Section 4-5

4. Audits and Monitoring Activities

4.1 General

Assessment of compliance of an establishment with C-PIQ Program requirements, and the assessment of product to meet quality requirements for grade, size and maturity is accomplished by audit. C-PIQ audits are performed by a team of CFIA inspectors, one auditor being identified as the lead.

Audits are of four (4) general types:

  • Pre-Validation;
  • Validation;
  • Verification;
  • Follow-up.

The frequency of audit depends upon the status of registration of the establishment and the previous audit history.

4.2 Pre-Validation

A Pre-Validation Audit is performed when the Operator feels that all the required pieces of the establishment's QA system are in place, and the establishment is ready for assessment by the CFIA. For Pre-Validation Audit, the CFIA will:

  • review the Company's completed Establishment Inspection Report (Appendix D) to ensure the establishment meets the requirements set out in Appendix A;
  • ensure that the establishment has in place the measures that they have described in their Company QA Manual, such as monitoring procedures and records, lot identification system is in place, training records available, and so on.

The frequency and number of Pre-Validation Audits will be dependent upon the preparedness of the QA system, but no more than three (3) of these audits will be performed, after which the establishment will be required to re-apply. If this number is exceeded, the Operator will need to re-apply as a new applicant and submit another application for registration along with applicable $500 fee.

4.3 Validation

Validation Audits will begin once the CFIA has completed the Pre-Validation Audit and the CFIA has determined that the establishment is ready to commence operation of the QA system. During Validation, audits will be conducted once per week for, the greater of, a minimum of five (5) weeks or 25 export shipments to the United States (where a shipment is 25,000 lbs or greater). In the case of low volume or infrequent packers of export shipments to the United States, upon agreement between the CFIA and the Operator of the establishment, the Company's QA system may be assessed taking into consideration interprovincial shipments occurring during the Validation Period.

Three (3) consecutive satisfactory audits must be obtained before an establishment may be recommended for registration. More than five (5) audits may be required where the Operator is unable to satisfactorily meet the requirements for Validation. However, if more than eight (8) audits are required, the Operator of the establishment must conduct and document a thorough review of the QA system and manual to fully address the non-conformities preventing validation.

If the Operator has not obtained a minimum of three (3) consecutive satisfactory audits after twelve (12) validation audits, additional audits will not be performed. The Operator must re-apply as a new applicant and submit another application for registration along with applicable $500 fee.

4.4 Verification

C-PIQ relies on the verification process to maintain program integrity. The Operator of the establishment must demonstrate effective control, maintenance and operation of their quality assurance program, have documented history of compliance with quality (grade, size and maturity) standards and applicable packaging and labelling requirements, and have demonstrated proper use and control of Export Documents.

The CFIA will commence Verification Audits of an establishment that has successfully completed the required number of Validation Audits and has been issued a Certificate of Registration.

Verification audit frequency will be divided into two (2) phases. However, every C-PIQ establishment shall be audited a minimum of two (2) times per shipping season.

Phase 1

Upon successful completion of the registration and Validation period, an establishment will be audited at a frequency of one (1) audit per each period of 28 production days. A production day is any day on which an establishment issues a C-PIQ Export Document and/or C-PIQ Establishment Transfer Document irrespective of the day on which the product was prepared, or the number of Export Documents or Transfer Documents issued on that day.

Phase 2

This frequency of audit allows for a reduction in CFIA presence for those establishments which demonstrate, on a consistent basis, that the Operator:

  • maintains and operates the establishment in accordance with the C-PIQ requirements;
  • prepares product that meets standards and requirements; and
  • has effective control of procedures and records (including C-PIQ Export Documents).

Following a minimum of two (2) calendar years of registration, and at the discretion of the CFIA, an establishment that has consistently met C-PIQ Program requirements may be eligible for a reduction in frequency of audit to one (1) audit per each 50 production days.

To be eligible for the reduced audit frequency, an establishment must:

  • have been registered for a period exceeding two (2) calendar years (at least two (2) full shipping season);
  • have been audited a minimum of five (5) times;
  • not have been assessed a Critical Non-Conformity;
  • not have had a registration suspended or cancelled, in the previous three (3) years.

While in Phase 2, the establishment must continue to operate and receive satisfactory audit results. Failure to attain a satisfactory audit result will result in a return to Phase 1 frequency of audit. While in Phase 1, to be eligible for the reduced audit frequency of Phase 2 once again, the establishment must have attained a minimum of three (3) consecutive satisfactory audit results.

Establishment Audits
Phase Audit Frequency Non-Conformities
Phase 1 1 audit / 28 days* Audits will be performed as follow-up to corrective actions required by the establishment
Phase 2** 1 audit / 50 days Audits will be performed as follow-up to corrective actions required by the establishment

* Days are considered to be days on which shipments of product are included on a C-PIQ Export Document or C-PIQ Establishment Transfer Document.

** Subject to performance and compliance history in previous Phase.

Verification Audits are unannounced and may be performed on any day during the audit period. Each C-PIQ establishment shall be audited a minimum of two (2) times per season regardless of the number of days of production. Any non-conformity found during Verification Audits will be documented in the C-PIQ Audit Report.

Audit frequency may be increased upon re-instatement of a suspended registration.

4.5 Follow-up Audits

Follow-up audits will be performed as necessary to verify that corrective actions identified by the CFIA at the time of Verification, have been completed, and are effective to address the non-conformities.

4.6 Inspection of Returned Shipments by the CFIA

Returned shipments will be examined for the purpose of verifying that the C-PIQ establishment is operating in compliance with the requirements of the C-PIQ Program, and that the product prepared by the establishment meets the Fresh Fruit and Vegetable Regulations or the U.S. Import Requirements of 7 U.S.C 608e-1, as applicable.

An inspection will be performed for verification purposes where the CFIA receives notification that a shipment was inspected or monitored by the USDA or Federal-State Inspection Service, and failed or was suspected to fail to meet the grade declared, or the US Import Requirements of 7 U.S.C 608e-1.

The operator of the C-PIQ establishment must provide written notification of the returned shipment within 24 hours following the shipment's return and the reason for return. The operator shall hold all returned shipments for inspection by the CFIA. This information, as well as the results of any inspection, will be used by the CFIA to determine if an inspection for verification purposes is required. A shipment will not normally be inspected where the shipment was returned because of factors over which the operator had no control (e.g. over-supply, failure to meet delivery times, cancelled order, failure to meet receiver's specifications, etc.).

Inspections for verification will include assessment of maturity, size and both condition and permanent factors. Failure to meet the maturity, size and permanent factors will be considered a Non-Conformity. A returned shipment which fails CFIA inspection for verification due to condition factors such as decay, sprouting, pressure bruises, etc., may not be considered a Non-Conformity where the condition factor may have progressed in the time elapsed between the original inspection and the inspection for verification. However, a Non-Conformity will be considered where a shipment fails for condition factors where the date of the original shipment is close to the date of inspection, and it is unlikely that the factors could have progressed significantly from the time of original shipment (e.g. less than 24 hours from date of shipment). No CFIA certificate will be issued in respect to inspection for verification.

Where a shipment is determined to fail to meet requirements, the operator shall take corrective actions to control the product and to ensure that the product is brought into compliance.

The Operator of the C-PIQ establishment must provide written evidence to effectively link the original C-PIQ Export Document, the CFIA inspection for verification, and the corrective action taken (issuance of replacement Export Document, regrade of product, dump, etc.).

5. Non-Conformities, Audit Ratings and Enforcement

5.1 General

The CFIA will conduct scheduled and un-scheduled audits to the C-PIQ establishment to verify compliance and continued participation in the C-PIQ Program. 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 C-PIQ Registered Establishment with the appropriate application fee of $500 and 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.

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