Canadian Partners in Quality (C-PIQ)
4. Audit 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 (Annex D) to ensure the establishment meets the requirements set out in Annex 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 consideration along with the applicable 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 consideration along with the applicable 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.

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 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 Safe Food for Canadians 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.).