conducted for ur startup inc. - safetyculturerequirements of iso 22000 standard? yes is the fsms...

ISO 22000 Audit Checklistconducted for

UR Startup Inc.

Conducted on (Date and Time)02 Aug 2018 03:06 PM

Inspected byAndy Dion

LocationChemin de sous le Clos 161232 ConfignonSwitzerland(46.1758650103172, 6.081072483226195)

Completed on02 Aug 2018 04:23 PM

Score323/326.0 - 99.08%

Failed ResponsesThis section lists responses that were set as "failed responses" in the template used for thisaudit

Question Response Details

Do records remain legible, readilyidentifiable and retrievable? No Some documents need to be reprinted

because of they’re faded.

Appendix 1

c) Origin? No Need to clarify what “other” means onthe document pertaining to origin.

Is it ensured that auditors do not audittheir own work? No Get external auditors to do the

assessment when applicable.

UR Startup Inc. / 02 Aug 2018 / Andy Dion - 2 -

Clause 4 - 24/25 96.00%


Food Safety Management System Score (24/25) 96.00%

General Requirements Score (10/10) 100.00%

Has the organization established,documented and implemented aneffective food safety managementsystem in accordance with therequirements of ISO 22000 standard?

Yes

Is the FSMS maintained and updated? Yes

Is the scope of the FSMS defined? Yes

Are the products or product categories,processes and production sites that areaddressed by the food safetymanagement system specified by scope?

Yes

Are the food safety hazards that may bereasonably expected to occur in relationto products within the scope of thesystem identified, evaluated andcontrolled in such manner that theproducts of theorganization do not,directly or indirectly, harm the consumer?

Yes

Are the appropriate information -regarding safety issues related to theproducts - communicated throughout thefood chain?

Yes

Are the information - concerningdevelopment, implementation andupdating of the FSMS throughout theorganization - communicated to theextent necessary to ensure the foodsafety required by the ISO 22000standard?

Yes

Does the organization periodicallyevaluate FSMS (and update whennecessary) to ensure that the systemreflects the organization's activities andincorporates the most recent informationon the food safety hazards subject tocontrol?

Yes

Score (24/25) 96.00%UR Startup Inc. / 02 Aug 2018 / Andy Dion

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Has the organization ensured controlover the outsourced processes that mayaffect end product conformity?

Yes

Is the control of such outsourcedprocesses identified and documentedwithin the FSMS?

Yes

Documentation Requirements Score (14/15) 93.33%

General Score (3/3) 100.00%

Does the FSMS documentation include:

a) Documented statements of a foodsafety policy and related objectives? Yes

b) Documented procedures and recordsrequired by ISO 22000 standard? Yes

c) Documents needed by the organizationto ensure the effective development,implementation and updating of the foodsafety management system?

Yes

Control of documents Score (9/9) 100.00%

Are the documents - which are requiredby the food safety management system -controlled?

Yes

Do the established controls ensure thatall proposed changes are reviewed priorto implementation to determine theireffects on food safety and their impact onthe food safety management system?

Yes

Does a documented procedure exist to define the controls needed:

a) To approve documents for adequacypriorto issue? Yes

b) To review and update as necessary andre-approve documents? Yes

c) To ensure that changes and thecurrent revision status of documents areidentified?

Yes

d) To ensure that relevant versions ofapplicable documents are available atpoints of use?

Yes


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e) To ensure that documents remainlegible and readily identifiable? Yes

f) To ensure that relevant documents ofexternal origin are identified and theirdistribution controlled?

Yes

g) To prevent the unintended use ofobsolete documents, and to applysuitable identification to them if they areretained for any purpose?

Yes

Control of records Score (2/3) 66.67%

Are required records established andmaintained in order to provide evidenceof conformity to requirements andevidence of the effective operation of thefood safety management system?

Yes

Do records remain legible, readilyidentifiable and retrievable? No Some documents need to be reprinted

because of they’re faded.

Appendix 1

Does a documented procedure exist inorder to define the controls needed forthe correction, identification, storage,protection, retrieval, retention time anddisposition of records?

Yes

Please proceed to Section 5.


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Clause 5 - 63/63 100.00%


Management responsibility Score (63/63) 100.00%

Management commitment Score (6/6) 100.00%

Is top management able to provideevidence of its commitment to thedevelopment and implementation of thefood safety management system?

Yes

Is top management able to provide evidence that the effectiveness of the food safety managementsystem is continually improved by:

a) Showing food safety is supported bythe business objectives of theorganization?

Yes

b) Communicating to the organizationthe importance of meeting therequirements of ISO 22000 standard, anyrelevant statutory and regulatoryrequirements, as well as customerrequirements relating to food safety?

Yes

c) Establishing the food safety policy? Yes

d) Conducting management reviews? Yes

e) Ensuring the availability of resources? Yes

Food safety policy Score (7/7) 100.00%

Has top management defined,documented and communicated its foodsafety policy?

Yes

Does top management ensure that the food safety policy:

a) Is appropriate to the role of theorganization in the food chain? Yes

b) Conforms with both statutory andregulatory requirements and withmutually agreed food safetyrequirements of customers?

Yes

c) Is communicated, implemented andmaintained at all levels of theorganization?

Yes


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d) Is reviewed for continued suitability? Yes

e) Adequately addresses communication? Yes

f) Is supported by measurable objectives? Yes

Food safety management system planning Score (2/2) 100.00%

Does top management ensure that:

a) The planning of the food safetymanagement system is carried out tomeet the requirements in clause 4.1, aswell as the objectives of the organizationthat support food safety?

Yes

b) The integrity of the food safetymanagement system is maintained whenchanges to the food safety managementsystem are planned and implemented?

Yes

Responsibility and authority Score (3/3) 100.00%

Does top management ensure that theresponsibilities, authorities are definedand communicated within theorganization to ensure the effectiveoperation and maintenance of the foodsafety management system?

Yes

Is the responsibility assigned to allpersonnel to report the problems withthe food safety management to identifiedperson(s)?

Yes

Are there designated personnel withdefined responsibility and authority toinitiate and record actions?

Yes

Food safety team leader Score (4/4) 100.00%

Has top management appointed a food safety team leader who, irrespective of otherresponsibilities, shall have responsibility and authority:

a) To manage a food safety team andorganize its work? Yes

b) To ensure relevant training andeducation of the food safety teammember?

Yes


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c) To ensure that the food safetymanagement system is established,implemented, maintained and updated?

Yes

d) To report to the organization's topmanagement on the effectiveness andsuitability of the food safetymanagement system?

Yes

NOTE: The responsibility of the food safety team leader may include liaison with external parties onmatters relating to the food safety management system.

Communication Score (25/25) 100.00%

External communication Score (9/9) 100.00%

Has the organization established, implemented and maintained effective arrangements forcommunicating with:

a) Suppliers and contractors? Yes

b) Customers or consumers, in particularin relation to product information(including instructions regardingintended use, specific storagerequirements and, as appropriate, shelflife), inquiries, contracts or orderhandling including amendments, andcustomer feedback including customercomplaints?

Yes

c) Statutory and regulatory authorities? Yes

d) Other organizations that have animpact on, or will be affected by, theeffectiveness or updating of the foodsafety management system?

Yes

Does such communication provideinformation on food safety aspects(especially to known food safety hazardsthat need to be controlled by otherorganizations in the food chain) of theorganization's products that may berelevant to other organizations in thefood chain?

Yes

Are records of communicationsmaintained? Yes


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Are the food safety requirements - fromstatutory and regulatory authorities andcustomers – available?

Yes

Are there designated personnel withdefined responsibility and authority tocommunicate externally any informationconcerning food safety?

Yes

Is information obtained through externalcommunication included as input tosystem updating and managementreview?

Yes

Internal communication Score (16/16) 100.00%

Has the organization established,implemented and maintained effectivearrangements for communicating withpersonnel on issues having an impact onfood safety?

Yes

Has the organization ensured that the food safety team is informed in a timely manner of changes,including but not limited to the following:

a) Products or new products? Yes

b) Raw materials, ingredients, andservices? Yes

c) Production systems and equipment? Yes

d) Production premises, location ofequipment, and surroundingenvironment?

Yes

e) Cleaning and sanitation programmes? Yes

f) Packaging, storage and distributionsystems? Yes

g) Personnel qualification levels and/orallocation of responsibilities andauthorizations?

Yes

h) Statutory and regulatoryrequirements? Yes

i) Knowledge regarding food safetyhazards and control measures? Yes


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j) Customer, sector, and otherrequirements that the organizationobserves?

Yes

k) Relevant inquiries from externalinterested parties? Yes

l) Complaints indicating food safetyhazards associated with the product? Yes

m) Other conditions that have an impacton food safety? Yes

Does the food safety team ensure thatabove mentioned information is includedin the updating of the food safetymanagement system?

Yes

Does top management ensure thatrelevant information is included as inputto the management review?

Yes

Emergency preparedness and response Score (1/1) 100.00%

Has top management established,implemented and maintained proceduresto manage potential emergencysituations and accidents that can impactfood safety and which are relevant to therole of the organization in the foodchain?

Yes

Management review Score (15/15) 100.00%


Does top management review theorganization’s food safety managementsystem, at planned intervals, to ensure itscontinuing suitability, adequacy andeffectiveness?

Yes

Does this review include assessingopportunities for improvement and theneed for changes to the food safetymanagement system, including the foodsafety policy?

Yes

Are records from management reviewsmaintained? Yes


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Review input Score (8/8) 100.00%

Does the input to management review include information about:

a) Follow-up actions from previousmanagement reviews? Yes

b) Analysis of results ofverificationactivities? Yes

c) Changing circumstances that can affectfood safety? Yes

d) Emergency situations, accidents andwithdrawals? Yes

e) Reviewing results of system-updatingactivities? Yes

f) Review of communication activities,including customer feed-back? Yes

g) External audits or inspections? Yes

Are the data presented in a manner thatenables top management to relate theinformation to stated objectives of thefood safety management system?

Yes

Review output Score (4/4) 100.00%

Does the output from the management review include any decisions and actions related to:

a) Assurance of food safety? Yes

b) Improvement of the effectiveness ofthe food safety management system? Yes

c) Resource needs? Yes

d) Revisions of the organization's foodsafety policy and related objectives? Yes

Please proceed to Section 6


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Clause 6 - 12/12 100.00%


Resource management Score (12/12) 100.00%

Provision of resources Score (1/1) 100.00%

Does the organization provide adequateresources for the establishment,implementation, maintenance andupdating of the food safety managementsystem?

Yes

Human resources Score (9/9) 100.00%


Are the food safety team and the otherpersonnel carrying out activities havingan impact on food safety, competent onthe basis of appropriate education,training, skills and experience?

Yes

Are there available records of agreementor contracts defining the responsibilityand authority of external experts, wherethe assistance of external experts isrequired for the development,implementation, operation orassessment of the food safetymanagement system?

Yes

Competence, awareness and training Score (7/7) 100.00%

Does the organization:

a) Identify the necessary competenciesfor personnel whose activities have animpact on food safety?

Yes

b) Provide training or take other action toensure personnel have the necessarycompetencies?

Yes

c) Ensure that personnel responsible formonitoring, corrections and correctiveactions of the food safety managementsystem are trained?

Yes


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d) Evaluate the implementation and theeffectiveness of the actions taken in a), b)and c)?

Yes

e) Ensure that the personnel are aware ofthe relevance and importance of theirindividual activities in contributing tofood safety?

Yes

f) Ensure that the requirement foreffective communication is understoodby all personnel whose activities have animpact on food safety?

Yes

g) Maintain appropriate records oftraining and actions described in b) andc)?

Yes

Infrastructure Score (1/1) 100.00%

Does the organization provide theresources for the establishment andmaintenance of the infrastructureneeded to implement the requirementsof ISO 22000 standard?

Yes

Work environment Score (1/1) 100.00%

Does the organization provide theresources for the establishment,management and maintenance of thework environment needed to implementthe requirements of ISO 22000 standard?

Yes



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Clause 7 - 176/177 99.44%


Planning and realization of safe products Score (176/177) 99.44%


Does the organization plan and developthe processes needed for the realizationof safe products?

Yes

Does the organization implement,operate and ensure the effectiveness ofthe planned activities and any changes tothose activities? Note: This includesPRP(s) as well as operational PRP(s)and/or the HACCP plan.

Yes

Prerequisite programmes (PRPs) Score (24/24) 100.00%

Has the organization established, implemented and maintained PRP(s) to assist in controlling:

a) The likelihood of introducing foodsafety hazards to the product throughthe work environment?

Yes

b) Biological, chemical and physicalcontamination of the product(s),including cross-contamination betweenproducts?

Yes

c) Food safety hazard levels in theproduct and product processingenvironment?

Yes

Are the PRP(s):

a) Appropriate to the organizationalneeds with regard to food safety? Yes

b) Appropriate to the size and type of theoperation and the nature of the productsbeing manufactured and/or handled?

Yes

c) Implemented across the entireproduction system, either asprogrammes applicable in general or asprogrammes applicable to a particularproduct or operational line?

Yes

d) Approved by the food safety team? Yes


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Does the organization identify statutoryand regulatory requirements related tothe above?

Yes

Does the organization consider andutilize appropriate information, whenselecting and/or establishing PRP(s)?

Yes

Does the organization consider the following (when establishing PRP(s)):

a) Construction and layout of buildingsand associated utilities? Yes

b) Layout of premises, includingworkspace and employee facilities? Yes

c) Supplies of air, water, energy and otherutilities? Yes

d) Supporting services, including wasteand sewage disposal? Yes

e) The suitability of equipment and itsaccessibility for cleaning, maintenance,and preventative maintenance?

Yes

f) Management of purchased materials(e.g. raw materials, ingredients,chemicals, and packaging), supplies (e.g.water, air, steam, and ice), disposals (e.g.waste and sewage) and handling ofproducts (e.g. storage andtransportation)?

Yes

g) Measures for the prevention ofcross-contamination? Yes

h) Cleaning and sanitizing? Yes

i) Pest control? Yes

j) Personal hygiene? Yes

k) Other aspects as appropriate? Yes

Is verification of PRP(s) planned? Yes

Are PRP(s) modified as necessary? Yes

Are records of verifications andmodifications maintained? Yes


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Do documents specify how activitiesincluded in the PRP(s) are managed? Yes

Preliminary steps to enable hazard analysis Score (38/39) 97.44%


Are all relevant information - needed toconduct the hazard analysis - collected,maintained, updated and documented?

Yes

Are the records related to hazard analysismaintained? Yes

Food safety team Score (3/3) 100.00%

Has a food safety team been appointed? Yes

Do the members of the food safety teamprovide a combination ofmulti-disciplinary knowledge andexperience in developing andimplementing the food safetymanagement system? Note: Thisincludes, but need not be limited to, theorganization's products, processes,equipment and food safety hazardswithin the scope of the food safetymanagement system.

Yes

Are records - that demonstrate that thefood safety team has the requiredknowledge and experience - maintained?

Yes

Product characteristics Score (18/19) 94.74%

Raw material, ingredients, and product contacted material Score (9/10) 90.00%

Are all raw materials, ingredients and product-contact materials described in documents to theextent needed to conduct the hazard analysis, including the following, as appropriate:

a) Biological, chemical, and physicalcharacteristics? Yes

b) Composition of formulatedingredients, including additives andprocessing aids?

Yes

c) Origin? No Need to clarify what “other” means onthe document pertaining to origin.


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d) Method of production? Yes

e) Packaging and delivery methods? Yes

f) Storage conditions and shelf life? Yes

g) Preparation and/or handling beforeuse or processing? Yes

h) Food safety-related acceptance criteriaor specifications of purchased materialsand ingredients appropriate to theirintended uses?

Yes

Does the organization identify statutoryand regulatory food safety requirementsrelated to the raw materials, ingredientsand product-contact materials?

Yes

Are the descriptions kept up-to-dateincluding, when required? Yes

Characteristics of end products Score (9/9) 100.00%

Are the characteristics of end products described in documents to the extent needed to conduct thehazard analysis, including information on the following, as appropriate:

a) Product name or similar identification? Yes

b) Composition? Yes

c) Biological, chemical and physicalcharacteristics relevant to food safety? Yes

d) Intended shelf life and storageconditions? Yes

e) Packaging? Yes

f) Labeling relating to food safety and/orinstructions for handling, preparation,and usage?

Yes

g) Method(s) of distribution? Yes

Does the organization identify statutoryand regulatory food safety requirementsrelated to the characteristics of endproducts?

Yes



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Intended use Score (3/3) 100.00%

Are the intended use, the reasonablyexpected handling of the end product,and any unintended but reasonablyexpected mishandling and misuse of theend product considered and described indocuments to the extent needed toconduct the hazard analysis?

Yes

Are groups of users and, whereappropriate, groups of consumersidentified for each product, andconsumer groups are known to beespecially vulnerable to specific foodsafety hazards considered?

Yes


Flow diagrams, process steps, and control measures Score (12/12) 100.00%

Flow diagrams Score (10/10) 100.00%

Are flow diagrams prepared for theproducts or process categories coveredby the food safety management system?

Yes

Do flow diagrams provide a basis forevaluating the possible occurrence,increase or introduction of food safetyhazards?

Yes

Are flow diagrams clear, accurate andsufficiently detailed? Yes

Do flow diagrams, as appropriate, include the following:

a) The sequence and interaction of allsteps in the operation? Yes

b) Any outsourced processes andsubcontracted work? Yes

c) Where raw materials, ingredients, andintermediate products enter the flow? Yes

d) Where reworking and recycling takeplace? Yes


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e) Where end products, intermediateproducts, byproducts, and waste arereleased or removed?

Yes

Does the food safety team verify theaccuracy of the flow diagrams by on-sitechecking?

Yes

Are verified flow diagrams maintained asrecords? Yes

Description of process steps and control measures Score (2/2) 100.00%

Are the existing control measuresprocess parameters and/or therigorousness with which they are applied,or the procedures that may influencefood safety, described to the extentneeded to conduct the hazard analysis?

Yes

Are external requirements (e.g.regulatory authorities ore costumes) thatmay impact the choice or rigorousness ofthe control measures described andupdated?

Yes

Hazard analysis Score (30/30) 100.00%


Does the food safety team conduct ahazard analysis to determine whichhazards need to be controlled, thedegree of control required to ensure foodsafety, and which combination of controlmeasures is required?

Yes

Hazard identification and determination of acceptable levels Score (12/12) 100.00%

Are all food safety hazards that arereasonably expected to occur in relationto the type of product, type of processand actual processing facilities identifiedand recorded?

Yes

Is the identification based on:

a) The preliminary information and datacollected in preliminary steps to enablehazard analysis?

Yes


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b) Experience? Yes

c) External information including, to theextent possible, epidemiological andother historical data?

Yes

d) Information from the food chain onfood safety hazards that may be ofrelevance for the safety of the endproducts, intermediate products, and thefood at consumption?

Yes

Are the step(s) (from raw materials,processing, and distribution) - at whicheach food safety hazard may beintroduced – indicated?

Yes

Is the consideration - when identifying the hazards - given to:

a) The steps preceding and following thespecified operation? Yes

b) The process equipment,utilities/services, and surroundings? Yes

c) The preceding and following links inthe food chain? Yes

Are the acceptable level of the foodsafety hazard in the end productdetermined (whenever possible) for eachof the food safety hazards identified?

Yes

Does the determined level take intoaccount established statutory andregulatory requirements, customer foodsafety requirements, the intended use bythe customer and other relevant data?

Yes

Are the justification for, and the result of,the determination of the acceptable levelof the food safety hazard recorded?

Yes

Hazard assessment Score (4/4) 100.00%

Is a hazard assessment conducted todetermine, for each food safety hazardidentified, whether its elimination orreduction to acceptable levels is essentialto the production of a safe food andwhether its control is needed to enablethe defined acceptable levels to be met?

Yes


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Is each food safety hazard evaluatedaccording to the possible severity ofadverse health effects and the likelihoodof their occurrence?

Yes

Is the methodology used for the hazarddescribed? Yes

Are the results of the food safety hazardassessment recorded? Yes Backup copies of assessments are in

cloud storage.

Selection and assessment of control measures Score (13/13) 100.00%

Is an appropriate combination of controlmeasures selected (based on the hazardassessment), which is capable ofpreventing, eliminating or reducing thesefood safety hazards to defined acceptablelevels?

Yes

Is each of the selected control measuresreviewed with respect to its effectivenessagainst the identified food safetyhazards?

Yes

Is each selected control measure categorized as to whether it needs to be managed throughoperational PRP(s) or by the HACCP plan, using a logical approach that includes assessments withregard to the following:

a) Its effect on identified food safetyhazards relative to the strictness applied? Yes

b) Its feasibility for monitoring (e.g. abilityto be monitored in a timely manner toenable immediate corrective actions)?

Yes

c) It is placed within the system relative toother control measures? Yes

d) The likelihood of failure in thefunctioning of a control measure orsignificant processing variability?

Yes

e) The severity of the consequence(s) inthe case of failure in its functioning? Yes

f) Whether the control measure isspecifically established and applied toeliminate or significantly reduce the levelof hazard(s)?

Yes


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g) Synergistic effects (i.e. interaction thatoccurs between two or more measuresresulting in their combined effect beinghigher than the sum of their individualeffects)?

Yes

Are control measures - categorized asbelonging to the HACCP plan –implemented?

Yes

Are other control measures implementedas operational PRPs? Yes

Are the methodology and parameters -used for this categorization - described indocuments?

Yes

Are the results of the assessmentrecorded? Yes

Establishing the operational prerequisite programmes (PRPs) Score (7/7) 100.00%

Are the operational PRPs documented? Yes

Are the operational PRPs included the following information for each programme:

a) Food safety hazard(s) to be controlledby the programme? Yes

b) Control measure(s)? Yes

c) Monitoring procedures thatdemonstrate that the operational PRPsare in place?

Yes

d) Corrections and corrective actions tobe taken if monitoring shows that theoperational PRPs are not in control?

Yes

e) Responsibilities and authorities? Yes

f) Record(s) of monitoring? Yes

Establishing the HACCP plan Score (28/28) 100.00%

HACCP plan Score (8/8) 100.00%

Is the HACCP plan documented? Yes

Is the HACCP plan included the following information for each identified critical control point (CCP):


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a) Food safety hazard(s) to be controlledat the CCP? Yes

b) Control measure(s)? Yes

c) Critical limit(s)? Yes

d) Monitoring procedure(s)? Yes

e) Corrections and corrective action(s) tobe taken if critical limits are exceeded? Yes

f) Responsibilities and authorities? Yes

g) Record(s) of monitoring? Yes

Identification of critical control points Score (1/1) 100.00%

Are CCP(s) identified for the controlmeasures identified, for each hazard thatis to be controlled by the HACCP plan?

Yes

Determination of critical limits forCCP(s) Score (5/5) 100.00%

Are critical limits determined for themonitoring established for each CCP? Yes

Are critical limits established on such away to ensure that the identifiedacceptable level of the food safety hazardin the end product is not exceeded?

Yes

Are critical limits measurable? Yes

Are the rationale for the chosen criticallimits documented? Yes

Are critical limits - based on subjectivedata (such as visual inspection ofproduct, process, handling, etc.) -supported by instructions orspecifications and/or education andtraining?

Yes

System for the monitoring of critical control points Score (9/9) 100.00%

Is a monitoring system established foreach CCP to demonstrate that the CCP isin control?

Yes


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Are all scheduled measurements orobservations - relative to the criticallimit(s) - included in the monitoringsystem?

Yes

Does the monitoring system consist of relevant procedures, instructions, and records that cover thefollowing:

a) Measurements or observations thatprovide results within an adequate timeframe?

Yes

b) Monitoring devices used? Yes

c) Applicable calibration methods? Yes

d) Monitoring frequency? Yes

e) Responsibility and authority related tomonitoring and evaluation of monitoringresults?

Yes

f) Record requirements and methods? Yes

Are the monitoring methods andfrequency capable of determining whenthe critical limits have been exceeded intime for the product to be isolated beforeit is used or consumed?

Yes

Actions when monitoring results exceed critical limits Score (5/5) 100.00%

Are planned corrections and correctiveactions - to be taken when critical limitsare exceeded - specified in the HACCPplan?

Yes

Do the actions ensure that:

a) The cause of nonconformity isidentified? Yes

b) The parameter(s) controlled at the CCPis (are) brought back under control? Yes

c) Recurrence is prevented? Yes

Are documented procedures establishedand maintained for the appropriatehandling of potentially unsafe productsto ensure that they are not released untilthey have been evaluated?

Yes


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Updating of preliminary information and documentsspecifying the PRPs and the HACCP plan

Score (6/6) 100.00%

Does the organization update the following information in operational PRP(s) and/or the HACCPplan, if necessary:

a) Product characteristics? Yes

b) Intended use? Yes

c) Flow diagrams? Yes

d) Process steps? Yes

e) Control measures? Yes

Are the HACCP plan and the proceduresand instructions specifying the PRP(s)amended, if necessary?

Yes

Verification planning Score (9/9) 100.00%

Does verification planning define thepurpose, methods, frequencies, andresponsibilities for the verificationactivities?

Yes

Do the verification activities confirm that:

a) The PRP(s) are implemented? Yes

b) Input to the hazard analysis iscontinually updated? Yes

c) The operational PRP(s) and theelements within the HACCP plan areimplemented and effective, d) hazardlevels are within identified acceptablelevels?

Yes

e) Other procedures required by theorganization are implemented andeffective?

Yes

Is the output of verification planning in aform suitable for the organization'smethod of operations?

Yes

Are verification results recorded andcommunicated to the food safety team? Yes


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Are verification results provided on suchway to enable the analysis of the resultsof the verification activities?

Yes

Are the affected lots of product handledas potentially unsafe, if systemverification is based on testing of endproduct samples, and where such testsamples show lack of conformity with theacceptable level of the food safetyhazard?

Yes

Traceability system Score (4/4) 100.00%

Has the organization established anddoes it apply a traceability system thatenables the identification of product lotsand their relation to batches of rawmaterials, processing, and deliveryrecords?

Yes

Is the traceability system able to identifyincoming material from the immediatesuppliers and the initial distribution routeof the end product?

Yes

Are traceability records maintained for adefined period for system assessment toenable the handling of potentially unsafeproducts and in the event of productwithdrawal?

Yes

Are records in accordance with statutoryand regulatory requirements andcustomer requirements?

Yes

Control of nonconformity Score (23/23) 100.00%

Corrections Score (8/8) 100.00%

Does the organization ensure that whencritical limits for CCP(s) are exceeded orthere is a loss of control of operationalPRP(s), the end products affected areidentified and controlled with regard totheir use and release?

Yes

Is a documented procedure established and maintained defining:


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a) The identification and assessment ofaffected end products to determine theirproper handling?

Yes

b) A review of the corrections carried out? Yes

Are potentially unsafe products -manufactured under conditions wherecritical limits have been exceeded -handled?

Yes

Are products - manufactured underconditions where operational PRP(s) havenot been conformed with - evaluatedwith respect to the cause(s) of thenonconformity and to the consequencesthereof in terms of food safety?

Yes

Are these products, where necessary,handled? Yes

Is the evaluation recorded? Yes

Are all corrections approved by theresponsible person(s), and recordedtogether with information on the natureof the nonconformity, its cause(s) andconsequence(s), including informationneeded for traceability purposes relatedto the nonconforming lots?

Yes

Corrective actions Score (4/4) 100.00%

Are data - derived from the monitoring ofoperational PRPs and CCPs - evaluated bydesignated person(s) with sufficientknowledge and authority to initiatecorrective actions?

Yes

Are corrective actions initiated whencritical limits are exceeded or when thereis a lack of conformity with operationalPRP(s)?

Yes


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Has the organization established anddoes it maintain documented proceduresthat specify appropriate actions toidentify and eliminate the cause ofdetected nonconformities, to preventrecurrence, and to bring the process orsystem back into control afternonconformity is encountered?Note:These actions includea) reviewing nonconformities (includingcustomer complaints),b) reviewing trends in monitoring resultsthat may indicate development towardsloss of control,c) determining the cause(s) ofnonconformities,d) evaluating the need for action toensure that nonconformities do notrecur,e) determining and implementing theactions needed,f) recording the results of correctiveactions taken, andg) reviewing corrective actions taken toensure that they are effective.

Yes

Are corrective actions recorded? Yes

Handling of potentially unsafe products Score (11/11) 100.00%


Does the organization handle nonconforming products by taking action(s) to prevent thenonconforming product from entering the food chain unless it is possible to ensure that

a) The food safety hazard(s) of concernhas(ve) been reduced to the definedacceptable levels?

Yes

b) The food safety hazard(s) of concernwill be reduced to identified acceptablelevels prior to entering into the foodchain?

Yes

c) The product still meets the definedacceptable level(s) of the food safetyhazard(s) of concern despite thenonconformity?

Yes


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Are all lots of product - that may havebeen affected by a nonconformingsituation - held under control of theorganization until they have beenevaluated?

Yes

Does the organization notify relevantinterested parties and initiate awithdrawal, if products that have left thecontrol of the organization aresubsequently determined to be unsafe?Note: The term “withdrawal” includesrecall.

Yes

Are the controls and related responsesand authorization for dealing withpotentially unsafe products documented?

Yes

Evaluation for release Score (3/3) 100.00%

Is each lot of product affected by the nonconformity released as safe only when any of the followingconditions apply:

a) Evidence other than the monitoringsystem demonstrates that the controlmeasures have been effective?

Yes

b) Evidence shows that the combinedeffect ofthe control measures for thatparticular product complies with theperformanceintended?

Yes

c) The results of sampling, analysisand/or other verification activitiesdemonstrate that the affected lot ofproduct complies with the identifiedacceptable levels for the food safetyhazard(s) concerned?

Yes

Disposition of nonconforming products Score (2/2) 100.00%

Is the lot of product - which is not acceptable for release - handled (after evaluation) by one of thefollowing activities:

a) Reprocessing or further processingwithin or outside the organization toensure that the food safety hazard iseliminated or reduced to acceptablelevels?

Yes

b) Destruction and/or disposal as waste? Yes


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Control of nonconformity Score (5/5) 100.00%

Withdrawals Score (5/5) 100.00%

To enable and facilitate the complete and timely withdrawal of lots of end products which have beenidentified as unsafe

a) Has top management appointedpersonnel having the authority to initiatea withdrawal and personnel responsiblefor executing the withdrawal?

Yes

b) Has the organization established anddoes it maintain a documentedprocedure for1) notification to relevant interestedparties (e.g. statutory and regulatoryauthorities, customers and/orconsumers),2) handling of withdrawn products aswell as affected lots of the products stillin stock, and3) the sequence of actions to be taken?.

Yes

Are withdrawn products secured or heldunder supervision until they aredestroyed, used for purposes other thanoriginally intended, determined to besafe for the same (or other) intended use,or reprocessed in a manner to ensurethey become safe?

Yes

Are the cause, extent and result of awithdrawal recorded and reported to topmanagement as input to themanagement review?

Yes

Does the organization verify and recordthe effectiveness of the withdrawalprogramme through the use ofappropriate techniques (e.g. challengetesting, mock withdrawal or practicewithdrawal)?

Yes



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Clause 8 - 48/49 97.96%


Validation, verification, and improvement of the FSMS Score (48/49) 97.96%


Does the food safety team plan andimplement the processes needed tovalidate control measures and/or controlmeasure combinations, and to verify andimprove the food safety managementsystem?

Yes

Validation of control measure combinations Score (4/4) 100.00%

Does the organization validate (prior to implementation of control measures to be included inoperational PRP(s) and the HACCP plan and after any change therein) that:

a) The selected control measures arecapable of achieving the intended controlof the food safety hazard(s) for whichthey are designated?

Yes

b) The control measures are effective andcapable of, in combination, ensuringcontrol of the identified food safetyhazard(s) to obtain end products thatmeet the defined acceptable levels?

Yes

Are the control measure and/orcombinations thereof modified andre-assessed when the result of thevalidation shows that one or both of theabove elements cannot be confirmed?

Yes

Note: Modifications may include changesin control measures (i.e. processparameters, rigorousness and/or theircombination) and/or change(s) in the rawmaterials, manufacturing technologies,end product characteristics, methods ofdistribution and/or intended use of theend product.

Yes


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Control of monitoring and measuring Score (12/12) 100.00%

Is there evidence that the specifiedmonitoring and measuring methods andequipment are adequate to ensure theperformance of the monitoring andmeasuring procedures?

Yes

Are the measuring equipment and methods used:

a) Calibrated or verified at specifiedintervals, or prior to use, againstmeasurement standards traceable tointernational or national measurementstandards? Note: Where necessary toensure valid results

Yes

b) Adjusted or re-adjusted as necessary? Yes

c) Identified to enable the calibrationstatus to be determined? Yes

d) Safeguarded from adjustments thatwould invalidate the measurementresults?

Yes

e) Protected from damage anddeterioration? Yes

Are records of the results of calibrationand verification maintained? Yes

Does the organization assess the validityof the previous measurement resultswhen the equipment or process is foundnot to conform to requirements?

Yes

Does the organization take actionappropriate for the equipment and anyproduct affected, If the measuringequipment is non-conforming?

Yes

Are records of such assessment andresulting actions maintained? Yes

Is the ability of computer softwareconfirmed to satisfy the intendedapplication when used in the monitoringand measurement of specifiedrequirements?

Yes


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Is the confirmation of computer softwareundertaken prior to initial use andreconfirmed as necessary?

Yes

FSMS verification Score (22/23) 95.65%

Internal audit Score (8/9) 88.89%

Does the organization conduct internal audits at planned intervals to determine whether the foodsafety management system:

a) Conforms to the plannedarrangements, to the food safetymanagement system requirementsestablished by the organization, and tothe requirements of this InternationalStandard?

Yes

b) Is effectively implemented andupdated? Yes

Is an audit programme planned, takinginto consideration the importance of theprocesses and areas to be audited, aswell as any updating actions resultingfrom previous audits?

Yes

Are the audit criteria, scope, frequency,and methods defined? Yes

Do the selection of auditors and theconduct of audits ensure objectivity andimpartiality of the audit process?

Yes

Is it ensured that auditors do not audittheir own work? No Get external auditors to do the

assessment when applicable.

Are the responsibilities and requirementsfor planning and conducting audits, andfor reporting results and maintainingrecords defined in documentedprocedure?

Yes

Does the management responsible forthe area being audited to ensure thatactions are taken without undue delay toeliminate detected nonconformities andtheir causes?

Yes

Do follow-up activities include theverification of the actions taken and thereporting of verification results?

Yes


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Evaluation of individual verification results Score (6/6) 100.00%

Does the food safety team systematicallyevaluate the individual results of plannedverification?

Yes

Does the organization take action toachieve the required conformity, whenverification does not demonstrateconformity with the plannedarrangements?

Yes

Does action – taken for achieving the required conformity – include (but is not limited to), review of:

a) Existing procedures andcommunication channels? Yes

b) The conclusions of the hazard analysis,the established operational PRP(s) andthe HACCP plan?

Yes

c) The PRP(s)? Yes

d) The effectiveness of human resourcemanagement and of training activities? Yes

Analysis of results of verification activities Score (8/8) 100.00%

Does the food safety team analyze theresults of verification activities, includingthe results of the internal audits andexternal audits?

Yes

Is the analysis carried out in order

a) To confirm that the overallperformance of the system meets theplanned arrangements and the foodsafety management systemrequirements established by theorganization?

Yes

b) To identify the need for updating orimproving the food safety managementsystem?

Yes

c) To identify trends which indicate ahigher incidence of potentially unsafeproducts?

Yes


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d) To establish information for planningof the internal audit programmeconcerning the status and importance ofareas to be audited?

Yes

e) To provide evidence that anycorrections and corrective actions thathave been taken are effective?

Yes

Are the results of the analysis and theresulting activities recorded andreported, in an appropriate manner, totop management as input to themanagement review?

Yes

Are the results of the analysis and theresulting activities used as an input forupdating the food safety managementsystem?

Yes

Improvement Score (9/9) 100.00%

Continual improvement Score (1/1) 100.00%

Does top management ensure that theorganization continually improves theeffectiveness of the food safetymanagement system through the use of:- communication,- management review,- internal audit,- evaluation of individual verificationresults,- analysis of results ofverificationactivities,- validation of controlmeasurecombinations,- corrective actions and- food safety management systemupdating?

Yes

Updating the food safety management system Score (8/8) 100.00%

Does top management ensure that thefood safety management system iscontinually updated?

Yes

Does the food safety team evaluate thefood safety management system atplanned intervals in order to achieve thatFSMS is continually updated?

Yes


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Does the team consider whether it isnecessary to review the hazard analysis,the established operational PRP(s) andthe HACCP plan?

Yes

Are the evaluation and updating activities based on:

a) Input from communication, external aswell as internal? Yes

b) Input from other informationconcerning the suitability, adequacy, andeffectiveness of the food safetymanagement system?

Yes

c) Output from the analysis of results ofverification activities? Yes

d) Output from management review? Yes

Are system updating activities recordedand reported, in an appropriate manner,as input to the management review?

Yes

Completion

Recommendation

Inspector's Full nameand Signature

Andy Dion 02 Aug 2018 04:09 PM


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Media

UR Startup Inc. / 02 Aug 2018 / Andy Dion - 37 -

Appendix 1