted for Quality Team Members who develop and maintain the food quality plan. The last training in applying HACCP principles to food quality occurred on 2019.05.10, where the instructor was the SQF practitioner.

2.9.4 HACCP Training Requirements Module 2 (Manufacturing)




2.9.4.1 HACCP training shall be provided for staff involved in developing and maintaining food safety plans.

Compliant

2.9.4 Summary

HACCP training for personnel involved in the development and maintaining the food safety plan is administered. The last training was received from AIB International training, HACCP II: Validation and Verification, that was provided on 2018.10.02-04 and the FSPC Preventive Controls for Human Foods training was provided to the SQF practitioner on 2017.05.09 – 11.

2.9.5 Language Module 2 (Manufacturing)


Evidence

2.9.5.1 Training materials and the delivery of training shall be provided in language understood by staff. Compliant

2.9.5 Summary

The training language and materials are in Spanish (and English for specific external training provided to QC manager) used in the operation and understood by all plant personnel.

2.9.5 Language Module 2 (Quality)


2.9.5.1 Training materials and the delivery of training shall be provided in language understood by staff. Compliant

2.9.5 Summary

The training language and materials are in Spanish used in the operation and understood by all plant personnel.

2.9.6 Refresher Training Module 2 (Quality)


2.9.6.1 The training program shall include provision for identifying and implementing the refresher training needs of site personnel Compliant

2.9.6 Summary



Periodic refresher training needs have been identified and implemented for site personnel in the Training Program. Interviews with quality technicians in hard candy, moguls and packagingareas, showed that proper refresher training has been conducted to ensure food quality requirements are met.

2.9.6 Refresher Training Module 2 (Manufacturing)


Evidence

2.9.6.1 The training program shall include provision for identifying and implementing the refresher training needs of the organization. Compliant

2.9.6 Summary

Periodic refresher training needs have been identified in the Training Program. From a review of refresher training records covering cleaning and disinfection dated 2018.06.06, GMP dated 2019.01.15, pest control dated 2019.02.25, HACC/SQF dated 2019.05.06, Quality dated 2019.05.10, Glass and blood control dated 2019.04.03, Allergen control dated 2019.04.03, CTPAT and Food defense dated 2019.02.27 and interviews with floor cooker of section 3A and 3B, quality technicians – metal detector monitor, security guard, and maintenance, it was evident the proper refresher training has been conducted to ensure food safety is maintained.

2.9.7 Training Skills Register Module 2 (Manufacturing)


2.9.7.1

A training skills register describing who has been trained in relevant skills shall be maintained. The register shall indicate the: i. Participant name; ii. Skills description; iii. Description of the training provided; iv. Date training completed; v.Trainer or training provider; and vi. Supervisor's verification that the training was completed and that the trainee is competent to complete the required tasks.

Compliant

2.9.7 Summary

A training skills register (Matrix de entrenamiento) is maintained by the Trainer Supervisor and during the review was found to have a listing of the trainee, trainer, the description of the training, the date of training and verification by supervision that the training was completed. The site verifies the effectiveness of training by quizzes before and after training. Plant employees interviewed on the production floor cooker of section 3A and 3B, quality technicians – metal detector monitor, security guard, and maintenance staff were found to have current training records on the register.

2.9.7 Training Skills Register Module 2 (Quality)


2.9.7.1 A training skills register describing who has been trained in relevant skills shall be maintained. The register shall indicate the: i. Participant name; ii. Skills Compliant



description; iii. Description of the training provided; iv. Date training completed;v. Trainer or training provider; and vi. Supervisor's verification the training was completed and that the trainee is competent to complete the required tasks.

2.9.7 Summary

A training skills register is maintained by the Trainer Supervisor and included the quality training conducted. The register was found to have a listing of the trainee, trainer, the description of the training, the date of training and verification by supervision that the training was completed. The site verifies the effectiveness of training by quizzes before and after training. Plant employees who had been interviewed on the production floor, quality technicians were found to have current quality training records on the register.

11.1.1 Premises Location and Approval Module 11


Response Evidence

11.1.1.1 The location of the premises shall be such that adjacent and adjoining buildings, operations and land use do not interfere with safe and hygienic operations. Compliant

11.1.1.2 The construction and ongoing operation of the premises on the site shall be approved by the relevant authority. Compliant

11.1.1 Summary

The supplier's buildings, property and surroundings do not pose a risk to food safety. The supplier maintains the required approvals by relevant authorities, as evidenced by FDA establishment registration number XXXXXXX80074, COFEPRIS operation notice issued 2018.05.22 and Juarez Municipality operation Permit 18674, valid through 2019.12.18, for their ongoing operations.

11.2.1 Materials and Surfaces Module 11


11.2.1.1

Product contact surfaces and those surfaces not in direct contact with food in food handling areas, raw material storage, packaging material storage, and cold storage areas shall be constructed of materials that will not contribute a food safety risk.

Compliant

11.2.1 Summary

Product contact surfaces, surfaces not in contact with food and storage areas are constructed of suitable materials including stainless steel, food grade plastics, coper, and galvanized steel. They were observed during the audit to be properly maintained so that food safety is not compromised.

11.2.2 Floors, Drains, and Waste Traps Module 11




Evidence

11.2.2.1 Floors shall be constructed of smooth, dense impact resistant material that can be effectively graded, drained, impervious to liquid and easily cleaned. Minor

Some spots on the floors of curing rooms #4 and #5 were observed with aggregate exposed.

11.2.2.2 Floors shall be sloped to floor drains at gradients suitable to allow the effective removal of all overflow or waste water under normal working conditions. Compliant

11.2.2.3 Drains shall be constructed and located so they can be easily cleaned and not present a hazard. Compliant

11.2.2.4 Waste trap system shall be located away from any food handling area or entrance to the premises. Compliant

11.2.2 Summary

Floors are constructed of smooth and dense impact resistant concrete, properly graded for effective drainage of overflow or waste water. Minor NC – 11.2.2.1 Some spots on the floors of ripening rooms #4 and #5 were observed with aggregate exposed. Waste water during the audit was observed to be properly discharged. Water that is discharged from the preparation operation was regularly removed to the drainage by operators between batch preparation. Drains were observed to be located and constructed for ease of cleaning and inspection. Waste traps systems are located indoors in food handling areas. Procedures designed to minimize environment contamination Limpieza de Drenajes 30.SAN.BB.FS.032, updated on 2019.02.19 are implemented. Records of drain cleaning and sanitation "Limpieza de coladeras (drenajes) 60.SAN.BB.FS.043 dated 2019.05.06 to 2019.05.12 were reviewed.

11.2.3 Walls, Partitions, Floors and Ceilings Module 11


11.2.3.1 Walls, partitions, ceilings and doors shall be of durable construction. Internal surfaces shall be smooth and impervious with a light-colored finish, and shall be kept clean (refer to 11.2.13.1).

Compliant

11.2.3.2 Wall to wall and wall to floor junctions shall be designed to be easily cleaned andsealed to prevent the accumulation of food debris. Compliant

11.2.3.3 Ducting, conduit and pipes that convey services such as steam or water shall be designed and constructed to prevent the contamination of food, ingredients and food contact surfaces and allow ease of cleaning.

Compliant

11.2.3.4

Pipes carrying sanitary waste or waste water that are located directly over product lines or storage areas shall be designed and constructed to prevent the contamination of food, materials, ingredients and food contact surfaces, and shall allow ease of cleaning.

N/AThere are no pipes carrying sanitary waste or waste waterlocated directly over product lines or storage areas.

11.2.3.5

Doors, hatches and windows and their frames in food processing, handing or storage areas shall be of a material and construction which meets the same functional requirements as for internal walls and partitions. Doors and hatches shall be of solid construction and windows shall be made of shatterproof glass or

Compliant



similar material.

11.2.3.6 Product shall be processed and handled in areas that are fitted with a ceiling or other acceptable structure that is constructed and maintained to prevent the contamination of products.

Compliant

11.2.3.7 Drop ceilings shall be constructed to enable monitoring for pest activity, facilitate cleaning and provide access to utilities.

Compliant

11.2.3 Summary

Walls, ceilings and doors are of durable construction with smooth and light-colored surfaces and were observed to be clean during the audit tours. Wall to wall and wall to floor junctures were observed to be sealed and free of debris. Ducting, piping and conduit conveying services were observed to be installed for ease of cleaning. Overhead cleaning was found to be part of the master cleaning schedule. Doors, windows and frames were observed to be properly constructed of materials with the same functional requirements as internal walls and partitions.The ceilings in all food processing and handling areas are constructed of metal insulated panel, which are easily cleaned and prevent product contamination. Drop ceilings were observed to allow for cleaning and inspection. There are no pipes carrying sanitary waste or waste water located directly over product lines or storage areas.

11.2.4 Stairs, Catwalks and Platforms Module 11


11.2.4.1

Stairs, catwalks and platforms in food processing and handling areas shall be designed and constructed so as not to present a product contamination risk, and with no open grates directly above exposed food product surfaces. They shall be kept clean (refer to 11.2.13.1).

Compliant

11.2.4 Summary

Stairs, catwalks and platforms were observed during facility tours to be constructed and designed so that food contamination is avoided.

11.2.5 Lightings and Light Fittings Module 11


11.2.5.1 Lighting in food processing and handling areas and at inspection stations shall be of appropriate intensity to enable the staff to carry out their tasks efficiently and effectively.

Compliant

11.2.5.2

Light fittings in processing areas, inspection stations, ingredient and packaging storage areas, and all areas where the product is exposed shall be shatterproof, manufactured with a shatterproof covering or fitted with protective covers and recessed into or fitted flush with the ceiling. Where fittings cannot be recessed, structures must be protected from accidental breakage, manufactured from

Compliant



cleanable materials and addressed in the cleaning and sanitation program.

11.2.5.3 Light fittings in warehouses and other areas where the product is protected shall be designed such as to prevent breakage and product contamination. Compliant

11.2.5 Summary

Lighting was of the appropriate intensity for employees to carry out their tasks efficiently. All lighting is either covered or is shatter-proof. There is a glass and brittle plastic register for eacharea of the facility included in Inspeccion de vidrio y plastico quebradizo. Monthly audits are completed for each area and all lighting in warehouses is protected and included in the glass and brittle plastic inspections. The most recent glass and brittle plastic inspection was conducted on 2019.05 by QC technicians.

11.2.6 Inspection / Quality Control Area Module 11


Response Evidence

11.2.6.1 A suitable area shall be provided for the inspection of the product if required. Compliant

11.2.6.2

The inspection/quality control area shall be provided with facilities that are suitable for examination and testing of the type of product being handled/processed. The inspection area shall: i. Have easy access to hand washing facilities; ii. Have appropriate waste handling and removal; and iii. Be kept clean to prevent product contamination.

Compliant

11.2.6 Summary

Areas within processing are provided and suitable for product inspections. There are appropriate hand washing facilities, waste handling and removal and the areas were observed to be well lit and clean.

11.2.7 Dust, Insect, and Pest Proofing Module 11


11.2.7.1 All external windows, ventilation openings, doors and other openings shall be effectively sealed when closed and proofed against dust, vermin and other pests. Minor

External door 1D was observed not effectively sealed when closed, leaving a space of less than 1 cm along the door.

11.2.7.2 External personnel access doors shall be provided. They shall be effectively insect-proofed and fitted with a self-closing device and proper seals to protect against ingress of dust, vermin and other pests.

Compliant

11.2.7.3

External doors, including overhead dock doors in food handling areas used for product, pedestrian or truck access shall be insect-proofed by at least one or a combination of the following methods: i. A self-closing device; ii. An effective air curtain; iii. An insect-proof screen; iv. An insect-proof annex; v. Adequate sealing

Compliant



around trucks in docking areas.

11.2.7.4

Electric insect control devices, pheromone or other traps and baits shall be located so as not to present a contamination risk to the product, packaging, containers or processing equipment. Poison rodenticide bait shall not be used inside ingredient or product storage areas or processing areas.

Compliant

11.2.7 Summary

Windows, doors and other openings are sealed to prevent any pest infestation or dust coming into the facility. External personnel access doors are self-closing and sealed to protect against any pest or dust ingress. External doors and dock doors were sealed to prevent infestation, except external door 1D. Electric insect devices, interior and exterior rodent stations are located so product is not at risk for contamination. Bait is only used on the outside of the facility. NC – 11.2.7.1 External door 1D was observed not effectively sealed when closed, leaving a space of less than 1 cm along the door.

11.2.8 Ventilation Module 11


11.2.8.1 Adequate ventilation shall be provided in enclosed processing and food handlingareas.

Compliant

11.2.8.2 All ventilation equipment and devices in product storage and handling areas shall be adequately cleaned as per 11.2.12, to prevent unsanitary conditions. Compliant

11.2.8.3

Extractor fans and canopies shall be provided in areas where cooking operationsare carried out or a large amount of steam is generated and shall have the following features: i. Capture velocities shall be sufficient to prevent condensation build up and to evacuate all heat, fumes and other aerosols to the exterior via an exhaust hood positioned over the cooker(s); ii. Fans and exhaust vents shall be insect-proofed and located so as not to pose a contamination risk; and iii. Where appropriate, positive air-pressure system shall be installed to prevent airborne contamination.

Compliant

11.2.8 Summary

Adequate ventilation was observed in enclosed processing and food handling areas to prevent condensation. All ventilation equipment and devices are adequately cleaned. Air ventilation and heat extraction were observed to be adequate above processing areas with cookers and heating operations and no condensation was noted.

11.2.9 Equipment, Utensils, and Protective Clothing Module 11


11.2.9.1 Specifications for equipment, utensils and protective clothing, and procedures forpurchasing equipment shall be documented and implemented. Compliant



11.2.9.2 Equipment and utensils shall be designed, constructed, installed, operated and maintained to meet any applicable regulatory requirements and not to pose a contamination threat to products.

Compliant

11.2.9.3

Benches, tables, conveyors, mixers, mincers, graders and other mechanical processing equipment shall be hygienically designed and located for appropriate cleaning. Equipment surfaces shall be smooth, impervious and free from cracks or crevices.

Compliant

11.2.9.4

Product containers, tubs, bins for edible and inedible material shall be constructed of materials that are non-toxic, smooth, impervious and readily cleaned as per 11.2.13. Bins used for inedible material shall be clearly identified.

Compliant

11.2.9.5 Waste and overflow water from tubs, tanks and other equipment shall be discharged direct to the floor drainage system, and to meet local regulatory requirements.

MinorWater spill from the "mazeta" preparation tank was observed on the floor of the Mogul III kitchen platform dueto a defective pipe connection.

11.2.9.6 Protective clothing shall be manufactured from material that will not contaminate food and is easily cleaned.

Compliant

11.2.9.7 Racks shall be provided for the temporary storage of protective clothing when staff leaves the processing area and shall be provided in close proximity or adjacent to the personnel access doorways and hand washing facilities.

Compliant

11.2.9.8 All equipment, utensils and protective clothing shall be cleaned after use or at a frequency to control contamination, and stored in a clean and serviceable condition to prevent microbiological or cross-contact allergen contamination.

Compliant

11.2.9 Summary

Specifications for equipment, utensils and building are documented in Sanitary Design Procedure 30.ENG.SW.SS.001, 2018.08.02 and implemented. Equipment and utensils are designed, constructed, installed, operated and maintained so they meet the applicable regulatory requirements and there is no contamination threat to product. Guia para Diseno Sanitario provided to purchase department on 2019.01 was reviewed. Mechanical processing equipment are hygienically designed and located for appropriate cleaning. Equipment surfaces were observed to be smooth, impervious and free from cracks and crevices. Containers and bins are made of non-toxic materials and were labeled or color-coded, as edible or non-edible and ready cleaned. Waste water from tanks, tubs and other equipment is usually discharged to the floor drainage system. It was observed that protective clothing is made of material not likelyto contaminate product. Employees store protective clothing on racks adjacent to access points when going on breaks. All equipment, utensils and protective clothing observed were cleaned after use and stored in a clean and serviceable condition. Minor 11.2.9.5 –Water spill from the "mazeta" preparation tank was observed on the floor of the Mogul III kitchen platform due to a defective pipe connection.

11.2.10 Premises and Equipment Maintenance Module 11


Response Evidence

11.2.10.1 The methods and responsibility for the maintenance and repair of plant, equipment and buildings shall be documented, planned and implemented in a Compliant



manner that minimizes the risk of product, packaging or equipment contamination.

11.2.10.10 Equipment located over product or product conveyors shall be lubricated with food grade lubricants and their use controlled to minimize the contamination of the product.

Compliant

11.2.10.11 Paint used in a food handling or contact zone shall be suitable for use and in good condition and shall not be used on any product contact surface. Compliant

11.2.10.2

Routine maintenance of plant and equipment in any food processing, handling orstorage area shall be performed according to a maintenance-control schedule and recorded. The maintenance schedule shall be prepared to cover building, equipment and other areas of the premises critical to the maintenance of productsafety and quality.

Compliant

11.2.10.3 Failures of plant and equipment in any food processing, handling or storage areashall be documented, reviewed and their repair incorporated into the maintenance control schedule.

Compliant

11.2.10.4 Maintenance staff and contractors shall comply with the site's personnel and process hygiene requirements (refer to 11.3.1, 11.3.2, 11.3.3, 11.3.4).

Compliant

11.2.10.5 All maintenance and other engineering contractors required to work on site shall be trained in the site's food safety and hygiene procedures, or shall be escorted at all times, until their work is completed.

Compliant

11.2.10.6 Site supervisors shall be notified when maintenance or repairs are to be undertaken in any processing, handling or storage area. Compliant

11.2.10.7

The maintenance supervisor and the site supervisor shall be informed if any repairs or maintenance pose a potential threat to product safety (i.e. pieces of electrical wire, damaged light fittings, and loose overhead fittings). When possible, maintenance is to be conducted outside processing times.

Compliant

11.2.10.8

Temporary repairs, where required shall not pose a food safety risk and shall be included in the cleaning program. There shall be a plan in place to address completion of temporary repairs to ensure they do not become permanent solutions.

Compliant

11.2.10.9

Maintenance staff and contractors shall remove all tools and debris from any maintenance activity once it has been completed and inform the area supervisor and maintenance supervisor so appropriate hygiene and sanitation can be completed and a pre-operational inspection conducted prior to the commencement of site operations.

Compliant

11.2.10 Summary

A procedure documented in Programa de Mantenimiento 30.MNT.BB.SS.001, dated 2019.03.24 defines the methods and responsibilities for the maintenance and repair of all plant equipment and buildings. There is a schedule of planned Preventive Maintenance tasks documented in excel sheets than later is incorporated in the ERP maintenance system. Work orders for preventive maintenance are then issued and completed. WO 6626 of biweekly preventive maintenance of cooling system heat exchanger dated 2019.04.28, WO 66508 of



weekly refrigeration unit dated 2019.05.16, and WO 67366 of the biannual change of air compressed system filters dated 2019.05.19 were reviewed. Failures of plant and equipment are documented, reviewed and their repair incorporated into the maintenance control schedule. The documentation found on file in work orders input in the maintenance system, later printed and signed by the user and leader of the workshop, was reviewed during the audit and found to be complete. Maintenance personnel and contractors comply with personnel and process hygiene requirement and are trained in the site's good manufacturing practices and food safety in conformance with the policy of Requerimientos Generales de Prestadores de Servicios 30.QCD.BB.FS.020, dated 2019.01.08. Records of the attendance sheet to the GMP training course 60.CAP.SB.TG.005 that was provided two suppliers and contractors on 2019.03.22 was reviewed. The maintenance schedule is prepared every year, and reviewed on a weekly basis to cover building, equipment and other areas of the premises. Maintenance activities and repairs are carried out in coordination with production and quality staff. Most of maintenance activities are performed during week end when the site is not in operation. Temporary repairs, are allowed in the nonconforming equipment procedure Detencion y Disposicion de Equipo No Conforme 30.MNT.BB.SS.008, 2019.03.24, however, temporary repair is not conducted in the facility and none was observed during the onsite audit. When repairs and maintenance work are completed, personnel document accounting of tools and cleanliness of the work areas and a preoperational inspection is conducted. Machinery, conveyers and other equipment over or near food or food contact surfaces are lubricated with food grade materials. The food grade lubricants (Lubriplate SFL-2, Food grade anti-Seize, CRC Food Grade Belt dressing, FMO 350 Aw Spray) were noted to be stored separately and labeled properly in dedicated cabinet in the Mogul workshop. Paint is not used on food contact surfaces and any paint in processing areas was noted to be in good condition with no flaking noted.

11.2.11 Calibration Module 11


11.2.11.1

The methods and responsibility for the calibration and re-calibration of measuring, test and inspection equipment used for monitoring activities outlined in pre-requisite program, food safety plans and food quality plans and other process controls, or to demonstrate compliance with customer specifications shall be documented and implemented. Software used for such activities shall bevalidated as appropriate.

Compliant

11.2.11.2 Procedures shall be documented and implemented to address the disposition of potentially affected products should measuring, test and inspection equipment be found to be out of calibration state.

Compliant

11.2.11.3 Calibrated measuring, test and inspected equipment shall be protected from damage and unauthorized adjustment.

Compliant

11.2.11.4

Equipment shall be calibrated against national or international reference standards and methods or to accuracy appropriate to its use. In cases where standards are not available, the site shall provide evidence to support the calibration reference method applied.

Compliant

11.2.11.5 Calibration shall be performed according to regulatory requirements and/or to theequipment manufacturers recommended schedule. Compliant

11.2.11.6 Calibration records shall be maintained. Compliant

11.2.11 Summary



A procedure defining the methods and responsibilities for calibrating measuring, testing and inspection equipment is documented in Procedimientos de Calibracion 30.QCD.BB.QC.008, 2019.04.29 and has been implemented. The policy includes the procedures to address the disposition of any affected product should inspection equipment be found to be out of calibration, written in paragraph 11 Procedimientos de Calibracion 30.QCD.BB.QC.008. Inspection and testing equipment is protected from damage or unauthorized use by authorized maintenance staff, QC staff, and by contracted third party calibration services. Equipment is calibrated against national (CENAM) or international standards (NIST). The facility has developed a calibration schedule with all devices listed. This documentation is located in Programa de Calibracion Externa 60.QCD.BB.IT.003 and verified weekly by QC staff as determined in 30.QCD.BB.QC.008 and scheduled in Verificacion semanal de basculas 60.QCP.BB.IT.012. The frequency of inspections is based on the manufacturer's recommendations,corporate or customer requirements. A review of the calibration records for metal detectors ID 31, by ISEI dated 2018.12.04, refractometers S/N 01053-0913 by Laboratorios industriales de Mexico dated 2019.03.13; potentiometer, thermometer and thermo balance by Techmaster de Mexico dated 2019.01.09, 2019.02.21, and 2019.02.01 confirms the schedule is being followed.

11.2.12 Pest Prevention Module 11


11.2.12.1

The methods and responsibility for pest prevention shall be documented and effectively implemented. The premises, its surrounding areas, storage facilities, machinery and equipment shall be kept free of waste or accumulated debris so as not to attract pests and vermin.

Compliant

11.2.12.2 Identified pest activity shall not present a risk of contamination to food products, raw materials or packaging. Compliant

11.2.12.3

Food products, raw materials or packaging that are found to be contaminated by pest activity shall be effectively disposed of, and the source of pest infestation investigated and resolved. Records shall be kept of the disposal, investigation, and resolution.

N/AThere has not been any events of food products, raw materials, or packaging contaminated with pest activity since the last audit.

11.2.12.4

The pest prevention program shall: i. Describe the methods and responsibility forthe development, implementation and maintenance of the pest prevention program; ii. Record pest sightings and trend the frequency of pest activity to target pesticide applications; iii. Outline the methods used to prevent pest problems; iv. Outline the pest elimination methods; v. Outline the frequency with which pest status is to be checked; vi. Include on a site map the identification, location, number and type of bait stations set; vii. List the chemicals used (they are required to be approved by the relevant authority and their Safety Data Sheets (SDS) made available); viii. Outline the methods used to make staff aware of the bait control program and the measures to take when they come intocontact with a bait station; ix. Outline the requirements for staff awareness and training in the use of pest and vermin control chemicals and baits; and x. Measure the effectiveness of the program to verify the elimination of applicable pests.

Compliant

11.2.12.5 Inspections for pest activity shall be undertaken on a regular basis by trained personnel and the appropriate action taken if pests are present. Compliant



11.2.12.6 Records of all pest control applications shall be maintained. Compliant

11.2.12.7

Pesticides and other toxic chemicals shall be clearly labeled and stored as described in element 11.6.5 and handled and applied by properly trained personnel. They shall be used by or under the direct supervision of trained personnel with a thorough understanding of the hazards involved, including the potential for the contamination of food and food contact surfaces.

N/AThe facility does not store pest control chemicals on site and the PCO disposes of empty containers.

11.2.12.8

Pest contractors shall be: i. Licensed and approved by the local relevant authority; ii. Use only trained and qualified operators who comply with regulatory requirements; iii. Use only approved chemicals; iv. Provide a pest prevention plan (refer to 2.3.3) which will include and maintain a site map indicating the location of bait stations traps and other applicable pest control/monitoring devices; v. Report to a responsible authorized person on entering the premises and after the completion of inspections or treatments; and vi. Provide a written report of their findings and the inspections and treatments applied.

Compliant

11.2.12.9

The site shall dispose of unused pest control chemicals and empty containers in accordance with regulatory requirements and ensure that: i. Empty chemical containers are not reused; ii. Empty containers are labeled, isolated and securelystored while awaiting collection; and iii. Unused and obsolete chemicals are stored under secure conditions while waiting authorized disposal by an approvedvendor.

Compliant

11.2.12 Summary

The procedure Prevencion de Plagas 30.QCD.BB.FS.010, 2019.01.08 defining the methods and responsibilities for pest prevention has been effectively implemented. The premises were free of waste and debris as observed during the interior and exterior tours. Pest activity observed during the plant inspection does not present any risk of contamination. In the case of events of pest activity that would contaminated food products, raw materials, or packaging these will be disposed and the source of pest infestation investigated and resolved as included in the SOP. The pest prevention procedure refers to the integrated control program required to the contracted pest control operator and includes all the requirements of the standard. Internal mechanical / glue board traps, UV light traps and external bait stations were inspected at random and they include internal cards to record week monitoring. Internal traps and external baits were properly located and maintained. No pest harborage was observed. Records of pest control applications dated 2019.01.17 to 2019.03.09 were reviewed. The annual assessment of the effectiveness of the program to verify the elimination of applicable pests dated 2019.01.08 was reviewed. Trends of the first quarter of 2019 were reviewed. Pesticides and other toxic chemicals are transported in the PCO vehicles when required, maintained secured in plastic containers and not stored within the facility. A Pest Control Operator has been contracted for pest management and an updated scope of service dated 2019.01.02 defines the methods of pest control, frequency of interior and exterior inspections and targeted pests. A current site map dated 2019.05.10 is accurate showing the location of external and internal devices. A pesticide application log gives details and dates of all chemical usage. Licenses ofthe Pest Control Operator 04-08099 from state health authorities are current and indicate employees are trained and competent (Constancias de Competencia o de Habilidades Laborales DC-3 dated 2018.10.02 were reviewed). A list of chemicals used by the Pest Control Operator is found in the PCO binder and includes SDS information. Inspection activity reports are signed by the QC supervisor after visits and were reviewed and found to be completed as scheduled (the last activity report dated 2019.05.16 were reviewed). Any observations or issues highlighted by the Pest Control Operator are addressed and documented by the supplier, as reviewed in the service order and the Pest control inspection report 60.QCD.BB.FS.032 dated 2019.05.17. There has not been any events of food products, raw materials, or packaging contaminated with pest activity since the last audit. The facility does not store pest control chemicals on site and the PCO disposes of empty containers.



11.2.13 Cleaning and Sanitation Module 11


Response Evidence

11.2.13.1

The methods and responsibility for the cleaning of the food handling and processing equipment and environment, storage areas, staff amenities and toilet facilities shall be documented and implemented. Consideration shall be given to:i. What is to be cleaned; ii. How it is to be cleaned; iii. When it is to be cleaned; iv. Who is responsible for the cleaning; v. Methods used to confirm the correct concentrations of detergents and sanitizers, and vi. The responsibility and methods used to verify the effectiveness of the cleaning and sanitation program.

Compliant

11.2.13.10

The site shall dispose of unused detergents and sanitizers and empty containersin accordance with regulatory requirements and ensure that: i. Empty detergent and sanitizer containers are appropriately cleaned, treated and labeled before use; ii. Empty detergent and sanitizer containers are labeled, isolated and securely stored while awaiting collection; and iii. Unused and obsolete detergents and sanitizers are stored under secure conditions while waiting authorized disposal by an approved vendor.

Compliant

11.2.13.11 A record of pre-operational hygiene inspections, cleaning and sanitation activities, and verification activities shall be maintained. Compliant

11.2.13.2 Provision shall be made for the effective cleaning of processing equipment, utensils and protective clothing. Compliant

11.2.13.3

Suitably equipped areas shall be designated for cleaning product containers, knives, cutting boards and other utensils and for cleaning of protective clothing used by staff. These cleaning operations shall be controlled so as not to interfere with manufacturing operations, equipment or product. Racks and containers for storing cleaned utensils shall be provided as required.

Compliant

11.2.13.4

Cleaning in place (CIP) systems where used shall not pose a chemical contamination risk to raw materials, ingredients or product. CIP parameters critical to assuring effective cleaning shall be defined, monitored and recorded (e.g., chemical and concentration used, contact time and temperature). CIP equipment including spray balls shall be maintained and modifications to CIP equipment shall be validated. Personnel engaged in CIP activities shall be effectively trained.

N/A There is no CIP operation on site.

11.2.13.5

Pre-operational inspections shall be conducted following cleaning and sanitation operations to ensure food processing areas, product contact surfaces, equipment, staff amenities and sanitary facilities and other essential areas are clean before the commencement of production. Pre-operational inspections shallbe conducted by qualified personnel.

Compliant

11.2.13.6 Staff amenities, sanitary facilities and other essential areas shall be inspected byqualified personnel to ensure the areas are clean, at a defined frequency. Compliant



11.2.13.7 The responsibility and methods used to verify the effectiveness of the cleaning procedures shall be documented and implemented. A verification schedule shallbe prepared.

Compliant

11.2.13.8

Detergents and sanitizers shall be suitable for use in a food manufacturing environment, labelled according to regulatory requirements, and purchased in accordance with applicable legislation. The organization shall ensure: i. The sitemaintains a list of chemicals approved for use; ii. An inventory of all chemicals purchased and used shall be maintained; iii. Detergents and sanitizers are stored as outlined in element 11.6.4; iv. Safety Data Sheets (SDS) are provided for all detergents and sanitizers purchased; and v. Only trained staff handles sanitizers and detergents.

Compliant

11.2.13.9

Detergents and sanitizers that have been mixed for use shall be correctly mixed according to manufacturers' instructions, stored in containers that are suitable foruse, and clearly identified. Mix concentrations shall be verified and records maintained.

Compliant

11.2.13 Summary

The supplier has a Cleaning and Sanitation Program that describes the methods and responsibilities for cleaning of processing equipment, the environment, storage areas, bathrooms andbreak rooms. Sanitation Standard Operating Procedures are written and include what is cleaned, chemical usage (concentrations, etc.), cleaning methods and who is responsible. The SOP Procedimiento de Limpieza General 30.SAN.BB.FS.027, dated 2018.08.15 was reviewed. A master sanitation plan includes all areas of the facility with frequencies and responsibilities for deep cleaning. A review of the plan for the hard candy line #3 "Programa Maestro de Limpieza – Reporte Semanal 60.SAN.BB.FS.064" for dates 2019.05.13 to 2019.05.18 showed tasks were completed as scheduled. There is a suitable room for cleaning and sanitizing trays and plastic baskets and sinks dedicated for cleaning utensils that does not cause a contamination risk to food product. Sanitation tasks are documented as well as pre-operational inspections. Monitoreo de parametros de lavado y desinfeccion 60.SAN.BB.FS.001 dated 2019.04.26, 2019.05.03, 2019.05.10, and 2019.05.13. A verification schedule includes the methods, frequencies and responsibilities for verifying the effectiveness of cleaning methods. Work instructions for determination of ATP in food contact surfaces 40.QCD.BB.IT.019, 2019.03.14; determination of proteins in food contact surfaces 40.QCD.BB.IT.018, 2019.03.14; and determination of specific allergenic protein in food contact surfaces 40.QCD.BB.IT.031, 2019.03.28 were reviewed. Essential areas are inspected regularly by qualified personnel as documented in Programa Maestro de Limpieza – Otras actividades 2019 and Reporte Semanal Sanitation 60.SAN.BB.FS.073. Records dated 2019.05.13 to 2019.05.19 were reviewed. Cleaning materials are stored securely, labeled in conformance with regulations, and a list of chemicals approved for use maintained, with SDS information available to all employees. Chemicals Lift III, Whisper V, LFC and Oxonia Active were observed to have SDS on hand. Sanitation personnel are properly trained in cleaning methods and the safe use of chemicals. The last chemical handling training was conducted 2018.06.06. Cleaning chemicals are mixed, stored, and its concentration verified according manufacturers' instructions and release by QC technicians and containers clearly identified. Records of Verificacion de dispensadores 60.QCD.BB.FS.099, dated 2019.05.12 to 19 were reviewed. All chemical containers are disposed of in accordance with regulatory requirements. Pre-operational inspections of the washing room 60.SAN.BB.FS.040 for dates 2019.05.21 to2019.05.22 hard candy chocolate 60.QCD.BB.FS.027, dated 2019.05.18; start up and product changeover inspection of hard candy continuous line #2 60.PRO.BB.IT.048, dated 2019.05.20 were reviewed and had proper corrective actions documented as required. There is no CIP operation on site.

11.3.1 Personnel Module 11


Response Evidence



11.3.1.1

Personnel who are known to have been known to be carriers, or are carriers, of infectious diseases that present a health risk to others through the packing or storage processes shall not engage in the processing or packing of food, or enter storage areas where food is exposed.

Compliant

11.3.1.2

The site shall have measures in place to prevent contact of materials, ingredients, food packaging, food, or food contact surfaces from any bodily fluidsfrom open wounds, coughing, sneezing, spitting, or any other means. In the event of an injury which causes spillage of bodily fluid, properly trained employeeshall ensure that all affected areas including handling and processing areas havebeen adequately cleaned and that all materials and products have been quarantined and disposed of.

Compliant

11.3.1.3

Personnel with exposed cuts, sores or lesions shall not be engaged in handling or processing products or handling primary packaging materials or food contact surfaces. Minor cuts or abrasions on exposed parts of the body shall be coveredwith a colored bandage containing a metal strip or an alternative suitable waterproof and colored dressing.

Compliant

11.3.1.4

Smoking, chewing, eating, or spitting is not permitted in areas where product is produced, stored, or otherwise exposed. Drinking of water is permissible only under conditions that prevent contamination or other food safety risks from occurring. Drinking water containers in production and storage areas shall be stored in clear, covered containers, and in designated areas away from raw materials, packaging or equipment.

Compliant

11.3.1 Summary

A Good Manufacturing Practice policy for all employees has been documented in Buenas Practicas de Personal 30.ADM.BB.FS.001, which has been implemented. Employees are prohibited from working in food handling areas where food is exposed when are known or have been known to be carriers of infectious and communicable diseases that present a health risk to others through the packing or storage process. Measures are in place to prevent contact with bodily fluids as determined in Politica Exposicion de Sangre en la Planta Laboral 30.QCD.SB.FS.009, 2019.03.21. Trained employees properly clean and all materials in contact with bodily fluid from an injury is quarantine and disposed of. Records of event 2019.03.01, that includes Reporte de exposicion de sangre 60.QCD.BB.FS.100; Producto detenido 60.QCD.BB.NX.001, and Inspeccion Preoperacional 60.QCD.BB.FS.021 were reviewed Employeesare prohibited from working in food handling and processing areas if have exposed cuts, sores or lesions. The policy requires that minor cuts or abrasions be covered with a waterproof, metal detectable and colored bandage or dressing and the use of nitrile gloves. The GMP policy prohibits smoking, eating, chewing or spitting in production, storage or exposed product areas. Smoking is permitted only in designated areas. Drinking water is permitted only in designated areas away from raw materials, packaging or equipment. Employee interviews confirmed that employees are trained in good manufacturing practices and are knowledgeable of the requirements.

11.3.2 Hand Washing Module 11


11.3.2.1 Hand wash basins shall be provided adjacent to all personnel access points and in accessible locations throughout food handling and processing areas as Compliant



required.

11.3.2.2

Hand wash basins shall be constructed of stainless steel or similar non-corrosivematerial and as a minimum supplied with: i. A potable water supply at an appropriate temperature; ii. Liquid soap contained within a fixed dispenser; iii. Paper towels in a hands free cleanable dispenser; and iv. A means of containing used paper towels.

Compliant

11.3.2.3 The following additional facilities shall be provided in high risk areas: i. Hands free operated taps; and ii. Hand sanitizers. Compliant

11.3.2.4 A sign instructing people to wash their hands, and in appropriate languages, shall be provided in a prominent position. Compliant

11.3.2.5

Personnel shall have clean hands and hands shall be washed by all personnel, including staff, contractors and visitors: i. On entering food handling or processing areas; ii. After each visit to a toilet; iii. After using a handkerchief; iv. After smoking, eating or drinking; and v. After handling wash down hoses, dropped product or contaminated material.

Compliant

11.3.2.6 When gloves are used, personnel shall maintain the hand washing practices outlined above.

Compliant

11.3.2 Summary

Hand wash basins are located at appropriate employee access points to processing areas. Hand wash sinks are made of non-corrosive materials and supplied with tempered potable water. Soap in a fixed dispenser, and air dryers. Hands free operated taps and hand sanitizers are available in all areas of the facility. Signs are posted reminding employees to wash their hands before returning to work. Signs are posted at hand wash stations and in bathrooms. A policy covering hand washing requirements has been documented and implemented. Employees are required to wash hand when wearing gloves. Employees were observed to wash their hands properly during the audit and to use proper glove use procedures.

11.3.3 Clothing Module 11


11.3.3.1 The site shall undertake a risk analysis to ensure that the clothing and hair policyprotects materials, food and food contact surfaces from unintentional microbiological or physical contamination.

Compliant

11.3.3.2 Clothing worn by staff engaged in handling food shall be maintained, stored, laundered and worn so as not to present a contamination risk to products. Compliant

11.3.3.3 Clothing including shoes, shall be clean at the commencement of each shift and maintained in a serviceable condition. Compliant

11.3.3.4 Excessively soiled uniforms shall be changed or replaced where they present a product contamination risk. Compliant

11.3.3.5 Disposable gloves and aprons shall be changed after each break, upon re-entry into the processing area and when damaged. Non-disposable aprons and glovesshall be cleaned and sanitized as required and when not in use stored on racks

Compliant



provided in the processing area or designated sealed containers in personnel lockers and not on packaging, ingredients, product or equipment.

11.3.3 Summary

The policy defining clothing requirements has been documented and implemented. Employees use smock and hard toe shoes. PPE are hard cap, safety fabric gloves for packaging operators, wrist protection, cotton gloves for handling hot candy paste, vest, and plastic boots, as appropriate. Clothing including shoes are required to be clean at the commencement of the shift and changed if excessively soiled. Disposable fabric gloves are to be changed when soiled or damaged. Non-disposable gloves are not used. Employees were observed to be following the clothing requirements of the facility.

11.3.4 Jewelry and Personal Effects Module 11


Response Evidence

11.3.4.1

Jewelry and other loose objects shall not be worn or taken into a food handling or processing operation or any area where food is exposed. The wearing of plainbands with no stones and prescribed medical alert bracelets can be permitted, however the site will need to consider their customer requirements and the applicable food legislation.

Compliant

11.3.4 Summary

A policy defining jewelry has been written and implemented. Jewelry and other loose objects are prohibited in food processing and handling areas. Employees were observed to be in compliance with the jewelry policy during the audit tours.

11.3.5 Visitors Module 11


11.3.5.1 All visitors, including management and maintenance staff, shall wear suitable clothing and footwear when entering any food processing or handling area. Compliant

11.3.5.2 All visitors shall be required to remove jewelry and other loose objects. Compliant

11.3.5.3 Visitors exhibiting visible signs of illness shall be prevented from entering areas in which food is handled or processed. Compliant

11.3.5.4 Visitors shall enter and exit food handling areas through the proper staff entrance points and comply with all hand washing and personnel practice requirements.

Compliant

11.3.5.5 All visitors shall be trained in the site's food safety and hygiene procedures before entering any food processing or handling areas, or shall be escorted at alltimes in food processing, handling and storage areas.

Compliant



11.3.5 Summary

A policy defining requirements for visitor, including management, maintenance staff, and contractor, has been documented and implemented. Visitors are required to follow the facility rulesincluding use of suitable protective clothing and footwear. Compliance with the policy of removal of jewelry and other loose objects was observed. Visitors were not observed exhibiting visible signs of illness when entered food handling and processing areas. Visitors and contractors are also required using proper access points, comply with hand wash requirements, and personnel practice requirements. Visitors are trained in the site's food safety and hygienic procedures prior entering food processing or accompanied all times for designated personnel.

11.3.6 Staff Amenities Module 11


11.3.6.1 Staff amenities supplied with appropriate lighting and ventilation shall be made available for the use of all persons engaged in the handling and processing of product.

Compliant

11.3.6 Summary

Employee bathrooms and break rooms are appropriately lit and ventilated and available for all personnel at the facility.

11.3.7 Change Rooms Module 11


11.3.7.1 Facilities shall be provided to enable staff and visitors to change into and out of protective clothing as required. Compliant

11.3.7.2 Change rooms shall be provided for staff engaged in the processing of high risk foods or processing operations in which clothing can be soiled.

N/A Change rooms are not required at the facility.

11.3.7.3 Provision shall be made for staff to store their street clothing and personal items separate from food contact zones and food and packaging storage areas.

Compliant

11.3.7.4 Where required, a sufficient number of showers shall be provided for use by staff. N/A Showers are not required.

11.3.7 Summary

There are facilities for employees to change into and out of protective clothing. Provisions have been made for storage of street clothing and personal items and are separate from processing and storage areas. Change rooms are not required at the facility. Showers are not required.

11.3.8 Laundry Module 11




Evidence

11.3.8.1 Provision shall be made for the laundering and storage of clothing worn by staff engaged in high risk processes and for staff engaged in processing operations inwhich clothing can be heavily soiled.

Compliant

11.3.8 Summary

Provisions have been made for the laundering and storage of clothing for employees working in all areas. Laundering of uniforms is conducted by an outside contractor

11.3.9 Sanitary Facilities Module 11


Response Evidence

11.3.9.1

Toilet rooms shall be: i. Designed and constructed so that they are accessible to staff and separate from any processing and food handling operations; ii. Accessed from the processing area via an airlock vented to the exterior or through an adjoining room; iii. Sufficient in number for the maximum number of staff; iv. Constructed so that they can be easily cleaned and maintained; v. Include an area inside or nearby, for storing protective clothing, outer garments and other items while using the facilities; and vi. Kept clean and tidy.

Compliant

11.3.9.2 Sanitary drainage shall not be connected to any other drains within the premises and shall be directed to a septic tank or a sewerage system in accordance in regulations.

Compliant

11.3.9.3 Hand wash basins shall be provided immediately outside or inside the toilet roomand designed as outlined in 11.3.2.2.

Compliant

11.3.9 Summary

Bathrooms are designed and constructed so they are separate from food processing and handling areas and accessed via a separate room or airlock. Bathrooms were observed to be sufficient in number for all employees, were found to be cleaned and maintained on a scheduled basis, and include an area for storing protective clothing. Sanitary drainage is separated from plant drainage. Bathrooms have hand wash sinks and comply with requirements in 11.3.2.2.

11.3.10 Lunch Rooms Module 11


11.3.10.1 Separate lunch room facilities shall be provided away from a food contact/handling zone.

Compliant



11.3.10.2

Lunch room facilities shall be: i. Ventilated and well lit; ii. Provided with adequatetables and seating to cater for the maximum number of staff at one sitting; iii. Equipped with a sink serviced with hot and cold potable water for washing utensils; iv. Equipped with refrigeration and heating facilities enabling them to store or heat food and to prepare non-alcoholic beverages if required; and v. Kept clean and free from waste materials and pests.

Compliant

11.3.10.3 Where outside eating areas are provided, they should be kept clean and free from waste materials and maintained in a manner that minimizes the potential forintroduction of contamination including pests to the site.

Compliant

11.3.10.4 Signage in appropriate languages instructing people to wash their hands before entering the food processing areas shall be provided in a prominent position in lunch rooms and at lunch room exits, and in outside eating areas, if applicable.

Compliant

11.3.10 Summary

Lunch rooms properly separate from production are available. Catering is provided for all personnel by a contracted service that are audited by the same company and by the site. Lunch rooms are well lit, and ventilated and appropriately sized for the number of facility employees. Lunch rooms include hot and cold potable water, food storage areas, refrigerators with hand and utensil washing capabilities. Lunch rooms were observed to be clean and well maintained during the audit tours. Signs are posted at the exit reminding employees to wash their handsbefore returning to work.

11.4.1 Staff Engaged in Food Handling and Processing Operations Module 11


11.4.1.1

All personnel engaged in any food handling, preparation or processing operations shall ensure that products and materials are handled and stored in such a way as to prevent damage or product contamination. They shall comply with the following processing practices: i. Personnel entry to processing areas shall be through the personnel access doors only; ii. All doors are to be kept closed. Doors shall not be left open for extended periods when access for wasteremoval or receiving of product/ingredient/packaging is required; iii. Packaging material, product, and ingredients shall be kept in appropriate containers as required and off the floor; iv. Waste shall be contained in the bins identified for this purpose and removed from the processing area on a regular basis and not left to accumulate; v. Staff shall not eat or taste any product being processed in the food handling/contact zone, except as noted in element 11.4.1.2; vi. The wearing of false fingernails, false eyelashes, eyelash extensions, long nails or fingernail polish is not permitted when handling exposed food; vii. Hair restraints are used where product is exposed.

Compliant

11.4.1.2 In circumstances where it is necessary to undertake sensory evaluations in a food handling/contact zone the site shall implement proper controls and Compliant



procedures to ensure: i. Food safety is not compromised; ii. Sensory evaluations are conducted by authorized personnel only; iii. A high standard of personal hygiene is practiced by personnel conducting sensory evaluations; iv. Sensory evaluations are conducted in areas equipped for the purpose; and v. Equipment used for sensory evaluations is sanitized, maintained and stored separate from processing equipment.

11.4.1.3 All wash down hoses shall be stored on hose racks after use and not left on the floor. Compliant

11.4.1 Summary

Food handling procedures for all employees are documented in Buenas Practicas de Personal 30.ADM.BB.FS.001 and implemented. Personnel are required to access the processing areas through personnel doors only and doors were observed closed. Packaging material, product, and Ingredients were in appropriate, labeled containers and kept off the floor. No evidence of staff eating product in the food handling zone was observed. False fingernails, false eyelashes, eyelash extensions, long nails or fingernail polish is prohibited when handling exposed product and no violations were noted. Use of hair restrains was observed where product was exposed. Sensory evaluations were conducted in designated areas that were well lit and appropriately equipped for that purpose and personnel conducting sensory evaluations are trained and maintain high hygienic standards. Wash down hoses were observed to be properly stored on racks when not in use.

11.5.1 Water Supply Module 11


11.5.1.1 Adequate supplies of potable water drawn from a known clean source shall be provided for use during processing operations, as an ingredient and for cleaning the premises and equipment.

Compliant

11.5.1.2 Supplies of hot and cold water shall be provided as required to enable the effective cleaning of the premises and equipment. Compliant

11.5.1.3 The delivery of water within the premises shall ensure potable water is not contaminated. Compliant

11.5.1.4

The use of non-potable water shall be controlled such that: i. There is no cross contamination between potable and non-potable water lines; ii. Non-potable water piping and outlets are clearly identified. iii. Hoses, taps, or other similar sources of possible contamination are designed to prevent back flow or back siphonage

Compliant

11.5.1.5 Where water is stored on site, storage facilities shall be adequately designed, constructed and maintained to prevent contamination. Compliant

11.5.1 Summary

Potable water is sourced for use in the facility for processing and cleaning the premises and equipment. Potable water is supplied from the Juarez municipality. It was determined that there was adequate hot and cold water for cleaning and processing. Plant schematics were reviewed and non-potable water (such as fire suppression sprinkler systems) is separated from



the potable source. Back flow devices are installed on main water lines. Water storage facilities on site are designed, constructed and maintained to prevent contamination. Preventive maintenance of water storage tanks carried out twice a year and record of the last maintenance dated 2019.04.06 were reviewed.

11.5.2 Water Treatment Module 11


Evidence

11.5.2.1 Water treatment methods, equipment and materials, if required, shall be designed, installed and operated to ensure water receives an effective treatment. Compliant

11.5.2.2 Water treatment equipment shall be monitored regularly to ensure it remains serviceable. Compliant

11.5.2.3 Treated water shall be regularly monitored to ensure it meets the indicators specified. Compliant

11.5.2.4 Water used in as an ingredient in processing, or in cleaning and sanitizing equipment, shall be tested, and if required, treated to maintain potability (refer to 11.5.2.1).

Compliant

11.5.2 Summary

Water is treated effectively (chlorination with sodium hypochlorite), and the water treatment equipment is serviced on a regular basis through the preventive maintenance program. The lastpreventive maintenance was performed as scheduled on the first week of May 2019. The treated water is monitored daily, every shift, by QC staff (pH, Chlorine, turbidity, color and flavor) and if required adjustment to the sodium hypochlorite dosing pump carried out to maintain potability. Records 60.QCD.BB.IT.020 dated 2019.04.22 to 26, 2019.05.06 to 10, and 2019.05.13 to 17 were reviewed.

11.5.3 Ice Supply Module 11


11.5.3.1 Ice provided for use during processing operations or as a processing aid or an ingredient shall comply with 11.5.4.1. N/A Ice is not used at the facility.

11.5.3.2 Ice rooms and receptacles shall be constructed of materials as outlined in elements 11.2.1, 11.2.2 and 11.2.3 and designed to minimize contamination of the ice during storage and distribution.

N/A Ice is not used at the facility.

11.5.3 Summary

Ice is not used at the facility.

11.5.4 Monitoring Water Microbiology and Quality Module 11




Evidence

11.5.4.1

Water shall comply with local, national or internationally recognized potable water microbiological and quality standards as required when used for i. washing, thawing and treating food; ii. handwashing iii. to convey food; iv. as an ingredient or food processing aid; v. cleaning food contact surfaces and equipment; vi. the manufacture of ice; or vii. the manufacture of steam that will come into contact with food or used to heat water that will come in contact with food.

Compliant

11.5.4.2

Microbiological analysis of the water and ice supply shall be conducted to verify the cleanliness of the supply, the monitoring activities and the effectiveness of the treatment measures implemented. Samples for analysis shall be taken at sources supplying water for the process or cleaning, or from within the site. The frequency of analysis shall be risk-based, and at a minimum annually.

Compliant

11.5.4.3 Water and ice shall be analyzed using reference standards and methods. Compliant

11.5.4 Summary

Water used in processing, treating and cleaning, handwashing, and the manufacture of steam that will come into contact with food or used to heat water that will come in contact with food complies with potable water microbiological and quality national standards. Samples are sent to an outside lab for analysis. (Microlab Industrial, accreditation issued by EMA no. AG-208-039/09). The last potability test was conducted on a sample taken on 2019.02.25 and tested against NOM-127. Water from sources in the facility is analyzed weekly for cleanliness (thermophilic coliforms, total coliforms, total plate count, E. coli, yeast and mold, chlorine and lead) by a 3rd party accredited laboratory ((CBM – Centro de Deteccion Microbiologica accreditation issued by a2La 4955.01. The frequency of analysis is risk based. The last test results were dated 2019.04.229 and demonstrated the operation's processing water was potable. The laboratory uses reference standards and methods.

11.5.5 The Quality of Air and Other Gasses Module 11


11.5.5.1 Compressed air or other gasses (e.g. nitrogen, carbon dioxide) that contacts food or food contact surfaces shall be clean and present no risk to food safety. Compliant

11.5.5.2

Compressed air systems, and systems used to store or dispense other gasses used in the manufacturing process that come into contact with food or food contact surfaces shall be maintained and regularly monitored for quality and applicable food safety hazards.

Compliant

11.5.5 Summary

Filters for compressed air are located near the point of use, at the drop ceiling of the curing rooms of the Mogul 3 line and are of the appropriate micron size to effectively filter the air before contacting food or food contact surfaces (oil 0.05 microns, humidity 0.05 microns, and particles 0.001 microns). Filter inspections and changes or systems used to store or dispense



compressed air are on the preventive maintenance schedule. The last date scheduled 2019.05.19 (WO 67366) was reviewed and completed. Water additive for boiler used to generate steam that is in direct contact with WIP is NSF registered G6 (steam produced may contact edible products).

11.6.1 Storage and Handling of Goods Module 11


Evidence

11.6.1.1 The site shall document and implement an effective storage plan that allows for the safe, hygienic storage of raw materials (i.e. frozen, chilled, and ambient), ingredients, packaging materials, equipment, and chemicals.

Compliant

11.6.1.2 The responsibility and methods for ensuring effective stock rotation principles are applied shall be documented and implemented. Compliant

11.6.1.3 Procedures shall be in place to ensure that all ingredients, materials, work-in-progress, rework, and finished product are utilized within their designated shelf-life.

Compliant

11.6.1.4 Equipment storage rooms shall be designed and constructed to allow for the hygienic and efficient storage of equipment and containers. Minor

Maintenance storage room located aside the hazardous chemical room were observed not clean with items directly above the floor.

11.6.1.5

Where goods described in 11.6.2 to 11.6.4 are held under temporary or overflow conditions that are not designed for the safe storage of goods, a risk analysis shall be undertaken to ensure there is no risk to the integrity of those goods or contamination or adverse effect on food safety.

N/AThe supplier does not require temporary or overflow storage.

11.6.1.6 Records shall be available to validate alternate or temporary control measures for the storage of raw materials, ingredients, packaging materials, equipment, chemicals, or finished products.

N/AThe supplier does not require temporary or overflow storage.

11.6.1 Summary

The procedure to allow for the safe, hygienic storage of raw materials, ingredients, packaging materials, and chemicals is documented in Procedimiento de Control de Calidad de Almacen 30.QCD.BB.QC.006, updated on 2019.03.06 and implemented. The site has a procedure for stock rotation supported by the ERP system in place that record the inventory of raw materials, packaging materials and process aids by product, amount, due date, and location in the warehouse. These procedures ensure that ingredients, packaging and work-in-progress are used within the defined shelf-life. Through observation during the plant tours, and interviews with plant employees CA and IA, the inventory rotation program was found to be properly implemented. NC – 11.6.1.4 Maintenance storage rooms located aside the hazardous chemical room were observed not clean with items above the floor. The supplier does not require temporary or overflow storage.

11.6.2 Cold Storage, Freezing and Chilling of Foods Module 11


Response Evidence



11.6.2.1

The site shall provide confirmation of the effective operational performance of freezing, chilling and cold storage facilities. Chillers, blast freezers and cold storage rooms shall be designed and constructed to allow for the hygienic and efficient refrigeration of food and easily accessible for inspection and cleaning.

N/A

There is no chiller, freezer or cold storage, but there are two cool rooms, one outside trailer for flavors (flammable chemicals) and a storage room (Mogul 4) for WIP containing gelatin that are maintained below 75 degrees Fahrenheit.

11.6.2.2 Sufficient refrigeration capacity shall be available to chill, freeze, store chilled or store frozen the maximum anticipated throughput of product with allowance for periodic cleaning of refrigerated areas.

N/A There is no chiller, freezer or cold storage.

11.6.2.3 Discharge from defrost and condensate lines shall be controlled and discharged to the drainage system. N/A There is no chiller, freezer or cold storage.

11.6.2.4

Freezing, chilling and cold storage rooms shall be fitted with temperature monitoring equipment and located to monitor the warmest part of the room and be fitted with a temperature measurement device that is easily readable and accessible.


11.6.2.5 Loading and unloading docks shall be designed to protect the product during loading and unloading.


11.6.2 Summary

There is no chiller, freezer or cold storage, but there are two cool rooms, one outside trailer for flavors (flammable chemicals) and a storage room (Mogul 4) for WIP containing gelatin that are maintained below 75 degrees Fahrenheit.

11.6.3 Storage of Dry Ingredients, Packaging, and Shelf Stable Packaged Goods Module 11


11.6.3.1 Rooms used for the storage of product ingredients, packaging, and other dry goods shall be located away from wet areas and constructed to protect the product from contamination and deterioration.

Compliant

11.6.3.2

Racks provided for the storage of packaging shall be constructed of impervious materials and designed to enable cleaning of the floors and the storage room. Storage areas shall be constructed to prevent packaging from becoming a harborage for pests or vermin.

Compliant

11.6.3.3 Vehicles used in food contact, handling or processing zones or in cold storage rooms shall be designed and operated so as not to present a food safety hazard. Compliant

11.6.3 Summary

Storage areas for raw materials, packaging and finished goods were observed to be located away from any wet areas, clean and well maintained. Product is protected from contamination and deterioration. Racking is designed and constructed from impervious materials and located so storage areas can be cleaned and inspected. Forklifts and other vehicles in processing areas and storage areas do not present a food hazard.



11.6.4 Storage of Hazardous Chemicals and Toxic Substances Module 11


Evidence

11.6.4.1

Hazardous chemicals and toxic substances with the potential for food contamination shall be stored so as not to present a hazard to staff, product, packaging, product handling equipment or areas in which the product is handled,stored or transported.

Compliant

11.6.4.2 Processing utensils and packaging shall not be stored in areas used to store hazardous chemicals and toxic substances. Compliant

11.6.4.3

Daily supplies of chemicals used for continuous sanitizing of water or as a processing aid, or for emergency cleaning of food processing equipment or surfaces in food contact zones, may be stored within or in close proximity to a processing area provided access to the chemical storage facility is restricted to authorized personnel.

Compliant

11.6.4.4

Pesticides, rodenticides, fumigants and insecticides shall be stored separate from sanitizers and detergents. All chemicals shall be stored in their original containers, or in clearly labelled and suitable secondary containers if allowed by applicable legislation.

N/A Pest control chemicals are not stored on site.

11.6.4.5

Hazardous chemical and toxic substance storage facilities shall: i. Be compliant with national and local legislation and designed such that there is no cross-contamination between chemicals; ii. Be adequately ventilated; iii. Be provided with appropriate signage indicating the area is a hazardous storage area; iv. Be secure and lockable to restrict access only to those personnel with formal training in the handling and use of hazardous chemicals and toxic substances; v.Have instructions on the safe handling of hazardous chemicals and toxic substances readily accessible to staff; vi. Be equipped with a detailed and up-to-date inventory of all chemicals contained in the storage facility; vii. Have suitable first aid equipment and protective clothing available close to the storage area; viii. In the event of a hazardous spill, be designed such that spillage and drainage from the area is contained; and ix. Be equipped with spillage kits and cleaning equipment.

Compliant

11.6.4 Summary

Any hazardous chemicals were observed to be properly stored and labeled and did not appear to present a hazard to personnel and food products. No processing utensils or packaging were stored next to chemicals. Daily supplies of chemicals were stored properly. Chemical storage areas were observed to be locked and had instructions on handling hazardous chemicals, an up-to-date inventory of all chemicals, available first aid and spill containment equipment. All stored chemicals have current SDS information on file at the facility. SDS information was reviewed for Pail Hydraulic Oil, Zaak Epoxico Catalizado enamel, PAA Sanitizer, Nex Guard 22352 water additive for boilers). Pest control chemicals are not stored on site.



11.6.5 Loading, Transport, and Unloading Practices Module 11


Evidence

11.6.5.1

The practices applied during loading, transport and unloading of food shall be documented, implemented and designed to maintain appropriate storage conditions and product integrity. Foods shall be loaded, transported and unloaded under conditions suitable to prevent cross contamination.

Compliant

11.6.5 Summary

A policy defining the practices for loading, unloading and storage of food products has been documented and implemented. It was observed during the audit tours that food is unloaded, stored and loaded under conditions that prevent cross contamination.

11.6.6 Loading Module 11


11.6.6.1

Vehicles (e.g. trucks/vans/containers) used for transporting food shall be inspected prior to loading to ensure they are clean, in good repair, suitable for the purpose and free from odors or other conditions that may impact negatively on the product.

Compliant

11.6.6.2 Loading practices shall be designed to minimize unnecessary exposure of the product to conditions detrimental to maintaining the product and package integrity during loading and transport.

Compliant

11.6.6.3 Vehicles (e.g. trucks/vans/containers) shall be secured from tampering using a seal or other agreed upon, acceptable device or system. Compliant

11.6.6 Summary

The supplier's policy requires that all trailers be inspected for cleanliness, infestation, odors, damage, etc. before loading. Records "Inspeccion de contenedor para embarque de producto terminado" 60.QCD.BB.TT.006 and "Finish good export form" 60.MLD.SB.SH.001 was reviewed for 2019.05.22. It was observed during the audit tours that loading practices do not expose products to detrimental conditions and vehicles are secured from tampering using a seal.

11.6.7 Transport Module 11


11.6.7.1 Refrigerated units shall maintain the food at required temperatures and the unit'stemperature settings shall be set, checked and recorded before loading and

N/A The supplier's products are not required to be



product temperatures recorded at regular intervals during loading as appropriate. refrigerated.

11.6.7.2 The refrigeration unit shall be operational at all times and checks completed of the unit's operation, the door seals and the storage temperature checked at regular intervals during transit.

N/AThe supplier's products are not required to be refrigerated.

11.6.7 Summary

The supplier's products are not required to be refrigerated.

11.6.8 Unloading Module 11


ResponseEvidence

11.6.8.1

Prior to opening the doors, the refrigeration unit's storage temperature settings and operating temperature shall be checked and recorded. Unloading shall be completed efficiently and product temperatures shall be recorded at the commencement of unloading and at regular intervals during unloading.

N/A No refrigerated items are received by the supplier.

11.6.8.2 Unloading practices shall be designed to minimize unnecessary exposure of the product to conditions detrimental to maintaining the product and package integrity.

Compliant

11.6.8 Summary

It was observed that unloading practices are designed to prevent product contamination. No refrigerated items are received by the supplier.

11.7.1 Process Flow Module 11


11.7.1.1

The process flow shall be designed to prevent cross contamination and organized so there is a continuous flow of product through the process. The flow of personnel shall be managed such that the potential for contamination is minimized.

Compliant

11.7.1 Summary

The process flow is logical with a continuous flow and designed to prevent cross contamination. It was observed during audit tours that the flow of employees is such that any cross contamination is minimal.



11.7.2 Receipt of Raw and Packaging Materials and Ingredients Module 11


Response Evidence

11.7.2.1

Dry ingredients and packaging shall be received and stored separately from frozen and chilled raw materials to ensure there is no cross contamination. Unprocessed raw materials shall be received and segregated to ensure there is no cross contamination.

N/AUnprocessed raw materials, frozen or refrigerated items are not received in the facility.

11.7.2 Summary

Unprocessed raw materials, frozen or refrigerated items are not received in the facility.

11.7.3 Thawing of Food Module 11


11.7.3.1 Thawing of food shall be undertaken in equipment and rooms appropriate for thepurpose. N/A The facility does not require thawing of any product.

11.7.3.2

Equipment for water thawing shall be continuous flow to ensure the water exchange rate and temperature does not contribute to product deterioration or contamination. Water overflow shall be directed into the floor drainage system and not onto the floor.

N/A The facility does not require thawing of any product.

11.7.3.3 Air thawing facilities shall be designed to thaw food under controlled conditions at a rate and temperature that does not contribute to product deterioration or contamination.

N/A The facility does not require thawing of any product.

11.7.3.4 Provision is to be made for the containment and regular disposal of used cartonsand packaging from thawed product so that there is no risk to the product. N/A The facility does not require thawing of any product.

11.7.3 Summary

The facility does not require thawing of any product.

11.7.4 High Risk Processes Module 11


11.7.4.1 The processing of high risk food shall be conducted under controlled conditions such that sensitive areas in which high risk food has undergone a "kill" step, a N/A The facility does not produce high risk products.



"food safety intervention" or is subject to post process handling, are protected/segregated from other processes, raw materials or staff who handle raw materials to ensure cross contamination is minimized.

11.7.4.2 Areas in which high risk processes are conducted shall only be serviced by staff dedicated to that function.

N/A The facility does not produce high risk products.

11.7.4.3 Staff access points shall be located, designed and equipped to enable staff to don distinctive protective clothing and to practice a high standard of personal hygiene to prevent product contamination.

N/A The facility does not produce high risk products.

11.7.4.4 Staff engaged in high risk areas shall change into clean clothing or temporary protective outerwear when entering high risk areas. N/A The facility does not produce high risk products.

11.7.4.5 Product transfer points shall be located and designed so as not to compromise high risk segregation and to minimize the risk of cross contamination. N/A The facility does not produce high risk products.

11.7.4 Summary

The facility does not produce high risk products.

11.7.5 Control of Foreign Matter Contamination Module 11


11.7.5.1 The responsibility and methods used to prevent foreign matter contamination of the product shall be documented, implemented and communicated to all staff. Minor

Work in progress in reinforced plastic trays with slots in the lower part stacked on plastic pallets and stored in racks of four levels in the Mogul 4 warehouse and each stacking is protected with an empty tray with grooves. It was observed that the product in process are not completely protected from the foreign matter that could come from the pallet stored in the upper level.

11.7.5.2 Inspections shall be performed to ensure plant and equipment remains in good condition, equipment has not become detached or deteriorated and is free from potential contaminants.

Compliant

11.7.5.3 All glass objects or similar material in food handling/contact zones shall be listed in a glass register including details of their location. Compliant

11.7.5.4

Containers, equipment and other utensils made of glass, porcelain, ceramics, laboratory glassware or other like material (except where the product is contained in packaging made from these materials, or measurement instrumentswith glass dial covers or MIG thermometers required under regulation) shall not be permitted in food processing /contact zones.

Compliant



11.7.5.5 Regular inspections of food handling/contact zones shall be conducted to ensurethey are free of glass or other like material and to establish changes to the condition of the objects listed in the glass register.

Compliant

11.7.5.6 Glass instrument dial covers on processing equipment and MIG thermometers shall be inspected at the start of each shift to confirm they have not been damaged.

Compliant

11.7.5.7 Wooden pallets and other wooden utensils used in food handling/contact zones shall be dedicated for that purpose, clean, maintained in good order. Their condition shall be subject to regular inspection.

Compliant

11.7.5.8 Loose metal objects on equipment, equipment covers and overhead structures shall be removed or tightly fixed so as not to present a hazard. Compliant

11.7.5.9 Knives and cutting instruments used in processing and packaging operations shall be controlled, and kept clean and well maintained. Snap-off blades shall not be used in manufacturing or storage areas.

Compliant

11.7.5 Summary

A policy defining the methods and responsibilities for preventing foreign material contamination has been documented and implemented. NC – 11.7.5.1 Work in progress in reinforced plastic trays with slots in the lower part stacked on plastic pallets and stored in racks of four levels in the Mogul IV warehouse and each stacking is protected with an empty tray with grooves. It was observed that the product in process are not completely protected from the foreign matter that could come from the pallet stored in the upper level. Pre-operational inspections and regularly scheduled maintenance inspections are conducted for the condition of plant and equipment and is free from any potential contaminants. A glass register (Inspeccion de vidrio y plastico quebradizo) has been documented with glass, brittle plastic and ceramic sources included in all areas of the plant. The register is current as of 2019.05. Monthly are made of these areas to ensure breakage has not occurred and items are not missing or moved. The last inspections conducted on 2019.05 were reviewed and found to be completed as scheduled. Wood pallets are not used in open product areas. Periodic maintenance inspections include looking for loose objects and potential contaminants from overheads. The supplier has documented a knife policy and knives are controlled, cleaned and required to be in good condition.

11.7.6 Detection of Foreign Objects Module 11


11.7.6.1 The responsibility, methods and frequency for monitoring, maintaining, calibrating and using screens, sieves, filters or other technologies to remove or detect foreign matter shall be documented and implemented.

Compliant

11.7.6.2

Metal detectors or other physical contaminant detection technologies shall be routinely monitored, validated and verified for operational effectiveness. The equipment shall be designed to isolate defective product and indicate when it is rejected.

Compliant

11.7.6.3 Records shall be maintained of the inspection of foreign object detection devicesand of any products rejected or removed by them. Records shall include any corrective actions resulting from the inspections.

MinorThere is no record of inspection of the magnetic grid of the kitchen continuous line #3 and the filter of the preparation tank of the hard candy continuous line #3.



11.7.6 Summary

The procedure defining methods and responsibilities for the use of foreign material detection and removal devices has been documented in the HACCP Master Plan 60.QCD.BB.FS.013 and implemented. The devices used in the facility include filters, magnets, and metal detectors. NC – 11.7.6.3 There is no record of inspection of the magnetic grid of the kitchen continuous line #3 and the filter of the preparation tank of the hard candy continuous line #3. Metal detectors, filters and magnets are routinely monitored, validated and verified by operations personnel. Demonstration and documentation of the devices were observed during the audit tours. Interviews with employees EH, GR, and SR responsible for the monitoring indicated they were knowledgeable and understood what to do if the devices failed when tested with known samples. Metal detectors 04, 06, 48, 09, 43, 27 and 28 were observed to reject defective product physically and isolate product. Records of metal detector monitoring as CCP in packaging areas: 60.QCD.BB.FS.009 (horizontal) and 60.QCD.BB.FS.015 (vertical) reviewed on 2019.05.20; and records of metal detector monitoring as CP in Mogul 3 line 60.QCD.BB.FS.014 dated 2019.05.21 were complete for verifying the functioning of these devices and the rejection/removal of foreign objects and as well as the records of corrective actions resulting from inspections dated 2019.02.15 and 2019.04.21.

11.7.7 Managing Foreign Matter Contamination Incidents Module 11


Response Evidence

11.7.7.1 In all cases of foreign matter contamination the affected batch or item shall be isolated, inspected, reworked or disposed of. Compliant

11.7.7.2

In circumstances where glass or similar material breakage occurs, the affected area is to be isolated, cleaned and thoroughly inspected (including cleaning equipment and footwear) and cleared by a suitably responsible person prior to the commencement of operations.

Compliant

11.7.7 Summary

The supplier's policy requires that any product affected by foreign material contamination be isolated, inspected, reworked or disposed of. The glass policy requires that a thorough cleanup and inspection occur if a glass breakage were to occur. A responsible person is required to inspect the affected area before the restarting of production.

11.8.1 Location Module 11


11.8.1.1 On site laboratories conducting chemical and microbiological analysis that may pose a risk to product safety, shall be located separate from any food processingor handling activity and designed to limit access only to authorized personnel.

Compliant

11.8.1.2

Provisions shall be made to isolate and contain all laboratory waste held on the premises and manage it separately from food waste. Laboratory waste water outlet shall as a minimum be down stream of drains that service food processing and handling areas.

N/A No hazardous waste is generated in the laboratory.

11.8.1.3 Signage shall be displayed identifying the laboratory area as a restricted area accessible only by authorized personnel. Compliant



11.8.1 Summary

An onsite analytical laboratory is located separately from the food handling/processing areas. The laboratory performs dextrose equivalent, acidity, pH, % humidity, Brix, and water activity.A sign indicates the laboratory is limited to only authorized personnel. No hazardous waste is generated in the laboratory.

11.9.1 Dry and Liquid Waste Disposal Module 11


Evidence

11.9.1.1 The responsibility and methods used to collect and handle dry, wet and liquid waste and store prior to removal from the premises shall be documented and implemented.

Compliant

11.9.1.2 Waste shall be removed on a regular basis and not build up in food handling or processing areas. Designated waste accumulation areas shall be maintained in a clean and tidy condition until external waste collection is undertaken.

Compliant

11.9.1.3 Trolleys, vehicles waste disposal equipment, collection bins and storage areas shall be maintained in a serviceable condition and cleaned and sanitized regularly so as not to attract pests and other vermin.

Compliant

11.9.1.4 Adequate provision shall be made for the disposal of all solid processing waste including trimmings, inedible material and used packaging. Compliant

11.9.1.5 Where applicable, a documented procedure shall be in place for the controlled disposal of trademarked materials. Where a contracted disposal service is used, the disposal process shall be reviewed regularly to confirm compliance.

Compliant

11.9.1.6 Inedible waste designated for animal feed shall be stored and handled so as to not cause a risk to the animal or to further processing.

N/A

11.9.1.7 Waste held on site prior to disposal shall be stored in a separate storage facility and suitably insect proofed and contained so as not to present a hazard. Compliant

11.9.1.8

Adequate provision shall be made for the disposal of all liquid waste from processing and food handling areas. Liquid waste shall be either removed from the processing environment continuously or held in a designated storage area in lidded containers prior to disposal so as not to present a hazard.

Compliant

11.9.1.9 Reviews of the effectiveness of waste management will form part of daily hygiene inspections and the results of these inspections shall be included in the relevant hygiene reports.

Compliant

11.9.1 Summary

The policy included in Manejo de Residuos Peligrosos y No Peligrosos 30.ENV.BB.EP.001, 2019.02.07 defining methods and responsibilities for handling dry, wet and liquid waste has been implemented. Waste was observed to be removed on a scheduled basis. Waste containers, hoppers, bins and storage areas were observed to be well maintained and clean on the exterior of the facility. Solid waste from processing was observed to be properly disposed of. The procedure Destruccion de Materiales con Marcas Registradas 30.QCD.BB.NC.003,



2018.11.18 defining methods and responsibilities for the controlled disposal of substandard trademark materials to prevent them finding their way on to the market. The disposal process by a contracted disposal service is verified regularly by the destruction manifest and photographic evidence. Records dated 2019.07.19 were reviewed. Food products intended to be supplied for animal feed are segregated from other waste materials, protected from contamination during storage, and managed separate so as not to cause a risk to the animal or to further processing, as reviewed in Manejo de Residuos No Peligrosos, 30.ENV.SB.SP.003, 2018.08.15. Waste water is discharged to plant drains and collected for disposal to contract service that treat water. Review of the effectiveness of waste management is recorded in Programa maestro de limpieza reporte seminal – saneamiento. 60.SAN.BB.FS.073. Records dated 2019.05.13 to 19 were reviewed.

11.10.1 Grounds and Roadways Module 11


Evidence

11.10.1.1 Measures shall be established to maintain a suitable external environment, and the effectiveness of the established measures shall be monitored and periodically reviewed.

Compliant

11.10.1.2 The grounds and area surrounding the premises shall be maintained to minimizedust and kept free of waste, accumulated debris or standing water so as not to attract pests and vermin.

Compliant

11.10.1.3 Paths, roadways and loading and unloading areas shall be maintained so as not to present a hazard to the food safety operation of the premises. Compliant

11.10.1.4 Paths, roadways, loading and unloading areas shall be adequately drained to prevent ponding of water. Drains shall be separate from the site drainage system and regularly cleared of debris.

Compliant

11.10.1.5 Surroundings shall be kept neat and tidy and not present a hazard to the hygienic and sanitary operation of the premises. Compliant

11.10.1.6 Paths from amenities leading to site entrances are required to be effectively sealed.

Compliant

11.10.1 Summary

Measures have been established to maintain a suitable external environment and the pest control operator performs weekly external inspections. The last external inspection was performed on 2019.05.16 and reviewed by management. The grounds and premises surrounding areas were observed to be free of dust and waste, so pests are not attracted. Paths, roadways and loading and unloading areas were well maintained and adequately drained. Surroundings are kept neat and tidy so not to present a hazard to the sanitary operation of the premises. Paths from employee amenities to facility entrances were sealed.