HACCP Hazard A Control Oints - IoPP

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HACCP: Hazard Analysis and Critical Control PointsA Food Safety Approach for Suppliers to the Food IndustryPackaging HACCP Plan Model: CUT and STACKCUTSTK1 Revision 05-06-2010LABELSPrepared by representatives of the following companies:Alcan PackagingGeneral MillsBerry PlasticsGraham Packaging CompanyCampbell Soup CompanyGraphic PackagingConAgra FoodsFood Safety Alliance for Packaging (FSAP)www.foodsafetyallianceforpackaging.comThis and all other FSAP HACCP Models are examples provided for guidance only. You need to assessyour own requirements and risks before implementing any HACCP program.Issue Date: Sept. 30 2009Page 1 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

1. What is HACCP?HACCP (Hazard Analysis and Critical Control Points) is “a systematic approach to theidentification, evaluation, and control of food safety hazards.” It is an internationallyrecognized system used to identify and control Food Safety hazards. It is a preventativeapproach to Food Safety developed in the early 1970s by the Pillsbury Company and NASA,the National Aeronautics and Space Administration.2. Why is HACCP Needed for Packaging Suppliers?Suppliers of packaging to food producing companies are part of the food industry. FoodSafety starts at the packaging supplier and continues through consumption. Packagingsuppliers, especially those with direct product contact and/or printed materials, are importantFood Safety partners.3. What are the Packaging HACCP Models?The Packaging HACCP Models are a series of publications designed to assist producers offood packaging with the implementation and installation of a HACCP program. They aredesigned to provide guidance in the development of HACCP plans. The Packaging HACCPModels have been created by the Food Safety Alliance for Packaging (FSAP).Food Safety Alliance for Packaging (FSAP) Initiative: The FSAP Initiative is a projectinvolving major food companies, packaging companies, food industry associations, andconsultants. The team’s primary goal is to provide guidance to packaging companies with anemphasis on packaging-related Food Safety concerns. The FSAP strives to elevate FoodPackaging Safety Awareness and provide resources for tools and training for the PackagingSupply Chain.4. Who should use them?The Packaging HACCP Models are intended to be used by companies supplying packagingcomponents to food producers. They may be used by those packaging companies that arejust beginning to implement HACCP and those wishing to evaluate their existing plan.5. Applying this Model – What to ExpectUpon reviewing this model and performing the applicable steps listed in sections 11 through20 of this document, the plant will have implemented a basic HACCP program. The plant canexpect to review existing documentation and create new documents. A small multi-disciplinaryteam will create the HACCP Plan and review and update it at least yearly. Upon following thesteps and successfully completing the suggested documentation in this model, the plant’sFood Safety program should be enhanced and meet the expectations of your customers.6. Definitionsa. HACCP Plan: The written document which is based upon the principles of HACCP andwhich requires the procedures to be followed.b. Hazard: A biological, chemical, or physical agent that is reasonably likely to causeillness or injury in the absence of its control.i. Chemical: e.g., Cleaning Compounds, Allergens, Pesticides, etc.ii. Physical: e.g., Glass, Metal, Plastic, Wood, etc.iii. Microbiological: e.g., Salmonella, Listeria, E. coli, etc.c. Hazard Analysis: The process of collecting and evaluating information on hazardsassociated with the packaging under consideration to decide which are significant andmust be addressed in the HACCP plan. A list of hazards associated with raw materialsIssue Date: Sept. 30 2009Page 2 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

and each process step is compiled. Each hazard will be evaluated when determiningCritical Control Points. The HACCP Team must consider where the end product will beused. Product safety concerns are considered during the hazard analysis, not qualityconcerns.d. CCP: Critical Control Point - A step at which control can be applied and is essential toprevent or eliminate a food safety hazard or reduce it to an acceptable level.1. CCP Validation/Verification plan: See section 21.e. CP: Control Point - Any step at which biological, chemical, or physical factors can becontrolled.f. QCP: Quality Control Point - A step in the process where a quality parameter may becontrolled.g. PP: Prerequisite Programs – Existing Operating, Environmental, and support systemsthat allow the plant to produce safe products. Examples include, but are not limited to,Pest Control, Good Manufacturing Practices (GMP), and Preventive Maintenance.Examples and more information are provided in Appendix A.7. Common Approach for HACCP ImplementationAction steps appear as Items 11 – 20 in this modela. Assemble HACCP Team (multi-disciplinary)See Item 11, Step 1b. Write Product Description (how is it made and what raw materials are used)See Item 12, Step 2c. Identify Target Audience (include markets and customers)See Item 12, Step 2d. Create Process Flow DiagramSee Item 13, Step 3e. Verify Process Flow DiagramSee Item 14, Step 4f.Identify HazardsSee Item 15, Step 5g. Perform Hazard AnalysisSee Item 15, Step 5h. Determine if Critical Control Points (CCP) exist. (Some processes will not have CCPs)See Item 16, Step 6i.1. Use CCP Decision Tree (See Appendix B)Establish Critical Control Point Limits (if applicable)j.Establish Monitoring Procedures for Critical Control Points (if applicable)See Item 17, Step 7See Item 18, Step 8k. Establish Corrective Actions for Critical Control Point Deviations (if applicable)See Item 19, Step 9l.Verify HACCP PlanSee Item 20, Step 108. Applying the Packaging HACCP Modela. Although cut and stack labels are a non-direct (or secondary) packaging, keep in mindthat the risk associated with this product is unlabeled allergens of the finished productcaused by a mixed label resulting in the mislabeling of food.b. It must be noted the Critical Control Points outlined in this model are only POTENTIALCCPs. The plan may/will vary depending on your processes and programs.Issue Date: Sept. 30 2009Page 3 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

9. HACCP Traininga. HACCP Team Leader – It is recommended that this person has formal training from anaccredited organization. (See FSAP website)b. HACCP Team Members – Team members should receive formal documented trainingfrom the team leader or person knowledgeable in HACCP.c. Plant Employees – Should receive documented training upon hiring and at leastannually thereafter.d. Those with CCP Monitoring Responsibility – Shall receive documented training specificto the CCP they monitor in addition to annually plant-wide training.e. Training Records – HACCP training must be documented and the records maintainedper the plant record retention policy.10.Record Keeping & Documentationa.b.c.d.e.Records provide evidence that procedures are being followed and CCPs are monitoredas required. They provide objective evidence to internal and external auditors. As inISO 9000, if something is not documented, it’s not done.Types of documents plant will need: Expected documentation is listed in section 11 –20 of this model. In short, the plant documentation will include: the HACCP Plan;Hazard Analysis; HACCP Procedures; HACCP Records; a list of HACCP trainedpersonnel and team members; and, supporting documentation from the PrerequisitePrograms (Appendix A).Completing HACCP Records: HACCP records shall be completed at the time of use.Information shall be recorded in permanent ink.Review of HACCP Records: CCP records should be reviewed by a trained companyrepresentative prior to releasing an order for shipment. The review must bedocumented.Proper documentation practices: The plant should follow proper documentationpractices such as prohibiting the use of correction fluid (Wite-out ) and pencil onpermanent records. Also, changes to entries should be made using a single line-outalong with initialing and dating the change. A documentation practices procedureshould be in place.HACCP Record Retention: The plant’s record retention policy should include aretention time for HACCP records. In many cases, this will be two years.Issue Date: Sept. 30 2009Page 4 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

PREPARING YOUR HACCP PLAN11.Step 1: Assemble HACCP Teama.b.c.d.Cross Functional TeamManagement Sponsorship / Buy-In / ParticipationHACCP TrainingDocuments: Team List / Charter with Management Sign-Off / Generic Facility TrainingLogFacility HACCP TeamFacility Name: StanLee Packaging, MarvelFacilityTeam Member NameDepartmentDate: June 30, 20XXTitleHACCP Team RoleC. KentFood SafetyFood SafetyManagerCoordinatorD. PrinceQualityQuality ManagerMemberS. KyleProductionWinder OperatorMemberB. BannerMaintenanceMaintenance ShiftSupervisorMemberP. ParkerTechnicalEngineerMemberB. WayneCustomer ServiceCS ManagerMemberIssue Date: Sept. 30 2009Page 5 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

Facility HACCP CharterFacility Name: StanLee Packaging, MarvelFacilityDate: June 30, 20XXThe purpose of the facility HACCP Team is to ensure safe products for our customersand their consumers. The HACCP Team will evaluate raw materials and processes todetermine Critical Control Points. Critical Control Points will be monitored as will otherpoints and processes. The team will provide documented training for the facility. Thefacility HACCP Plan will be re-assessed at least annually. Facility management willprovide adequate resources for the implementation and maintenance of the HACCPProgram.Sign-Off and ApprovalPositionNameSignatureHACCP Team LeaderC. KentC. KentManagement RepresentativeL. JefeL. JefeHACCP Team MemberD. PrinceD. PrinceHACCP Team MemberS. KyleS. KyleHACCP Team MemberB. BannerB. BannerHACCP Team MemberP. ParkerP. ParkerHACCP Team MemberB. WayneB. WayneIssue Date: Sept. 30 2009Page 6 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

Facility Training LogSubjectHACCP Hazard AnalysisDate(s)July 15, 20XXTrainer’s Name & TitleC. Kent – Food Safety ManagerMaterials UsedCCP Decision Tree, Internal SOPsPrint NameTitleDateR. SecrestPlant Manager7/15/20XXP. AbdulQuality Systems Engineer7/15/20XXS. TylerMaintenance Supervisor7/15/20XXJ. LopezCustomer TechnicalService7/15/20XXS. CowellCI Coordinator7/15/20XXR. JacksonQuality Manager7/15/20XXIssue Date: Sept. 30 2009Page 7 of 23 2009 Food Safety Alliance for Packaging (FSAP)TrainerCut & Stack Labels

12.Step 2: Write Product Descriptiona.b.c.d.e.f.What do you makeHow do you make itIntended usage (include time and temperature as applicable)What Raw Materials are usedIntended markets / customersDocument: Written Descriptions of what is made and production processProduct / Product Category DescriptionFacility Name:FacilityStanLee Packaging, MarvelDate: July 30, 20XXProduct/Product CategoryCut and Stack LabelsProcessPrinted [facility should define type: litho, roto, etc.]Secondary/Non-Direct Food ContactFood Safety CharacteristicsApplied labeling (if any) must be accurate to prevent/eliminate thepotential for mislabeling of finished products that could lead to allergenand /or regulatory food safety labeling non-compliance. Measure mustalso be instituted for the prevention of introduction of foreign objectssuch as metal contamination.Customer UseSecondary Packaging for Food and Non-Food Products(such as Canned Goods, Beverage Bottles, and Jarred Products)Target Market/ConsumerFinished Food and Non-Food Products for the General PublicGeneral Raw MaterialsPaper, Printing Inks, Powder, Coatings/Varnish, Banding, Shrink WrapFilm, Corrugate Cases/Cartons, Tape, Slipsheets (Cardboard), Pallets,Stretch Wrap FilmPackaging/PalletizationLabel bundles placed into cases/cartons, cases/cartons are stacked ontopallets with bottom slipsheet as one product per pallet, and individualpallets are stretch-wrappedShelf LifeNote specific time, if applicable. If there is no specified shelf life, listnone.Storage & DistributionStored warehouse (internal, external, or both) and distributed to foodand non-food contact manufacturing facilities.Condition: ambient, clean, dryNote: some labels may require more strict temperature/RH conditions(include specific label storage requirements, if applicable)OtherNone (in this example)Issue Date: Sept. 30 2009Page 8 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

13.Step 3: Create Process Flow Diagram (PFD)a.b.c.d.Block Diagram showing manufacturing stepsInclude Receipt of Raw Materials and Shipping of Finished GoodsDocument: Process Flow DiagramNote: Add CCPs to PFD after Step 6ReceivingWarehouseOrder Prep / Pre-PressCCP 1: Print/Layout UPC/2D CodeScanRoll Stock OperationPrintingFinishing(Jogging, Splitting, Cutting, Bundling,Casing)CCP 2: Bundle ScanCCP 3: Case/Contents ScanCCP 4: Pallet ScanOther processes to consider in theProcess Flow Diagram:WarehouseReworkReturned GoodsShippingCustomer14.Step 4: Verify Accuracy of Process Flow Diagram (PFD)a.b.c.d.Team walks through plant with PFDConfirm PFD with team and plant floor workersMake necessary changes before proceedingDocument: Edited Process Flow Diagram / Signed / ApprovedIssue Date: Sept. 30 2009Page 9 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

15.Step 5: Perform Hazard Analysisa.b.c.d.Evaluate Raw Materials for Chemical, Physical, Biological HazardsEvaluate Processes for Chemical, Physical, Biological HazardsDocument: Hazard Analysis Sheet for Raw MaterialsDocument: Hazard Analysis Sheet for ProcessesList every Bill of Material used in the manufacturing process for population into Column 1 ofRaw Material Hazard Analysis table.Instructions: Identify potential hazards associated with incoming materials and rework. Assess tothe best of your knowledge the likely risk associated with these materials and identify any specificpreventive programs or corrective steps that eliminate or reduce those risks to an acceptable level.Raw Material Hazard AnalysisFacility Name: StanLee Packaging, Marvel Facility1List each rawmaterial/ingredientin the process2Does this material/ingredientINTRODUCE apotential foodsafety hazard?Identify here.(Be as specific aspossible whenlisting the hazard.)C ChemicalP PhysicalB BiologicalPaperDate: August 24, 20XX3Is this hazardCONTROLLED bya PrerequisiteProgram or processstep?If YES, identify theProgram orprocess. If aPrerequisiteProgram or processis identified, do notcomplete Columns4-6 and go to nextprocess step.If NO, go to Column4.4Is this hazardELIMINATED by asubsequent (later)process step? IfYES, this step isNOT a CCP.Identify thesubsequentprocess step inColumn 5 andproceed to thenext process step.If the hazard iseliminated at thisstep (nosubsequentelimination step)enter NO and goto Column 6 andassign a CCPnumber.5Identify the lastprocess step that willeliminate thepotential hazard.(Example: metaldetector, filter, etc.).6Assign aCCP numberwhen theanswer inColumn 4 isNO.Otherwiseleave blank.C: -P: -B: -C: Heavy MetalsPrinting InksC: Off-flavor/odorC: ChemicalmigrationIssue Date: Sept. 30 2009Yes- Letters ofGuaranty, HeavyMetals WarrantyYes-Letters ofGuaranty fromsupplier.Yes-Letters ofGuaranty fromsupplier.Page 10 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

1List each rawmaterial/ingredientin the process2Does this material/ingredientINTRODUCE apotential foodsafety hazard?Identify here.(Be as specific aspossible whenlisting the hazard.)C ChemicalP PhysicalB Biological3Is this hazardCONTROLLED bya PrerequisiteProgram or processstep?If YES, identify theProgram orprocess. If aPrerequisiteProgram or processis identified, do notcomplete Columns4-6 and go to nextprocess step.If NO, go to Column4.4Is this hazardELIMINATED by asubsequent (later)process step? IfYES, this step isNOT a CCP.Identify thesubsequentprocess step inColumn 5 andproceed to thenext process step.If the hazard iseliminated at thisstep (nosubsequentelimination step)enter NO and goto Column 6 andassign a CCPnumber.5Identify the lastprocess step that willeliminate thepotential hazard.(Example: metaldetector, filter, etc.).6Assign aCCP numberwhen theanswer inColumn 4 isNO.Otherwiseleave blank.P: -B: -C: -PowderP: -B: -C: Heavy MetalsC: Off-Coatings/Varnishflavor/odorC: ChemicalMigrationYes- Letters ofGuaranty, HeavyMetals WarrantyYes-Letter ofguaranty fromsupplierYes-Letter ofguaranty fromsupplierP: -B: -C: -Banding (Plastic)P: -B: -C: --Shrink Wrap FilmP: -B: -C: --Corrugate CasesP: -B: -C: --TapeP: -B: -C: --Slipsheets(Paperboard)P: -B: --Issue Date: Sept. 30 2009Page 11 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

1List each rawmaterial/ingredientin the process2Does this material/ingredientINTRODUCE apotential foodsafety hazard?Identify here.(Be as specific aspossible whenlisting the hazard.)C ChemicalP PhysicalB Biological4Is this hazardELIMINATED by asubsequent (later)process step? IfYES, this step isNOT a CCP.Identify thesubsequentprocess step inColumn 5 andproceed to thenext process step.If the hazard iseliminated at thisstep (nosubsequentelimination step)enter NO and goto Column 6 andassign a CCPnumber.5Identify the lastprocess step that willeliminate thepotential hazard.(Example: metaldetector, filter, etc.).6Assign aCCP numberwhen theanswer inColumn 4 isNO.Otherwiseleave blank.Yes, Specificationto exclude usingwoodpreservatives,incominginspectionC: -- OdorPallets (wood)P: Foreign3Is this hazardCONTROLLED bya PrerequisiteProgram or processstep?If YES, identify theProgram orprocess. If aPrerequisiteProgram or processis identified, do notcomplete Columns4-6 and go to nextprocess step.If NO, go to Column4.Material (wood,nails, other)Yes- GMPs,Incoming MaterialInspectionProgramB: -C: -Stretch WrapFilmP: -B: --Issue Date: Sept. 30 2009Page 12 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

Process Hazard AnalysisFacility Name: StanLee Packaging, Marvel Facility1List each processstep from theProcess FlowDiagram.Also, bringforward eachingredient fromthe MaterialHazard AnalysisWorksheet thatwas determinedto be a CriticalIngredient.2Does thisingredient orprocess stepINTRODUCE apotential foodsafety hazard?Identify here.(Be as specific aspossible whenlisting the hazard.)C ChemicalP PhysicalB BiologicalDate: August 24, 20XX3Is this hazardCONTROLLED bya PrerequisiteProgram or processstep?If YES, identify theProgram orprocess. If aPrerequisiteProgram or processis identified, do notcomplete Columns4-6 and go to nextprocess step.If NO, go to Column4.4Is this hazardELIMINATED by asubsequent (later)process step? IfYES, this step isNOT a CCP.Identify thesubsequentprocess step inColumn 5 andproceed to thenext process step.If the hazard iseliminated at thisstep (nosubsequentelimination step)enter NO and goto Column 6 andassign a CCPnumber.NoNo5Identify the lastprocess step that willeliminate thepotential hazard.(Example: metaldetector, filter, etc.).6Assign aCCP numberwhen theanswer inColumn 4 isNO.Otherwiseleave blank.C: -ReceivingP: -B: -C: --WarehouseP: -B: -C: Error/AllergenOrder Prep/PrePressLabelingPrint/LayoutUPC/2D Code ScanCCP 1P: -B: -C: --Roll StockOperationP: -B: --C: Off-flavor/odorPrintingC: ChemicalmigrationYes-Process step:proper ink curingand solventflashing-off, snifftest, and/or GCconfirmationYes-Process step:proper ink curingand solventflashing-off, snifftest, and/or GCconfirmationP: -Issue Date: Sept. 30 2009Page 13 of 23 2009 Food Safety Alliance for Packaging (FSAP)Cut & Stack Labels

1List each processstep from theProcess FlowDiagram.Also, bringforward eachingredient fromthe MaterialHa

HACCP (Hazard Analysis and Critical Control Points) is “a systematic approach to the identification, evaluation, and control of food safety hazards.” . prevent or eliminate a food safety hazard or reduce it to an acceptable level. 1. CCP Validation/Verification plan: See section 21

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