IFS Food UFP Harmonized Checklist JUNE2014 2

8/9/2019 IFS Food UFP Harmonized Checklist JUNE2014 2

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Checklist & Guideline

IFS Food, version 6 – United Fresh Producers

Harmonized Checklist

Version 1, May 2014



IFS Food, version 6 – United Fresh Producers Harmonized Checklist & Guideline

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No IFSFood,version 6

Requirement IFS Food, version 6 No UFPHarmonizedChecklist

RequirementUFP Harmonized Checklist

What do you have to check?What must be asked?

KO / Major Cross reference(IFS requirements,importantdirectives, othercomments)

Cross referenceUS American regulations

1 S en io r M an ag eme nt Re spo ns ibi li ty

1.1 Corporate policy/Corporate principles This cross reference should be seen asintroduction. Please keep in mind thatyou have additional state regulations.There are a lot of product specific crossreferences.

1.1.1 The senior management shall draw up andimplement a corporate policy. This shallconsider as a minimum:• customer focus• environmental responsibility• sustainability• ethics and personnel responsibility• product requirements (includes: product

safety, quality, legality, process andspecification).

The corporate policy shall be communicatedto all employees.

1.1.1 A food safety policy shall be in place:A written policy shall outline acommitment to food safety, in generalterms, how it is implemented and how itis communicated to employees, and besigned by Senior Management.

• How and where is corporate policydocumented?

• What are the contents of the corporate policy?• How was corporate policy communicated to all

employees?

• <corporate policy>, <posters> <documentedevidence of corporate policy communication>Environmental responsibility and

sustainability are included in the IFS Foodstandard, even if it is a food safety and qualitystandard, in order to initiate/develop incompanies processes of awareness for bothtopics.

1.2 Corpo rate st ruc ture

1.2.2 Competences and responsibilities, includingdeputation of responsibility shall be clearlylaid down.

1.1.2 Management has designatedindividual(s) with roles and responsi-bilities for food safety functions: The

Food Safety Plan shall designate whohas the responsibility and authority forfood safety, including a provision for theabsence of key personnel. Twenty-fourhour contact information shall beavailable for these individuals in case offood safety emergencies. These roles andresponsibilities shall be communicatedwithin the organization.

• For which positions do written jobdescriptions exist?

• What is regulated in the job descriptions?

• Who, for example substitutes QA managerduring his absence?

• <Responsibility description for important keystaff “dedicated to a spec ific person”,e.g. QA Manager, Production Manager, ShiftLeader….. >

When a Food Safetyand Legality issueoccurs due to

failure to defineresponsibilities forexisting companyregulations.

21 CFR 110.80 21 CFR 120.10






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1.4 Management review

1.4.1 Senior management shall ensure that thequality and food safety management systemsare reviewed at least annually or morefrequently if changes occur. Such reviewsshall contain, at least, results of audits,customer feedbacks, process compliance andproduct conformity, status of preventive andcorrective actions, follow up actions fromprevious management reviews, changesthat could affect the food safety and qualitymanagement systems and recommendationsfor improvement.

To bechecked inan IFS Foodaudit in

additionto theHarmonizedChecklistrequirements.

• When is the quality management systemreviewed and evaluated?

• How often was the system reviewed last year?• What was the result of the review?

<review report>• Does the management review take into

consideration, as a minimum, the assessmentof the following:

• documents from the previous managementreview,

• results from internal and external audits, aswell as inspections,

• performance indicators for customers,complaints and withdraws/recalls,

• incidents, corrective actions, results outof specifications and non conformingmaterials,

• process performance and productcompliance,

• review of HACCP system and changes whichmay affect quality and food safety system,

• evolutions of scientific information relatedto products,

• improvement of quality system efficiencyand production process,

• improvement of product, related tocustomer requirements,

• needs in resources (includinginvestments)?

When the qualitymanagement systemis not reviewedregularly and there isno assurance that itworks properly.

Title 1 Sec 418 a-e

1.4.3 The company shall identify and reviewregularly (e.g. by internal audits or on-site

inspection) the infrastructure neededto achieve conformity to product require-ments. 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 investmentplanning.

To bechecked in

an IFS Foodaudit inadditionto theHarmonizedChecklistrequirements.

• When is infrastructure (building, machinery,transport) evaluated?

• What was the result of infrastructure evaluation?<audit report>

• Who evaluated infrastructure?• What were the results of the infrastructure

assessment? <corrective actions><investment plan>

• Were the results used for further infrastructure planning? <investment plan>

• What risks were identified according to theresults of infrastructure assessment?<risk analysis>

• What are infrastructure related investments forthe near future? <investment plan>

When infrastructureis not evaluated and

therefore a risk forlegality, safety andquality of productsoccurs.

Internal audits5.1.1

On site inspec-tions5.11.2

Internal audits 5.1.1On site inspections

5.11.2 FSMA Sec 307




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2. Qualit y and Food Safety

Management System

2.1 Quality management

2.1.1 Documentation requirements FSMA Titel I Sec 103

2.1.1.1 The system for food safety and qualitymanagement shall be documented andimplemented, and shall be retained in onelocation (food safety and quality manual orelectronic documented system).

1.4.1 Documentation shall be kept thatdemonstrates the Food Safety Plan isbeing followed: Documents and recordsof procedures, standard operatingprocedures (SOPs) and policies shall bein place for meeting each of the foodsafety standards identified in the FoodSafety Plan.

• Where is documentation concerning the qualitysystem for quality assurance and food safetyretained? <procedure for document control>

When there is noquality system forquality assurance andfood safety in place.

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging orholding human food (111 for dietarysupplements)110.110 Natural or unavoidable defectsin food for human use that present nohealth hazard.FSMA Titel I Sec 103

2.1.1.3 All documents shall be clearly legible,unambiguous and comprehensive.They shall be available to relevantpersonnel at all times.

1.4.2 Documentation shall be readilyavailable for inspection: Documentsand records may be maintained on-siteor at an off-site location, or accessibleelectronically (e.g., MSDS), and shall beavailable for inspection in a reasonabletime frame or as required by prevailingregulation.

• Are all documents legible?• Are the documents unambiguous?• Are the documents available at the right places?

Also after office hours?• How do relevant employees have access to

documents?• How are document changes communicated to

relevant employees?• Are there any distribution lists for documents?

<Examples>, <procedure>, <distribution lists>

When documents areunavailable and thisendangers legality,safety or quality ofthe product.

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging orholding human food (111 for dietarysupplements)120.7 Hazard Analysis

2.1.2 Record keeping

2.1.2.1 All relevant records necessary for the productrequirements shall be complete, detailed andmaintained and shall be available on request.

1.4.1 Documentation shall be kept thatdemonstrates the Food Safety Plan isbeing followed: Documents and recordsof procedures, standard operating

procedures (SOPs) and policies shall bein place for meeting each of the foodsafety standards identified in the FoodSafety Plan.

• What records exist?• Are the records complete?• Are the records available?

When insufficient orno records are madeand thus endangerlegality, safety or

quality.

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food (111 for dietary

supplements)120.13 Hazard Analysis

3.3.2

2.1.2.3 All records shall be kept in accordance withlegal requirements and for a minimum of oneyear after the shelf life. For products whichhave no shelf life, the duration of recordkeeping shall be justified and this justificationshall be documented.

1.4.3 Docum entation sh all be re taine d fo ra minimum period of two years, oras required by prevailing regulation:Document and record handling policy orprocedures require that documentationrequired by the Food Safety Plan shall beretained for a minimum of two years, oras required by prevailing regulation.

• Where are records stored?• Who stores records?• How long are records kept?

On what basis were record storage timesdefined?

• For products with a short shelf- life, was recordstorage time definition based on risk analysis?<procedure documents>, <risk analysis>

When records are notstored in accordanceto legal requirements.

Risk analysis




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NEW

2.1.2.5

Records shall be securely stored and easily

accessible.

1 .4 .2 D oc um en tat io n s hal l b e re ad il y a va il ab le

for inspection. Documents and recordsmay be maintained on-site or at an off-site location, or accessible electronically(e.g., MSDS), and shall be available forinspection in a reasonable time frame oras required by prevailing regulation.

This requirement has been added in order

to comply with GFSI Guidance Documentversion 6.

21 CFR Part: 120 – Hazard Analysis and

Critical Control Point (HACCP) systemFSMA Title I Sec 112120.07 Hazard Analysis

2.2 Food safety Management 21 CFR Part: 120 – Hazard Analysis andCritical Control Point (HACCP) system120.07 Hazard Analysis

2.2.1 HACCP system 21 CFR Part: 120 – Hazard Analysis andCritical Control Point (HACCP) system120.07 Hazard Analysis

2.2.1.1 The basis of the company’s food safety controlsystem shall be a fully implemented,systematic and comprehensive HACCPsystem, based upon the Codex Alimentariusprinciples. It shall take into account anylegal requirements of the production anddestination countries which may go beyondsuch principles. The HACCP system shall beimplemented at each production site.

1 .2 .1 T he re s ha ll b e a w ri tt en Fo od S af et y Pl an .The plan shall cover the operation. Theoperation and products covered shall bedefined: The Food Safety Plan shallidentify all locations of operationcovered by the plan and shall addresspotential physical, chemical, andbiological hazards and hazard controlprocedures, including monitoring,verification and record keeping, for allprovisions covered by this audit.

• Description of HACCP plans and available flowdiagrams. The company’s HACCP plan is basedon what principles?

• Has every site/plant a separate HACCP plan?• Which specific regulations are taken

care of in HACCP plan? <HACCP plan>• Are the legal requirements of the destination

country are known, especially the labelingregulation?- Does the hazard analysis outcome show

that not all of the HACCP principles arenecessary? In this case, which ones?

If there is no HACCPplan.If legal requirementsare not included inHACCP plan.If there is no HACCPplan for eachindividual site/plant.

NEW2.2.1.4

HACCP system shall be reviewed andnecessary changes shall be made when any

modification is made in the product, processor any step.

1.2.2 The Foo d Safety Plan shall be reviewedat least annually: Operation shall be re-

sponsible for reviewing their Food SafetyPlan at least annually, documenting thereview procedure and revising the planas necessary.

The update of HACCP system was missing in IFSFood version 5, therefore it has been added in

version 6.

21 CFR Part: 120 – Hazard Analysis andCritical Control Point (HACCP) system

120.07 Hazard Analysis






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3. Resource Management

3 .1 H um an re so urc es ma nag em en t 21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holding

human food110.10 Personnel

HACCP team, IFS manager, pestcontroller, cleaning & sanitation,maintenance

3.1.1 All personnel performing work that affectsproduct safety, legality and quality shall havethe required competence by education, workexperience and/ or training, commensuratewith their role, based on hazard analysis and

assessment of associated risks.

1.5.1 Al l person nel shall receive food safetytraining: All personnel shall receivetraining in the food safety policy andplan, food safety procedures, sanitationand personal hygiene appropriate to

their job responsibilities. Personnel shallreceive training at hire and refreshertraining at prescribed frequencies.Documentation of training is available.

• How is it assured that new employees have theright capabilities for the job?

When, due to lackof education,experience or trainingthe legality or safetyof the product is

jeopardized.

HACCP team,IFS manager,pestcontroller,cleaning and

sanitation,maintenance

3.2 Human resources

3.2.1 Personnel hygiene 21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.10 PersonnelRisk analysisFSMA Title I Sec 418 o 2




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3.2.1.1 There shall be documented requirementsrelating to personnel hygiene. These include, as a minimum, thefollowing fields:• 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 onhazard analysis and assessment ofassociated risks in relation to product

and process.

1.21.31.21.51.21.101.21.111.21.12

The practice of disposing of usedtoilet tissue on the floor, in trashreceptacles, or in boxes is prohibited.Operation shall instruct employeesthat used toilet tissue shall only bedisposed of in the toilet.

First aid kits shall be accessible toall personnel. The kits shall bereadily available in the facility andmaintained in accordance withprevailing regulation. The kitmaterials shall be within shelf lifeand kept in a sanitary and usablecondition.

Smoking, chewing, eating, drinking(other than water), chewing gum andusing tobacco shall be prohibitedexcept in clearly designated areas.Operation shall have policyprohibiting smoking, eating,chewing gum or tobacco, drinkingother than water except indesignated areas. Such areas shallbe designated so as not to providea source of contamination.

Personnel shall be required to washtheir hands before beginning orreturning to work, after each visit

to the toilet and whenever theirhands may have become a source ofcontamination: Personnel shall washtheir hands prior to start of work,after each visit to a toilet, after usinga handkerchief/tissue, after handlingcontaminated material, aftersmoking, eating or drinking, afterbreaks and prior to returning to workand at any other time when theirhands may have become a sourceof contamination.

• What is the policy regarding personalhygiene? <hygiene rules for employees>

• The rules regarding personnel hygiene includehand cleaning, food and beverages, smoking,handling of injuries, finger nails and jewellery,hair and beards?

• Are the rules based on a risk analysis?<risk analysis>

• Where is it allowed to smoke?• How should lesions be treated/covered?• What kinds of hair r estraints are needed in which

areas? Example of result from the hazard analysis andassessment of associated risks: if gloves are used,then hand disinfection is not required for low riskproduction.

When insufficientrules for personalhygiene cause asafety risk.When nocorrespondentrisk analysis exists.

Risk analysis 21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packagingor holding human food110.10 Personnel




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3.2.1.2

KO

KO N° 3: The requirements for personnel

hygiene shall be in place and applied by allrelevant personnel, contractors and visitors.

1 .2 1. 7 E mp lo ye es an d vi si to rs sh al l f ol lo w al l

personal hygiene practices as designatedby the Operation: Operation’s hygienepolicies shall apply to all employees,contractors, visitors, buyers, productinspectors, auditors, and other personnelin the facility. The Operation shalldesignate competent supervisorypersonnel to ensure compliance withthe requirements in this section.

• How is the hygiene policy communicated?

<hygiene rules for employees>• Are personnel hygiene rules also followed byexternal service providers/workmen and visitors?<hygiene rules for visitors>

• How is it assured that external persons know therelevant hygiene rules?<hygiene rules for visitors>

• How are employees monitored during work?<hand swab tests, etc.>

• Is employee compliance to hygiene rules checkedon a regular basis? <minutes site inspection>,<list of identified failures>, etc.

When, during the audit

major violations of therules are identified thatlead to a safety risk.

3.2.1.4 Visible jewellery (incl. piercing) and watchesshall not be worn. Any exceptions shall have

been comprehensively evaluated by hazardanalysis and assessment of associated risks inrelation to product and process. This shall beeffectively managed.

1 .2 1.17 The wea ring of jewelry , bod y piercingsand other loose objects (e.g. false nails)

shall be in compliance to company policyand applicable regulation: Operationshall have a policy to minimize risk for jewelry or loose objects to be a sou rceof product contamination. Policy shallbe in compliance with current industrypractices or regulatory requirements forthat commodity.

• Is it allowed to use jewellery and watches in

production areas? <personnel hygiene rules>

• Is allowance based on risk hazard analysis?<risk analysis>

When wearing jewellery or a watch

causes a food oremployee safety risk.

Risk analysis 21 CFR Part: 110 – Current Goodmanufacturing practice in

manufacturing, packaging or holdinghuman food110.10 Personnel

3.2.1.5 Cuts and skin abrasions shall be covered bya coloured plaster/ bandage (different fromthe product colour) – containing a metal strip,where appropriate – and in case of handinjuries, in addition to a plaster/bandage, asingle use glove shall be worn.

1 .2 1. 9 Pe rs on ne l w ith ex po se d c ut s, s ore s o rlesions shall not be engaged in handlingproduct. Minor cuts or abrasionson exposed parts of the body areacceptable if covered with anon-permeable covering, bandage

or glove. Bandages on hands shall becovered with gloves in compliancewith Operation’s glove policy.

• What colour is plaster and where is it used?• Does the plaster contain a metal strip?• What is an employee required to observe in case

of hand injury?<personnel hygiene rules>

When hand injuriesensue a product safetyrisk (e.g. an uncoveredpurulent wound thatcomes into contactwith the product).

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.10 Personnel

3.2.2 Protective clothing for personnel,contractors and visitors





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3.2.2.1 Company procedures shall exist to ensure

that all personnel, contractors and visitorsare aware of the rules regarding themanagement of wearing and changingof protective clothing in specified areas inaccordance with product requirements.

1 .2 1.15 I f protect iv e c lothing is r eq uired by t he

Operation in product handling areas, itshall be handled in a manner to protectagainst contamination: Protectiveclothing, such as aprons and gloves, shallnot be left on product, work surfaces,equipment or packaging material buthung on apron and glove racks or indesignated areas. Operation shall havea policy regarding whether protectiveclothing can be taken home.

• What are the rules regarding protective

clothing?<personnel hygiene rules>• Are the protective clothing rules based on risk

analysis?<risk analysis>

• When must protective clothing be changed?<personnel hygiene rules>

• Examples of areas: catering, changing rooms,smoking area, toilets, high risk areas, etc.

When the lack of

protective clothingensues a productsafety risk.

Risk analysis 21 CFR Part: 110 – Current Good

manufacturing practice inmanufacturing, packaging or holdinghuman food110.10 Personnel

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

1 .2 1. 16 T he us e o f h ai r c ove ri ngs sh al l b e i ncompliance to company policy andapplicable regulation. The Operationshall have a policy that addresses useof hair coverings (e.g., hair nets, be ardnets, caps), which is in compliance withprevailing regulation. The use of haircoverings shall be in compliance tocompany policy and applicableregulation.

• In which production areas is wearing of protective headgear and/or beard snoodmandatory?

• What kind of headgear is used?• How shall headgear be used?

<personnel hygiene rules>

When incorrectwearing or absenceof headgear and/orbear snood ensues aproduct safety risk.


3.2.2.3 Clearly defined usage rules shall exist for workareas/ activities where it is required to weargloves (coloured differently from the productcolour). Compliance with these rules shall bechecked on a regular basis.

1 .2 1.13 I f g loves a re used, t he O pera tion sha llhave a glove use policy.: If rubber,disposable, cloth or other gloves are usedin contact with product, the Operationshall have a glove use policy that specifiestypes of glove materials that are allowed,how and when gloves are to be used,cleaned, replaced and stored. Policy shallbe in compliance with current industry

practices or regulatory requirements forthat commodity.

• In which production areas is wearing of glovesmandatory? <personnel hygiene rules>

• What kinds of gloves are used?When must gloves be changed?

• How is the compliance with these rules checked?<glove swab test results ><on site inspections>

When missing orunclean gloves ensuea product safety risk.

C he ck -l is t 2 1 C FR Par t: 110 – Cu rre nt Go odmanufacturing practice inmanufacturing, packaging or holdinghuman food110.10 Personnel

3.2.2.6 Guidelines shall exist for laundering ofprotective clothing and a procedure shallbe in place for checking its cleanliness.

1 .2 1.14 Clothing, including footwea r, sha ll beeffectively maintained, stored, launderedand worn so as to protect product fromrisk of contamination: Operation shallhave a policy that employee clothingshall be clean and appropriate for theoperation.

• How is the laundering procedure checked foreffectiveness?<protective clothes swab test results>

• What guidelines exist regarding protectiveclothes laundering?<personnel hygiene rules>

C he ck -l is t 2 1 C FR Par t: 1 10 – C ur re nt G oo dmanufacturing practice inmanufacturing, packaging or holdinghuman food110.10 Personnel




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3.2.3 Procedures applicable to infectious

diseases

21 CFR Part: 110 – Current Good

manufacturing practice inmanufacturing, packaging or holdinghuman food 110.10 Personnel

3.2.3.1 There shall be written and communicatedmeasures for personnel, contractors andvisitors to declare any infectious disease whichmay have an impact on food safety.In case of declaration of infectious disease,actions shall be taken in order to minimizerisk of contamination of products.

1 .2 1. 8 Wo rk ers an d vi si to rs w ho s ho w s ign sof illness shall be restricted from directcontact with produce or food-contactsurfaces: Operation shall have a policythat restricts employees, contractors,visitors, buyers, product inspectors,auditors, and other personnel in thefacility who show signs of illness (e.g.,vomiting, jaundice, diarrhea) from contactwith product or food contact surfaces.

• How shall personnel and visitors behave incase or suspicion of an infectious disease?

• How is it ensured that personnel and visitorsknow the guidelines?<personnel hygiene rules><visitors hygiene rules>

When due to anemployee’s infectiousdisease a productsafety risk is givenand no preventivesteps are taken by thecompany.

3 .3 Tra in in g an d i ns tru ct io n 21 CFR Part: 110 – Current Good man-

ufacturing practice in manufacturing,packaging or holding human food110.10 PersonnelA lot of training references are made inthe product specific regulations. (e.g.113.10: 123.10)

21 CFR Part: 120 HACCP System120.13 Training

3.3.1 The company shall implement documentedtraining and/ or instruction programs withrespect to the product requirements and thetraining needs of the employees based ontheir job and shall include:• training contents

• training frequency• employee’s task• languages• qualified trainer/ tutor• evaluation methodology.

1.5.11.5.2

All personnel shall receive food safetytraining: All personnel shall receivetraining in the food safety policy and plan,food safety procedures, sanitation andpersonal hygiene appropriate to their jobresponsibilities. Personnel shall receive

training at hire and refresher training atprescribed frequencies. Documentationof training is available.

Personnel with food safety responsi-bilities shall receive training sufficientto their responsibilities: The individualdesignated for food safety responsibilitiesdemonstrates knowledge of food safetyprinciples. Food safety designate hascompleted at least one formal food safetycourse/workshop or by job experience.

• Who is responsible for training?<training proof>

• What are the evidences for the trainer’squalification?

• What was the content of the last training session?<training program>

• How are foreign employees trained/instructed?• Who participates in the training sessions?• How are the instruction necessities for each

employee determined?• How often are training sessions held?

<training schedule>

When due to lack orinsufficient traininga product safety orlegality risk exists.When legally requiredfood safety

instructions are notundertaken.

21 CFR Part: 120 HACCP System 120.13 Training120.10 Corrective action

2.2.2.1




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3.4 Sanitar y facil it ies, equipment

for personnel hygiene and staff facilities

3.4.1 The company shall provide staff facilities,which shall be proportional in size, equippedfor the number of personnel and designed andoperated so as to minimise food safety risks.Such facilities shall be kept in clean and goodcondition.

1.21.21.21.19

Toilet facilities shall be of adequatenumber, easily accessible to employeesand in compliance with applicableregulation. The Operation will haveverification that the number of toiletfacilities and their location relative toemployees meets the more stringent offederal, state or local regulations.

Break areas shall be designated andlocated away from food contact/handlingzones: Operation shall have a writtenpolicy that break areas are locatedso as not to be a source of product

contamination.

• How many employees are there?• Do they have access to a cafeteria?• Are there locker-rooms?• Where are the restrooms?• Are there bathing facilities?

<plant lay-out>• Staff facilities = e.g. changing room, smoking

area, dining room, etc.

When social facilitiesare underequipped orare out of proportionto the number ofemployees so that asafety issue arises.

3.4.2 The risk of product contamination by foreignmaterial from staff facilities shall be evaluatedand minimised. Consideration shall also begiven to food brought to work by personneland personal belongings.

1.21.181.21.19

Employees’personal belongings shall bestored in designated areas. Operationshall have a policy for when and howemployee’s personal belongings shall bestored so as not to be a source of productcontamination.

Break areas shall be designated andlocated away from food contact/handlingzones: Operation shall have a writtenpolicy that break areas are located soas not to be a source of productcontamination.

• May employees bring food from home?<personnel hygiene rules>

• May employees take medicine along to theirwork place?<personnel hygiene rules>

• Does a risk analysis exist regarding foreignbodies from social facilities?<risk analysis>

NEW3.4.3

There shall be in place rules and facilities toensure the correct management for personnelbelongings and for food brought to work bypersonnel, food coming from dining room andfrom vending machines. The food shall only bestored and/ or used in designated areas.

1 .2 1.18 Employees’personal belonging s sha ll bestored in designated areas. Operationshall have a policy for when and howemployee’s personal belongings shall bestored so as not to be a source of productcontamination.




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3.4.4 The company shall provide suitable changing

rooms for personnel, contractors and visitors.Where necessary, outdoor clothing andprotective clothing shall be stored separately.

1.21.6

1.21.18

When appropriate, racks and/or storage

containers or designated storage areafor protective clothing and tools usedby employees shall be provided: Whenemployees wear protective clothing, suchas aprons and gloves, the Operation shallhave a policy that the clothing not be lefton product, work surfaces, equipment orpackaging material but hung on apronand glove racks provided. Racks shall beavailable and located so as to avoidpotential contamination. In addition,storage containers or designated storageareas shall be provided to ensure toolsused by employees are properly storedprior to entering toilet facilities.

Employees’personal belongings shall bestored in designated areas. Operationshall have a policy for when and howemployee’s personal belongings shall bestored so as not to be a source of productcontamination.

• Are there locker-rooms for employees and visitorswith separation for outdoor and protectiveclothing?

When no locker-rooms

exist or there is noseparation betweenoutdoor andprotective clothingalthough high riskproducts are beingprocessed.

21 CFR Part: 110 – Current Good

manufacturing practice inmanufacturing, packaging or holdinghuman food110.37 Sanitary facilities and controls(additional requirements in the stand-ard)

3.4.5 Toilets shall not have direct access to an areawhere food products are handled.The toilets shall be equipped with adequatehand washing facilities. Sanitary facilitiesshall have adequate natural or mechanicalventilation. Mechanical airflow from acontaminated area to a clean area shall beavoided.

1.21.11.21.4

Restrooms shall be designed, constructed,and located in a manner that minimizesthe potential risk for product contami-nation: Restrooms shall be designed andconstructed in a manner that minimizesthe potential risk for product contami-nation, are located away from producehandling areas, and are directly accessiblefor servicing.

Toilet and hand wash stations shallbe maintained in a clean and sanitarycondition. Toilet paper shall be availablein toilet facility. Restrooms shall includehand wash facilities with water that meetsthe microbial standard for drinking water,hand soap, disposable towels or otherhand drying device, and towel disposalcontainer. Gray water is plumbed orcaptured for disposal.

• Do toilets open directly into production areas? When toiletexhaustion poses acontamination risk.

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.37 Sanitary facilities and controls

2.2.2.1






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4.2 Specifications and formulas

4.2.1 Specifications

4.2.1.1 Specifications shall be available and in placefor all finished products. They shall be up todate, unambiguous and be in compliance withlegal and customer requirements.

1.10.2 I f p ro du ct i s i nt en de d fo r e xpo rt,pre- and post-harvest agriculturalchemical use shall consider requirementsin the intended country of destination.The operation shall have procedures, suchas review of pre-harvest intervals andadjustment of post-harvest applicationrates, sufficient to meet the MRL entryrequirements of the country(ies) in whichthe product is intended to be traded, ifknown during post-harvest handling.

• How are specifications compiled, checked andapproved?

• Are there specifications for all final products?• How are up to date specifications recognizable?

<specifications>

When not allspecifications forfinal products areup to date and inconformance withlegal requirements.

21 CFR 189 Substances prohibited fromuse in human food.

21 CFR 182 Substances generally recog-nized as safe

21 CFR 185 Direct food substancesaffirmed as generally recognized as safe(GRAS)

21 CFR 186 Indirect food substancesaffirmed as generally recognized as safe

21 CFR 101 Food labeling

21 CFR 130 Food Standards: General

2.2.3.1

4.2.1.2KO

KO N° 4: Specifications shall be available andin place for all raw materials (raw materials/ingredients, additives, packaging materials,rework). Specifications shall be up to date,unambiguous and be in compliance withlegal requirements and, if existing, withcustomer requirements.

To be checkedin an IFS Foodaudit inaddition to theHarmonizedChecklistrequirements

• Description of name of specifications (e.g. forraw materials, ingredient, additives, packagingmaterials) which have been checked during theIFS audit. Are specifications available for all rawmaterials, ingredients, additives, packagingmaterials and rework?

• What assurance is given that specifications arefollowed?<proof of specification compliance, e.g. labresults>

• What assurance is given that specifications arein conformance with legal requirements?

• Who writes, checks and approves specifications?

When not all rawmaterials, ingredients,additives, packagingmaterials and reworkhave specifications.When specifications donot comply with legalrequirements.




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4.2.2 Formula/recipes

4.2.2.1 KO N° 5: Where there are customeragreements in relation to the productformula/ recipe and technologicalrequirements, these shall be compliedwith.

To be checkedin an IFS Foodaudit inaddition to theHarmonizedChecklistrequirements.

• The auditor shall provide the followinginformation: • How many technological requirements and/or

formulas agreed between the contract partners have been checked during the IFSaudit? Which kind of requirements?

• If no specific technological requirements and/orformulas are agreed between the contract partners, NA scoring is possible. What assuranceis given that specified recipe is followed?

• How is recipe compliance checked?• If no specific technological requirements and/or

formulas are agreed between the contract partners, the formula of the supplier is the basis.In this case the requirement shall be rated withN/A

When there isevidence that recipeand finished productspecifications do notfit together.When during atraceability test thereis evidence thatagreed upon recipe isnot complied with.

4 .3 . P ro du ct d eve lo pm en t/Product modification/

Modification of production processes

The requirements for product development haveto be checked even if there are only productmodifications (new ingredient used, changesin packaging) or modifications of productionprocesses.

2.1.1.2

NEW4.3.6

A process shall be in place to ensure thatlabelling complies with current legislationof destination country and customerrequirements.


• Export goes to which countries?Which countries have special requirements?

• Who issues the labels?• Who approves labels?• How is conformity of the product and label

ensured and reviewed?

Product and labellingare not in conformitywith each other, thuscreating a legalityproblem.




18 | 45







4.4 Purchasing 21 CFR Part: 110 – Current Goodmanufacturing practice in

manufacturing, packaging or holdinghuman foodSubpart B Production andProcess control

4.4.1 General purchasing

4.4.1.1 The company shall control purchasingprocesses to ensure that all externallysourced materials and services, whichhave an impact on food safety and quality,conform to requirements. Where a companychooses to outsource any process that mayhave an impact on food safety and quality,the company shall ensure control over

such processes. Control of such outsourcedprocesses shall be identified anddocumented within the food safetyand quality management system.

To bechecked in

an IFS Foodaudit in

addition

to theHarmonized

Checklist

4.4.1.2 There shall be a procedure for approval andmonitoring of suppliers (internal and external),outsourced production or part of it.

1.3.1 Ope ratio n h as an Approved Supplierprogram for all incoming materials,including packaging: Operation has andmaintains a current list of approved rawmaterial suppliers. Approved Supplierprogram includes a procedure foraccepting materials from alternatesources.

• Does an approval procedure exist for newsuppliers and co-packers?<supplier procedures>

• How are supplies monitored?• Are suppliers graded?

<supplier grading systems>• Have suppliers been barred?• How is a barred supplier identified?• How is the qualification of suppliers ensured?

<product entry monitoring><supplier audits>

<lab tests>• Are there any co-packers? <co-packers list>• How are co-packers monitored?• Are co-packers IFS certified? <certificate>• How does the company check the supplier

performance?• How does the company control outsourced

processes?

When there are noapproval proceduresfor suppliers and thisensues a safety risk.




19 | 45







4.5 Product packaging

4.5.2 Detailed specifications shall exist for allpackaging materials which comply with thecurrent relevant legislation.

1 .2 3.2 Speci fica tions for a ll packa ging mat er ia lsthat impact on finished product safetyand quality shall be provided and complywith prevailing regulations: The methodsand responsibility for developing andapproving detailed specifications andlabels for all packaging shall be docu-mented. A register of packagingspecifications and label approvals shallbe maintained and kept current.

• How is it ensured that packaging materialcomplies with current relevant legislation?

• Who develops, reviews new packaging material?• Are specifications available for all packaging

materials used?<packaging material specifications>

Packaging materialthat does not complywith legislation. Not allpackaging materialshave specifications.

www.foodcontactmaterials.com

21 CFR 109 Unavoidablecontaminants in food for humanconsumption and packaging material21 CFR 170 Food additives21 CFR 171 Food additive petitions21 CFR 172 Food additives permittedfor direct addition to food for humanconsumption21 CFR 173 Secondary direct foodadditives permitted in food for humanconsumption21 CFR 178 Indirect food additives:Adjuvants, production aids, andsanitizers21 CFR 180 Food additives permittedin food or in contact with food on aninterim basis pending additional study

NEW4.5.3

For all packaging material which could havean influence on products, certificates ofconformity shall exist which comply withcurrent legal requirements. In the event thatno specific legal requirements are applicable,evidence shall be available to demonstratethat packaging material is suitable for use.This applies for packaging material whichcould have an influence on raw materials,semi-processed and finished products.

1 .1 2. 5 Op era ti on has wr it te n p ol ic y pro hi bi ti nguse of product-contact containers fornon-product purposes unless clearlymarked or labeled for that purpose:Food-contact totes, bins and otherproduct-contact containers shall notbe used for other purposes unless theOperation has a policy or procedure thatclearly designates approved non-productcontact uses and how the containers areto be marked or labeled for that purpose.Food-contact totes, bins and otherpacking containers and equipment thatare no longer cleanable shall not be usedfor packing but can be used for othernon-food uses if clearly marked/labeled.

NEW4.5.5

The company shall ensure that thepackaging used corresponds to theproduct being packed. The use ofcorrect packaging shall be regularlychecked and checks shall be documented.

1 .1 2. 4 Op era ti on has wr it te n p ol ic y re gar di ngacceptable product-contact containers:The types and construction of product-contact containers and packing materialsshall be appropriate to the commoditybeing handled and suited for theirintended purpose. Produce shall only bestored in clean and sanitary containers.




20 | 45







4.7 Factory Exterior

4.7.2 All external areas of the factory shall bemaintained in good condition. Where naturaldrainage is inadequate, a suitable drainagesystem shall be installed.

1 .1 3. 11 T he p lan t gro un ds are re as on ab ly f re eof litter, vegetation, debris and standingwater: Operation has procedures tomaintain the grounds surrounding thebuilding in a manner to minimize sourcesof contamination, such as litter, vegeta-tion, debris and standing water that m aybe pest attractants or harborages.Vegetation that does not serve as anattractant or harborage is permitted.

• Are grounds within the factory premises in goodcondition?

• Is natural drainage sufficient?• If natural drainage is insufficient, has a suitable

drainage system been installed?

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food (111 for dietary supple-ments)110.20 Plant and grounds21 CFR Part: 110 – Current Good man-ufacturing practice in manufacturing,packaging or holding human food110.37 Sanitary facilities and controls

4.7.3 Outdoor storage shall be kept to a minimum.Where goods are stored outside, hazardanalysis and assessment of associated risksshall be undertaken in order to ensure thatthere is no risk of contamination or adverse

effect on quality and food safety.

1 .1 6. 1 Op era ti on has pro ce du re s t o p re ve nt pe stharborage in any equipment stored nearthe building: Equipment stored outside isstored away from the building perimeter.Equipment is not to accumulate near the

building. Bone yards are located awayfrom the building. Outside equipmentstorage areas are included in pest controlprogram.

• Are goods stored outdoors? • What is stored outdoors?• What rules exist for outdoor storage?• Is outdoor storage based on risk analysis?

<risk analysis>

No risk analysis existsfor outdoor storage.Goods under outdoorstorage are influencedin a way that a safety

risk is given (e.g.unprotected primarypackaging materialis kept outdoors,becomes moldy and isnot barred from use).

Risk analysis 21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food (111 for dietary supple-ments) 110.20 Plant and grounds

Risk analysis

4.8 Plant layout and process f lows

4.8.1 Plans clearly describing internal flows offinished products, packaging materials, rawmaterials, waste, personnel, water, etc. shall bein place. A site map covering all buildings ofthe facility shall be available.

1.11.2 A water system de scription shallbe prepared: Water sources and theoperations they serve shall bedocumented and current.The description shall include oneor more of the following: maps,photographs, drawings (hand drawings

are acceptable) or other means tocommunicate the location of watersource(s), permanent fixtures and theflow of the water system (includingholding systems, reservoirs or any watercaptured for re-use). Permanent fixturesinclude wells, gates, reservoirs, valves,returns, backflow prevention and otherabove ground features that make up acomplete water distribution system shallbe documented in such a manner as toenable location in the operation.

• How is it ensured that cross-contamination isavoided?<waste elimination plan><personnel flow plan><materials flow plan><process flow plan><hydraulic plan>

When there are noflow plans and internalflows do not respectthe segregation ofproduct processes (e.g.separation of “dirty”from “clean”processing

areas but personnelcross boundarieswithout accordingprotective clothing).




21 | 45







4.9 Constructional r equi rements forproduction and storage areas

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.35 Sanitary operations

4.9.1 Constructional requirements

4.9.1.1 Rooms where food products are prepared,treated, processed and stored shall bedesigned and constructed so that food safetyis ensured.

1.13.11.14.51.19.3

Facility shall be designed, constructed andmaintained in a manner that preventscontamination of produce during stagingand cooling: Facility and equipmentstructures and surfaces (floors, walls,ceilings, doors, frames, hatches, etc.) shallbe constructed in a manner that facilitatescleaning and sanitation and does not serveas harborage for contaminants or pests.Chill and cold storage loading dock areasshall be appropriately sealed, drainedand graded. Fixtures, ducts, pipes andoverhead structures shall be installed andmaintained so that drips and condensationdo not contaminate produce, raw materialsor food contact surfaces. Water fromrefrigeration drip pans shall be drainedand disposed of away from product andproduct contact surfaces. Drip pans anddrains shall be designed to assure conden-sate does not become a source of contami-nation. Air intakes shall not be located nearpotential sources of contamination.

Adequate space shall be maintainedbetween rows of stored materials to allowcleaning and inspection. Materials shall

be stored away from walls and ceilings.Written procedures shall be followed toguarantee the proper cleaning, inspectionand monitoring for pest activity in storageareas.

Catwalks above product zones areprotected to prevent produce orpackaging contamination. Where workerswalk over product contact surfaces, thosewalkways are solid surface or have catchtrays installed, are protected by kick plates,product covers or other barriers.

• Are there “dirty”and “clean”areas?• Are there appropriate storage rooms?

No separation of“dirty”and “clean”areaseven though legallyprescribed.When there is nocompliance with legalrequirements.

21 CFR 110 – Current Goodmanufacturing practice in manufactur-ing, packaging or holding human food




22 | 45







4 .9 .6 D oo rs a nd g at es

4.9.6.2 External doors and gates shall be constructedto prevent the ingress of pests; if possible, theyshall be self-closing.

1 .2 4. 2 Op era ti on re st ri ct s an im al s f ro m f oo dhandling facilities. Domestic animals areprohibited from pack house, cooling, andstorage facilities unless procedures are inplace for their safe presence. Proceduresare in place to exclude wild and feralanimals to the degree practical.

• Do outer doors prevent pest entrance into production areas?

4.9.7 Lighting

4.9.7.1 All working areas shall have adequate lighting. 1.13.6 Adequate lighting shall be provided inall areas: Lighting in all areas shall besufficient to enable cleaning, sanitation,repairs, etc.

• What is the assurance that all working areas areadequately illuminated?

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food 110.20 Plant and ground

4.9.9 Water su pply

4.9.9.1 Water which is used as ingredient in theproduction process, or for cleaning, shall beof potable quality and supplied in sufficientquantity; this also applies to steam and iceused within the production area. A supply ofpotable water shall be available at all times.

1.11.12.3

Water use SOPs address the microbialquality of water or ice that directlycontacts the harvested crop or is usedon food-contact surfaces. If water orice directly contacts the harvested cropor is used on food-contact surfaces,Operation’s water use SOP requires thatwater or ice when applied meets themicrobial standards for drinking water, asdefined by prevailing regulation or thecountry in which the product is intendedto be traded, whichever is more stringent.Water may be treated (e.g., with chlorine)to achieve the microbial standards or toprevent cross-contamination. Ice andwater shall be sourced/manufactured,transported, and stored under sanitaryconditions.

Operation has documentation demon-strating regulatory approval of the washwater antimicrobials in use: Only washwater antimicrobials or antimicrobialsystems registered or approved by EPA,FDA or the prevailing regulatory agencyfor their specific intended use may beused in the dump tank wash water, on thespray line or other food contact purposes.

• Where does water supply come from?(City supply, well water, tanker…)?

• Is water demand always covered?

Resources1998-83-EU(Drinking Water)

21 CFR Part: 130 – Food standards:General 130.12 General methods for watercapacity and fill of containers21 CFR Part: 110 – Current Goodmanufacturing practice in

manufacturing, packaging or holdinghuman food110.80 Production and process controls




23 | 45







4.9.9.2 Recycled water which is used in the processshall not pose a contamination risk.The water shall comply with applicable legalrequirements for potable water; records ofcompliance testing shall be available.

1.11.11.11.31.11.51.11.6

Water use SOPs address the microbial quality ofwater or ice that directly contacts the harvest-ed crop or is used on food-contact surfaces.If water or ice directly contacts the harvestedcrop or is used on food-contact surfaces, Oper-ation’s water use SOP requires that water or icewhen applied meets the microbial standardsfor drinking water, as defined by prevailingregulation or the country in which the productis intended to be traded, whichever is morestringent. Water may be treated (e.g., withchlorine) to achieve the microbial standards orto prevent cross-contamination. Ice and watershall be sourced/manufactured, transported,and stored under sanitary conditions.

Documented scheduled assessment of watersystem including delivery equipment shall be

performed. The water-delivery system shallbe maintained so as not to serve as a sourceof contamination of produce, water suppliesor equipment with pathogens, or to create anunsanitary condition. Water installations andequipment are constructed and maintainedto prevent back siphonage backflow and crossconnections between product contact waterand waste water. Routine checks verify thatback siphonage and backflow prevention unitsare functioning properly (annual or as neededto maintain continuous protection). Results aredocumented.

Water-change schedules shall be developedfor all uses of water where water is re-used:Operation shall have procedures for changingwater that is re-used, such as recirculatedwater, flumes and dump tanks.

Re-circulated water that contacts product orfood contact surfaces shall be treated using anapproved antimicrobial process or chemicaltreatment: Re-circulated water shall be treatedusing an antimicrobial treatment sufficient toprevent cross- contamination. Treatments shallbe in compliance with prevailing regulation orthe country in which the product is intended tobe traded, whichever is more stringent.

• What for is water used in the company (socialfacilities, cleaning procedures, product ingredient,for washing fruits and vegetables)?

• Is water treated on site (water hardness correction,chlorination, sterilization, filtration…)?

• Are local legal requirements on hand? • Is water analysed according to legal requirements

(own water supply, outside supply).Do results comply with standards?

<several analysis results>

There is evidence thatwater does not complywith microbiologicalor chemical legalstandards and isused for cleaningprocedures of surfacesin direct contactwith foodstuff oras ingredient, orcompany can notshow that watercomplies with requiredstandards.The checking intervalfor relevant watersafety issues has been

clearly overdrawn.The company has nowater analysis planeven though it ismandatory and wateris used for cleaningprocedures or as aningredient.

5.11.2if identifieddeficits are notfixed within areasonable time

5.11.2 if identified deficits are notfixed within a reasonable time




24 | 45







4.9.9.3 The quality of water, steam or ice shallbe monitored following a risk basedsampling plan.

Documented scheduled assessmentof water system including delivery

equipment shall be performed.The water-delivery system shall bemaintained so as not to serve as a sourceof contamination of produce, watersupplies or equipment with pathogens,or to create an unsanitary condition.Water installations and equipment areconstructed and maintained to preventback siphonage backflow and crossconnections between product contactwater and waste water. Routine checksverify that back siphonage and backflowprevention units are functioningproperly (annual or as needed tomaintain continuous protection).Results are documented.

Operation has documentationdemonstrating regulatory approval ofthe wash water antimicrobials in use:Only wash water antimicrobials orantimicrobial systems registered orapproved by EPA, FDA or the prevailingregulatory agency for their specificintended use may be used in the dumptank wash water, on the spray line orother food contact purposes.

• Is water, steam or ice used - is a stationmonitoring in place?

<maintenance> ,analysis results>• What kind of piping system exists?

(Ring-pipes, water-tanks)• What is piping made from? • Is analysis and sampling plan based on risk

analysis?

When contaminatedwater reaches theproduct due to badconditions of pipingor improper pipingmaterial.

MaintenanceMonitoringsystem, HACCP,risk analysis,filters

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.37 Sanitary facilities and controls




25 | 45







4.9.9.4 Non-potable water shall be transported in

separate, properly marked piping. Such pipingshall not be connected to the drinking water

system, or allow the possibility of reflux to

contaminate potable water sources or thefactory environment.

1.11.3

1.11.4

Documented scheduled assessment of

water system including delivery equipment

shall be performed: The water-delivery

system shall be maintained so as not to

serve as a source of contamination of

produce, water supplies or equipment with

pathogens, or to create an unsanitary

condition. Water installations and

equipment are constructed and maintained

to prevent back siphonage backflow and

cross connections between product contact

water and waste water. Routine checks

verify that back siphonage and backflow

prevention units are functioning properly

(annual or as needed to maintain continu-

ous protection). Results are documented.

The sewage disposal system is adequate

for the process and maintained to prevent

direct or indirect product contamiantion.

The human waste and gray water sewage

system has sufficient capacity to handle

the operation’s peak flows and not cause

direct or indirect product contamination.

Cross-connections with product contact

water systems are prohibited.

• Is drinking water system completely separatedfrom non potable water piping?

<hydraulic system lay-out>• What other systems are there? (e.g. used water, cooling water, water used for

fire fighting).• Are water systems properly marked and where

they are? • Are reflux avoidance equipments installed

wherever necessary?

All existing water

systems areinterconnected, no

reflux avoidance

equipments exist,therefore a

contaminationhazard is given.

Infra st ruct ur e Infra st ruct ur e

NEW

4.9.10

Compressed air




26 | 45







4.10 Cleaning and disinfection

4.10.1 Based on hazard analysis and assessment ofassociated risks, cleaning and disinfectionschedules shall be available and 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).

1.13.21.13.5

A Preventive Maintenance and/or MasterCleaning Schedule, with related SOPs,shall be established: There is a writtencleaning and sanitation schedule forall food and non-food contact surfacesincluding floors, drains, walls, ceilings andother surfaces that may pose a sourceof product contamination. Roof leaksshall be promptly identified, controlledand repaired. Operation has proceduresfor cleaning and sanitation of coolingequipment. Drip pans and drains shall bemaintained to assure condensate doesnot become a source of contamination.

Food contact surfaces shall be cleaned,

sanitized and maintained according tothe Food Safety Plan: Prior to use, thelines used for washing, grading, sorting,or packing shall be cleaned and sanitizedas appropriate per risk assessment. Whenin use, the lines shall be maintained so asnot to be a source of contamination withpathogens.

• Who is in charge of cleaning and disinfection? <cleaning schedule>• What kind cleaning products and disinfectants

are used? <up to date cleaning products and disinfectant

list>• What must be observed when using different

cleaning products and disinfectants? <product instructions>• What areas are cleaned and disinfected? <cleaning schedule>• How often are areas cleaned and disinfected? • Where are cleaning and disinfection procedures

documented? <cleaning procedures documentation>• Do hazard symbols exist?

• Does a contract exist for external service provider? <external services contract>• Cleaning schedules can include SSOP’s

When a contaminationof food products ortools exists due tothe use of inefficientor wrong kind ofchemicals or inefficientcleaning procedures.

Monitoringsystem, HACCP

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.35 Sanitary operations

NEW4.10.2

Cleaning and disinfection schedules shall beimplemented and documented.

1 .1 3. 2 A Pre ve nt ive Mai nt en an ce an d/ or Ma st erCleaning Schedule, with related SOPs,shall be established: There is a writtencleaning and sanitation schedule forall food and non-food contact surfacesincluding floors, drains, walls, ceilings andother surfaces that may pose a source

of product contamination. Roof leaksshall be promptly identified, controlledand repaired. Operation has proceduresfor cleaning and sanitation of coolingequipment. Drip pans and drains shall bemaintained to assure condensate doesnot become a source of contamination.




27 | 45







NEW4.10.6

The intended use of cleaning utensils shall beclearly identified. Cleaning utensils shall be

used in a way to avoid contamination.

1 .1 3. 4 E qu ip me nt , u te ns il s an d to ol s u se d f orcleaning or sanitizing, including food

contact and non-food contact surfaces,are maintained in a manner sufficientto avoid becoming a source of producecontamination and are stored away fromproduct handling areas.

4.10.7 Current material safety data sheets (MSDS)and instructions for use shall be available forchemicals and cleaning agents. Personnelresponsible for cleaning shall be able todemonstrate their knowledge of suchinstructions, which shall be always availableon site.

1.10.11.10.31.13.3

Use of agricultural chemicals shall complywith label directions and prevailingregulation. Agricultural chemicals appliedpost-harvest (e.g., biocides, waxes andplant protection products) must beregistered for such use as required byprevailing regulation, and used inaccordance with label directionsincluding application rates, workerprotection standards, personal protection

equipment, container disposal, storage,and all requirements specified for thechemical or compound. Records of useare maintained.

Agricultural chemicals shall be applied bytrained, licensed or certified applicationpersonnel, as required by prevailingregulation. Operation maintains recordsdemonstrating that all personnel respon-sible for chemical applications are trainedand/or licensed, or supervised by licensedpersonnel, in compliance with prevailingregulation.

All cleaning agents shall be approvedfor their intended use on food contactsurfaces: All chemicals used for cleaningor sanitizing of food contact equipment,tools, utensils, containers and otherfood contact surfaces shall be approvedfor that use, according to the chemicalmanufacturer or supplier and all federal,state and local requirements, and shallbe used in a manner consistent with theapproved use.

• Are material safety data sheets available for allcleaning chemicals?

• Are these no older than two years? • Are cleaning chemicals instructions up to date? • How are instructions transmitted to personnel in

charge of cleaning procedures? • Where and when can the instructions be

inspected?

When a safety riskoccurs due to deficientmaterial safety datasheets.

Dangeroussubstancesregulation






29 | 45







4.12 Risk of foreign material, metal,

broken glass and wood

4.12.1KO

KO N° 6 Based on hazard analysis andassessment of associated risks, proceduresshall be in place to avoid contaminationwith foreign material. Contaminatedproducts shall be treated asnon-conforming products.

2.6 Foreign material control devices areinspected and maintained: If includedin the Food Safety Plan, foreign materialcontrol devices shall be included as partof a Preventive Maintenance Schedule orother program and maintained to ensureeffective operation. Calibration checksshall be performed according to writtenprocedure or manufacturer’s recommen-dations.

• What kinds of foreign bodies may be found? • Where foreign body sources identified through risk

analysis? <risk analysis>• Are staples used? • How are contaminated products handled? <segregation records>• What is done in case of glass breakage? <glass breakage prevention procedures>• What shall be considered when glass fixtures are

replaced?<glass handling procedures>

When a foreign bodiescontamination occursdue to lack of riskanalysis or whenforeign body sourcesare insufficientlyconsidered.

HACCPRisk analysis

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food 110.20 Plant and grounds

4.12.2 In all areas, e.g. handling of raw materials,processing, packing and storage, where hazardanalysis and assessment of associated risks

have identified the potential for product con-tamination, the use of wood shall be excluded.Where the use of wood cannot be avoided, therisk shall be controlled and the wood shall bein good order and clean.

1 .1 2. 6 Pa ll ets sh al l b e k ep t c le an an d i n go odcondition as appropriate for theirintended use: Operation inspects pallets

prior to use for conditions that may be asource of produce contamination. Palletsthat are not cleanable are removed fromuse. Pallets and other wooden surfacesare properly dried after being washed.

• Under what circumstances is the use of woodallowed?

<risk analysis>

• Is the wooden tool in use in good and cleanconditions? • Who inspects and how often is the wooden tool

condition inspected? <plant inspections>

When wood gets incontact with openproduct.

When wood poses acontamination risk forfood product. Whenwooden tool conditionis not inspected anda contamination riskensues.

Risk analysis 21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holding

human food 110.80 Processes andcontrols

4.12.5 The appropriate accuracy of detectors shallbe specified. Checks of proper function ofdetectors shall be carried out regularly. In caseof malfunction or failure of a metal and/ or for-eign material detector, corrective actions shallbe defined, implemented and documented.

2.6 Foreign material control devices areinspected and maintained. If includedin the Food Safety Plan, foreign materialcontrol devices shall be included as partof a Preventive Maintenance Schedule orother program and maintained to ensureeffective operation. Calibration checksshall be performed according to writtenprocedure or manufacturer’s recommen-

dations.

• How often are detector accuracies checked? • Who checks detector accuracy? <metal detector check-list>• What corrective actions exist when a detector is

defective? • Are corrective actions verified? • Are operational defects documented? <defect/failure protocols>

When properoperation ormeasuring accuracyis not checkedand a foreign bodyrisk occurs.

Monitoringsystem

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food 110.40 Equipment andutensils

4.12.7 In all areas, e.g. handling of raw materials,processing, packing and storage, where hazardanalysis and assessment of associated riskshave identified a potential product contamina-tion, the presence of glass and brittle materialshall be excluded. Where the presence of glassor brittle plastic cannot be avoided, appro-priate measures shall be in place to protectagainst breakage.

1 .1 7. 1 On ly es se nt ial gl as s a nd br it tl e p la st icshall be present in the facility: Light bulbs,fixtures, windows, mirrors, skylights andother glass and brittle plastic in the facilityor in the product path entering or exitingthe facility shall be of the safety type, orshall be otherwise protected to preventbreakage. If glass or brittle plastic mustbe used, there shall be a written glass andbrittle plastic control policy, including aglass and brittle plastic register.

• Does a risk analysis exist concerningcontamination through glass?

<risk analysis>• Where is glass used in the plant? • How is glass protected from breakage? <glass register>

When no risk analysishas been conducted.When there exists acontamination risk dueto glass usage. Whenglass is unprotectedand a contaminationrisk ensues.

Risk analysis 21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food 110.80 Processes andcontrols






31 | 45







4.14.2 The storage conditions of raw materials,semi-processed and finished products as well

as packaging shall in each case correspondto product requirements (e.g. refrigeration,protective covers) and shall not be detrimentalto other products.

1.12.21.14.1

1.14.21.14.4

Operation has written policy regardingwhether product-contact containers

are permitted in direct contact with theground. I f produce does not normallycontact the ground during production,Operation has considered and developedwritten policies regarding placement ofproduct-contact containers directly onthe ground, or whether a physical buffer(e.g., buffer bin or slip sheet) is required,or use of containers constructed toprevent contact of the produce orproduce contact surfaces with theground. Policy shall be consistent withindustry standards.

Product storage areas and conditionsshall be appropriate to the commodities

stored. Produce storage locations andconditions shall not pose a risk of producecontamination, consistent with industrystandards or prevailing regulation.

Iced produce is handled so as not to serveas a source of contamination: Protectivemeasures are provided in areas whereiced product is stored over food itemsin order to prevent melting ice fromcontaminating product below.

Materials and packaging materialsshall be protected from contaminants.Materials stored in uncovered areas shallbe protected from condensate, sewage,dust, dirt, chemicals, allergens or other

contamination. Materials shall be storedoff the floor/ground on pallets, slip-sheetsor stands and covered where applicable.

• Where are raw materials, half finished productsand packaging materials stored?

<storage plan>• How is cross-contamination avoided? <product flow plan>

When goods areimproperly stored and

a contamination riskensues.

21 CFR Part: 110 – Current Goodmanufacturing practice in

manufacturing, packaging or holdinghuman food110.40 Equipment and utensils

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.80 Processes and controls




32 | 45







4.14.3 Raw materials, packaging, semi-processedand finished products shall be stored so as to

minimise the risk of cross contamination.

1.12.11.14.1

Operation has written policy regardingstorage and post-storage handling of

product-contact containers: Product-contact containers, as appropriate to thespecific operation (e.g., harvest bins, totes,crates, sacks, buckets, finished productclam shells, bags or packaging films), shallbe stored, or handled (e.g., cleaned priorto post-storage use), in a manner so asnot to serve as a source of contamination.

Product storage areas and conditionsshall be appropriate to the commoditiesstored. Produce storage locations andconditions shall not pose a risk of producecontamination, consistent with industrystandards or prevailing regulation.

• Where and how are packaging materials andequipments stored?

<materials flow-diagram>• How is cross-contamination through packaging

materials avoided? <materials flow-diagram>• How is return of packaging materials to the store

room regulated? • What kind of storage regulations exist?• Are pests taken into account during storage? Are pallets located approximately 1 m from walls?

<plant inspection protocol>• Are there baits laid out in storage rooms? <pest control schedule>• Are there sensitive products stored? • What kinds of preventive measures are in place

for these goods? <preventive measures>

A product contamina-tion risk is given due to

storage of packagingmaterials and equip-ments(e.g. unprotectedexternal storage ofpackaging material)When storage facilitiesare not inspected forpest presence.

21 CFR Part: 101, 102, 104 (Coloradditive 21 CFR Part: 70, 71, 80, 81, 82)

FSMA Title I Sec 111

4.14.4 Appropriate storage facilities shall be availablefor the management and storage of workingmaterials, process aids, and additives.The personnel responsible for themanagement of storage facilities shallbe trained.

1.14.31.14.4

Non-product storage areas shall bemaintained so as not to be a source ofproduct or materials contamination.Areas designated to store materials,whether indoors or out, shall be clean,well ventilated, and designed to protectmaterials and produce from contami-nants.

Materials and packaging materialsshall be protected from contaminants.Materials stored in uncovered areas shallbe protected from condensate, sewage,dust, dirt, chemicals, allergens or othercontamination. Materials shall be stored

off the floor/ground on pallets, slip-sheetsor stands and covered where applicable.

• How are chemicals stored? • Who uses chemicals and takes them out of

storage? <responsibility list>• Are the chemicals users trained? • Is training documented?

<training documentation>

When a food orutensils contamina-tion occurs due toinappropriate storageconditions.When a food orutensils contaminationoccurs due to insuffi-cient knowledge.

3.1.1 whentraining deficitsmay become asafety issue

21 CFR Part: 101, 102, 104 (Coloradditive 21 CFR Part: 70, 71, 80, 81, 82)21 CFR Part: 130 – Food standards:General130.11 Label designations of ingredientsfor standardized foods




33 | 45







4.15 Transport FSMA Title II Sec 204

4.15.1 Before loading transport vehicles, theircondition (e.g. absence of strange smells, highdust load, adverse humidity, pests, mould)shall be checked and action taken, if necessary.

3 .2 .1 T he Op erat io n s hal l h ave a p ol ic y, w ri tte nprocedures, and a checklist to verifycleanliness and functionality of shippingunits (e.g., trailer): Shipping units shallbe clean, functional and free ofobjectionable odors before loading,in compliance with current industrypractices or regulatory requirements forthat commodity. Refrigeration units, ifused, must be in working order.Procedures include prohibition of rawanimal or animal product transport, orother materials that may be a source ofcontamination with pathogens. Unlessvehicles are dedicated to transport ofproduce, procedure requires review of

transport history for immediate past 3loads, or that trailer must first be cleanedsufficient to prevent producecontamination. A responsible individualshall sign the completed checklist orinspection report.

• What is checked before loading? <expedition inspection>• Where is inspection documented? • What corrective actions are ta ken?

21 CFR 101 Labeling21 CFR 104 Nutritional qualityguidelines for foods21 CFR 110 GMP

Product specific regulations (e.g. 21CFR 106, 21 CFR 107,

4.15.2 Where goods must be transported atcertain temperatures, before loading, thetemperature inside the vehicle shall bechecked and documented.

3.1.23.1.4

Prior to loading, the vehicle shall bepre-cooled: The proper temperature forpre-cooling is appropriate to the type ofproduce and as specified by documentedprotocol.

Where required, temperatures of productare taken and recorded prior to orupon loading: Operation has a writtenprocedure for when and how to measureproduct temperatures prior to or duringloading

• May goods be transported alongside with nonfood products?

• How is cross-contamination prevented?

When a contamina-tion can occur duringtransport.




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4.15.3 Procedures to prevent contamination duringtransport shall be implemented (food/ non-

food/ different categories of goods).

3 .2 .1 T he Op erat io n s hal l h ave a p ol ic y, w ri tte nprocedures, and a checklist to verify

cleanliness and functionality of shippingunits (e.g., trailer):Shipping units shall beclean, functional and free of objection-able odors before loading, in compliancewith current industry practices or regu-latory requirements for that commodity.Refrigeration units, if used, must be inworking order. Procedures include pro-hibition of raw animal or animal producttransport, or other materials that maybe a source of contamination with path-ogens. Unless vehicles are dedicated totransport of produce, procedure requiresreview of transport history for immediatepast 3 loads, or that trailer must f irst becleaned sufficient to prevent producecontamination. A responsible individualshall sign the completed checklist orinspection report.

• Are products which require a certain temperaturebeing loaded?

• Is vehicle temperature checked and documentedbefore loading?

<expedition inspection>• What are the procedures when vehicle

temperature is not according to specifications? <expedition inspection>• How the company ensure the compliance of

temperatures during transport? <”temperature indicator” occasionally placed in

Products>

When there arecertain temperature

specifications foroutgoing product butthey are not checkedbefore loading anda health issue for theconsumer occurs.

4.15.4 Where goods must be transported at certaintemperatures, maintaining the adequate rangeof temperatures during transport shall beensured and documented.

3.1.13.1.4

There is a written policy for transportersand conveyances to maintain a specifiedtemperature(s) during transit: Trans-porters have written, predeterminedtemperature ranges for commoditiesbeing transported.

Where required, temperatures of productare taken and recorded prior to orupon loading: Operation has a writtenprocedure for when and how to measureproduct temperatures prior to or duringloading.

• Are vehicles equipped with thermostats andregistering devices?

<registering devices>• How is it ensured that products reach destination

under good conditions?

When there aretemperaturespecifications forthe product andtemperature controlis not ensured duringtransport so that ahealth issue for theconsumer may occur.

5.3.2 5.3.2

4.15.5 Adequate hygienic requirements for all trans-port vehicles and equipment used for loading/unloading (e.g. hoses of silo installations) shallexist. There shall be records of the measurestaken.

3.2.2 Loadin g/u nloading procedu res andequipment shall minimize damage toand prevent contamination of produce:Personnel responsible for the loading andunloading of produce shall take stepsto minimize the potential of physicaldamage to produce, which can introduceand/or promote the growth of pathogens.Loading/unloading equipment shall beclean and well maintained and of suitabletype to avoid contamination of theproduce.

• Are transport vehicles cleaned? • Where are cleaning procedures documented? <cleaning protocol>

When absence ofcleaning proceduresensue a productcontaminationproblem.

Regulation 852/2004 Annex 2Chapter IV No. 1




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4 .1 6 M ai nt en an ce an d re pa ir

4.16.1 An adequate system of maintenance shallbe in place, maintained and documented,covering all critical equipment (incl. transport)for compliance with product requirements.This applies both for internal and externalmaintenance activities.

3.1.3 The ref rigerated transpor t veh icle sshall have properly maintained andfully functional refrigeration equipment:Operation has a written policy that refrig-erated transportation equipment shallbe controlled by a thermostatic device asnecessary to maintain temperatures in thecargo area for the particular type of pro-duce being transported and as specifiedby documented protocol.

• How is maintenance organized? <maintenance plan>• Where are maintenance procedures documented? • Which equipments are subject to external

maintenance?• Does the company has a maintenance program?

No maintenancesystem exists.

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging orholding human food (111 for dietarysupplements)110.40 Equipment and utensils

4.16.5 Temporary repairs shall be carried out so thatproduct requirements are not affected. Suchwork shall be documented and a short-termdeadline set for eliminating the fault.

1 .2 0. 1 An y te mp ora ry re pa ir s o n f oo d c on ta ctsurfaces are constructed of food-gradematerial. Operation has a procedure toensure that permanent repairs are imple-mented in a timely manner: Operation

has procedures to ensure temporaryrepairs are compliant with all food safetyrequirements, and do not create potentialsources of chemical, microbiologicalor physical contamination. Permanentrepairs are implemented as soon as prac-tical; Operation establishes timelines andresponsibilities for completion.

• Are temporary repairs allowed? • Where are these documented? • How fast must temporary repairs be definitely

mended? • Who verifies this?

4.17 Equipment

4.17.2 For all equipment and tools with directfood contact, certificates of conformity shallexist which confirm compliance with currentlegal requirements. In case no specific legalrequirements are applicable, evidence shall be

available to demonstrate that all equipmentand tools are suitable for use. This applies forall equipment and tools in direct contact withraw materials, semi-processed and finishedproducts.

1 .1 8. 1 E qu ip me nt lu bri cat io n i s m an ag ed so asnot to contaminate food products: Onlyfood-grade lubricants are used on foodprocessing and packaging equipment, oron any other equipment where incidental

food contact may occur, unless theequipment manufacturer specifies only anon-food grade lubricant. Lubricant leaksare fixed or catch pans are ins talled toprevent product contamination.

• Are conformity certificates or other certificatesavailable for all packaging materials which comeinto direct contact with food products?

<conformity certificates>• Are conformity certificates available for packaging

materials which come into direct contact with rawmaterials, half-finished or finished products?

<conformity certificates>• Are conformity certificates available for containers

and conveyor belts? <conformity certificates>

Packages andpackaging materialswhich come intodirect contact withfoods are not suitable

for intended use andtherefore a safetyrisk exists for theconsumer.

Migrationarticles andutensils incontact withfoodstuffs

articles, utensilsand feedstuffslegislation.

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.20 Plant and grounds




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4.17.3 Equipment shall be designed and located sothat cleaning and maintenance operations can

be effectively performed.

1.13.81.13.9

1.19.11.19.2

Cooling equipment shall be maintainedso as not to be a source of product

contamination: Cooling equipment (e.g.hydrocoolers, air coolers), shall beinspected, all debris removed, andcleaned and sanitized according towritten sanitation SOPs.

Transporting equipment shall bemaintained to prevent contaminationof products being transported. Pallet jacks, carts, trolleys and forklifts, shall bemaintained to prevent contamination ofproducts being transported and are listedon the Preventive Maintenance and/orMaster Cleaning Schedules.

All food contact equipment, tools and

utensils are designed and made ofmaterials that are easily cleaned andmaintained: The Operation shall develop,implement, and schedule repair,cleaning, sanitizing, storage and handlingprocedures of all food contact surfacesto reduce and control the potential forcontamination. These procedures shallbe documented. Product contact tools,utensils and equipment shall be madeof materials that can be cleaned andsanitized.

Equipment is installed in a way thatprovides access for cleaning. Cooling,packing and other food contactequipment is installed away from walls

and otherwise positioned so as not toinhibit access for proper cleaning.

• Are equipments suitably designed and were theychecked before start up?

<start up protocol>• What rules exist for start up of new equipments? • Were new equipments immediately considered

in maintenance plan? • Does an equipment installation plan exist? <machinery installation plan>

When equipmentis installed in a

way that cleaningprocedures arehindered andthus constitute a

contaminationsource.

NEW4.17.4

The company shall ensure that all productequipment is in good condition without anynegative influence on food safety.

1 .1 3. 8 C oo li ng e qu ip me nt s ha ll b e m ai nta in edso as not to be a source of productcontamination: Cooling equipment(e.g. hydrocoolers, air coolers), shall beinspected, all debris removed, andcleaned and sanitized according towritten sanitation SOPs.




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4.18 Traceability (including GMOs andallergens)

21 CFR Part: 110 – Current Good man-ufacturing practice in manufacturing,

packaging or holding human foodSubpart B Production and Processcontrol

4.18.1KO

KO N° 7: A traceability system shall be inplace which enables the identification ofproduct lots and their relation to batches ofraw materials, packaging in direct contactwith food, packaging intended or expectedto be in direct contact with food. The tracea-bility system shall incorporate all relevantreceiving processing and distributionrecords. Traceability shall be ensured anddocumented until delivery to the customer.

1.6.1 A do cume nte d trac eabil ity programshall be established: Records that enablereconciliation of product delivered torecipients (one step forward) shall bemaintained except for direct to consumersales. Records shall be maintained thatlink product with source of the produceand other supplies and raw materials (onestep backward). Records shall include theitems and date of receipt, lot numbers,quantities, source of the produce, andtransporter. Additional information may

be included. Contents and retention ofrecords shall be consistent withapplicable regulations.

• How is traceability ensured? <traceability procedures>• What products come from which supplier? • Is there a list available with all current suppliers? <supplier list>

When no traceabilitysystem exists andthe system doesnot include raw andpackaging materials.When traceability isnot complete up tothe supplier.

4.18.4 The traceability system shall be tested on aperiodic basis - at least annually and each timetraceability system changes. The test shallverify upstream and downstream traceability(from delivered products to raw materials, andvice versa), including quantity checking.Test results shall be recorded.

1 .6 .2 T he tr ac e b ac k a nd t ra ce f or wa rd e xe rc is eshall achieve accurate traceabilitywithin 4 hr or as required by applicableregulations. Trace exercise shall achieve99-101% reconciliation.

• When was the last traceability test in bothdirections done?

<traceability test results>• What percentage of total amount was traced? • How big is a lot?

When traceabilitysystem is not tested inboth directions so thatno assurance is givenas to its effectiveness.When test resultsare negative and nocorrective actions aretaken.




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4.20 Allergens and specific conditions ofproduction


4.20.1 Raw material specifications identifyingallergens requiring declaration that arerelevant to the country of sale of the finishedproduct shall be available. The company sh allmaintain a continuously up to date listing ofall raw materials containing allergens used atits premises, which also identifies all blendsand formulas to which such raw materialscontaining allergens are added.

1 .2 3. 1 I f a pp li cab le , Op er at io n h as a w ri tte nAllergen Control Program: The AllergenControl Program lists the allergens inuse or storage at the facility specific tocountry regulations. If applicable,procedures address identification andsegregation of allergens duringstorage and handling as based on a riskassessment conducted by the facility.

• Are allergens identified in specifications? • Does a list exist that covers allergens in use? <allergen list>

Allergens are notidentified and acustomer safetyissue ensues.

Food Allergen Labeling and ConsumerProtection Act of 2004(Title II of Public Law 108-282)Different Allergens in US and EU

21 CFR Part: 130 – Food standards:General130.8 Conformity to definitions ansstandards identity130.9 Sulfites in standardized food130.10 Requirements for foods namedby use of nutrient content claim and astandardized term21 CFR 179 Irradiation in the

production, processing and handlingof food.

4.20.2 The manufacturing of products which containallergens requiring declaration shall be carriedout as to ensure cross contamination is mini -mised as far as possible.

1 .2 3. 1 I f a pp li cab le , Op er at io n h as a w ri tte nAllergen Control Program: The AllergenControl Program lists the allergens inuse or storage at the facility specific tocountry regulations. If applicable,procedures address identificationand segregation of allergens duringstorage and handling as based on a riskassessment conducted by the facility.

• Is a procedure in place to avoid contamination ofallergen free products?

• How often is effectiveness of these proceduresreviewed?

• Where are these proofs documented? • <examples>




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5. Measurements, Analysis,

Improvements

5.1 Internal audits

5.1.1KO

KO N° 8: Effective internal audits shall beconducted according to a defined agreedaudit program and shall cover at least allrequirements of the IFS Standard. Scopeand frequency of internal audits shall bedetermined by hazard analysis andassessment of associated risks. This is alsoapplicable for off site storage locationsowned or rented by the company.

1.9.1 The Ope ration sh all have docum entedself-audit procedures.: Internal audits willbe conducted at a minimum annually byan assigned individual who is knowledge-able in this standard, utilizing this stand-ard to assist in the self-audit. All aspectsof the Operation’s Food Safety Plan will beaudited and a written record of requiredcorrective action will be documented.

• Does an up to date internal audit plan exist? <audit plan>• Is audit plan based on risk analysis? <risk analysis>

No internal audits areperformed.

Risk analysis Directly required for infant food

Risk analysisFSMA Title I Sec 103

5.3 Process val idation and contr ol

5.3.2 In circumstances where the controlof process and working environmentparameters (temperature, time, pressure,chemical properties etc.) is essential toensure the product requirements, suchparameters shall be monitored andrecorded continuously and/or atappropriate intervals.

1.11.81.22.1

If applicable to the specific commodity,water use SOPs address control of im-mersion water temperature. For producethat is immersed in water and demon-strated as being susceptible to microbialinfiltration from water, water temperaturedifferentials during immersion shall becontrolled in accordance with prevailingregulation or industry guidelines.

When produce is cooled, it is cooled totemperatures appropriate to the com-modity according to current establishedregulatory or industry standards: Whenrequired for food safety or by industry

guidelines, steps are taken to minimizetemperature increases and minimize thetime between produce receipt and cool-ing at the operation. The product temper-ature and equipment control mechanismsare calibrated and monitored at a definedfrequency and temperatures are keptappropriate to the commodity. Recordsare maintained.

• How are temperatures monitored? • Where are temperatures recorded? <printed measurement data>

In case a legality issueoccurs due to missingrecords. 4.12.4.

Monitoring oftemperaturesin the meansof transport,warehousingand storage ofquickfrozenfoodstuffsintendedfor humanconsumption.

21 CFR Part: 110 – Current Goodmanufacturing practice inmanufacturing, packaging or holdinghuman food110.80 Processes and controls




40 | 45







5.4 Calibration, adjustment and checking ofmeasuring and monitoring devices

5.4.2 All measuring devices shall be checked,adjusted and calibrated, under a monitoringsystem, at specified intervals and inaccordance with defined recognised standard/methods. The results of the checks, adjust-ments and calibrations shall be documented.Where necessary, corrective actions on devicesand, if necessary, on process and productsshall be carried out.

1.13.71.22.12.5

Where temperature control is requiredfor food safety, cooling facilities shallbe fitted with temperature monitoringequipment or suitable temperaturemonitoring device: Temperaturemonitoring equipment shall be located inall temperature controlled areas, and shallbe located so as to accurately monitorthe temperature. Temperature measuringdevices shall be monitored and calibratedon a scheduled basis or as needed.

When produce is cooled, it is cooled totemperatures appropriate to the com-modity according to current established

regulatory or industry standards: Whenrequired for food safety or by industryguidelines, steps are taken to minimizetemperature increases and minimize thetime between produce receipt andcooling at the operation.The product temperature and equipmentcontrol mechanisms are calibrated andmonitored at a defined frequency andtemperatures are kept appropriate to thecommodity. Records are maintained.

All instruments used to measuretemperature, pH, antimicrobial levelsand or other important devices used tomonitor requirements in this section

shall be calibrated at a frequencysufficient to assure continuous accuracy:Records shall be kept. If an ORP systemis used, an independent measurementshall be used to verify compliance. Testmethods or test strips used to monitorrequirements shall be appropriate totheir use and sufficiently sensitive to theirintended purpose.

• How is measuring devices check organized?<calibration procedures>

• Are measuring devices regularly calibrated? <calibration protocol>• Who is responsible for calibration? • How is calibration done? Where is it documented? <calibration records>• What corrective actions are ta ken when a

tolerance deviation is found? <corrective actions> <calibration protocol>• Is calibration up to date? <calibration certificate>Is the monitoring system based on recognizedstandards?

No calibration isperformed.




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5.6 Product analysis

5.6.1 There shall be procedures ensuring thatall specified product requirements are met,including legal requirements andspecifications. Microbiological, physicaland chemical analysis required for thatpurpose shall be performed internallyand/or subcontracted.

1.11.71.25.4

If used, water antimicrobial treatmentsshall be monitored sufficiently to assurecontinuous control: Microbial, physicalor chemical testing shall be performed,as appropriate to the specific operation,to demonstrate that acceptance criteriahave been met.

All required testing shall include test pro-cedures and actions to be taken based onthe results: For all microbiological testingrequired by the Food Safety Plan, Opera-tion has a written testing procedure thatincludes test frequency, sampling, testprocedures, responsibilities and actions tobe taken based on results.If finished product is tested for pathogensor other adulterants, Operation’sprocedures require that it shall not bedistributed outside the Operation’scontrol until test results are obtained.

• Which physical, chemical or microbiologicalanalyses are made or subcontracted?

<analyses results>

No results of analysesare available.

Cross reference in product specificregulations

5.6.2 Analyses, which are relevant for food safety,shall preferably be performed by laboratorieshaving appropriate accredited programs/methods (ISO 17025). If the analyses areperformed by a factory internal or a laboratorynot having appropriate accredited programs/methods, the results shall be verified on a reg-ular basis by laboratories accredited on theseprograms/methods (ISO 17025).

1 .2 5. 1 Wh ere la bo rat or y a na ly si s i s re qu ire din the Food Safety Plan, testing shall beperformed by a GLP laboratory usingvalidated methods. Operation utilizeslaboratories that have, at minimum,passed a Good Laboratory Practices (GLP)audit or participates in aProficiency Testing program, and utilizesBAM, AOAC International or testing

methods that have been validated fordetecting or quantifying the targetorganism(s) or chemical(s).

• Is there an analytical laboratory on site? Is itaccredited under ISO 17025?

<accreditation evidence>• Are internal lab results verified by an

accredited lab? • Which external laboratories are used? Are these

accredited under ISO 17025? <accreditation evidence>

120.25 Process verification for certainprocessors21 CFR 120 Subpart B PathogenReductionFSMA Title II Sec 202




42 | 45







5.6.4 A test plan shall be drawn up for internal andexternal analysis, based on hazard analysis and

assessment of associated risks, which coversraw materials, semi-processed and finishedproducts as well as processing equipmentsand packaging materials, and where necessaryenvironmental tests. The test results shall bedocumented.

1.25.21.25.3

Where microbiological analysis isrequired in the Food Safety Plan, samples

shall be in accordance with an establishedsampling procedure: Operation utilizesa written sampling protocol whencollecting samples for microbiologicaltesting.

Tests, their results and actions takenmust be documented: All results formicrobiological testing required in theOperation’s Food Safety Plan shall berecorded and the records maintainedfor two years.

• Does an inspection plan exist? <inspection plan>

• Who organizes inspection plan? Which products are encompassed by

inspection plan? (raw materials, half-finishedand finished products, packaging materials,environmental tests?) <inspection plan>

• Is inspection plan based on risk analysis? <risk analysis>• Where are test results documented? <test results>

No inspection planexists.

Risk an alys is Risk analysis

5.7 Product quarantine (blocking/hold) and

product release

5.7.1 A procedure shall be in place, based on hazard

analysis and assessment of associated risks, forthe quarantine (blocking/hold) and release ofall raw materials, semi-processed and finishedproducts and packaging materials. Theprocedure shall ensure that only products andmaterials conforming to product requirementsare processed and dispatched.

To be checked

in an IFS Foodaudit inaddition to theHarmonizedChecklistrequirements.

• Who quarantines or releases products?

<job description>• How are quarantined products identified?• Is there a procedure for product release?

When no procedures

exist for productquarantine or release.When quarantinedproducts gounchecked intofurther use and asafety issue occurs.

Risk analysis Process authority and/or product

release required in product specificregulations(e.g. 21 CFR 106, 21 CFR 113)

Risk analysisFSMA Title II Sec 207

5.8 Manag ement of compl ai nts fr om authori -ties and customers

5.8.1 A system shall be in place for the managementof product complaints.

To be checkedin an IFS Foodaudit inaddition to theHarmonized

Checklistrequirements.

• How are complaints handled? <complaint handling procedure>

If there is noprocedure forcomplaint handling.

21 CFR Part: 7– Enforcement Policy

7.40 Recall policyFSMA Title II Sec 206

7.41 Health hazard evaluation andrecall classification

7.42 Recall strategy7.45 FDA requested Recall7.46 Firm-initiated recall7.49 Recall communications7.50 Public notification of recall7.51 Recall status reports7.55 Termination of a recall7.59 General Industry guidance




43 | 45







5.9 Manag ement of i ncidents, product

withdrawal, product recall

5.9.1 A documented procedure shall be defined formanagement of incidents and of potentialemergency situations that impact food safety,legality and quality. This procedure shall beimplemented and maintained. This includesas a minimum: the nomination and trainingof a crisis team, an alert contact list, sources oflegal advice (if necessary), contacts availability,customer information, and a communicationplan, including information to consumers.


• Who belongs to incident management staff? <phone list>• Who is informed when an incident occurs? • How are incidents managed? <crisis management procedures>• What is an incident? <incident management procedures>• communication plan: definition of the internal

and external communication (in the case ofincidents, product withdrawal, product recall),

Who is allowed to report what to whom?

If there is no incidentmanagement systemimplemented.

21 CFR Part: 7– Enforcement Policy7.40 Recall policyFSMA Title II Sec 206

7.41 Health hazard evaluation and recallclassification

7.42 Recall strategy7.45 FDA requested Recall7.46 Firm-initiated recall7.49 Recall communications7.50 Public notification of recall

7.51 Recall status reports7.55 Termination of a recall7.59 General Industry guidance

5.9.2 KO N° 9: There shall be an effective procedurefor the withdrawal and recall of all products,which ensures that involved customers areinformed, as soon as possible. This procedureshall include a clear assignment of respon-sibilities.

1.7.1 A do cume nte d rec all program, inclu din gwritten procedures, shall be established:The recall program shall have a desig-nated recall team. A mock recall exerciseshall be performed at least annually at theOperation being audited. The mock recallshall include the trace back and traceforward exercise and shall be completedas stated in the program and in compli-ance to applicable regulations.

• How much is distribution involved with incidentmanagement?

• When and who informs customer? <alarm plan> <phone list>A withdrawal / recall management procedure isnot enough to define an incident managementprocedure.

If there is noprocedure for recalland withdraw inplace.




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5.10 Management of non-conformities andnon conforming products

5.10.1 A procedure shall exist for the management ofall non-conforming raw materials,semi-finished and finished products,processing equipment and packagingmaterials. This shall include, 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/ post treatment, blocking,quarantine, rejection/ disposal).

2.2 Debris and damaged produce shall beremoved from wash areas/dump tanksto the extent possible: Operation hasprocedures to determine how and whendebris shall be removed from wash areas/dump tanks.

• What procedures exist for non-conforming products management?

• How are non-conforming products identified? • What rules exist for product quarantine procedures?

<quarantine tickets>

When noprocedures existfor non-conformingproductsmanagement.

21 CFR 189 Substances prohibited fromuse in human food.

21 CFR 182 Substances generally recog-nized as safe

21 CFR 185 Direct food substancesaffirmed as generally recognized as safe(GRAS)

21 CFR 186 Indirect food substancesaffirmed as generally recognized as safe

5 .1 1 C orr ec ti ve ac ti on s • In case of a renewal audit: were the correctiveactions of the previous IFS audit applied?

5.11.1 A procedure shall be in place for the recordingand analysis of the non-conformities with theobjective to avoid recurrences by preventiveactions and/ or corrective actions.

1.8.1 The Ope ration sh all have docum entedcorrective action procedures:A documented Corrective Action isrequired for an observation or audit thatcontains a non-conformance with foodsafety requirements. The responsibility,methods, and timelines to addressCorrective Actions shall be documentedand implemented.

• What are corrective actions procedures? <corrective actions procedures>

No corrective actionsprocedures exist.

21 CFR 120 HACCP120.8 HACCP plan120.10 Corrective actions120.11 verification and validation

5.11.2KO

KO N° 10: Corrective actions shall be clearlyformulated, documented and undertaken, assoon as possible to avoid fur ther occurrenceof non-conformity. The responsibilities and

the timescales for corrective action shall beclearly defined. The documentation shall besecurely stored, and easily accessible.

To be checkedin an IFS Foodaudit inaddition to the

HarmonizedChecklistrequirements.

• Which corrective actions were implemented? <model corrective action procedures>• Where are corrective actions documented? <model corrective action procedures >

• Who is responsible for corrective actions? <model corrective action procedures >• How long may it take to implement corrective

actions? <model corrective action procedures >

No corrective actionsare taken.Corrective actionsare not implemented

within a short timespan.Corrective actions arenot documentedNo responsibilities areassigned to implementcorrective actions.

FSMA Title I Sec 418 g










6. Food defense and external inspectionsMandatory check-list

6.1 Defense assessment

6.1.1 Responsibilit ies for food defense shall beclearly defined. Those responsible shall bekey staff or shall have access to the topmanagement team. Sufficient knowledgein this area shall be demonstrated.


• Who has the accountability for the food defense program?

• What are the competence and qualificationsdemonstrated for the person(s) responsible forthe food defense program?

• What is the position of the person(s) responsiblefor the food defense program with respect to themanagement team?

• How do management teams support the person(s)responsible for the food defense program?

• Where are the responsibilities clearly defined? • Was this communicated to the members of the

company? How?

6.1.2 A food defense hazard analysis and assessmentof associated risks shall have been performedand documented. Based on this assessment,and based on the legal requirements, areascritical to security shall be identified.Food defense hazard analysis and assessmentof associated risks shall be conducted annuallyor upon changes that affect food integrity.An appropriate alert system shall be definedand periodically tested for effectiveness.


• What are the legal / customer food defenserequirements applicable to the company?

• How can the company demonstrate compliancewith such requirements?

• What is the process / procedure used to performthe hazard analyisis and assessment of associatedrisks?

• Is the hazard analysis in line with legal and/orcustomer needs and/or expectations?

• How do the systems assist the company to identifycritical or high risk areas?

• How often is a review of the food defense program performed?

• What criteria does the company consider in orderto determine the frequency to perform the hazard

analysis, if is not done annually? • How is the company alerted of any food defense

breach? • How does the company evaluate the effectiveness

of the food defense program?
