Food > FSEP / HACCP > FSEP Implementation Manual > Appendices  

Food Safety Enhancement Program Manual

Printer-friendly PDF version - Appendix II

Appendix II - FSEP Prerequisite Program Review Worksheet

Establishment Name ___________________________

Registration Number: ________

CFIA Auditor: Review the establishment’s written prerequisite programs (complete the checklist below, if needed). Assess each sub-element for completeness 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 over to the FSEP Audit Worksheet (Appendix VI)

Establishment HACCP Coordinator: During the self-evaluation, assess each sub-element for completeness using the Complete Written Program Guidelines (Appendix VI) and if your written programs are complete check off the "complete" box. If they are "incomplete", the written procedures must be corrected immediately. Use the comments section to note any deficiencies identified during the self-evaluation (internal audit). Identify if no deficiencies were noted. Long term action plans must accompany the written notice (Chapter Three, Section 2.3) indicating the self assessment is completed.

(A) Premises - (A1) Building Exterior

A 1.1 - Outside Property and Building

A 1.1.1 - Building facilities not located in close proximity to any environmental contaminants and the surrounding/roadways are free of debris and refuge, adequately drained and maintained to minimize environmental hazards.

A 1.1.2 - Building exterior designed, constructed and maintained to prevent entry of contaminants and pests, e.g. no unprotected opening, air intake appropriately located and the roof, walls and foundation are maintained to prevent leakage

(A) Premises - (A2) Building Interior

A 2.1 - Design, Construction and Maintenance

A 2.1.1 - Where required/appropriate, areas of the establishment are provided with an adequate number of conveniently located hands free hand washing stations with trapped waste pipes to drains and sanitizer hands dips.

A 2.1.2 - Floors, walls, ceilings constructed of material that is durable, impervious, smooth, cleanable, and suitable for the production conditions in the area and where appropriate joints are sealed and angles are coved to prevent contamination and facilitate cleaning.

A 2.1.3 - Floors, walls and ceilings composed of materials that are listed in the " Reference Listing of Accepted Construction Materials. Packing Materials and Non-Food Chemicals Products", published by CFIA or the manufacturer has a "letter of no objection" from Health Canada and will not result in the contamination of the environment or food.

A 2.1.4- Floors sufficiently sloped to permit liquids to drain to trapped outlets.

A 2.1.5 - Ceilings, overhead structures, stairs, and elevators designed, constructed and maintained to prevent contamination.

A 2.1.6 - Windows sealed or equipped with close fitting screens and where there is likelihood of breakage of glass windows that could result in the contamination of food, the windows are constructed of alternative materials or are adequately protected.

A 2.1.7 - Doors have smooth, non-absorbent surfaces and are close fitting and self closing where appropriate.

A 2.1.8 - Building and facilities are designed to facilitate hygienic operations by means of a regulated flow in the process from the arrival of the raw material at the premises to the final product. The traffic pattern of employees, product flow and equipment prevents contamination of food through physical or operational separation. Procedures and policies are used to prevent potential cross-contamination during the production process (e.g. employee work descriptions allergen program, etc.). Where appropriate, blueprints and/or process flow diagrams are available.

A 2.1.9 - Living quarters / areas where animals are kept are separated and do not open directly into food handling, processing or packaging areas. Physical and operational separation of incompatible operations are provided where cross contamination may result.

A 2.2 - Lighting

A 2.2.1 - Lighting is appropriate such that the intended production or inspection activity can be effectively conducted, does not alter the food colour and meets the respective commodity standards.

A 2.2.2 - Lights bulbs and fixtures located in areas where there is exposed food or packaging materials are of a safety type or are protected to prevent contamination of food in case of breakage.

A 2.3 - Ventilation

A 2.3.1 - Ventilation provides sufficient air exchange to prevent unacceptable accumulations of steam, condensation or dust and to remove contaminated air. Filters are cleaned or replaced as appropriate.

A 2.3.2 - In microbiologically sensitive areas positive air pressure is maintained.

A 2.3.3 - Where required, air used as a processing technique (e.g. pneumatic conveying, air agitation, air blows, air dryer etc.) is appropriately sourced and treated (air intakes, filters, compressors), to reduce any source of contamination.

A 2.4 - Waste Disposal

A 2.4.1 - Establishments are designed and constructed so that there is no cross-connection between the sewage system and any other waste effluent system in the establishment and they do not pass directly over or through production areas unless they are controlled to prevent contamination. These systems are equipped with (functional) traps and vents which do not emit odours.

A 2.4.2 - Adequate facilities, equipment and containers that are clearly identified, leak proof and, where appropriate, covered, are provided and maintained for the storage of waste and inedible material prior to removal from the establishment. Waste is removed and facilities and containers are cleaned and sanitized at an appropriate frequency to minimize contamination.

A 2.5 - Inedible Areas

A 2.5.1 - A separate facility is provided for the cleaning and sanitizing of equipment used for inedible materials. Where no separate facility is provided, cleaning and sanitizing of equipment used for inedible materials is adequately separated from production and storage areas to minimize contamination.

A 2.5.2 - Sufficient inedible areas are located, ventilated and refrigerated (where necessary) to ensure no cross contamination of edible product.

A 2.5.3 - Inedible product is denatured as per program requirements.

(A) Premises - (A3) Sanitary Facilities

A 3.1 - Employees Facilities

A 3.1.1 - Washrooms and hand wash stations have hot and cold potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and a cleanable waste receptacle. Hand washing notices are posted in appropriate areas.

A 3.1.2 - As required, washrooms, lunchrooms and change rooms are provided with adequate floor drainage, ventilation and are maintained in a manner to prevent contamination. They are separated from and do not open directly into food processing areas.

A 3.2 - Equipment Cleaning and Sanitizing Facilities

A 3.2.1 - Equipment cleaning and sanitizing facilities are constructed of corrosion resistant materials capable of being easily cleaned, and are provided with potable water at temperatures appropriate for the cleaning and sanitizing chemicals used. They are adequately separated from food storage, processing and packaging areas to prevent contamination.

A 3.2.2 - Where required, cleaning and sanitizing equipment is designed for its intended use and is properly maintained.

(A) Premises - (A4) Water/Steam/Ice Quality and Supply

A 4.1 - Water, ice and steam

A 4.1.1 - Water, ice and steam are analysed by the manufacturer at a frequency adequate to confirm its potability. Water from sources other than municipal supplies must be treated as necessary and tested to ensure potability. Water and ice potability records include: water source sampling site, analytical results, analyst and date. Water meets the requirements of Health Canada's "Guidelines for Drinking Water Quality".

A 4.1.2 - Boiler feed water and any water chemically treated, is monitored and controlled to deliver the desired concentration and to prevent contamination. Water treatment records include: method of treatment, sample site, analytical result, analyst and date.

A 4.1.3 - There are no cross-connections between potable and non-potable water supplies.

A 4.1.4 - All hoses, taps or other similar sources of possible contamination are designed to prevent back-flow or back siphonage.

A 4.1.5- Where filters are used they are kept effective and maintained in a sanitary manner.

A 4.1.6 - The volume, temperature and pressure of the potable water/steam is adequate for all operational and cleanup demands.

A 4.1.7 - Where it is necessary to store water, storage facilities are adequately designed, constructed and maintained to prevent contamination, e.g. covered.

A 4.1.8 - Recirculated water is treated, monitored and maintained as appropriate for the intended purpose and has a separate distribution system which is clearly identified.

(B) Transportation Receiving and Storage - (B1) Transportation

B 1.1 - Food Carriers

B 1.1.1 - The Manufacturer verifies that carriers are suitable for the transportation of food. For example:

1. Carriers are inspected by the manufacturer on receipt and prior to loading to ensure they are free from contamination and suitable for the transportation of food, and/or
2. The manufacturer has a program in place to demonstrate the adequacy of cleaning and sanitizing e.g. for bulk carriers a written cleaning and sanitizing procedure is available.

B 1.1.2 - Carriers are loaded, arranged and unloaded in a manner that prevents damage and contamination of the food and packaging materials.

B 1.1.3 - Incoming materials (food, non-food, packaging) are received in an area separate from processing area.

B 1.2 - Temperature Control

B 1.2.1 - Ingredients requiring refrigeration transported at a regulated and/or acceptable temperature to ensure production of safe food and are appropriately monitored. Frozen ingredients are transported at a regulated and/or acceptable temperature that does not permit thawing.

B 1.2.2- Finished product is transported under conditions to prevent damage or deterioration.

(B) Transportation Receiving and Storage - (B2) Receiving Storage

B 2.1 - Incoming Material Storage

B 2.1.1 - Ingredients requiring refrigeration are stored and prepared at a regulated and/or acceptable temperature to ensure production of safe food and are appropriately monitored. Frozen materials are stored at a regulated and/or acceptable temperature that does not permit thawing.

B 2.1.2 - Ingredients and packaging materials are handled, stored and prepared in a manner to prevent damage and/or contamination (e.g. material falling on floor, allergen control). Where appropriate, rotation is controlled.

B 2.1.3 -Ingredients are inspected at receiving, where possible, to ensure that the purchasing specifications have been met. Letters of Guarantee are on file for any incoming materials for which these letters are required or where desired to ensure purchasing specifications are met. Where organoleptic inspections are not effective as a means of confirming material acceptability for these materials, Certificates of Analysis or supplier audits may be used as a means to verify the commitments made in the Letters of Guarantee.

B 2.2 - Non-Food Chemicals Receiving and Storage

B 2.2.1 - All non-food chemicals, water treatment chemicals, boiler treatment chemicals, chemicals for sanitation, pesticides, coatings, paints, chemicals, lubricants and other materials used for food contact surfaces are listed in the " Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemicals Products", published by the Canadian Food Inspection Agency or the manufacturer has "a letter of no objection" from Health Canada.

B 2.2.2 - Chemicals are received and stored in a dry, adequately ventilated area which is designated such that there is no possibility for cross contamination of food or food contact surfaces.

B 2.2.3 - Where required for ongoing use in food handling areas these chemicals are stored in a manner that prevents contamination of foods, food contact surfaces, or packaging materials.

B 2.2.4 - Chemicals are stored and mixed in clean, correctly labelled containers and dispensed and handled only by authorized and properly trained personnel.

B 2.3 - Finished Product Storage

B 2.3.1 - Finished product is stored, rotated and handled under conditions to prevent damage or deterioration.

B 2.3.2 - Returned, defective, or suspect product is clearly identified and isolated in a designated area for appropriate disposition.

(C) Equipment - (C1) Equipment General

C 1.1 - Design and Installation

C 1.1.1 - Equipment and/or utensils are designed, constructed and installed:

• to ensure that is capable of delivering the requirements of the process;
• accessible for cleaning, sanitizing, maintenance and inspection;
• preventing contamination of the product during operations;
• permits proper drainage and where appropriate, is connected directly to drains;
• smooth, non corrosive, non absorbent, non toxic, free from pitting, cracks and crevices where there are food contact surface..

C 1.1.2 - Where necessary, equipment is exhausted to the outside to prevent excessive condensation.

C 1.1.3 - Equipment and utensils used to handle inedible material are not used to handle edible material and are clearly identified.

C 1.2 - Equipment Maintenance and Calibration

1.2.1 - The manufacturer has an effective written preventive maintenance program to ensure that equipment that may impact on food safety, functions as intended and that no physical or chemical hazards potential result.
This includes:

• A list of equipment requiring regular maintenance
• The maintenance procedures and frequencies, e.g. equipment inspection, adjustment and parts' replacements are based on the equipment manufacturer's manual or equivalent, or are based on operating conditions that could affect the condition of the equipment
• Reason for the activity.

1.2.2 - The manufacturer has an effective calibration program for equipment monitoring and/or controlling devices that may impact on food safety.

(D) Personnel - (D1) Training

D 1.1 - General Food Hygiene Training

D 1.1.1 - The manufacturer has a written training program for employees which includes :

• appropriate training in personal hygiene and hygienic handling of food at the beginning of their employment; and is
• reinforced and updated at appropriate intervals.

D 1.2 - Technical Training

D 1.2.1 - Training is appropriate for the complexity of the manufacturing process and the tasks assigned, (e.g. personnel are trained to understand the importance of the works/task performed to ensure the integrity of the HACCP system including the procedures to be followed for monitoring, the action to be taken if the standard is not met, procedures for verification and the records to be kept). Personnel must understand the critical control points for which they are responsible the critical limits, the procedures to be followed if limits are not met and the records to be kept. Training is reinforced and updated at appropriate intervals.

D 1.2.2 - Personnel responsible for maintenance of equipment impacting on food safety, have been appropriately trained to identify deficiencies that could affect product safety and to take the appropriate corrective action. Individuals performing maintenance on specific equipment are appropriately trained. Training is reinforced and updated at appropriate intervals.

D 1.2.3 - Personnel and supervisors responsible for the sanitation program are appropriately trained to understand the principles and methods required for effective cleaning and sanitizing. Training is reinforced and updated at appropriate intervals.

D 1.2.4 - Additional training is provided as necessary to ensure current knowledge of equipment and process technology e.g. specific technical training, apprenticeship programs etc.

(D) Personnel - (D2) Hygiene and Health Requirements

D 2.1 - Cleanliness and Conduct

D 2.1.1 - The manufacturer has and enforces a policy to ensure good personal hygiene and hygienic behavior and habits must be followed to prevent contamination of food products; Hand washing/sanitizing, protective clothing, hygienic practices (e.g. no food, gum, tobacco), procedures to prevent cross contamination during production.

D 2.1.2 - Building and property is secure. Access of personnel and visitors is controlled to prevent contamination.

D 2.2 - Communicable Diseases/Injuries

D 2.2.1 - The manufacturer has and enforces a policy to prevent personnel known to be suffering from, or known to be carriers of a disease transmissible through food, from working in food handling areas.

D 2.2.2 - The manufacturer requires that employees advise management when they are suffering from a communicable disease likely to be transmitted through food.

D 2.2.3 - Employees having open cuts or wounds do not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering, e.g. rubber gloves.

(E) Sanitation and Pest Control - (E1) Sanitation

E 1.1 - Sanitation Program

E 1.1.1 - The manufacturer has a cleaning and sanitizing program for all equipment (COP and CIP) which includes: chemicals and concentration used, temperature requirements, procedures for cleaning and sanitizing, disassembly and assembly instructions.

E 1.1.2 - The manufacturer has and applies a cleaning and sanitation program for premises, production and storage areas which includes: chemicals and concentration used, temperature requirements and procedures for cleaning and sanitizing. Special sanitation and housekeeping procedures required during production are specified.

E 1.1.3 Where required, operations begin only after sanitation requirements are met.

(E) Sanitation and Pest Control - (E2) Pest Control

E 2.1 - Pest Control Program

E 2.1.1 - There is an effective written pest control program for the premises and equipment that includes:

• The name of the person at the manufacturer assigned responsibility for pest control.
• Where applicable, the name of the pest control company or the name of the person contracted for the pest control program.
• Outline how pests are controlled in the establishment
• The list of chemicals used, the concentration in accordance with label instructions, the location where applied, method and frequency of application
• A map of pest control devices which are monitored to ensure that the needs of the establishment are met..

(F) Recall - (F1) Recall System

F 1.1 - Program

F 1.1.1 - The manufacturer has an effective Health and Safety recall program which will include:

• Tracking, analysis, actions taken and records of product complaints.
• The person or persons responsible e.g. recall co-ordinator(s).
• The roles and responsibilities for co-ordination and implementation of a recall.
• Methods to identify, locate and control recalled product.
• A requirement to investigate other products that may be affected by the hazard and that should be included in the recall.
• Procedure for monitoring the effectiveness of the recall (e.g. mock recall - effectiveness check to the appropriate level of distribution specified in the recall notice).
• Procedures to verify the capability of the program to rapidly identify and control a code lot of potentially affected product and reconcile the amount of product produced, in inventory and in distribution. Deficiencies are identified and corrected.

F 1.1.2 - Immediate notification of the Area Recall coordinator of the Canadian Food Inspection Agency. This notification includes the following:

• Amount of product produced, in inventory and distributed.
• Name, size, code or lot numbers of food recalled.
• Area of distribution of product e.g. local, national, international.
• Reason for the recall.

F 1.2 Product Code Identification and Distribution Details

F 1.2.1 - Each prepackaged food has permanent, legible code marks or lot numbers on the packages.

• The code identifies the establishment, the day, month and year in which the food was produced.
• Code marks used and the exact meaning of the code are available.
• Where used, case codes are legible and represent the container code within.

F 1.2.2 - For each lot of product, the manufacturer must have:

• Records of customer names, addresses and telephone numbers.
• Records of production, inventory and distribution by lot are available for the lot tested.

Previous / Next