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1、1Hazard Analysis Critical Control Point (HACCP) Standard Prerequisite Programs Checklist REQUIREMENTS RESULTS / COMMENTS 1.SANITATIONPlant has a documented Sanitation Program ?Master Cleaning Schedule has been developed.?Facility (floors, walls, non-processingequipment, etc are included ?All process
2、 lines are included?Processing utensils are included?Written cleaning procedures are developed for allplant areas and equipment?Food contact surfaces have been identified.?Chemicals, chemical concentration, detailedcleaning procedures, etc identified?Post-maintenance equipment cleaningrequired for f
3、ood contact surfaces?Cleaning activities are documented?Appropriate procedures used to verifycleaning chemical concentration?Appropriate used to verify equipment rinseprocedure following sanitation?Post sanitation/pre-start up inspectionscompleted?Corrective action is documented?Plant has validated
4、cleaning procedures2.GMP PROGRAMSPlant has a documented 3rd party inspections Plant has a documented Internal Inspection Program ?Internal inspections required and completed asscheduled?Corrective action follow up required anddocumentedPlant has a documented Internal Audit Program ?Results completed
5、 and documented asscheduled?Corrective action follow up required anddocumentedPlant has documented GMP Programs ?Personnel Hygiene Program?Employee uniform policy?Employee glove policy?Cuts, open sores, illness, etc policy?Blood Borne Pathogen/Body Fluid Program?Clean up kit available?Metal Detector
6、 Reject Review Program?Sifter Tailing Review Program (if applicable)?Air Quality Program?Glass and Brittle Plastic Control Program2Plant has a documented Buildings and Ground Program ?Design and construction standards areestablished?Building exterior and grounds are properlymaintained?Building inter
7、ior, maintenance, design,construction, lighting, ventilation foot traffic, etcsupport food safety?Product flow is designed to reduce or eliminatethe potential for cross contamination?Sanitary facilities (rest rooms and hand washingfacilities) maintained for employees.Plant has a documented Water Qua
8、lity Program ?A water quality certificate is on file (city water) orannual checks completed (well).?Internal water analysis (TPC/coliform) completedper plant schedule (at least twice per year)?Ice is tested or a COA is available (if applicable)for TPC/Coliform?Back flow preventors in place?Location(
9、s) identified (must be on the mainwater line)?Annual certification completed on main waterline?Hoses have check valve at inlet.?Check valves are dated and replaced on pre-scheduled basisPlant has a documented Transportation and Storage Program ?Food carriers and distribution vehicles areinspected pr
10、ior to unloading/loading?Truck, load and driver identification arechecked and documented?Bulk tank number recorded?Bulk tank wash tickets inspected?Wash ticket for current load or withinapproved schedule?Bulk seals verified against supplier record?Appropriate facilities for raw material and finished
11、product storage are provided?Date of receipt recorded?Lot number recorded?Temperature controls are appropriate andmonitored.Plant has a documented Equipment Maintenance Program ?Design standards established?Equipment is designed for the process.?Equipment calibration procedures establishedand docume
12、nted3?Equipment maintenance procedures establishedand documented?Preventative?EmergencyPlant has a documented Training Programs ?GMP?Personnel Hygiene?Sanitation?Personal Safety?HACCP?General training for all employees?Specific training for personnel at CCPs?All training activities documented3.FOOD
13、SAFETY CUSTOMER COMPLAINTSPlant has a documented Customer/Consumer Complaint Program. ?Food safety complaints available at the plant?Food Safety complaints separated from all othercomplaints?Annual documented evaluation of food safetycomplaints by HACCP Team?All food safety complaints investigated?C
14、orrective action procedure in-place?Corrective action has been documented.4.TRACEABILITY AND RECALLPlant has a documented Traceability Program ?Name of records required for tracing productidentified?Location of trace records identified?Lot identification procedures are included?Traceability exercise
15、s conducted at least twiceannually?Traceability exercise results are documented?Traceability exercise has been completedbackwards (Supplier information, deliveryvehicle identification, date and quantity ofreceipt?Traceability exercise has been completedforwards (First point of shipment)?Traceability
16、 exercise effectiveness isdocumented. (At least two customerscontacted)oCustomer data confirms plant dataPlant has a documented Recall Program ?Plan is plant specific?Plant Recall Team members identified?Coordinator identified?Alternates identified?Emergency contact numbers available?Roles and respo
17、nsibilities for all Team Membersdocumented4?Method to identify and locate products(Traceability Program) identified?Recall exercises performed at least annually?Recall exercise results are documented.?Recall exercise time (from initial call to firstteam member to exercise completion)documented?Post
18、Recall exercise evaluation completed anddocumented.?Follow up to issues identified and addressed5.CHEMICAL CONTROL PROGRAMPlant has a documented Chemical Control Program ?Chemical approval process identified?A Chemical Log is available.?All chemicals are identified?Sanitation chemical quantities agr
19、ee with theChemical Log.?Chemical storage maintains control of chemicals?Chemical storage allows for separation ofchemical types?Sanitation?Pest Control?Maintenance?BoileroApproved for incidental food contact ifsteam comes in direct contact with food?Laboratory?MSDS forms available for all chemicals
20、?Contractor chemical approval procedureavailable?Approval procedure identified?MSDS forms available6.PEST CONTROL PROGRAMPlant has a documented Pest Control Program ?Individual responsible (plant personnel) isidentified?There is a certified PCO on staff (if applicable)External Service ?An outside pe
21、st control service is used (Name)?Company s license is available and currentoLicense is for working in food plants?Insurance is available and current.?Applicators license available and currentoLicense is for working in food plantsInternal or External ?Record of pest control chemicals?All pest contro
22、l chemicals identified?Pest control chemicals used according tolabel directions?MSDS sheets are available?Pest chemical labels available5?Pest control chemicals stored in accordancewith state and federal regulations (ifapplicable)?Inspection or service reports are available?All pest activity is note
23、d?Pest control device information is on file?Map of all pest control devices is available?All rodent bait stations are located outsidethe facilityoType of bait (liquid, granular, block)identified?Pheromone trap information notedoPheromone traps are dated and current?Insect light traps notedoLight bu
24、lbs are dated and current?Corrective action taken in regards to pestactivities has been noted and recorded7.ALLERGEN CONTROL PROGRAMPlant has a documented Allergen Control Program ?Recognized allergens listed?All allergen containing raw materials identified?Warehouse has designated allergen storagea
25、rea?Allergens are clearly identified.?Like allergens stored like above like?All allergen containing formula identified?Weigh area control procedures identified andimplemented?Allergen containers have individual scoops ormeasuring devices?All critical process/plant areas and equipmentidentified?Clean
26、ing procedures between allergen runsidentified?Allergen cleaning activities documented?Rework control implemented.?“Like into Like” procedure used?Rework usage documented?Package labels for allergen containing productshave appropriate allergens in their ingredientstatement.6Hazard Analysis Critical
27、Control Point (HACCP) Standard HACCP Manual & HACCP Plan Checklist REQUIREMENTS RESULTS / COMMENTS SECTION 1: PLANT INFORMATION This is a descriptive section telling about the plant, where it is located, who is in charge and products produced. ?Plant description is completed?Address and contact info
28、rmation available?Management Team is identified?History of operation is completed?Location of plant is identified?Products produced are listedSECTION 2: HACCP TEAMThis is a description of the HACCP Team. ?HACCP Team is identified?HACCP Coordinator is identified?Training of the HACCP Coordinatorident
29、ified?HACCP Team represents all aspects ofoperation?HACCP Team members participate in andunderstand the HACCP Plan development andimplementation.SECTION 3: PREREQUISITE PROGRAMSEach Prerequisite Program identified in the Process Hazard Analysis should be described in the manual. Information should b
30、e comprehensive enough that the reader will know the program is in effect, where it can be located and who is responsible for it. ?Sanitation Program?Good Manufacturing Practices (GMPs)?Customer Complaint Program?Pest Control Program?Chemical Control Program?Recall Program?Allergen Control Program?A
31、ny other Prerequisite Program or ProcessControl identified in the Process Hazard AnalysisSECTION 4: INGREDIENT HAZARD ANALYSIS A Hazard Analysis should be completed for each raw material used in the plant. Often a single hazard analysis will be completed for all raw materials. The Raw Material Hazar
32、d Analysis will focus on Biological, Chemical and Physical hazards associated with the raw material. Quality issues should not be addressed in this analysis. ?All raw materials have been identified.?All biological, chemical and physical hazardshave been noted.?Hazards have been assessed for signific
33、ance.?Control measures have been developed andimplemented to control all hazards.?External resources used to supplement Team7SECTION 5: PRODUCT DESCRIPTION A Product Description must be completed for each process or family of products. This description will include general information about the prod
34、uct, a technical description of the product and package, and food safety issues and their control associated with the product. Finished Product or Process ?Finished product or process description isprovided. ?Distribution and storage conditions are outlined.?Product use and consumer is identified.?S
35、ensitive group(s) (elderly, infirm, children, etc.)is (are) identified.?A technical description of the product or processis given.?Product shelf life and lot identification isidentified.?Possible food safety and misuse?Food safety control activities identified for eachpossible food safety issue.?Pro
36、duct Description is signed and dated by thesenior management representative.SECTION 6: FLOW DIAGRAM A flow diagram should be completed for each process. This should start with raw material receiving and continue through the individual processing steps. The flow diagram should be detailed enough to s
37、how each processing step and each CCP. ?A detailed Process Flow has been developed.?All operations are included.?Process Flow Diagram starts with Receivingand ends with Distribution / Shipping.?All process steps are identified.?Each CCP is identified on the flow diagram?A floor diagram is available.
38、?The Process Flow Diagram has been verified bythe HACCP Team.?A simplified Process Flow Diagram is in the Plan?Each CCP is identified on the flow diagramSECTION 7: PROCESS HAZARD ANALYSIS This information must be completed for each step shown in the Process Flow Diagram. The Process Hazard Analysis
39、will focus on Biological, Chemical and Physical hazards associated with the process. Quality issues should not be addressed in this analysis. ?A hazard analysis has been completed for eachprocess step identified on the process flowdiagram. (Principle 1)?All biological, chemical and physical hazardsh
40、ave been noted.?Hazards have been assessed for significance.?Control measures have been developed andimplemented to control all hazards.?External resources used to supplement Team8?The process hazard analysis worksheetadequately determines CCPs (if applicable)(Principle 2)? CCPs have been identified
41、 for eachsignificant hazard that is not controlled by apre-requisite program.? These are the correct CCPs to controlhazards.? External resources used to supplement TeamSECTION 8: MASTER PLAN The Master Plan is a single sheet for each product or group of products. It includes the plant information (n
42、ame, location), product(s) name, distribution method, customer (general population, elderly, infants), and each of the seven HACCP principles (hazard analysis, CCPs, CLs, etc.). ?A HACCP Master Plan has been developed foreach product, process or group of products.Master Plan ?A Master Plan has been
43、developed for eachCritical Control Point.?Critical Control Point(s) are indicated.?Critical Hazards (Biological, Physical, andChemical) are identified.?Critical Limit (Actual Measurable Value) isestablished for each CCP. (Principle 3)?The critical limits have been verified by anoutside source. oCrit
44、ical limits were determined by anoutside source.oCritical limits were determined byexperimentation.oExternal resources are being used tosupplement team knowledge.?Monitoring requirements are established.(Principle 4)? Monitoring procedures specify who, what,when, how and where.? Frequency is suffici
45、ent to ensure control.? Product lot identification is consistent withmonitoring frequency.? Monitoring records are signed.? Monitoring records are verified on a timelybasis.?Corrective Action in the event of a Critical Limitfailure during Monitoring is described.(Principle 5)? Corrective actions dev
46、eloped for each CCP.? Corrective actions ensure process has beenbrought under control.? Corrective actions ensure all suspect producthas been identified and captured.? Corrective actions include procedures toprevent recurrence.?Verification procedures are described andimplemented. (Principle 6)9? Ve
47、rification procedures have beenimplemented to demonstrate effectiveness ofHACCP Plan.? Reference device(s) accreditation(s).?Records are available for all CCPs. (Principle 7)? All CCP critical limits have been met.? Corrective action records are available for alldeviations.? Records are available fo
48、r all verificationactivities.? Record of “trained individual” training isavailable.? Records of employee training are available.?There is a document control program.?All changes are recorded.?All changes are dated.Section 9: Deviation Report This may be a document developed by the company or one iss
49、ued by a regulatory agency. It must include the product, date, lot number, description of the unusual occurrence, CL(s) exceeded, corrective action, any action to prevent reoccurrence, recommended HACCP Plan modification (if necessary), signature of individual who completed the form, date, and signa
50、ture of HACCP Coordinator and date. It is recommended the plant include a blank copy of their Deviation Report in their HACCP Plan. ?The manual contains a blank copy of theDeviation Record used by the facility.?Validation Procedures are described andimplemented.? There is a program in place to verify HACCPPlan.? The HACCP Plan has been updated.? The HACCP Plan update has beendocumented.? The scientific basis for HACCP Plan isvalidated annually.? The scientific basis for HACCP Plan wasvalidated initially.