Improved Food Inspection Model
Revised Draft

Consultation: The Revised Draft Improved Food Inspection Model

Overview
Guide for navigating the document
1.0 Introduction
2.0 Licensing
3.0 Risk-based inspection oversight
- Introduction
4.0 Overview of inspection
5.0 Imports
6.0 Exports
7.0 Compliance and enforcement
8.0 System performance and continuous improvement
9.0 Transparency
Annexes

Overview

Canada has one of the best food inspection systems in the world. However, in response to pressures from increased globalization in the food industry and advances in science and technology, the Canadian Food Inspection Agency (CFIA) is modernizing its approach to food inspection to maintain a robust approach to food safety and consumer protection. The proposed move towards a more prevention focussed and systems-based approach under the improved food inspection model would enable both the CFIA and regulated parties to more readily adapt to emerging global and scientific trends. Canadians will continue to be protected by an effective food safety system that is both science- and risk-based.

The intent of the inspection modernization initiative is to build on the existing, strong foundation by standardizing the approach to inspection and providing for consistent and appropriate oversight across all regulated food commodities. Continuous improvement is a hallmark of a modern, well-functioning food safety system.

On November 22, 2012, the CFIA achieved an important milestone in its food safety modernization efforts, when the Safe Food for Canadians Act received royal assent. The proposed new and stronger approach to inspection across all food is consistent with and complementary to the new Safe Food for Canadians Act. The Act sets the broad framework for a new approach to food safety and provides the legal basis for consistent regulatory requirements and inspection approaches across all food.

Reaction from stakeholders to the initial draft was generally supportive and positive with requests for

more details,
adequate training and guidance,
incremental implementation and time to transition,
an open and transparent system, and
clear communication and continued consultation.

The key concepts of the model remain the same. This document describes the details of the CFIA’s proposed improved food inspection model and outlines the actions and activities the CFIA will undertake to verify compliance with federal food legislation in Canada. This revised draft was prepared taking into account the feedback obtained from CFIA employees, front-line inspectors, bargaining agents, regulated industry, consumer groups, and federal/provincial/territorial and international partners.

This draft includes additional details about the following:

licensing: who is and is not subject to licensing and the proposed general processes for applying for, issuing, amending, suspending and cancelling a licence
preventive control plans: draft expected outcomes and associated performance criteria for each element, including more details on the licence holder’s responsibility for monitoring and verifying that the preventive controls are functioning as intended and that the plan is effectively achieving food safety and regulatory compliance
inspection: activities designed to assess whether the licence holder’s preventive controls effectively achieve food safety and regulatory compliance, including a description of the standardized process that CFIA inspectors will undertake to verify industry compliance with regulatory requirements and guidance on how non-compliance would be assessed using a systems-based approach
the risk-based framework: how to assess risk to determine the level of oversight and frequency of inspection
a single compliance and enforcement framework: the range of responses that CFIA inspectors may use to address non-compliance by a regulated party
system performance: ways to measure whether the food inspection program is being delivered consistently and effectively and whether what the CFIA and the regulated parties are doing is achieving the intended food safety outcome
terminology: a glossary to provide for a consistent interpretation of terms used in the draft model

All of the requirements, activities and actions described in this model were developed to promote the preparation, importation and exportation of safe and compliant food, and should be applicable to all food commodities. Representatives from the CFIA's plant and animal programs provided input during the early stage of model development. While the model is currently focussed on food, the CFIA is moving forward to include these program areas as well.

The CFIA is currently redesigning many of its business functions to support this model. This diagram illustrates those that are necessary to support the core components of the model, as defined by Licensing, CFIA Oversight, Inspection, Compliance and Enforcement, and System Performance.

This diagram identifies which current CFIA functions, including both service delivery and core activities, would remain intact or would change.

This diagram identifies which current Canadian Food Inspection Agency functions, including both service delivery and core activities, would remain intact or would change.

The CFIA welcomes input and feedback on this draft of the improved food inspection model and intends to finalize the model in spring 2013.

Guide for navigating the document

A key component of the proposed model is the mandatory licensing of importers, exporters and domestic food businesses that prepare food for interprovincial and export trade. Section 2 and Annex A outline the conditions and processes around licensing.

A key requirement of the licensing regime is the condition that licence holders develop and implement effective preventive control plans suitable to the size and complexity of their operations. Section 2 and Annex B provide additional details on the proposed elements of the preventive control plan and the expected outcomes and performance criteria. CFIA inspectors would be guided by the inspection activities described in Annex B to assess how effectively a licence holder’s preventive control plan achieves regulatory compliance with the expected outcomes.

Section 3 provides information about the risk-based inspection framework and the elements the CFIA would consider when the determining the level of inspection oversight. The CFIA will prioritize inspecting licence-holder’s where the consequence of non-compliance would have a greater impact on public health.

Section 4 and Annex C provide an overview of inspection, including work planning, priorities and the general procedures inspectors would follow when conducting an on-site or follow-up inspection.

Section 5 and Section 6 cover the unique aspects associated with imported and exported food commodities. The licensing conditions proposed under the model apply to both importers and exporters, including the requirement to develop, implement and maintain a preventive control plan. Importers and exporters may need to develop alternate strategies to address risk. For importers, some examples of alternate strategies are included in Annex B exporters will need strategies to meet the foreign country’s regulatory requirements. In both cases, the Product and Process Control element of the preventive control plan would need to reflect controls appropriate to managing compliance with either Canada’s import requirements or the foreign country requirements in the case of exports.

Section 7 and Annex D are dedicated to a single, streamlined compliance and enforcement strategy across all food. Annex D provides an overview of the range of possible responses the CFIA may use to respond to an incident of non-compliance.

Section 8 System performance and continuous improvement and Annex E outline a system for continuous improvement, which focusses on consistency and quality of delivery, system design and overall system performance. As part of inspection modernization, the CFIA proposes to introduce a more systematic way of monitoring and evaluating overall effectiveness of the food safety system. While additional development in this area is required, some preliminary key performance indicators are outlined for stakeholders’ consideration in Annex E.

Section 9 provides a general overview of how transparency would be applied under the proposed model. The CFIA has made a commitment to providing the public with useful and timely information on its programs and services, regulatory requirements, and the outcomes of its enforcement actions and decisions. The CFIA is examining opportunities for making the results of inspection available to the public to enable consumers to make informed buying choices.

Annex F provides an overview of the CFIA’s initial thinking about exemptions. Further consultations on exemptions will be carried out as part of the CFIA’s regulatory modernization initiative.

Annex G provides a draft glossary of terminology. It is designed to standardize the language used and support consistent interpretation of terminology used in the food inspection program.

Throughout the document, there are grey call-out boxes containing information on changes from the initial draft improved food inspection model.

1.1 CFIA’s legislative authorities

The CFIA plays a key role in maintaining Canada's food safety system. The Agency has a mandate to administer and/or enforce food-related standards and other requirements.

The Safe Food for Canadians Act received Royal Assent on November 22, 2012. It consolidates authorities and requirements covered by the Canada Agricultural Products Act, the Fish Inspection Act, the Meat Inspection Act and the food provisions of the Consumer Packaging and Labelling Act. The Food and Drugs Act and regulations will continue to apply to all food sold in Canada.

Once the Act is in force, the CFIA will rely on the authorities of the Safe Food for Canadians Act to carry out its mandate with respect to food safety. New regulations will be made under the Act; however, in the interim, the existing legislation and related regulations will remain in force.

1.2 Guiding principles

The CFIA’s inspection modernization initiative will apply food safety management concepts that are globally recognized for how effectively they achieve the safety and suitability of food for human consumption and trade. These globally-recognized concepts build from the foundation of prevention. They include systems-based, performance-based and risk-based approaches that are

founded on science, based on risk, and use common inspection procedures and tools;
aligned with international standards, such as those developed by Codex Alimentarius¹;
based on the premise that industry is responsible for its products and processes and must demonstrate ongoing compliance with legislative requirements;
flexible, to accommodate the complexity and size of an operation; and
supported by information management / information technology (IM/IT) solutions that will facilitate planning, reporting and decision making.

Canada is not alone in using a risk-based approach. Food inspection systems in the United States, Australia, New Zealand and other countries are also adopting risk-based approaches that compare risk across food commodities.

1.3 Roles and responsibilities

1.3.1 Regulated parties

Regulated parties are responsible for complying with the law. They demonstrate this commitment to complying with the law by understanding their roles and responsibilities with regard to the Acts and regulations that apply to them and ensuring that food commodities and processes for which they are responsible meet regulatory requirements. Regulated parties also provide the CFIA with input and information that is essential for regulatory decision making and for setting regulatory requirements and standards.

1.3.2 Roles and responsibilities of the CFIA

The CFIA verifies industry compliance through activities that include licensing, inspection, surveillance, sampling and testing. These activities are used to assess whether a licence holder has developed, documented, implemented and maintained written preventive control measures, whether these measures are effective, and whether regulatory requirements and licence conditions have been met. Where non-compliance is identified, the CFIA takes appropriate compliance and enforcement action.

The CFIA derives its inspection authorities through Acts and regulations and is responsible for enforcing requirements in the Acts and regulations.

The CFIA has regulatory oversight and responsibility for interprovincial and internationally-traded food commodities and shares responsibility for the health and safety of intraprovincially-traded food commodities with provinces and territories.

2.0 Licensing

Introduction
2.1 Parties subject to licensing
2.2 Licensing requirements
2.3 Period of validity
2.4 Issuing, renewing and amending a licence
2.5 Suspension of a licence
2.6 Cancellation of a licence
2.7 Preventive control plans

Introduction

To support regulatory oversight activities, the CFIA requires information from regulated parties. The CFIA needs to know where food businesses are located and what activities they are conducting in relation to food commodity preparation and sale. Licences would allow the CFIA to authorize a regulated party to conduct a specific activity and, where relevant, to attach specific conditions to these activities.

A single, non-transferable licence would be issued to the applicant to carry out his/her operations. The licence would describe all relevant activities the applicant is approved to conduct; additional licences would not be required for each activity or food commodity. A licence application may be made for each physical location, a number of physical locations, or by activity (for example, import, export), at the discretion of the applicant.

2.1 Parties subject to licensing

Regulated parties who are subject to the Acts and regulations administered and enforced by the CFIA would be identified for licensing if they

import or export food commodities, or
prepare food commodities for export or interprovincial trade.

Not all operations involved in the preparation of food commodities would require a licence. Under the proposed model, some may not be subject to licensing. For example, operations not subject to licensing would include

those that sell food only within the province (intraprovincial²) but that must meet the requirements of the appropriate legislation (for example, the Food and Drugs Act)
transporters
any facilities that store food but that are not involved in importing, exporting or preparing food
retailers that are not involved in importing or exporting food but that must meet the requirements of the appropriate legislation (for example, the Food and Drugs Act)

Generally, primary producers, such as field crop growers and commercial fishers, would not be covered by the proposed licensing regime. However, in certain circumstances, primary production sites are the only effective mitigation point for food safety risks. The CFIA may require licensing of these primary producers. Any final decision from the CFIA in this regard would include a comprehensive policy review and consultation process.

Operations not subject to licensing may choose to apply for a licence under the federal scheme. If a licence were to be issued, the licence holder would be subject to all requirements of the federal legislation and the licensing regime.

2.2 Licensing requirements

An applicant for a licence must be located in Canada to enable the CFIA to carry out inspection activities and take compliance and enforcement actions as necessary.

As a condition of obtaining and maintaining a licence, applicants would be required to

implement a written preventive control plan to meet food safety and other regulatory requirements,
complete a licensing application, and
pay the licence fee.

Preventive control plans must be made available to the CFIA upon request.

2.3 Period of validity

The CFIA is currently proposing a two year licence period.

The CFIA is currently proposing a two-year licence period. A licence would be valid for the period indicated on the licence certificate. Licence holders may apply to renew their licence upon expiry.

A listing of valid licence holders could be published on the CFIA external website.

2.4 Issuing, renewing and amending a licence

The following subsections outline the approach that would be used for issuing, renewing and amending a licence. Additional information on the approach, including a draft licence application form, can be found in Annex A.

2.4.1 Issuing a licence

A pre-licensing inspection may be required for high-risk activities and would be a priority for first-time applicants. Notification would be sent if a pre-licensing inspection is required.

In order to obtain a licence, the applicant would be required to submit a licence application to the CFIA. A new licence would be required if the ownership of a food business (legally responsible party) were to change.

2.4.2 Renewing a licence

A licence holder would be permitted to apply for renewal before the end of the licence’s period of validity. A licence could not be renewed if there were any outstanding penalties or fees.

2.4.3 Amending a licence

A licence holder would be required to request an amendment to their licence when there is a change in their business profile or operations. The licence holder’s preventive control plan would need to be updated to reflect any changes.

Amendments could also be made by the Minister (or delegate) with or without a request from the licence holder.

2.5 Suspension of a licence

Reasons to suspend a licence include the following:

the licence holder had committed deceptive practices to obtain the licence, such as providing false or misleading information to the CFIA;
the licence holder had failed to comply with the conditions of the licence or with regulatory requirements;
the licence holder had failed to address and/or correct regulatory non-compliance;
there are unpaid fees or administrative penalties;
the licence holder had obstructed or hindered a CFIA inspector from exercising their powers, or carrying out their duties or functions; or
public health would be endangered if the operations were to continue.

The suspension would continue until the reason for the suspension was resolved or, if unresolved, until a decision to cancel the licence was rendered or the licence expired.

2.6 Cancellation of a licence

A licence may be cancelled for reasons that include the following:

the licence holder had committed deceptive practices to obtain the licence, such as providing false or misleading information to the CFIA;
the reason for the suspension cannot be resolved;
the licence holder continued to operate while his/her licence was suspended or
public health would be endangered if the operation were to continue.

2.7 Preventive control plans

Globally, retailers are also starting to require their suppliers to demonstrate that food safety oversight systems and approaches are effective. Preventive control plans are recognized internationally as the best way to mitigate and demonstrate that food safety risks and hazards are controlled or eliminated.

As a condition of a licence, anyone who imports, exports or prepares food commodities destined for interprovincial trade or export is required to develop, document, implement, and maintain a preventive control plan³ suitable to his/her operations. The requirement for the preventive control plan and its content would be set out in regulations.

To assist small industries in meeting this requirement, the CFIA is considering developing model systems and tools as available resources. The CFIA’s Compliance Promotion Strategy is currently under development and will outline possible ways by which industry can seek assistance. Some sectors have already implemented preventive control systems to meet compliance (for example, voluntary Food Safety Enhancement Program, Quality Management Program). They would be able to transition to the new model with little or no adjustment.

A preventive control plan is a systems-based approach that focusses on prevention as a way to achieve food safety and other regulatory compliance. This approach would require licence holders to consistently monitor and control their operations, correct any deviations as they occur, and maintain ongoing compliance. The process of managing a preventive control plan would continually generate new information that could be used to actively improve operations in ways that maximize food safety and regulatory compliance.

2.7.1 Elements of a preventive control plan

Depending on the nature of the operation, preventive control plans would include some or all of the following elements:

processes and products
sanitation and pest control
employee hygiene and training
equipment design and maintenance
physical structure and maintenance of the establishment
receiving, transportation and storage
traceability, recall and complaints

The eighth element – company verification process – from the initial draft has been embedded in the management of preventive control plans.

The licence holder would be responsible for developing a preventive control plan that ensures his/her operation meets these outcomes and performance criteria, including ways to continually verify the effectiveness of the plan.

The preventive control plan would have to address the following:

a. Food safety hazards and controls

The plan would have to

identify potential food safety hazards at any stage in an operation or in the food commodity, and specify control measures for these hazards, including any critical limits;
describe how the licence holder would validate that the control measures will achieve the critical limits and the outcomes before implementation; and
describe how the control measures would be re-validated whenever there is a change that may impact the process parameters.

b. Other regulatory requirements and controls

In preparing the revised draft model, the CFIA has refined the outcomes and measurable performance criteria (see Annex B) for each element of the preventive control plan.

The preventive control plan would have to identify other regulatory requirements for the food commodity and specify control measures for these requirements (for example, product composition, allergens, net quantity, quality [grade], label declarations).

c. Monitoring procedures

Monitoring confirms that food safety and other control measures are followed, and would include

identifying an appropriately-trained responsible person(s)
establishing and following the monitoring frequency
recording the monitoring results
establishing procedures to follow when deviations occur, including isolation of potentially-affected food commodities or production lots

d. Verification procedures

Verification procedures confirm that monitoring procedures are followed and control measures are capable of consistently achieving the outcome, and would include

identifying an appropriately-trained responsible person(s), other than the person(s) who conducts the monitoring
establishing the verification frequency
recording the results of verification
establishing procedures to follow when deviations occur
where sampling and testing are used (of the environment or a food commodity), the procedures would
- be described
- use techniques that do not contaminate the samples
- use accepted test methodologies that provide accurate and meaningful results

e. Corrective actions

The preventive control plan would outline steps that would be taken following a deviation, and would include

determining the root cause of the deviation, and preventing recurrence;
controlling the food commodity by
- determining if the food commodity is safe for consumption and suitable for use and
- bringing an affected food commodity into compliance or disposing of it as appropriate; and
recording corrective actions taken.

f. Management review (review by the licence holder)

The licence holder would review the preventive control plan and its associated records to assess its ongoing effectiveness. The review would include

identifying team members who will conduct the review
establishing the review frequency (at least annual)
determining whether the preventive control plan has achieved the outcomes
identifying and implementing necessary changes for continuous improvement
recording the results of the review

g. Records⁴

The preventive control plan would outline all records associated with each element of the preventive control plan and where and how long they would be retained, including

validation of critical limits
monitoring
deviations and corrective actions
verification
management review by licence holder

3.0 Risk-based inspection oversight

Introduction

Introduction

The CFIA, like all other similar regulatory agencies in the world, uses scientific knowledge and risk analysis to inform its inspection activities. It is well understood that different food commodities and different preparation or processing approaches pose different risks.

Risk is generally determined by the scientific process of risk assessment in line with the Codex Alimentarius Working Principles for risk analysis. This process, among other things, considers the:

biological, chemical and physical hazards that are reasonably likely to occur in relation to a food commodity – Hazard Identification;
process used to prepare the food commodity (for example, the likelihood a hazard could be introduced during preparation and/or the likelihood a hazard is controlled or reduced through the effective application of preventive controls) - Hazard Characterization;
volume of production and target consumer groups – Exposure Assessment; and;
potential for illness to occur and impact consumers, if hazards are not adequately and properly controlled, reduced or prevented – Risk Characterization.

Food commodity risks posed by biological, chemical and physical hazards must be managed or eliminated during food production, processing, importing and distribution. It is the responsibility of licence holders to produce safe food and mitigate food safety risks associated and demonstrate a commitment to a food safety culture within their operations by preventing, eliminating or reducing the risk to an acceptable level either through processing controls (for example, heat treatment) or through cross contamination controls (for example, sanitation and hygiene).

The CFIA uses various information sources (for example, environmental scanning information, Codex Alimentarius standards, effectiveness of preventive control plans as demonstrated through inspection data and compliance data) and has implemented a number of monitoring and surveillance programs to expand the mapping of food-hazard combinations. This type of information, along with risk assessment, assists the CFIA in informing its approach for risk management, part of which is inspection oversight.

Currently, the eight different food commodity programs are using somewhat different risk management approaches. The current risk management approaches are not accessible and are not structured similarly.

In some cases, inspection activities and oversight are also affected by international requirements. Based on foreign country requirements, some licence holders are subject to specific oversight requirements for eligibility to export to certain countries. Generally, these considerations flow from some countries having different standards for commodities. Canada also applies specific requirements to imported food commodities to establish compliance with our standards. For example, imported dairy products must be manufactured from sound raw materials, prepared under sanitary conditions, and, at the time of shipment to Canada, must be sound and fit for human consumption to be considered to meet Canada’s import requirements. Canada ’s regulatory requirements for food specify a consistent expectation for safety of all food commodities.

The CFIA takes the information related to the risk and national and international standards (such as those developed by Health Canada or the Codex Alimentarius Commission), as well as international obligations into consideration as it organizes its inspection activities. Consequently, under the current food inspection system, establishments preparing or handling high risk commodities, such as ready-to-eat meat, for example, have daily inspector presence; while establishments preparing lower risk commodities, such as dry pasta and honey products, are inspected only on a periodic basis.

What is being proposed?

To improve inspection oversight, on a risk basis, the CFIA is proposing to:

take a more structured approach to analysing risks related to different food commodities by:
1. updating food commodity risk information on a regular basis to take into consideration any developments in science, experiences in Canada or other countries, or new information;
2. making the risk information more accessible and transparent; and
3. applying this approach across all food commodities.
add a common systematic approach to assessing the track record of licence holders (including associated surveillance and recall data and the licence holder’s compliance history) to determine if inspection activities need to be strengthened , enhanced and/or improved. For example, once a licence holder has established a compliance history, the intensity of inspection and/or methods of inspection may be adjusted to correspond with the licence holder’s effectiveness in preparing safe and compliant food.

The CFIA would rank food-hazard combinations from high to low in likelihood to pose a public health or trade impact. This ranking approach would allow the CFIA to apply a base level of inspection by food sector.

On a predetermined basis, the CFIA would review the food commodity risks and licence holder track record history to confirm and/or update its information inventory. Based on the information, the CFIA would direct its inspection activities and resources in a manner that would reflect the consequences that non-compliance could have in relation to the potential for an adverse impact on public health. Of course, the CFIA would also continue to take into account any specific requirements of other countries to facilitate access to export markets.

In addition to the risk factors and the international obligations to maintain access to export markets, there are a number of triggers that could initiate an inspection. These include:

response to food safety complaints or illness investigations
results of concern from an inspection process or sampling
information about a potential issue received from
- a third party
- another government department
- an international trading partner
a request for inspection by a licence holder (for example, for export marketing purposes)

How would all of this work?

This systematic and structured risk-based approach would help the CFIA enhance its determination:

of whether an inspection is required prior to licensing
at what intensity the CFIA would inspect domestic food establishments and importers, and
of how the CFIA would conduct activities like market surveillance and border blitzes.

Graphic 1 is provided to illustrate how the CFIA would apply the proposed structured approach to conducting a food commodity risk analysis that would lead to the determination of a base level of inspection.

Graphic 1: Factors in determining a base level of inspection

A base level of inspection would be applied to all food business operations based on the determination of the food commodity risk. Therefore the base level of inspection would be based primarily on the risks associated with the food hazard-process combination. From a risk management perspective, the CFIA would group food commodities and preparation processes with similar levels of risk and apply a base level of inspection to each grouping. For example, licence holders who prepare or import ready-to-eat foods (for example, cheese and chopped salads) that support the growth of pathogens like salmonella (biological hazards) may be subject to a different base level of inspection than licence holders who prepare or import ready-to eat foods that are shelf-stable (for example, honey products and bakery products) and do not support the growth of pathogens.

From the base level of inspection, inspection activities would be adjusted depending on the track record of the licence holder as it respects compliance with food safety and other regulatory requirements. Using the enhanced approach, if a trend in non-compliance was observed at a specific licence holder’s operation, the CFIA could:

enhance its inspection oversight by adjusting the frequency, intensity or type of inspection activity (for example, use of enhanced directed sampling and testing when there is a recurring microbiological issue) and/or
apply other compliance and enforcement tools to support continued compliance.

Any inspection activities required to support export market access would be performed as part of the base level of inspection, as applicable. Graphic 2 is provided as an example to illustrate how a specific licence holder’s track record may impact the base level of inspection.

Graphic 2: Consideration of track record

Food science knowledge and tools available for analysing the risks associated with food are in constant evolution. Canada is committed to using the most modern tools and systems as it respects risk management and delivery of its inspection activities.

4.0 Overview of inspection

Introduction
4.1 Inspection work planning and priorities
4.2 Inspection procedures

Introduction

The purpose of the CFIA’s inspection is to assess whether a licence holder has developed, documented, implemented and maintained written preventive control measures, whether these measures are effective, and whether regulatory requirements and licence conditions have been met.

Inspection activities related to a preventive control plan would be organized by the seven elements of the preventive control plan. Inspectors would use a combination of traditional inspection where the focus is on the end-product and processing environment and audit techniques (such as record review, interviews, and observation) for assessing compliance and evaluating the impact of non-compliance.

4.1 Inspection work planning and priorities

The CFIA’s inspection activities are determined from a national work plan. As a government agency, the CFIA is accountable to the public for showing how it allocates its resources. In terms of CFIA’s inspection activities, this is accomplished through the work planning process.

Work plans indicate the number of inspectors the CFIA has and the amount and type of inspection activities they will perform each fiscal year. The various CFIA District Offices across Canada use the national work plan as a basis of their individual office work plans.

4.1.1 National work plan

As the national work plan is developed, inspection priorities would be based on risk and compliance data and could consider

inspection and surveillance data
environmental scanning
recalls and illness investigations

There are a number of triggers that could initiate an inspection that is not part of the work plan. These include

food safety complaints or illness investigations
results of an inspection process or sampling
information about a potential issue received from
- a third party
- another government department
- an international trading partner
a request for inspection by a licence holder (for export or marketing purposes)

If the CFIA observes a trend in non-compliance, the work plan could include targeted surveillance activities. For technical incidents of non-compliance, a targeted inspection response might be developed—which could include further clarification of the requirements or policy—followed by a compliance and enforcement strategy.

4.2 Inspection procedures

Inspection procedures provide a systematic way to approach inspections. Inspection activities could include making visual observations, evaluating records, interviewing personnel, sampling and testing.

The procedures would provide inspectors with the flexibility to adapt to different situations that may arise during an inspection; the inspector would be able to assess the potential impact of non-compliance to determine whether and what further actions are required.

There are four basic steps to inspection:

Step 1: Preparing for an inspection

Preparation for an inspection would include determining a preliminary scope. Scope can be based on the national work plan but may be adjusted for a variety of reasons (for example, changes in activity, compliance history). Preparation would also include determining whether an inspection would be announced or unannounced, reviewing the applicable Acts, regulations and other reference materials, and finally, gathering all tools, equipment and supplies needed.

Step 2: Conducting an inspection

During an inspection, all findings would be recorded, including any discussions. Additional objective evidence, such as physical samples, photographs, and copies of documents or records would also be collected. The process of conducting inspections would include the following activities:

a) Opening meeting: An opening meeting would introduce all CFIA staff and outline the scope of the inspection. It would provide the licence holder with the opportunity to confirm any changes to his or her company profile and preventive control plan (since last inspection). It would also provide the CFIA with an opportunity to update the licence holder on any changes to the inspection process and/or relevant regulations.

b) Initial walk-through inspection: This part of the inspection would serve to identify areas that should also be added to the scope of the inspection or targeted for more intensive inspection.

c) Confirmation of scope: Based on recorded observations from the initial walk-through inspection, the scope would be confirmed or amended accordingly.

d) Completion of inspection: Conducting an inspection would include using traditional and audit techniques. Namely, visual inspection, record review, interviews, sampling, etc.

e) Assigning a level of non-compliance: There are three levels of non-compliance that could be used, based on the impact on food safety:

critical : immediate impact on food safety or repeated serious non-compliance
serious : potential impact on food safety
technical : non-compliance with regulatory requirements that are not related to food safety

Renamed “other non-compliance to “technical non-compliance” to reflect the nature and the impact of the non-compliance.

If serious or critical non-compliance were detected, a corrective action request would be issued, indicating which regulatory requirement(s) had not been met. Technical non-compliances would be recorded and corrected by the licence holder, but a corrective action request would not need to be issued.

Repeated technical non-compliance would no longer escalate to serious non-compliance but would be managed through other graduated compliance actions, up to and including prosecution.

f) Completion of inspection report: The inspection report would include the inspection findings, corrective action requests issued, technical non-compliance observed and actions taken.

Step 3: Communicating the inspection results

A closing meeting would be held with the licence holder to discuss the outcomes of the inspection, including any incidents of non-compliance and next steps. The inspection report would also be shared once completed.

Step 4: Conducting a follow-up inspection:

A follow-up inspection would be conducted to confirm that the corrective action has been completed and is effective, and that any changes in the preventive control plan are documented.

For additional information on the basic inspection steps and a draft template of an inspection report, see Annex C.1.

Inspection activities have been drafted to guide inspectors in determining compliance to the performance criteria and outcomes of each element.

For details on inspection activities in relation to the elements of the preventive control plan, see Annex B.

5.0 Imports

5.1 Preventive control plans
5.2 Inspection
5.3 Surveillance

The licensing conditions proposed under the model apply equally to importers.

Some example strategies can be found in see Annex B sub-element 1.3 of Element 1: Import control outcome: Performance criteria.

5.1 Preventive control plans

Food products entering Canada must meet all regulatory requirements for safety, nutrition, composition, labelling, packaging and quality, as applicable. Importers do not have direct control over food production and would therefore need to develop other strategies to address risks.

Importers would need to include elements of the preventive control plan that apply to their operation (see Annex B). For example, importers without facilities would not be expected to address physical structure and maintenance. However, all importers would, at a minimum, need to include the following elements in their preventive control plans:

Element 1: Product and Process
Element 7: Traceability, recall and complaints

Importers who are involved in further handling or repackaging of food would need to address all seven elements of the preventive control plans.

5.2 Inspection

The proposed inspection approach in section 4.2 would be used to verify the effectiveness of the importer’s preventive control plan. The CFIA would use product surveillance and foreign country audits as a tool to determine the level of compliance for products entering Canada.

When notified by an importer of non-compliant product, the CFIA would take steps appropriate to the nature and severity of the issue to prevent further product from entering the country until corrective action had been taken at the source. The CFIA would notify all known importers of the affected product through an import alert and the competent authority in the exporting country.

The importer would also be required to submit evidence of compliance before the CFIA would give permission to resume importation of a food commodity.

Depending on the nature and severity of non-compliance, the CFIA might review technical arrangements or other bilateral agreements to determine whether amendments would be required.

5.3 Surveillance

Surveillance of imported food is a key activity when

food is prepared outside the country where requirements or competent authority oversight is not comparable, or
on-site verification of the processing controls cannot be conducted by the CFIA.

The CFIA would use product surveillance as a tool to identify gaps and trends, to determine sector performance, or to provide baseline information such as the level of chemical contaminants in certain foods. Analysis of this type of information would provide a mechanism for continuous improvement through activities such as adjusting the level of oversight priorities, changing standards or requirements, and planning work.

6.0 Exports

6.1 Preventive control plans
6.2 Inspection
6.3 Issuance of export certificates

The licensing conditions proposed under the model apply equally to exporters.

See Annex B sub-element 1.4 of Element 1: Export control outcome: Performance criteria criteria for additional performance criteria.

6.1 Preventive control plans

Food products exported from Canada must meet all foreign regulatory requirements. In addition to their domestic preventive control plan, exporters would require export controls that address any foreign regulatory requirements (for example, labelling requirements).

6.2 Inspection

The proposed inspection approach in section 4.2 would be used to verify the effectiveness of the exporter’s preventive control plan.

6.3 Issuance of export certificates

The model proposes that export certificates be issued based on the exporter’s compliance with his or her export controls, and that they could be issued without further lot-by-lot product inspection. Clearly, this approach would only be used if it were accepted by the importing country. The CFIA would continue to negotiate with its trading partners to promote this concept. If required by the foreign country, the CFIA could conduct food commodity inspection of lots to be exported.

If notified by an exporter that a non-compliant food commodity had been exported, the CFIA would take appropriate steps to monitor the recovery and control of the non-compliant food commodity. Trading partners would be alerted to this non-compliance using established protocols. The exporter would have to adjust his or her preventive controls to address this non-compliance.

7.0 Compliance and enforcement

Introduction
7.1 CFIA response when non-compliance is detected
7.2 Compliance and enforcement actions

Introduction

The model proposes to apply a single, consistent compliance and enforcement strategy across all food commodities. This strategy would be based on the principle that industry is responsible for producing safe food that complies with regulatory requirements. When non-compliance is found, industry would be responsible for taking appropriate action to correct the situation. The model aims to make compliance and enforcement transparent and appropriate to the level of non-compliance. For critical or repeated non-compliance, licences could be suspended or cancelled.

The processes that lead to inspection decisions—or compliance and enforcement actions—must be objective, impartial and equitable. They must be in keeping with the CFIA’s values and ethics and respect the regulated party’s rights.

For more information, visit the Compliance and Enforcement Operational Policy.

7.1 CFIA response when non-compliance is detected

The inspector would respond to non-compliance. Specific responses could be directed at the food commodity (for example, seizure and detention of product) and/or the regulated party (for example, issue a corrective action request). The inspector would have the flexibility to select the appropriate response based on the gravity of the non-compliance, considering factors such as the potential or actual harm, the compliance history of the regulated party and the intent.

The appropriate level, type and extent of response would depend on a range of factors, including

the potential impact or potential for harm, such as
- the degree to which non-compliance has impacted or has the potential to impact food safety, public health or consumer protection
- the magnitude of the non-compliance (critical, serious, technical)
- whether the food commodity is within the regulated party’s control
the intent of the regulated party, including
- whether non-compliance was intentional, accidental or negligent
- the extent to which the regulated party had exercised due diligence
the regulated party’s demonstrated performance, including
- its compliance history
- the history of complaints
- the level of commitment by management

When dealing with imports, the CFIA might require importers to provide documentation or information to demonstrate that the food commodity is compliant with the legislation. An importer who has a history of importing non-compliant food commodities may be required to submit evidence of compliance before the CFIA would give permission to import a food commodity. For example, an importer could be required to provide the CFIA with documentation from an accredited laboratory or other documented evidence of analytical results demonstrating compliance for five consecutive shipments following the non-compliant importation.

7.2 Compliance and enforcement actions

The CFIA recognizes that, for many regulated parties, the transition to the improved food inspection model would require time to

document a preventive control plan,
apply for a licence,
make changes to their practices, and
adapt to the risk-based approach proposed under the model.

Because many regulated parties' business models would need to evolve, the CFIA intends to conduct educational activities and employ transitional enforcement guidelines in the initial stages of implementing the model and proposed single food regulations, to give industry stakeholders time to adapt.

If there is critical or serious non-compliance, the affected food commodity would be controlled and the non-compliance would be addressed to prevent recurrence. At the end of the interim period, the CFIA would use its single compliance and enforcement strategy to respond to the non-compliance and would take action by using any of the tools found in Annex D.

Administrative Monetry Penalties (AMPs), enabled by the Agriculture and Agri-Food Administrative Monetary Penalties Act (AAAMP), are an important element of a modern enforcement and inspection regime and offer specific benefits.

AMPs allow for alternate actions to be taken to help ensure compliance with requirements, without having to immediately resort to the revocation of licences or proceedings being instituted;
AMPs provide an avenue other than the penalties section of an Act for encouraging compliance with requirements;
AMPs allow for regulated parties to request a review of the facts by the Canada Agricultural Review Tribunal; and
AMPs can take the form of either a notice of violation with a warning, or a notice of violation with a penalty determined in accordance with the AAAMP.

Under the Safe Food for Canadians Act, the CFIA will have the authority to adopt AMPs as an enforcement tool for food commodities.

8.0 System performance and continuous improvement

Introduction
8.1 Framework for the assessment of system performance
8.2 Evaluation methodology

Introduction

Mitigating risks to food safety is the CFIA's highest priority, and the health and safety of Canadians is the driving force behind the design and development of CFIA programs. Using system performance methodology that supports a philosophy of continuous improvement, measuring outcomes should deliver findings that the CFIA and regulated parties can use to adapt, improve, and become more effective at managing risks to food safety. In general, system performance is about assessing the strengths and weaknesses of the food inspection system against key outcomes.

As part of inspection modernization, the CFIA proposes to introduce a more systematic way of monitoring and evaluating overall effectiveness of the food safety system. As part of the approach, the CFIA would measure how well the single food program design, inspection activities, business processes, and services contribute to the higher level outcome of mitigating risks and protecting the health and safety of Canadians from preventable health risks. To perform the assessment, the CFIA would conduct environmental scans, evaluate field inspections, review inspection and surveillance data, and complete trend analyses on an annual basis.

The objective would be to

assess the overall effectiveness of the food inspection system
assess whether the inspection program is delivered as designed, and is delivered consistently, effectively and efficiently
identify emerging risks
identify gaps
identify areas for improvement

The results of the performance evaluation could also be used by the CFIA for

corporate reporting
benchmarking over time
international comparative analysis
continuous improvement to program design, training, and inspection delivery
adjusting work plans

To objectively measure how successfully a program has been in achieving its stated objectives, goals, and planned program activities, there must be clear and strong relationships to activities and outputs and in turn a clear and strong relationship between the outputs and the ultimate outcomes.

To build its approach to measuring system performance, the CFIA will develop a logic model to map out the logical relationships between the inputs (the resources), the activities, the outputs and the outcomes.

A logic model is a systematic and visual way to present the relationships among the resources the CFIA has to operate the program, the activities the CFIA plans to do (business processes and services that produce outputs), and the results the CFIA hopes to achieve in terms of immediate results (outputs) and outcomes.

From the logic model, the CFIA can develop key performance indicators to check whether policies, procedures and practices that are critical for food safety are successful in achieving the desired results. A key performance indicator is a selected indicator that is considered key for monitoring the performance of a strategic objective, outcome, or key result area important to the success of an activity.

Measuring performance is a CFIA responsibility. Performance indicators and targets are currently being developed to support effective performance reviews. Some preliminary key performance indicators have been included in Annex E.

8.1 Framework for the assessment of system performance

Two levels of assessment are required to ensure that system performance objectives are met. Based on the information obtained at each level, a comprehensive analysis would be conducted and systemic improvements would be scheduled and implemented through the work planning process. Higher-priority improvements should be scheduled sooner, when required.

The two levels of assessment are as follows:

Level 1:

Consistency and quality of delivery: Internal audit

Objective: To measure the consistency and quality of the delivery of the inspection program. For example:

Are work plans delivered?
Are service standards met?
Are inspection steps followed?
Are inspection forms complete and accurate?
Are decisions consistent?

Level 2:

Program design

Objective: To assess that the program is designed appropriately and is meeting food safety and regulatory objectives. For example:

Is there an effective regulatory framework?
Are policies clear, complete and current?
Does the program include appropriate tools and supporting processes, including effective training?
Does the program support innovation?
Are the outcomes clear and achievable for industry and inspectors?
Is compliance achieved?
How effectively does the system meet the CFIA’s objectives?
Is the system accepted internationally?
What is the compliance profile and trend of the industry?

8.2 Evaluation methodology

a. Review of inspection data

Targets for file and on-site reviews would be established as part of the work planning process.

b. Field observation

Specialized teams, composed of CFIA employees, would

conduct inspections for system performance, including effectiveness and quality of service delivery
use data to identify gaps and issues to facilitate continuous improvement

An on-site review would be conducted to evaluate delivery of inspection activities, with attention to

national consistency
the level of understanding of responsibilities
appropriate identification of non-compliance

As per the work plan, a field observation would be conducted, using an overlapping oversight approach that involves local and national perspectives.

c. Internal and external surveys

Surveys would be conducted on an annual basis to seek input from staff and regulated parties on the function and quality of the system and the tools provided and to seek suggestions for improvement.

9.0 Transparency

The safety of food is important to all concerned, from producers to consumers; in fact, many players are responsible for contributing to food safety. Consumers’ confidence in the safety and quality of their food supply depends in part on their perception of the effectiveness of food inspection system.

The consequences of consuming unsafe food can be significant and, if an organization is not sufficiently transparent and responsible, there is a lack of accountability, trust is damaged, and credibility is at risk. For these reasons, it is important that the CFIA operates as a more transparent organization by involving all those who have a stake in safe food.

One of the principle outputs from the CFIA’s transparency initiative is to provide information to consumers that will enable them to make informed buying decisions. However, the value of transparency is more far-reaching in terms of the impact that it can have on influencing behaviours that promote compliance and mitigate risk. The potential value of transparency initiatives is realized when

behaviours of licence holders are influenced and trends towards improvements in compliance levels are observed,
continuous improvement becomes an objective of all food businesses, and
consumers are better informed and have confidence that the food they are eating is safe and compliant with regulatory requirements.

From an outcomes perspective, the CFIA envisions that improvements in transparency will help increase the public’s understanding of the public health impact of the CFIA’s activities and will promote confidence in the safety and quality of Canada’s food supply.

The CFIA has made a commitment to providing the public with useful and timely information about its programs and services, regulatory requirements, and the outcomes of its enforcement actions and decisions.

In meeting this commitment, the CFIA began publishing information on its compliance and enforcement activities on its website in March, 2011. The information includes

food imports that have been refused entry into Canada;
federally-registered food establishments whose licences have been suspended, cancelled or reinstated; and
notices of violations with warnings and penalties, including identification of repeat offenders of animal transport regulations.

Several other initiatives have also been undertaken to improve transparency, including

Service delivery
The CFIA has released a Statement of Rights and Services that provides stakeholders with information on their rights and what they can expect from their interactions with the CFIA. Six accompanying "guides to inspection" (for consumers, producers, processors, animal transporters, importers and exporters) have also been prepared and are available.
Complaints and appeals
The CFIA’s complaints mechanism provides stakeholders with a more transparent and accessible way to register complaints and appeals. Data from this initiative can help to improve information distributed to regulated parties.
Information sharing
The CFIA is examining opportunities for making the results of inspections, licence cancellations and licence suspensions available to the public to enable consumers to make informed buying choices.

In examining approaches used by other nations with strong food safety systems, the CFIA has observed that governments that are accountable for delivering on food safety are moving to

posting online listings of food businesses that are licensed, registered or subject to government oversight;
posting online summaries of the most common inspection observations of objectionable conditions or practices that are made during inspections;
posting results from targeted surveillance activities designed to establish baseline safety or compliance levels for food commodities;
providing inspection result summaries online that include the name and address of the inspected establishment, the date(s) of inspection, type of regulated food commodities involved, and inspection findings; and
alerting the public in a consistent manner about enforcement actions by making information available through news releases and social media outlets.

Through inspection modernization, the CFIA is exploring opportunities to increase transparency related to its inspection and enforcement activities. The CFIA is considering making some changes to the way the public can access information about inspection results.

Annexes

Annex A: Details for issuing, renewing and amending a licence
Annex B: Elements of the preventive control plan: outcomes, performance criteria and inspection activities
Annex C: Basic inspection steps and draft inspection report
Annex D: Compliance and enforcement: range of possible responses
Annex E: System performance: preliminary draft indicators
Annex F: Exemptions
Annex G: Draft glossary of terms

Annex A: Details for issuing, renewing and amending a licence

The following provides additional information on the approach for licensing. More detailed procedures will be developed.

Applying for / obtaining a licence

Applicants for a licence would submit the following information to the CFIA:

Application status (applicant would check one that applies)
- new
- amendment
- renewal
Business activities information (applicants would check all that apply)
- operations importing food with storage / distribution facilities
- operations importing food without storage / distribution facilities
- operations exporting food with storage / distribution facilities
- operations exporting food without storage / distribution facilities
- operations preparing food for interprovincial trade
- operations preparing food for export
- operations not falling within one of the above categories
Contact and legal information (all fields must be completed)
- business name and operating name
  - copies of the applicant’s articles of incorporation or provincial registration, if any
- legal (civic) address (physical location) in Canada
  - all physical location(s) covered under the licence in Canada
- mailing address (if different from legal address)
- address where records will be available (if different from legal address)
- fax/telephone number, email address
- name of operator (licence holder)
- name of primary contact person at each physical location
- name of emergency contact
Business status (applicants would check one that applies)
- active
- inactive
- seasonal
Note: If an applicant’s food business is a seasonal operation, then he or she would be required to notify the CFIA of the planned start and end date for operations.
Hours and days of operation
- applicant would enter the hours of operation
- applicant would enter days of operation
Commodity information (applicants would check all that apply)
- alcoholic beverages
- non-alcoholic beverages
- confectionery, sweeteners, snack foods (containing or not containing nuts), desserts
- dairy
- egg and egg products
- fats and oils
- fish and seafood products (including bivalve molluscs)
- food chemicals (for example, additives, processing aids)
- fresh fruit
- fresh vegetables
- grain-derived foods (for example, breakfast cereal, bread and bakery, pasta)
- honey and honey products
- infant foods
- maple products
- meat and poultry
- multiple/mixed foods (for example, pizza, frozen meals, sandwiches)
- nuts, grains, seeds
- processed fruit products
- processed vegetables
- spices, herbs, flavours, condiments, dressings
- other (please specify)
Business size
- number of employees (ranges to be provided as options—applicants would check one that applies)
- annual volume of production or importation or exportation (ranges to be provided as options—applicants would check one that applies)
Food commodity type, handling information and volumes (applicants would check all that apply)
- ready-to-eat
  - pathogen reduction step
  - control of contamination
- not ready-to-eat
- importation
  - prepackaged foods only
  - foods for packaging, labelling, re-labelling, further processing
- number of different types of food commodity (ranges to be provided as options—applicants would check one that applies)
- estimated annual volume of production, importation or distribution (ranges to be provided as options—applicants would check one that applies)

Amendments and renewals

For amendments and renewals, the licence holder would access his/her unique account in the CFIA web portal; select the activity he/she needs (for example, renewal, amendment); modify the information in the application form, as applicable; pay the required fee, if any and submit.

Process for issuing a licence

Step 1: Application review

Upon receipt of the licence application, the CFIA would review it and, if an issue were identified, document the relevant facts.

The Minister (or delegate) could refuse to issue a licence if the applicant
- does not meet conditions of licensing
- has submitted inaccurate information
- has provided false or misleading information, documents or records
- engaged in deceptive practices in order to obtain a licence
The Minister (or delegate) would review the facts before rendering a decision. If required, expert advice would be sought to ensure that the licensing criteria were applied consistently.
- A pre-licensing inspection may be required for high-risk activities and would be a priority for first-time applicants. Notifications would be sent if a pre-licensing inspection were required.

Step 2: Communication of decision

If a licence were to be issued, the licence holder would be notified of his/her initial priority level, and provided the Statement of Rights and Service for Producers, Consumers, and Other Stakeholders.
If a licence were to be refused, a written notice of refusal would be sent, with the justification for the refusal.
The applicant could request a review of the refusal and present facts to support the request.

Step 3: Decision review

The CFIA is currently reviewing options for a recourse mechanism that would be made available to regulated parties following a decision to refuse to issue a licence.

Process for suspending a licence

Step 1: Initiation

The inspector would identify an issue and gather facts to support a suspension.
The inspector would inform his or her management of the facts.
The licence holder would receive a report of the inspection and would be provided an opportunity to remedy the non-compliance⁵.

Step 2: Evaluation

If the non-compliance were not addressed, the licence could be suspended. The Minister (or delegate) would review the file and possibly seek expert advice, as appropriate, to ensure that the suspension criteria were being applied consistently⁶.
The Minister (or delegate) would render a decision.

Step 3: Communication of decision

If the licence were to be suspended, the licence holder would receive a written notice of the decision, and the reasons for the decision.

Step 4: Lifting of a suspension

The licence holder would submit a written plan to address the issues that resulted in suspension of the licence.
The inspector would follow up to determine whether the issues indicated in the suspension were addressed.
If the issues were addressed, the inspector would report his or her findings and close the file. The suspension would be lifted if the Minister (or delegate) was satisfied that the issue had been addressed. Additional conditions could be imposed on the licence by the Minister.
If the issues were not resolved, the process would move to that described below (Process for cancelling a licence).

Process for cancelling a licence

Step 1: Initiation

If the inspector were to identify unresolved issues as per section 2.6 (Cancellation of a licence), the cancellation process would be initiated.

Step 2: Evaluation

The Minister (or delegate) would review the file and seek expert advice, as appropriate, to ensure that the cancellation criteria had been applied consistently.
The Minister (or delegate) would be available to meet to discuss findings, explain the process, and give the licence holder an opportunity to respond.
The Minister (or delegate) would render a decision.

Step 3: Communication of decision

The licence holder would receive written notification of the decision. If the licence were to be cancelled, this would include the reasons for the decision to cancel the licence.
The licence holder could request a review of the cancellation and present facts to support the request.

Step 4: Decision review

The CFIA is currently reviewing options for a recourse mechanism that would be made available to licence holders after a decision to cancel their licence.

Annex A.1: Draft licence application form

PDF (327 kb)

Annex B: Elements of the preventive control plan: outcomes, performance criteria and inspection activities

Each element of a preventive control plan has associated outcomes and performance criteria. A licence holder would address the criteria to support achieving the outcome.

Following the performance criteria listed below for each element, are related lists of inspection activities that inspectors could use to assess compliance.

Element 1: Product and process outcomes and performance criteria for licence holders

Expected Outcomes

1. Product and process controls contribute to the production of safe and compliant food.

1.1 Process control outcome
- The process is controlled to achieve food safety and other regulatory compliance.
1.2 Product control outcome
- Finished products are appropriately packaged and labelled, and meet regulatory requirements.
1.3 Import control outcome
- Imported foods meet food safety and other regulatory requirements, including labelling.
1.4 Export control outcome
- Exported foods meet foreign country import requirements and conditions and Canadian export requirements, where applicable.

The following performance criteria would have to be addressed by the licence holder to achieve the process and product control outcomes (1.1 and 1.2).

1.1 Process control outcome: performance criteria

a. Incoming ingredients and raw materials

identification of incoming ingredients, with written specifications, if
- there is a potential food safety concern
- an ingredient is critical to product composition and/or nutrition profile
documented handling procedures for ingredients to prevent degradation

b. Product formulation and specifications

written formula for each food commodity that is being prepared
written specifications for each final food commodity
food additives and chemicals used are permitted for use in the food commodity

c. Processing

written description of
- processing steps (for example, mixing records), associated control measures and critical limits
- food commodity movement (for example, process flow diagram)
- food commodity changeover procedures
critical limits are validated using scientific data
imported food commodities are prepared under conditions that are comparable to Canadian requirements

Rationale

Inadequate incoming ingredient / raw material controls could result in product contamination, inadequate processing or misrepresentation of the product.
Inaccurate product formulation and/or mixing could result in product adulteration, inadequate processing, etc.
Inadequate process controls could lead to pathogenic organisms, toxins, undeclared allergens and other hazards in the food.

1.2 Product control outcome: performance criteria

a. Packaging

There is a written specification for packaging materials that come in contact with food.
All packaging materials are suitable for the intended use.

b. Labelling

The information on the label is complete, truthful and not misleading, and accurately represents the content of the food commodity.

c. Finished Product

The finished food commodity is evaluated for compliance with prescribed requirements.

Rationale

Inadequate food commodity controls could result in

the use of packaging that may contaminate or permit contamination of the food commodity,
inaccurate and incomplete information on labels, and
final product that is not compliant.

The additional performance criteria below would also have to be addressed by the licence holder to achieve the control outcomes for import export (1.3 and 1.4).

1.3 Import control outcome: performance criteria

Control measures and sourcing are done to ensure that food commodities meet Canadian requirements. Possible strategies include
- selecting suppliers whose exports are certified by a foreign country competent authority,
- selecting suppliers who are identified on a list of eligible exporters by a foreign country competent authority,
- selecting suppliers who are subject to third-party audits by internationally-recognized accreditation or certification,
- auditing to confirm suppliers can meet Canadian requirements,
- selecting suppliers who conduct regular sampling and testing and provide certificates of analysis, or
- using accredited or recognized sampling and testing laboratories to do testing at the time of importation.

Rationale

Importers do not have direct control of the preparation of the food commodity; therefore, it is important to maintain effective strategies to source and verify that their products meet Canadian requirements.

1.4 Export control outcome: performance criteria

Documentation of the exported food commodity and corresponding foreign country import requirements.
Verification that the export requirements are being met, which includes records of rejected shipments to foreign countries including reasons for rejection.
- When export certificates are issued by the CFIA based on system compliance, the licence holder would notify the CFIA when a food shipment is rejected because of evidence of a food safety or public health concern in the importing country.
Control and segregation of food commodities destined for export that do not meet Canadian requirements and are not permitted to enter the Canadian marketplace.

Rationale

Food commodities for export may contain ingredients that are not permitted in Canada. Segregation would prevent the food commodities from reaching the Canadian marketplace.

Element 1: Inspection activities for process and product controls

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 1.1: Process controls

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.

a. Incoming ingredients and raw materials

Review records to determine if there is potential for any incoming ingredients and/or raw materials to contain allergens or other food hazards. Adjust the scope of the inspection, if necessary.
Check whether raw materials or incoming ingredients that could contain allergens or other food hazards are properly identified and segregated.
Observe how raw materials are received to verify that there is no cross-contamination or degradation.

b. Product formulation and specification

Review the product listing of all food commodities and adjust the scope of the inspection to incorporate higher-risk processes.
Confirm that the current formula is available for each food commodity.
- Assess any changes to product formulations for any impact on label accuracy and food safety.
Confirm that any food additives are permitted for use in the particular food.

c. Processing

Select a product that is being processed at the time of inspection, and follow it through the processing steps to confirm that
- the product formulation matches the recipe and note any product substitutions and appropriate adjustments to processing or labelling,
- ingredients and raw ingredients are accurately measured and blended, and
- processing controls are monitored and critical limits are met.
Review process validation records to confirm that processes and parameters are current.
Observe product and process flow for potential cross-contamination.
Observe that procedures are being followed for the use of rework and product changeover and that there is no cross-contamination.

Inspection activities for sub-element 1.2: Product controls

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.

a. Packaging

Confirm food packaging material meets the requirement of the Food and Drug Regulations, Part B, Division 23, Food Packaging Materials.
Observe the packaging process to verify that contaminated, damaged or defective packaging material is not used, and that the food commodity is not damaged or contaminated.

b. Labelling

Select a food commodity or commodities to verify that labels accurately represent content. For example:
- foods containing priority allergens are labelled;
- nutrition labelling requirements are met;
- all nutrition claims are factual, not false and not misleading; and
- any other labelling requirements are met, including mandatory information, type size, bilingual requirements, net quantity declarations, ingredient declarations, health or product claims.

c. Finished product

Review sampling and testing results to see if any deviations are noted and, if so, review their associated corrective actions.
- Take samples of final product, if necessary, to confirm that it is in compliance with regulatory requirements.

Inspection activities for sub-element 1.3: Import controls

Review imported product records to determine
- what food commodities were imported and from where,
- the results of control measures and sourcing to ensure that food commodities meet Canadian requirements (for example, certificates of analysis, audit results, competent authority certification), and
- if any food commodities were rejected and, if so, what was the issue and what corrective action was taken.

Inspection activities for sub-element 1.4: Export controls

Review exported food shipment records to determine
- to what countries shipments were conveyed, and
- if any shipments were rejected and, if so, what was the issue and what corrective action was taken.

Element 2: Sanitation and pest control outcomes and performance criteria for licence holders

Expected outcomes

2.1 Sanitation

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

2.2 Pest Control

An effective pest control program is in place to prevent entry of pests, to detect and eliminate pests and to prevent the contamination of food.

2.3 Chemicals

Chemicals are stored and used in a manner and under conditions that do not contribute to the contamination of food.

The following performance criteria would have to be addressed by the licence holder to achieve the sanitation, pest control and chemical outcomes (2.1, 2.2, 2.3 and 2.4).

2.1 Sanitation outcome: performance criteria

There is a schedule for cleaning and/or sanitizing, which includes the concentration of chemicals to be used, and temperature and pressure requirements (if applicable), for
- the establishment, including preparation and storage areas;
- equipment; and
- food contact surfaces, including containers and utensils.
Equipment used for cleaning and/or sanitizing is capable of delivering the requirements of the sanitation program.
Cleaning and/or sanitizing is carried out in a manner that does not contaminate food or packaging materials during or after cleaning and/or sanitizing.
Effectiveness of cleaning and/or sanitation is assessed visually or through environmental sampling.
Food contact surfaces are free from the accumulation of dust, dirt, food residue and other debris.
Environmental sampling is conducted in accordance with Health Canada 2011 Policy on Listeria monocytogenes in Ready-to-Eat Foods.

Rationale

Improper or inadequate sanitation activities can lead to contamination of food, packaging materials and food contact surfaces.
Cross-contamination from cleaning activities during operation can cause chemical or biological contamination.

2.2 Pest control outcome: performance criteria

There is a program for pest control and removal.
There is a schedule for monitoring for evidence of pest activity.

Rationale

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

2.3 Chemicals outcome: performance criteria

A listing of chemicals or specification sheets for chemicals used in sanitation and pest control is maintained.
The use of chemicals does not contaminate food, equipment, utensils or food contact surfaces.
Chemicals are suitable for their intended use.
Chemicals are properly stored, controlled, and labelled.
Chemicals are dispensed and handled by trained personnel.

Rationale

The use of improper chemical concentrations and/or improper chemical application or rinsing procedures can lead to both chemical contamination (for example, chemical residue due to poor rinsing, no-rinse chemicals in excess of approved concentration) and biological contamination (for example, bacteria not effectively removed from food contact surfaces).
Improperly stored chemicals can lead to contamination of the food preparation environment.

Element 2: Inspection activities for sanitation and pest control

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 2.1: Cleaning and sanitation

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Confirm cleaning and sanitizing is being done according to the procedures and schedule.
- Review records
  - Review the licence holder’s procedures for verifying that clean in place and cleaning in general is effective.
  - Review procedures for verifying that equipment is functioning as intended.
  - Check whether any issues or deviations have been identified and note what actions were taken.
  - Review any results of environmental sampling, if applicable.
- Observe responsible employees performing the activity
  - Verify that floor sprays are not contaminating food contact surfaces, and that there are no other sources of cross-contamination.
  - Confirm temperature, chemical concentrations and pressure is being verified.
Visually verify that cleaning procedures are effectively removing dirt and debris.
- Look for evidence of dirt, debris and food material on food contact surfaces, including containers and utensils.
Take environmental samples—if necessary to confirm observations—for ready-to-eat food preparation areas.

Inspection activities for sub-element 2.2: Pest control

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Visually verify that there is no evidence of pests—particularly in food processing, storage and handling areas.
If there is evidence of pests, review records to
- identify if there are any trends, and
- confirm what actions have been taken to address the issue.

Inspection activities for sub-element 2.3: Chemicals

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Confirm there is a listing of chemicals used (including pesticides/rodenticides), or specification sheets available.
- Chemicals used on food or food contact surfaces must meet the requirements of the Food and Drugs Act or Pest Control Products Act, as applicable.
Check that chemicals are stored separately from food, clearly identified and dispensed with utensils that are not used for food preparation.
Check that label instructions for any chemicals used are being followed.

Element 3: Hygiene and employee training outcomes and performance criteria for licence holders

Expected outcomes

3.1 Hygiene

Employees and visitors are not a source of contamination of food, packaging materials or food contact surfaces.

3.2 Employee training

Employees have adequate technical knowledge and understanding of operation(s) or process(es) for which they are responsible and of how they may impact food safety and other regulatory requirements.

The following performance criteria would have to be addressed by the licence holder to achieve the hygiene and employee training outcomes (3.1 and 3.2).

3.1 Hygiene outcome: performance criteria

Effective biosecurity practices are in place, including
- controlled access
- employee facilities, hand-washing and sanitizing stations
- use of sanitary clothing and footwear
Hygienic practices are in place, including
- proper hand-washing or use of sanitizers/gloves
- rules for employee conduct
- precautions for personnel with open wounds or a communicable disease

Rationale

Personnel training and hygiene contribute to the production of safe food.
Employees and visitors who do not follow hygienic practices can cause food contamination.

3.2 Employee training outcome: performance criteria

A written description of training requirements for employees responsible for activities under the preventive control plan is maintained.
Employees are trained to carry out the range of tasks and duties they are required to perform.

Rationale

Proper training promotes an understanding of the risk of biological, chemical and physical contamination.

Element 3: Inspection activities for hygiene and employee training

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 3.1: Hygiene

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Confirm that the biosecurity practices are in place.
Verify that biosecurity practices are being followed.
- Movement of employees and access of visitors is controlled.
- Footbaths and hand dips, if used, are properly maintained.
- Any required clothing—including gloves, hair coverings, and footwear—is maintained in a sanitary manner.
- Employee hand-washing facilities are available and clean.
Observe employee behaviours occurring in food preparation areas.
- Employees are washing hands when required (for example, when returning to the processing area).
- Personal objects are prevented from falling into food.
- Unhygienic practices, such as spitting, and use of tobacco, chewing gum, and consumption of food are not occurring.
Confirm that employees handling food do not have open wounds or exhibit signs of having a communicable disease.

Inspection activities for sub-element 3.2: Employee training

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Review training records and check that employees are following procedures when carrying out duties and responsibilities.
Observe and interview employees to confirm they have the appropriate technical knowledge to carry out their respective duties. For example, they may need an understanding of
- potential sources of contamination
- proper handling of food commodities and ingredients (for example, temperature control, segregation of food commodities)
- personal hygiene
- equipment maintenance and calibration
- general sanitation and cleanliness
Confirm that employees receive ongoing training to maintain current specialized knowledge; such as, knowledge of control measures and critical limits or regulatory requirements.

Element 4: Equipment design and maintenance outcomes and performance criteria for licence holders

Expected outcomes

Equipment, utensils and containers are designed, maintained and used in a manner that does not result in contamination of food or food packaging materials and are effective for the purpose for which they are intended.
Controlling or measuring devices are calibrated for accuracy.

The following performance criteria would have to be addressed by the licence holder to achieve the equipment design and maintenance outcomes.

All equipment, utensils, containers, and controlling and measuring devices used in food preparation and storage are
- used only for the intended purpose,
- functioning as intended,
- maintained in a good state of repair,
- cleanable, and
- properly stored.
Controlling devices used in the preparation of food are calibrated and maintained to ensure measurement accuracy and effectiveness.

Rationale

Poor design and installation can make it difficult to properly clean and maintain equipment.
Improper maintenance of equipment may lead to the contamination of food.
Improper calibration or maintenance of controlling devices may lead to inadequate processing of food or other regulatory non-compliance.

Element 4: Inspection activities for equipment design and maintenance

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Confirm that equipment is being used as per procedures and review maintenance records, if necessary.
Confirm that equipment is being calibrated according to schedule.
Check that equipment, containers and utensils are in good repair (for example, check for rust, peeling paint, leaking lubricants).

Element 5: Physical structure and maintenance outcomes and performance criteria for licence holders

Expected outcomes

5.1 Outside premises and surroundings

Outside premises and surroundings do not contribute to the contamination of food.

5.2 Buildings

Buildings are constructed and maintained to support cleaning and sanitation and prevent the entry of pests and contaminant.

5.3 Water, ice and steam

Water, ice and/or steam that come into contact with food and/or food contact surfaces is potable or safe for intended use.

5.4 Waste disposal

Effluent and waste storage and disposal systems are designed, constructed and maintained to prevent contamination of food, preparation areas or water.

The following performance criteria would have to be addressed by the licence holder to achieve the physical structure and maintenance outcomes (5.1, 5.2, 5.3 and 5.4).

5.1 Outside premises and surroundings outcome: performance criteria

The surroundings/roadways are maintained to minimize refuse, dirt, dust, fumes, and other environmental contaminants and pest harbourage areas.

Rationale

Outside sources of contamination can potentially contaminate food.

5.2 Buildings outcome: performance criteria

a. Exterior building structures

The exterior of the building is maintained to prevent entry of pests and contaminants.

Rationale

Proper facility design and construction, including maintenance, prevents or mitigates the entry of pests or contaminants.

b. Interior building structures

Floors, walls and ceilings are
- cleanable
- made of materials that will not contaminate food
- in good repair
In food preparation areas
- floors are constructed and maintained to permit adequate drainage
- glass, where breakage may contaminate food, is properly protected

Rationale

Standing water can become stagnant and therefore a source of contamination.
Cleanable surfaces will support effective cleaning and minimize the build up of unsanitary conditions (for example, presence of bacteria, mould).
Proper protection of glass will prevent foreign material contamination of food, ingredients, packaging materials and food contact surfaces.

c. Hygienic flow and separation

Where there is potential for cross-contamination, incompatible operations are adequately separated by physical or other effective means.

Rationale

Separation or control between incompatible operations helps to prevent cross-contamination of finished food.
Separation is inadequate if cross-contamination occurs.

d. Lighting

There is sufficient light to allow the intended activity to be conducted effectively.
Lighting equipment (bulbs and fixtures) that is located where breakage could contaminate food is properly protected.

Rationale

If lighting levels are inadequate, employees may not be able to properly carry out his/her activities (including processing, quality control, reading of critical instrumentation, cleaning and sanitizing).
If a light bulb or lighting fixture breaks over exposed food, ingredients, packaging materials or food contact surfaces, it presents a potential physical hazard.

e. Ventilation

Ventilation provides sufficient air exchange to control moisture and minimize condensation.
Ventilation systems are designed and constructed so that air flow into clean areas is not contaminated.
Ventilation systems are adequately maintained and cleaned.

Rationale

Adequate ventilation minimizes condensation which could contaminate food.
The flow of contaminated air through an establishment can be a source of bacterial contaminants for microbiologically-sensitive food processing areas (for example, ready-to-eat processing rooms and aseptic rooms).
The ventilation system requires cleaning and maintenance so that it can function properly.

f. Employee facilities

The location and design of employee facilities such as washrooms, lunch rooms and change rooms do not contribute to or cause contamination of food or food processing areas.
An adequate means of hygienically washing and drying hands is provided (including wash basins and a supply of safe water).
- The location of hand-washing and sanitizing stations in processing areas does not contribute to or cause contamination of food.

Rationale

Adequate and clean washroom, change room and lunch room facilities will support personal hygiene and reduce the risk of contaminants.
Hand-washing and sanitizing stations can become a source of contaminants if they are not properly located, designed or maintained.

5.3 Water, ice and steam outcome: performance criteria

a. Water, ice and steam safety

Water, ice and steam that come in contact with food commodities or food contact surfaces meet safety requirements as defined in Health Canada’s Guidelines for Canadian Drinking Water Quality – Summary Table or are safe for use (for example, sea water used in rinsing and packing fish products).
There is no cross-contamination between safe and unsafe water supplies.
Safety of water must be confirmed using recognized methods at a frequency adequate to confirm its safety.
- Where municipal sources are used, municipal test results may be accepted.

Rationale

Since water, ice and steam can be used for a variety of purposes (for example, sanitation, hand washing, as an ingredient or processing aid), it is important that water be safe for use.

b. Water, ice and steam handling equipment

Equipment is designed, installed and maintained in a manner that will not jeopardize the safety of water.

Rationale

Water, ice and steam can be a source of biological, chemical or physical contaminants.

5.4 Waste disposal outcome: performance criteria

Waste storage areas and containers are identified, of suitable capacity and cleaned to avoid attracting pests.
Waste disposal, including effluent lines, do not contaminate food or food preparation areas.
Drainage and sewage systems are adequate for the volume and type of effluent being produced during normal processing and cleaning operations, and backflow is prevented.

Rationale

An effective waste removal and disposal system will reduce pest harbourage and the risk of cross-contamination of food, ingredients, packaging material, food contact surfaces or the safe water supply (for example, drain back-ups leading to flooding).
Cleanable and properly identified containers and utensils used for waste will prevent misuse that may result in cross-contamination.
The presence of mechanisms to prevent backflow (for example, trapping, venting) will prevent sewer gases, pests, micro-organisms or other contaminants from entering the establishment through the plumbing system.

Element 5: Inspection activities for physical structure and maintenance

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 5.1: Outside premises and surroundings

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Visually verify if there are any sources of external contamination (for example, build up of garbage, smoke or fumes from neighbouring facilities).

Inspection activities for sub-element 5.2: Interior and exterior building structures

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.

a and b. Exterior and interior building structures

Review maintenance records for building interior and exterior, including the air filter replacement records.
Check that floors, walls and ceilings are made of non-porous materials that will withstand cleaning, and that floors are draining properly.
Check that glass is properly protected in places where breakage could contaminate food.
Confirm that
- openings to exterior areas are protected or effective control measures are in place;
- air intakes are filtered or positioned to prevent the introduction of contaminants;
- doors are tight-fitting and equipped with self-closing devices, if required; and
- there are no signs of water leakage.

c. Hygienic flow and separation

Confirm that incompatible operations are separated by physical or other means (for example, sequencing of food commodities to prevent introduction of allergens).

d. Lighting

Verify that lighting is adequate to accurately read instruments and record monitoring and verification results.

e. Ventilation

Verify that there is positive pressure in food preparation areas, where necessary, to prevent contamination.
Check whether there is condensation dripping on food or food contact surfaces.

f. Employee facilities

Confirm that washrooms do not open directly into food processing area.
Check that washrooms, lunch rooms and change rooms are properly maintained (for example, hot water, hand-washing and drying equipment, functional lavatories).

Inspection activities for sub-element 5.3: Water, ice and steam

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Confirm that safe water is being used, such as
- municipal water, or
- tested water with available test results.
If water is treated, confirm that any chemicals⁸ used are accepted for that use (for example, a letter of no objection from Health Canada) and that appropriate procedures are followed. See the Guidelines for Incidental Additive Submissions

Inspection activities for sub-element 5.4: Waste disposal

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Check that waste disposal does not contaminate food preparation areas (for example, leakage and spillage).
Verify that waste containers are identifiable and cleaned at regular intervals.
Observe that waste does not accumulate in food handling areas.
Note any odours that are not characteristic of the food being prepared.

Element 6: Receiving, transportation and storage outcomes and performance criteria for licence holders

Expected outcome

Food commodities (including incoming ingredients) and packaging materials are transported, received and stored in conditions that prevent damage, spoilage and contamination.

The following performance criteria would have to be addressed by the licence holder to achieve the receiving, transportation and storage outcome.

Conveyances, when used for the transport of food
- are clean and protect the food from contamination, damage and deterioration, including refrigeration; and
- are not being used to transport any material or substance that might contaminate or adulterate the food commodity.
Food commodities in need of refrigeration or freezing are not left out at ambient temperatures for prolonged periods.
Conveyances are loaded, arranged and unloaded in a manner that prevents damage and contamination of the incoming materials and/or finished food commodities.
Food storage areas allow the
- separation of food and other materials, including returned food commodities;
- control of temperature and humidity to prevent deterioration and spoilage; and
- stock to be rotated to maintain suitability, quality and safety.

Rationale

Food commodities may become contaminated, or may not reach their destination in a suitable condition, unless effective control measures are taken during transport or at loading/unloading and storage.
The safety and quality of food commodities that require temperature and humidity control can be impacted negatively if left at ambient temperatures for prolonged periods.

Element 6: Inspection activities for receiving, transportation and storage

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Confirm, by visual observations or reviewing records, that food commodities that require environmental control are transported and stored at an appropriate temperature and humidity.
- Note if any food commodities are left out at ambient temperatures, which would impact food safety or quality (for example, thawing or sweating).
Visually confirm that incompatible food commodities are not transported or stored together unless there is an effective way to separate them.
- Review records to confirm that conveyances that are used for multiple, incompatible purposes are cleaned between uses.
Confirm that incoming ingredients and materials are managed to minimize spoilage or contamination at receiving.
Review shipping records and visually verify that stock is being rotated.

Element 7: Traceability, recall and complaints outcomes and performance criteria for licence holders

Expected Outcomes

7.1 Traceability

Foods are adequately identified to enable removal from the marketplace.

7.2 Recalls

Non-compliant food commodities are effectively prevented from entering the marketplace and can be rapidly retrieved from the marketplace if distributed.

7.3 Complaints

Complaints related to food safety and product misrepresentation are investigated to determine root cause and corrective actions are taken.

The following performance criteria would have to be addressed by the licence holder to achieve the traceability, recall and complaints outcomes (7.1, 7.2 and 7.3).

7.1 and 7.2 Traceability and recall outcomes: performance criteria

The traceability and recall system must be able to
- identify sources of ingredients for the implicated food commodity,
- stop any further distribution and sale,
- trace food (including by-products, if implicated) to the next point of distribution,
- contact customers and the CFIA, and
- retrieve the implicated food.

For more information on food recall and emergency response.

Rationale

Identifying and controlling implicated food quickly and effectively is crucial for protecting consumers from preventable health risks.

7.3 Complaints outcome: performance criteria

Complaints received by the licence holder are investigated to determine if there is non-compliance with legislative requirements.
Corrective action is taken for non-compliance, to address
- the implicated food commodity, and
- any changes required to processes or procedures to prevent recurrence.

Rationale

Complaints from any source (for example, consumers, other industry members, customers) are important indicators of possible deficiencies in the system. When the complaint handling system itself is deficient, it could result in failure to identify and eliminate risks.

Element 7: Inspection activities for traceability, recall and complaints

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-elements 7.1 and 7.2: Traceability and recall

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Review records to identify any previous recalls and confirm that product was effectively recalled (volume distributed and volume returned) and disposed of or handled as per procedures.
Determine if the cause of the recall was identified and if this information was used to make adjustments to prevent recurrence.
Review test results if the recall system has been periodically tested.
If appropriate, request a mock recall (for example, request a trace of a food commodity).

Inspection activities for sub-element 7.3: Complaints

Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
Follow general inspection step 2 in Annex C.
Review complaint records to determine if there are any trends that may require further investigation or if the scope of the inspection should be adjusted.
Where complaints are substantiated, confirm that root cause was determined and whether this information was used to prevent recurrence.
Verify that the corrective action taken has addressed the issue.

Annex C: Basic inspection steps and draft inspection report

Details of basic inspection steps for inspectors

The following outlines the basic inspection steps that may be used by CFIA inspectors. It provides a consistent approach to performing inspections under the improved food inspection model.

Step 1: Prepare for the inspection

a. Determine preliminary scope of inspection.

Once a facility has been identified for inspection, based on the work plan and priorities, the scope of the inspection may be adjusted in response to

changes in activity (for example, operation has begun exporting),
triggers (for example, recalls, complaints),
compliance history (for example, repeated non-compliance),
any element of the preventive control plan that is a priority (for example, Element 1: Process and product control), and
other elements that are not covered by a previous inspection.

Over time, the licence holder’s entire system should be inspected to verify compliance with all food safety and other regulatory requirements.

b. Determine whether the inspection will be announced or unannounced.

Inspections may be announced or unannounced, at the inspector’s discretion. Both approaches will be used.

Announced inspections provide inspectors with the opportunity to discuss and make prior arrangements with the operator and key personnel for interviews and to obtain a commitment that relevant documentation will be available.
Unannounced inspections provide the opportunity to view operations without prior notification. This may limit the scope of the inspection if certain personnel are not on site or certain activities are not being conducted.

c. Review the applicable Acts and regulations and other reference documents.

Where required, technical advice or guidance may be sought from system assessment officers or the Centres of Expertise.

d. Gather inspection documents and tools, sampling equipment, protective wear, safety equipment and applicable supplies.

Step 2: Conducting the inspection

During the inspection, record all findings, including any discussions. Additional objective evidence, such as physical samples, photographs and copies of documents or records may also be gathered.

a. Opening meeting

introduce all CFIA staff present and explain each person’s role;
outline the scope of the inspection, the process to be used, and the date and time of the closing meeting;
identify any staff or resources required to support conducting the inspection and confirm the key contact;
update the licence holder on any changes to the inspection process and/or relevant regulations;
confirm any changes to the information in the company profile;
confirm any changes to the preventive control plan since the last inspection and modify the scope of the inspection, if needed;
confirm the operation’s security and safety requirements (for example, hygienic measures, people flow restrictions, protective equipment, etc.);
indicate that the operation will be advised of any changes to the scope during the inspection; and
for inspections longer than one day, advise that an end-of-day meeting may be conducted to notify of any non-compliance(s) that may have been observed.

b. Initial walk-through inspection

This part of the inspection serves to identify areas that should be added to the scope of the inspection or targeted for more intensive inspection. It can also confirm the accuracy of the profile.

Observe general conditions of the facility (including conditions outside and inside).
Focus efforts on identifying potential sources of contamination of the food commodity, food contact surfaces or equipment that require further consideration.

When outside the facility observe the general cleanliness of the surrounding area and any conditions that could contribute to food contamination.

Consider:

harbourage of pests
environmental contaminants
uncontrolled access points to preparation areas
deterioration in condition of buildings that would permit entry of pests or other potential sources of contamination

When inside the facility, begin at the finished product area and progress towards incoming product and ingredients areas. Observe the general cleanliness and any conditions that could contribute to food contamination.

Consider:

conditions of floors, walls, ceilings (for example, clean, in a good state of repair)
employee hygiene and work practices
appropriate temperatures
evidence of pest activity
lighting (for example, protective shields in food processing areas, none broken)
ventilation (for example, odours that are not characteristic of the process or food commodity, visible condensation)

Document all observations. Make note of any questions to ask personnel that arise during the inspection or records that should be reviewed to help confirm observations.

c. Confirm the scope of inspection

Based on recorded observations from the walk-through, consider whether the scope of the inspection should be adjusted.

d. Complete the inspection

Review records

Review the preventive control plan and records for the elements that fall within the scope of the inspection. The number of records selected reflects performance over time. Focus on records for food commodities that will be prepared during the inspection so that employee actions can be observed and on-site interviews can be conducted.

Address the following for each element examined:

the responsible employee(s)
the outcome
the control measures
the monitoring procedures for each control
any corrective actions for deviations
the verification activities
the required records

Review monitoring records to determine if

control activities are performed as specified (for example, equipment calibration, processing times, temperature checks, sanitation checks)
the controls are met
deviations are identified and appropriate actions are taken

Review verification records to determine if

monitoring activities are performed as specified
the operation’s control measures are effective
deviations are identified and appropriate actions are taken

If there are repeated deficiencies, determine if the licence holder has implemented additional measures or made changes to the preventive control plan.

Any records supporting the preventive control plan can be checked during an inspection (for example, training records, consumer complaints). Be clear in describing the types of records to which access is required.

Use judgement to decide whether it is necessary to take samples of the food commodity or swabs of the equipment and environment to verify inspection observations and to help determine whether the licence holder is compliant. Send any samples collected to the appropriate CFIA laboratory for analysis.

Observe activities and conduct interviews

Use judgement to decide what to do first: observe operations or conduct interviews. There is no prescribed order to using these techniques—the objective is to collect the most accurate information possible.

During observations, confirm that the employees are following the preventive control plan procedures. Interview employees to gather further information to support the observations. Use open-ended questions such as

What are you doing and/or recording?
What is the purpose of what you are doing?
How does it help to confirm that the control is effective?
What do you do when there is a deviation?

If compliance is achieved with regulatory requirements, go to section f. Inspection report. If non-compliance is identified, the level must be assessed.

e. Assign a level of non-compliance

Assign a level of non-compliance to each element, based on its potential impact on food safety.

There are three levels of non-compliance:

critical: immediate impact on food safety or repeated serious non-compliance
serious: potential impact on food safety
technical: non-compliance with regulatory requirements that are not related to food safety

Any other observations that do not have an impact on food safety or regulatory requirements may be noted in the report as “opportunities for improvement.”

If any serious or critical non-compliance is detected, issue a corrective action request that indicates which regulatory requirement(s) have not been met. Record technical non-compliance. Though these must be corrected, a corrective action request need not be issued.

Where critical food safety issues are observed, take the following steps:

Communicate and discuss the issue with the key contact to determine if further action is required.
If further action is required, request immediate action to control affected food commodity and correct the issue.
- Determine if all of the affected food commodity is under control.
- Initiate compliance or enforcement action (for example, seize and detain product, stop production) if the product is not effectively controlled.

f. Inspection report

The inspection report includes the inspection findings, corrective action requests issued, technical non-compliance observed and actions taken.

Documentation of the records reviewed includes the following:

information that identifies the specific records assessed
date of record

Documentation of observations and interviews includes the following:

name, title and area of responsibility of personnel interviewed and/or observed
area of the facility/procedure observed
description of any non-compliance observed

Record all incidents of non-compliance in the final inspection report. The nature of the non-compliance must be described in clear, factual and concise terms.

Step 3: Communicate the inspection results

Hold closing meeting with the licence holder to discuss the outcomes of the inspection, including any incidents of non-compliance and next steps. Share the written inspection report, once completed.

At the closing meeting

discuss overall findings of the inspection, including any trends
report any incidents of non-compliance, and issue any corrective action requests
provide clarification to any questions or concerns
obtain licence holder’s commitment to address any corrective action requests issued, and note his/her proposed interim measures, if any
inform the licence holder of any lab samples submitted for analysis and of when the results are expected
provide a copy of the inspection report and associated documents if completed, or note when they will be available
discuss next steps, including timelines for letting the CFIA know when corrective actions will be completed
advise of any follow-up activities or inspections

Step 4: Conduct a follow-up inspection

A follow-up inspection may be needed to confirm that the corrective action has been completed, is effective, and that any changes to the preventive control plan are documented. An extension of the deadline for completing corrective actions may be granted in certain circumstances, including the following:

a written request for an extension is submitted, with reasons and the proposed new completion date
food safety is not compromised

When reviewing corrective actions:

confirm what actions were taken and why, the appropriateness of the actions, including disposition of the affected food commodity
review any records that demonstrate the effectiveness of the corrective actions
observe the changes, if any
review any amendments to the preventive control plan

If the corrective actions have been implemented effectively, close the corrective action request.

If the corrective actions have not been implemented effectively and an extension is not granted, take the appropriate compliance and enforcement action.

a. Continued or repeated non-compliance

The following table shows guidelines for compliance and enforcement action in the case of continued or recurring incidents of non-compliance.

Continued or repeated non-compliance	The inspector	The licence holder is required to
For a critical non-compliance	Initiates enforcement action (for example, suspension of licence)	Take immediate action to address the non-compliance, and control the affected food commodity, if necessary
For a serious non-compliance	Elevates to a critical corrective action request	Control the affected food commodity immediately and address the non-compliance to prevent reoccurrence
For a technical non-compliance	Initiates corrective action and appropriate enforcement (for example, AMPs, product seizure and detention)	Correct the affected food commodity

Annex C.1: Draft inspection report

PDF (205 kb)

Annex D: Compliance and enforcement: range of possible responses

The following is a list of the CFIA’s possible responses to incidents of non-compliance, listed in no particular order (in order of magnitude). This list is not comprehensive and more than one response may be used in any given situation.

a) Inspection

An assessment and verification of compliance of the regulated party to Acts or regulations administered or enforced by the CFIA.

b) Refusal to issue export certificate/documents

The Minister may refuse to issue export documents if the regulated party’s export controls outlined in the preventive control plan were not effective or the food commodity did not comply with other legislative requirements. In these cases, the CFIA may consider lot-by-lot inspection to check for compliance.

c) Start or stop activities

If critical non-compliance were to be found during an inspection, the inspector may order any person who conducts an activity regulated under the Safe Food for Canadians Act to start or stop the activity.

d) Seizure and detention

Seizure and detention allow the CFIA to control anything that the inspector has reasonable grounds to believe was used or obtained in contravention of any provision of the Safe Food for Canadians Act or the regulations. For example, a food commodity can be seized and detained until

the food commodity is brought into compliance,
the court or AMP proceedings are complete, or
it is ordered returned by the Tribunal or court.

e) Removal or destroy order

If an importer does not possess a valid licence or if an imported food commodity does not comply with legislative requirements or is imported illegally, the inspector may order the food commodity removed from Canada, or if removal is not possible, destroyed.

f) Corrective action request

A corrective action request is an inspection document that the CFIA issues to a licence holder in cases of serious or critical non-compliance. The corrective action request requires the licence holder to undertake a corrective action and to implement corrective measures within a defined timeframe.

g) Meeting with the licence holder

If non-compliance is not resolved, a meeting may be held with the licence holder to discuss the need to apply corrective actions, set timelines and outline possible further action if the non-compliance were to remain unresolved.

h) Notice of non-compliance

The licence holder may be sent a notice of non-compliance if he/she has failed to respond to the CFIA’s corrective action request and further enforcement action is being considered.

i) Publication of non-compliance

Compliance and enforcement actions may be published on the CFIA external website.

j) Dispose

A food commodity (or anything) that has been seized under the Safe Food for Canadians Act may be ordered disposed of if the thing is perishable or it presents a risk of injury to human health and its disposal is necessary to respond to the risk.

A seized product may also be disposed of or destroyed if it has been forfeited or if the regulated party consents to its disposal.

k) Injunction

On application by the Minister, the court may order a person to stop doing an activity that may be in violation of the Safe Food for Canadians Act, or start an activity to prevent the commission of an offence under this Act. Under section 18 of the Canadian Food Inspection Agency Act, the CFIA may apply to a court of competent jurisdiction for an interim injunction.

l) Recall

Recalling a product would be appropriate when there are reasonable grounds to believe the regulated product poses a risk to the public or animal or plant health. If the regulated party were to refuse to initiate a recall of the product, a recall order may be issued pursuant to section 19 of the Canadian Food Inspection Agency Act, which provides that: “the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister.”

m) Actions taken with regard to licences

A licence may be suspended and/or cancelled if the licence holder does not comply with the regulatory requirements or conditions of the licence. Refer to the licensing section (Section 2) for a list of conditions and more details.

Furthermore, the Minister may make a licence subject to any additional conditions that he/she considers appropriate.

n) AMPs

Under consideration and will be consulted on during the food regulatory modernization initiative.

o) Recommendation to prosecute

The Public Prosecution Service of Canada (PPSC) has the responsibility for all prosecutions relating to legislation enforced by the CFIA. If the CFIA were to conclude that prosecution is the most appropriate response, briefs of evidence would be forwarded to the PPSC with the recommendation that charges be laid. The PPSC would then decide whether to initiate prosecution.

Annex E: System performance: preliminary draft indicators

Level 1 System performance

Consistency and quality of delivery

Theme	Considerations for future indicators
1. On-site review
Preparation
Inspector authorization	the inspector has the appropriate designation to conduct the activity the person exercising powers or performing duties or functions has a valid CFIA badge and identification card that is legible, valid, has the correct name, etc.
Inspector training	required training is identified the inspector has successfully completed the required training
Reference and inspection documents and tools	the inspector has the appropriate documents, tools and supplies for the inspection
Determine scope	the regulated party who requires verification is identified appropriately from the work plan or triggers the regulated party file is reviewed and scope is appropriately identified
Conducting the inspection
Opening meeting	an opening meeting is conducted appropriately and scope is adjusted, if required
Initial walk-through inspection	initial on-site assessment of the general conditions is conducted and scope adjusted if required—taking into account any previous corrective action requests
Confirm scope of inspection	scope is adjusted based on observations of the initial walk-through
Completing the inspection	visual verification, record review and staff interviews are used appropriately to collect facts
Product and environmental sampling	samples are collected, identified, handled, stored, packaged, tagged and shipped appropriately
Determining level of compliance	non-compliance is appropriately identified and potential impacts are assessed the appropriate level of compliance is assigned and supported by facts, and recorded appropriately
Communication of the inspection results
Closing meeting	results are communicated in a clear, concise, factual and timely manner and questions are addressed a corrective action request for critical and serious non-compliance is discussed any other regulatory non-compliance is discussed licence holder commitment is obtained or, if not, a proper note is included in the report
Follow-up inspection
	corrective measures have been completed, are effective at addressing the corrective action request and have been documented corrective action requests are closed as per procedures where corrective action requests are not addressed, appropriate action is taken for repeated technical non-compliances, enforcement action is taken
2. Documentation review
Issuing a licence	applications are reviewed for completeness an appropriate licensing decision is made the risk level is correctly assigned the licence or notice of refusal is issued within the service standard
Inspection report	the inspection report provides the regulated party with an accurate summary of the verification and includes any corrective action requests the inspection report conveys the results in a clear, concise, factual, complete and accurate manner a corrective action request is issued for critical and serious non-compliance
Export certificates	the export certificate is complete and accurate the decision to issue a certificate is justified
Laboratory analysis reports	the sample submission form is complete and accurate the sample integrity is maintained the sample is sent to the appropriate laboratory the results of analysis are communicated
Other forms	documents are complete and accurate, such as notice of non-compliance detention documentation
Analysis of compliance and enforcement actions	Are the decisions justified? Is the appropriate Act or regulation cited? Were procedures followed? Was non-compliance rated appropriately? Was corrective action confirmed to be effective and timely? Was the closing of the corrective action request justified?
Delivery of work plan	confirmation that the inspection schedule reflects priorities of the work plan work planning targets are achievable and met inspection priorities are established based on risk and compliance data
Level of oversight	changes in level of oversight are justified
Unplanned inspections	are delivered in accordance with priorities

Level 2: Measuring inspection system design and performance

System design: process management

Theme	Considerations for future indicators
Quality design
Risk levels	inspection and surveillance data, consumer complaints, recalls, etc., are used to establish and adjust risk levels other intelligence, such as identification of emerging risks, is incorporated into the adjustment of the risk level
Licensing	Are food safety events attributable to non-licensed parties? Are conditions of licensing appropriate? Are there trends in licence suspension and/or cancellation?
Preventive control plan	Are elements of the preventive control plan consistent with advances in international or scientific information? trends and causes of foodborne illnesses and recalls identify areas for improvement in expected outcomes, performance criteria or inspection activities
Inspection	increase or decrease in compliance levels trend analysis for critical corrective action requests trend analysis for serious corrective action requests trend in escalation of serious corrective action requests to critical corrective action requests trend analysis for technical non-compliance trend analysis for import alerts analysis of complaints from industry
Export certification	trends of rejection when certified lot-by-lot system trends of rejection when not certified
Exemption requests	impact on regulatory framework
Response to food safety events	recalls of food triggered by illness recalls of food not triggered by illness
Communication with industry
Compliance promotion
Effectiveness of the overall system
Transparency	the information posted is useful
Recognized internationally—demonstrates confidence in Canadian system	risk and science is incorporated into decision making market access is regained following food safety incidents
Effective use of human resources	roles and responsibilities are documented competencies are identified recruitment strategy quality of training
Continuous improvement	integrated feedback loop is created to support continuous improvement

Annex F: Exemptions

The Safe Food for Canadians Act is an act respecting food commodities, including

their inspection;
their safety;
their labelling and advertising;
their import, export and interprovincial trade;
the establishment of standards for them;
the registration or licensing of persons who perform certain activities related to them;
the establishment of standards governing establishments where those activities are performed; and
the registration of establishments where those activities are performed.

Within the Act, in the section that provides the Governor in Council the authority to make regulations, paragraph 51(1)(w) provides for exempting, or permitting the Minister to exempt, with or without conditions, any item to which the Act applies. In addition, the paragraph provides that any person or activity in respect of a food commodity may be exempted from the application of the Act or the regulations or a provision of the Act or the regulations.

The existence of this authority within the Act provides some flexibility to manage situations where it would be appropriate for the provisions of the Act or regulations to not apply to a particular activity, food commodity or regulated party without compromising food safety.

Different types of exemptions are provided for within the legislation currently administered and enforced by the CFIA. Some are more temporary, while others are specific to a commodity sector’s operating environment. Exempting provisions often apply to persons or classes of persons who carry out a specific activity or class of activities in relation to a food commodity.

As part of inspection modernization and regulatory modernization initiatives, the CFIA is examining how best to

include exemptions within a single regulatory framework for food, and, in turn,
administer and enforce the exemptions.

As part of the exercise, the CFIA is assessing the exemption provisions included in current commodity sector–based food regulations made pursuant to the Meat Inspection Act, Fish Inspection Act, and Canada Agricultural Products Act. In considering exemptions, for example, it is not the intention of the CFIA to regulate the preparation of food for one’s own personal enjoyment, or the importing of food for one’s own personal use. At the same time, it is recognized that an exemption that permits the importation of food commodities that do not meet Canadian requirements may be required to meet specific operational needs of licence holders; for example, a non-compliant food commodity is imported for further processing, preparation or conditioning in Canada. In these cases, it is expected that the final product would meet Canadian requirements if it is sold or made available in Canada.

Further consultation on exemptions will be performed during the regulatory modernization initiative. In all cases, if the food commodity is intended to be consumed, it must meet Canada’s food safety requirements.

Annex G: Draft glossary of terms

This glossary of terminology is designed to standardize the language used by the CFIA’s Food Business Line and support consistent interpretation of terminology used in the food inspection program.

| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z |

Terminology	Definition
A Applicant (Demandeur)	Any person who applies for a licence, exemption or certificate.
B Biological hazard (Danger biologique)	Any illness- or disease-causing pathogens or micro-organisms that pose a danger to food safety.
C Certification (Certification)	Written assurance from a competent authority that foods or preventive control systems conform to requirements.
Chemical hazard (Danger chimique)	A chemical substance that poses a danger to food safety.
Compliant food (aliment conforme)	Food commodities that meet food safety and other regulatory requirements.
Contaminant (Contaminant)	Any biological, physical, chemical agents or other substances that are present in food and that compromise food safety or suitability.
Contamination (Contamination)	The presence of any contaminant in food or food contact surfaces.
Control measure (Mesure de contrôle)	Any action or activity that can be used to prevent⁹ or eliminate a food safety hazard or reduce it to an acceptable level. (Hazard Analysis and Critical Control Point System and Guidelines for Its Application, Annex to CAC/RCP 1-1969 (Rev.4 – 2003), FAO/CODEX)
Corrective action (Mesure corrective)	The steps that a regulated party takes to address non-compliance, which can include controlling affected product, conducting root cause analysis and preventing recurrence.
Corrective action request (CAR) (Demande de mesure corrective (DMC))	A document that the CFIA issues to a regulated party in cases of serious or critical non-compliance. The corrective action request describes the non-compliance and requires the licence holder to take corrective actions.
Critical non-compliance (Non-conformité critique)	Repeated serious non-compliance or non-compliance that has an immediate impact on food safety.
Cross-contamination (Contamination croisée)	A situation that occurs when hazards that are carried by utensils, equipment, surfaces or food handlers are transferred from one food, ingredient or surface to another.
D Distributor (Distributeur)	A person, including a wholesaler, who distributes food or other materials.
Distribution centre (Centre de distribution)	A warehouse or other specialized building that is stocked with food or things to be redistributed to retailers, wholesalers or directly to consumers.
E Employee (Employé)	A person who is employed by a food operation or establishment.
Establishment (Établissement)	Any place, including a conveyance, where a food commodity is manufactured, prepared, stored, packaged or labelled . (Safe Food for Canadians Act)
Exporter (Exportateur)	Any person who sells or trades food from Canada to another country.
F Food grade materials (Matériaux de qualité alimentaire)	A designation that means that a material is safe for human consumption, is permitted to come in contact with food contact surfaces or is food intended for human consumption.
H Hazard analysis (Analyse de danger)	The process of collecting and interpreting information on hazards and on conditions that lead to hazards, to decide which activities pose a significant risk to food safety and therefore should be addressed in the preventive control plan.
I Importer (Importateur)	Any person in Canada who imports food commodities into Canada.
Ingredient (Ingrédient)	An individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an integral unit of food that is sold as a prepackaged product (Food and Drug Regulations)
M Monitoring (Surveillance)	The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control. (Codex)
N Non-compliance (Non-conformité)	The state that occurs when a regulated party or thing does not conform to statutory or regulatory requirements.
Not ready-to-eat food (Aliment qui n’est pas du prêt-à-manger)	Foods that require a cooking step before consumption by consumers for safety. The cooking step is required to kill pathogenic micro-organisms that may be present in the food.
O Objective evidence (Preuve objective)	Information directly collected by an inspector through observation, measurement, testing or other means.
Oversight (Surveillance)	Inspection activities designed to determine whether a regulated party is complying with Acts and regulations administered or enforced by the CFIA
P Pests (Organismes nuisibles/parasites)	Any animal, plant, fish or insect of public health importance including, but not limited to, birds, rodents, roaches, flies and larvae that may carry pathogens that can contaminate foods.
Physical hazard (Danger physique)	Any foreign materials that are not normally found in food and that pose a danger to food safety.
Premises (Lieux)	The lands, buildings and facilities where food is prepared.
Prepare (Conditionnement)	In respect of a food commodity, includes to process, treat, preserve, handle, test, grade, code or slaughter it or to do any other activity in respect of it that is prescribed.
Preventive control plan (Plan de contrôle préventif)	A combination of control measures¹⁰ that, when taken as a whole, provide for a science-based approach to managing risks posed by hazards.
Primary producer (Producteur primaire)	A person who cultivates, grows, produces, raises, picks or harvests agricultural products or fishery products and does not alter the nature of the raw product.
R Ready-to-eat food (aliment prêt-à-manger)	(a) do not require any further preparation before consumption, except perhaps washing/rinsing, thawing or warming for aesthetics or palatability (b) are in a form that is edible without additional preparation to achieve food safety (c) do not require further preparation or cooking before consumption (d) are ordinarily consumed in the same state as that in which they are sold
Regulated party (Partie réglementée)	A person (including an individual, corporation, partnership or organization) carrying on business in Canada who is subject to the Acts and regulations administered by the CFIA.
Representative sample (Échantillon représentatif)	The collection of a selected portion or subset of the thing that is intended to provide information on a given characteristic and that accurately reflects the characteristics of that thing.
Requirements (Exigences)	The criteria set down in acts or regulations administered or enforced by the CFIA.
Risk (Risque)	A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food. (CODEX Procedural Manual, 20^th Edition, FAO, 2011)
Risk-based inspection (Inspection fondée sur le risque)	A method for using risk to prioritize and manage inspection efforts.
S Serious non-compliance (Non-conformité grave)	Non-compliance that has a potential impact on food safety.
Surveillance (Surveillance)	The collection, analysis and interpretation of food sampling and inspection information to establish baseline data or identify trends.
Systems-based approach (Approche axée sur un système)	An integrated, flexible, multi-faceted approach to analysing and managing risk that considers the underlying actions of all of the steps or processes and controls that make up food production.
T Third-party verification (Vérification par une tierce partie)	The use of a private, independent service provider, organization or company to verify that a regulated party has adhered to a standard.
V Validation (Validation)	Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. (CODEX, Guidelines for validation of food safety control measures, CAC/GL 69-2008)
Verification (Vérification)	The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether the control measure is or has been operating as intended. (CODEX, Guidelines for validation of food safety control measures, CAC/GL 69-2008)
Violation (Infraction)	Any contravention of the acts or regulations administered or enforced by the CFIA or any refusal or neglect to perform any duty imposed by or under the acts or regulations

Additional resources:

Codex Alimentarius Commission

Hazard Analysis and Critical Control Point System and Guidelines for Its Application, Annex to CAC/RCP 1-1969 (Rev.4 – 2003)
Principles for Food Import and Export Inspection and Certification , CAC/GL 20-1995
CODEX Procedural Manual, 20^th Edition, FAO, 2011

Department of Justice, Food and Drug Regulations, C.R.C, c. 870. Available: http://laws-lois.justice.gc.ca/PDF/C.R.C.,_c._870.pdf

Health Canada, Food Directorate, Food-related health risk assessment. Available: http://www.hc-sc.gc.ca/fn-an/securit/chem-chim/food_risk-risq_alim-eng.php

Risk-based Inspection as part of an Overall Inspection Management Program (121kb). Available: http://visionsenterprise.com/pdf/rbimanagementprogram.pdf

¹Codex Alimentarius is the standard-setting body under the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).

² The CFIA shares responsibility of oversight of intraprovincially-traded food with the provincial and territorial governments for health and safety.

³ Preventive control plans are based on Codex Alimentarius principles and standards.

⁴Preventive control plans must be made available to the CFIA upon request.

⁵Depending on the circumstances, there may be situations in which immediate suspension of the licence would be justified and appropriate in order to protect human health.

⁶This would apply only to situations in which suspension is not effective immediately.

⁸ If these substances are misused, resulting in contamination of foods, such an action would be considered to be in violation of paragraph 4(a) of the Food and Drugs Act, which states, " No person shall sell an article of food that has in or upon it any poisonous or harmful substance."

⁹ See “Preventive Control Program” definition.

¹⁰ See “Control measure” definition.

Improved Food Inspection Model Revised Draft

2.4.1 Issuing a licence

2.4.2 Renewing a licence

2.4.3 Amending a licence

2.7.1 Elements of a preventive control plan

a. Food safety hazards and controls

b. Other regulatory requirements and controls

c. Monitoring procedures

d. Verification procedures

e. Corrective actions

f. Management review (review by the licence holder)

g. Records4

What is being proposed?

How would all of this work?

4.1.1 National work plan

Step 1: Preparing for an inspection

Step 2: Conducting an inspection

Step 3: Communicating the inspection results

Step 4: Conducting a follow-up inspection:

a. Review of inspection data

b. Field observation

c. Internal and external surveys

Applying for / obtaining a licence

Amendments and renewals

Process for issuing a licence

Process for suspending a licence

Process for cancelling a licence

Element 1: Product and process outcomes and performance criteria for licence holders

Expected Outcomes

1.1 Process control outcome: performance criteria

1.2 Product control outcome: performance criteria

1.3 Import control outcome: performance criteria

1.4 Export control outcome: performance criteria

Element 1: Inspection activities for process and product controls

Inspection activities for sub-element 1.1: Process controls

Inspection activities for sub-element 1.2: Product controls

Inspection activities for sub-element 1.3: Import controls

Inspection activities for sub-element 1.4: Export controls

Element 2: Sanitation and pest control outcomes and performance criteria for licence holders

2.1 Sanitation outcome: performance criteria

2.2 Pest control outcome: performance criteria

2.3 Chemicals outcome: performance criteria

Element 2: Inspection activities for sanitation and pest control

Inspection activities for sub-element 2.1: Cleaning and sanitation

Inspection activities for sub-element 2.2: Pest control

Inspection activities for sub-element 2.3: Chemicals

Element 3: Hygiene and employee training outcomes and performance criteria for licence holders

3.1 Hygiene outcome: performance criteria

3.2 Employee training outcome: performance criteria

Element 3: Inspection activities for hygiene and employee training

Inspection activities for sub-element 3.1: Hygiene

Inspection activities for sub-element 3.2: Employee training

Element 4: Equipment design and maintenance outcomes and performance criteria for licence holders

Element 4: Inspection activities for equipment design and maintenance

Element 5: Physical structure and maintenance outcomes and performance criteria for licence holders

5.1 Outside premises and surroundings outcome: performance criteria

5.2 Buildings outcome: performance criteria

5.3 Water, ice and steam outcome: performance criteria

5.4 Waste disposal outcome: performance criteria

Element 5: Inspection activities for physical structure and maintenance

Inspection activities for sub-element 5.1: Outside premises and surroundings

Inspection activities for sub-element 5.2: Interior and exterior building structures

Inspection activities for sub-element 5.3: Water, ice and steam

Inspection activities for sub-element 5.4: Waste disposal

Element 6: Receiving, transportation and storage outcomes and performance criteria for licence holders

Element 6: Inspection activities for receiving, transportation and storage

Element 7: Traceability, recall and complaints outcomes and performance criteria for licence holders

7.1 and 7.2 Traceability and recall outcomes: performance criteria

7.3 Complaints outcome: performance criteria

Element 7: Inspection activities for traceability, recall and complaints

Inspection activities for sub-elements 7.1 and 7.2: Traceability and recall

Inspection activities for sub-element 7.3: Complaints

Details of basic inspection steps for inspectors

Step 1: Prepare for the inspection

Step 2: Conducting the inspection

Step 3: Communicate the inspection results

Step 4: Conduct a follow-up inspection

a) Inspection

b) Refusal to issue export certificate/documents

c) Start or stop activities

Improved Food Inspection Model
Revised Draft

g. Records⁴