Good Importing Practices for Food - First Edition

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TABLE OF CONTENTS

Preface

1. Control of Imported Product
   • 1.1 Product and Shipment Information/Specifications
     • 1.1.1 Shipment Information
     • 1.1.2 Assessment of Foreign Manufacturers/Suppliers
     • 1.1.3 Product Labelling and Composition
     • 1.1.4 Food Additives
     • 1.1.5 Net Quantity
     • 1.1.6 Grade
   • 1.2 Receiving of Imported Product
     • 1.2.1 Incoming Food Product Control
   • 1.3 Product Coding Control
     • 1.3.1 Product Coding
   • 1.4 Deviations and Corrective Action
     • 1.4.1 Deviation Control
     • 1.4.2 Corrective Action
   • 1.5 Verification
     • 1.5.1 Verification Procedures
2. Equipment
   • 2.1 General Equipment
     • 2.1.1 Equipment Maintenance
     • 2.1.2 Instrumentation Maintenance and Calibration Program
3. Premises
   • 3.1 Building Exterior
     1. 3.1.1 Outside Property and Building
   • 3.2 Building Interior
     • 3.2.1 Design, Construction and Maintenance
     • 3.2.2 Lighting
     • 3.2.3 Ventilation
     • 3.2.4 Waste disposal
   • 3.3 Sanitary Facilities
     • 3.3.1 Employee Facilities
   • 3.4 Water/Ice Quality
     • 3.4.1 Water and Ice
4. Sanitation and Pest Control
   • 4.1 Sanitation
   • 4.1.1 Sanitation Program
   • 4.2 Pest Control
     • 4.2.1 Pest Control Program
5. Personnel
   • 5.1 Hygiene and Health Requirements
     • 5.1.1 Cleanliness and Conduct
     • 5.1.2 Communicable Diseases / Injuries
   • 5.2 Training
     • 5.2.1 General Food Hygiene Training
     • 5.2.2 Technical Training
6. Transportation and Storage
   • 6.1 Transportation
     • 6.1.1 Food Carriers
     • 6.1.2 Temperature Controls
   • 6.2 Storage
     • 6.2.1 Food Product Storage
     • 6.2.2 Non-Food Chemicals - Receiving and Storage
7. Records
   • 7.1 General Records
     • 7.1.1 General Record Requirements
   • 7.2 Receiving of Imported Product Records
     • 7.2.1 Incoming Imported Product Control Records
     • 7.2.2 Net Quantity Records
     • 7.2.3 Deviations and Corrective Action Records
     • 7.2.4 Verification Records
   • 7.3 Equipment
     • 7.3.1 Equipment and Instrumentation Maintenance and Calibration Records
   • 7.4 Premises
     • 7.4.1 Water/Ice Quality Records
   • 7.5 Sanitation and Pest Control
     • 7.5.1 Sanitation Records
     • 7.5.2 Pest Control Records
   • 7.6 Complaint Handling and Recalls
     • 7.6.1 Complaint Records
     • 7.6.2 Distribution Records
8. Complaint Handling and Recalls
   • 8.1 Complaint Handling
     • 8.1.1 Product Complaints
   • 8.2 Recall System
     • 8.2.1 Recall Procedure
     • 8.2.2 Recall Capability

Glossary

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PREFACE

Effective hygiene controls are vital to preventing food borne illness, food borne injury and food spoilage. Good Importing Practices For Food (GIP) is a voluntary code of practice to be used as a guideline for Canadian importers. It is designed to encourage them to create their own hygiene controls to help improve food safety and meet regulatory requirements.

The GIP is broad in scope and nature. It deals not only with the key controls necessary to limit safety risks but also provides direction on control measures related to fraud, and on preventing deviations in standard, grade and composition of imported food.

The Canadian Food Inspection Agency (CFIA) in consultation with the food industry has up-dated the June, 1998 version of the GIP. Although some sections of the GIP may not be applicable to every importer, it is intended for broad use across the industry. Where further guidance is needed, the CFIA may develop specific codes of practice for a variety of situations.

Canadian importers are expected to be aware of the hazards involved in importing food and of the controls needed to demonstrate that their imported foods are safe and meet the applicable legislation in Canada. They are also expected to have access to records that will demonstrate that the foreign manufacturers of these imported products have the necessary controls in place. The GIP 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 GIP is not meant to serve as a complete HACCP plan, it is a useful reference. Additional reference material be found on the CFIA Web site at: http://www.inspection.gc.ca.

The GIP: An Assessment Tool

The GIP will be used by the CFIA to assist in assessing importers on their ability to ensure imported food meets Canadian legislation. The GIP can be applied to import, storage, transportation and relabelling activities. Any importers who repackage or process imported products should also refer to the CFIA General Principles of Food Hygiene, Composition and Labelling Code of Practice for further guidance on processing controls.

The GIP is based on the Recommended International Code of Practice - General Principles of Food Hygiene adopted by the Codex Alimentarius Commission. 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. The GIP is also consistent with the CFIA Import Control Policy, since it identifies risk management criteria that are targeted to meet the specific requirements of food safety and consumer protection.

Using the GIP

Each chapter of the GIP describes specific criteria and procedures. Each sub-section includes a principle statement and when necessary, a rationale, followed by 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 (Control of Imported Product, Equipment and Records) to explain the nature of the concern or potential hazard(s) and the need for control.

Assessment Criteria

Assessment criteria included in the GIP will provide information on the factors that may be considered in assessing adherence to the objectives, as expressed in the principle statements of the GIP. The CFIA considers these factors during the course of its risk-based investigation or inspection activities.

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

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1.0 CONTROL OF IMPORTED PRODUCT

1.1 PRODUCT AND SHIPMENT INFORMATION/SPECIFICATIONS

1.1.1 Shipment Information

Rationale

The importer requires basic written information to identify each imported product in order to ensure that the finished product meets the requirements of Canadian legislation.

Assessment Criteria

Commodity Specific Regulatory Requirements

• Importers obtain and maintain current licences, permits and other specified documentation as evidence of compliance with commodity specific regulatory requirements.
• Where required the importer provides suppliers/shippers with written specifications of commodity specific regulatory requirements with which they are expected to comply.

  NOTE: Certain agricultural commodities are subject to additional regulatory requirements, such as import documentation, licensing, etc. The following are some of the pertinent regulations: Processed Products Regulations, Fresh Fruit and Vegetable Regulations, Licensing and Arbitration Regulations, etc.,

Product Information

• A written product description is available and current for each product. The following information may apply:
  • common name of the product,
  • brand name,
  • net quantity declaration,
  • product variety,
  • grade,
  • product specifications and characteristics,
  • container size,
  • copy of the Canadian label,
  • list of ingredients,
  • packaging material,
  • final use of the product,
  • origin of the product,
  • labelling instructions when further labelling is required,
  • handling and storage instructions when special requirements exist. (Examples include the following: do not store with non-food items; keep refrigerated; keep frozen; store at room temperature; etc.)

NOTE: When an imported product regulated under the Food and Drugs Act and Regulations does not meet Canadian requirements, importers may avail themselves of Section A.01.044 of the Regulations which permits the importation of a product that violates the Act or Regulations provided that the product may be brought into compliance after its relabelling or modification. Two conditions apply: the importer must notify a CFIA inspector prior to importation, and the product must be corrected before sale.

Tracing Products and Shipments

• A product code and/or lot code is available for each product. (For products such as low acid canned foods, this is a regulatory requirement.)
• The total net quantity of the shipment is available (the number of units times the unit weight).
• Written flow documentation is available for each imported product. This is necessary to trace products and shipments, and to identify and locate the points where control measures and monitoring procedures are required. The importer requires knowledge of the following:
  • the controls to which the product has been subjected,
  • the product flow (i.e., the port of entry, the carrier, and (if applicable) the import broker),
  • the supplier list and relevant supplier information,
  • purchase records (the quantity, the product code, the date, the buyer),
  • the adequacy of the conditions of transportation and storage to which the product has been exposed.
• The importer is able to obtain the above information upon request.

  NOTES:

  i. Not all the requirements listed above apply to all food commodities. However, Canadian food legislation may specify further requirements for some products. When different lots of bulk product have been blended and it is not possible to trace specific lots, all product involved is treated as a single product.

  ii. For information about downstream traceability (tracing a product's record of sale and distribution), see Section 7.6.2, Distribution Records, in this document. Downstream traceability is necessary in cases where product is recalled.

1.1.2 Assessment of Foreign Manufacturers/Suppliers

Rationale

The safety of food products and their compliance with Canadian regulatory requirements is dependent upon the processing procedures and controls in place at the manufacturing facility. Manufacturing facilities should comply with good manufacturing practices (GMP) equivalent to the Codex Alimentarius General Principles of Food Hygiene, and where required, the manufacturer should have a HACCP (Hazard Analysis Critical Control Points) system in place. These controls are necessary to prevent such problems as microbiological, physical and chemical contamination (including contamination with undeclared allergens), and to prevent misrepresentation and fraud.

Assessment Criteria

• The importer can obtain information on request to demonstrate that the critical steps of the manufacturing process are adequately controlled to ensure safety and quality, and to prevent misrepresentation and fraud.
• Evaluation of foreign manufacturers/suppliers is conducted by technically competent personnel.
• In the absence of these controls, the importer conducts increased product control (e.g., sampling, product and laboratory evaluation, third party review) to ensure risks are controlled.

1.1.3 Product Labelling and Composition

Rationale

Compliance with Canadian food safety standards and compositional requirements promotes a safe food supply and helps ensure that consumers' expectations are met with respect to food composition and quality. The declared composition, compositional standards, nutrition information and claims must be adequately controlled to prevent misrepresentation and fraud, and to prevent such health hazards as the presence of undeclared food allergens.

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

• providing basic product information (e.g., the product's common name, its list of ingredients, its net quantity, its durable life date and country of origin, as well as the name and address of the manufacturer, dealer or importer), and
• providing health, safety and nutrition information (e.g., instructions for safe storage and handling, nutrition information in the Nutrition Facts table, and specific information on products for special dietary use).

  NOTE: "Mandatory information" is determined by the commodity and its regulatory requirements.

Assessment Criteria

Composition

• Control factors that are critical to the safety and integrity of the product are identified. (This includes microbiological, chemical or physical concerns, as well as concerns related to allergens, extraneous matter, etc.) Their specifications and limits are identified (e.g., thermal process, pH and water activity for ready-to-eat fermented meats, salt content for brined mushrooms, sulphur content on dried fruit, freedom from Salmonella, etc.)
• Procedures are in place to ensure that imported food which is sold in Canada complies with Canadian nutrient composition and nutrition labelling requirements. This may concern the following:
  • added nutrients (i.e., vitamins and minerals) permitted in the specific foods are added at appropriate levels as set out in the Food and Drug Regulations;
  • foods for which there are nutrient composition requirements (e.g., meal replacements, nutritional supplements, flour, etc.) meet these requirements;
  • the nutrient content of the product is accurately reflected on the label and in compliance with the Food and Drug Regulations (i.e., the list of ingredients and Canadian Nutrition Facts table);
  • products for which there are nutrient content claims and/or diet-related health claims meet the Canadian compositional and labelling requirements under the Food and Drug Regulations. (See Section 7, Nutrient Content Claims, and Section 8, Diet-Related Health Claims, in the Guide to Food Labelling and Advertising.)
• Procedures are in place to enable the verification of a product's formulation, its list of ingredients, its nutrient content and nutrient values as stated on the label. These procedures may include, but are not limited to:
  • a documented communication system with suppliers which permits access to product specific information (e.g., names and amounts of ingredients, components, additives, and if applicable, added nutrients);
  • an overview of the method(s) used to determine nutrient values (e.g., laboratory analysis, the use of a database for finished foods, the use of an ingredient/recipe data base, published values, the use of a consultant or other technical expertise, etc.);
  • the name and address of the person responsible for the values;
  • possession of, or ability to obtain, complete and current written specification sheets detailing product ingredient and nutrient information;
  • product testing and/or information linkages with suppliers of products that are sole sources of nutrients (such as baby formula) and foods for special dietary use (such as meal replacements and nutrition supplements).
• Products are periodically reviewed against the Nutrition Labelling Compliance Test to assess the accuracy of nutrient values. The Compliance Test is available on the CFIA Web site: www.inspection.gc.ca.

Food Standards

•  Controls are in place to ensure that standardized products meet labelling and/or legislative compositional requirements (e.g., Brix for jam). These controls may include, but are not limited to:
  • vendor certification,
  • product testing (including testing some products to Canadian and/or international standards).
• For products that are subject to intentional adulteration, such as olive oil, the importer has more stringent verification controls in place. This should include testing for authenticity at a Canadian laboratory certified with the Canadian Standards Board for testing of the specific food, or another scientific organization, such as AOAC, etc.

Labelling

• The importer has procedures in place to ensure that all mandatory information is properly declared on food labels in compliance with Canadian food labelling requirements, and that all label claims are accurate and not misleading. Examples of such procedures are listed below.
• Labels are reviewed both for compliance with Canadian legislation (e.g., presence of mandatory labelling), and for accuracy and correctness of information. This assessment includes, but is not limited to:
  • mandatory information, quality claims (e.g., organic, natural, fresh, Kosher, etc.), compositional claims (e.g., no preservatives, etc.), nutrition claims, and standards of identity.
• Any changes to labels (e.g., changes to artwork, text and layout) and packaging (e.g., changes in the size of the principle display surface, available display surface or the location of the principle display panel) are reviewed, in conjunction with suppliers, for compliance with Canadian legislation.
• Any changes in formulations are assessed, in conjunction with suppliers, for their impact on product labelling. This includes any changes in suppliers or brands of ingredients, which can have an impact on labelling, composition, or claims (for all formats of the specific product).
• In the case of corrective labels applied in Canada, incoming labels from labelling and/or printing companies are reviewed against signed-off proofs.
• All pamphlets, posters, handouts and other Canadian advertising materials developed and/or distributed by the importer are reviewed and verified for accuracy and compliance with Canadian legislation. (See Section 3 of the Guide to Food Labelling and Advertising.)
• The importers have obtained allergy-related information from their suppliers and manufacturers. This information can be used to conduct hazard analysis and assess the need for label changes, including the need for any precautionary statements on the label (e.g., "may contain peanuts").

  NOTE:

  i. Labelling requirements are set out in the Guide to Food Labelling and Advertising. The above is not a complete listing of all labelling requirements.

  ii. The following guidance documents provide further direction on compositional and labelling issues and are available on the CFIA Web site at www.inspection.gc.ca.

  - For a list of allergens to be assessed, see the Letter dated March 23, 2007, to food manufacturers, importers, distributors and their associations on Declaration of Food Allergens - Pre-Packaged Foods

  - For the labelling requirements for nutrition labelling, see the CFIA document Evaluation Standard for Nutrition Labelling.

1.1.4 Food Additives

Rationale

Inadequate control of food additives could result in chemical/biological hazards and violation of Canadian regulations.

Assessment Criteria

• The importer ensures that all food additives contained in an imported food product are permitted for use in the particular food and meet the requirements of the Food and Drug Regulations (Division 16) and other applicable regulations.
• The importer has access to specifications for all food additives.
• Where there are no specifications in the Food and Drug Regulations, the importer requires that all food additives meet the specifications of the Food Chemical Codex (FCC) or equivalent. For example, suppliers may use specification sheets or blanket guarantees.
• The importer can demonstrate that any food additive which is used is within the maximum level specified in the Food and Drug Regulations.

1.1.5 Net Quantity

Rationale

The net quantity declaration provides important information which 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 importers to provide the quantity declared on a product's label. 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.

Canada, as a member of Organisation Internationale de Métrologie Légale (OIML), uses an international measurement standard 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.

Assessment Criteria

• The importer has procedures in place to ensure that the product's net quantity is in compliance with the Average System of Net Quantity Determination as outlined in Section 39 of the Consumer Packaging and Labelling Regulations. These procedures may include, but are not limited to:
  • documented communication systems with suppliers, from which the importers can obtain, upon request, detailed net quantity verification information (e.g., results of net quantity verifications, sample scheduling and protocol, corrective actions on failed lots, etc.);
  • in-house net quantity verifications of imported products. The frequency of these verifications is determined by several factors, such as the type of product, its packaging technology and its source. (For example, has the supplier a track record for reliability?)

1.1.6  Grade

Rationale

Inadequate control of grade may result in misrepresentation of the product. It may also may lead to the increased importation of sub-standard product. Grades exist under the Canada Agricultural Products Act and Regulations.

Assessment criteria

• Controls are in place to ensure that imported products meet the grade requirements prescribed by the pertinent Canadian regulations. These control mechanisms may include the following:
  • the importer has written purchasing specifications to ensure product meets the prescribed grade;
  • the importer retains copies of written grade specifications for shipments of product purchased;
  • where required, the importer ensures that each shipment is accompanied by a valid foreign grade certificate from sources prescribed by the regulations;
  • where applicable, the importer obtains the appropriate Canadian grade inspection certificate to verify compliance with the legislated requirements;
  • where grade certificates are not available from foreign or local inspection services, the importer has a system to monitor the grade and/or quality requirements of arriving product;
  • the importer has access to trained personnel (such as graders and quality control personnel) to assess the grade of incoming product.
• For imported products arriving in damaged or deteriorated condition, the importer follows procedures to ensure that products or commodities are brought into compliance by:
  • re-grading the produce and providing evidence that the re-graded lot meets the specified grade (by providing a valid CFIA grade inspection certificate, for example);
  • providing evidence of the disposal or dumping of deteriorated product which does not meet grade (by providing a CFIA dump certificate, for example);
  • providing evidence of the use of the shipments for processing (by providing an invoice from the processor indicating the quantity used for processing, and a letter on company letterhead confirming the use of the product for processing);
  • providing evidence of disposition of the products for charitable use (by providing a letter on the letterhead of a charitable organization acknowledging the disposition of the shipment to charity).
• For other graded product, the importer employs qualified graders and/or inspectors to sample and grade the contents of each shipment, and retains a copy of the Grade Inspection report for each shipment.

1.2  RECEIVING OF IMPORTED PRODUCT

1.2.1 Incoming Food Product Control

Rationale

Importers are responsible for ensuring that imported products meet the specifications set out in the Section 1.1 of this document, Product Information/Specification. Prevention of health hazards and fraud begins with control of incoming materials. Inadequate incoming product controls (e.g., lack of appropriate product testing and sorting, lack of verification of labels, etc.) could result in the sale of contaminated products, misrepresented products or products that do not meet grade, composition or quality standards.

NOTE: Not all Incoming Food Products require the same degree of control. The degree of control exercised should be appropriate to the level of risk posed by the food product.

Assessment Criteria

• All incoming product is visually inspected to ensure each product meets specifications and Canadian requirements.
• The importer has identified, for each product, the specific concerns that apply, considering various types of hazards (microbiological, chemical and physical hazards, and extraneous matter) and issues such as fraud, grade, etc.
• The importer has set "Acceptance/Rejection" criteria for each product.
• Personnel involved in the inspection of incoming material have adequate technical knowledge and understanding of the significance of the concerns.
• Packaging material is suitable for the product. Packaging will vary with the product and process and the associated contamination risks. Packaging material which may affect the quality of the product is listed in the Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents published by CFIA, which can be found on the CFIA Web site. http//www.inspection.gc.ca/english/fssa/reference/refere.shtml.
• The importer controls incoming products through one of the following programs or equivalent, listed as Options 1 - 4 below.

  NOTE:

  i. The above controls may be carried out by the importer or by a designate, e.g., a public warehouse representative, a client or a third party.
  ii. The nutrition information may be conveyed on an accompanying hard copy document with the delivery of the food.
  iii. 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 on the basis of the first shipment. The purchaser should be advised of any change to the nutrition information as a result of formulation changes or other influences.

Controlling Incoming Products: Options 1 - 4

The first three options apply to products where the risks to safety are high. The fourth option applies only to food products which are not likely to pose a safety risk, but may require controls of quality and composition.

OPTION 1: Periodic Evaluation of Incoming Products

• The importer obtains a certificate of analysis (in English or French) for each lot ,which includes the following:
  • the sampling procedure(s) and analytical method(s) used to ensure the lots are acceptable by the CFIA;
  • the date, the type of determination to which the food was submitted, the individuals/organizations conducting the analysis, product identification (including the brand and lot number), and the name and signature of the analyst;
  • a verification that the lot was recently sampled and was stored under appropriate conditions to prevent any changes which may render the product unacceptable for sale.
• A representative sample is regularly taken and analysed to verify the accuracy of the certificates of analysis. Samples are taken at a scheduled frequency (e.g., monthly).
• The importer maintains a documented history for each supplier, indicating the supplier's adherence to specifications (e.g., documenting analytical results).
• A new history of adherence to specifications is established when a firm changes suppliers, purchases product from a new supplier, purchases a new product from an existing supplier or when the importer's sample results do not agree with the certificate of analysis.

OPTION 2: 100% Lots Inspected

• Each incoming lot is sampled according to a pre-determined sampling plan and analysed for adherence to specifications.

OPTION 3: Vendor Certification

• When the importer relies on vendor certification, the importer has data to demonstrate the capability of the supplier's process to consistently manufacture within specifications. This may include process capability studies. Statistical process control charts for each critical control point must be available upon request from each supplier.
• Prior to implementing a periodic monitoring program, the importer has analyzed an appropriate number of consecutive lots to establish an historical data base to confirm adherence to specifications.
• The importer conducts periodic monitoring to verify adherence to specifications (e.g., annually).
• The importer conducts vendor audits to validate the status of the vendor certification program.

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

• Where incoming products are not likely to have an impact on the food safety, the importer conducts periodic monitoring to verify adherence to specifications (e.g., annually), or obtains a certificate of analysis.

  NOTE: For certain products (i.e., some fresh fruit and vegetables), the frequency of monitoring to verify adherence is mandated by regulation.

Non-Conforming Incoming Products

• When products fail to meet specifications, the importer investigates and identifies the root cause. Procedures are in place to ensure that non-conforming products are not sold in Canada, or that the non-conformance is corrected prior to sale. (See Section 1.4 of this document, Deviations and Corrective Action.)

1.3 PRODUCT CODING CONTROL

1.3.1 Product Code

Rationale

Coding permits products to be traced through the distribution chain and facilitates recalls. Where the code is also a best before date or an expiry date, it provides information on shelf life and safe consumption of the product.

NOTE: Mandatory coding requirements vary between commodities, and are specified in appropriate legislation. To confirm specific requirements governing various food products, importers should consult with inspection authorities.

Assessment criteria

• The importer ensures that, where required or applicable, imported food has been permanently marked with a legible code or lot identification. The coding system:
  • identifies the establishment, as well as the day, month and year in which the food was produced.
• The importer ensures that the code marks used and the exact meaning of the code (e.g., colour codes) are available.
• Where used, case codes are legible and represent the container code within.
• Where applicable, the code accurately reflects the best before date, expiration date, or shelf life of the food.
• Where applicable, the manufacturer controls the application of codes to ensure that the integrity of the container is not compromised.

1.4 DEVIATIONS AND CORRECTIVE ACTION

1.4.1 Deviation Control

Rationale

Inadequate deviation procedures or non-adherence to procedures could result in the sale of unsafe products, misrepresented products or products of inferior grade.

NOTE: Deviation procedures apply to all sections of this standard, where appropriate.

Assessment Criteria

• The importer has a pre-determined and documented deviation procedure to identify deviations in products and procedures, to isolate affected products, and to evaluate them. Criteria are described below.

Identification of Deviation

• The importer has a system in place to identify deviations when they occur.

Isolation of Affected Product

• The importer has effective procedures in place to isolate all product manufactured during the deviation period. All unsatisfactory product is isolated back to the point where the process was last in control. This could be beyond the last satisfactory record.
• Isolated product is clearly marked (e.g., firmly attached tags contain the following information: hold number, product, the amount, the date held, the reason for the hold, and the name of the person holding the product).
• The importer maintains control of all product manufactured during the deviation period (i.e., from the time the product was first put on hold until final disposition).

Evaluation of Affected Product

• Product evaluation is conducted by a qualified person.
• Disposition of affected product (e.g., sorting of suspect lots, disposal, etc.) is conducted in an appropriate manner by adequately trained personnel.
• Evaluation is adequate to detect potential health hazards, or to identify misrepresentation or product that does not meet quality or grade requirements. For example:
  • sampling is adequate to identify the extent of the problem, the tests are appropriate, the judgement is based on sound science and the product is not released until the evaluation has determined that the product is in compliance with appropriate legislation.

1.4.2  Corrective Action

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

• As part of the deviation procedure, the importer has a set of documented corrective actions that include:
  • an investigation to determine the cause of the deviation;
  • effective measures taken to prevent recurrence of the deviation;
  • verification by the importer of the effectiveness of the corrective action taken.

See Section 7.2.3, Deviations and Corrective Action Records.

1.5  VERIFICATION

1.5.1  Verification Procedures

Rationale

The purpose of verification is to assess the effectiveness of existing controls in preventing health hazards, economic fraud and deviations from Canadian regulatory requirements, and to indicate areas where improvements are required.

Assessment Criteria

• The importer verifies the effectiveness of controls affecting product safety, misrepresentation and other concerns.

NOTE: The verification methods will vary with the product and process, since the methods must be appropriate to the specific hazards and risks which may be encountered. Verification applies to all sections of this standard (e.g., from receiving product to training personnel), where appropriate.

Examples of Verification Methods

• Verification methods may include the following:
  • sampling and analysis of finished product for the appropriate chemical, microbiological or physical hazards;
  • sampling and analysis of finished product for composition and net quantity;
  • independent, external audits;
  • internal audits;
  • incubation testing to confirm commercial sterility/hermetic seal;
  • visual/mechanical/electronic screening;
  • analysis of consumer complaint trends;
  • vendor audits.

Frequency of Verification

• The importer conducts verification to validate the effectiveness of the manufacturing controls at a frequency appropriate to the hazards associated with the product and process.

Responsibility for Verification

• Individuals or organizations responsible for verification are identified. These individuals or organizations are suitably qualified.

See Section 7.2.4, Verification Records.

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2.0 EQUIPMENT

NOTE: In import premises, "equipment" refers primarily to refrigeration units, freezers and relabelling equipment. The requirements outlined in this section are similar to those in the domestic General Principles of Food Hygiene, Composition and Labelling Code of Practice.

2.1 GENERAL EQUIPMENT

2.1.1  Equipment Maintenance

Assessment Criteria

• The importer has an effective written preventative maintenance program to ensure that equipment that may impact on food safety and on the accuracy of net quantity, functions as intended. This includes:
  • a list of equipment requiring regular maintenance;
  • a program of maintenance procedures including frequencies (such as equipment inspection, adjustments and part replacements) which is based either on the equipment importer's manual or equivalent, or based on operating conditions that could affect the condition of the equipment.
• The preventative maintenance program is adhered to.
• Written protocols, including calibration methods and frequencies, are established by the importer, for monitoring equipment and/or controlling devices that may impact on food safety, net quantity and quality.
• Equipment is maintained to ensure there is no potential for physical or chemical hazards (e.g., no inappropriate repairs, no flaking paint and rust, no excessive lubrication).
• Maintenance and calibration of equipment is performed by appropriately trained personnel.

2.1.2  Instrumentation Maintenance and Calibration Program

Rationale

Control of environmental conditions (temperature and humidity) may be crucial to the safety, quality and integrity of specific foods.

Assessment criteria

• Instruments which control factors critical to product safety and to the maintenance of quality and net quantity are designed, installed, constructed and calibrated as necessary to ensure that they function as intended. The following are some examples of instrumentation that may be required to control critical factors.

  Temperature Measuring Devices

  • Temperature measuring devices are installed, calibrated and maintained as necessary to ensure accuracy, based on the equipment manufacturers' specifications and instructions.

  MIG Thermometers

  • Mercury in glass thermometers is calibrated against a known standard just prior to installation, and thereafter a minimum of once per year, or more frequently as necessary to ensure accuracy, based on the equipment manufacturers' specifications and instructions. If there is a deviation of more than 0.5°C (1°F) from the standard thermometer, corrective action is taken.
  • Thermometer scales are within the operating range, are easily readable to 0.5°C (1°F) and do not contain more than 4°C/cm (17°F/in).

  Temperature Recorders

  • The accuracy of temperature recorders is verified upon installation, and thereafter a minimum of once per year, or more frequently as necessary to ensure their accuracy, based on the equipment manufacturers' specifications and instructions.

  Scales/Metering Devices

  • The sensitivity is appropriate to the use.
  • Scales are designed and installed to withstand the environmental conditions or are adequately protected (e.g., away from drafts, rust, corrosion, etc.)
  • Scales and meters are calibrated as necessary to ensure accuracy at all times, based on the equipment manufacturers' specifications and instructions.

  Other Instrumentation

  • Other specialized instrumentation necessary for the control of critical factors is in place and calibrated as necessary, based on the equipment manufacturers' specifications and instructions.

  NOTE: The importer should initiate corrective action as per Section 1.4 of this document, Deviations and Corrective Action, whenever products could have been affected as a result of a deviation in the accuracy of instrumentation. Importers should consider not only the lot which was found to be faulty, but all lots that might have been affected by the instrument inaccuracy.

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3.0  PREMISES

3.1 BUILDING EXTERIOR

3.1.1  Outside Property and Building

Assessment Criteria

Grounds, Roadways and Drainage

• The surrounding land is maintained to control sources of contamination such as debris and pest harbourage areas.
• The building is not located in close proximity to any environmental contaminants.
• Roadways are properly graded, compacted, dust proofed and drained.
• The surrounding property is adequately drained.

Exterior Building Structure

• The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests. For example, the exterior has no unprotected openings; air intakes are appropriately located, and the roof, walls and foundation are maintained to prevent leakage.

3.2 BUILDING INTERIOR

3.2.1  Design, Construction and Maintenance

Assessment Criteria

Floors, Walls and Ceilings

• Floors, walls and ceilings are constructed of material that is durable, impervious, smooth, cleanable, and suitable for handling and storing foods in a manner which will not result in the contamination of the environment or food.
• Where appropriate, wall, floor and ceiling joints are sealed and angles are coved to prevent contamination and facilitate cleaning.
• Floors, walls and ceilings are composed of materials that will not result in the contamination of the environment or food.
• Floors are sufficiently sloped to permit liquids to drain to trapped outlets.
• Ceilings, overhead structures, stairs and elevators are designed, constructed and maintained to prevent contamination.

Windows and Doors

• Windows are sealed or equipped with close-fitting screens.
• Where there is a likelihood of breakage of glass windows that could result in the contamination of food, the windows are constructed of alternative materials or are adequately protected.
• Doors have smooth, non-absorbent surfaces and are close fitting and self-closing where appropriate.

Area Separation

• Activities, food and non-food products are adequately separated by physical or other effective means, where cross contamination may result.

3.2.2  Lighting

Assessment Criteria

• Lighting is appropriate such that the intended production or inspection activity can be effectively conducted. Note that inspection areas are defined as any point where the food product or container is visually inspected or instruments are monitored, including product sorting areas. The lighting should not be less than the following:
  • 540 lux (50 foot candles) in inspection areas;
  • 220 lux (20 foot candles) in work areas;
  • 110 lux (10 foot candles) in other areas.
• Lighting does not alter the perception of food colour for purposes of grading.
• Light bulbs and fixtures located in areas where there is exposed food are of a safety type or are protected to prevent contamination of food in case of breakage.

3.2.3  Ventilation

Assessment Criteria

• Ventilation provides sufficient air exchange to prevent unacceptable accumulation of steam, condensation or dust.
• Ventilation openings are equipped with close-fitting screens or filters as appropriate to prevent the intake of contaminated air. Filters are cleaned or replaced as necessary.

3.2.4  Waste Disposal

Assessment Criteria

• Drainage and sewage systems are equipped with appropriate traps and vents.
• Establishments are designed and constructed so that there is no cross-connection between the sewage system and any other waste effluent system in the establishment.
• Effluent or sewage lines do not pass directly over or through packaging areas unless they are controlled to prevent contamination.
• Adequate facilities and equipment are provided and maintained for the storage of waste and inedible material prior to its removal from the establishment. These facilities are designed to prevent contamination.
• Containers used for waste are clearly identified, leak proof and covered where appropriate.
• Waste is removed and containers are cleaned and sanitized at an appropriate frequency to minimize contamination potentials.

3.3 SANITARY FACILITIES

3.3.1  Employee Facilities

Assessment Criteria

• Premises are provided with an adequate number of conveniently located hand washing stations with trapped waste pipes to drains.
• Washrooms have hot and cold potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and a cleanable waste receptacle.
• Washrooms, lunch rooms and change rooms are maintained in a clean condition.
• Hand washing notices are posted in appropriate areas.

3.4 WATER/ICE QUALITY

3.4.1  Water and Ice

Assessment Criteria

• Potable water meets the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality. Water is analysed by the importer or municipality at a frequency adequate to confirm its potability.
• There are no cross-connections between potable and non-potable water supplies or all hoses, taps and other similar sources of possible contamination are designed to prevent back-flow or back siphonage.
• Where it is necessary to store water, storage facilities are adequately designed, constructed and maintained to prevent contamination (e.g., covered).
• Water treatment chemicals, where used, are listed in the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products published by CFIA, or the importer has a "letter of no objection" from Health Canada.
• The chemical treatment is monitored and controlled to deliver the desired concentration and to prevent contamination.
• Ice used as an ingredient or in direct contact with food is made from potable water and is protected from contamination. Ice purchased by the importer is treated as an incoming ingredient and is assessed under Section 1.2.1, Incoming Food Product Control.

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4.0  SANITATION AND PEST CONTROL

4.1 SANITATION

4.1.1  Sanitation Program

Assessment Criteria

• The importer has a written cleaning and sanitation program for all equipment which includes:
  • the identification of the responsible person;
  • the frequency of the activity;
  • the chemicals and concentrations used;
  • the temperature requirements;
  • the procedures for cleaning and sanitizing. For example, procedures identify Cleaned Out of Place Equipment (C.O.P.) such as hand-cleaned equipment and utensils, and outline disassembly/reassembly instructions as required for cleaning and inspection. Areas on equipment which require special attention are identified, and the methods of cleaning, sanitizing and rinsing are outlined.
• The importer has a written cleaning and sanitation program for the premises (packaging and storage areas) which specifies the areas to be cleaned, the method of cleaning, the person responsible and the frequency of the activity.
• Chemicals are used in accordance with the chemical manufacturer's instructions and are listed in the Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents published by CFIA, or the importer has a "letter of no objection" from Health Canada. The Reference Listing can be found on the CFIA Web site, http://www.inspection.gc.ca/english/fssa/reference/refere.shtml.
• Cleaning and sanitizing equipment is designed for its intended use and is properly maintained.
• The sanitation program is carried out in a manner that does not contaminate food or packaging materials during or subsequent to cleaning and sanitizing (e.g., no contamination from aerosols or chemical residues).
• Effectiveness of the sanitation program is monitored and verified (e.g., by routine inspection of premises and equipment and/or microbiological testing) and where necessary, the program is adjusted accordingly.
• Packaging operations begin only after sanitation requirements have been met.

See Section 7.5.1, Sanitation Records.

4.2 PEST CONTROL

4.2.1  Pest Control Program

Assessment Criteria

• There is an effective written pest control program for the premises and equipment that includes:
  • the identification of the person to whom the importer has assigned responsibility for pest control;
  • where applicable, the name of the pest control company or the name of the person contracted for the pest control program;
  • the list of chemicals used, the concentration, the location where applied, and the method and frequency of application;
  • a map of trap locations;
  • the type and frequency of inspection to verify the effectiveness of the program.
• Pesticides used are registered under the Pest Control Products Act and Regulations and are listed in the Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents, published by CFIA. Pesticides are used in accordance with the label instructions. The Reference Listing can be found on the CFIA Web site, http://www.inspection.gc.ca/english/fssa/reference/refere.shtml.
• Treatment of equipment, premises or ingredients to control pests is conducted in a manner to ensure that the maximum residue limit of the Food and Drugs Act and Regulations is not exceeded (e.g., the number of fumigation treatments per lot is limited).
• Poisonous rodenticides are not used in food packaging or storage areas.
• Birds and animals are excluded from establishments.

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5.0  PERSONNEL

5.1 HYGIENE AND HEALTH REQUIREMENTS

5.1.1  Cleanliness and Conduct

Assessment Criteria

• All persons wash their hands upon entering unprotected food handling areas: before starting work, after handling contaminated materials, after breaks and after using toilet facilities. Where necessary to minimize microbiological contamination, employees use disinfectant hand dips.
• Protective clothing, hair covering, footwear and/or gloves appropriate to the operation in which the employee is engaged, are worn and maintained in a sanitary manner (e.g., employees in packaging areas wear effective hair coverings).
• Any behaviour which could result in contamination of food, such as eating, use of tobacco, chewing gum, or unhygienic practices such as spitting are prohibited in food handling areas.
• All persons entering unprotected food handling areas remove jewellery and other objects which may fall into, or otherwise contaminate, food. Jewellery which cannot be removed, including wedding bands and medical alerts, is covered.
• Personal effects and street clothing are not kept in unprotected food handling areas and are stored in a manner that prevents contamination.
• Access of personnel and visitors is controlled to prevent contamination. The traffic pattern of employees prevents cross-contamination of the product.

5.1.2  Communicable Diseases/Injuries

Assessment Criteria

The importer has a policy, and enforces the policy, to prevent personnel who are known to be suffering from a disease, or who are known to be carriers of a disease transmissible through food, from working in food handling areas.

• The importer requires that employees advise management when they are suffering from a communicable disease likely to be transmitted through food. Conditions which are to be reported include:
  • jaundice;
  • diarrhoea;
  • vomiting;
  • fever;
  • sore throat with fever;
  • discharges from the ear, eye or nose.
• Employees having open cuts or wounds do not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering (e.g., rubber gloves).

5.2 TRAINING

5.2.1  General Food Hygiene Training

Assessment Criteria

• The importer has a written training program for employees which is delivered as follows:
  • appropriate training in personal hygiene and hygienic handling of food is provided to all food handlers at the beginning of their employment;
  • the original food hygiene training is reinforced and updated at appropriate intervals.

5.2.2  Technical Training

Assessment Criteria

• Training is appropriate to the level of risk associated with the product and the tasks assigned. For example:
  • personnel are trained to understand the manufacturing process involved in the production of the product, the importance of the critical limits, the procedures for monitoring, the action to be taken if the limits are not met and the records to be kept;
  • personnel are trained to understand labelling requirements;
  • personnel responsible for the maintenance of scales and metering devices for net quantity controls are trained to identify deficiencies and to take the appropriate corrective action;
  • personnel and supervisors responsible for the sanitation program are appropriately trained to understand the principles and methods required for effective cleaning and sanitizing.
• Training is appropriate to ensure that personnel have a current understanding of Canadian food legislation and importing policies. For example, the importer has trained personnel responsible for:
  • label development, design and sign-off;
  • import documents and administrative regulatory requirements.

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6.0  TRANSPORTATION AND STORAGE

6.1 TRANSPORTATION

6.1.1 Food Carriers

Assessment Criteria

• The importer verifies that carriers are free of contamination and suitable for the transportation of food. For example:
  • carriers are inspected by the importer prior to loading and upon receipt of products to ensure they are free from contamination and suitable for the transportation of food;
  • the importer can demonstrate that the carrier has an adequate cleaning and sanitizing program (e.g., for bulk carriers, a written cleaning and sanitizing procedure is available).
• Where the same carriers are used for food and non-food loads (e.g., dual use), procedures are in place to restrict the type of non-food loads to those that do not pose a risk to food loads in the same shipment, or in subsequent shipments (after an acceptable clean out). For example:
  • the importer receives a cleaning certificate and a record of the previous material transported prior to loading or unloading dual use tankers;
  • the importer has a program in place to verify the adequacy of cleaning (e.g., tanker inspections, sensory evaluation of ingredients and/or analysis as appropriate).
• Carriers are loaded, arranged and unloaded in manner that prevents damage and contamination of the food.
• Bulk tanks are designed and constructed to permit complete drainage and to prevent contamination.
• Where appropriate, materials used in carrier construction are suitable for food contact.

6.1.2  Temperature Controls

Assessment Criteria

• Products requiring refrigeration are transported at 4°C (39°F) or less and are appropriately monitored. Frozen products are transported at temperatures that do not permit thawing.
• Products are transported under conditions to minimize microbiological, physical and chemical deterioration (e.g., thermophilic spoilage, rusting or corrosion of the container in the case of low acid canned foods).

6.2  STORAGE

6.2.1  Food Product Storage

Assessment Criteria

• Products requiring refrigeration are stored at 4°C (39°F) or less and are appropriately monitored. Frozen products are stored at temperatures that do not permit thawing and are appropriately monitored.
• Products are handled and stored in a manner to prevent damage and/or contamination (e.g., thermophilic spoilage, rusting or corrosion of containers, protection of susceptible products from the effects of light, control of stacking heights and forklift damage).
• Stock rotation is controlled to minimize deterioration and prevent spoilage that could present a health hazard (e.g., rusting of containers, container corrosion resulting in leakage, products exceeding shelf life).
• Humidity sensitive products are stored under appropriate conditions to prevent deterioration.
• Defective or suspect products that have been returned are clearly identified and isolated in a designated area for appropriate disposition/sorting.

6.2.2  Non-Food Chemicals - Receiving and Storage

Assessment Criteria

• Non-food chemicals are received and stored in a dry, well-ventilated area.
• Non-food chemicals are stored in designated areas such that there is no possibility for cross-contamination of food or food contact surfaces.
• Where required for ongoing use in food handling areas, these chemicals are stored in a manner that prevents contamination of food, food contact surfaces or packaging materials.
• Non-food chemicals are stored and mixed in clean, correctly labelled containers.
• Non-food chemicals are dispensed and handled only by authorized and properly trained personnel.

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7.0  RECORDS

7.1 GENERAL RECORDS

7.1.1  General Record Requirements

Assessment Criteria

• Records kept by the importer are legible, permanent and accurately reflect actual events, conditions or activities.
• Errors or changes are identified so that the original record remains clear (e.g., strike out with a single stroke and initial the correction/change).
• Each entry on a record is made by the responsible person at the time that the specific event occurred. The completed records are signed and dated by the responsible person.
• Critical records are signed by a qualified individual designated by management prior to distribution of the product. All other records are reviewed at an appropriate frequency to provide an early indication of potentially serious deficiencies.
• Records are retained for at least one year after the expiry date on the label or container, or if there is no expiry date, for at least two years after the date of sale.
• Records are maintained and are available upon request.
• Importers are expected to have access to the foreign manufacturer's records, upon request, concerning critical control points in the manufacturing process.

7.2 RECEIVING OF IMPORTED PRODUCT RECORDS

7.2.1  Incoming Imported Product Control Records

Rationale

Records are necessary to verify the importer's control over biological, physical or chemical hazards, representation, composition and quality.

Assessment Criteria

• The minimum record requirements for the four monitoring and/or certification options (Periodic Evaluations, 100% Lot Inspection, Vendor Certification, and Non-Conforming Imported Product) are outlined below.

Periodic Evaluations

• The importer has records to:
  • document the history of adherence to specifications (i.e., analytical results);
  • state the results of spot checks (i.e., analytical results).

100% Lot Inspection

• The importer has analytical results for each incoming lot.

Vendor Certification

• The importer has records which:
  • demonstrate knowledge of the supplier's process (e.g., process flow charts, critical control point identification, process specifications, critical limits, monitoring and verification reports, corrective action plans and reports, and on-site evaluation reports);
  • demonstrate the capability of supplier's process (e.g., capability studies), with statistical process control charts available upon request;
  • provide an historical data base (e.g., analytical results on consecutive lots);
  • record results of periodic monitoring (e.g., analytical results);
  • state the results of supplier audits (e.g., audit reports).

Non-Conforming Imported Product

• The importer keeps records which:
  • identify the imported product;
  • identify the deficiency;
• specify the preventative and corrective action taken.

7.2.2  Net Quantity Records

Rationale

Records are required to verify that the net quantity declarations are accurate.

Assessment Criteria

• Records are available to verify that reliable procedures have been followed in determining the net quantity of pre-packaged products.
• Records are available to demonstrate that the net quantity protocol is being followed.

7.2.3  Deviations and Corrective Action Records

Rationale

Records are required to verify that the importer has control of deviations and that corrective action has been effective.

Assessment Criteria

• The importer supplies records of deviations and corrective actions which contain the information specified below.

Deviation/Hold

• Records contain the product/code, the date the product was held/released, the reason for the hold, the amount of product held (e.g., back to the point where the process was last in control), the results of the evaluation/sort (e.g., the amount analysed and an analysis report of the number and nature of defects).
• The records further contain information about the disposition of the held product (e.g., the amount sorted, amounts destroyed, amounts reconditioned, amounts disposed of through employee sales, distress or salvage, and retail sales).
• Records include the signature of personnel responsible for the hold and evaluation, and the signed authorization for disposition.

Corrective Action

• Records identify the cause of deviation, the corrective action taken to correct the deficiency, and a follow-up/assessment to gauge the effectiveness of the corrective action.
• Records include the date the corrective action was taken and verified and the signature of person responsible.
• Records further include the preventative action plan that was developed as a result of the product deviation.

7.2.4  Verification Records

Rationale

Records show the results of verification and confirm the effectiveness of control measures.

Assessment Criteria

• Records of verification include the methods utilized, the date, the individuals/organizations responsible, the results/findings and the action taken.

7.3 EQUIPMENT

7.3.1  Equipment and Instrumentation Maintenance and Calibration Records

Rationale

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

Assessment Criteria

• In Maintenance Records for critical equipment, the importer typically includes an identification of the equipment, the maintenance activity, the date of maintenance, the person responsible, and the reason for the activity.
• In Calibration Records for critical equipment, the importer typically includes an identification of equipment, the date of calibration, the person responsible, the calibration results, the reference standard and the materials used.

7.4  PREMISES

7.4.1  Water/Ice Quality Records

Assessment Criteria

• The importer has records available to demonstrate the adequacy of the microbiological and/or chemical safety of the water supply, including Water Potability Records and Water Treatment Records.
• Water Potability Records include identification of the water source and the sample site, the date the sample was taken, the analytical results, the name of the analyst and his/her certification/accreditation.
• Water Treatment Records include identification of the method of treatment, the date of the treatment, the sample site, the analytical results, the name of the analyst and his/her certification/accreditation.

7.5  SANITATION AND PEST CONTROL

7.5.1  Sanitation Records

Assessment Criteria

• The records of sanitation activities include the date, the person responsible, the findings, the corrective action taken, and the microbiological test results where appropriate.

7.5.2  Pest Control Records

Assessment Criteria

• Minimum pest control records include:
  • the results of the inspection programs and the corrective action taken (e.g., the findings in traps, the location of insect infestations);
  • a record of pest control activities (e.g., the pesticide used, the method and location of application, the dates of fumigation, etc.), including the date;
  • the person responsible and their qualifications.

7.6  COMPLAINT HANDLING AND RECALLS

7.6.1  Complaint Records

Rationale

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

Assessment Criteria

• The establishment maintains detailed records of consumer complaints received and the investigation, including corrective action taken.

Consumer Complaints

• The importer's records contain, at a minimum
  • the name, address and telephone number of the complainant, and the date the complaint was received;
  • details of complaint and/or illness;
  • the product's name, code and size;
  • the retail outlet where the product was purchased.

Investigation

• The importer's records contain, at a minimum
  • the name of person responsible for the investigation;
  • the action taken (concerning the product and/or the process) as a result of the investigation;
  • the corrective action taken to prevent a recurrence;
  • a follow-up/assessment of the effectiveness of the corrective action.

7.6.2  Distribution Records

Assessment Criteria

• Distribution records contain sufficient information to permit a product to be traced to a particular code or lot number. The importer has, at a minimum, distribution records containing:
  • the product identification (e.g., the product's common name, its code marks or lot numbers, the manufacturing establishment where it was produced, its date of production, its date of importation, its size).
• Records further specify the purpose of the recall and the amount of recalled product(s), broken down as follows:
  • the total quantity of the recalled food originally in the importer's possession;
  • the total quantity distributed at the time of the recall;
  • the total quantity remaining in the company's possession.
• Records further include the areas where the recalled food was distributed by regions, cities and provinces:
  • including retailers' and wholesalers' names and addresses;
  • including customer names, addresses and phone numbers to the initial level of product distribution.
• Records also provide information on any other product which could be affected by the same hazard.

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8.0  COMPLAINT HANDLING AND RECALLS

8.1 COMPLAINT HANDLING

8.1.1  Product Complaints

Rationale

Product complaints are an important indicator 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

• The importer has a system in place to handle and investigate product complaints as follows:
  • the importer has identified the person or persons responsible for receiving, evaluating, categorizing and/or investigating complaints;
  • complaints are accurately categorized according to safety, composition, quality and other regulatory concerns;
  • potentially serious complaints are forwarded immediately to appropriate personnel for action;
  • safety and contamination complaints are investigated by appropriately trained technical personnel;
  • examination of the complainant's specimen, the retail product or other product of the same code is conducted on complaints related to food safety;
  • complaints pertaining to composition, quality, fraud and other regulatory concerns are investigated in an effective manner;
  • the depth of the investigation is appropriate to the risk and similar complaint trends;
  • appropriate corrective action is taken for deviations identified during the investigation.

See Section 7.6.1, Complaint Records

8.2 RECALL SYSTEM

8.2.1  Recall Procedure

Assessment Criteria

• The written procedure identifies the person or persons responsible (e.g., recall coordinators) and the roles and responsibilities of those who coordinate and implement a recall.
• The procedure specifies methods to identify, locate and control recalled product, and includes a requirement to investigate other products that may be affected by the hazard, and should be included in the recall.
• The procedure requires that the recall be monitored to assess its effectiveness (e.g., an "effectiveness check" is conducted to the appropriate level of distribution specified in the recall notice).
• Records on the recall and on the effectiveness check are available.
• The Canadian Food Inspection Agency is immediately notified in the region where the importer is located. This notification includes the following:
  • the amount of product produced, the amount in inventory and the amount distributed;
  • the name, size, code or lot numbers of the food recalled;
  • the area in which the product was distributed (e.g., local, national, international);
  • the reason for the recall.

8.2.2  Recall Capability

Assessment Criteria

• The importer demonstrates the capability to provide accurate information on a timely basis, to verify the company's capability to rapidly identify all affected product and remove it from the marketplace. For example, the importer conducts periodic testing (e.g., internal simulations) to verify capabilities to control a code lot and to reconcile the amount of product produced imported, in inventory and in distribution. (Note: Importers should also be able to verify that their procedure will identify other lots that might have been affected.) Any deficiencies in the recall procedure are identified and corrected.

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GLOSSARY

Allergens - for the purposes of this document, those substances that may cause serious or life threatening reactions in sensitive segments of the population. Allergens include: peanuts; tree nuts (almonds, Brazil nuts, cashews, hazelnuts [filberts], macadamia nuts, pecans, pinenuts, pistachios, walnuts); sesame seeds; milk; eggs; fish, crustaceans (e.g., crab, crayfish, lobster, shrimp) and shellfish (e.g., clams, mussels, oysters, scallops); soy; wheat; sulphites.

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 - the procedure by which official certification bodies and other officially recognized bodies provide written or equivalent assurance that foods or food control systems conform to requirements. Certification may be, as appropriate, based on a range of inspection activities which may include continuous on-line inspection, auditing of quality assurance systems and examination of finished products. (Codex)

Control - means that an operation performs consistently within pre-determined 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 with a constant composition, quality and net quantity.

Control (noun) - the state wherein correct procedures are being followed and criteria are being met.

Country of Origin - for the purposes of food labelling, that country where 51% or more of the cost of the product was incurred, including manufacturing and labour, and where the product came into being.

Corrective action - the actions to be taken when the result of monitoring a Critical Control Point (CCP) indicates 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 should be 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 factor - any property, characteristic, condition, aspect, or other parameter, variation of which may affect the safety, quality, composition or quantity of the product or the process beyond critical limits.

Critical limit - a value which separates acceptability from unacceptability.

Container size - for the purposes of this document, container size includes the full range of sizes from the smallest size of the containers sold at retail to include bulk amounts in packages sold per litre, kilogram, etc.

Deterioration - for the purposes of 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 or quality of the food.

Deviation - failure to meet the critical limits or other specified requirements for a critical factor.

Deviation procedure - a pre-determined and documented set of corrective actions which are implemented when a deviation occurs. The goal is to re-establish control of the process and hence, of the affected product.

Documents - for the purposes of this text, documents refer to written formulae, procedures or specifications used by, or required of, an importer or manufacturer.

Final use of product - the nature of the product at the time of sale (for example, ready-to-eat, re-processed, repackaged).

Food - please refer to definition in the CFIA Import Policy document.

Handling instructions - instructions on the label or in the product description document explaining how the consumer should store or handle the food in preparation for eating (i.e., keep refrigerated after opening, keep frozen, cooking instructions - microwave or oven cooking).

Hazard - the potential to cause harm. A biological, chemical or physical property that may cause an unacceptable consumer health risk, or a problem/situation that may cause a deviation in the composition or quality of a food product.

Incubation - tests in which the heat processed products are kept at a specific temperature for a specified period of time in order to determine if outgrowth of microorganisms or other problems occur under these conditions.

Inspection areas - for the purposes of the Section 3.2.2 of this document dealing with lighting requirements, any point where food products or containers are visually inspected or instruments are monitored.

Labelling instructions - details required on the label and in the product description document as per the Consumer Packaging and Labelling Act & Regulations, or applicable labelling sections in other Acts and Regulations enforced by the CFIA.

List of ingredients - a listing of ingredients and components (ingredients of ingredients) of a food product, listed in descending order of their proportion by weight.

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 CCP (or other activity) is under control.

Origin of product - for the purposes of the Product Information described in Section 1.1.1, the country in which the product was manufactured or grown.

Packaging material - the type of container in which the product is packaged (e.g., glass, wood, plastic, cardboard).

Product specifications and characteristics - for the purposes of Section 1.1, Product and Shipment Information/Specification Product Description, including the Shipment Information sub-section, those features that characterize the product by identifying safety and quality risks, and handling and storage requirements. Examples include frozen foods, canned foods, low-acid canned foods, acidified-low-acid-canned foods, marinated foods, foods with > 4.3 pH., foods packed in 6% sugar or packed in light syrup, etc.

Product description - the defining characteristics of a product that enables its identification.

Product name - the common name of the food as set out by the Food and Drug Regulations: a) the name of a food printed in bold name type in the Food and Drug Regulations; b) the name prescribed by any other Regulations; or c) if the name is not so printed or prescribed, the name by which it is commonly known. Examples include: canned apple sauce, milk chocolate, whiskey, bottled water, (naming the fruit) juice, frozen mixed vegetables, dried kidney beans, etc.

Product specifications - are the measurable levels and tolerances of characteristics which influence the level of risk associated with each product.

Product variety - the specific type of the commodity (where applicable), such as Macintosh apples, 1/a pears.

QMS - Quality Management System - one of the six principles outlined in the CFIA Import Policy document.

Recall: periodic testing - internal activities conducted on a periodic basis to verify the capability of the importer to rapidly identify and control a given lot of product. These activities do not necessarily require the importers to contact customers.

Records - for the purposes of this document, observations and measurements recorded by an importer and a manufacturer to determine adherence to critical limits or other specified requirements for critical factors or critical control points.

Health Risk - an estimate of the likelihood of the occurrence and the likely magnitude of the consequences of an adverse event to animal or human health in the importing country during a specified time.

Spoilage - a process whereby food is rendered unacceptable through microbiological or chemical reaction.

Vendor - for the purpose 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 importer 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.