GAP Analysis
Content
GAP ANALYSIS – MARCH 2013
FOOD SAFETY SYSTEMS INITIATIVE GAP ASSESSMENT CHECKLIST
Name of Firm: Address of Firm: Contact Name: Company Category: Assessor Name: Assessor Signature: Assessment Date: Year Month Day Phone #:
Processing Plant Background:
Briefly describe the products and processes:
Does the processing facility have a potentially high-risk product or situation?
Refrigerated ready-to-eat food capable of supporting the growth of pathogens
Raw Food of Animal Origin Thermal Process Allergens What Prerequisite programs are important for the plant?
What Standard Operating Procedures are important for the plant?
Has the Product Background Form been completed for any products? Yes No
Are there items from the Product Background Form that should be further addressed? Yes No If yes, these items become part of the work plan. Comments:
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FSSI GAP ASSESSMENT CHECKLIST
Rating System Fully Somewhat Does not Critical Not FM SM DNM CF N/A Meets Meets meet Failure Applicable “Critical Failure’ is for items of high importance to food safety which are not in place “Does not meet” is used for all other items that are not in place. On the checklist: N/E Not Evaluated
Regular type indicates condition or activity Italics indicates written document. Bold (regular type or italics) indicates items of high importance to food safety. * Indicates items in a “more advanced program”
A.
Item
PREMISES PREREQUISITE PROGRAM
Rating Comments
Building Interior Design, Construction, Maintenance
Floors, walls, ceilings, doors, windows – materials are smooth, cleanable, impervious, durable, suitable Clean and in good repair Floors, walls, ceilings, doors, windows – materials/finishes are on CFIA Reference List Overhead walkways shielded underneath Product flow/employee traffic patterns designed to prevent contamination. *Plant schematic showing product and employee flow is available. Floors sloped to trapped drains Premises connected to sewage system, sewage pipes do not pass over or through production areas Sufficient, leak-proof, labeled waste storage containers available within plant, located to prevent cross- contamination. Wastes removed to disposal bin at least daily. *Air filters present and cleaned/replaced per maintenance schedule Ventilation is adequate to prevent accumulations of dust, condensation, steam and to remove contaminated air *Air used as processing technique is sourced (air intake) and treated (filters) to reduce sources of contamination *SOP and records for checking/cleaning/replacing air filters, for checking airflow and for duct cleaning *Equipment cleaning area located (and/or cleaning is scheduled) so as to prevent contamination of product/packaging *Drainage is adequate. *Written SOP/Corrective Action protocol/Records for interior building inspection.
Food Konnect 2013 – GAP ANALYSIS
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A.
PREMISES PREREQUISITE PROGRAM (continued)
Comments
(Building Interior continued) Rating Item Sanitary Facilities
Sufficient number of hand wash stations, conveniently located in processing area, washrooms and elsewhere as needed Hand wash stations have hot and cold water, soap dispensers, paper towels or air dryers, waste receptacle, plus sanitizer if required Washrooms, lunchrooms, change rooms clean and well maintained *Taps are “hands free” *“Wash Hands” signs are posted *Washrooms adequately ventilated and do not open directly into processing areas *Boot dips available at entry to processing areas *Lunchrooms and change rooms adequately ventilated, do not open directly into processing areas *Written SOPs/ Corrective Action protocols/ records for checking washroom/hand wash /sanitizer facilities for cleanliness, supplies, sanitizer levels.
Lighting
Adequate lighting intensity for safety, for inspections Lights/ windows adequately shielded against breakage
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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A.
PREMISES PREREQUISITE PROGRAM (continued)
Building Exterior
Item
Rating
Comments
General Environment
Building not in close proximity to environmental contaminants Surrounding grounds/driveways free of garbage and debris Surrounding grounds free of rodent harbourage (e.g. overgrown areas/disused items) Sufficient leak-proof, covered garbage disposal bins available Surrounding grounds adequately drained to prevent pooling of water and/or water entry into building
General Design, Construction, Maintenance
Building exterior designed & maintained to prevent entry of pests. Doors/windows screened Air intake appropriately located and screened against pest entry Roof, walls, doors, windows, foundation maintained to prevent water leakage *Adequate exterior lighting *Access doors designed to prevent unauthorized entry (e.g. self closing, locking) *Written SOP, Corrective Action protocol, records for exterior building inspection *Written security program in place
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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A.
PREMISES PREREQUISITE PROGRAM (continued)
Water Ice and Steam
Item Water Quality Advisory SOP in place *Water, ice, steam are analyzed at a frequency adequate for confirming potability All required permits / approvals are in place (multi-agency) Non-Municipal water supplies treated and tested to ensure potability
Water storage facilities designed, maintained to prevent contamination (covered!)
Rating
Comments
Water storage facilities treated and monitored Written water treatment and testing SOP for non-municipal water supplies. Records include water source sampling site, analytical results, analyst and date. *Written SOP, Corrective Action protocol and records for recirculated water system treatment and testing *Written SOP, Corrective Action protocol and records for water storage facility treatment and testing *Hoses/taps have back-flow prevention devices *Water pressure/temperature/volume adequate for all uses. *If Bottling water, access to water source is adequately protected
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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B.
TRANSPORTATION, RECEIVING, AND STORAGE
PREREQUISITE PROGRAM
Receiving Incoming Materials
Item Rating Comments
Incoming Materials
Incoming food, non-food items, packaging received in area separate from processing area Carriers are inspected for cleanliness, temperature, and suitability for food. Incoming materials inspected to ensure they meet specifications: approved supplier, Letter of Guarantee/ Certificate of Analysis. Master list of Ingredients/Suppliers available Incoming materials inspected for condition, temperature Receiving temperature log kept Lot numbers of ingredients recorded Allergens clearly identified Guidelines available for rejecting shipments *Incoming materials handled so as to prevent damage or contamination *SOPs in place for cleaning/sanitizing carriers, esp. bulk tankers SOP for receiving in place *SOP/records for returning rejected shipments returned products identified
Non-Food Materials
*Non-food materials checked against approved list *Non-food materials approved list available and checked against CFIA Reference list.
Storage of incoming material and finished product
Refrigerated storage < 4 C o Frozen Storage < -18 C Temperature logs kept Chemicals handled separately from foods to prevent contamination, and stored in clearly identified areas Allergens stored separately, in clearly identified areas/containers Returned, defective, suspect product is clearly identified and isolated in designated area Stock rotation practiced (incoming and finished product). Written SOP. *Food storage-off the floor, away from wall
o
Food Konnect 2013 – GAP ANALYSIS
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B.
TRANSPORTATION, RECEIVING, AND STORAGE
PROGRAM (continued)
PREREQUISITE Finished Product Control
Item Carrier is inspected for cleanliness, temperature, suitability for food Outgoing product is checked for condition, temperature *Temperature log is kept
Rating
Comments
Allergen Control Program Allergen identification and Control
Allergen-containing raw materials identified at receiving, marked Allergens stored separately in clearly identified areas/containers Colour-coded utensils used for allergens Master list of products/ingredients in each/ allergens in each is available *Allergen control SOPs in place for transport/receiving/storage/shipping *List of allergens available
Allergen Production Control
Allergen control SOPs in place for production Sanitation SOPs address risks of allergen cross-contamination Production sequencing in place to prevent allergen cross-contamination Rework SOPs in place to prevent allergen cross-contamination *SOP for staff allergen control training
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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B.
TRANSPORTATION, RECEIVING, AND STORAGE
PROGRAM
PREREQUISITE
Product Labeling and Packaging
Item Product labeling meets regulations (CFIA) All possible allergens in product are declared on label Written SOPs in place to prevent mislabeling Written procedure in place to review and update labels Rating Comments
Supplier Quality Assurance Supplier Quality Assurance Program
Letters of Guarantee (or Certificates of Analysis) available for all incoming materials Supplier Approval Process in place
Approved Supplier Records
List of Approved Suppliers available Master list of Ingredients available with specification sheets for each
Product Specifications Product Specifications
Product specifications are available indicating all ingredients and sub-ingredients Product specifications are monitored through evaluation of product
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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C.
EQUIPMENT PREREQUISITE PROGRAM
Equipment
Item Rating Comments
Equipment Design and Installation
All equipment is food grade presenting no hazards to product Equipment design ensures cleanability Equipment is accessible for cleaning *Equipment allows for proper drainage *Where needed, equipment is directly exhausted to the outside to prevent accumulations of condensation *Equipment specifications are available
Food Contact Surfaces
Food contact surfaces are smooth, noncorrosive, non-absorbent, non-toxic, free of chips, cracks, crevices, pitting Utensils used for food, for allergens, for non-edibles are clearly identified (colour coding) *Chemicals, paints or lubricants used on food contact surfaces are food-grade (On CFIA Reference List)
Equipment Maintenance and Calibration
Written Preventive Maintenance Schedule is available and includes: list of equipment, maintenance procedures and frequencies Maintenance schedule is followed Maintenance records are complete Working calibration equipment is available and/or off-site calibration is available Written, validated calibration SOPs in place, especially for critical monitoring equipment Calibration records are complete & current Repair Program is in place including names and contact numbers of repair personnel or company
Food Konnect 2013 – GAP ANALYSIS
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D.
PERSONNEL PREREQUISITE PROGRAM
Policy Development
Item Rating Comments
In-house hygiene policies
Employee Health & Hygiene policy is posted Written hygiene policy includes: Hand washing, proper use of gloves, hair restraint, removal of jewelry, wearing uniform, no personal items in production, no food/gum/tobacco use in production area, Written illness and injury policy includes not working with food if suffering from/carrying disease transmissible through food, cuts must be completely covered by waterproof covering, employees must advise management if they have a disease communicable through food *Written SOP for hand washing available
Visitor Food Safety and Hygiene
Visitor Food Safety and Hygiene Policy is posted Visitor policy includes: Sign-in and wear ID Protective clothing requirements (e.g. hair restraint, coverall, boot dip, safety gear) How access is controlled and limited to relevant areas
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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D.
PERSONNEL PREREQUISITE PROGRAM (continued)
Training
Item Rating Comments
Food Safety and Hygiene training
*Written training program for food safety and hygiene includes Skills and knowledge objectives, Importance of food safety/hygiene Training methods and materials, including professional training if required *Skills/Knowledge is evaluated and updated regularly *Hygiene training records on file *Training program is reviewed at set intervals and updated as needed
Technical training
*Written training program for technical skills (critical processes and operation of equipment, monitoring, sanitation, calibration, maintenance, general plant knowledge) includes: Skills and knowledge objectives Importance of task/information Detailed SOPs for task Critical Limits, monitoring procedure, Corrective Action, records, and verification for CCPs and monitoring SOPs Training methods and materials including professional training if required *Skills and knowledge are evaluated and updated *Technical training records are on file *Training program is reviewed at set intervals and updated as needed. *Comprehensive training program for all employees
Food Konnect 2013 – GAP ANALYSIS
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E.
SANITATION AND PEST CONTROL PREREQUISITE PROGRAM
Sanitation
Item Rating Comments
Sanitation Program
Master Cleaning Schedule available and includes in-process, daily, weekly, monthly, annual, periodic cleaning tasks Written SOP available for all tasks/areas relevant to food safety Written SOPs include chemical (sanitizer) concentration required, water temperature and water pressure if appropriate Sanitizer levels are monitored and recorded *Premises is in a sanitary condition
Pre-operational & In-process Sanitation
Pre-operational inspection is done to verify cleaning *Routine verification monitoring (observation, swabbing) is done *Sign-off sheets available for cleaning/monitoring/verification of sanitation tasks
Pest Control
Item Rating Comments
Pest Control Program
Written Pest Control program includes: Name of person responsible for pest control Name and contact information of pest control company on contract (License) Outline of pest control measures taken for premises List of chemicals used (if any), concentration, location where applied, method and frequency of application Map showing location of pest control devices Monitoring of pest control devices (person responsible and frequency) Use of poison bait prohibited inside facility
Food Konnect 2013 – GAP ANALYSIS
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E.
SANITATION AND PEST CONTROL PREREQUISITE PROGRAM
(continued)
Item
Rating
Comments
Pest Control Program
No evidence of pest activity in premises Only approved pest control chemicals are used *Written reports of pest control on file, including Corrective Actions taken
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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F.
Item
RECALL PREREQUISITE PROGRAM
Rating Comments
Complaint Handling
Customer complaints are documented and investigated Records kept regarding follow up and Corrective Action taken *Written SOP for handling customer complaints *Customer complaint form available
Recall System
Persons responsible for recalls and their roles Master list of ingredients and suppliers with contact info is available Master list of finished products and customers with contact info is available Written methods to identify, locate and control recalled product- both finished product and recalled raw materials Ingredients traceable through lot numbers or codes Finished product traceable through lot numbers or codes *Mock recalls performed and documented for finished product recall *Mock recalls performed and documented for raw material recall Corrective Actions regarding Recalls are documented Records of production, inventory and distribution by lot are available *Codes identify establishment, day, month and year of production *If packing for private label owners, Lot ID allows for distinguishing each private label product *Codes used and their meaning is available.
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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F.
RECALL PREREQUISITE PROGRAM (continued)
Rating Comments
Recall Notification
Item Names and contact number for responsible CFIA staff Amount of affected product produced, in inventory, and in distribution Product name, size, code or lot number of affected product
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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G.
CRITICAL CONTROL POINTS
Preliminary Items for HACCP
Item *HACCP Team in Place *Written Commitment from management regarding PP and/or HACCP program *HACCP Team leader adequately trained *HACCP team members responsibilities delegated in SOPs *Product Background Form completed for each Product group (each Process) *For each product - list of ingredients with sources/suppliers identified for each and all allergens associated with product identified *For each process - Plant schematic showing all equipment, product flow, employee flow *For each process – Process flow chart completed *Hazard Analysis worksheet completed for each Product group (i.e. each process) *For each process – all Biological, Chemical and Physical Hazards identified and described (including “because of”) for each process step – including crosscontamination and equipment hazards *Risk analysis done as part of hazard analysis *Control Measures identified for each hazard
Rating
Comments
Critical Control Points
Critical Control Points identified: For each identified hazard determination made as to whether it is fully controlled by a Prerequisite Program (named) or must be a CCP. (CCP Decision Tree is used to justify choice.) Critical Limits identified for each CCP: Reliable sources/data/expertise used to determine Critical Limits (ie. Validation by HACCP team) Sources etc are documented *Critical Limits state specifically what standard must be met at the CCP *Critical Limits can be accurately and consistently observed and/or measured.
Food Konnect 2013 – GAP ANALYSIS
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CRITICAL CONTROL POINTS
Preliminary Items for HACCP (continued)
Item Monitoring Procedure identified for each CCP. Monitoring procedures detailed in SOPs (including equipment used, frequency, person responsible, and records) *Monitoring method, equipment validated by HACCP team Rating Comments
Records for Control of Operation
Batch reports completed for product All critical limits are monitored and records completed
Deviations/ Corrective Actions
Corrective Action Plan in place for each CCP Corrective Action report forms availableincludes confirmation that the problem was addressed Detailed SOP available for each Corrective Action for each possible deviation from Critical Limit at each CCP. Stated in “if” “then” format *“Triggers” for Corrective Action accurately defined *Extent of authority to take Corrective Action is clearly defined *Amount of product included in Corrective Action is clearly defined and means of identifying affected product is defined *Disposal of affected product is clearly described with appropriate SOPs
Verification Procedures
Verification methods identified for each CCP Verification methods validated *Verification of monitoring is done by someone other than person doing the monitoring *Verification of monitoring is done at appropriate frequency *Monitoring records *Correction Action records *Verification records *Training records
Food Konnect 2013 – GAP ANALYSIS
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G.
CRITICAL CONTROL POINTS
Preliminary Items for HACCP (continued)
Verification of HACCP System
Item *HACCP plan requires annual verification of system – records, staff evaluations PPs/CCPs, on-site observation of PPs/CCPs, external audit *Annual Verifications of PPs, CCPs, HACCP preliminary steps, Supplier review/certification, plus hazard analysis, CCP/CL/Monitoring/CA determination *Verification of performance: of system checks, testing equipment for CCPs/critical PPs, sampling/testing for hazard control efficacy, *Review of validation data *Records and follow up on inadequacies found in system checks or audits *Prompt correction of inadequacies *Procedure in place to repeat verification to ensure inadequacies were corrected *Audit records are complete and signed off Rating Comments
HACCP System Records (adequately designed)
*HACCP plan (plus preliminary documents needed to write a HACCP plan) *CCP monitoring templates *Process deviation, Corrective Action templates *HACCP team records of meetings *Hold/release memos adequately designed, appropriate authority limits detailed *Validation data documented *Verification and audit records
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
FOOD SAFETY SYSTEMS INITIATIVE GAP ASSESSMENT CHECKLIST
Name of Firm: Address of Firm: Contact Name: Company Category: Assessor Name: Assessor Signature: Assessment Date: Year Month Day Phone #:
Processing Plant Background:
Briefly describe the products and processes:
Does the processing facility have a potentially high-risk product or situation?
Refrigerated ready-to-eat food capable of supporting the growth of pathogens
Raw Food of Animal Origin Thermal Process Allergens What Prerequisite programs are important for the plant?
What Standard Operating Procedures are important for the plant?
Has the Product Background Form been completed for any products? Yes No
Are there items from the Product Background Form that should be further addressed? Yes No If yes, these items become part of the work plan. Comments:
Page 2 of 18
FSSI GAP ASSESSMENT CHECKLIST
Rating System Fully Somewhat Does not Critical Not FM SM DNM CF N/A Meets Meets meet Failure Applicable “Critical Failure’ is for items of high importance to food safety which are not in place “Does not meet” is used for all other items that are not in place. On the checklist: N/E Not Evaluated
Regular type indicates condition or activity Italics indicates written document. Bold (regular type or italics) indicates items of high importance to food safety. * Indicates items in a “more advanced program”
A.
Item
PREMISES PREREQUISITE PROGRAM
Rating Comments
Building Interior Design, Construction, Maintenance
Floors, walls, ceilings, doors, windows – materials are smooth, cleanable, impervious, durable, suitable Clean and in good repair Floors, walls, ceilings, doors, windows – materials/finishes are on CFIA Reference List Overhead walkways shielded underneath Product flow/employee traffic patterns designed to prevent contamination. *Plant schematic showing product and employee flow is available. Floors sloped to trapped drains Premises connected to sewage system, sewage pipes do not pass over or through production areas Sufficient, leak-proof, labeled waste storage containers available within plant, located to prevent cross- contamination. Wastes removed to disposal bin at least daily. *Air filters present and cleaned/replaced per maintenance schedule Ventilation is adequate to prevent accumulations of dust, condensation, steam and to remove contaminated air *Air used as processing technique is sourced (air intake) and treated (filters) to reduce sources of contamination *SOP and records for checking/cleaning/replacing air filters, for checking airflow and for duct cleaning *Equipment cleaning area located (and/or cleaning is scheduled) so as to prevent contamination of product/packaging *Drainage is adequate. *Written SOP/Corrective Action protocol/Records for interior building inspection.
Food Konnect 2013 – GAP ANALYSIS
Page 3 of 18
A.
PREMISES PREREQUISITE PROGRAM (continued)
Comments
(Building Interior continued) Rating Item Sanitary Facilities
Sufficient number of hand wash stations, conveniently located in processing area, washrooms and elsewhere as needed Hand wash stations have hot and cold water, soap dispensers, paper towels or air dryers, waste receptacle, plus sanitizer if required Washrooms, lunchrooms, change rooms clean and well maintained *Taps are “hands free” *“Wash Hands” signs are posted *Washrooms adequately ventilated and do not open directly into processing areas *Boot dips available at entry to processing areas *Lunchrooms and change rooms adequately ventilated, do not open directly into processing areas *Written SOPs/ Corrective Action protocols/ records for checking washroom/hand wash /sanitizer facilities for cleanliness, supplies, sanitizer levels.
Lighting
Adequate lighting intensity for safety, for inspections Lights/ windows adequately shielded against breakage
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
Page 4 of 18
A.
PREMISES PREREQUISITE PROGRAM (continued)
Building Exterior
Item
Rating
Comments
General Environment
Building not in close proximity to environmental contaminants Surrounding grounds/driveways free of garbage and debris Surrounding grounds free of rodent harbourage (e.g. overgrown areas/disused items) Sufficient leak-proof, covered garbage disposal bins available Surrounding grounds adequately drained to prevent pooling of water and/or water entry into building
General Design, Construction, Maintenance
Building exterior designed & maintained to prevent entry of pests. Doors/windows screened Air intake appropriately located and screened against pest entry Roof, walls, doors, windows, foundation maintained to prevent water leakage *Adequate exterior lighting *Access doors designed to prevent unauthorized entry (e.g. self closing, locking) *Written SOP, Corrective Action protocol, records for exterior building inspection *Written security program in place
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
Page 5 of 18
A.
PREMISES PREREQUISITE PROGRAM (continued)
Water Ice and Steam
Item Water Quality Advisory SOP in place *Water, ice, steam are analyzed at a frequency adequate for confirming potability All required permits / approvals are in place (multi-agency) Non-Municipal water supplies treated and tested to ensure potability
Water storage facilities designed, maintained to prevent contamination (covered!)
Rating
Comments
Water storage facilities treated and monitored Written water treatment and testing SOP for non-municipal water supplies. Records include water source sampling site, analytical results, analyst and date. *Written SOP, Corrective Action protocol and records for recirculated water system treatment and testing *Written SOP, Corrective Action protocol and records for water storage facility treatment and testing *Hoses/taps have back-flow prevention devices *Water pressure/temperature/volume adequate for all uses. *If Bottling water, access to water source is adequately protected
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
Page 6 of 18
B.
TRANSPORTATION, RECEIVING, AND STORAGE
PREREQUISITE PROGRAM
Receiving Incoming Materials
Item Rating Comments
Incoming Materials
Incoming food, non-food items, packaging received in area separate from processing area Carriers are inspected for cleanliness, temperature, and suitability for food. Incoming materials inspected to ensure they meet specifications: approved supplier, Letter of Guarantee/ Certificate of Analysis. Master list of Ingredients/Suppliers available Incoming materials inspected for condition, temperature Receiving temperature log kept Lot numbers of ingredients recorded Allergens clearly identified Guidelines available for rejecting shipments *Incoming materials handled so as to prevent damage or contamination *SOPs in place for cleaning/sanitizing carriers, esp. bulk tankers SOP for receiving in place *SOP/records for returning rejected shipments returned products identified
Non-Food Materials
*Non-food materials checked against approved list *Non-food materials approved list available and checked against CFIA Reference list.
Storage of incoming material and finished product
Refrigerated storage < 4 C o Frozen Storage < -18 C Temperature logs kept Chemicals handled separately from foods to prevent contamination, and stored in clearly identified areas Allergens stored separately, in clearly identified areas/containers Returned, defective, suspect product is clearly identified and isolated in designated area Stock rotation practiced (incoming and finished product). Written SOP. *Food storage-off the floor, away from wall
o
Food Konnect 2013 – GAP ANALYSIS
Page 7 of 18
B.
TRANSPORTATION, RECEIVING, AND STORAGE
PROGRAM (continued)
PREREQUISITE Finished Product Control
Item Carrier is inspected for cleanliness, temperature, suitability for food Outgoing product is checked for condition, temperature *Temperature log is kept
Rating
Comments
Allergen Control Program Allergen identification and Control
Allergen-containing raw materials identified at receiving, marked Allergens stored separately in clearly identified areas/containers Colour-coded utensils used for allergens Master list of products/ingredients in each/ allergens in each is available *Allergen control SOPs in place for transport/receiving/storage/shipping *List of allergens available
Allergen Production Control
Allergen control SOPs in place for production Sanitation SOPs address risks of allergen cross-contamination Production sequencing in place to prevent allergen cross-contamination Rework SOPs in place to prevent allergen cross-contamination *SOP for staff allergen control training
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
Page 8 of 18
B.
TRANSPORTATION, RECEIVING, AND STORAGE
PROGRAM
PREREQUISITE
Product Labeling and Packaging
Item Product labeling meets regulations (CFIA) All possible allergens in product are declared on label Written SOPs in place to prevent mislabeling Written procedure in place to review and update labels Rating Comments
Supplier Quality Assurance Supplier Quality Assurance Program
Letters of Guarantee (or Certificates of Analysis) available for all incoming materials Supplier Approval Process in place
Approved Supplier Records
List of Approved Suppliers available Master list of Ingredients available with specification sheets for each
Product Specifications Product Specifications
Product specifications are available indicating all ingredients and sub-ingredients Product specifications are monitored through evaluation of product
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
Page 9 of 18
C.
EQUIPMENT PREREQUISITE PROGRAM
Equipment
Item Rating Comments
Equipment Design and Installation
All equipment is food grade presenting no hazards to product Equipment design ensures cleanability Equipment is accessible for cleaning *Equipment allows for proper drainage *Where needed, equipment is directly exhausted to the outside to prevent accumulations of condensation *Equipment specifications are available
Food Contact Surfaces
Food contact surfaces are smooth, noncorrosive, non-absorbent, non-toxic, free of chips, cracks, crevices, pitting Utensils used for food, for allergens, for non-edibles are clearly identified (colour coding) *Chemicals, paints or lubricants used on food contact surfaces are food-grade (On CFIA Reference List)
Equipment Maintenance and Calibration
Written Preventive Maintenance Schedule is available and includes: list of equipment, maintenance procedures and frequencies Maintenance schedule is followed Maintenance records are complete Working calibration equipment is available and/or off-site calibration is available Written, validated calibration SOPs in place, especially for critical monitoring equipment Calibration records are complete & current Repair Program is in place including names and contact numbers of repair personnel or company
Food Konnect 2013 – GAP ANALYSIS
Page 10 of 18
D.
PERSONNEL PREREQUISITE PROGRAM
Policy Development
Item Rating Comments
In-house hygiene policies
Employee Health & Hygiene policy is posted Written hygiene policy includes: Hand washing, proper use of gloves, hair restraint, removal of jewelry, wearing uniform, no personal items in production, no food/gum/tobacco use in production area, Written illness and injury policy includes not working with food if suffering from/carrying disease transmissible through food, cuts must be completely covered by waterproof covering, employees must advise management if they have a disease communicable through food *Written SOP for hand washing available
Visitor Food Safety and Hygiene
Visitor Food Safety and Hygiene Policy is posted Visitor policy includes: Sign-in and wear ID Protective clothing requirements (e.g. hair restraint, coverall, boot dip, safety gear) How access is controlled and limited to relevant areas
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
Page 11 of 18
D.
PERSONNEL PREREQUISITE PROGRAM (continued)
Training
Item Rating Comments
Food Safety and Hygiene training
*Written training program for food safety and hygiene includes Skills and knowledge objectives, Importance of food safety/hygiene Training methods and materials, including professional training if required *Skills/Knowledge is evaluated and updated regularly *Hygiene training records on file *Training program is reviewed at set intervals and updated as needed
Technical training
*Written training program for technical skills (critical processes and operation of equipment, monitoring, sanitation, calibration, maintenance, general plant knowledge) includes: Skills and knowledge objectives Importance of task/information Detailed SOPs for task Critical Limits, monitoring procedure, Corrective Action, records, and verification for CCPs and monitoring SOPs Training methods and materials including professional training if required *Skills and knowledge are evaluated and updated *Technical training records are on file *Training program is reviewed at set intervals and updated as needed. *Comprehensive training program for all employees
Food Konnect 2013 – GAP ANALYSIS
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E.
SANITATION AND PEST CONTROL PREREQUISITE PROGRAM
Sanitation
Item Rating Comments
Sanitation Program
Master Cleaning Schedule available and includes in-process, daily, weekly, monthly, annual, periodic cleaning tasks Written SOP available for all tasks/areas relevant to food safety Written SOPs include chemical (sanitizer) concentration required, water temperature and water pressure if appropriate Sanitizer levels are monitored and recorded *Premises is in a sanitary condition
Pre-operational & In-process Sanitation
Pre-operational inspection is done to verify cleaning *Routine verification monitoring (observation, swabbing) is done *Sign-off sheets available for cleaning/monitoring/verification of sanitation tasks
Pest Control
Item Rating Comments
Pest Control Program
Written Pest Control program includes: Name of person responsible for pest control Name and contact information of pest control company on contract (License) Outline of pest control measures taken for premises List of chemicals used (if any), concentration, location where applied, method and frequency of application Map showing location of pest control devices Monitoring of pest control devices (person responsible and frequency) Use of poison bait prohibited inside facility
Food Konnect 2013 – GAP ANALYSIS
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E.
SANITATION AND PEST CONTROL PREREQUISITE PROGRAM
(continued)
Item
Rating
Comments
Pest Control Program
No evidence of pest activity in premises Only approved pest control chemicals are used *Written reports of pest control on file, including Corrective Actions taken
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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F.
Item
RECALL PREREQUISITE PROGRAM
Rating Comments
Complaint Handling
Customer complaints are documented and investigated Records kept regarding follow up and Corrective Action taken *Written SOP for handling customer complaints *Customer complaint form available
Recall System
Persons responsible for recalls and their roles Master list of ingredients and suppliers with contact info is available Master list of finished products and customers with contact info is available Written methods to identify, locate and control recalled product- both finished product and recalled raw materials Ingredients traceable through lot numbers or codes Finished product traceable through lot numbers or codes *Mock recalls performed and documented for finished product recall *Mock recalls performed and documented for raw material recall Corrective Actions regarding Recalls are documented Records of production, inventory and distribution by lot are available *Codes identify establishment, day, month and year of production *If packing for private label owners, Lot ID allows for distinguishing each private label product *Codes used and their meaning is available.
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
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F.
RECALL PREREQUISITE PROGRAM (continued)
Rating Comments
Recall Notification
Item Names and contact number for responsible CFIA staff Amount of affected product produced, in inventory, and in distribution Product name, size, code or lot number of affected product
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
Page 16 of 18
G.
CRITICAL CONTROL POINTS
Preliminary Items for HACCP
Item *HACCP Team in Place *Written Commitment from management regarding PP and/or HACCP program *HACCP Team leader adequately trained *HACCP team members responsibilities delegated in SOPs *Product Background Form completed for each Product group (each Process) *For each product - list of ingredients with sources/suppliers identified for each and all allergens associated with product identified *For each process - Plant schematic showing all equipment, product flow, employee flow *For each process – Process flow chart completed *Hazard Analysis worksheet completed for each Product group (i.e. each process) *For each process – all Biological, Chemical and Physical Hazards identified and described (including “because of”) for each process step – including crosscontamination and equipment hazards *Risk analysis done as part of hazard analysis *Control Measures identified for each hazard
Rating
Comments
Critical Control Points
Critical Control Points identified: For each identified hazard determination made as to whether it is fully controlled by a Prerequisite Program (named) or must be a CCP. (CCP Decision Tree is used to justify choice.) Critical Limits identified for each CCP: Reliable sources/data/expertise used to determine Critical Limits (ie. Validation by HACCP team) Sources etc are documented *Critical Limits state specifically what standard must be met at the CCP *Critical Limits can be accurately and consistently observed and/or measured.
Food Konnect 2013 – GAP ANALYSIS
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CRITICAL CONTROL POINTS
Preliminary Items for HACCP (continued)
Item Monitoring Procedure identified for each CCP. Monitoring procedures detailed in SOPs (including equipment used, frequency, person responsible, and records) *Monitoring method, equipment validated by HACCP team Rating Comments
Records for Control of Operation
Batch reports completed for product All critical limits are monitored and records completed
Deviations/ Corrective Actions
Corrective Action Plan in place for each CCP Corrective Action report forms availableincludes confirmation that the problem was addressed Detailed SOP available for each Corrective Action for each possible deviation from Critical Limit at each CCP. Stated in “if” “then” format *“Triggers” for Corrective Action accurately defined *Extent of authority to take Corrective Action is clearly defined *Amount of product included in Corrective Action is clearly defined and means of identifying affected product is defined *Disposal of affected product is clearly described with appropriate SOPs
Verification Procedures
Verification methods identified for each CCP Verification methods validated *Verification of monitoring is done by someone other than person doing the monitoring *Verification of monitoring is done at appropriate frequency *Monitoring records *Correction Action records *Verification records *Training records
Food Konnect 2013 – GAP ANALYSIS
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G.
CRITICAL CONTROL POINTS
Preliminary Items for HACCP (continued)
Verification of HACCP System
Item *HACCP plan requires annual verification of system – records, staff evaluations PPs/CCPs, on-site observation of PPs/CCPs, external audit *Annual Verifications of PPs, CCPs, HACCP preliminary steps, Supplier review/certification, plus hazard analysis, CCP/CL/Monitoring/CA determination *Verification of performance: of system checks, testing equipment for CCPs/critical PPs, sampling/testing for hazard control efficacy, *Review of validation data *Records and follow up on inadequacies found in system checks or audits *Prompt correction of inadequacies *Procedure in place to repeat verification to ensure inadequacies were corrected *Audit records are complete and signed off Rating Comments
HACCP System Records (adequately designed)
*HACCP plan (plus preliminary documents needed to write a HACCP plan) *CCP monitoring templates *Process deviation, Corrective Action templates *HACCP team records of meetings *Hold/release memos adequately designed, appropriate authority limits detailed *Validation data documented *Verification and audit records
Rating System Fully FM Meets
SM
Somewhat Meets
DNM
Does not meet
CF
Critical Failure
N/A
Not Applicable
N/E
Not Evaluated
Food Konnect 2013 – GAP ANALYSIS
