international featured standards (ifs) food version 6 ... za...

International Featured Standards (IFS) Food Version 6, January 2012

DANA, d.o.o.

Mirna SLOVENIA

Version 6 Audit number: IFS-IS 147839 of 61 Lead Auditor: J. Cetkovic

This report shall not be reproduced in part without the permission of ISACert B.V., P.O. Box 8006, 6710 AA Ede, the Netherlands, Tel: +31(0)318 658750; email: [email protected]

International Featured Standards (IFS) Food Version 6, January 2012

ISACert Audit Report

Report to:

DANA, d.o.o.

Glavna cesta 34

8233Mirna

SLOVENIA

Date(s) of audit: 23-04-2014, 24-04-2014, 25-04-2014

Audit type: Repeat

Auditor(s): J. Cetkovic

CONFIDENTIAL

All rights reserved. No part of this report may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without the prior written permission of ISACert B.V. Notwithstanding all due care that was given to the writing of this report, ISACert B.V. cannot be held liable for any damage that might result as the consequence of any mistake that might be included in this report.

This audit report may not be used as a proof for certification.

This audit report may not be given to a third party, other than in full.

Audit Report of DANA, d.o.o.

Version 6 Audit number: IFS-IS147839 of 61 Lead Auditor: J. Cetkovic


1. Audit procedure

This report gives the details of the audit of DANA, d.o.o. against the International Featured Standards (IFS) Food, Version 6 from January 2012. The audit was performed by J. Cetkovic. Pre-audit requirements:

1. The audit report of conformance to the International Featured Standards (IFS) Foodcannot be used to prove

or disprove compliance with other Standards.

2. Audit results were obtained by sampling. In the case that no non-conformities were reported, this is no

proof for the complete absence of non-conformances.

2. Audit details

Audit details

Name of Certification Body: ISACert B.V.

Auditor(s):

J. Cetkovic

Date/time of current audit:

23-04-201409:00 - 18:00

24-04-201408:00 - 17:00

25-04-201408:00 - 16:00

-

Date of initial audit:

Name and address of the company (or headquarter):

DANA, d.o.o.

Glavna cesta 34

8233Mirna

SLOVENIA

Name and address of the audited site:

DANA, d.o.o.

Glavna cesta 34

8233Mirna

SLOVENIA

COID:20677

Phone:

+38673462200

Fax:

+38673462210

Phone:

+38673462200

Fax:

+38673462210

Emailaddress: [email protected]

Scope of audit

Aseptic filling, pasteurization, filtration to remove hazards, microfiltration, cooling, chilling and respective cool storing, white room technology, reverse osmosis, distillation, bottling, blending and mixing of fruit juices and nectars, syrups, soft drinks and spirits. Bottling of water. Excluded: filling of water in gallons 18.9l and products in tetra pack 1.5l

Product and technology scope(s)

8, B, C, D, E, F




Audit participants

Name Position Opening meeting

Documentation review

Site assessment

(Audit)

Closing meeting

Marko Hren Director X X

Marija Krištof QAM X X X X

Mitja Majzelj Head of production X X

Renata Gorec Buèar Technologist X X X

Mojca Novak Head of HR X

Meteja Grabnar Head of sales X

Igor Koren Commercial Director X

Irena Kurent Head of development X

Suzana Povše Technologist in development department

X

Lana Nikoliæ Auditor in training X X X X

Final result of audit

As a result of the audit performed on 23-04-2014, 24-04-2014, 25-04-2014, ISACert B.V. found that the processing activities of DANA, d.o.o.for the above mentioned scope of production comply with the requirements set out in the IFS Food, Version 6, at Higher Level, with a score of 96.81%.

The ISACert certification manager has decided on 02-06-2014 to grant a IFS certificate with the identification: IFS-IS 147839.

Next audit has to be performed in time period 8 weeks before and 2 weeks after:20-06-2015.

Company profile

Company is privately owned, does not belong to a larger organisation, independent. Plant was built in 1950. The latest expansion was done in 2007-new buildings (offices) of and filling line for filling into a PET packaging. The surface of the plant is 5 ha from which is production area 1200 square meters. Last investments made in production areas in 2007: new line for PET. In total 75 employees are working within the company of which 65 full time, 10 part time. The company is working in dayshift. Water, soft drinks, fruit nectars and juices, syrups and spirits are produced on this site, using following technologies aseptic filling, thermal pasteurization (P2), filtration, microfiltration (P5), cooling, chilling and respective cool storing (P6), white room technology (P9), reverse osmosis (P10) bottling (P11), blending and mixing (P12), distillation (P13). Therefore certification scope is: Aseptic filling, pasteurization, filtration to remove hazards, microfiltration, cooling, chilling and respective cool storing, white room technology, reverse osmosis, distillation, bottling, blending and mixing of fruit juices and nectars, syrups, soft drinks and spirits. Bottling of water. Excluded: filling of water in gallons 18.9l and products in tetra pack 1.5l. Outsourced processes:production of products in tetra pack 1.5l-what is out of scope. Seasonal breaks of more than one week namely does not exist. during the audit, it was observed producing of water with CO2 0.5 l for Spar (shelf life till 23.04.2015.) on Alsim line, natural mineral water "Dana" 0.5 l on Combi line-Naravna mineralna voda, preparing of syrup "Dana" gozdna jagoda in aloa vera 1000 l (order 101028/2014-20924), mixing and filtration of rum (Domaæi rum 37.5%) trough filter 280 XE (LOT 3102003) dated 24.04.2014., and production




(filling) of Dana 0.2 l èrni ribez nectar order 101041/2014 with shelf life till 24.10.2015. Traceability test is performed on TUŠ apple nectar 1L LOT and shelf life 27-06-2015; syrup PIKA sirup pomarandža (orange) LOT and shelf life 11-05-2014; and spirit drink VODKA TUŠ LOT L0214. No traded products present. The company does not need formal approval from authorities. Other certificates held by the company ISO 9001. The audit duration is conform requirements. The IFS logo is not used by the company. Contact person in case of emergency is Marija Krištof +38673462221.

Reviewer

K. Ilieva




3. Result

The processing activities of company DANA, d.o.o.met the requirements of the IFS food Version 6. The company passed with a score of 96.81% at:

Score: 96.81% Higher level Summary overview:

Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6

Senior

Management Responsibility

Quality and Food Safety Management

System

Resource Management

Planning and Production

Process

Measurements, Analysis,

Improvements

Food Defense and External Inspections

KO 0 0 0 0 0 0

Major 0 0 0 0 0 0

A 21 32 25 119 43 7

B 1 1 0 1 1 0

C 0 0 1 5 0 1

D 0 0 1 0 0 0

N/A 0 0 1 20 1 0

General summary table for all chapters:




Observations regarding KO’s and Majors:

No. Level Requirement set out in the IFS Food Rating Observation auditor




Overall summary of the audit: The management is involved in the daily process. The effectiveness of operations is monitored. Employees are made aware of their responsibilities. Responsible for food safety is the QAM. Objectives 2014 are documented. A management review is carried out. Number of HACCP plans is 8. The CCP’s are: 4 of them is temperature of pasteurization-for every type of products there is different temperature and CCP 5 is disinfection of water. All CCP's are validated. For each CCP a monitoring system is defined per batch and per hour. Records are verified by Head of production. The risks from chemical, physical or microbiological contamination are identified. Control measures for e.g. preventing foreign materials are implemented by means of filters and visual inspection. Seen overview of allergen-containing materials and risk assessment of 17.12.2013. Company does not work with GMO products. Specifications are in place. No traded goods. List of purchased goods row materials, packaging materials, chemicals for cleaning. Specific requirements agreed for private labels are approved. Certificates of conformity for packaging materials seen. The intended use of packing materials is communicated to the suppliers. A system is in place for traceability. This includes traceability of primary packaging materials, raw materials, semi-finished products, and finished products. Frequency of traceability test is once per year. Last traceability test is dated 02.04.2014.During the audit a traceability trail was performed on following products chosen by the auditor: TUŠ apple nectar 1L LOT and shelf life 27-06-2015; syrup PIKA sirup pomarandža (orange) LOT and shelf life 11-05-2014; and spirit drink VODKA TUŠ LOT L0214. No deviations spotted in the related specification, recipe and work instructions. Access to the site is regulated by porter on the gate. He controls access, checked and registered all visitors. He must be sure that everyone (visitors) leave their identity card at the entrance. Visitors and contractors are included in the access policy. Personal hygiene rules are communicated and compliance is checked every day visually and internally by swabs. Worker had appropriate trainings and tests about hygiene. The interviewed employees acted in accordance with the company rules. Walls, floors and ceilings are in good condition, suitable and clean. No excessive amount of water used. Potable water in sufficient amount available. Samples are analysed. Pest control is operated by an external pest controller (Zavod za javno varstvo Novo Mesto-seen contract signed in 28.01.2014.), and by the company itself. Pest inspection is carried out 3 times per year externally and 2 times per month internally. Laboratory testing is scheduled based on risk assessment. Pathogen testing like Yeasts, Molds, Aerobic mesophilic bacteria is performed by a contracted laboratory. The quantity control system based on minimum weight is checked at a frequency of at least once per hour and meets legal requirements. Description of follow up of corrective actions from the previous audit: Number of NC's from last audit was 7, 1 B, 3 C and 3 D grades, mostly from chapter 4. All NC's were effectively solved. Seen records on site.

Chapter 1: Senior Management Responsibility Summary of all Chapter 1 deviations and non-conformities found:


1.2.3

Job descriptions with clearly defined responsibilities shall exist and shall be applicable for employees whose work has an effect on product requirements.

B

Job descriptions for QAM is not detailed enough. It is written-she has duties according IFS standard, but it is not defines which duties she has according this standard. For all other employees, job descriptions are appropriate




Chapter 2: Quality and Food Safety Management System Summary of all Chapter 2 deviations and non-conformities found:


2.1.2.1

All relevant records necessary for the product requirementsshall be complete, detailed and maintained and shall beavailable on request.

B

It was seen that in one record from cleaning (performed after production of product with gluten, and before production of products without allergens), it was not recorded time of cleaning. Time of analysis (titration; with intention to be checked concentration of CIO (Diversprey and P3-horolit)), and record of quantity of chemicals which are used for cleaning, are recorded appropriate. All other records are appropriate




Chapter 3: Resource Management Summary of all Chapter 3 deviations and non-conformities found:


3.2.2.1

Company procedures shall exist to ensure that all personnel,contractors and visitors are aware of the rules regarding themanagement of wearing and changing of protective clothingin specified areas in accordance with product requirements.

D

Even exist specific rules about wearing of protective clothing, it was observed that few workers went out in that clothing (including caps)-that workers do not work in production area and with open products.

3.3.1

The company shall implement documented training and/orinstruction programs with respect to the product requirementsand the training needs of the employees based ontheir job and shall include:– training contents– training frequency– employee’s task– languages– qualified trainer/tutor– evaluation methodology.

C

Seen training program, records from training and checking of effectiveness of trainings during 2013, but program for 2014 is not complete.




Chapter 4: Planning and Production Process Summary of all Chapter 4 deviations and non-conformities found:


4.2.1.1

Specifications shall be available and in place for all finishedproducts. They shall be up to date, unambiguous and be incompliance with legal and customer requirements.

C

In specification for water is not written origin even in label it is-"From Slovenia”. Also in specification is not written shelf life. Shelf life is not written and in specification for one syrup "Pika sirup pomoranèa". In other specifications for finished products, all is written appropriate.

4.9.2.1

Walls shall be designed and constructed to prevent the accumulationof dirt, to reduce condensation and mould growth,and to facilitate cleaning.

C

Walls are damaged in a few places in the storage for finished goods. Even exist protections to infrastructure be saved, seen a few small damages on the wall made by forklifts. All other walls, especially in production area, are in good condition.

4.9.6.2

External doors and gates shall be constructed to prevent theingress of pests; if possible, they shall be self-closing.

C

One external door in the storage for expedite is not in good condition (goods there are ready for expedition and packed and in secondary packaging materials). There is a gap between walls and door. Second door is new and self closing.

4.12.7

In all areas, e.g. handling of raw materials, processing, packingand storage, where hazard analysis and assessment ofassociated risks have identified a potential product contamination,the presence of glass and brittle material shall beexcluded. Where the presence of glass or brittle plastic cannotbe avoided, appropriate measures shall be in place toprotect against breakage.

C

In the register of glass, plastic and similar materials, there are no watch placed in production of syrup and plastics pallets from production area. Both of them are checked, but there are no results of checking. All other are in the register.

4.13.4

Baits, traps and insect exterminators shall be functioning,shall be in sufficient numbers and shall be placed in anappropriate position. They shall be constructed and positionedas not to cause any contamination risk. C

One insect exterminator is not located appropriate. It is very close, not directly above, but very close to be direct above, dish where the company prepare a syrup. During preparation (dosing), that equipment is open

4.13.5 Incoming deliveries shall be checked on arrival for the presenceof pests. Any infestation shall be documented and controlmeasures taken.

B The company checks every incoming deliveries, but they do not record results of checks.




Chapter 5: Measurements, Analysis, Improvements Summary of all Chapter 5 deviations and non-conformities found:


5.11.3

The performance of the implemented corrective actions shallbe documented and the effectiveness shall be checked.

B

The performance of the implemented corrective actions are documented; effectiveness are checked according Standard. Anyway, it was seen that for a two nonconformities which are found during internal audit, roots ware not identified appropriate-corrections and corrective actions are provided appropriate-seen records.




Chapter 6: Food Defense and External Inspections Summary of all Chapter 6 deviations and non-conformities found:


6.1.2

A food defense hazard analysis and assessment of associatedrisks shall have been performed and documented.Based on this assessment, and based on the legal requirements,areas critical to security shall be identified.Food defense hazard analysis and assessment of associatedrisks shall be conducted annually or upon changes that affectfood integrity.An appropriate alert system shall be defined and periodicallytested for effectiveness.

C

Alert system is defined, but it is not tested yet. Hazard analysis is done.




4. Report of the N/A evaluations


3.4.8

Where highly perishable food products are handled, the followingadditional requirements regarding hand hygieneshall also be provided:– hand contact-free fittings– hand disinfection– adequate hygiene equipment– signage highlighting hand hygiene requirements– waste container with hand contact-free opening.

N/A

No high care area present.

4.4.2.1 In case a company trades manufactured goods, it shall beensured that a process for approving and monitoring suppliersexists and is implemented.

N/A Traded goods no longer in scope of IFS Food 6.

4.4.2.2

In case of traded manufactured goods, the process forapproving and monitoring suppliers shall contain clearassessment criteria such as: audits, certificates of analysis,supplier reliability, complaints as well as required performancestandards.

N/A

Traded goods no longer in scope of Food v6.

4.4.2.3 In case of private labels, a supplier approval system inaccordance with customer requirements shall exist for pre-suppliersof finished or semi-finished products.


4.7.3

Outdoor storage shall be kept to a minimum. Where goodsare stored outside, hazard analysis and assessment of associatedrisks shall be undertaken in order to ensure that thereis no risk of contamination or adverse effect on quality andfood safety.

N/A

No outside storage.

4.8.3 In case of microbiologically sensitive production areas, theseshall be operated and monitored to ensure product safety isnot compromised.

N/A No high care area required.

4.9.4.2 Where false ceilings are used, an access to the void shall beprovided in order to facilitate cleaning, maintenance andinspections for pest control.

N/A No false ceilings in production areas.

4.9.8.4 Dust extraction equipment shall be installed in areas whereconsiderable amounts of dust are generated.

N/A No necessary to extract dust.

4.9.9.2

Recycled water which is used in the process shall not pose acontamination risk. The water shall comply with applicablelegal requirements for potable water; records of compliancetesting shall be available.

N/A

In the process recycled water is not used.

4.10.10 Where a company hires a third-party service provider forcleaning and disinfection activities, all requirements specifiedwithin section 4.10 shall be clearly defined in the respectivecontract.

N/A The company does not hire third party service provider.

4.12.3

Where metal- and/or other foreign material detectors arerequired, they shall be installed to ensure maximum efficiencyof detection, in order to avoid subsequent contamination.Detectors shall be subjected to regular maintenance toavoid malfunction.

N/A

Metal detectors are not used. The company use filters-seen and analyse for filters-Declaration of compliance-valid till 28.02.2015.-membracard XLII filters cartrigs-they use filters XE 50, XE 20, XE 280. Beside that, the company use light screen to check condition of bottles. One worker check every bottle trough the screen (in every 2 hours worker be changed with another one because eyes become tired and checking can not be enough adequate if he/she would not be replaced). If he/she found anything, glass immediately be removed and recorded- every day the head of production verify it.

4.12.5 The appropriate accuracy of detectors shall be specified.Checks of proper function of detectors shall be carried outregularly. In

N/A There is no metal detector. The company use filters-for water 0.2




case of malfunction or failure of a metal and/orforeign material detector, corrective actions shall be defined,implemented and documented.

and 1 µm, for other products XE 50, XE 20, XE 280...

4.12.6 In cases where special equipment or methods are used todetect foreign material, these shall be properly validated andmaintained.

N/A There is no metal detector.

4.14.6

Where a company hires a third-party storage service provider,the service provider shall be subject to IFS Logisticsrequirements. If the third party service provider is not certifiedto IFS Logistics, all relevant requirements equivalent tothe company’s own warehousing practices shall be fulfilledand this shall be clearly defined in the respective contract.

N/A

The company does not hire third-party storage provider.

4.15.3 Where goods must be transported at certain temperatures,before loading, the temperature inside the vehicle shall bechecked and documented.

N/A No controlled temperature needed.

4.15.4 Where goods must be transported at certain temperatures,maintaining the adequate range of temperatures duringtransport shall be ensured and documented.


4.19.1

For products being delivered to customers and/or countrieswith GMO requirements, the company shall have in placesystems and procedures to allow the identification of productsconsisting of GMOs, containing GMOs or producedfrom GMOs, including food ingredients, additives andflavouring(s).

N/A

Company does not work with GMO products.

4.19.2

Raw material specifications and delivery documents identifyingproducts consisting of, being made from, or containingGMOs shall be available. The assurances concerning theGMO status of the raw materials shall be agreed by contractwith the supplier or the relevant technical documents shallspecify the GMO status. The company shall maintain a continuouslyupdated listing of all GMO raw materials used atits premises, which also identifies all blends and formulas towhich such GMO raw materials are added.

N/A

The company does not work with products consisting of, containing or produced with GMOs

4.19.3

There shall be adequate procedures to ensure that whereproducts consisting of or containing GMOs are manufactured,contamination of non-GMO products is avoided. Adequatecontrol measures shall be in place to avoid GMO crosscontamination. The effectiveness of these procedures shallbe monitored by testing.

N/A


4.19.4

Finished products containing GMOs or labelled as not containingGMOs shall be declared in accordance with currentlegal requirements. Delivery documents shall include thecorresponding reference to GMOs.

N/A


4.19.5 Customer requirements concerning the GMO status of productsshall be clearly implemented by the company. N/A


5.5.5 For purchased, already pre-packed products from third parties,there shall be evidence about the compliance with thelegal requirements for nominal quantity.

N/A No pre-packed products in the audit scope.




5. Corrective Action Plan

Company: DANA, d.o.o.

Glavna cesta 34

8233Mirna

SLOVENIA

Date(s) of Audit:

23-04-2014, 24-04-2014, 25-04-2014

List of Non-Conformities

No.

Level

Requirement set out in the IFS Food

Ratin

g

Observation auditor Root cause

analysis

Corrective action implemented +

date

Responsible function

Review result of the auditor

Comment Advice

1.2.3


B


Job description is an old version, we are in the preperation of new version.

A new version of job description for QAM is going to have a detailed definition of duties according to IFS standard. (15-5-2014)

Marija Krištof CAP is appropriate

Positive




2.1.2.1


B


The operater didn't make a record of the hour.

Recording of the hour of cleaning has been done immediately, also the instructions for the operators were refreshed and forwarded again. IFS representative will check effectiveness during internal inspections. (25-4-2014)


Positive

3.2.2.1


D


Because there is no open product area, the rules are not so strict, but we did not wrote it in procedure.

Implementation of specific rules about wearing outside the production areas, depending on the risk assessment and product demands. (4-6-2014)

Renata Gorec Bucar

CAP is appropriate

Positive

3.3.1


C


The program is not yet completed,it is in preparation, but auditor saw that all planned training were made.

Completion of the program. IFS representative will check effectiveness during internal inspections. (31-5-2014)

Mojca Novak CAP is appropriate

Positive




4.2.1.1

Specifications shall be available and in place for all finishedproducts. They shall be up to date, unambiguous and be incompliance with legal and customer requirements.

C


The label for water has changed, but the specification is not yet corrected. Shelf life in Pika sirup pomaranca has not been written in specification, it is in other instructions.

Correction and fulfilling of the specifications. IFS representative will check effectiveness during internal inspections. (31-5-2014)

Irena Kurent CAP is appropriate

Positive

4.9.2.1


C


The damage was done by the forklifts recently.

Repairing of the walls. IFS representative will check effectiveness during internal inspections. (31-5-2014)

Mitja Majzelj CAP is appropriate

Positive

4.9.6.2


C


The doors are old. Correction of the doors. IFS representative will check effectiveness during internal inspections. (31-5-2014)

Mitja Majzelj CAP is appropriate

Positive

4.12.7


C


The watch and plastic pallets were checked only visually without the records, because we it was mentioned that if it is broken we will make a records.

Completion of the register and implementation of appropriatte records for the checking. (31-5-2014)

Miro Marn CAP is appropriate

Positive




4.13.4

Baits, traps and insect exterminators shall be functioning,shall be in sufficient numbers and shall be placed in anappropriate position. They shall be constructed and positionedas not to cause any contamination risk.

C


The insect exterminator was not optimally located, the responsibility for that have Pest control company.

Moving of the exterminator to appropriate location. IFS representative will check effectiveness during internal inspections. (31-5-2014)

Renata Gorec Bucar

CAP is appropriate

Positive

4.13.5

Incoming deliveries shall be checked on arrival for the presenceof pests. Any infestation shall be documented and controlmeasures taken. B

The company checks every incoming deliveries, but they do not record results of checks.

The implementation of the records was not done yet also because the presense of the pests on incoming deliveries is not problematic.

Implementation of the records.IFS representative will check effectiveness during internal inspections. (31-5-2014)

Marjan Dim CAP is appropriate

Positive

5.11.3


B


There is no section in the formular for putting the root analysis.

Correction of the formular for internal audit and training of internal auditors. (31-5-2014)


Positive

6.1.2


C


On the basis of the risk assesment we have assumed that the risk is low.

Test of the food safety system in Dana will be done. (30-6-2014)


Positive




6. Detailed Audit Report

Company: DANA, d.o.o.

Glavna cesta 34

8233Mirna

SLOVENIA

Date(s) of Audit:

23-04-2014, 24-04-2014, 25-04-2014

No.

Level

Requirement set out in the IFS Food R

atin

g

Observation auditor

1 Senior Management Responsibility

1.1Corporate policy/Corporate principles

1.1.1

The senior management shall draw up and implement a corporate policy. This shall consider as a minimum:– customer focus– environmental responsibility– sustainability– ethics and personnel responsibility– product requirements (includes: product safety, quality, legality, process and specification).The corporate policy shall be communicated to all employees.

A

The company policy is dated “Politika kakovosti in varnosti izdelkov” 28.01.2013. and signed by director Marko Hren. The employees of the company are informed of the policy through the training. The content of the policy complies with the requirements of the standard.

1.1.2

The content of the corporate policy shall have been broken down into specific objectives for the related departments.The responsibility and the time scale for achievement shall be defined for each department of the company.

A

Clear objectives and targets are set for production for 2014. Seen records "Plan poslovanja za leto 2014", "Plan investicij 2014", "Plan izobraževanja za leto 2014". Once per year the company establish objectives. One objective for production is to connect Combi production line with Alsim line and to invest into more automatized packaging machine for big boxes, to return some private labels-during 2013 the company lost opportunity o produce private label for some retailers, development of new products, buying of tetra pack machine, producing of functional drinks... Realization of objectives is reviewed once a month through meetings with director and all departments managers. Seen reports from meeting 27.01.2014.

1.1.3

From the corporate policy, the quality and food safety objectives shall be communicated to the employees in the respective departments and shall be effectively implemented.

A

The corporate policy, the quality and food safety objectives are communicated to the employees in the respective departments and are effectively implemented.

1.1.4

The senior management shall ensure that the achievement of all objectives is regularly reviewed, as a minimum at least once a year.

A

Records from management review 27.01.2014 checked. Objectives include targets for complaints, product quality, trainings, production costs, investments, purchasing new materials, customer satisfaction, employees satisfaction... The objectives are communicated to the employees by training. Objectives are reviewed minimum once per year. Progress to date show that most objectives are on the target. Seen objectives for 2013 “Plan poslovanja za leto 2013” dated February 2013. and realization of objectives and goals for 2013 dated 27.01.2014. and objectives for 2014




1.1.5

All relevant information related to food safety and quality shall be communicated effectively and in a timely manner to the relevant personnel.

A

All relevant information related to food safety and quality are communicated effectively to the relevant personnel every two months director has meeting with all employees, and every month director has a meeting with QAM, Head of production, Head of laboratory, Head of development, Head of selling and Head of purchasing-no deviation was found.

1.2Corporate structure

1.2.1

An organisation chart shall be available showing the structure of the company.

A

The organization chart shows adequately the structure of the organization. Seen "Odgovornosti in poblastila v Dani, d.o.o." dated 17.12.2012. and 12.05.2014.

1.2.2

Competences and responsibilities, including deputation of responsibility shall be clearly laid down.

A

Competences and responsibilities are described in job descriptions. Seen job descriptions Opis delovnega mesta for Marija Krištof-QAM dated 01.12.2006. and for Head of production Mitja Majzelj. Also seen deputation list Nadomešèanje vodji v èasu njihove odsotnosti, dated 10.04.2014.

1.2.3


B


1.2.4 KO

KO n° 1: The senior management shall ensure that employees are aware of their responsibilities related to food safety and quality and that mechanisms are in place to monitor the effectiveness of their operation. Such mechanisms shall be clearly identified and documented.

A

The management team consists of director, QAM, Head of production, Head of Purchasing, Head of Sales, Manager for HR. They have meeting every two weeks. One per month they summarized results from last month and one per year they organize management review where they analyze whole production and everything what is related with their business. The day-to-day supervision on the organization is done through key personnel. During the audit interviews are held with QAM, head of production, administrator and worker on CCP. It was established that these employees were aware of their responsibilities. The effectiveness of operations is monitored by tests, during internal audits and during daily control in production. Employees are made aware of their responsibilities through instruction which are placed in a few places in production area and during daily meeting with Head of production. Senior management ensures that employees know their responsibilities through daily control, weekly control and internal audits. Responsible for food safety QAM.

1.2.5

Employees with influence on product requirements shall be aware of their responsibilities, and shall be able to demonstratetheir understanding of their responsibilities.

A

The relevant tasks, responsibilities and authorities are documented and communicated by rules - DPP – Dobra proizvodna praksa. During the audit interviews are held with Marija Krištof-QAM dated 01.12.2006., for Head of quality Renata Gorec Buèar dated 01.12.2006., for Head of production Mitja Majzelj dated 01.12.2006.. It was established that these employees were aware of their responsibilities.




1.2.6 The company shall have an IFS representative nominated by senior management.

A IFS representative is Marija Krištof-QAM

1.2.7 The senior management shall provide sufficient and relevantresources to meet the product requirements. A

The senior management has defined following resources; budget plan, investment plan, eduction plan.

1.2.8 The department responsible for quality and food safety managementshall have a direct reporting relationship to the seniormanagement.

A QAM has a direct report with the senior management and participates in meetings with the senior management

1.2.9 The company shall ensure that all processes (documented and undocumented) are known by the relevant personnel and are applied consistently.

A The relevant personnel are aware of the processes and those are applied consistently.

1.2.10

The company shall have a system in place to ensure that it is kept informed of all relevant legislation on food safety and quality issues, scientific and technical developments and industry codes of practice. A

The company is aware of the legal requirements. The company is kept informed of the relevant developments concerning legislation and science by means of Lex Slovenia. The company is aware of the legal requirements of EU countries and USA where they export goods.

1.2.11

The company shall inform its customers, as soon as possible, of any issue related to product specification, in particular of all non-conformity(ies) identified by competent authorities related to products which could have, has or has had a defined impact on safety and/or legality of respective products. This could include, but are not limited to cautionary issues.

A

No deviation was found- during the audit it was observed that there is exist person who is responsible for external communication- Marko Hren-director. He is responsible to inform customers as soon as possible about any issue related to product specification and other issue related to products

1.3Customer focus

1.3.1

A documented procedure shall be in place to identify fundamentalneeds and expectations of customers.

A

Customer requirements are reviewed and communicated in accordance with FSQMS Manual. Customer requirements are reviewed and communicated in accordance with procedure “Procedure of verification of customer satisfaction”. Customer satisfaction is done via questionnaire, surveys about satisfaction, promotions... Monitoring and measuring customer satisfaction is done two times a year by Commercial manager.

1.3.2

The results of this procedure shall be evaluated and considered to determine quality and food safety objectives.

A

Customer requirements are reviewed and communicated in accordance with FSQMS Manual. This is done by questionnaires, promotion and survey interviews with customers. Customer satisfaction index, complaints and returns are used to evaluate customer satisfaction. Seen results of customer satisfaction at the end of 2013.

1.4Management review




1.4.1

Senior management shall ensure that the quality and food safety management systems are reviewed at least annually or more frequently if changes occur. Such reviews shall contain, at least, results of audits, customer feedbacks, process compliance and product conformity, status of preventive and corrective actions, follow up actions from previous management reviews, changes that could affect the food safety and quality management systems and recommendations for improvement.

A

The management review of 27.01.2014. demonstrates that the senior management is in control of meeting the requirements of the standard. Senior and middle management meetings are implemented to monitor progress. During internal audit which was performed in 07.03.2014. (that one one topic during MR) , it was found a few NCs. Two of them are: the scale for grading of customer satisfaction questionnaires is 1-3 what is not enough to show real picture about company. Idea was given during the audit that new scale be minimum 1-5. It was just remark, but the company started to increase scale and analyse results of customer satisfaction more detailed. One NC was-in the area where the company produce syrup, there are wooden pallets instead of plastic pallets. Root was not adequate control of foreign bodies-according register, pallets must be plastic. During control, worker did not pay attention on it, and after cleaning of plastic pallets, instead of them, in production area ware entered wooden (which ware in good condition). Correction was-to replace them with plastic pallets and to train workers. All corrective actions ware closed and verified. Completion of actions is verified by QAM.

1.4.2

This review shall include the evaluation of measures for the control of the quality and food safety management system and for the continuous improvement process.

A

The management review includes the criteria of the standard.

1.4.3

The company shall identify and review regularly (e.g. by internal audits or on-site inspection) the infrastructure needed to achieve conformity to product requirements. This shall include, as a minimum, the following:– buildings– supply systems– machines and equipment– transport.The results of the review shall be considered, with due consideration to risk, for investment planning.

A

The frequency of internal audits is based on a risk assessment and Annual Schedules, at least once per year. The scope includes all aspects of the quality system, all departments, buildings and infrastructure, working environment. An up-to-date internal audit plan is available – seen Audit schedule 2014.

1.4.4

The company shall identify and review regularly (e.g. by internal audits or on-site inspection) the work environment needed to achieve conformity to product requirements. This shall include, as a minimum the following:– staff facilities– environmental conditions– hygienic conditions– workplace design– external influences (e.g. noise, vibration).The results of the review shall be considered, with due consideration to risk for investment planning.

A

The frequency of internal audits is based on a risk assessment and Annual Schedules, at least once per year. The scope includes all aspects of the quality system, all departments, buildings and infrastructure, working environment. An up-to-date internal audit plan is available – seen Audit schedule 2014.




No.

Level


Ratin

g

Observation auditor

2 Quality and Food Safety Management System

2.1 Quality Management

2.1.1 Documentation requirements

2.1.1.1

The system for food safety and quality management shall bedocumented and implemented, and shall be retained in onelocation (food safety and quality manual or electronic documentedsystem).

A

Relevant documentation is accessible for employees by intranet and by paper instruction. Documentation is sufficiently detailed to support operations "Navodila za delo skladišèa surovin" and "Uputstvo za parter STORK" NA.PR.079 dated 24.06.2010. Interviews with Avguštin Smoliè and Head of production Mitja Majzelj demonstrated knowledge of relevant procedures.

2.1.1.2

A documented procedure shall exist for the control of documentsand their amendments.

A

Procedure is in place and includes how obsolete documents should be controlled in order to preserve relevant information and destroyed to avoid its misuse. Information documents also considered in the procedure.

2.1.1.3

All documents shall be clearly legible, unambiguous andcomprehensive. They shall be available to relevant personnelat all times.

A

All documents are clearly legible, unambiguous and comprehensive. Documents were seen to be adequately written.

2.1.1.4 All documents which are necessary for compliance with theproduct requirements shall be available in their latest version.

A All documents which are necessary for compliance with the product requirements are available and in their latest version.

2.1.1.5

The reason for any amendments to documents critical forthe product requirements shall be recorded.

A

All documents are authorised, have a reference number, date and version. Index in place showing what version number was current.

2.1.2Record keeping

2.1.2.1


B


2.1.2.2

Records shall be legible and genuine. They shall be maintainedin a way that subsequent manipulation of records isprohibited.

A

Records are legible and genuine. The records with regard to the control of CCP's and CP’s were assessed. These records did meet the criteria of the standard.

2.1.2.3

All records shall be kept in accordance with legal requirementsand for a minimum of one year after the shelf life. Forproducts which have no shelf life, the duration of recordkeeping shall be justified and this justification shall be documented.

A

The record keeping duration is at least three years.

2.1.2.4 Any amendments to records shall only be carried out byauthorised persons.

A Alterations are to be authorized.

2.1.2.5 Records shall be securely stored and easily accessible.

A Records are stored in intranet. All documents are easily accessible.




2.2 Food Safety Management

2.2.1 HACCP system

2.2.1.1

The basis of the company’s food safety control system shallbe a fully implemented, systematic and comprehensiveHACCP system, based upon the Codex Alimentarius principles.It shall take into account any legal requirements of theproduction and destination countries which may go beyondsuch principles. The HACCP system shall be implemented ateach production site.

A

The HACCP plan includes producing of water, fruit juices and nectars, syrups soft drinks and spirits. The method used was the Codex Alimentarius decision tree combined with a risk analysis based in likelihood of occurrence and severity of the hazard. The HACCP study is fully documented. 5 relevant critical control points were identified in terms of food safety: There are 5 CCP’s. CCP 1- CCP 4 are T of pasteurisation - achieved pasteurisation temperature has to be between 94 and 99 oC, for STORK line (glass bottles) and 96 and 99 for other lines (PKL line and ALSIM line 96-99 oC, and for COMBI line 97-99 oC. CCP is desinfection of water-concentration free ClO2 of the network-minimum is 0.1-0.15 mg/l (maximum is 0.2 mg/l)). Seen flow diagrams for every process.

2.2.1.2

The HACCP system shall cover all raw materials, products orproduct groups as well as every process from goods intodispatch, including product development and product packaging.

A

The scope of the system is clearly defined and covers all materials, products and processes. All the products produced in this site are included in the scope. Following product group is defined: water, fruit juices and nectars, syrups, soft drinks and spirits. Subject to the audit is: Aseptic filling, pasteurization, filtration to remove hazards, microfiltration, cooling, chilling and respective cool storing, white room technology, reverse osmosis, distillation, bottling, blending and mixing of fruit juices and nectars, syrups, soft drinks and spirits. Bottling of water. Excluded: filling of water in gallons 18.9l and products in tetra pack 1.5l.

2.2.1.3

The company shall ensure that the HACCP system is basedupon scientific literature, or technical verified specificationsrelating to the manufactured products and procedures. Thisshall be maintained in line with new technical process development.

A

The following information is used for conducting the hazard analysis: Applicable Slovenia legal requirements, Codex Alimentarius principles, Technical verified specifications related to the manufactured product and procedures.

2.2.1.4 HACCP system shall be reviewed and necessary changesshall be made when any modification is made in the product,process or any step.

A HACCP system is regularly reviewed.

2.2.2 HACCP team

2.2.2.1

Assemble HACCP team (CA Step 1)The HACCP team shall be multidisciplinary and include operationalstaff. Personnel appointed as HACCP team membersshall have specific knowledge of HACCP, product and processknowledge and the associated hazards. Where competentknowledge is not available, external expert advice shallbe obtained.

A

The HACCP team consists of Director, Head of production, QAM for production, Maintenance Responsible, Purchasing Manager and Sales Manager. The team leader is qualified through: education, external training, experience.

2.2.2.2

Those responsible for the development and maintenance ofthe HACCP system shall have an internal team leader andshall have received adequate training in the application ofthe HACCP principles.

A

The company has internally adequate competence knowledge. The company has not obtained external expert advice. Seen record from external training for QAM who is leader for HACCP (IFS) team Marija Krištof performed by Bureau Veritas 07.06.2013.

2.2.2.3 The HACCP team shall have strong senior management supportand shall be well known and established across thewhole facility.

A The senior management has demonstrated commitment to the HACCP.




2.2.3HACCP analysis

2.2.3.1

Describe product (CA Step 2)A full description of the product including all relevant informationon product safety exists such as:– composition– physical, organoleptic, chemical and microbiologicalparameters– legal requirements for the food safety of the product– methods of treatment– packaging– durability (shelf life)– conditions for storage, method of transport and distribution.

A

Following product groups are defined: fruit juices and nectars, syrups, soft drinks, alcoholic drinks and water; shelf life of 12 months for water, 18 months for nectars and no shelf life for alcoholic drinks (traced was vodka); compositions are-on example: for black currant fruit nectar compositions are: water, black current juice made from concentrated juice, sugar, citric acid; for apple nectar compositions are: water, apple juice, citric acid, calcium, extract of stevia; for apple juice fruit content 100%; for rum: color, vanilla, rum punch, alcohol. Packaging material are: combiblock, PET bottles with PET bottom 330 ml, 500ml, 1500 ml, glass bottles 200 ml and 1 l, and PET caps, labels and carton box; method of treatment- aseptic filling, thermal pasteurusation (P2), filtration, microfiltration (P5), cooling, chilling and respective cool storing (P6), white room technology (P9), reverse osmosis (P10) bottling (P11), blending and mixing (P12), destilation (P13)

2.2.3.2

Identify intended use (CA Step 3)The intended use of the product shall be described in relationto the expected use of the product by the end consumer,taking into account vulnerable groups of consumers.

A

Intended use: All products are suitable for general use. Vulnerable consumer group are people allergic on milk and gluten in liqueur. Also for alcoholic drink there are intended use- products are suitable for general use except pregnant women and for children under 18 years. All other products are suitable for general use.

2.2.3.3

Construct flow diagram (CA Step 4)A flow diagram shall exist for each product, or productgroup, and for all variations of the processes and sub-processes(including rework and reprocessing). The flow diagramshall be dated, and clearly identify each CCP with thenumber assigned to it. In the event of any changes the flowdiagram shall be updated.

A

Flow diagram for producing of water start with moulding and production of plastic bottles from preform. Next operation is: directly moulded plastic bottles are then transported to the filling machines in sterile air with disinfection of bottles and bottle caps by sterile water. After preparation of packaging material, next operations are: filling, labelling, automatic palletization and transport to a storehouse. Flow diagram for producing of juice consist: receipt and control of raw materials, dissolving sugar, filtration of sugar solutions, mixing syrup with water, pasteurization, additives dosing, dosing of N2, the formation of packaging and filling of water, cooling, packaging, palletizing, storage; for juice in glass bottles: preparation of syrup, preparation and desinfection of bottles, preheating, deareation, homogenization, pasteurization, hot filling, cooling, labeling, packaging, storage. Seen flow diagrams: HACCP-PD-Stork linija-the last verification was 07.05.2013., HACCP-PD linija Alsim-last verification was in 08.05.2013., HACCP-pretoèni diagram-linija PKL-last verification was in 08.05.2013. and HACCP-PD-linija Combi-last verification was in 08.05.2013

2.2.3.4

On-site confirmation of the flow diagram (CA Step 5)The HACCP team shall verify the flow diagram, by on-sitechecks, at all operation stages. Amendments to the diagramshall be made, where appropriate. A

Seen flow digrams: HACCP-PD-Stork linija-the last verification was 07.05.2013., HACCP-PD linija Alsim-last verification was in 08.05.2013., HACCP-pretoèni diagram-linija PKL-last verification was in 08.05.2013. and HACCP-PD-linija Combi-last verification was in 08.05.2013.




2.2.3.5.1

A hazard analysis shall be available for all physical, chemicaland biological hazards, including allergens, which may reasonablybe expected.

A

Significant hazards are: physical hazard in row material-on example metal, risk from small tools; biological hazard-hands from worker. Verified hazard analyses for TUŠ Vodka 1l, PIKA sirup pomarandža, TUŠ jabolko nektar. The occurrence and severity is assessed. The applied method for determining CCP’s is by decision tree and risk matrix.

2.2.3.5.2 The hazard analysis shall consider the likely occurrence ofhazards and severity of their adverse health effects.

A Seen hazard analysis for every product groups.

2.2.3.6.1

The determination of relevant critical control points (CCP’s)shall be facilitated by the application of a decision tree orother tool(s), which demonstrates a logical reasoned approach. A

The applied method for determining CCP’s is by decision tree and risk matrix. The company identified 5 CCP’s. Seen “Seznam kritiènih kontrolnih toèki v Dani” dated 08.10.2010. CCP1-CCP4 (biological) - pasteurisation and CCP5 is disinfection of water.

2.2.3.6.2

For all steps which are important for food safety, but whichare not CCP’s, the company shall implement and documentcontrol points (CP’s). Appropriate control measures shall beimplemented.

A

For all steps which are important for food safety, but which are not CCP’s, the company implemented and documented CP’s. The CP’s are monitored. On example-control of glass bottles. The company use light screen to check condition of bottles. One worker check every bottle trough the screen (in every hour worker be changed with another one because eyes become tired and checking can not be enough adequate if he/she would not be replaced). If he/she found anything, glass immediately be removed and recorded- every day the head of production verify it. CP is washing of tubes / disinfection with H2O2 (limit 500g H2O2/h for 1.5l and 200g H2O2/h for 0.5 l)-control is every hour on display-seen record Šaržni kontrolni list NA.PR095.One CP is dosing of N2 (0.5-0.7 bar)-control is every hour. Control perform laborant-seen Šaržni kontrolni list

2.2.3.7

Establish critical limits for each CCP (CA Step 8 – Principle 3)For each CCP, the appropriate critical limits shall be definedand validated in order to clearly identify when a process isout of control.

A

The company has 8 HACCP plans. List of CCPs with critical limits: CCP 1- CCP 4 are T of pasteurisation - achieved pasteurisation temperature has to be between 94 and 99 oC, for STORK line (glass bottles) and 96 and 99 for other lines (PKL line and ALSIM line 96-99 oC, and for COMBI line 97-99 oC. CCP is desinfection of water-concentration free ClO2 of the network-minimum is 0.1-0.15 mg/l (maximum is 0.2 mg/l))Validation was checked for following CCPs: )). All CCP's are validated by guidance products, good manufacturing practice, microbiological criteria-seen results of validation and also limits based on legislation and scientific data




2.2.3.8.1 KO

KO N° 2: Specific monitoring procedures shall be establishedfor each CCP to detect any loss of control at that CCP. Recordsof monitoring shall be maintained for a relevant period. Eachdefined CCP shall be under control. Monitoring and controlof each CCP shall be demonstrated by records. The recordsshall specify the person responsible as well as the date andresult of the monitoring activities.

A

Monitoring system for CCPs: For each CCP a monitoring system is defined per batch and per hour. On example-for temperature of pasteurisation, there are thermographic record (on line). 1 per hour worker read temperature on display and record it in Kontrolni list. Also, company does microbiological analysis of each LOT. If temeprature is less than 94 (96, 97) degrees-production is stopped automatically (alarm start), product are removed and marked as non-conforming product, labelled with name, date, number of shift. Seen record-Managing with nonconforming products and nonconforming products. The same procedure is in case that temperature is over 92 For CCP 5 disinfection of water, worker write how much is added for every dosing (c of ClO2) in Evidenca vsebnosti-dnevnik. One per shift laborant take a sample of water and checks concentration of it and perform microbiological analyse of water-seen record Mikrobiološki dnevnik. If something is wrong, alarm switches automatically, after that Head of production take sample of water for one more analyse, and perform correction according results-if it is necessary to correct disinfection with more chlor-seen NA.PR071.The person responsible for verification of records is Head of production and QAM. All CCPs are under control.

2.2.3.8.2 The operative personnel in charge of the monitoring of CCP’sshall have received specific training/instruction. A

All workers on CCP had approriate trainings-seen records from training which is performed in 20.05.2013. and 27.05.2013.

2.2.3.8.3 Records of CCP’s monitoring shall be checked.

A Records of CCP's are checked and verified by QAM.

2.2.3.8.4

The CP’s shall be monitored and this monitoring shall berecorded.

A

The CP’s are monitored. On example-control of glass bottles. The company use light screen to check condition of bottles. One worker check every bottle trough the screen (in every hour worker be changed with another one because eyes become tired and checking can not be enough adequate if he/she would not be replaced). If he/she found anything, glass immidiatelly be removed and recorded- every day the head of production verify it.




2.2.3.9

Establish corrective actions (CA Step 10 – Principle 5)In the event that the monitoring indicates that a particularCCP or CP is not under control, adequate corrective actionsshall be taken and documented. Such corrective actions shallalso take into account any non-conforming products.

A

There are defined procedures on how to act when a critical limit is exceeded. For CCP1-CCP4 temperature of pasteurisation, there are thermographic record (on line). If temperature is less than 94 (96, 97) degrees-production be stopped automatically, product be removed and marked as non-conforming product, be labelled with name, date, number of shift. Seen record-Managing with nonconforming products and nonconforming products. The same procedure is in case that temperature is over 92. For CCP 5-If something is wrong (water is not according specification and microbiological criteria), alarm switches automatically, after that Head of production take sample of water for one more analyse, and perform correction according results-if it is necessary to correct disinfection with more chlor-seen NA.PR071. QAM verified it.

2.2.3.10

Establish verification procedures (CA Step 11 – Principle 6)Procedures of verification shall be established to confirmthat the HACCP system is effective. Verification of the HACCPsystem shall be performed at least once a year. Examples ofverification activities include:– internal audits– analysis– sampling– evaluations– complaint by authorities and customers.The results of this verification shall be incorporated into theHACCP system.

A

The last verification was in 20.05.2013. Seen Potrditev pretoenih diagramov v proizvodnji na licu mesta. Verification is done according Standard

2.2.3.11

Establish documentation and record keeping(CA Step 12 – Principle 7)Documentation shall be available covering all processes,procedures, control measures and records. Documentationand record keeping shall be appropriate to the nature andsize of the company.

A

Established documentation and records were available.




No.

Level


Ratin

g

Observation auditor

3 Resource Management

3.1 Human resources management

3.1.1

All personnel performing work that affects product safety, legality and quality shall have the required competence by education, work experience and/or training, commensurate with their role, based on hazard analysis and assessment of associated risks.

A

The personnel training procedure is documented in the Training Plan for 2014. The training plan is defined after assessment of personnel performance and the assessment of training needs. Quality Department is specifically involved in the assessment of the training needs related to the food safety and quality.

3.2 Human resources

3.2.1Personnel hygiene

3.2.1.1

There shall be documented requirements relating to personnelhygiene. These include, as a minimum, the followingfields:– protective clothing– hand washing and disinfection– eating and drinking– smoking– actions to be taken in case of cuts or skin abrasions– fingernails, jewellery and personal belongings– hair and beards.The requirements shall be based on hazard analysis andassessment of associated risks in relation to product andprocess.

A

Personal hygiene rules are present for own personnel as well as for visitors/contractors. These rules do comply with the requirements of the standard. Seen DHP – Dobra higijenska praksa v Dani, d.o.o.– dated 13.11.2012.

3.2.1.2 KO

KO N° 3: The requirements for personnel hygiene shall be inplace and applied by all relevant personnel, contractors andvisitors.

A

Personnel is aware of personal hygiene rules. All persons in factory seen by the auditor acted conform the company rules which are in line with the standard. Personal hygiene rules are present for own personnel as well as for visitors/contractors. These rules do comply with the requirements of the standard. Compliance with the requirements is checked by frequent hygiene inspections and internal audits. Personal hygiene rules are communicated and compliance is checked every day visually and internally by swabs every shift. Worker had appropriate trainings and tests about hygiene. The interviewed employees acted in accordance with the company rules. Seen results of swabs (Super Snap) in 24.04.2014. Hands and cleanliness of clothing is checked according plan internally and 2-3 times per year externally




3.2.1.3

Compliance with personnel hygiene requirements shall bechecked regularly.

A

Personal hygiene rules are present for own personnel as well as for visitors/contractors. These rules do comply with the requirements of the standard. Compliance with the requirements is checked by frequent hygiene inspections and internal audits. Personal hygiene rules are communicated and compliance is checked every day visually and internally by swabs every shift. Worker had appropriate trainings and tests about hygiene. The interviewed employees acted in accordance with the company rules.During the factory inspection, non compliances with the company's hygiene policy were not detected. Hygiene policy is appropriately communicated. All the workers when entering the company have an initial training that includes quality and food safety. Good hygiene practices are communicated in this initial training. The company ensures that all employees and contractors know company's hygiene standards. Personnel is controlled during their work-by swabs and visual. Compliance with the requirements is checked by frequent hygiene inspections and internal audits. Vistors also get instruction about hygiene in the entrance (all employees got the same and trained according that instruction). That guideline includes wearing of suitable clothing, consisting of a factory coat and a headwear covering (all hair must be cover), wearing of jewellery is forbidden; smoking, drinking, eating, having medicine in production area are forbidden also; washing hands rules; touching of products is allowed only for employees..

3.2.1.4

Visible jewellery (incl. piercing) and watches shall not beworn. Any exceptions shall have been comprehensivelyevaluated by hazard analysis and assessment of associatedrisks in relation to product and process. This shall be effectivelymanaged.

A

The company has policy about visible jewellery-that is not allowed.

3.2.1.5

Cuts and skin abrasions shall be covered by a coloured plaster/bandage (different from the product colour) – containinga metal strip, where appropriate – and in case of hand injuries,in addition to a plaster/bandage, a single use glove shallbe worn.

A

There are plasters in different colour than products. Workers wear gloves, therefore in instruction is defined that plasters must be covered and by gloves also.

3.2.2Protective clothing for personnel, contractors and visitors

3.2.2.1


D


3.2.2.2 In work areas where wearing headgear and/or beard snood(coverings) is required, the hair shall be covered completely,so that product contamination is prevented.

A All hear and beard must be covered.

3.2.2.3

Clearly defined usage rules shall exist for work areas/activitieswhere it is required to wear gloves (coloured differentlyfrom the product colour). Compliance with these rules shallbe checked on a regular basis.

A

No deviation was found.

3.2.2.4

Suitable protective clothing shall be available in sufficientquantity for each employee.

A

The company provides suitable protective clothing for personnel and visitors. Every employee does have minimum 5 sets of clothing-each for every day.




3.2.2.5

All protective clothing shall be thoroughly and regularlylaundered. Hazard analysis and assessment of associatedrisks, together with consideration given to the processes andproducts of the company shall determine if clothing shall bewashed by a contract laundry, on site laundry or by theemployee.

A

Laundry is outsourced to an approved contractor. No home laundry.

3.2.2.6 Guidelines shall exist for laundering of protective clothingand a procedure shall be in place for checking its cleanliness.

A The company checks condition of cleanliness of protective clothing by swabs and visual.

3.2.3Procedures applicable to infectious diseases

3.2.3.1

There shall be written and communicated measures for personnel,contractors and visitors to declare any infectious diseasewhich may have an impact on food safety. In case ofdeclaration of infectious disease, actions shall be taken inorder to minimize risk of contamination of products.

A

Employees are instructed to report contagious disease. Visitors are being asked to fill in a health questionnaire. Seen records of ZDRAVSTVENA STANJE OB.PR01 – Zdravstveno stanje zaposlenih.

3.3 Training and instruction

3.3.1


C


3.3.2

The documented training and/or instruction shall apply to allpersonnel, including seasonal and temporary workers andemployees from external companies, employed in therespective work area. Upon employment, and before commencingwork, they shall be trained in accordance with thedocumented training/instruction programs.

A

An adequate training program is present. Assessment and records demonstrate that personnel is adequately trained. Interviews with two operators Martin Koprivec and Marijetka Breznikar confirmed this. Seen records from training performed in 08.05.2013. about hygiene, 07.06.2013. according IFS, 20.05.2013. about allergens, 21.06.2013. and 28.06.2013. from training for new employees, quality and safety performed by SGS in 05.06.2013. and food defense in 24.03.2014.

3.3.3

Records shall be available of all training/instruction events,stating:– list of participants (this shall include their signature)– date– duration– contents of training– name of trainer/tutor.There shall be a procedure or program in place to prove theeffectiveness of the training and/or instruction programs.

A

The training provided is recorded per individual. Records include list of participants, date, duration, content of training and name of trainer. All personnel is trained. Initial induction training in food safety and quality and security and health at work is given to all workers. Seen records from training about policy, hygiene, food defense, cleaning, allergens, HACCP...

3.3.4

The contents of training and/or instruction shall be reviewedand updated regularly and take into account company’s specificissues, food safety, food related legal requirements andproduct/process modifications.

A

The reviewed training program comply with the Standard.

3.4Sanitary facilities, equipment for personnel hygiene

3.4.1

The company shall provide staff facilities, which shall beproportional in size, equipped for the number of personneland designed and operated so as to minimise food safetyrisks. Such facilities shall be kept in clean and good condition.

A

The company provide staff facilities proportional in size for the number of personnel.

3.4.2

The risk of product contamination by foreign material fromstaff facilities shall be evaluated and minimised. Considerationshall also be given to food brought to work by personneland personal belongings.

A

The risk of product contamination by foreign material from staff facilities are evaluated and minimised.




3.4.3

There shall be in place rules and facilities to ensure the correctmanagement for personnel belongings and for foodbrought to work by personnel, food coming from diningroom and from vending machines. The food shall only bestored and/or used in designated areas.

A


3.4.4

The company shall provide suitable changing rooms for personnel,contractors and visitors. Where necessary, outdoorclothing and protective clothing shall be stored separately. A

Changing facilities are adequate and situated correctly. Segregation between private and company clothing is provided. All rules about keeping of protective and civil clothing in lockers are described in SPLOŠNO - NA.PR110 – Navodilo za urejenost garderob in garderobnih omaric.

3.4.5

Toilets shall not have direct access to an area where foodproducts are handled. The toilets shall be equipped with adequatehand washing facilities. Sanitary facilities shall haveadequate natural or mechanical ventilation. Mechanical airflowfrom a contaminated area to a clean area shall beavoided.

A


3.4.6

Adequate hand hygiene facilities shall be provided at accesspoints to and within production areas, as well as at staff facilities.Based on hazard analysis and assessment of associatedrisks, further areas (e.g. packaging area) shall be similarlyequipped.

A

Hand hygiene facilities meet the requirements of the IFS standard.

3.4.7 Hand washing facilities shall provide as a minimum:– running potable water at an appropriate temperature– liquid soap– appropriate equipment for hand drying.

A Hand hygiene facilities meet the requirements of the IFS standard.

3.4.8

Where highly perishable food products are handled, the followingadditional requirements regarding hand hygieneshall also be provided:– hand contact-free fittings– hand disinfection– adequate hygiene equipment– signage highlighting hand hygiene requirements– waste container with hand contact-free opening.

N/A

No high care area present.

3.4.9 Based on hazard analysis and assessment of associatedrisks, there shall be a program to control effectiveness ofhand hygiene.

A No deviation was found.

3.4.10

Changing rooms shall be situated so that they allow directaccess to the areas where food products are handled. Basedon hazard analysis and assessment of associated risks,exceptions shall be justified and managed.

A

Changing facilities are situated correctly-direct access to the areas where food products are handled is allowed.

3.4.11

Where the hazard analysis and assessment of associatedrisks show the necessity, cleaning facilities shall be availableand used for boots, shoes and further protective clothing.

A





No.

Level


Ratin

g

Observation auditor

4 Planning and Production Process

4.1 Contract agreement

4.1.1

The requirements which are defined between the contractpartners shall be established, agreed upon and reviewedconcerning their acceptability before a supply agreementis concluded. All clauses related to quality and food safetyshall be known and communicated to each relevant department.

A

All clauses to quality and food safety (in relation with the contract partners) are known and communicated to each relevant department-seen contract with retailers. All clauses are also defined in procedure for selling also. Seen contract with Lidl d.o.o. and SPLOŠNO - OB.PR44 – Zahteve kupcev pri izdelavi izdelkov izvoznih naroèil.

4.1.2 Changes of existing contractual agreements shall be documentedand communicated between the contract partners.


4.2 Specifications and formulas

4.2.1Specifications

4.2.1.1

Specifications shall be available and in place for all finishedproducts. They shall be up to date, unambiguous and be incompliance with legal and customer requirements. C


4.2.1.2 KO

KO N° 4: Specifications shall be available and in place for allraw materials (raw materials/ ingredients, additives, packagingmaterials, rework). Specifications shall be up to date,unambiguous and be in compliance with legal requirementsand, if existing, with customer requirements. A

Specifications concerning raw materials and packaging materials are in place. The assessed specifications are up to date and comply with legal requirements. Specifications includes physical, chemical and microbiological parameters. Following specifications were examined in detail- seen for Dana natural mineral water 1,5l, TUŠ Jabolko nektar s stevio in kalcijem 1,5l, PIKA sirup pomarandža 1l and TUŠ vodka spirit drink 1l.

4.2.1.3

Where required by customers, product specifications shallbe formally agreed.

A

Product specifications and other customer requirements are formally agreed, evidence seen for TUŠ Jabolko nektar s stevio in kalcijem 1,5l-product which the company produce only for retail Tuš

4.2.1.4

Specifications and/or their contents shall be provided in therelevant location and accessible to all relevant personnel. A

For the same products, different specifications (with different detail) are available: internal, customer and supplier specification. Production is informed of the recipes to be used.

4.2.1.5

There shall be a procedure for the creation, the modificationand approval of specifications for all parts of the process,which shall include the preliminary acceptance of the customer,if specifications have been agreed with customers.

A

Defined in procedure for managing with documentation.

4.2.1.6

The specification control procedure shall include the updateof finished product specification in case of any modification:– of raw material– of formula/recipe– of process with influence on the final products– of packaging with influence on the final products.

A

Defined in procedure for managing with documentation.

4.2.2Formula/recipes




4.2.2.1 KO

KO N° 5: Where there are customer agreements in relationto the product formula/recipe and technological requirements,these shall be complied with.

A

During the audit a traceability trail was performed on following products chosen by the auditor: TUŠ apple nectar 1L LOT and shelf life 27-06-2015; syrup PIKA sirup pomarandža (orange) LOT and shelf life 11-05-2014; and spirit drink VODKA TUŠ LOT L0214. No deviations spotted in the related specification, recipe and work instructions.

4.3Product development/Product modification/Modification of production processes

4.3.1

A procedure for product development shall be in place whichincorporates the hazard analysis principles, in accordancewith the HACCP system.

A

A procedure for product development is in place and operational. Application is verified on the recently developed product – DANA Fruty drink-seen Razvojni zadatak OB.RAZ.01 dated 15.10.2013. First filling was in 28.02.2014. taste-cherry, multivitamin, lemon.

4.3.2

Product formulation, manufacturing processes, processparameters and the fulfilment of product requirements shallbe established and shall have been assured by factory trialsand product testing.

A

Validation and test runs are part of the procedure. No deviation was found.

4.3.3

Shelf life tests or adequate processes shall be carried outand consideration given to product formulation, packaging,manufacturing and declared conditions; “Use by” or “Bestbefore” dates shall be established accordingly.

A

Shelf life is assessed and verified by internal organoleptic and microbiological testing and external organoleptic and microbiological/chemical testing for every group of products and for every type of packaging materials. Seen records of Krem liker-on that was, checking of product during and after shelf life, shelf life is increased from 12 to 18 months-seen results from analyse for liquer filled in 26.10.2010. performed in 15.06.2011. Seen and analyse for Ice tea-shelf life was till 15.03.2014.; analyse was performed in 18.03.2014. results are appropriate

4.3.4

When establishing and validating the shelf life of the product(including long shelf life product i.e. labelled with a “bestbefore date”), the results of organoleptic tests shall also betaken into account.

A

The company perform shelf life test according procedure. Seen shelf life test for new product which is developed last year and for nectars also (microbiologicala analyse 7 days after filling, half year after filling and in the end of shelf life-shelf life is 1 year). Seen and organoleptic tests after producing Ocenjivanje kakovosti izdelka. Products tests and industrial test were carried in the development process. Seen for Dana vode s sokom èešnje & vrtnica 1.5l i 0.5 l.

4.3.5 Product development shall consider the results of organolepticassessments.


4.3.6 A process shall be in place to ensure that labelling complieswith current legislation of destination country and customerrequirements.


4.3.7 Recommendations for preparation and/or use of the foodproducts shall be established. Where appropriate, customerrequirements shall be included.

A Documented procedure and final sign off by director.




4.3.8

The company shall demonstrate through studies and/or performrelevant tests in order to validate nutritional informationor claims which are mentioned on labelling. This appliesboth for a new product and during all its period of sale.

A

Product claims are verified. Allergen claims are validated during analysis in external and internal laboratory. After production of product with milk, before they start to produce products without that allergen, first step is CIP cleaning, and after that they start with producing, Once per year, after CIP cleaning, next step is analyse of sample (rinse) by test tape "Ridaquick gliadin test"-presence of milk, or in a case of presence of gluten in external laboratory-seen analyse performed by Elda-method 210-I

4.3.9 The progress and results of product development shall beproperly recorded.

A Documented procedure and final sign off by director.

4.3.10

The company shall ensure that in the event of changes toproduct formulation, including rework and packaging material,process characteristics are reviewed in order to assurethat product requirements are complied with.

A


4.4 Purchasing

4.4.1 General purchasing

4.4.1.1

The company shall control purchasing processes to ensurethat all externally sourced materials and services, whichhave an impact on food safety and quality, conform torequirements. Where a company chooses to outsource anyprocess that may have an impact on food safety and quality,the company shall ensure control over such processes. Controlof such outsourced processes shall be identified anddocumented within the food safety and quality managementsystem.

A

The procedure for purchasing exist. The monitoring of relevant requirements is included. An overview of suppliers and products is available. All suppliers of products and services have to be approved firstly by director.

4.4.1.2

There shall be a procedure for approval and monitoring ofsuppliers (internal and external), outsourced production orpart of it.

A

There is a documented supplier approval procedure for purchasing. Suppliers are categorized into risk levels and approved through following mechanisms: questionnaire for suppliers and supplier auditing, every year. They assess all suppliers with who the company has cash flow over 40.000 EUR. Seen assessment for service supplier Pomorske mlekarne d.d.- filling of one product and Lindstorm d.o.o. laundering service assessed in 04.03.2014. Final approval is done by director. The company has outsourced following process- production of tetra pack drinks 1,5l-what is out of scope. The supplier is monitored as follows 3rd party certificates, own audits and incoming product monitoring.




4.4.1.3

The approval and monitoring procedure shall contain clearassessment criteria such as: audits, certificates of analysis,supplier reliability and complaints, as well as required performancestandards.

A

The company assessed suppliers regularly. Deliveries of new suppliers are checked according to the procedure, records are available. New suppliers start in a trail period. Criteria for approval and monitoring of raw materials suppliers are: certificates of analysis, complaints, Food safety certificate company, importance for product requirements. Different criteria are for the services supplier. Seen evaluation of outsourced services-on example packaging material Vetropak, for outsourced service provider Dugafruit. Seen list of approved suppliers. If the company be unsatisfied with some supplier, they assess them immidiately again. If final mark of assessment be under acceptable limit, they stop to work with that supplier and he is automatically removed from the list.

4.4.1.4

The results of suppliers’ assessments shall be reviewed regularlyand this review shall be based on hazard analysis andassessment of associated risks. There shall be records of thereviews and of the actions taken as a consequence of assessment.

A

Records are available to link the products to their supplier. Deliveries of new suppliers are checked according to the procedure, records are available. New suppliers start in a trail period.

4.4.1.5

The purchased products shall be checked in accordance withthe existing specifications and their authenticity, based on hazard anlysis and assessment of associated risks. The schedule of these checksshall, as a minimum, take into account the following criteria;product requirements, supplier status (according to itsassessment) and impact of the purchased products on thefinished product. The origin shall be additionally checked, ifmentioned in the specification.

A

Acceptance and release is based on visual inspection, certificates of conformance, certificates of analysis, product sampling, complaints. An inspection procedure is operational for incoming goods.

4.4.1.6

The purchased services shall be checked in accordance withthe existing specifications. The schedule of these checks shallat least take into account the following items: service requirements,supplier status (according to its assessment) andimpact of the service on the finished product.

A

Following services are contracted pest control, laundry, equipment maintenance, calibration of measuring equipment, transport for transport goods abroad, laboratory testing, catering, waste management. Reviewed contract of transport service Eurotek Trebnje and pest control service are appropriate.

4.4.2Trade of manufactured goods

4.4.2.1 In case a company trades manufactured goods, it shall beensured that a process for approving and monitoring suppliersexists and is implemented.


4.4.2.2

In case of traded manufactured goods, the process forapproving and monitoring suppliers shall contain clearassessment criteria such as: audits, certificates of analysis,supplier reliability, complaints as well as required performancestandards.

N/A

Traded goods no longer in scope of Food v6.

4.4.2.3 In case of private labels, a supplier approval system inaccordance with customer requirements shall exist for pre-suppliersof finished or semi-finished products.


4.5Product packaging

4.5.1

Based on hazard analysis, assessment of associated risksand intended use, the company shall determine the keyparameters for the packaging material.

A

For packaging materials Certificates of Conformity are present. Auditor verified following materials preforms-plastic bottles with PET bottom, plastic caps for bottles, glass bottles, aluminium caps. The supplier is made aware of the intended use of the packaging material.




4.5.2

Detailed specifications shall exist for all packaging materialswhich comply with the current relevant legislation.

A

Specifications concerning raw materials, packaging materials, rework and finished products are in place. Contracts are in place concerning service suppliers.

4.5.3

For all packaging material which could have an influence onproducts, certificates of conformity shall exist which complywith current legal requirements. In the event that no specificlegal requirements are applicable, evidence shall be availableto demonstrate that packaging material is suitable foruse. This applies for packaging material which could have aninfluence on raw materials, semi-processed and finishedproducts.

A

No deviation was found-seen for preforms for PET bottles report št. 13/00861 dated 25.03.2013.-that analyse includes migrations, heavy metals (Pb, Cd, Zn, Cr, As, Hg), microbiological analysis and organoleptic parametars. and for PET preforms-declaration of conformity dated 06.03.2013. by Gastro pet doo.

4.5.4

Based on hazard analysis and assessment of associatedrisks, the company shall verify the suitability of the packagingmaterial for each relevant product (e.g. organoleptictests, storage tests, chemical analysis, migration tests).

A


4.5.5

The company shall ensure that the packaging used correspondsto the product being packed. The use of correct packagingshall be regularly checked and checks shall be documented.

A

The company ensured that the packaging corresponds to the product being packed-seen the test during the storage-microbiological and chemical tests of packed finished products-no deviation was found.

4.5.6

Labelling information shall be legible, indelible and shallcomply with agreed customer product specifications. Thisshall be regularly checked and checks shall be documented.

A


4.6Factory location

4.6.1

The company shall investigate to what extent the factoryenvironment (e.g. ground, air) may have an adverse impacton product safety and product quality. Where it is establishedproduct safety and quality could be compromised, appropriatemeasures shall be established. The effectiveness of theestablished measures shall be periodically reviewed (examples:extremely dusty air, strong smells).

A

Site is suitable for the production of food, in good repair and well maintained. No risks from local activities.

4.7 Factory Exterior

4.7.1 The factory exterior shall be maintained to be clean and tidy. A

The condition of the surrounding area is fine. This is checked during internal audit and hygiene inspection.

4.7.2 All external areas of the factory shall be maintained in goodcondition. Where natural drainage is inadequate, a suitabledrainage system shall be installed.

A External areas are well maintained and external traffic routes are paved and in good condition.

4.7.3

Outdoor storage shall be kept to a minimum. Where goodsare stored outside, hazard analysis and assessment of associatedrisks shall be undertaken in order to ensure that thereis no risk of contamination or adverse effect on quality andfood safety.

N/A

No outside storage.

4.8Plant layout and process flows

4.8.1

Plans clearly describing internal flows of finished products,packaging materials, raw materials, waste, personnel, water,etc. shall be in place. A site map covering all buildings of thefacility shall be available.

A

There is a clear site plan present, meeting all requirements of the standard.

4.8.2

The process flow, from receipt of goods to dispatch, shall bein place so that contamination of raw materials, packaging,semi-processed and finished products is avoided. The risk ofcross-contamination shall be minimised through effectivemeasures.

A

The process flow from receipt to dispatch is good and organized.




4.8.3 In case of microbiologically sensitive production areas, theseshall be operated and monitored to ensure product safety isnot compromised.

N/A No high care area required.

4.8.4 Laboratory facilities and in-process controls shall not affectthe product safety. A

Laboratory facilities are in separate building from building where the company produce their products.

4.9Constructional requirements for production

4.9.1 Constructional requirements

4.9.1.1 Rooms where food products are prepared, treated, processedand stored shall be designed and constructed so thatfood safety is ensured.

A In area where food products are prepared, treated, processed and stored hygiene is ensured.

4.9.2 Walls

4.9.2.1


C


4.9.2.2 The surfaces of walls shall be in a good condition and easyto clean; they shall be impervious and wear-resistant.

A In area where food products are prepared, treated, processed and stored hygiene is ensured.

4.9.2.3 The junctions between walls, floors and ceilings shall bedesigned to facilitate cleaning. A

The junctions between walls and floors and corners are clean and suitable to be cleaned properly.

4.9.3 Floors

4.9.3.1

Floor covering shall be designed to meet production requirementsand shall be in good condition and easy to clean. Surfacesshall be impervious and wear-resistant.

A

Floor covering are designed to meet production requirements and they are in good condition and easy to clean.

4.9.3.2

The hygienic disposal of waste water shall be ensured. Drainagesystems shall be easy to clean and designed to minimisethe risk of product contamination (e.g. ingress of pests, etc.).

A

No non-conformities were noted with respect to drainage.

4.9.3.3 Water or other liquids shall reach drainage without difficulties,using appropriate measures. Puddles shall be avoided.


4.9.3.4 In food handling areas, machinery and piping shall bearranged so that waste water, if possible, goes directly into adrain.


4.9.4 Ceilings/Overheads

4.9.4.1

Ceilings (or, where no ceilings exist, the inside of roofs) andoverhead fixtures (incl. piping, cableway, lamps etc.) shall beconstructed to minimise the accumulation of dirt and shallnot pose any risk of physical and/or microbiological contamination.

A

Ceilings are constructed to minimise the accumulation of dirt.

4.9.4.2 Where false ceilings are used, an access to the void shall beprovided in order to facilitate cleaning, maintenance andinspections for pest control.

N/A No false ceilings in production areas.

4.9.5 Windows and other openings

4.9.5.1 Windows and other openings shall be designed and constructedto avoid the accumulation of dirt and shall be maintainedin good condition.

A Windows are clean and closed. Windows to be opened / ventilation openings are screened by fences.

4.9.5.2 Where there is risk of contamination, windows and roof glazingshall remain closed and fixed during production.





4.9.5.3

Where windows and roof glazing are designed to be openedfor ventilation purposes, they shall be fitted with easilyremovable, good condition pest screens or other measuresin order to avoid any contamination.

A

Where needed adequate pest screens are provided.

4.9.5.4 In areas where unpackaged product is handled, windowsshall be protected against breakage. A

In the areas where upacked product is handled, windows are protected against breakage.

4.9.6 Doors and gates

4.9.6.1 Doors and gates shall be in good condition (e.g. no splinteringparts, flaking paints or corrosion) and easy to clean.

A Doors are in good condition and clean.

4.9.6.2


C


4.9.7 Lighting

4.9.7.1 All working areas shall have adequate lighting. A All working area have adequate lighting.

4.9.7.2 All lighting equipment shall be protected by shatter proofcovers and installed to minimise the risk of breakage.

A All lighting are protected against breakage by shatter proof.

4.9.8 Air conditioning/Ventilation

4.9.8.1 Adequate natural and/or artificial ventilation shall exist in allareas.

A No excessive formation of dust or condensation observed.

4.9.8.2 If ventilation equipment are installed, filters and other componentswhich require cleaning or replacement shall be easilyaccessible.

A Cleaning and replacement of ventilation system is easy.

4.9.8.3

Air conditioning equipment and artificially generated airflowshall not lead to any product safety or quality risks.

A

The company use air for producing bottles from preforms. They analyse air one per year, and checks filter one per week-seen records of checking.

4.9.8.4 Dust extraction equipment shall be installed in areas whereconsiderable amounts of dust are generated.

N/A No necessary to extract dust.

4.9.9 Water supply

4.9.9.1

Water which is used as ingredient in the production process,or for cleaning, shall be of potable quality and supplied insufficient quantity; this also applies to steam and ice usedwithin the production area. A supply of potable water shallbe available at all times.

A

Potable water in sufficient amount available. It is obtained from an own well (1022m/1080m). This water is treated internally. Samples are analysed according sampling plan Plan uzorkovanja NA.SK6 – 1 per week the company checks filters and every day internal analyse-microbiological analyse (total number of aerobic mesofilic bacteria on 22 and 38 degrees, Enterococcus faecalis, coliforms and Pseudomonas aeruginosa), and chemical analyse; external analyse (wich includes chemical and mirobiological analyse and pesticides) is one per year performed by Zavod za javno varstvo Novo Mesto-seen the last external analyse performed 22.04.2014.

4.9.9.2

Recycled water which is used in the process shall not pose acontamination risk. The water shall comply with applicablelegal requirements for potable water; records of compliancetesting shall be available.

N/A

In the process recycled water is not used.




4.9.9.3

The quality of water, steam or ice shall be monitored followinga risk based sampling plan.

A

The quality of the water is checked at least once per year externaly. Last check was performed on 22.04.2014 and every day internaly- the company has their own microbiological and chemical laboratory.

4.9.9.4

Non-potable water shall be transported in separate, properlymarked piping. Such piping shall not be connected to thedrinking water system, or allow the possibility of reflux tocontaminate potable water sources or the factory environment.

A

The company has two separated piping systems.

4.9.10Compressed air

4.9.10.1

The quality of compressed air that comes in direct contactwith food or primary packaging material shall be monitoredbased on hazard analysis and assessment of associatedrisks.

A

Air is used for bottles from preforms. They analyse air once per year, and check filter one per week-seen records of checking-disinfection is and with H2O2 (0.29-0.4 l)-p of sterile air is 45+/-10 mbar. Results show no deviations.Also, the company use N2 and CO2-seen analyse for N2 by Istrabenz Plini-does not have negative impact on health and declaration of conformity for CO2 my Messer 11.04.2014.

4.9.10.2 Compressed air shall not pose a risk of contamination.

A Compresed air does not pose a risk of contamination.

4.10 Cleaning and disinfection

4.10.1

Based on hazard analysis and assessment of associatedrisks, cleaning and disinfection schedules shall be availableand implemented. These shall specify:– objectives– responsibilities– the products used and their instructions for use– the areas to be cleaned and/or disinfected– cleaning frequency– documentation requirements– hazard symbols (if necessary). A

The cleaning procedure is documented in cleaning plans. Cleaning is performed by production personnel. Records are demonstrable. During the audit good standards of cleaning were observed. Seen procedure DHP – Dobra higienska praksa – nov 12 dated 13.11.2012, and instruction ÈIŠÆENJE - NA.PR007 – Seznam èistil v proizvodnji dated 26.04.2012 and records from training for personnel by supplier of cleaning products ECOLAB about cleaning and usage of chemical products dated 15.04.2013. Also, seen plans for cleaning (every line and space around line has own plan).




4.10.2

Cleaning and disinfection schedules shall be implementedand documented.

A

Cleaning and desinfection scheduled is documented in: ALSIM - NA.PR009 – Èišèenje linije ALSIM in okolice, ALSIM - NA.PR011 – Èišèenje pihalke SIDEL, transporterja plastenk in okolice, COMBI - NA.PR091 – Èišèenje linije COMBI in okolice, COMBI – OB.PR22 - Kontrola Èišèenja na COMBI liniji - navodilo, Èišèenje- NA.PR038 – Èišèenje in sanitacija prostorov, DESTILACIJA – NA.PR0125 – Èišèenje destilacijskih naprav in okolice, PKL - NA.PR008 – Èišèenje polnilne linije PKL in okolice, STORK - NA.PR092 – Èišèenje linije STORK in okolice, ALSIM – OB.PR13 – Kontrola Èišèenja – ALSIM, OB.PR27 – Èišèenje linije COMBI in okolice, DESTILACIJA – OB.PR38 – Èišèenje destilacije, PKL - OB.PR02 – Èišèenje polnilne linije PKL in okolice, PKL - OB.PR23 – kontrola eišeenja na PKL liniji, SKLADIŠÈE - OB.PR31 – Èišèenje skladišènih prostorov surovin in repromaterialov, SKLADIŠEE - OB.PR32 - Èišèenje skladišènih prostorov gotovih izdelkov, STORK – OB.PR28 – Èišèenje STORK linije – sokovi, sirupi, voda in okolice STORK – OB.PR28A - Èišèenje STORK linije – alkohol.

4.10.3

Only qualified personnel shall be allowed to undertake cleaningand disinfection. The personnel shall be trained andretrained to carry out the cleaning schedules.

A

Cleaning is executed by trained personnel. Seen training records of training for all employees dated 20.05.2013. and 27.05.2013.

4.10.4

The effectiveness and safety of the cleaning and disinfectionmeasures, based on hazard analysis and assessment ofassociated risks, shall be verified and documented accordingto a sampling schedule by using appropriate procedures.Resultant corrective actions shall be documented.

A

Acceptable levels of cleanliness are defined and validated by swabs-every day before filling, test filter for filtration of water once per week, equipment according sampling plan. The company use he last analyse was in 24.04.2014. In external laboratory, swabs are performed twice per year for equipment. Results are analysed on trends once per year minimum.

4.10.5

Cleaning and disinfection schedules shall be reviewed andmodified, if necessary, in the event of a change to product,process or cleaning equipment.

A

The company is adapting the cleaning procedures due to the new production line being installed. If the company change anything in cleaning process, they validate new way of cleaning. Seen records- CIP – menjave in konec produkcije - ALSIM.

4.10.6 The intended use of cleaning utensils shall be clearly identified.Cleaning utensils shall be used in a way to avoid contamination.

A No deviation was found-the intended use of cleaning utensils are clearly identified.

4.10.7

Current material safety data sheets (MSDS) and instructionsfor use shall be available for chemicals and cleaning agents.Personnel responsible for cleaning shall be able to demonstratetheir knowledge of such instructions, which shall bealways available on site.

A

Material safety data sheets and instructions are available (e.g. Topax, Ultraclean, Johnson Diversey)-all chemicals must be in the list of approved cleaning chemicals Spisak dozvoljenih sredstva i postupak OB.PR3.

4.10.8

Cleaning chemicals shall be clearly labelled, used and storedappropriately, to avoid contamination.

A

Cleaning chemicals are clearly labelled, used and stored appropriately to avoid contamination. Chemicals are stored in a closed cabinet.

4.10.9 Cleaning activities shall be carried out in periods of non-production.If this is not possible, these operations shall be controlledas to not affect the product.

A No deviation was found-cleaning activities are carried out in periods of non-productions.




4.10.10

Where a company hires a third-party service provider forcleaning and disinfection activities, all requirements specifiedwithin section 4.10 shall be clearly defined in the respectivecontract.

N/A

The company does not hire third party service provider.

4.11Waste disposal

4.11.1 A waste management procedure shall exist and shall beimplemented to avoid cross contamination. A

A waste management procedure exist- ODPADKI-NA.PR085– Naèrt gospodarjenja z odpadki dated 28.10.2008.

4.11.2

All current legal requirements for waste disposal shall bemet.

A

Waste disposal is carried out by the company through authorized contractors (seen contracts with Surovina dd, Plasta, Koto, Komunalno Trebnje, Biotera and Kemis).

4.11.3 Food waste and other waste shall be removed as quickly aspossible from areas where food is handled. The accumulationof waste shall be avoided.

A The accumulation of waste is prevented, sufficient waste deposits are available throughout the production area.

4.11.4

Waste collection containers shall be clearly marked, suitablydesigned, in good state of repair, easy to clean, and wherenecessary disinfected. A

Waste containers were suitably identified-what kind of waste can be stored in every container. All waste collection containers have lids and all of them are appropriate for cleaning and disinfection.

4.11.5 Waste collection rooms and containers (incl. compactors)shall be designed to be kept clean to minimise pest attraction.

A Waste containers and compactor are kept in adequate condition to minimise pest attraction.

4.11.6

Waste shall be collected in separate containers in accordancewith the intended means of disposal. Such waste shallbe disposed by authorised third parties only. Records ofwaste disposal shall be kept by the company.

A

Separation of cardboard and paper, glass material, plastic materials and organic materials are done by the company. Waste disposal is carried out by the company through authorized contractors.

4.12 Risk of foreign material, metal, broken glass and wood

4.12.1 KO

KO N° 6: Based on hazard analysis and assessment of associatedrisks, procedures shall be in place to avoid contaminationwith foreign material. Contaminated products shall betreated as non-conforming products.

A

The risks from chemical, physical or taint contamination are identified. Control measures for e.g. preventing foreign materials are implemented by means of filters, light screen and visual inspection.

4.12.2

In all areas, e.g. handling of raw materials, processing, packingand storage, where hazard analysis and assessment ofassociated risks have identified the potential for productcontamination, the use of wood shall be excluded. Where theuse of wood cannot be avoided, the risk shall be controlledand the wood shall be in good order and clean.

A

Where possible the use of wood is prohibited in open product areas. Only pallets are allowed which are inspected before entry into production.

4.12.3

Where metal- and/or other foreign material detectors arerequired, they shall be installed to ensure maximum efficiencyof detection, in order to avoid subsequent contamination.Detectors shall be subjected to regular maintenance toavoid malfunction.

N/A

Metal detectors are not used. The company use filters-seen and analyse for filters-Declaration of compliance-valid till 28.02.2015.-membracard XLII filters cartrigs-they use filters XE 50, XE 20, XE 280. Beside that, the company use light screen to check condition of bottles. One worker check every bottle trough the screen (in every 2 hours worker be changed with another one because eyes become tired and checking can not be enough adequate if he/she would not be replaced). If he/she found anything, glass immediately be removed and recorded- every day the head of production verify it.




4.12.4

Potentially contaminated products shall be isolated. Accessand actions for further handling or checking for these isolatedproducts shall be carried out only by authorised personnelaccording to defined procedures. After this check,contaminated products shall be treated as non-conformingproducts.

A

Potentially contaminated products are isolated-in the covered stainless container. Handling these products are described in documented procedure.

4.12.5

The appropriate accuracy of detectors shall be specified.Checks of proper function of detectors shall be carried outregularly. In case of malfunction or failure of a metal and/orforeign material detector, corrective actions shall be defined,implemented and documented.

N/A

There is no metal detector. The company use filters-for water 0.2 and 1 µm, for other products XE 50, XE 20, XE 280...

4.12.6 In cases where special equipment or methods are used todetect foreign material, these shall be properly validated andmaintained.

N/A There is no metal detector.

4.12.7


C


4.12.8

All stationary objects made of or incorporating glass or brittlematerial present in areas of handling of raw materials,processing, packing and storage shall be listed in a specificregister, including details of their exact location. An assessmentof the condition of objects on the register shall be performedon a regular basis and recorded. Frequency of thischeck shall be justified by documents.

A

The glass handling procedure is documented in OB.PR 20. The glass and plastic register is checked once per year according register (the last checking was in 24.02.2014.), and every day they check all of it, but do not record it-record only breakages of glass-see record of breakages-one piece of plastic is broken on packaging machine OB.RT.02-on Alsim line in 22.05.2013.

4.12.9 Breakages of glass and brittle material shall be recorded.Exceptions shall be justified and documented.

A All breakages are recorded.

4.12.10

Procedures shall be in place describing the measures to betaken in case of breakage of glass and/or brittle material.Such measures shall include identifying the scope of goodsto be isolated, specifying authorised personnel, cleaning theproduction environment and release of production line forcontinued production.

A

Actions to be taken are included in the procedure. The glass handling procedure is documented in the same procedure.

4.12.11

Based on hazard analysis and assessment of associatedrisks, preventive measures shall be in place for handling ofglass packaging, glass containers or other kinds of containersin the production process (turn over, blow, rinse, etc.).After this process step there shall be no further risk of contamination. A

The packaging material are inverted and rinsed with water before filling. Transport lines are covered. Every bottle is checked by visual before it would be placed in machine, and rinsed with water (50 degrees); filling is hot filling (minimum 76 degrees), after what the filled bottle goes on pasteurisation (92-97 degrees). Anyway, there are light screens with purpose that the company checks and presence of foreign materials-like piece of glass in glass bottles.

4.12.12

Where visual inspection is used to detect foreign material,the employees shall be trained and operative change shallbe performed at an appropriate frequency to maximise effectivenessof process.

A

The company use as method of checking of foreign metal-filter, light screen and visual. Workers are trained appropriate to perform visual inspection.

4.13 Pest monitoring/Pest control




4.13.1

The company shall have a pest control system in place whichis in compliance with local legal requirements, taking intoaccount, as a minimum:– the factory environment (potential pests)– site plan with area for application (bait map)– identification of the baits on site– responsibilities, in-house/external– used products/agents and their instructions for use andsafety– the frequency of inspections.The pest control system shall be based on hazard analysisand assessment of associated risks.

A

Pest control is operated by an external pest controller (Zavod za javno varstvo Novo Mesto-seen contract signed in 28.01.2014.), and by the company itself every 15 days. Pest inspection is carried out 3 times per year externally and twice per month internally. The pest program includes control of rodents, insects. The inspection reflects all activities of the site.

4.13.2

The company shall have qualified and trained in-house staffand/or employ the services of a qualified external provider.Where an external provider is used, the activities required onsite shall be specified in a written contract.

A

The company signed contract with external pest control service. Seen licence and certificate that external service provider is qualified for pest control and insect control.

4.13.3

Pest control inspections and resulting actions shall be documented.Implementation of actions shall be monitored andrecorded.

A

Actions in the event of pest activity were sufficient. Recommendations on prevention/hygiene aspects are carried out in a timely manner. Seen records OB.PR 17 and OB.PR 16 and trends from 11.04.2014. after what the company makes decision what to keep or change from implemented measures

4.13.4

Baits, traps and insect exterminators shall be functioning,shall be in sufficient numbers and shall be placed in anappropriate position. They shall be constructed and positionedas not to cause any contamination risk.

C


4.13.5 Incoming deliveries shall be checked on arrival for the presenceof pests. Any infestation shall be documented and controlmeasures taken.

B The company checks every incoming deliveries, but they do not record results of checks.

4.13.6 The effectiveness of the pest control shall be monitored withthe help of regular trend analyses. A

No deviation was found. Trend analyse is done – seen trends dated 11.04.2014.-less number of bites-less number of rodents.

4.14 Receipt of goods and storage

4.14.1

All incoming goods, including packaging materials andlabels, shall be checked for conformity against specificationsand to a determined inspection plan. The inspection planshall be risk based. Test results shall be documented.

A

Checks of received and dispatched goods are recorded. Traceability is part of this checks.

4.14.2

The storage conditions of raw materials, semi-processedand finished products as well as packaging shall in each casecorrespond to product requirements (e.g. refrigeration, protectivecovers) and shall not be detrimental to other products.

A


4.14.3 Raw materials, packaging, semi-processed and finishedproducts shall be stored so as to minimise the risk of crosscontamination.

A Everything is stored in that way that the cross contamination is avoided.

4.14.4

Appropriate storage facilities shall be available for the managementand storage of working materials, process aids,and additives. The personnel responsible for the managementof storage facilities shall be trained.

A

The personnel are appropriate trained. Condition in storage are appropriate, also.

4.14.5 All products shall be clearly identified. Use of products shallbe undertaken in accordance with the principles of FirstIn/First Out and/or First Expired/First Out.

A All products are clearly identified. The company respect FIFO principle.




4.14.6

Where a company hires a third-party storage service provider,the service provider shall be subject to IFS Logisticsrequirements. If the third party service provider is not certifiedto IFS Logistics, all relevant requirements equivalent tothe company’s own warehousing practices shall be fulfilledand this shall be clearly defined in the respective contract.

N/A

The company does not hire third-party storage provider.

4.15 Transport

4.15.1

Before loading transport vehicles, their condition (e.g.absence of strange smells, high dust load, adverse humidity,pests, mould) shall be checked and action taken, if necessary. A

Transport is outsourced for transport goods in abroad. For transport in Slovenia the company use their own vehicles.Transport conditions are controlled. Hygiene conditions are checked and documented. Records seen appropriate for vehicles which are used for transport- Dnevnik kontrole èistosti kamiona.

4.15.2

Procedures to prevent contamination during transport shall be implemented (food/non-food/different categories ofgoods).

A

Vehicles are inspected before loading on following aspects hygiene. Inspection records are maintained. Transport procedures to maintain product safety and quality are implemented covers rules for loading, unloading, and checking and records of temperature and hygiene. Vehicles are maintained.

4.15.3 Where goods must be transported at certain temperatures,before loading, the temperature inside the vehicle shall bechecked and documented.


4.15.4

Where goods must be transported at certain temperatures,maintaining the adequate range of temperatures duringtransport shall be ensured and documented.

N/A

No controlled temperature needed.

4.15.5

Adequate hygienic requirements for all transport vehiclesand equipment used for loading/unloading (e.g. hoses ofsilo installations) shall exist. There shall be records of themeasures taken.

A

Hygiene plan established for all vehicles.

4.15.6 Loading and unloading areas shall have equipment in placeto protect transported products from external influences.

A Loading and unloading areas is protected by shelter.

4.15.7

Where a company hires a third-party transport service provider,all the requirements specified within section 4.15 shallbe clearly defined in the respective contract or the serviceprovider shall be subject to IFS Logistics requirements.

A

Contracts assessed with third party service provider Eurotek Trebnje-seen contract 438/N signed in 03.04.2009. and Autoprevozništvo Aleš Zupanèiè signed 10.09.2013. In contracts are defined all requirements according ILS.

4.15.8 Security of transport vehicles shall be appropriately maintained.


4.16 Maintenance and repair

4.16.1

An adequate system of maintenance shall be in place, maintainedand documented, covering all critical equipment (incl.transport) for compliance with product requirements. Thisapplies both for internal and external maintenance activities.

A

Maintenance and inspections of relevant equipment are planned and recorded. Verified for pasteurizator and packaging machine. Since last audit no new equipment added. Seen preventive plan Plan preventivnih popravil and register of intervent maintenance Evidencija popravki OB.09.037.

4.16.2

Product requirements and prevention of contamination shallbe ensured during and after maintenance and repair work.Records of maintenance and repair work and of correctiveactions taken shall be kept.

A

After maintenance activities, there is an appropriate procedure to release the line before start-up. Responsible person is Head of production.




4.16.3

All materials used for maintenance and repair shall be fit forthe intended use.

A

The company only used food grade lubricants and oils-seen certificate from producer-Wurth (approved lubricants and oils must be from the list of approved materials:MAZIVA - NA.PR102 – Vrsta maziv v proizvodnji dated 07.05.2012.) Seen and certificate that valves are suitable for contact with food (according EC 42/2006 EC 1935/2004), DIN EN 292-1, DIN EN 292-2, DIN EN 1672-2 (Kieselmann) and also for pipes also-seen certificate of conforming dated 08.10.2012.-Peters Rubber &Plastic BV.

4.16.4

Failures of plant and equipment (incl. transport) covered bythe maintenance system shall be documented and reviewedwith a view to adapting the maintenance system.

A

The company only used food grade lubricants and oils-seen certificate from producer-Wurth. Seen and certificate that valves are suitable for contact with food (according EC 42/2006 EC 1935/2004), DIN EN 292-1, DIN EN 292-2, DIN EN 1672-2 (Kieselmann) and also for pipes also-seen certificate of conforming dated 08.10.2012.-Peters Rubber &Plastic BV.

4.16.5

Temporary repairs shall be carried out so that productrequirements are not affected. Such work shall be documentedand a short-term deadline set for eliminating thefault.

A

Company keeps records of equipment failure. A software for management of maintenance is used. All temporary repairs are written in software system.

4.16.6

Where a company hires a third-party maintenance and repairservice provider, all the company specified requirementsregarding material and equipment shall be clearly defined,documented and maintained.

A


4.17 Equipment

4.17.1

Equipment shall be suitably designed and specified for theintended use. Before commissioning, it shall be verified thatthe product requirements are complied with.

A

Equipment are suitably designed and specified for the intended use.

4.17.2

For all equipment and tools with direct food contact, certificatesof conformity shall exist which confirm compliancewith current legal requirements. In case no specific legalrequirements are applicable, evidence shall be available todemonstrate that all equipment and tools are suitable foruse. This applies for all equipment and tools in direct contactwith raw materials, semi-processed and finished products.

A

The company only used food grade lubricants and oils-seen certificate from producer-Wurth. Seen and certificate that valves are suitable for contact with food (according EC 42/2006 EC 1935/2004), DIN EN 292-1, DIN EN 292-2, DIN EN 1672-2 (Kieselmann) and also for pipes also-seen certificate of conforming dated 08.10.2012.-Peters Rubber &Plastic BV.

4.17.3

Equipment shall be designed and located so that cleaningand maintenance operations can be effectively performed.

A

Declarations of suitability and other relevant information for pipes and valves is assessed and found adequate. There is sufficient space for cleaning and servicing.

4.17.4 The company shall ensure that all product equipment is ingood condition without any negative influence on foodsafety.

A All product equipment is in good condition.

4.17.5

The company shall ensure that in the event of changes toprocessing methods and equipment, process characteristicsare reviewed in order to assure that product requirementsare complied with.

A


4.18 Traceability (including GMOs and allergens)




4.18.1 KO

KO N° 7: A traceability system shall be in place which enablesthe identification of product lots and their relation tobatches of raw materials, packaging in direct contact withfood, packaging intended or expected to be in direct contactwith food. The traceability system shall incorporate all relevantreceiving processing and distribution records. Traceabilityshall be ensured and documented until delivery to thecustomer.

A

A system is in place for traceability. This includes traceability of primary packaging materials, raw materials, semi-finished products, and finished products. Traceability is maintained by paper and software system.

4.18.2

Downstream traceability records (from production sites tothe customers) shall be available. The timeframe for producingthese records for review shall be compliant with customer’srequirements.

A


4.18.3 Traceability shall be in place to identify the relationshipbetween batches of final products and their labels.


4.18.4

The traceability system shall be tested on a periodic basis -at least annually and each time traceability system changes.The test shall verify upstream and downstream traceability(from delivered products to raw materials, and vice versa),including quantity checking. Test results shall be recorded.

A

Frequency of traceability test is once per year. Last traceability test is dated 02.04.2014. During the audit a traceability trail was performed on following products chosen by the auditor products TUŠ apple nectar 1L LOT and shelf life 27-06-2015; syrup PIKA sirup pomarandža (orange) LOT and shelf life 11-05-2014; and spirit drink VODKA TUŠ LOT L0214. System is effective. Whole production could be traced.

4.18.5

Traceability shall be ensured at all stages, including work inprogress, post treatment and rework.

A

Traceability of rework is in place and maintained by adequate labelling of rework (which goods, date of production and results of control-only inspected goods can be again on process).

4.18.6

Labelling of semi-finished or finished product lots shall bemade at the time when the goods are directly packed toensure a clear traceability of goods. Where goods are labelledat a later time, the temporarily stored goods shall have beenprovided with a specific lot labelling. The shelf life (e.g. bestbefore date) of the labelled goods shall be calculated fromthe original production batch.

A

Labeling product lots is made at the time when the goods are directly packed.

4.18.7

If required by customer, identified samples representativefor the manufacturing lot shall be stored appropriately andkept until expiration of the “Use by” or “Best before date” ofthe finished product and if necessary for a determined periodbeyond this date.

A


4.19Genetically modified organisms (GMOs)

4.19.1

For products being delivered to customers and/or countrieswith GMO requirements, the company shall have in placesystems and procedures to allow the identification of productsconsisting of GMOs, containing GMOs or producedfrom GMOs, including food ingredients, additives andflavouring(s).

N/A

Company does not work with GMO products.

4.19.2

Raw material specifications and delivery documents identifyingproducts consisting of, being made from, or containingGMOs shall be available. The assurances concerning theGMO status of the raw materials shall be agreed by contractwith the supplier or the relevant technical documents shallspecify the GMO status. The company shall maintain a continuouslyupdated listing of all GMO raw materials used atits premises, which also identifies all blends and formulas towhich such GMO raw materials are added.

N/A





4.19.3

There shall be adequate procedures to ensure that whereproducts consisting of or containing GMOs are manufactured,contamination of non-GMO products is avoided. Adequatecontrol measures shall be in place to avoid GMO crosscontamination. The effectiveness of these procedures shallbe monitored by testing.

N/A


4.19.4

Finished products containing GMOs or labelled as not containingGMOs shall be declared in accordance with currentlegal requirements. Delivery documents shall include thecorresponding reference to GMOs.

N/A


4.19.5 Customer requirements concerning the GMO status of productsshall be clearly implemented by the company. N/A


4.20Allergens and specific conditions of production

4.20.1

Raw material specifications identifying allergens requiringdeclaration that are relevant to the country of sale of the finishedproduct shall be available. The company shall maintaina continuously up to date listing of all raw materials containingallergens used at its premises, which also identifies allblends and formulas to which such raw materials containingallergens are added.

A

Company has a clear overview of allergen-containing materials. The last risk assessment was on 17.12.2013. The following allergens are used on site: gluten (wheat fibres Vitacel) and milk (cream liquere concentrate). Seen Seznam alergenih substanc v izdelnih Dana and instruction NA.RT07 dated 17.12.2013.

4.20.2

The manufacturing of products which contain allergensrequiring declaration shall be carried out as to ensure crosscontamination is minimised as far as possible. A

An overview of allergen-containing materials is available as well as a procedure. The effectiveness of this procedure is tested. The following allergens are present in the company: gluten and milk. Control measures are taken through: segregation, logistical planning, cleaning and analysis.

4.20.3

Finished products containing allergens requiring declarationshall be declared in accordance with current legal requirements.For the adventitious or unintentional presence, thelabelling of legally declared allergens and traces shall bebased on hazard analysis and assessment of associatedrisks.

A

Cross contamination is prevented. No warnings on the label for juices, syrups and nectars. For alcoholic drinks, the company put warning in label-“there is possibility to be found” or “contain allergen”.

4.20.4

Where customers specifically require that products are “freefrom” certain substances or ingredients (e.g. gluten, pork,etc.), or that certain methods of treatment or production areexcluded, verifiable procedures shall be in place.

A

Allergen claims are validated during analysis in external and internal laboratory. After production of product with milk, before they start to produce products without that allergen, first step is CIP cleaning, and after that they start with producing, Once per year, after CIP cleaning, next step is analyse of sample (rinse) by test tape "Ridaquick gliadin test"-presence of milk, or in a case of presence of gluten in external laboratory-seen analyse performed by Elda-method 210-I




No.

Level


Ratin

g

Observation auditor

5 Measurements, Analysis, Improvements

5.1 Internal audits

5.1.1 KO

KO N° 8: Effective internal audits shall be conducted accordingto a defined agreed audit program and shall cover atleast all requirements of the IFS Standard. Scope and frequencyof internal audits shall be determined by hazardanalysis and assessment of associated risks. This is alsoapplicable for off site storage locations owned or rented bythe company.

A

Internal audits are conducted minimum once per year. Than, whole factory is assessed. The auditors check documentation, process, analysis, hygiene, personnel, environment. Frequency is based on risk assessment. Seen Plan for internal audits 2014 and results from last internal audit. The last internal audit was carried out in 07.03.2014.

5.1.2 Internal audits of activities which are critical to food safetyand product specifications shall be carried out at least oncea year.

A Audits that the company has identified as critical are production area and are audited at an annual frequency.

5.1.3

The auditors shall be competent and independent from theaudited department.

A

Internal auditors are independent and are trained internally by QAM who had external training from Bureau Veritas in 24.03.2010. Seen evidence from training and also procedure for main subjects of the audit- Oporne toèke pri presoji proizvodnih procesev dated 27.01.2014.

5.1.4

Audit results shall be communicated to the senior managementand to responsible persons of concerned department.Necessary corrective actions and a schedule for implementationshall be determined and documented and communicatedto every relevant person.

A

Corrective actions are defined including timescale and responsible person. Seen results from last internal audit performed in 07.03.2014. including corrective action and verification by QAM. During internal audit, it was found a few NCs. Two of them are: the scale for grading of customer satisfaction questionnaires is 1-3 what is not enough to show real picture about company. Idea was given during the audit that new scale be minimum 1-5. It was just remark, but the company started to increase scale and analyse results of customer satisfaction more detailed. One NC was-in the area where the company produce syrup, there are wooden pallets instead of plastic pallets. Root was not adequate control of foreign bodies-according register, pallets must be plastic. During control, worker did not pay attention on it, and after cleaning of plastic pallets, instead of them, in production area ware entered wooden (which ware in good condition). Correction was-to replace them with plastic pallets and to train workers. All corrective actions ware closed and verified.

5.1.5 It shall be documented how and when the corrective actionsresulting from the internal audits shall be verified.

A Responsibilities for verification of implementation and effectiveness defined for each non-conformities.

5.2Site factory inspections

5.2.1

Factory inspections shall be planned and carried out (e.g.product control, hygiene, foreign material hazards, personnelhygiene and housekeeping). The frequency of inspectionsin every area (including outdoor areas) and every singleactivity shall be based on hazard analysis and assessmentof associated risks and on the history of previous experience.

A

The frequency of internal audits is based on a risk assessment. The scope includes all aspects of the quality system, all departments, buildings and infrastructure. An up to date internal audit plan is available. Audits are done according plan of audits. Results of internal audits are reported. Corrective actions are defined including timescale and responsible person.




5.3Process validation and control

5.3.1 The criteria for process validation and control shall be clearlydefined. A

The criteria for process validation and control are clearly defined. Seen DPP – Dobra proizvodna praksa.

5.3.2

In circumstances where the control of process and workingenvironment parameters (temperature, time, pressure,chemical properties etc.) is essential to ensure the productrequirements, such parameters shall be monitored andrecorded continuously and/or at appropriate intervals.

A

Process monitoring checks conducted include temperature of pasteurization, temperature of heating of glass bottles, temperature of storage of raw materials, checking of weights, microbiological and chemical analysis of products..An in-line alert system exist for temperature of pasteurization-temperature is defined by computer for every kind of products. If temperature is not adequate, system is activated automatically-first signal is given by machine-alarm.

5.3.3 All rework operations shall be validated, monitored and documented.These operations shall not affect the productrequirements.


5.3.4 There shall be appropriate procedures for prompt notification,recording and monitoring of equipment malfunctionand process deviations.

A In case of equipment failure corrective actions are taken such as putting on hold of products.

5.3.5

Process validation shall be performed using the collecteddata that is relevant for product safety and the processes. Ifsubstantial modifications occur, a revalidation shall be carriedout.

A


5.4Calibration, adjustment and checking of measuring

5.4.1

The company shall identify the measuring and monitoringdevices required to ensure compliance with product requirements.These devices shall be recorded on a document andclearly identified.

A

Calibration of measuring equipment is in place. Seen overview of measuring devices. Seen results for digital balance Mettler and termometers. Calibration methods are traceable to recognized standards. In case of malfunctioning corrective actions towards device and products are part of procedure. Seen and the list of measuring equipment and plan of calibration of measuring devices-Zapisnik skupinske kalibracije.

5.4.2

All measuring devices shall be checked, adjusted and calibrated,under a monitoring system, at specified intervals andin accordance with defined recognised standard/methods.The results of the checks, adjustments and calibrations shallbe documented. Where necessary, corrective actions ondevices and, if necessary, on process and products shall becarried out.

A

A calibration place is available. All the on-line scales are annually calibrated. The calibration of balance was seen-Ravbar Janez-Alsim Mettler Toledo SI 990503 for weight control is assessed-last calibration was in 13.06.2012. Seen and calibration for termometers- method: comparison with the reference thermometer at ambient temperatures 0, 50, 95 degrees (referent: Hart Scientific 1521)-No of certificate 12D05-calibrated in 21.12.2012. by Laboratorij za meritre v procesnem strojništvu.

5.4.3

All measuring devices shall be used exclusively for theirdefined purpose. Where the results of measurements indicatea malfunction, the device in question shall be immediatelyrepaired or replaced.

A

The measuring devices are adequately used.

5.4.4 The calibration status of the measuring devices shall beclearly identified (labelling at the machine or on a list of testdevices).

A The calibration status of the measuring equipment is clearly identified at the machines.

5.5 Quantity checking (quantity control/filling quantities)




5.5.1

The frequency and methodology of quantity checking shallbe determined so that the legal requirements and customerspecifications, or if appropriate, guidelines for nominalquantity are met.

A

A well documented system for quantity control is in place. This is based on minimum weight. Checks are done for packed products at least every hour. All checks seen were OK.

5.5.2

A procedure shall exist to define compliance criteria for lotquantity checking. This procedure shall also, among others,take into consideration the tare, the density and other criticalattributes.

A


5.5.3 Checks shall be implemented and recorded, according to asampling plan which ensures a proper representation of themanufacturing lot.


5.5.4 Results of these checks shall be compliant with defined criteriafor all products ready to be delivered. A

The quantity of the product SPAR gazirana voda was conform with product specification (limit is 500+/-5g).

5.5.5 For purchased, already pre-packed products from third parties,there shall be evidence about the compliance with thelegal requirements for nominal quantity.

N/A No pre-packed products in the audit scope.

5.5.6 If applicable, all equipment used for final checking shall belegally approved.

A All equipment are legally approved.

5.6Product analysis

5.6.1

There shall be procedures ensuring that all specified productrequirements are met, including legal requirements andspecifications. Microbiological, physical and chemical analysisrequired for that purpose shall be performed internallyand/or subcontracted.

A

Laboratory testing is scheduled based on risk assessment for for all raw materials, surroundings, finished product (groups) according sampling plan. The company has their own laboratory every day internaly-microbiological analyse every day of water and products (total number of aerobic mesofilic bacteria on 22 (28) and 37 degrees, E.facealis. P. Aeruginosa, Coliforms), and chemical analyse (hardness of water on 60+/-8 degrees, content of Cl, total acids, dry matter content, (Ca, nitrit 3-4 times per year)). Pathogen testing like Yeasts, Moulds, mesophilic aerobic bacteria is performed by contracted laboratory. Seen analyse for PIKA orange syrup 2013/10057 from 12.11.2013. by Zavod za zdravstveno varstvo Novo Mesto. Seen and results of external analyse for water (whch includes chemical and mirobiological analyse and pesticides) is once per year performed by Zavod za javno varstvo Novo Mesto-seen the last external analyse Poroèlo o preskušanju performed in 18.04.2014..

5.6.2

Analyses, which are relevant for food safety, shall preferablybe performed by laboratories having appropriate accreditedprograms/methods (ISO 17025). If the analyses are performedby a factory internal or a laboratory not havingappropriate accredited programs/methods, the results shallbe verified on a regular basis by laboratories accredited onthese programs/methods (ISO 17025).

A

The lab is ISO 17025 accredited for the assessed analyses.

5.6.3

Procedures shall exist which ensure the reliability of theinternal analysis results on the basis of official recognisedanalysis methods. This shall be demonstrated by ring testsor other proficiency tests.

A

Adequacy of results are confirmed by checking the some raw materials in external accredited laboratories (e.g. pesticides, microbiological and chemical results of finished products).




5.6.4

A test plan shall be drawn up for internal and external analysis,based on hazard analysis and assessment of associatedrisks, which covers raw materials, semi-processed and finishedproducts as well as processing equipment and packagingmaterials, and where necessary environmental tests.The test results shall be documented.

A

A testing program for products and environment is in place. Methods, frequency and specified limits are documented. Auditor saw testing program for water from different pouring station, final products, packaging and this was found to be conform.

5.6.5

Results of analysis shall be evaluated promptly. Appropriatecorrective measures shall be introduced for any unsatisfactoryresults. The analytical results shall be reviewed regularlyin order to identify trends. Trends indicating potential unsatisfactoryresults shall be taken into consideration.

A

Analytical results are reviewed regularly. Any negative trend identified.

5.6.6

Where internal analysis is undertaken, qualified and trainedpersonnel shall be in place, as well as appropriate equipmentand premises.

A

Trained staff for the analysis carried out internally. Microbiological and organoleptic tests carried out in the site-the company has microbiological and chemical laboratory.

5.6.7

For verification of finished product quality, internal organoleptictests shall be carried out regularly. These tests shall bein accordance with specifications and related to the impacton respective parameters of product characteristic. Theresults of these tests shall be documented.

A

All lots are organoleptically assessed daily.

5.6.8

Based on hazard analysis, assessment of associated risksand on any internal or external information on product riskswhich may have an impact on food safety and/or quality(incl. adulteration and fraud), the company shall update itscontrol plan and/ or take any appropriate measure to controlimpact on finished products.

A

Risks with impact on food safety, quality (including adulteration and fraude) are determined. Examples of risks covered: with a goal that product be food safety, there are filters and control in external accredited laboratory. To be sure, that product can be used till the moment which the company put in the label, the company analyze products during shelf life in appropriate condition and in condition which can be found in store (not in totally appropriate condition).

5.7Product quarantine (blocking/hold) and product release

5.7.1

A procedure shall be in place, based on hazard analysis andassessment of associated risks, for the quarantine (blocking/hold) and release of all raw materials, semi-processed andfinished products and packaging materials. The procedureshall ensure that only products and materials conforming toproduct requirements are processed and dispatched.

A

Products are release by Head of production and QAM. Seen records of Tuš s stevio in kalcijem 20.03.2014. with shelf life till 27.06.2015. Quarantine is always minim 3 days till all analysis do not be finished.

5.8Management of complaints from authorities and customers




5.8.1

A system shall be in place for the management of productcomplaints.

A

Complaints are recorded, investigated and root cause analysis is applied where possible. Appropriate actions are identified. The auditor assessed two complaints: one was from 07.03.2014. for DAN jagodni nekatar 1L because packaging was damage. Root- transport conditions, CA was to write a formal letter of apology to customer and send new products. Second complaint was received in 2014. according not adequate packaging material-longitudinal var was not closed well. Root was in packaging machine. After changing of parameters for packaging machine, there was no any problem after that. Control of packaging material and packed products become stronger. Both were handled conform procedure and standard. There were no complaints from the authorities. All complaints are received by email, post, phone.. All of them arev investigate and if they are justified, corrective actions are started in a moment when problem is detected. All complaints are in register

5.8.2 All complaints shall be assessed by competent staff. Whereit is justified appropriate actions shall be taken immediately,if necessary.

A Complaints are assessed by the quality department. Quartely analysis is made.

5.8.3 Complaints shall be analysed with a view to implementingpreventive actions which avoid the recurrence of the nonconformity.

A Complaint data are analysed for trends by QAM used to avoid recurrence and shared with relevant staff.

5.8.4

The results of complaint data analysis shall be made availableto the relevant responsible persons and to the seniormanagement.

A

Statistical analysis of complaints is available (last done for the 1st quarter 2014. and last quartal of 2013.-seen records). Complaints are treated and corrective actions are open to prevent the recurrence of the non-conformity.

5.9Management of incidents, product withdrawal, product recall

5.9.1

A documented procedure shall be defined for managementof incidents and of potential emergency situations thatimpact food safety, legality and quality. This procedure shallbe implemented and maintained. This includes as a minimum:the nomination and training of a crisis team, an alertcontact list, sources of legal advice (if necessary), contactsavailability, customer information, and a communicationplan, including information to consumers.

A

During the audit the company provided product recall/withdrawal procedures: Postopek umika/odpoklica dated 12.06.2013. Procedures includes contacts of customers, suppliers, authorities and communication to consumers. In situations of incidents with potential implications in terms of food safety a crisis management team starts operating.

5.9.2 KO

KO N° 9: There shall be an effective procedure for the withdrawaland recall of all products, which ensures that involvedcustomers are informed, as soon as possible. This procedureshall include a clear assignment of responsibilities.

A

There is a documented procedure for recall/withdrawal (Postopek umika/odpoklica) including all requirements of the standard. Since the last audit there were no recalls or withdrawals.

5.9.3

Updated emergency contact details (such as names andphone numbers of suppliers, customers and competentauthorities) shall be available. A person of the company,who has the authority to initiate the incident managementprocess, shall be permanently available.

A

Emergency contact person: Marija Krištof +38673462221. Seen and updated emergency contact details-all customers, authority, CB...on the list




5.9.4

The feasibility, effectiveness and timeliness of implementationof the withdrawal procedure shall be subject to regularinternal testing, based on hazard analysis and assessment ofassociated risks but carried out at least once a year. This shallbe carried out in a manner to ensure the effective implementationand operation of the procedure.

A

Recall and Withdrawal procedures are tested once per year. Last test was performed on 02.04.2014. with following conclusion- the system is effective. For whole process, the company needs 3 hours to collect all facts and to inform all costumers, authority... In 24 hours all goods ware in the company,s storage.

5.10Management of non-conformities and non-conforming products

5.10.1

A procedure shall exist for the management of all non-conformingraw materials, semi-finished and finished products,processing equipment and packaging materials. This shallinclude, as a minimum:– isolation/quarantine procedures– hazard analysis and assessment of associated risks– identification (e.g. labelling)– decision about the further use (e.g. release, rework/posttreatment, blocking, quarantine, rejection/disposal).

A

Non-conforming product is identified by visual, filters, light screen and analyse. Release of non-conforming product is approved by Director of production

5.10.2

The responsibilities for the management of non-conformingproducts shall be clearly identified. The procedure for themanagement of non-conforming products shall be understoodby all relevant employees. A

The responsibility are clearly identified in job descriptions. Quality Department has the responsibility for the assessment of the non conform product. In terms of food safety issues it is responsibility of the Quality Department in determine the destination of the final product.

5.10.3 Where non-conformities are present, immediate correctionsshall be taken to ensure that product requirements are compliedwith.


5.10.4

Out of specification, final packaged products or packagingmaterials, both related to private labels, shall not be placedin the market under the label concerned. Exceptions shall beagreed in writing with the contract partners.

A


5.11Corrective actions

5.11.1

A procedure shall be in place for the recording and analysisof the non-conformities with the objective to avoid recurrencesby preventive actions and/or corrective actions.

A

A procedure is in place.

5.11.2 KO

KO N° 10: Corrective actions shall be clearly formulated, documentedand undertaken, as soon as possible to avoid furtheroccurrence of non-conformity. The responsibilities andthe timescales for corrective action shall be clearly defined.The documentation shall be securely stored, and easilyaccessible.

A

Two corrective actions were assessed. During internal audit which was performed in 07.03.2014., it was found a few NCs. Two of them are: the scale for grading of customer satisfaction questionnaires is 1-3 what is not enough to show real picture about company. Idea was given during the audit that new scale be minimum 1-5. It was just remark, but the company started to increase scale and analyse results of customer satisfaction more detailed. One NC was-in the area where the company produce syrup, there are wooden pallets instead of plastic pallets. Root was not adequate control of foreign bodies-according register, pallets must be plastic. During control, worker did not pay attention on it, and after cleaning of plastic pallets, instead of them, in production area ware entered wooden (which ware in good condition). Correction was-to replace them with plastic pallets and to train workers. All corrective actions ware closed and verified. Verification was done by QAM.




5.11.3


B





No.

Level


Ratin

g

Observation auditor

6 Food Defense and External Inspections

6.1 Defense assessment

6.1.1

Responsibilities for food defense shall be clearly defined.Those responsible shall be key staff or shall have access tothe top management team. Sufficient knowledge in this areashall be demonstrated.

A

Responsibilities for food defense are clearly defined in job descriptions.

6.1.2


C


6.1.3 If legislation makes registration or on-site inspections necessary,evidence shall be provided.

A Seen Certificate of registration (FDA) 15551623870 from 28.09.2013.

6.2 Site Security

6.2.1

Based on a hazard analysis and assessment of associatedrisks, identified areas critical to security shall be adequately protected to prevent unauthorized access.Access points shall be controlled.

A

Access to the site is regulated by porter on the gate. He controls access, checks and register all visitors. He must be sure that everyone (visitors) leave their identity card at the entrance. Visitors and contractors are included in the access policy. The security procedure is trained. All employees have their own identity card with which they can come on the site. Beside that, the company signed the contract with security agency Santal.

6.2.2

Procedures shall be in place to prevent tampering and/orallow identification of signs of tampering.

A

Procedure is in place- Pravila o vhodih in izhodih podjetja ter evidence and Pravilo vstopov v upravno stavbo dated 15.06.2012.. For all visitors there is procedure "Navodilo za obiskovalce".

6.3 Personnel and Visitor Security

6.3.1

Visitor policy shall contain aspects of food defense plan.Delivery and loading staff in contact with the product shallbe identified and shall respect the access rules of the company.Visitors and external service providers shall be identifiedin areas with product storage and shall be registered atthe time of access. They should be informed about the sitepolicies and their access controlled accordingly.

A


6.3.2

All employees shall be trained in food defense with respect to the product requirements and thetraining needs of the employees or when significant program changes occur. The training sessions shall be documented. Employee hiring and employment terminationpractices shall consider security aspects as permitted by law

A

All employees are trained according procedure Pravila o vhodih in izhodih podjetja ter evidence and Pravilo vstopov v upravno stavbo. Seen records from last training for food defense dated 24.03. and 31.03.2014.

6.4 External Inspections

6.4.1 A documented procedure shall exist for managing externalinspections and regulatory visits. Relevant personnel shallbe trained to execute the procedure.

A It would be external inspection by FDA in July-seen procedure.




7. Explanations regarding the audit report

Evaluation of requirements

Result Explanation Points

A Full compliance 20 points

B (deviation) Almost full compliance 15 points

KO requirement scored with a B

Almost full compliance 15 points

C (deviation) Small part of the requirement has been implemented 5 points

D (deviation) Requirement has not been implemented -20 points

Major When there is a substantial failure to meet the requirements of the Standard, which includes food safety and/or the legal requirements of the production and destination countries. A major can also be given when the identified non-conformity can lead to a serious health hazard. A major can be given to any requirement which is not defined as KO.

15 % of thepossible totalamount of pointsis subtracted.

KO requirement scored with a D

The KO requirement has not beenImplemented. 50 % of thepossible totalamount of pointsis subtracted.

N/A Not applicable. Requirement not applicable for a company.

N/A requirementswill be excludedfrom the finalscoring.




Scoring and awarding of certificates

Audit result Status Action company Report from Certificate

At least 1 KO scored with D

Not approved Actions and new initial audit to be agreed upon.

Report givesstatus

No

> 1 Major and/or < 75 % of the requirements are fulfilled

Not approved Actions and new initial audit to be agreed upon.

Report givesstatus

No

Max 1 Major and ≥ 75 % of the requirements are fulfilled

Not approved unless further actions taken and validated after follow-up audit.

Send completed action plan within 2 weeks of receiving the preliminary report. Follow-upaudit max.6 months afterthe audit date.

Report including action plan gives status.

Certificate at foundationlevel, if the major non-conformity is finally solved as controlled during the follow-up audit.

Total score is≥ 75 % and< 95 %

Approved at foundationIFS Foodlevel afterreceipt of theaction plan.

Send completedaction planwithin 2 weeksof receiving the preliminary report.


Yes, certificate at foundation level, 12 months validity.

Total score is≥ 95 % Approved at higher IFS Food level after receipt of the action plan.

Send completed action plan within 2 weeks of receiving the preliminary report.


Yes, certificate at higher level, 12 months validity.