Appendix II FSEP Prerequisite Program Checklist - … Sample Documents/CFIA_APP2...2007-04-01 FSEP Manual ... note any objective evidence on the appropriate section of the checklist

Appendix IIFSEP Prerequisite Program Checklist

2007-04-01 FSEP Manual - Appendix II page 1

Appendix II - FSEP Prerequisite Program Checklist

Establishment Name ___________________________ Registration Number: ________

CFIA Auditor: Review the establishment’s written prerequisite programs (complete the checklist below, if needed). Assess each sub-element forcompleteness using the Complete Written Program Guidelines (Appendix VI). Indicate all written incomplete in the appropriate section of the checklist. When conducting the onsite during Regulatory System Audits, note any objective evidence on the appropriate section of the checklist and transfer overto the FSEP Audit Worksheet (Appendix VI)

Establishment HACCP Coordinator: During the self-evaluation, assess each sub-element for completeness using the Complete Written ProgramGuidelines (Appendix VI) and if your written programs are complete check off the “complete” box. If they are “incomplete”, the written procedures mustbe corrected immediately. Use the comments section to note any deficiencies identified during the self-evaluation (internal audit). Identify if nodeficiencies were noted. Long term action plans must accompany the written notice (Chapter Three, Section 2.3) indicating the self assessment iscompleted.


Prerequisite Programs - (Bullets)

Who: Position or Personresponsible

Frequency: When monitoring,verification is conducted.

What/how: Indicates the company standard and how monitoring, deviation and verification is carried out to ensure thecompany standard is being met.

Records:Identifies the title of therecord (s)

(A) Premises (A 1) Building Exterior (A 1.1) Outside Property and Building Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 1.1.1Building facility is not located inclose proximity to anyenvironmental contaminants andthe surrounding/roadways are freeof debris and refuse, adequatelydrained and maintained tominimize environmental hazards.

Monitoring

A 1.1.1 Deviation

A 1.1.1 Verification

A 1.1.2Building exterior designed,constructed and maintained toprevent entry of contaminants andpests, eg., no unprotectedopenings, air intakes areappropriately located, and the roof,walls and foundation aremaintained to prevent leakage.

Monitoring

A 1.1.2 Deviation








(A) Premises (A 2) Building Interior ( A 2.1) Design, construction and Maintenance Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 2.1.1Where required/ appropriate,areas of the establishment areprovided with an adequate numberof conveniently located cleaningand sanitizing instalations toeffectively control the potential forcross-contamination fromemployees, such as:

• hands free hand washingstations that havefunctional trapped drains.

• sanitizer hand dips.• sanitizer boot dips/sprays .

Monitoring

A 2.1.1 Deviation








A 2.1.2Floors, walls, ceilings constructedof material that is durable,impervious, smooth, cleanable,and suitable for the productionconditions in the area and whereappropriate joints are sealed andangles are coved to preventcontamination and facilitatecleaning.

Monitoring

A 2.1.2 Deviation


A 2.1.3Floors, walls and ceilingscomposed of materials that arelisted in the "Reference Listing ofAccepted Construction Materials,Packaging Materials and Non-Food Chemical Products",published by CFIA or themanufacturer has a letter of noobjection" from Health Canada andwill not result in the contaminationof the environment or food.

Monitoring

A 2.1.3 Deviation








A 2.1.4Floors sufficiently sloped to permitliquids to drain to trapped outlets.

Monitoring

A 2.1.4 Deviation


A 2.1.5Ceilings, overhead structures,stairs, and elevators designed,constructed and maintained toprevent contamination.

Monitoring

A 2.1.5 Deviation


A 2.1.6Windows sealed or equipped withclose fitting screens and wherethere is a likelihood of breakage ofglass windows that could result inthe contamination of food, thewindows are constructed ofalternative materials or areadequately protected.

Monitoring

A 2.1.6 Deviation








A 2.1.7Doors have smooth, non-absorbent surfaces and are closefitting and self closing whereappropriate.

Monitoring

A 2.1.7 Deviation


A 2.1.8Buildings and facilities aredesigned to facilitate hygienicoperations by means of aregulated flow in the process fromthe arrival of the raw material atthe premises to the final product. The traffic pattern of employees, product flow and equipmentprevents contamination of foodthrough physical or operationalseparation. Procedures andpolicies are used to preventpotential cross-contaminationduring the production process (eg.,employee work descriptions,allergen program, etc.). Whereappropriate, blueprints and/orprocess flow diagrams areavailable.

Monitoring

A 2.1.8 Deviation








A 2.1.9Living quarters/areas whereanimals are kept are separated &do not open directly into foodhandling, processing, packagingareas. Physical and operationalseparation of incompatibleoperations are provided wherecross-contamination may result.

Monitoring

A 2.1.9 Deviation








(A) Premises (A 2) Building Interior ( A 2.2) Lighting Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 2.2.1Lighting is appropriate such thatthe intended production orinspection activity can beeffectively conducted, does notalter food colour and meets therespective commodity standards.

Monitoring

A 2.2.1 Deviation


A 2.2.2Light bulbs and fixtures located inareas where there is exposed foodor packaging materials are of asafety type or are protected toprevent contamination of food incase of breakage.

Monitoring

A 2.2.2 Deviation








(A) Premises (A 2) Building Interior ( A 2.3) Ventilation Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 2.3.1Ventilation provides sufficient airexchanges to preventunacceptable accumulations ofsteam, condensation or dust andto remove contaminated air. Filters are cleaned or replaced asappropriate.

Monitoring

A 2.3.1 Deviation


A 2.3.2In microbiologically sensitive areaspositive air pressure is maintained.

Monitoring

A 2.3.2 Deviation


A 2.3.3Where required, air used as aprocessing technique (e.g.pneumatic conveying, air agitationair blows, air dryer , etc.) isappropriately sourced and treated(air intakes, filters, compressors),to reduce any source ofcontamination.

Monitoring







A 2.3.3 Deviation







(A) Premises (A 1) Building Interior ( A 2.4) Waste Disposal Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 2.4.1Establishments are designed andconstructed so that there is nocross-connection between thesewage system and any otherwaste effluent system in theestablishment and they do notpass directly over or throughproduction areas unless they arecontrolled to preventcontamination. These systems areequipped with functionnal trapsand vents which do not emitodours.

Monitoring

A 2.4.1 Deviation








A 2.4.2Adequate facilities, equipment andcontainers that are clearlyidentified, leak proof and whereappropriate, covered, are providedand maintained for the storage ofwaste and inedible material prior toremoval from the establishment. Waste is removed and facilitiesand containers are cleaned andsanitized at an appropriatefrequency to minimizecontamination.

Monitoring

A 2.4.2 Deviation








(A) Premises (A 2) Building Interior (A 2.5) Inedible Areas Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 2.5.1A separate facility is provided forthe cleaning and sanitizing ofequipment used for inediblematerials. Where no separatefacility is provided, cleaning andsanitizing of equipment used forinedible materials is adequatelyseparated from production andstorage areas to minimizecontamination.

Monitoring

A 2.5.1 Deviation


A 2.5.2Sufficient inedible areas arelocated, ventilated and, wherenecessary, refrigerated to ensureno cross contamination of edibleproduct.

Monitoring

A 2.5.2 Deviation








A 2.5.3Inedible product is denatured asper program requirements.

Monitoring

A 2.5.3 Deviation








(A) Premises (A 3) Sanitary Facilities (A 3.1) Employees Facilities Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 3.1.1Washrooms and hand washstations have hot and cold potablerunning water, soap dispensers,soap, sanitary hand dryingequipment or supplies and acleanable waste receptacle. Handwashing notices are posted inappropriate areas.

Monitoring

A 3.1.1 Deviation


A 3.1.2As required, washrooms,lunchrooms and change rooms areprovided with adequate floordrainage, ventilation and aremaintained in a manner to preventcontamination. They areseparated from and do not opendirectly into processing areas.

Monitoring

A 3.1.2 Deviation








(A) Premises (A 3) Sanitary Facilities (A 3.2) Equipment Cleaning & Sanitizing Facilities Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 3.2.1Equipment cleaning andsanitizing facilities areconstructed of corrosion resistantmaterials capable of being easilycleaned, and are provided withpotable water at temperaturesappropriate for the cleaning andsanitizing chemicals used. Theyare adequately separated fromfood storage, processing andpackaging areas to preventcontamination.

Monitoring

A 3.2.1 Deviation


A 3.2.2Cleaning and sanitizingequipment is designed for itsintended use and is properlymaintained.

Monitoring

A 3.2.2 Deviation








(A) Premises (A 4) Water/Steam/Ice Quality and Supply (A 4.1) Water, Ice & Steam Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

A 4.1.1Water, Ice and Steam areanalysed by the manufacturer at afrequency adequate to confirm itspotability. Water from sourcesother than municipal supplies mustbe treated as necessary andtested to ensure potability. Waterand ice potability records include:water source sampling site,analytical results, analyst anddate. Water meets therequirements of Health Canada's"Guidelines for Canadian DrinkingWater Quality”.

Monitoring

A 4.1.1 Deviation








A 4.1.2Boiler feed water and any waterchemically treated, is monitoredand controlled to deliver thedesired concentration and toprevent contamination. Watertreatment Records include:method of treatment, sample site,analytical result, analyst and date.

Monitoring

A 4.1.2 Deviation


A 4.1.3There are no cross-connectionsbetween potable and non-potablewater supplies.

Monitoring

A 4.1.3 Deviation


A 4.1.4All hoses, taps or other similarsources of possible contaminationare designed to prevent back-flowor back siphonage.

Monitoring

A 4.1.4 Deviation








A 4.1.5Where filters are used they arekept effective and maintained in asanitary manner.

Monitoring

A 4.1.5 Deviation


A 4.1.6The volume, temperature andpressure of the potablewater/steam are adequate for alloperational and cleanup demands.

Monitoring

A 4.1.6 Deviation


A 4.1.7Where it is necessary to storewater, storage facilities areadequately designed, constructed,and maintained to preventcontamination. eg. covered.

Monitoring

A 4.1.7 Deviation








A 4.1.8Recirculated water is treated,monitored and maintained asappropriate for the intendedpurpose and has a separatedistribution system which is clearlyidentified.

Monitoring

A 4.1.8 Deviation








(B) Transportation Receiving & Storage (B 1) Transportation (B 1.1) Food Carriers Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

B 1.1.1The manufacturer verifies thatcarriers are suitable for thetransportation of food. Forexample:1) Carriers are inspected by themanufacturer on receipt and priorto loading to ensure they are freefrom contamination and suitablefor the transportation of food,and/or2) The manufacturer has aprogram in place to demonstratethe adequacy of cleaning andsanitzing eg., for bulk carriers awritten cleaning and sanitizingprocedure is available.

Monitoring

B 1.1.1 Deviation

B 1.1.1 Verification

B 1.1.2Carriers are loaded, arranged andunloaded in a manner thatprevents damage andcontamination of the food andpackaging materials.

Monitoring







B 1.1.2 Deviation


B 1.1.3Incoming materials (food, non-food, packaging) are received inan area separate from processingarea.

Monitoring

B 1.1.3 Deviation







Records:Identifiesthe title ofthe record(s)

(B) Transportation Receiving & Storage (B1) Transportation (B 1.2) Temperature Control Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

B 1.2.1Ingredients requiring refrigerationare transported a regulated and/oracceptable temperature to ensurethe production of safe food andare appropriately monitored. Frozen ingredients are transportedat temperatures that do not permitthawing.

Monitoring

B 1.2.1 Deviation


B 1.2.2Finished product is transportedunder conditions to preventdamage or deterioration.

Monitoring

B 1.2.2 Deviation








(B) Transportation Receiving & Storage (B 2) Receiving & Storage (B 2.1) Incoming material receiving and storage Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

B 2.1.1Ingredients requiring refrigerationare stored and prepared at aregulated and/or acceptabletemperature to ensure theproduction of safe food and areappropriately monitored. Frozeningredients are stored attemperatures that do not permitthawing.

Monitoring

B 2.1.1 Deviation


B 2.1.2Ingredients and packagingmaterials are handled , stored andprepared in a manner to preventdamage and/or contamination (eg.,material falling on floor, allergencontrol). Where appropriate,rotation is controlled.

Monitoring

B 2.1.2 Deviation








B 2.1.3 Incoming materials are inspectedat receiving, where possible, toensure that the purchasingspecifications have been met. Letters of Guarantee are on file forany incoming materials for whichthese letters are required or wheredesired to ensure purchasingspecifications are met. Whereorganoleptic inspections are noteffective as a means of confirmingmaterial acceptability for thesematerials, Certificates of Analysisor supplier audits may be used asa means to verify thecommitments made in the Lettersof Guarantee.

Monitoring

B 2.1.3 Deviation








(B) Transportation Receiving & Storage (B 2) Receiving & Storage (B 2.2) Non-Food Chemicals Receiving and Storage Cross ReferenceWritten Review Complete ‘ Incomplete ‘

COMMENTS

B 2.2.1All non-food chemicals, watertreatment chemicals, boilertreatment chemicals, chemicals forsanitation, pesticides, coatings,paints, chemicals, lubricants andother materials used for foodcontact surfaces are listed in the“Reference Listing of AcceptedConstruction Materials, PackagingMaterials and Non-Food ChemicalProducts”, published by CFIA orthe manufacturer has “a letter ofno objection “ from Health Canada.

Monitoring

B 2.2.1 Deviation


B 2.2.2Chemicals are received and storedin a dry, adequately ventilatedarea which is designed such thatthere is no possibility for crosscontamination of food or foodcontact surfaces.

Monitoring

B 2.2.2 Deviation








B 2.2.3Where required for ongoing use infood handling areas thesechemicals are stored in a mannerthat prevents contamination offood, food contact surfaces, orpackaging materials.

Monitoring

B 2.2.3 Deviation


B 2.2.4Chemicals are stored and mixed inclean, correctly labelled containersand dispensed and handled onlyby authorized and properly trainedpersonnel.

Monitoring

B 2.2.4 Deviation








(B) Transportation Receiving & Storage (B 2) Receiving & Storage (B 2.3) Finished Product Storage Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

B 2.3.1Finished product is stored, rotatedand handled under conditions toprevent damage or deterioration.

Monitoring

B 2.3.1 Deviation


B 2.3.2Returned defective or suspectproduct is clearly identified andisolated in a designated area forappropriate disposition.

Monitoring

B 2.3.2 Deviation








C) Equipment C 1) Equipment General C 1.1) Design & Installation Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

C 1.1.1-Equipment and/or utensils are designed, constructed andinstalled;-to ensure that it is capable ofdelivering the requirements of theprocess;-accessible for cleaning, sanitizing,maintenance and inspection;-preventing contamination of theproduct during operations;-permits proper drainage andwhere appropriate, is connecteddirectly to drains;-smooth, non corrosive, nonabsorbent, non toxic, free frompitting, cracks and crevices wherethere are food contact surfaces.

Monitoring

C 1.1.1 Deviation

C 1.1.1 Verification

C 1.1.2Where necessary, equipment isexhausted to the outside toprevent excessive condensation.

Monitoring

C 1.1.2 Deviation








C 1.1.3Equipment and utensils used tohandle inedible material are notused to handle edible material andare clearly identified.

Monitoring

C 1.1.3 Deviation








C) Equipment C 1) Equipment General C 1.2) Equipment Maintenance & Calibration Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

C 1.2.1-The manufacturer has an effectivewritten preventative maintenanceprogram to ensure that equipmentthat may impact on food safety,functions as intended and that nophysical or chemical hazardpotentials result.This includes: -A list of equipment requiringregular maintenance. -The maintenance procedures andfrequencies, eg., equipmentinspection, adjustment and parts’replacements are based on theequipment manufacturer’s manualor equivalent, or are based onoperating conditions that couldaffect the condition of theequipment. -Reason for the activity.

Monitoring

C 1.2.1 Deviation








C 1.2.2The manufacturer has an effectivecalibration program for equipmentmonitoring and/or controllingdevices that may impact on foodsafety.

Monitoring

C 1.2.2 Deviation








(D) Personnel (D 1) Training (D 1.1) General Food Hygiene Training Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

D 1.1.1-The manufacturer has a writtentraining program for employeeswhich includes:-appropriate training in personalhygiene and hygienic handling offood at the beginning of theiremployment; and is - reinforcedand updated at appropriateintervals.

Monitoring

D 1.1.1 Deviation

D 1.1.1 Verification







(D) Personnel (D 1) Training (D 1.2) Technical Training Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

D 1.2.1Training is appropriate for thecomplexity of the manufacturingprocess and the tasks assigned,(eg., personnel are trained tounderstand the importance of thework/task performed to ensure theintegrity of the HACCP systemincluding the procedures to befollowed for monitoring, the actionto be taken if the standard is notmet, procedures for verificationand the records to be kept. Personnel must understand thecritical control points for which theyare responsible, the critical limits,the procedures to be followed iflimits are not met and the recordsto be kept. Training is reinforcedand updated at appropriateintervals.

Monitoring

D 1.2.1 Deviation








D 1.2.2 Personnel responsible formaintenance of equipmentimpacting on food safety, havebeen appropriately trained toidentify deficiencies that couldaffect product safety and to takethe appropriate corrective action. Individuals performingmaintenance on specificequipment are appropriatelytrained. Training is reinforced andupdated at appropriate intervals.

Monitoring

D 1.2.2 Deviation


D 1.2.3 Personnel and supervisorsresponsible for the sanitationprogram are appropriately trainedto understand the principles andmethods required for effectivecleaning and sanitizing. Trainingis reinforced and updated atappropriate intervals.

Monitoring

D 1.2.3 Deviation








D 1.2.4Additional training is provided asnecessary to ensure currentknowledge of equipment andprocess technology eg., specifictechnical training, apprenticeshipprograms etc.

Monitoring

D 1.2.4 Deviation








(D) Personnel (D 2) Hygiene & Health Requirements (D 2.1) Cleanliness & Conduct Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

D 2.1.1The manufacturer has andenforces a policy to ensure goodpersonal hygiene and hygienicbehaviour and habits must befollowed to prevent contaminationof food products: Handwashing/sanitizing, protectiveclothing, hygienic practices (nofood, gum, tobacco), procedures toprevent cross contaminationduring production.

Monitoring

D 2.1.1 Deviation


D 2.1.2Building and property is secure. Access of personnel and visitors iscontrolled to preventcontamination.

Monitoring

D 2.1.2 Deviation








(D) Personnel (D 2) Hygiene & Health Requirements (D 2.2) Communicable Diseases/Injuries Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

D 2.2.1The manufacturer has andenforces a policy to preventpersonnel known to be sufferingfrom, or known to be carriers of adisease transmissible throughfood, from working in foodhandling areas.

Monitoring

D 2.2.1 Deviation


D 2.2.2The manufacturer requires thatemployees advise managementwhen they are suffering from acommunicable disease likely to betransmitted through food.

Monitoring

D 2.2.2 Deviation








D 2.2.3Employees having open cuts orwounds do not handle food or foodcontact surfaces unless the injuryis completely protected by asecure waterproof covering, eg.,rubber gloves.

Monitoring

D 2.2.3 Deviation








(E) Sanitation & Pest Control (E 1) Sanitation (E 1.1) Sanitation Program Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

E 1.1.1The manufacturer has a cleaningand sanitizing program for allequipment (COP & CIP) whichincludes: chemicals andconcentration used, temperaturerequirements, procedures forcleaning and sanitizing anddisassembly and assemblyinstructions.

Monitoring

E 1.1.1 Deviation

E 1.1.1 Verification

E 1.1.2The manufacturer has and appliesa cleaning and sanitation programfor premises, production andstorage areas which includes:chemicals and concentration used,temperature requirements andprocedures for cleaning andsanitizing. Special sanitation andhousekeeping procedures requiredduring production are specified.

Monitoring

E 1.1.2 Deviation








E 1.1.3Where required, operations beginonly after sanitation requirementsare met.

Monitoring

E 1.1.3 Deviation








(E) Sanitation & Pest Control (E 2) Pest Control (E 2.1) Pest Control Program Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

E 2.1.1-There is an effective written pestcontrol program for the premisesand equipment that includes:-The name of the person at themanufacturer assignedresponsibility for pest control-Where applicable, the name ofthe pest control company or thename of the person contracted forthe pest control program-Outline how pests are controlledin the establishment-The list of chemicals used, theconcentration in accordance withlabel instructions, the locationwhere applied, method andfrequency of application.-A map of pest control deviceswhich are monitored to ensure thatthe needs of the establishment aremet.

Monitoring

E 2.1.1 Deviation








(F) Recall (F 1) Recall System (F 1.1) Program Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

F 1.1.1-The manufacturer has an effectiveHealth and Safety recall programwhich will include: -Tracking, analysis, actions taken &records of product complaints-The person or persons responsibleeg., recall co-ordinator(s)-The roles and responsibilities for co-ordination and implementation of arecall-Methods to identify, locate and controlrecalled product-A requirement to investigate otherproducts that may be affected by thehazard and that should be included inthe recall-Procedure for monitoring theeffectiveness of the recall (eg.,mockrecall - effectiveness check to theappropriate level of distributionspecified in the recall notice-Procedures to verify the capability ofthe program to rapidly identify andcontrol a code lot of potentiallyaffected product and reconcile theamount of product produced, ininventory and in distribution. Deficiencies are identified andcorrected

Monitoring

F 1.1.1 Deviation







F 1.1.1 Verification

F 1.1.2-Immediate notification of the AreaRecall coordinator of the CanadianFood Inspection Agency. Thisnotification includes the following:-Amount of product produced, ininventory and distributed-Name, size, code or lot numbersof food recalled-Area of distribution of product eg.,local, national, international-Reason for the recall

Monitoring

F 1.1.2 Deviation








(F) Recall (F 1) Recall System (F 12) Product Code Identification and Distribution Details Cross Reference: Written Review Complete ‘ Incomplete ‘

COMMENTS

F 1.2.1-Each prepackaged food haspermanent, legible code marks orlot numbers on the packages.-The code identifies theestablishment, the day, month andyear in which the food wasproduced.-Code marks used and the exactmeaning of the code are available.-Where used, case codes arelegible and represent the containercode within.

Monitoring

F 1.2.1 Deviation








F 1.2.2-For each lot of product, themanufacturer must have:-Records of customer names,addresses and telephone numbers-Records of production, inventoryand distribution by lot are availablefor the lot tested

Monitoring

F 1.2.2 Deviation
