Canadian Partners in Quality (C-PIQ)
5. Non-conformities, Audit Ratings and Enforcement

5.1 General

The CFIA will conduct scheduled and un-scheduled audits to the C-PIQ establishment as well as Standard Inspection Procedure (SIP) inspections to verify compliance with the C-PIQ Program and the Safe Food for Canadians Regulations. Non-compliances will be recorded as objective evidence in a C-PIQ Audit Report. At the close of each audit, the report will be provided to the Operator, clearly indicating the audit results, the non-conformities, the requests for corrective actions, and the status of the registration of the establishment. It is the Operator's responsibility to submit a written corrective action plan which will address each non-compliance in a timely manner. The Operator must implement procedures to prevent repetition of non-conformities.

The audit team will assess the non-conformities to determine whether an audit result is satisfactory or unsatisfactory, which will, in turn, determine continued registration and C-PIQ participation.

5.2 Types of non-conformities and audit ratings

5.2.1 General

Non-compliance with the requirements of the C-PIQ Program may be of several types. The objective evidence identified by the audit team will be assessed to determine the severity and overall impact on the integrity of the C-PIQ Program. These non-compliances may represent non-conformities with respect to:

1. the Participation Agreement;
2. the C-PIQ Program Manual;
3. the C-PIQ establishment's Quality Assurance Manual; or
4. the quality standards.

An effective corrective action is required for all non-conformities. Non-conformities may be such that immediate corrective action is required (e.g. failed product, unsanitary conditions, etc.), or they may be of a minor nature but cumulative and repetitive, the consequences becoming more severe over time and with continued identification by the CFIA (e.g. procedures not followed, missing entries on records, etc.). Other non-conformities may indicate an issue with respect to the ongoing operation and maintenance of the establishment (lights not of proper type, premises not protected from entry of pests, records not maintained, etc.).

All non-conformities will be identified and reported in a C-PIQ Audit Report and assessed for overall impact on the integrity of the C-PIQ Program and the quality of the product.

There are three (3) main types of non-conformities which are categorized as outlined in the following sections.

5.2.2 Category "A" non-conformities and unsatisfactory audit rating

Non-conformities which fall under Category "A" are considered to be Critical Non-Conformities which result in an Unsatisfactory Audit rating and an immediate suspension of registration for a minimum of seven (7) calendar days. The following examples are deemed Critical Non-Conformities:

• serious risk to human health;
• obstruction or hindrance of an inspector, including making any false or misleading statement;
• falsification of records or documents;
• removal, alteration or interference with a thing seized or detained;
• A C-PIQ establishment which permits another facility to use C-PIQ Export Documents which were issued to the C-PIQ establishment;
• failure to take, or inability to take effective corrective actions by the dates established after having been given the opportunity to address the non-compliance three (3) times.

5.2.3 Category "B" non-conformities and unsatisfactory audit rating

Non-conformities which fall under Category "B" are those which directly impact on product quality, traceability, lot identification and Export Document control, and also include returned loads not identified to the CFIA. These non-conformities will be reported in a C-PIQ Audit Report and result in an Unsatisfactory audit. A Corrective Action Request will also be issued with a maximum of 14 calendar days for implementation of effective corrective measures, as determined by a satisfactory CFIA follow-up audit. The date may be extended by agreement with the CFIA prior to the due date.

The following examples represent Category "B" Non-Conformities:

• a lot of finished product failing to meet quality requirements for the intended market;
• a lot of product not properly identified in the establishment;
• inability to trace within establishment a shipped lot to point of receipt;
• issuance of a C-PIQ Export Document or C-PIQ Transfer Document without supporting quality monitoring documents;
• failure to provide the CFIA with a copy of completed and issued C-PIQ Export Documents and/or C-PIQ Transfer Documents;
• CFIA not notified of returned loads.

Unsatisfactory Audits due to these types of non-conformities will result in an increase in follow-up audits for verification of quality, traceability and document control requirements. At their discretion, the CFIA may make unannounced visit(s) to the establishment for the purpose of verification.

5.2.4 Category "C" non-conformities and satisfactory audit rating

Non-conformities which fall under Category "C" are those which may not negatively impact on the operation of the establishment, production of safe food, quality of product, export certification or those mentioned in the preceding sections (refer to 5.2.2 and 5.2.3).

The following examples of non-conformities would be reported in a C-PIQ Audit Report and result in a satisfactory audit with a request for corrective action:

• monitoring frequency not respected in In-Line Verification system;
• sampling plan not followed;
• verification records not complete;
• minor sanitation issue;
• calibration records missing;
• training records not kept up to date.

5.2.5 Cumulative and repetitive non-conformities

Each non-conformity must be addressed by a Corrective Action Request. The Operator will be provided the opportunity to discuss, with the audit team, the date by which the corrective action must be completed and be verified effective. Failure to address a non-conformity, or failure to address a non-conformity by the date agreed upon after having been given the opportunity to address the non-compliance three (3) times, will elevate the seriousness of the non-compliance and will result in suspension.

A same or similar non-conformity identified repetitively during the course of a verification audit or different verification audits will be treated as an inability to effectively correct the non-conformity and may elevate the seriousness which would result in an Unsatisfactory audit or suspension.

5.3 Suspension and cancellation of registration

5.3.1 Suspension of registration

A written Notice of Suspension of Registration will be sent to the Operator of an establishment where:

• A Critical Non-Conformity was identified;
• An Operator has three (3) times been provided with an opportunity to make effective corrective action for the same non-conformity.

Suspension of registration will remain in effect:

• in all cases, until the required corrective actions have been taken and verified by the inspector;
• for a minimum of seven (7) calendar days if a Critical Non-Conformity was identified;
• until the CFIA has inspected and certified a minimum of 125,000 kg of produce (shipped from the C-PIQ establishment in export trade to the United States) if non-conformities are in relation to the quality of finished product, traceability, lot identification or issuance of C-PIQ Export or Transfer Documents;
• until the CFIA has provided written notification to the Operator that the registration is no longer under suspension.

A failure to meet applicable quality requirements during this period of suspension may result in an extension of suspension based on findings of CFIA hands on inspection.

During a period of suspension, the Operator of the establishment must continue to fully operate and maintain the establishment, and must fully implement all QA procedures and policies. In addition, the Operator must request inspection and certification of product from the CFIA.

Where the registration was suspended, the Operator does not need to submit a new application for registration, but may be required to re-submit the establishment's QA Manual if significant amendments were made. The CFIA will perform a Verification Audit upon commencement of operation.

5.3.2 Cancellation of registration

A written Notice of Cancellation of Registration will be sent to the Operator of an establishment where:

• the establishment has failed to provide and implement the effective corrective actions by the date specified in the Notice of Suspension;
• Because of failure to comply with the requirements stated in the Participation Agreement and termination of the Agreement;
• the Operator of a C-PIQ establishment has requested that the Participation Agreement be terminated and the registration be cancelled; or
• the registration of an establishment has been suspended three (3) times.

The Operator of the establishment will be provided with a written Notice of Cancellation of participation in the C-PIQ Program from the CFIA identifying the date on which the cancellation will be effective, and will be provided with an opportunity to be heard, by way of a written submission, in respect of the cancellation prior to the date of the cancellation.

5.3.3 Re-Instatement of registration

The Operator of an establishment must apply to the CFIA, in writing, for re-instatement of registration following cancellation. Where the registration was cancelled, the Operator must re-submit an Application for consideration along with the applicable fee and re-submit a Company QA Manual. Where a C-PIQ registration was cancelled and the Operator re-applies, a Pre-Validation Audit and the required Validation Audits must be performed.