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Archived - Food Safety Enhancement Program Manual

This page has been archived

This page was archived due to the coming into force of the Safe Food for Canadians Regulations. Archived information is provided for reference, research or record-keeping purposes only. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. For current information visit Food.

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List of modifications

Glossary of Terms

Acceptable level of a food safety hazard
The level at which the finished product will not cause harm to the consumer when it is prepared and/or consumed according to its intended use.
Codex Alimentarius Commission
A subsidiary body of the Food and Agriculture Organization and the World Health Organization of the United Nations.
Control measures
Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Critical Control Point (CCP)
A point or a step at which a control measure can be applied and a food safety hazard can be prevented, eliminated or reduced to an acceptable level.
Critical limit
A criterion that separates acceptability from unacceptability.
Deviation
A failure to meet required critical limits for a critical control point, or a failure to meet a standard identified in a prerequisite program or a process control.
Deviation procedure
A documented set of corrective actions that are implemented when a deviation occurs.
Establishment
A CFIA-registered company, plant or manufacturer that processes agri-food products (meat and poultry, dairy, processed fruits and vegetables, shell eggs, processed eggs, honey, and maple). Hatcheries are considered establishments.
Finished product
Product that will undergo no further processing or transformation by the establishment.
Note: A product that undergoes further processing or transformation by another establishment is a finished product, in the context of the first establishment and a raw material or an ingredient in the context of the second establishment.
Food additive
(Excerpt from Food and Drug Regulations, B.01.001) Any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include:
(a) any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;
(b) vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16,
(c) spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;
(d) agricultural chemicals, other than those listed in the tables to Division 16,
(e) food packaging materials and components thereof; and
(f) drugs recommended for administration to animals that may be consumed as food.
Food processing aid
A food processing aid is a substance that is used for a technical effect in food processing or manufacture, the use of which does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-products in or on the finished food.
Food Safety Enhancement Program (FSEP)
A CFIA program that specifies the minimum requirements for an effective food safety management system based on HACCP principles and encourages its development, implementation and maintenance in all federally registered establishments, excluding federally registered fish establishments.
Food safety
is a concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.
Food safety recall
A food recall is an action by a manufacturer, to remove unsafe food products from the market to help protect the public.
Hazard Analysis Critical Control Point (HACCP)
A systematic approach to identifying and assessing hazards and risks associated with a food operation and defining the means of their control.
HACCP plan
A written document designed in order to control hazards associated with specific processes and/or products within an establishment.
HACCP system
A system that includes prerequisite programs, one or more HACCP plan(s), validation documentation of control measures that have an immediate impact on food safety as well as maintenance and reassessment procedures as defined by the Food Safety Enhancement Program (FSEP).
Hazard
An entity, a condition or a circumstance that has the potential to cause harm. Hazards can be biological, chemical or physical.
Incompatible operations
In respect of activities taking place in a food establishment - activities that cannot take place at the same time in the same area because it creates a potential risk of food products being contaminated.
Monitoring
The act, by company personnel of conducting a planned sequence of observations, tests or measurements to assess whether a CCP, a process control and/or a prerequisite program is under control. This includes recording the results of those observations.
Nutrients
Vitamins, minerals and amino acids listed in Part D of the Food and Drug Regulations.
Operational Prerequisite Program
Food Safety related procedures essential in order to control the likelihood of introducing food safety hazards to and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment.
Prerequisite Program (PP)
[Food safety] basic conditions and activities that are necessary to maintain a hygienic environment and good manufacturing practices throughout the establishment.
Preventative measure
A corrective action resulting from an investigation to determine the root cause of a deviation. A preventative measure includes subsequent steps required to prevent reoccurrence of the deviation.
Process Control (PC)
Where more than one step in an overall process may contribute to the reduction of a particular hazard, process controls are developed for the early steps of the process where the hazard cannot be fully controlled, but a subsequent step will result in the elimination or reduction of this particular hazard to an acceptable level. This final step would be determined to be a CCP.
Regulatory requirements
All pertinent acts, regulations and directives.
Responsible inspector
A CFIA-designated inspector who is responsible for inspecting a federally registered establishment.
Risk
An estimate of the likely occurrence of a hazard and the severity of possible adverse health effect.
Senior management
Management at the establishment with authority to ensure adherence to responsibilities outlined in section 2.2.1 of the FSEP Manual.
Standard
Criteria or specifications that can be judged or evaluated and that define the limit of acceptability associated with prerequisite programs and process controls.
Task
Operational activities that are carried out by designated employees to prevent a food safety hazard. For example, the equipment maintenance program describes the tasks to be performed by the maintenance staff at a pre-determined frequency.
Validation
Obtaining evidence that a control measure, if properly implemented, is capable of controlling the hazard to a specified outcome.
Verification
A company's use of methods, procedures, tests and other evaluations, in addition to monitoring, to determine its conformance to and the effectiveness of its HACCP system.

Section 1 - Food Safety Enhancement Program Description

1.1 Introduction

The objective of the Food Safety Enhancement Program (FSEP) of the Canadian Food Inspection Agency (CFIA) is to specify minimum requirements for an effective food safety management system. FSEP provides a mechanism for operators of establishments to demonstrate their ability to control food safety hazards in order to ensure that food is safe for the consumer. In addition, it enhances the establishment's ability to achieve and maintain compliance with the relevant regulatory requirements.

FSEP is based on the principles of the Hazard Analysis and Critical Control Point (HACCP) system developed by the Codex Alimentarius Commission. HACCP is an internationally recognized, science-based food safety system, designed to prevent, reduce or eliminate potential biological, chemical and physical food safety hazards.

A HACCP system is the responsibility of the establishment (see section 2). The food manufacturer has the most control over the product and thus can have the greatest impact on the safety of the food produced.

FSEP specifies the requirements for an effective HACCP system that combines the following key elements to ensure the production of safe food:

FSEP outlines the process for HACCP recognition by the CFIA (see section 4). The recognition process applies to the following federally registered commodity groups: dairy, processed fruits and vegetables, shell eggs, processed eggs, honey, maple, and hatcheries. For establishments registered under the Meat Inspection Regulations in which a HACCP system in accordance with the FSEP Manual requirements is mandatory, please refer to the Meat Hygiene Manual of Procedures - Chapter 2 (Guidelines for the Applicant/Operator to the Registration of an Establishment and Licensing of an Operator).

FSEP details the changes to a recognized HACCP system that must be communicated to the CFIA (see section 5).

And finally, FSEP provides the necessary information for industry about the CFIA verification of FSEP voluntarily recognized establishments (see section 6). For establishments registered under the Meat Inspection Regulations, please refer to the Meat Hygiene Manual of Procedures - Chapter 18 (Compliance Verification System).

FSEP is consistent with the CFIA's Quality Management Program (QMP) for fish and seafood products and with HACCP initiatives being developed by provincial governments.

1.2 Types of food safety hazards controlled by a HACCP system

For the purposes of HACCP, hazards refer to agents in or conditions of food that can cause illness, injury or death of a person. These hazards fall into three categories: biological, chemical and physical.

Biological Hazards (B)

Biological hazards are those caused by micro-organisms (bacteria, virus, parasites and moulds) and are often associated with the failure of a process step. (e.g., Pathogen survival due to improper time/temperature applications during pasteurization)

Chemical Hazards (C)

Chemical hazards include those caused by substances/molecules that:

  • Are naturally derived from plants or animals (e.g., poisonous mushrooms);
  • Are intentionally added to the food during growth or during food processing. These substances are considered safe at established levels but are dangerous above these levels (e.g., sodium nitrite, pesticides);
  • Contaminate the food accidentally (e.g., cleaning chemicals);
  • Cause some individuals to experience an immune system response (food allergens).
Physical hazards (P)

Physical hazards include substances not normally found in food that can cause physical injury to the person consuming the food (e.g., wood slivers, glass fragments, metal shavings, bone pieces).

1.3 Benefits of HACCP

Although the adoption of HACCP systems worldwide is due primarily to the added food safety protection provided to consumers, there are other benefits to the food industry that can be realized by implementing a successful HACCP system.

  1. Formally incorporates food safety principles as integral steps of production processes
    HACCP recognition status cannot be completed without a firm commitment by senior management to formally support food safety control measures throughout the production process. The implementation and maintenance of those control measures play a critical role in raising awareness of front line production management and staff of the presence and importance of specific food safety procedures within their process.
  2. Increased employees' ownership of the production of safe food
    As a sign of this commitment, it is the responsibility of senior management to foster the idea within the facility that food safety is the responsibility of everyone. Through the process of developing and implementing a HACCP system, employees become more aware of food safety and their role in contributing to food safety. This increased knowledge leads to ownership of and pride in the production of a safe food product.
  3. Increased buyer and consumer confidence
    Establishments that have implemented a HACCP system provide buyers and consumers with a greater degree of confidence that the facility is producing a safe food product. Establishments can demonstrate by showing documents and records that food safety is under control.
  4. Maintaining or increasing market access
    Market forces continue to drive HACCP implementation throughout the food industry. In many cases, buyer demands and foreign governments require HACCP implementation to maintain market share and/or gain access to previously inaccessible markets. As HACCP systems are accepted worldwide, FSEP helps the Canadian industry to maintain and expand its international markets.
  5. Reduced waste
    The preventative nature of HACCP allows a company to control costs by minimizing the amount of product requiring rejection or recall, and by focusing resources on areas that have been identified as critical in the manufacture of a safe food product. With the regular monitoring inherent in a HACCP system, establishments become aware of problems earlier and the costs of waste are reduced.

Section 2 - Responsibilities

2.1 CFIA responsibilities

Under FSEP, the responsibilities of CFIA are to:

2.2 Establishment responsibilities

2.2.1 Establishment senior management commitment

Under FSEP, the responsibilities of the establishment's senior management are to:

A letter of commitment shall be included in the HACCP System documentation. The letter of commitment shall be signed and dated by a representative of senior management at the establishment with authority to ensure adherence to responsibilities described in this section. The letter shall be signed on an annual basis and when that senior manager is replaced. The letter must:

2.2.2 HACCP team leader

Senior Management shall appoint a HACCP team leader who, irrespective of other responsibilities, shall have the responsibility and authority:

Note: It is recommended that the HACCP team leader be on the premises on a regular basis. Where the HACCP team leader is not at the establishment on a regular basis, an on-site liaison person must be identified to take on these responsibilities and authorities.

2.2.3 HACCP team

The HACCP team consists of assigned personnel that have adequate knowledge and or experience. Representing various areas within an establishment such as production, sanitation, quality control, food microbiology and equipment maintenance, they are responsible for assisting the HACCP team leader in developing, implementing and maintaining the HACCP system.

The number of people on the HACCP team may vary based on the complexity of the process and the number of employees at the establishment. In small plants with a limited number of staff, the HACCP team may be made up of a few people that have a good understanding of the facility and its products, as well as HACCP.

The HACCP team should meet on a regular basis to discuss, among other points:

It is recommended that representatives from senior management participate periodically in HACCP team meetings to be aware of the HACCP system performance within their facility.

2.2.4 Competency

The HACCP team leader should, at a minimum, be knowledgeable of:

The HACCP team should be knowledgeable of:

Designated employees involved in the delivery of procedures developed in response to the requirements of the prerequisite programs, CCPs, process controls and reassessment activities must, at a minimum, be knowledgeable of their roles and responsibilities within the HACCP system.

It is important to note that the ultimate responsibility for a food safety system resides with the establishment operator and their employees. They cannot rely solely on the expertise of external consultants.

2.2.5 HACCP system performance reporting

A documented procedure shall be established which defines how the HACCP system performance is communicated to the senior manager who has signed the letter of commitment (see section 2.2.1).

The procedure shall include as a minimum:

The main objectives of the communication process are to:

2.2.6 Signing and dating the HACCP system documentation

The first page of the prerequisite programs, HACCP plan(s) and process control(s) shall be signed and dated by the HACCP team leader or senior management representative:

All pages of the prerequisite programs, HACCP plan(s), process control(s) and supporting documentation linked to the HACCP system (standard operating procedures, work instructions, etc.) shall be dated:

The signature shall signify that the prerequisite programs, HACCP plan(s), process control(s) and supporting documentation have been approved by the HACCP team leader or senior management representative and will be implemented as specified.

The establishment's HACCP team leader or senior management representative may utilize an electronic signature or a stamp in lieu of their signature. The stamp must have their actual signature and may also incorporate the date. Procedures must be in place to ensure control over access and use of the stamp(s). The establishment must implement appropriate controls to ensure the integrity of electronic signatures.

2.2.7 Control of records

Records shall be maintained to provide evidence of conformity to requirements and evidence of the effective operation of the HACCP system.

Records maintained on computers are acceptable provided the establishment implements appropriate controls to ensure the integrity of the electronic data and signatures.

Unless otherwise specified in CFIA program requirements, records shall be retained for at least one year or for the shelf life of the product, whichever is greater.

Section 3 - HACCP System Documentation

The HACCP system shall include:

3.1 Prerequisite programs

Prior to developing HACCP plans, the establishment shall develop and implement prerequisite programs to assist in controlling the likelihood of introducing food safety hazards to the product through the work environment and operational practices.

The prerequisite programs shall be documented, updated whenever there are changes associated with the prerequisite programs and reassessed at least annually.

The prerequisite program requirements outlined in this manual are generic in nature. Establishments must ensure that their prerequisite programs reflect the current work environment and operational practices within their establishment and comply with specific commodity policies, manuals, procedures and associated regulations.

An establishment may develop their prerequisite programs using a structure other than the one described in this section as long as the prerequisite program requirements are covered as well as the monitoring, deviation and record keeping components.

There are seven (7) prerequisite programs:

  1. Premises
  2. Transportation, Purchasing/Receiving/Shipping and Storage
  3. Equipment
  4. Personnel
  5. Sanitation and Pest Control
  6. Recall
  7. Operational Prerequisite Programs

Each prerequisite program is divided into Elements, Sub-elements and Bullets which include the requirements.

A - Program (e.g., Premises)

A.2 - Element (e.g., Building)

A.2.2 - Sub-element (e.g., Lighting)

A.2.2.1 - Bullet (Lighting is appropriate such that food colour is not altered and the intended production or inspection activity can be effectively conducted.)

Each establishment must create a documented program that responds to each prerequisite program bullet requirement (see section 3.1.1). The documented program shall include:

The record keeping shall meet the requirements defined in 3.1.4.

The establishment may have to develop more programs, standard operating procedures or tasks to meet applicable regulatory requirements and/or to facilitate the control of the prerequisite program requirements in their establishment. Any additional food safety related programs, procedures or tasks shall be referenced within the respective bullet.

Note: The individuals responsible for specific control measures within a prerequisite program, monitoring and deviation procedures may be identified by a position title or the term designate. In this case, the establishment must be able to demonstrate that individuals have received adequate training.

3.1.1 Prerequisite programs requirements

The seven prerequisite programs include the following elements and sub-elements:

(A) Premises (see section 3.1.1.1)
(B) Transportation, Purchasing/Receiving/Shipping and Storage (see section 3.1.1.2)
(C) Equipment (see section 3.1.1.3)
(D) Personnel (see section 3.1.1.4)
(E) Sanitation and Pest Control (see section 3.1.1.5)
(F) Recall (see section 3.1.1.6)
(G) Operational Prerequisite Programs (see 3.1.1.7)

Each prerequisite program sub-element is organized under the following headings:

As the FSEP Manual applies to all food commodity groups, there will inevitably be situations where some of the specific requirements are not applicable. The requirements indicate where such questions are likely to arise by using the phrases where necessary, where appropriate or where applicable. In deciding whether a requirement is necessary or appropriate, an assessment of the risk and the regulatory requirements must be made and the result of the assessment must be recorded.

3.1.1.1 (A) Premises
A.1 Outside Property
A.1.1 Outside Property
Requirements

A.1.1.1
Building facility is located away from or protected against potential sources of external contaminants that may compromise the safety of food.

The surrounding/roadways are free of debris and refuse, adequately drained and maintained to minimize environmental hazards.

Rationale
A.2 Building
A.2.1 Building Design, Construction and Maintenance
Requirements

A.2.1.1
The building is designed and constructed:

A.2.1.2
The building is maintained so:

Rationale
A.2.2 Lighting
Requirements

A.2.2.1
Lighting is appropriate such that food colour is not altered and the intended production or inspection activity can be effectively conducted.

A.2.2.2
Light 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.

Rationale
A.2.3 Ventilation
Requirements

A.2.3.1
Ventilation provides sufficient air exchanges 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
Ventilation systems ensure that air does not flow from the most contaminated areas to the least contaminated areas.

A.2.3.3
Where required, ambient air, compressed air or gases utilized in processing equipment that contact product or packaging are appropriately sourced and treated to minimize contamination of product and packaging.

Rationale
A.2.4 Waste and Inedible/Food Waste Disposal

Waste is defined as unwanted materials left over from the manufacturing processes. This includes but is not limited to garbage, discarded packaging, broken pallets, discarded construction materials etc.

Inedible product or food waste is defined as any food product that is not considered suitable for human consumption as defined in applicable legislation.

Requirements

A.2.4.1
The establishment has and implements documented procedures to control the hazards associated with waste and inedible/food waste products. The procedures shall include but are not limited to:

Rationale
A.3 Sanitary Facilities
A.3.1 Employees Facilities
Requirements

A.3.1.1
Washrooms have hot and cold or warm potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and cleanable waste receptacles. 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 and ventilation. They are maintained in a manner to prevent contamination.

Rationale
A.3.2 Hand-washing Stations and Sanitizing Installations
Requirements

A.3.2.1
Where required or 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.

Hand-washing stations are properly maintained and are provided with hot and cold or warm potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and cleanable waste receptacles. Hand-washing notices are posted in appropriate areas.

A.3.2.2
Where required/appropriate, areas of the establishment are provided with sanitizing installations, such as:

Sanitizing installations are properly maintained and are provided with potable water at temperatures and, where applicable, chemical concentrations appropriate for their intended use.

Rationale
A.4 Water/Ice/Steam Quality, Protection and Supply
A.4.1 Water/Ice/Steam Quality, Protection and Supply
Requirements

A.4.1.1
The establishment has and implements documented water safety procedures to ensure that water and ice meet the potability requirements of the appropriate regulatory authority.

The water safety procedures shall include but are not limited to:

A.4.1.2
Where applicable, the establishment has and implements documented water treatment procedures to ensure that:

The water treatment procedures shall include but are not limited to:

A.4.1.3
Where required, hoses, taps or other similar sources of possible contamination are designed to prevent back-flow or back siphonage.

A.4.1.4
Where filters are used they are kept effective and maintained in a sanitary manner.

A.4.1.5
The volume, temperature and pressure of the potable water/steam are adequate for all operational and cleanup demands.

A.4.1.6
Where it is necessary to store water or ice, storage facilities are adequately designed, constructed, and maintained to prevent contamination.

Rationale
3.1.1.2 (B) Transportation, Purchasing/Receiving/Shipping and Storage
B.1 Transportation
B.1.1 Food Carriers
Requirements

B.1.1.1
Carriers used for transport of food:

B.1.1.2
Carriers are loaded, arranged and unloaded in a manner that:

Rationale
B.2 Purchasing/Receiving/Shipping and Storage
B.2.1 Purchasing/Receiving/Shipping
Requirements

B.2.1.1
The establishment has and implements documented purchasing procedures to ensure that:

Requirements related to Letters of Guarantee

Note 1: Responsibility for providing letters of guarantee rests with the firm whose trade or firm name that appears on the material as it is marketed to the establishment.

Note 2: The documentation supporting letters of guarantee may include, but is not limited to, chemical migration data, physical characteristics or evidences of approval from other jurisdictions such as the United States of America, Europe or Australia-New Zealand.

Letters of guarantee for packaging material which is intended to come in direct or indirect contact with food products must at least contain the following information.

Letters of guarantee for construction materials used in rooms where food is manufactured, stored, packaged, received or shipped, must at least contain the following information:

Letters of guarantee for non-food chemical products coming into contact with food or food contact surfaces must at least contain the following information:

List of materials and non-food chemical products exempted from the submission of a letter of guarantee

The following products may be used in federally registered food establishments without the need for written guarantees. The use of these products must not directly or indirectly contaminate food products during either their application or storage.

B.2.1.2
Returned, defective or suspect product is clearly identified and isolated in a designated storage area, where it is assessed to determine the appropriate disposition.

B.2.1.3
Only approved and properly labelled/identified ingredients, products and materials are received into the establishment.

Incoming ingredients, products and materials are assessed at receiving to ensure that their conditions are satisfactory and that the purchasing specifications have been met.Footnote 5

Where applicable, receiving of live animals is controlled as per regulatory requirements.

B.2.1.4
All food safety specifications or requirements of the finished product have been met prior to shipping to retail/the customer. (e.g., temperature, certificate of analysis)

Finished product is adequately protected against intentional or unintentional contamination and deterioration prior to shipping.

Rationale
B.2.2 Storage
Requirements

B.2.2.1
Temperatures of storage areas, processing areas, coolers and freezers meet regulated and/or acceptable temperatures.

B.2.2.2
Ingredients, finished products and packaging materials are handled and stored in a manner to prevent damage, deterioration and contamination.

Where appropriate, ingredients and finished products present in processing rooms are managed in a manner to prevent increase of temperature above regulatory requirements and/or acceptable validated temperatures.

Where appropriate, rotation is controlled to prevent deterioration.

B.2.2.3
Non-food chemicals are received and stored in a dry, adequately ventilated area which is designed such that there is no possibility for cross-contamination of food, packaging materials or food contact surfaces.

When required for ongoing use in food handling areas, non-food chemicals are stored in a manner that prevents contamination of food, food contact surfaces or packaging material.

Non-food chemicals are mixed in clean, correctly labelled containers and dispensed and handled only by authorized and properly trained personnel.

Rationale
3.1.1.3 (C) Equipment
C.1 Equipment General
C.1.1 Design & Installation
Requirements

C.1.1.1
Equipment is designed, constructed and installed to ensure that:

Utensils are constructed of non-toxic materials, do not present a foreign material hazard that could contaminate the food, and are easy to clean and sanitize.

Rationale
C.1.2 Equipment Maintenance and Calibration
Requirements

C.1.2.1
The establishment has and implements a documented Preventative Equipment Maintenance Program which includes but is not limited to:

Note 1: The maintenance procedures are based on the equipment manufacturer's manual or equivalent, or are based on operating conditions that could affect the condition of the equipment.

Note 2: Equipment and pieces of equipment requiring regular maintenance that must be included in the Preventative Maintenance Program:

C.1.2.2
The establishment has and implements a documented Equipment Calibration Program which includes but is not limited to:

Note: The calibration procedures are based on the equipment manufacturer's manual or equivalent.

Rationale
3.1.1.4 (D) Personnel
D.1 Training
D.1.1 General Food Hygiene Training
Requirements

D.1.1.1
The establishment has and implements a documented general food hygiene training program which includes but is not limited to:

Rationale
D.1.2 Technical Training
Requirements

D.1.2.1
The establishment has and implements a documented Technical Training Program which includes but is not limited to:

Rationale
D.2 General Food Hygiene Program
D.2.1 General Food Hygiene Program
Requirements

D.2.1.1
The establishment has and implements a documented General Food Hygiene Program which includes, but is not limited to:

Rationale
3.1.1.5 (E) Sanitation and Pest Control
E.1 Sanitation
E.1.1 Sanitation Program
Requirements

E.1.1.1
The establishment has and implements a documented Sanitation Program which includes but is not limited to:

Rationale
E.2 Pest Control
E.2.1 Pest Control Program
Requirements

E.2.1.1
The establishment has and implements a documented Pest Control Program which includes but is not limited to:

Rationale

Pests (e.g., insects, rodents and birds) can contaminate food, ingredients, packaging materials and food contact surfaces. Pests in or around an establishment can lead to contamination from dropping, larvae and dead insects or animals.

3.1.1.6 (F) Recall
F.1 Recall System
F.1.1 Recall Plan

Note: For detailed information on developing a recall plan, please refer to the CFIA Web site.

The CFIA representatives will use the information described on the CFIA Web site to assess completeness of the establishment written recall plan.

Requirements

F.1.1.1
The establishment has and implements a documented Recall Plan which includes but is not limited to:

Rationale
F.1.2 Product Coding and Labelling
Requirements

F.1.2.1
The establishment has and implements documented operational procedures to ensure that:

The procedure to prevent incorrect labelling/coding shall include but is not limited to:

Rationale
3.1.1.7 (G) Operational Prerequisite Programs
G.1 Allergens, Nutrients, Food Additives and Processing Aids
G.1.1 Allergen Control Program

For hypersensitive individuals, certain foods and their derivatives can cause allergic reactions. Food allergy is an abnormal immune response to proteins found in food. Allergic reactions cannot occur in the absence of proteins. These proteins (antigens) are capable of stimulating the production of antibodies in the body, thereby, triggering allergic reactions. Immediate response to an allergic reaction can range in severity from a skin rash or itching of the mouth, to migraine headaches, a drop in blood pressure, anaphylaxis (a very severe allergic reactions to food involving failure of multiple organ systems), and death. There is no cure for food allergies and the only way for an allergic individual to protect themselves is strict avoidance of the allergen.

This sub-element outlines the requirements that an Allergen Control Program must meet to control the use of ingredients identified as allergens in an establishment, as well as to prevent or identify the presence of undeclared allergen ingredients in finished food products.

Unlike microbial hazards, there is no lethality or post processing step that will reduce or eliminate the presence of undeclared allergens in food products. Allergen hazard control is dependent on prevention throughout the process as well as appropriate product labelling to ensure full disclosure of a product's contents.

The list of the priority food allergens is available on the CFIA website.

Although sulphites are not considered to be true allergens, for sensitive persons they produce an adverse reaction which can be life threatening. It is the serious outcome of the reaction that has resulted in the inclusion of sulphites on the priority allergen list.

Ingredients which can cause non-immune reactions such as lactose intolerance should be considered when developing this control program.

A company may have to identify additional allergens of specific concern to its product or its target market. Manufacturers exporting outside of Canada should be aware that the list of priority allergens in other countries may be different from those listed in Canada.

Note 1: Each of the requirements outlined below may not be applicable to an establishment. In cases where an operator determines that a certain requirement does not apply, the result of the risk assessment must be available for CFIA review.

Note 2: Reference to existing prerequisite programs or CCPs that cover the requirements mentioned in this section is acceptable. The purpose of the allergen control program is to gather all of the allergen controls in one location in the HACCP system.

Requirements

G.1.1.1
Where applicable, documented procedures and/or policies are developed and implemented to ensure proper control of new or modified product formulations. This must include a minimum of:

G.1.1.2
Where applicable, documented procedures and/or policies related to purchasing of ingredients are developed and implemented to ensure proper control and identification of allergens for incoming ingredients. This must include a minimum of:

G.1.1.3
Where applicable, documented procedures and/or policies are developed and implemented to ensure proper control of new or modified labels. This must include a minimum of:

G.1.1.4
Where applicable, documented procedures and/or policies related to receiving of ingredients and externally printed labels are developed and implemented to ensure that:

G.1.1.5
Where applicable, documented procedures associated with Weighing/Blending/Mixing/Formulation are developed and implemented to ensure that the correct ingredient is added to the correct product as indicated in the formula. This must include a minimum of:

G.1.1.6
Where applicable, documented procedures and/or policies related to the use of rework are developed and implemented to ensure that the rework formulation ingredients and the product formulation ingredients match, specifically as it applies to allergen ingredients.

G.1.1.7
Where applicable, documented procedures related to labelling of finished product are developed and implemented to ensure that the finished product label information accurately represents the product name and the composition of the product on which the label is affixed. This must include a minimum of:

G.1.1.8
Where applicable, documented procedures and/or policies for disposal of obsolete materials are developed and implemented to prevent their inadvertent use. Obsolete materials include:

G.1.1.9
Where applicable, documented procedures and/or policies are developed and implemented to control cross-contamination of undeclared allergens in the food products. Procedures include as a minimum, the management and control of:

Rationale
G.1.2 Food Additives and Nutrients
Requirements

This sub-element applies to three operational activities requiring control measures.

  1. The use of food additives identified in Health Canada’s Lists of Permitted Food Additives for which a maximum level of use is determined. (The 15 lists of permitted food additives are meant to replace the food additive tables housed under Division 16 of the Food and Drug Regulations.)
  2. The use of nutrients listed in Part D - Vitamins, Minerals and Amino Acids of the Food and Drug Regulations for which a minimal and maximal amount is specified in Part B of the Regulations.
  3. The use of modified atmosphere packaging systems.
    • Modified atmosphere packaging: any atmosphere in an enclosed package which differs from normal atmospheric air mixtures. This includes vacuum pack.
G.1.2.1

Where applicable, documented procedures associated with Formulation and Addition of food additives and nutrients are developed and implemented to ensure that the concentrations remain within the allowable parameters specified in the Food & Drug Regulations. This must include a minimum of:

G.1.2.2

Where applicable, documented procedures associated with modified atmosphere packaging systems are developed and implemented to ensure that the standards defining the modified atmosphere are met. This must include a minimum of:

Rationale
G.1.3 Food Processing Aids
Requirements

This sub-element applies to food processing aids for which maximum levels of use have been established by Health Canada.

In order to avoid confusion, please consult the Health Canada policy for differentiating food additives and processing aids.

G.1.3.1

Where applicable, documented procedures associated with steps where food processing aids are used are developed and implemented to ensure that the concentrations remain within the allowable parameters specified for the use of that particular processing aid. This must include a minimum of:

Rationale
G.2 Foreign Material Control Program
G.2.1 Foreign Material Control Program

Note: Reference to existing prerequisite programs or CCPs that cover the requirements mentioned in this section is acceptable.

Requirements
G.2.1.1

Where applicable, the establishment has and implements documented procedures to control the contamination of product by foreign material. This may include but is not limited to the following elements:

G.2.1.2

Where applicable, the establishment has and implements a documented program for monitoring equipment such as filters, sieves, magnets, metal detectors, x-ray equipment, optical sorting equipment, scanner technology, in-line container cleaning, etc. that is/are used to detect and/or remove foreign materials. The program includes but is not limited to:

The program shall also include procedures to follow when products are rejected by detection systems or when foreign materials are removed by removal systems. The procedures include but are not limited to:

Note: Calibration and maintenance of equipment used to detect and/or remove foreign materials are covered under 3.1.1.3 - C.1.2 Equipment Maintenance and Calibration.

Rationale

The risk of product contamination are prevented, reduced or eliminated by the effective use of equipment to detect/remove foreign materials and/or the implementation of other control procedures.

3.1.2 Monitoring procedures (for prerequisite programs)

Documented monitoring procedures shall be established for each prerequisite program bullet and shall specify any tests, measurements or observations to assess whether:

The monitoring procedure shall at least include:

The monitoring frequency must:

Standards are criteria or specifications that can be judged or evaluated and that define the limit of acceptability associated with a prerequisite program requirement. Criteria must be measurable. These may either be quantitative (e.g., degrees) or qualitative (e.g., no holes in the carrier, product is stored off the floor). Criteria must be clearly described to be easily understood and uniformly applied by those responsible for monitoring.

There may be specific regulatory standards that apply to specific prerequisite program requirements. The establishment may require higher standards than the existing regulatory requirements. In this case, the CFIA staff would verify compliance to the regulatory standards.

To ensure validity of results, tests, methods and instructions must be described in enough detail to ensure consistency in delivery between different monitors.

3.1.3 Deviation procedures (for prerequisite programs)

Documented deviation procedures shall specify any planned or appropriate corrective actions to be taken when monitoring results demonstrate that:

The deviation procedure shall at least include:

3.1.4 Record keeping (for prerequisite programs)

Records shall be kept to demonstrate the effective application of the prerequisite programs and to facilitate official verifications by the CFIA or other competent authority. Records shall be established to document:

Records must be up-to-date, legible, accurate and properly filed.

Each monitoring record and/or action taken in response to a deviation shall be signed or initialed by the employee making the entry using a permanent ink pen or, when computer records are used, the record may be signed electronically. Monitoring records and/or action taken in response to a deviation shall be dated.

Deviation records shall identify a target date for completion of preventative measures.

Any incorrect entry made to a record and subsequently changed shall be crossed out and initialed by the employee making the change.

3.2 HACCP plan(s)

Establishments shall conduct a complete hazard analysis for all of their processes and products in order to identify and control all hazards effectively.

A HACCP Plan is a written document designed in accordance with the following steps to ensure control of food safety hazards within an establishment.

There are 12 steps to developing each HACCP plan. These steps are as follows:

  1. Assemble the HACCP team
  2. Describe the product and identify its intended use
  3. List product ingredients and incoming material
  4. Construct a process flow diagram and confirm its accuracy
  5. Construct a plant schematic and confirm its accuracy
  6. Identify and analyze hazards (Principle 1)
  7. Determine critical control point(s) (CCP) and other control measures i.e. process control (PC) and prerequisite programs (PP) (Principle 2)
  8. Establish critical limits for CCP (Principle 3)
  9. Establish monitoring procedures for CCP (Principle 4)
  10. Establish deviation procedures for CCP (Principle 5)
  11. Establish verification procedures for CCP (Principle 6)
  12. Establish record keeping for CCP (Principle 7)

Steps 1 to 5 are preliminary steps to enable hazard analysis. Steps 6 to 12 incorporate the 7 principles of HACCP developed by the Codex Alimentarius Commission.

All relevant information needed to conduct the preliminary steps, the hazard analysis, and the establishment of the critical control points and process controls shall be documented, updated whenever there are changes, and reassessed at least annually.

FSEP has created specific forms that can be used for the documentation of a HACCP plan. If an establishment uses other documentation than the one describe below to capture the Codex Alimentarius HACCP approach, the content must be equivalent and meet the requirements of this manual.

The FSEP-HACCP Plan forms are:

Blank template forms, including an example of an alternative form that will allow for the combination of forms 5, 6, 7, 8 and 9 can be found in section 3.5.

In performing the step by step analysis above, the HACCP team may determine that several products share similar hazards, processing steps or equipment. In that case, the HACCP team may group these products or processes into one HACCP plan.

If an establishment chooses to group dissimilar processes or products into one HACCP plan, they will be required to demonstrate to the CFIA that the HACCP plan identifies and controls all potential hazards to each process or product.

3.2.1 Describe product and identify its intended use (Form 1)

The description of finished products shall be documented in form 1 or equivalent to the extent needed to conduct the hazard analysis, including information on the following, as appropriate:

The HACCP team shall identify regulatory food safety requirements related to the above.

3.2.1.1 Process/product type name

The generic or common name of the product family or process covered by the HACCP plan shall be documented in form 1 or equivalent.

3.2.1.2 Product name

The brand name and/or common name of the individual products covered by the HACCP plan shall be documented in form 1 or equivalent. Reference to a list of product names is acceptable.

3.2.1.3 Important product characteristics

The physio-chemical characteristics of the product (such as pH, Aw, salt content, concentration of preservatives, etc.) that could affect food safety if not properly controlled shall be documented in form 1 or equivalent.

3.2.1.4 Intended use

The intended use is based on the expected uses of the product by the end user (e.g., ready-to-eat food product, ready-to-cook, for further processing).

The intended use shall be described in form 1 or equivalent.

3.2.1.5 Packaging

All types of packaging to be used by the establishment for the final product (e.g., drums, pails, cryovac bags, modified atmosphere, hermetically sealed) and their applicable size (e.g., consumer-size, bulk packs destined for further processing) shall be documented in form 1 or equivalent to enable hazard analysis.

A reference to a list of types of packaging and applicable sizes is acceptable.

3.2.1.6 Intended shelf life and storage conditions

The intended shelf life of the product under normal marketing conditions at a given storage temperature and, where applicable, humidity shall be documented in form 1 or equivalent to enable hazard analysis.

When establishing product shelf life, it is the responsibility of the manufacturer to ensure and to demonstrate that the safety of the food product can be retained throughout the maximum period specified.

3.2.1.7 Where the product will be sold

The points of sale, target groups of users and, where appropriate, more specific groups of consumers shall be identified on form 1 or equivalent for each product (e.g., retail, general population, infants, hospital). More specifically consumer groups known to be especially vulnerable to specific food safety hazards shall be considered.

3.2.1.8 Labelling instructions related to food safety

Any labelling instructions for handling, preparation and usage which have an impact of food safety shall be identified in form 1 or equivalent (e.g., cooking and storage instructions, best before date).

3.2.1.9 Special distribution control

Special controls required during transportation and storage (e.g., temperature, humidity) shall be documented in form 1 or equivalent.

3.2.2 List product ingredients and incoming materials (Form 2)

All ingredients, including composition of formulated ingredients (with reference to other documents if needed), additives, processing aids and incoming materials that come in contact with the product or are used in preparing the product shall be described in form 2 or equivalent, to the extent needed to conduct the hazard analysis.

Particular care must be taken for additives, processing aids and ingredients (including second generation ingredients), that have received regulatory approval for specific products only.

3.2.3 Construct a process flow diagram and confirm its accuracy (Form 3)

Flow diagram(s) shall be prepared for the product(s) or process categories covered by the HACCP plan. Flow diagrams shall provide a basis for evaluating the possible occurrence or introduction of and/or increase in food safety hazards.

Flow diagrams shall be clear, accurate and sufficiently detailed. Flow diagrams shall, as appropriate, include:

The HACCP team shall verify the accuracy and completeness of the flow diagrams by on-site checking.

3.2.4 Construct a plant schematic and confirm its accuracy (Form 4)

A plant schematic shall be prepared for the products or process categories covered by the HACCP plan. Plant schematic provides a basis for evaluating potential areas of cross-contamination by pathogens, foreign materials, chemicals or allergens.

Plant schematic shall be clear, accurate and sufficiently detailed. Plant schematic shall at least include:

The HACCP team shall verify the accuracy and completeness of the plant schematic by on-site checking.

The overall evaluation of potential areas of cross-contamination at the establishment should include any other plant schematic from other HACCP plan(s).

3.2.5 Identify and analyze hazards (HACCP Principle 1) (Forms 5, 6, 7)

The hazard identification shall be based on:

If biological (B), chemical (C) or physical (P) hazards associated with the ingredients and incoming materials are identified, the letters B, C or P shall be indicated in form 2 or equivalent beside each corresponding ingredient or incoming material. The hazards shall be fully described in forms 5, 6, 7 or equivalent.

If biological, chemical or physical hazards associated with the processing steps are identified, the letters B, C or P shall be indicated in form 3 or equivalent beside each corresponding step. The hazards shall be fully described in forms 5, 6, 7 or equivalent.

If biological, chemical or physical hazards associated with cross-contamination points are identified, the letters B, C or P shall be indicated in form 4 or equivalent at the corresponding cross-contamination point. The hazards shall be fully described in forms 5, 6, 7 or equivalent.

3.2.6 Determination of CCP and other control measures (HACCP Principle 2) (Form 8)

For each hazard identified, an analysis shall be conducted to determine:

The establishment shall use Form 8 or equivalent to document the hazard analysis as well as the prerequisite programs, the process controls (PC) and the CCP selected to control the food safety hazards identified.

All PC(s) and CCP(s) associated with the processing steps shall be indicated beside the corresponding step in form 3 or equivalent.

Note: To facilitate verification by CFIA representatives, FSEP recommends establishments number the CCP sequentially and identify the hazard(s) each controls i.e., B for biological, C for chemical, P for physical hazards. (e.g., CCP1-BCP, CCP2-B).

3.2.6.1 Using form 8 - decision tree - CCP determination and other control measures (PP, PC)
Form 8 - Column 1

List each ingredient and incoming material, process step and cross-contamination point where a hazard has been identified. Use one line per hazard.

Form 8 - Column 2

Categorize (biological, chemical, physical) and fully describe each of the identified hazards. Where multiple hazards exist at one point, each hazard should be analyzed separately.

For each hazard, determine whether it is fully controlled by one or more prerequisite programs. If the answer is yes, identify the prerequisite program bullet(s) that provides full control over this hazard.

To assess whether the hazard is fully controlled by a prerequisite program, the HACCP team must first review the documented written program(s) for the specific bullet(s). They must then conduct a record review and on-site observations to ensure that the policies and procedures in place provide effective control over the hazard identified in the HACCP plan.

If the HACCP team determines that the hazard is not fully controlled by a prerequisite program, proceed to Question 1.

Form 8 - Question 1

Q1. Could a control measure(s) be used by the establishment at any process step?

Could a control measure occur at this step - or at any other process step - to control the hazard? Does the establishment have or could they add a process step to control the hazard?

If the answer is yes, describe the control measure and proceed to Q2.

If the answer is no (a control measure cannot be implemented at a process step), identify how the hazard will be controlled before or after the manufacturing process on Form 9 or equivalent and proceed to the next identified hazard.

Form 8 - Question 2

Q2. Is it likely that contamination with the identified hazard could occur in excess of the acceptable level or could increase to an unacceptable level?

Question 2 refers to the probability and seriousness of the hazard. If there were no controls in place, how likely is this hazard to occur in excess of acceptable levels?Footnote 11

Conduct a hazard analysis based on all the information that the HACCP team has gathered.

If information gathered suggests that contamination with the identified hazard could increase to an unacceptable level and result in a health hazard, answer yes and proceed to QuestionQ3. Identify the acceptable level of the food safety hazard in the finished product, wherever possible.

If contamination is not likely to occur, or is not known to affect the safety of the product, answer no and proceed to the next identified hazard. For further reference, the HACCP team must document the reasons for answering no.

Form 8 - Question 3

Q3. Is this process step specifically designed to prevent, eliminate or reduce the likely occurrence of the identified hazard to an acceptable level?

If the process step has been specifically designed to prevent, eliminate or reduce the likely occurrence of the hazard to an acceptable level, answer yes. Designate this process step as a CCP and identify it in the last column. If the answer is no, proceed to Question 4.

Note: Question 3 applies only to processing steps. For incoming materials, write not applicable (N/A) and proceed to Question 4.

Form 8 - Question 4

Q4. Will a subsequent step eliminate the identified hazard or reduce its likely occurrence to an acceptable level?

Answer no if no subsequent processing steps listed on the process flow diagram will eliminate or reduce the hazard to an acceptable level. Designate this process step a CCP and identify it in the last column and proceed to the next identified hazard.

If the answer is yes, identify the subsequent step or steps that control the hazard. Then proceed to Question 5.

Form 8 - Question 5

Q5. Does this step provide partial control of the identified hazard?

If the answer is yes, this process step is a process control. Enter the process control number in the last column then proceed to the next identified hazard. If the answer is no, proceed to the next identified hazard.

3.2.6.2 Hazards not controlled by the establishment (Form 9)

All hazards that affect the establishment products shall be analyzed. Hazards that are out of the control of the establishment, as well as a description of how the hazard is controlled before or after the production process shall be documented on form 9 or equivalent.

3.2.7 Critical control points (Form 10)

A CCP is a point or a step at which a control measure is applied and where it is essential to prevent or eliminate one or more food safety hazards or reduce them to an acceptable level.

Each CCP shall be documented in form 10 or equivalent and shall include the following information:

The record keeping shall meet the requirements defined in 3.2.7.5.

The CCP shall be validated, updated whenever there are changes associated with the CCP and reassessed at least annually.

Note: The individual(s) responsible for monitoring, deviation and verification procedures may be identified by a position title or the term designate. In this case, the establishment must be able to demonstrate that individuals have received adequate training.

3.2.7.1 Critical limits (HACCP Principle 3)

Critical limits are criteria that separate acceptability from unacceptability. These parameters, if properly maintained, will confirm the safety of the product.

Critical limits shall be determined for the monitoring established for each CCP. One or more critical limits may be used to control the identified hazards.

Critical limits shall be established to ensure that the identified acceptable level of the food safety hazard in the finished product is not exceeded. Where government regulations exist, the critical limit, at a minimum, must meet those regulations. In this case, the CFIA staff would verify compliance to the regulations.

Critical limits shall be measurable. Critical limits based on subjective data (such as visual inspection of product) shall be clearly described to be easily understood and uniformly applied by those responsible for monitoring.

3.2.7.2 Monitoring procedures (for CCPs) (HACCP Principle 4)

Documented monitoring procedures shall be established for each CCP and shall specify any tests, measurements or observations to assess whether:

The monitoring procedures shall at least include:

The monitoring methods and frequency shall be able to detect loss of control at the CCP in time for the product to be isolated before it leaves the control of the producing establishment.

All monitoring devices/equipment requiring maintenance and calibration for accuracy must be controlled through the preventative maintenance and calibration programs.

3.2.7.3 Deviation procedures (for CCPs) (HACCP Principle 5)

Documented deviation procedures shall specify any planned or appropriate corrective actions to be taken when monitoring results demonstrate that:

The deviation procedure shall at least include:

Documented procedures shall be established and maintained for the appropriate handling of potentially unsafe products to ensure that they are not released until they have been evaluated.

When an unforeseen hazard is identified, the company should perform a reassessment to determine whether the newly identified hazard should be incorporated into the HACCP plan.

Any deviation at a CCP will require an evaluation of the supporting PC(s), where appropriate, as part of the deviation procedures associated with that CCP.

3.2.7.3.1 Assessment for release

No product that is injurious to health or otherwise adulterated as a result of the deviation may be allowed to enter commerce. When found to be in deviation, each lot of product shall only be released as acceptable when any of the following conditions apply:

The controls and results of the assessment shall be documented.

3.2.7.3.2 Disposition of noncompliant product

Following assessment, if the lot of product is not acceptable for release it shall be handled by one of the following activities:

The disposition of the noncompliant product shall be documented.

3.2.7.4 Verification procedures (for CCPs) (HACCP Principle 6)

Verification is the application of methods, procedures, tests, sampling and other evaluations, in addition to monitoring, to determine whether:

Documented verification procedures shall be established and shall at least include:

Note: A distinction must be made on the verification record to differentiate between a record review and an on-site observation.

Verification shall be carried out by someone other than the person who is responsible for performing the monitoring activities (i.e. Verifiers cannot verify their own work).

The frequency of verification should be sufficient to confirm that the CCP(s) remains in control of any hazards.

3.2.7.5 Record keeping (for CCPs) (HACCP Principle 7)

Records shall be kept to demonstrate the effective application of the critical control points and to facilitate official verifications by the CFIA or other competent authority.

Records shall be established to document:

Records must be up-to-date, legible, accurate and properly filed.

Each entry on a monitoring, deviation and verification record shall include the date and the exact time of the event, and shall be signed or initialed by the employee making the entry using a permanent ink pen or, where computer records are used, electronically.

Deviation records shall identify a target date for completion of preventative measures.

Any incorrect entry made to a record and subsequently changed shall be crossed out and initialed by the employee making the change.

3.2.8 Process controls (Form 11)

Where more than one step in an overall process may contribute to the reduction of a particular hazard, process controls may be developed for the early points of the process where the hazard cannot be fully controlled, but a subsequent step will result in the elimination or reduction of this particular hazard to an acceptable level. This final control would be determined to be a CCP.

In the Meat and Poultry commodity, CFIA has designed some process controls as an integral part of an overall inspection program, such as the Modernized Poultry Inspection Program. In this case, the PCs are mandated. The mandated PC standards are published in the applicable CFIA specific program Manual of Procedures (MOP), and must be implemented as outlined in the MOP. If additional mandated PCs are developed by the CFIA, they will be published in the appropriate manuals.

In any commodities (including Meat & Poultry) subject to FSEP, operators may also develop their own process controls, where multiple process steps provide control over one specific hazard. These operators would be expected to validate the entire procedure to demonstrate that their process control meets all of the necessary parameters and is effective. The resulting material must be submitted to the CFIA Area FSEP Coordinator for review and acceptance, prior to implementation.

Each PC shall be documented in form 11 or equivalent and shall include the following information:

The record keeping shall meet the requirements defined in section 3.2.8.4.

The PCs shall be updated whenever there are changes associated with the process control requirements and reassessed at least annually.

3.2.8.1 Monitoring procedures (for PCs)

Documented monitoring procedures shall specify any tests, measurements or observations to assess whether the process control standards are met.

The monitoring procedures shall at least include:

3.2.8.2 Deviation procedures (for PCs)

Documented deviation procedures shall specify any planned or appropriate corrective actions to be taken when monitoring results demonstrate that the PC standards are not met.

The deviation procedure shall at least include:

3.2.8.3 Verification procedures (for PCs)

Documented verification procedures shall specify any planned sequence of observations, tests and other evaluations, in addition to monitoring, to determine whether:

The verification procedures shall at least include:

Verification shall be carried out by someone other than the person who is responsible for performing the monitoring activities (i.e., verifiers cannot verify their own work).

3.2.8.4 Record keeping (for PCs)

Records shall be kept to demonstrate the effective application of the process controls and to facilitate official verifications by the CFIA or other competent authority.

Records shall be established to document:

Records must be up-to-date, legible, accurate and properly filed.

Each entry on a monitoring, deviation and verification record shall include the date and the exact time of the event, and shall be signed or initialed by the employee making the entry using a permanent ink pen or, where computer records are used, electronically.

Deviation records shall identify a target date for completion of preventative measures.

Any incorrect entry made to a record and subsequently changed shall be crossed out and initialed by the employee making the change.

3.3 Validation

Every establishment shall demonstrate that the critical control points are capable, on a consistent basis, of achieving the intended level of hazard control.

Validation is performed at the time the CCP is designed, or when changes indicate the need for re-validation. Validation of a CCP is, whenever possible, performed before it is fully implemented.

Depending on the CCP that is being validated, the validation documentation may include:

CFIA may request validation documentation for any control measures within the HACCP system that have an immediate impact on food safety.

3.4 Maintenance and reassessment of the HACCP system

3.4.1 HACCP system maintenance procedures

Whenever any changes or situations occur that could affect the hazard analysis or alter the HACCP system, the establishment shall:

Here are examples of potential triggers which could lead to the need to update and/or to perform a reassessment of parts of the HACCP system:

The establishment has and implements documented procedures to ensure that the HACCP system is effectively maintained.

The procedures shall include as a minimum:

Benefits of implementing effective maintenance procedures:

3.4.2 HACCP system reassessment procedures

Whenever any changes or situations occur that could affect the hazard analysis or alter the HACCP system, the establishment shall reassess completeness and effectiveness of the updated part of the HACCP system and document the reassessment activities conducted in the HACCP system modification log book as described in 3.4.1.

At least annually, the establishment shall reassess its entire HACCP system to determine whether the system:

Documented reassessment procedures shall be established and shall at least include the following 5 components:

1. Responsibility, frequency and record keeping
2. Reassessment of the HACCP System Maintenance Procedures
3. Reassessment of HACCP Plan(s)
4. Reassessment of Prerequisite Programs
5. Reassessment of Record Design

Note: When an operator identifies a deficiency with their HACCP system design during performance of their reassessment activities, it is the responsibility of the operator to determine the appropriate deadline for completion of corrective measures and whether or not additional interim measures are required to control any food-safety related hazards which may have resulted from the deficiency.

3.5 FSEP forms

Form 1: Product Description

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Form for Product Description. Description follows.
Description for Form 1: Product Description

The description of finished products shall be documented in form 1 or equivalent to the extent needed to conduct the hazard analysis. Includes information on the following, as appropriate:

  • Process/product type name;
  • Product name;
  • Important product characteristics;
  • Intended use;
  • Packaging;
  • Intended shelf life and storage conditions;
  • Where the product will be sold;
  • Labelling instructions relating to food safety;
  • Special distribution control.
Form 2: List of Product Ingredients and Incoming Material

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Form for List of Product Ingredients and Incoming Material. Description follows.
Description for Form 2: List of Product Ingredients and Incoming Material

All ingredients, including composition of formulated ingredients (with reference to other documents if needed), additives, processing aids and incoming materials that come in contact with the product or are used in preparing the product shall be described in form 2 or equivalent, to the extent needed to conduct the hazard analysis.

Form 3: Process Flow Diagram

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Diagram of the Process Flow. Description follows.
Description for Form 3: Process Flow Diagram

Flow diagram(s) shall be prepared for the product(s) or process categories covered by the HACCP plan. Flow diagrams shall provide a basis for evaluating the possible occurrence or introduction of and/or increase in food safety hazards. Flow diagrams shall be clear, accurate and sufficiently detailed. Flow diagrams shall, as appropriate, include:

  • The sequence and interaction of all steps in the operation from receiving to final shipping;
  • The introduction of ingredients and intermediate products into the process flow;
  • The introduction of products for reworking.
Form 4: Plant Schematic

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Form for Plant Schematic. Description follows.
Description for Form 4: Plant Schematic

A plant schematic shall be prepared for the products or process categories covered by the HACCP plan. Plant schematic provides a basis for evaluating potential areas of Plant schematic shall be clear, accurate and sufficiently detailed. Plant schematic shall at least include:

  • The flows of raw products, ingredients and finished products;
  • The flows of packaging materials;
  • The employee traffic pattern throughout the establishment including change rooms, washrooms and lunchrooms;
  • The flows of the waste, inedible products and other non-food products that could cause cross-contamination;
  • The hand/boot washing and sanitizing installations.
Form 5: Biological Hazard Identification

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Form for Biological Hazard Identification. Description follows.
Description for Form 5: Biological Hazard Identification

If biological (B) hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points are identified, the letter B shall be indicated on forms 2, 3 or 4. The hazards shall be fully described on Form 5.

Form 6: Chemical Hazard Identification

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Form for Chemical Hazard Identification. Description follows.
Description for Form 6: Chemical Hazard Identification

If Chemical (C) hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points are identified, the letter C shall be indicated on forms 2, 3 or 4. The hazards shall be fully described on Form 6.

Form 7: Physical Hazard Identification

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Form for Physical Hazard Identification. Description follows.
Description for Form 7: Physical Hazard Identification

If Physical (P) hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points are identified, the letter P shall be indicated on forms 2, 3 or 4. The hazards shall be fully described on Form 7.

Form 8: Decision Tree - CCP Determination and Other Control Measures

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Decision Tree for Critical Control Point Determination and Other Control Measures. Description follows.
Description for Form 8: Decision Tree - CCP Determination and Other Control Measures

For each hazard identified, an analysis shall be conducted to determine:

  • The likely occurrence of the hazard;
  • The severity of possible adverse health effect associated with the hazard;
  • If the identified hazard is controlled by prerequisite programs;
  • If the identified hazard is partially controlled by a process control;
  • If the identified hazard is controlled at a CCP;
  • If the identified hazard is out of the establishment's control.

The establishment shall use Form 8 or equivalent to document the hazard analysis as well as the prerequisite programs, the process controls (PC) and the CCP selected to control the food safety hazards identified.

Form 9: Hazards Not Controlled by the Establishment

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Form for Hazards Not Controlled by the Establishment. Description follows.
Description for Form 9: Hazards Not Controlled by the Establishment

All hazards that affect the establishment products shall be analyzed. Hazards that are out of the control of the establishment, as well as a description of how the hazard is controlled before or after the production process shall be documented on Form 9.

Form 10: Critical Control Point(s)

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Form for Critical Control Point(s). Description follows.
Description for Form 10: Critical Control Point(s)

Each CCP shall be documented in form 10 or equivalent and shall include the following information:

  1. Hazard(s) to be controlled at the CCP and description of control measure(s);
  2. Critical limit(s);
  3. Monitoring procedure(s);
  4. Deviation procedure(s);
  5. Verification procedure(s);
  6. Record keeping.
Form 11: Process Control(s) (PC)

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Form for Process Control(s). Description follows.
Description for Form 11: Process Control(s) (PC)

Each Process Control shall be documented in form 11 or equivalent and shall include the following information.

  • Food safety hazard(s) to be controlled at the Process Control.
  • The Critical Control Point number to which the Process Control is linked.
  • The monitoring procedures.
  • The deviation procedures.
  • The verification procedures.
  • The records keeping.
Example of an Equivalent Form: FSEP Forms 5, 6, 7, 8 and 9 Combined into one Form

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Example of Food Safety Enhancement Program Forms 5, 6, 7, 8 and 9 Combined. Description follows.
Description for Example of an Equivalent Form: FSEP Forms 5, 6, 7, 8 and 9 Combined into one Form

Within the ten forms of FSEP, forms 5, 6, & 7 are utilized to fully describe the biological, chemical and physical hazards before they are transferred to form 8, the decision tree, to determine the method of control for each of the identified hazards. This example of a modified form 8 incorporates forms 5, 6 & 7 (hazard description) and form 8 (decision tree) into one form.

Section 4 - Recognition Process

This section details the process for HACCP recognition by the CFIA. The recognition process applies to the following federally registered commodity groups:

For establishments registered under the Meat Inspection Regulations in which a HACCP system in accordance with the FSEP Manual requirements is mandatory, please refer to the Meat Hygiene Manual of Procedures - Chapter 2 (Guidelines for the Applicant/Operator to the Registration of an Establishment and Licensing of an Operator).

Note: Subparagraph 29(2)(b)(iii) of the Meat Inspection Regulations, 1990, requires that an application for a licence to operate a meat registered establishment includes a description of the prerequisite programs and HACCP plans for the registered establishment. This includes HACCP plans for all human-food product lines in the registered establishment.

For the other commodities, when requesting recognition, a registered establishment must already be conducting its operations under a HACCP system for all product lines in the registered establishment.

The purpose of the recognition is to determine whether the establishment's HACCP system is complete (i.e., meets FSEP and regulatory/program requirements), and is implemented effectively as described.

The CFIA recognizes that companies invest time and resources in developing their customized HACCP systems we treat each system as proprietary to the company that developed it.

4.1 CFIA Area FSEP Coordinator responsibilities

The CFIA Area FSEP Coordinator is responsible for:

4.2 Recognition process steps

The process covers 6 steps, as follows:

4.2.1 Letter requesting recognition by the CFIA

To begin the recognition process, an establishment must submit a letter to the CFIA's Area FSEP Coordinator. The letter must:

4.2.2 CFIA pre-meeting with the establishment's management

After receiving the establishment's letter, the CFIA Area FSEP Coordinator or their delegate will schedule a pre-meeting with the establishment to:

4.2.3 Submission of the HACCP system documentation package

The establishment must provide the CFIA Area FSEP Coordinator or their delegate with a documentation package that includes the following:

4.2.4 CFIA review of the HACCP system documentation package

The CFIA Area FSEP Coordinator or their delegate will review the entire HACCP system documentation package and communicate any unacceptable items from the HACCP documentation review to the applicant for correction prior to final on-site review.

The CFIA must follow-up on unacceptable items prior to the on-site review.

4.2.5 CFIA on-site review of the establishment's HACCP system

The on-site review determines whether the HACCP system has been implemented as described in the written programs and is effective in meeting food safety objectives. The on-site review is initiated only after the CFIA Area FSEP Coordinator or their delegate has deemed the establishment's written HACCP system complete.

The HACCP team leader or an on-site liaison person must be available during the on-site review.

The CFIA representatives must at least include the responsible inspector, a lead CFIA representative and if appropriate, a program specialist.

At the conclusion of the on-site review, the CFIA provides a verification report including any non-compliance identified during the on-site review.

Prior to recognizing an establishment, the CFIA must confirm that all non-compliance has been corrected by the establishment.

4.2.6 CFIA notification recognizing establishment's FSEP/HACCP status

The Area FSEP Coordinator issues an official notice to the establishment's management confirming that the CFIA has reviewed the establishment's HACCP system and found that it currently meets all of the HACCP requirements of the Food Safety Enhancement Program.

Section 5 - Changes to a recognized HACCP system

5.1 New HACCP plan

When an establishment adds a new HACCP plan to its system or a new process to an existing HACCP plan, the following information must be communicated to the responsible inspector prior to the commencement of the new process.

The responsible inspector/supervisor must communicate this information with the Area FSEP Coordinator who must conduct a review of the new HACCP plan or assign a delegate to do so.

A written review of HACCP plans associated with high risk category products/processes must be conducted by the CFIA prior to the commencement of the new processes for commerce.

High Risk Category

Loss of control of the process could result in a significantly high health risk. High risk category products or processes may involve any of the following criteria:

Lower Risk Category

Lower risk category products or processes may involve any of the following criteria:

5.2 Changes to a HACCP system

When an establishment changes its recognized HACCP system, it must enter the changes in the HACCP log book as described in section 3.4.1 of the FSEP manual. The data must be available for future review by the CFIA.

5.3 Changes in ownership

If there is a change in ownership in a FSEP recognized establishment and the originally recognized HACCP System is intact, the new owner will be required to submit a new letter of commitment to the CFIA Area FSEP Coordinator. The letter will confirm that the originally recognized HACCP System is intact and will not be changing as a result of the change in ownership. The letter will also confirm the commitment of the new owner as per the FSEP Manual.

If changes to the HACCP system are made, the new owner will be required to submit a new letter of commitment and a list of the changes made to the HACCP system to the CFIA Area FSEP Coordinator. The CFIA will evaluate the impact of the changes on the HACCP system and determine if the establishment has to undertake a new recognition process.

Section 6 - CFIA Verification of FSEP Voluntarily Recognized Establishments

This section describes the necessary information for industry about the CFIA verification of FSEP voluntarily recognized establishments. For establishments registered under the Meat Inspection Regulations, in which a HACCP system in accordance with the FSEP Manual requirements is mandatory, please refer to the Meat Hygiene Manual of Procedures - Chapter 18 (Compliance Verification System).

Note: FSEP voluntarily recognized establishments will continue to be inspected for compliance with requirements defined in applicable Acts and Regulations as per specific commodity inspection programs. The verification of compliance to FSEP requirements described in this section is in addition to the commodity inspection programs.

6.1 Objective

The objective of the verification by the CFIA is to confirm that the establishment's recognized HACCP system:

6.2 Frequency of verification

The verification frequency is once every two years and whenever the following situations occur:

6.3 Verification scope

The verification scope may include a review of:

The scope selection will be based on CFIA inspection results and situations that have occurred at the establishment that should have resulted in an update and/or a reassessment of parts of the HACCP system by the establishment.

6.4 Opening meeting

The following information will be given and confirmed during the opening meeting with the establishment representatives:

6.5 Gathering objective evidence to determine compliance

The CFIA will gather objective evidence to confirm whether or not the HACCP system:

The CFIA will gather objective evidence by:

6.6 Communication of results and actions required

Results of the verification are communicated to the establishment through a verification report or a corrective action request (CAR) during the closing meeting.

A verification report will be issued to the operator when the overall compliance level is acceptable even if no minor deficiencies have been noted. The CFIA will follow up on the resolution of any minor deficiencies that are identified on the FSEP Verification Report.

A CAR is issued to an establishment whenever non-compliance is determined by the CFIA. The CAR identifies the non-compliance and requires the establishment to implement corrective measures by:

6.7 Request for review of a CAR

An establishment may request a review of a CAR before the date specified for the submission of an action plan. The establishment must submit its reason for the request in writing, to the Area FSEP Coordinator. A written decision is forwarded back to the establishment.

The operator is required to correct any immediate food safety deficiencies described in the CAR while it is subject to the review process. When a request for review is submitted prior to the date for submission of an acceptable action plan, the operator will not be required to submit an action plan until the review results have been communicated to the operator and CFIA staff.

If the CAR is upheld, the establishment must submit an acceptable action plan and correct the non-compliance noted by the dates specified by the CFIA. If the CAR is overturned, the CAR will be cancelled.

6.8 Acceptable action plan

An acceptable action plan is to be submitted by the establishment to the CFIA on the date specified when the CAR was issued. The entire action plan must be implemented by the establishment by the specified date for completion of corrective measures stated on the CAR.

The following table describes each component of an acceptable action plan as well as the objectives of each component.

Component 1 - Description of the problem

The objective is to accurately describe the problem, which will assist to identify the:

  • Action to be taken on affected or potentially affected product.
  • Immediate measures necessary to restore control of the deviation.
  • Root cause(s).

Establishments must collect information to find out the exact problem. One situation of non-compliance is typically the result of multiple problems or causes.

  • What is the non-compliance?
  • Did the problem affect product?
  • Where is the problem located?
  • How widespread is this problem?
  • When did the problem occur?
  • Who is involved in this problem?
  • Is this the first time the problem occurred?
Written Action Plan
  • Describe the problem as it relates to the non-compliance noted on the CAR.

Component - Person(s) responsible for measures

The objective is to determine the people who have the knowledge, time, authority and competence to correct the non-compliance.

Written Action Plan
  • Identify the name or title of person(s) responsible for the immediate/short term and preventative measures.

Component 3 - Description of Immediate /short term measures

The objectives are to:

  • Control affected product or other thing(s).
  • Take immediate measures to restore control over the deviation so that food products are produced within the legislative requirements.
Written Action Plan
  • Describe the measures taken on affected or potentially affected product.
  • Describe the results of the assessment completed to determine if other products were implicated.
  • Describe the food safety assessment performed or to be performed on the affected or potentially affected product including any disposition of product.
  • Describe the immediate / short term measures taken to restore control over the deviation until permanent/preventative measures are planned and implemented.
  • Describe the procedure to verify the effectiveness of immediate/short term measures taken.
  • List records used to document the actions taken.

Note: Depending on the non-compliance, immediate measures may not be required.

Component 4 - Identification of root cause(s)

The objective is to identify the root cause(s) so establishments can form appropriate and comprehensive corrective measures that will prevent the recurrence of the deviation.

Start with the problem description:

  • Why has the CFIA found the deviation and not the establishment?
  • Identify all potential causes (Environment, Equipment, Personnel, Training, Written Programs, etc.).
  • Some causes have already been corrected by immediate measures.
  • Identify the root cause(s).
Written Action Plan
  • Describe root cause(s).

Component 5 - Description of Preventative measures

The objective is to identify and implement measures to eliminate the root cause(s) and prevent recurrence of the deviation.

Written Action Plan
  • Describe the preventative measures.
  • Establish a date for completion of each planned preventative measures.
  • List records used to document the preventative measures taken.

Component 6 - Description of activities planned to verify the effectiveness of preventative measures

The objective is to provide feedback as to whether or not further adjustment is necessary.

The assessment is the application of temporary procedures, tests or other evaluations to determine the effectiveness of the measures taken to correct the problem.

Examples:

  • On-site assessment of measures taken.
  • Ensuring that staff is adhering to new procedures/instructions by observing and interviewing them.
  • Temporarily increasing sampling.
  • Temporarily increasing monitoring procedures.

If the problem is not resolved:

  • Additional corrective measures are required.
Written Action Plan
  • Describe the activities planned to verify the effectiveness of preventative measures.
  • Establish a date for completion.
  • List records used to document the verification activities.

6.9 Action plan extension

The CFIA may grant an extension to the date for completion of corrective measures (the corrective actions and preventive measures outlined in the operator's action plan) under the following circumstances:

The establishment must submit its reasons, in writing, to the CFIA responsible inspector.

Note: All criteria must be met in order to qualify for an extension to the completion date.

6.10 CFIA follow-up

After the date for completion of corrective measures has passed, the CFIA follows up at the establishment to ensure that the corrective measures have been completed as described and are effective. If the corrective measures have been implemented effectively, the CAR is closed. If the corrective measures have not been effectively implemented, the CAR remains open and the CFIA takes the following actions:

6.11 Loss of recognition

Loss of recognition will render the establishment ineligible for FSEP verifications. In this case, the establishment will no longer be eligible to use any labels or advertising associated with HACCP or make claims regarding HACCP recognition.

When an establishment loses recognition, the CFIA Area FSEP Coordinator sends a letter to the establishment's management informing them that the establishment is no longer recognized under FSEP. This letter voids the original recognition letter.

Following loss of recognition, if an establishment wishes to re-apply for recognition, they shall investigate to determine the root cause(s) of the failure of their HACCP system and implement corrective measures. The results of the investigation and the corrective measures taken shall be documented in the new letter requesting recognition by the CFIA.

Records of Decision

Records of Decision

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