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General Principles of Food Hygiene, Composition and Labelling

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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.

First Edition - June 2011

Preface

Effective hygiene controls are vital to preventing food borne illness, food borne injury and food spoilage. The Canadian Food Inspection Agency's (CFIA) General Principles of Food Hygiene, Composition and Labelling (GPFHCL) is designed to serve as a guideline for Canadian food manufacturers and to assist them in establishing manufacturing practices that maintain food safety and meet regulatory requirements.

The CFIA has expanded the original Code of Practice – General Principles of Food Hygiene to address food compositional and labelling requirements. To reflect this change, the Code was renamed the General Principles of Food Hygiene, Composition and Labelling (GPFHCL). This expanded document includes the key controls necessary for manufacturers to control the safety, labelling and composition of food during manufacturing, processing, storage or distribution. It provides a sound foundation for the development of a system for ensuring food safety based on HACCP (Hazard Analysis Critical Control Point) principles. Although the GPFHCL is not meant to serve as a complete HACCP plan, it is a useful reference. Additional reference material can be found on the CFIA website.

The GPFHCL: An Assessment Tool

The GPFHCL is generic in nature, and the principles found within this document may be applied to all food processing or manufacturing establishments, regardless of their size or the food products they produce. In cases where manufacturers require further guidance, the CFIA may develop specific codes of practice for a variety of situations.

The CFIA's inspectors will utilize the GPFHCL to assist them in assessing whether an establishment complies with the requirements of the Food and Drugs Act, the Food and Drug Regulations and the Consumer Packaging and Labelling Act and Regulations. The GPFHCL is designed for establishments that are not specifically regulated under federal trade and commerce legislation such as the Meat Inspection Act, the Fish Inspection Act and the Canada Agricultural Products Act.

The GPFHCL is based on the Recommended International Code of Practice - General Principles of Food Hygiene adopted by the Codex Alimentarius Commission in 2003. This is consistent with the World Trade Organization's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), which directs members to base their sanitary and phytosanitary measures on international standards, guidelines and recommendations.

Using the GPFHCL

Each section of the GPFHCL describes specific requirements. Each sub-section includes a principle statement (in a box) and, when necessary, a rationale, followed by the CFIA's assessment criteria.

Principle Statement

Principle statements are outcome-based generic statements of objectives similar to those found in the Codex Code. They are intended to capture the intent of the guideline while allowing flexibility in addressing specific products or processes.

Rationale

Rationales are included only when the principle statement needs explanation. They are included in several chapters (such as Control of Operation, Equipment, and Records) to explain the nature of the concern or potential hazard(s) and the need for control.

Assessment Criteria

Assessment criteria in the GPFHCL will describe the factors used in assessing a manufacturer's adherence to the objectives in the principle statement. The CFIA considers these factors during the course of its risk-based investigation or inspection activities in the non-federally registered sector.

The assessment criteria are intended to guide industry. The CFIA recognizes that there may be alternative means of meeting the intent of the principle statement other than those specified in the assessment criteria. These alternative means may include a specific process step that will be used to control an associated food safety risk or meet a regulatory requirement. Therefore, the CFIA has carefully worded the document to accommodate options or equivalents.

The CFIA also recognizes that manufacturers may require additional guidance to expand upon the hygiene, labelling and compositional requirements associated with specific products or manufacturing processes. This guidance will be further developed as needs are identified.

1 - Control of Operation

1.1 Product Formulation and Composition

1.1.1 Availability and Accuracy of the Product Formula

A current written formula is available for each product processed.

Rationale

A current written formula provides a basis for assessment of food additives, composition, labelling, nutritional requirements, food allergens and the scheduled process.

Assessment Criteria

1.1.2 Identification of Critical Processing Factors in Product Formulation

Any factors in the product formulation that are critical to a safe process and to the delivery of a product with a uniform composition are identified.

Rationale

Inadequate identification of either critical ingredients and their specifications, or critical preparation/process steps, could result in an inadequate process, which could affect product safety or lead to inaccurate nutrient composition.

Assessment Criteria

1.1.3 Compositional Requirements

The nutrient content of the food is controlled to meet declared label values and applicable requirements found in the Food and Drugs Act and the Food and Drug Regulations.

The addition of vitamins, mineral nutrients and amino acids to food products is controlled to meet the requirements of the Food and Drugs Act and the Food and Drug Regulations.

Foods for which nutrient content claims and health claims are made meet the compositional requirements of the Food and Drug Regulations [Division 24, B.01.503, B.01.601].

Products comply with food standards when they exist.

Rationale

Formulation controls are necessary to prevent hazards that could result from excesses, inadequacies and omissions of nutrients. Examples include fortified foods and foods for which there are nutrition and/or health claims (e.g. calorie-reduced, low sodium).

Inaccurate nutrition information, nutrient content claims or health claims may pose a health risk to those under dietary management for chronic diseases (such as diabetes, heart disease, high blood pressure, cancer and osteoporosis) or for those who are making food choices based on the nutrient content of the food.

Inadequate control of food composition could also result in product misrepresentation and fraud. Consumers expect that the declared ingredients, compositional standards, nutrition information and claims accurately reflect the food's composition.

Assessment Criteria

Added nutrients

Nutritional composition requirements

Food standards

NOTE: The following documents provide further guidance on composition and labelling. They are available on the CFIA website.

  1. The Evaluation Standard for Nutrition Labelling addresses, in detail, the requirements of the Nutrition Facts table and the factors involved in determining nutrient content and producing a product with a consistent nutrient profile. This document may be found within the Nutrition Labelling Toolkit.
  2. The Guide to Food Labelling and Advertising provides detailed guidance on the requirements for nutrient content and diet-related health claims.
  3. The Nutrition Labelling Compliance Test constitutes the CFIA methodology for assessing the accuracy of nutrition labelling and claims

1.1.4 Food Additives

Food additives are controlled to meet the requirements of the Food and Drugs Act and the Food and Drug Regulations.

Rationale

Inadequate control of food additives could result in chemical or biological hazards.

Assessment Criteria

1.2 Labelling and Net Quantity

1.2.1 Labelling

The manufacturer has controls in place to ensure that the labels are complete and accurate, and meet the requirements of the Food and Drugs Act, the Food and Drug Regulations and the Consumer Packaging and Labelling Act and Regulations.

Rationale

Mandatory information on food labels allows consumers to make informed choices by:

Inaccurate labels may be considered false and misleading and in violation of section 5.1 of the Food and Drugs Act.

NOTE: Mandatory information is determined, in part, by the regulatory requirements specific to the commodity in question.

Assessment Criteria

NOTE: The CFIA website provides extensive information and guidance to the food industry regarding food allergens, including additional information on each of Canada's priority allergens, guidance on the Labelling of Foods Causing Allergies and Sensitivities and A Tool for Managing Allergen Risk in Food Products.

1.2.2 Net Quantity

Controls are in place to ensure that net quantity declarations are accurate and comply with the Consumer Packaging and Labelling Act and Regulations and the Weights and Measures Act and Regulations, where applicable.

Rationale

Companies that do not declare accurate net quantities for their products have an unfair competitive advantage within their market sector and do not contribute to the fair and effective operation of the marketplace.

The net quantity declaration provides important information that consumers use in making their purchasing decisions. Since the declaration helps consumers to know how much food is in a container, it enables them to compare prices. Consumers rely on net quantity declarations, trusting manufacturers to provide the quantity declared on a product's label.

Canada has adopted an international measurement standard, the Average System of Net Quantity Determination, as its method of determining the accuracy of net quantity declarations. The Average System is set out in section 39 of the Consumer Packaging and Labelling Regulations and section 52 of the Weights and Measures Regulations.

Assessment Criteria

NOTE: Control of scales, gravimetric and volumetric standards, and other measuring equipment is covered in Section 2.1 - General Equipment.

1.3 Process Design

1.3.1 Process Design

The manufacturer demonstrates that foods do not develop any safety hazards (biological, physical or chemical) and labelling inaccuracies are prevented.

Rationale

Written verification is necessary to demonstrate that each process adequately ensures uniform composition and a safe product. An inadequate process could result in unsatisfactory incorporation of ingredients and nutrients, or in the lack of control of pathogenic organisms, toxins and other hazards.

Assessment Criteria

See Section 7.2.1 - Process Design Records, for further information.

1.4 Incoming Material Control

1.4.1 Ingredients

The manufacturer controls incoming ingredients so that foods are not exposed to safety hazards (biological, physical and chemical) and remain both safe and correctly labelled.

Rationale

Prevention of health hazards and fraud begins with control of incoming materials. Inadequate incoming product controls, such as a lack of appropriate product testing and sorting or a failure to verify labels, could result in the sale of contaminated product, misrepresented product or product that does not meet grade, composition or quality standards.

NOTE: The degree of control exercised is appropriate to the level of risk posed by the ingredient to the safety or compositional integrity of the food.

Assessment Criteria

NOTE: 

  1. The nutrition information may be conveyed on a hard copy document which accompanies the delivery of the food.
  2. In the case of foods that are shipped to a purchaser on a continual basis with no change to the formulation, documentation may be provided to the purchaser with the first shipment. The purchaser is advised of any change to the nutrition information as a result of formulation changes or other influences.

Control of Incoming Products: Options 1 - 4

The manufacturer controls incoming ingredients through one of the four control processes outlined below. The first three options apply to ingredients that may be critical to safety (further processing is not likely to eliminate a hazard.)  The fourth option applies only to ingredients that do not pose a safety risk.

NOTE: Section 1.1.3 and Section 1.1.4 provide guidance for assessing specifications for food additives and nutrients.

Option 1:  Periodic Evaluation of Incoming Products

Option 2:  100% Lots Inspected

Option 3:  Vendor Certification

Option 4:  Specification Requirements (to be utilized only when food safety risks are unlikely)

Non-Conforming Ingredients

1.4.2 Incoming Packaging Material Control

The manufacturer controls incoming packaging materials to meet the requirements of the Food and Drugs Act and the Food and Drug Regulations and to prevent the introduction of biological, physical or chemical hazards.

Rationale

Controls are necessary to ensure that packaging materials meet the manufacturer's specifications. Inadequate controls could result in the use of containers that may contaminate the product or may permit physical, chemical or biological contamination of the product.

Assessment Criteria

NOTE: Additional requirements for evaluation of incoming packaging materials will depend on the type of product, the process and the sensitivity of the product.
           
Control of Incoming Packaging Material

See Options 1 - 4 of Section 1.4.1 - Control of Incoming Products.  

See Section 7.2.2 - Incoming Material Control Records.

1.5 Packaging Material Control

1.5.1 Packaging Material

Handling and use of packaging material is controlled to prevent product contamination.

Rationale

Inadequate control of packaging may result in the use of damaged, defective or contaminated packaging material, which may lead to contamination of the product.

Assessment Criteria

1.6 Product Preparation and Blending

1.6.1 Control of Preparation, Composition and Blending

Critical factors specified in the formulation are controlled during preparation and blending to minimize physical, chemical, nutritional and biological hazards, and to ensure accuracy of composition, nutrient content, product claims and net quantity.

Rationale

Inadequate control of critical factors associated with product preparation and blending could result in inadequate processing, the formation of toxins or the presence of undeclared allergens. The product may violate permissible levels of food additives, or may fail to meet compositional standards and/or the product's nutrient content declaration may be inaccurate.

Assessment Criteria

Microbial control during preparation and blending

  • The manufacturer controls conditions (e.g. time, temperature, pH, water activity) during preparation, blending and holding of in-process materials to prevent undesirable microbial growth or the production of metabolic by-products of microbial growth. Critical factors which may require control include the following:
    • size control: dicing, grinding, slicing;
    • temperature treatment control: heating, blanching (textural changes), defrosting, cooling;
    • moisture control: rehydration, concentration (e.g. viscosity, brix);
    • proportion control: weighing, volumetric control (e.g. metering);
    • pH/acidity control: pH measurement, titratable acidity; and
    • control of preservatives, such as nitrite.

Allergens

  • The manufacturer has controls in place to prevent the presence of undeclared allergens. Manufacturers may require controls to prevent the following:
    • misdirection of ingredients;
    • use of rework;
    • contamination by undeclared ingredients;
    • ingredient carryover;
    • ingredient substitutions; and
    • carryover from equipment (e.g. product changeovers).

Food additives

  • The manufacturer has controls in place to ensure that the food additives that are used are permitted and are used within allowable levels. Specifically, controls ensure:
    • clear identification of additives; 
    • accurate measurement; and
    • adequate blending for homogeneity.

Nutrient addition

  • The manufacturer has controls in place to ensure that nutrient levels comply with regulatory and label requirements. Specifically, controls ensure:
    • clear identification of nutrients;
    • proper storage and handling to maintain nutrient potency;
    • accurate measurement; and
    • adequate blending for homogeneity.

Composition

  • The manufacturer has controls in place to ensure that the composition of the product accurately reflects the formulation. Manufacturers may require controls to prevent the following:
    • misdirection of ingredients;
    • use of rework;
    • ingredient carryover;
    • ingredient substitutions; and
    • carryover from equipment (e.g. product changeovers).

See Section 7.2.3 - Product Preparation and Blending Records.

1.6.2 Cleaning and Sorting Contamination Control

Raw materials and ingredients are cleaned, sorted and/or prepared in such a manner as to prevent contamination.

Rationale

Adequate cleaning and sorting of raw materials and ingredients is necessary to prevent or remove contamination with biological, physical or chemical hazards.

Assessment Criteria

Biological hazards

Physical hazards

Chemical hazards

1.7 Product Coding Control

1.7.1 Product Coding

Each prepackaged food, where required, is identified with code marks or lot numbers on the label or container.

Rationale

Coding control permits products to be traced through the distribution chain and provides information on shelf life. Controls are also necessary to prevent damage that could compromise the container as the coding is being applied.

NOTE: Mandatory coding requirements vary, depending on the specific legislation that applies to the commodity. It is suggested that manufacturers consult with inspection authorities in order to confirm specific requirements applicable to products.

Assessment Criteria

1.8 Process Control

1.8.1 Processing Controls

All critical processing factors are controlled to ensure the safety and compositional integrity of the product.

Rationale

Inadequate process control of critical processing factors could result in microbial, chemical, nutritional or physical hazards.

Assessment Criteria

See Section 7.2.4 - Process Control Records.

1.9 Labelling Control

1.9.1 Prevention of Mislabelling

The manufacturer has controls in place to prevent mislabelling.

Rationale

Control of labelling is important to ensure that the correct label is applied to each product. Use of incorrect labels could mislead the consumer and could pose a potential health hazard to segments of the population who may be allergic to certain foods or who are monitoring their diet to treat certain diseases in which nutrition plays a role.

Assessment Criteria

1.10 Deviations and Corrective Action

1.10.1 Deviation Control

When critical limits are exceeded or defects occur that could affect product safety, composition or net quantity, procedures are in place to identify, isolate and evaluate the affected product.

Rationale

Deviations from critical limits and procedures, or the occurrence of defects, may affect the safety, authenticity and quality of the product. Inadequate deviation procedures or non-adherence to procedures could result in the sale of unsafe product, misrepresented product or product of inferior quality.

Assessment Criteria

Identification of deviation

Isolation of affected product

Evaluation of affected product

1.10.2  Corrective Action

Corrective action taken following any deviation is effective to rectify and to prevent recurrence of the deviation.

Rationale

Corrective action procedures are necessary to determine the cause of the problem and to take action to prevent recurrence. It is essential to follow-up any corrective action with monitoring and reassessment to ensure that the correction has been effective. Appropriate corrective action will address the root cause of any deviations of critical control points, thereby minimizing health risks and product misrepresentation.

Assessment Criteria

See Section 7.2.5 - Deviations and Corrective Action Records.

1.11 Verification of Product Safety

1.11.1 Verification Procedures

The manufacturer uses supplementary methods of evaluation to verify the effectiveness of controls affecting product safety, composition, representation, quality and compliance with Canadian legislation.

Rationale

The purpose of verification is to assess the effectiveness of existing controls and to indicate areas where improvements are required.

Assessment Criteria

NOTE: The verification methods will vary with the product and process, since the methods must be appropriate to the specific hazards and risks that may be encountered.

Examples of verification methods

Frequency of verification

Responsibility for verification

See Section 7.2.6 - Verification Records.

2 - Equipment

2.1 General Equipment

2.1.1 Design, Construction and Installation

All equipment and utensils are designed, constructed and installed to function as intended, to permit effective cleaning and sanitation and to prevent contamination.

Assessment Criteria

NOTE: Equipment design, construction and installation is not considered deficient if the potential hazards can be controlled by other procedures.

2.1.2 Food Contact Surfaces

Food contact surfaces are constructed of appropriate materials and are maintained in a manner to prevent contamination of food.

Assessment Criteria

2.1.3 Equipment Maintenance and Calibration Program

An effective maintenance and calibration program is in place to ensure that equipment performs consistently as intended and prevents contamination of the product.

Assessment Criteria

See Section 7.3.1 - Equipment Maintenance and Calibration Records.

2.1.4 Instrumentation Maintenance and Calibration Program

Instrumentation is designed, constructed, installed, calibrated and maintained such that the equipment is capable of delivering the required process, thereby ensuring product safety and net quantity accuracy.

Rationale

Improper design, installation, calibration or maintenance of instruments can lead to inadequate processing of the product or to improper use of food additives, nutritional inaccuracies or composition violations.

Assessment Criteria

Temperature measuring devices

Mercury in glass (MIG) thermometers

Temperature recorders

Timing devices

Pressure gauges

Electronic devices

Magnets

Metal detectors

Scales/metering devices

Other instrumentation

NOTE: The manufacturer initiates corrective action as per Section 1.10 - Deviations and Corrective Action, whenever products could have been affected and found not to meet specifications.

3 - Premises

3.1 Building Exterior

3.1.1 Outside Property and Buildings

Buildings and surrounding areas are designed, constructed and maintained in a manner which prevents conditions that may result in the contamination of food.

Assessment Criteria

Grounds, roadways and drainage

Exterior building structure

3.2 Building Interior

3.2.1 Design, Construction and Maintenance

Building interiors and structures are designed, constructed and maintained to prevent conditions that may result in the contamination of food.

Assessment Criteria

Floors, walls, ceilings

Windows and doors

Process flow separation

3.2.2 Lighting

Lighting is adequate for the activity being conducted. Where appropriate, light bulbs and fixtures are protected to prevent contamination of food.

Assessment Criteria

3.2.3 Ventilation

Adequate ventilation is provided to prevent excessive heat, steam, condensation and dust, and to remove contaminated air.

Assessment Criteria

3.2.4 Waste Disposal

Sewage, effluent and waste storage, and disposal systems are designed, constructed and maintained to prevent contamination.

Assessment Criteria

3.3 Sanitary Facilities

3.3.1 Employee Facilities

Employee facilities are designed, constructed and maintained to permit effective employee hygiene and to prevent contamination.

Assessment Criteria

3.3.2 Equipment Cleaning and Sanitizing Facilities

Facilities for cleaning and sanitizing equipment are adequately designed, constructed and maintained to prevent contamination.

Assessment Criteria

3.4 Water, Ice and Steam Quality

3.4.1 Water and Ice

The potability of hot and cold water is controlled to prevent contamination.

Assessment Criteria

3.4.2 Steam

The potability of steam that is in direct contact with food or food contact surfaces is controlled to prevent product contamination. Steam supply is adequate to meet operational requirements.

Assessment Criteria

See Section 7.4.1 - Water, Ice and Steam Quality Records.

4 - Sanitation and Pest Control

4.1 Sanitation

4.1.1 Sanitation Program

An effective sanitation program for equipment and premises is in place to prevent contamination of food.

Assessment Criteria

See Section 7.5.1 - Sanitation Records.

4.2 Pest Control

4.2.1 Pest Control Program

Effective pest control programs are in place to prevent entry of pests, to detect and eliminate pests and to prevent the contamination of food.

Assessment Criteria

See Section 7.5.2 - Pest Control Records.

5 - Personnel

5.1 Hygiene and Health Requirements

5.1.1 Cleanliness and Conduct

All persons entering food handling areas maintain an appropriate degree of personal cleanliness and take the appropriate precautions to prevent the contamination of food.

Assessment Criteria

5.1.2 Communicable Diseases and Injuries

No person who is known to be infected with a disease likely to be transmitted through food, or who has open cuts or wounds, is permitted to work in food handling areas where there is a likelihood of the person directly or indirectly contaminating the food.

Assessment Criteria

5.2 Training

5.2.1 General Food Hygiene Training

Food handlers are trained in personal hygiene and hygienic handling of food, and they understand the precautions necessary to prevent the contamination of food.

Assessment Criteria

5.2.2 Technical Training

To ensure food safety, accuracy of product representation and net quantity, personnel are trained such that they have adequate technical knowledge and understanding of the operation(s) or process(es) for which they are responsible.

Assessment Criteria

6 - Transportation and Storage

6.1 Transportation

6.1.1 Food Carriers

Carriers used by the manufacturer are designed, constructed, maintained, cleaned and utilized in a manner that prevents food contamination.

Assessment Criteria

6.1.2 Temperature Controls

Ingredients and finished product requiring temperature controls are transported in a manner to prevent temperature abuse that could result in deterioration of the product and affect its safety.

Assessment Criteria

6.2 Storage

6.2.1 Incoming Materials Storage

Storage and handling of incoming ingredients and packaging materials is controlled to prevent damage and contamination.

Assessment Criteria

6.2.2 Non-Food Chemicals – Receiving and Storage

Non-food chemicals are received and stored in a manner that prevents contamination of food, packaging materials and food contact surfaces.

Assessment Criteria

6.2.3 Finished Product Storage

Finished product is stored and handled in a manner that prevents damage and contamination.

Assessment Criteria

7 - Records

7.1 General Records

7.1.1 General Record Requirements

Information is recorded in a manner that represents an accurate history of the product or process. Records are retained for the required period of time.

Assessment Criteria

7.2 Records on Control of Operation

7.2.1 Process Design Records

Records are available to demonstrate the adequacy of procedures and methods used in process development.

Rationale

Records are necessary to verify that critical factors and critical limits are adequate to produce a safe product.

Assessment Criteria

7.2.2 Incoming Material Control Records

The manufacturer keeps records that demonstrate the adequacy of incoming material control.

Rationale

Records are necessary to verify the manufacturer's control over biological, physical and/or chemical hazards.

Assessment Criteria

Periodic evaluations

100% Lot inspection

Vendor certification

Non-conforming incoming materials

7.2.3 Product Preparation and Blending Records

Critical factor control records are maintained and are available on request.

Rationale

Records are necessary to verify that critical factors in preparation and blending are controlled.

Assessment Criteria

7.2.4 Process Control Records

Written records that adequately reflect the control of critical processing factors are available upon request.

Rationale

Records are necessary to verify the safety of the process and product composition.

Assessment Criteria

7.2.5 Deviations and Corrective Action Records

Records are available to demonstrate the control of deviations and the effectiveness of corrective actions taken.

Rationale

Records are necessary to verify that the manufacturer has control of deviations and that corrective action has been effective

Assessment Criteria

The manufacturer supplies records of deviations and corrective action that contain the information specified below, at a minimum.

7.2.6 Verification Records

Records are available to demonstrate the adequacy of verification procedures.

Rationale

Records show the results of verification and confirm the effectiveness of manufacturing controls.

Assessment Criteria

7.3 Records on Equipment

7.3.1 Equipment Maintenance and Calibration Records

Records are available to demonstrate adherence to the maintenance program for critical equipment.

Rationale

Records permit verification of the effectiveness of the equipment maintenance and calibration program.

Assessment Criteria

7.4 Records on Premises

7.4.1 Water, Ice and Steam Quality Records

Written records that adequately reflect control of water, ice and steam quality and treatment are available upon request.

Assessment Criteria

7.5 Records on Sanitation and Pest Control

7.5.1 Sanitation Records

Records are available to demonstrate the effectiveness of the sanitation program.

Assessment Criteria

7.5.2 Pest Control Records

Records are available to demonstrate the effectiveness of the pest control program.

Assessment Criteria

7.6 Records on Complaint Handling and Recalls

7.6.1 Complaint Records

Records of product complaints, investigation findings and action taken are available upon request.

Rationale

Records provide verification that the appropriate action was taken within a reasonable time frame.

Assessment Criteria

Consumer information

Investigation

7.6.2 Distribution Records

Product distribution records are available to enable the manufacturer to recall any lot of food in a timely fashion.

Assessment Criteria

8 - Complaint Handling and Recalls

8.1 Complaint Handling

8.1.1 Product Complaints

The establishment has an effective system for handling and investigating complaints.

Rationale

Product complaints are important indicators of possible deficiencies in manufacturing controls and/or deficiencies in the distribution handling system. When the complaint handling system itself is deficient, it could result in failure to identify and eliminate risks.

Assessment Criteria

See Section 7.6.1 - Complaint Records.

8.2 Recalls

8.2.1 Recall Procedure

Every manufacturer of a food establishes a written procedure to permit the complete, rapid recall of any lot of food from the market.

Assessment Criteria

See Section 7.6.2 - Distribution Records

8.2.2 Recall Capability

Recall procedures are tested periodically to verify the manufacturer's capability to rapidly identify and remove product from the market.

Assessment Criteria

Glossary / Resources

Allergen
Any substance capable of producing an abnormal immune response in sensitive individuals.
Capability
A standardized evaluation of the inherent capability of equipment to consistently perform a specified function under actual operating conditions after significant causes of variation have been eliminated.
Certification
In this document, certification refers to the guarantee a supplier (vendor) provides to a manufacturer, ensuring that the material meets the manufacturer's specifications (e.g. a Certificate of Analysis).
Control
Means that an operation performs consistently within predetermined limits based on process capability, meets process requirements, provides a mechanism to maintain the stability of the process and consistently results in a safe product.
Corrective action
The actions to be taken when the results of monitoring the critical control point indicate a loss of control. This term refers to any action taken to bring the process into control and deal with any affected product when critical limits or other criteria are not met. The action is prompt and appropriate to the seriousness of the deficiency.
Critical control point (CCP)
A point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels.
Critical equipment
Equipment that performs a function, whose impact on the process is such that a food safety hazard could be prevented, eliminated or reduced to acceptable levels.
Critical factor
Any property, characteristic, condition, aspect, or other parameter, a variation of which may affect the safety of the product or the process.
Critical limit
A value that separates acceptability from unacceptability. Critical limits are not control limits or specification limits. Control limits indicate what the process is capable of delivering and are tighter than specification limits which are, in turn, tighter than critical limits.
Deterioration
For food products discussed in this document, deterioration can be used interchangeably with spoilage. However, non-food products such as packaging materials can also deteriorate. For non-food items, deterioration is a physical or chemical change in the material that may adversely affect the safety of the food.
Deviation
Failure to meet the critical limits or other specified requirements for a critical factor.
Deviation procedure
A predetermined and documented set of corrective actions that are implemented when a deviation occurs. The goal is to re-establish control of the process and to control the affected product.
Documentation
For the purposes of this text, documentation refers to written formulas, procedures or specifications used by, or required of, a manufacturer.
Hazard
The potential to cause harm: a biological, chemical or physical property that may cause an unacceptable consumer health risk.
Hermetically sealed container
A container designed and intended to be secure against the entry of micro-organisms, including spores.
Incubation
Tests in which the heat-processed product is kept at a specific temperature for a specified period of time in order to determine if an outgrowth of micro-organisms or other problems occur under these conditions.
Lot
The amount of product of a specific container size, product style and code produced by a food establishment during a specified period of time.
Low acid food
A food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85.
Monitoring
A planned sequence of observations or measurements to assess whether a critical control point (or other activity) is under control.
Recall: Periodic testing
Internal activities conducted on a periodic basis to verify the capability of the manufacturer to rapidly identify and control a given lot of product. These activities do not necessarily require the manufacturer to contact customers. 
Records
Observations and measurements recorded by a manufacturer to determine adherence to critical limits or other specified requirements for critical factors.
Risk
An estimate of the likelihood of occurrence of a hazard.
Spoilage
A process whereby food is rendered unacceptable through microbiological or chemical reaction.
Vendor
For the purposes of this text, vendor is equivalent to supplier.
Vendor certification
The process of acceptance of incoming materials that does not rely on 100% inspection of incoming lots. The manufacturer conducts a series of events prior to receipt of the material that ensures the material meets the required specification.
Verification
Examination of the accuracy, correctness or effectiveness of validated processes or process controls through testing, investigation or comparison against a standard.

Resources

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