Canadian Partners in Quality (C-PIQ)

1. General program information

1.1 Introduction

This manual sets out the program requirements and operational procedures of the Canadian Partners in Quality (C-PIQ) Program. The C-PIQ Program is an integrated inspection system, which provides an alternative to the traditional hands on inspection by the Canadian Food Inspection Agency (CFIA) for tablestock potatoes exported to the United States. Companies wishing to operate under C-PIQ must meet a number of requirements in order to be registered by CFIA and obtain export certificate and must maintain a specific performance standard in order to remain in C-PIQ.

Participation in the program is voluntary. Operators will be required to sign a participation agreement with the CFIA. This agreement will outline the commitment and responsibilities for both the company and CFIA, right of CFIA access to company premises, criteria for termination, as well as fee structure.

In addition to meeting the criteria for C-PIQ, participants must meet all applicable requirements under the Safe Food for Canadian Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) which will include obtaining a Safe Foods for Canadians (SFC) licence. The requirements for the operation and maintenance of C-PIQ registered establishments (Annex A) apply to establishments registered under the C-PIQ Program. In the case of export shipments, produce packed in C-PIQ establishments must meet the requirements of the importing country.

As a licence holder participants must meet part 5 traceability and part 4 preventative controls requirements of the SFCR. Division 6 requires the documentation of preventative controls in a written preventative control plan (PCP) that must address both food safety and consumer protection. This includes the requirement to perform and document a full hazard analysis to identify any chemical, physical or biological hazards that require control. The plan must also detail the measures taken to ensure any requirements related to grade, standard of identity, labelling are being met.

Participants are responsible for the development of their own quality assurance system and production controls in accordance with C-PIQ requirements, which are implemented to ensure that quality (grade, size, maturity), and applicable packaging and labelling requirements are met. The quality assurance system will reflect the nature of their operation, type of product and the physical layout of their facility. The written procedures and control measures will constitute the Company Quality Assurance (QA) Manual, which must be provided to the CFIA at the time of application. The condition of the facility and the quality of the product are the responsibility of the Operator of the C-PIQ establishment. Credibility of the establishment in controlling their operation on a consistent basis is critical in maintaining C-PIQ integrity.

It is the Operator's responsibility to implement effective measures and procedures that are well documented and maintained for review by CFIA. It is the Operator's responsibility to provide training to staff and to control and complete export documents. Definitions set out in (Annex B) may be useful in understanding terminology relating to quality assurance systems.

The CFIA will maintain full responsibility and authority for the design and implementation of C-PIQ, registration of participants, verification of compliance, enforcement of
C-PIQ and legislated requirements, and issuance of C-PIQ export documents to C-PIQ establishments. CFIA will follow an established audit process to evaluate compliance with the C-PIQ Program.

1.2 Acceptance process

The C-PIQ acceptance process is designed to be consistent across the industry and to verify that companies are knowledgeable about and fully compliant with the principles of the C-PIQ Program. A company must demonstrate, on a consistent basis that they have operational control of their QA system and that product meets required quality standards.

Steps for registration under the C-PIQ program

1. Application – A copy of the application for consideration as an establishment under the Canadian Partners in Quality Program (C-PIQ) (Annex C), the C-PIQ Program Manual and participation agreement may be obtained from the local CFIA inspection office.
2. Companies who wish to proceed with registration must return a completed application form to the local CFIA office along with the appropriate application for consideration fee, which is non-refundable. The Operator will provide a written and electronic copy of the Company QA Manual. It is against this written plan that the operation and maintenance of the establishment will be assessed. Please note that the application fee is valid for 12 months, unless the applicant does not satisfactorily complete the pre-validation or validation periods, at which point the company will need to re-apply as a new applicant and submit another application for consideration along with the applicable fee.
3. The CFIA will review the Company QA Manual to confirm that it is acceptable to begin pre-validation, and ultimately, prior to granting registration, that it meets the requirements of the C-PIQ Program.
4. • The Operator shall perform a self-assessment of the establishment (facilities, surroundings, equipment, etc.) using the Establishment Inspection Report (Annex D) making corrective actions where the establishment does not comply with the necessary requirements. The completed Establishment Inspection Report must be submitted prior to the request for pre-validation audit.
   • Note: If the establishment has implemented Canada Gap (the Potato Producers and Packer On-Farm Food Safety program) and has been audited by an independent auditor within one year of application, the Operator may provide proof that the establishment has satisfactorily implemented all requirements, in lieu of the Establishment Inspection Report.
5. Prior to registration, a pre-validation audit by the CFIA must be requested by the Operator to verify compliance with the C-PIQ Program. This request is made 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. As part of this pre-validation audit, the CFIA will ensure the establishment meets the requirements set out in (Annex A) and has in place the control measures described in their Company QA Manual. This pre-validation audit is designed to identify any deficiencies and the need for changes or improvements. The Operator will be informed if there is a need for additional preparation and subsequent audits before proceeding to the validation period. The number of pre-validation audits shall not exceed 3. 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.
6. • The validation period is designed to confirm that the company is implementing C-PIQ on a consistent basis in accordance with their written quality assurance system, applicable regulations and C-PIQ requirements. During this validation period, all export shipments to the United States from the establishment must be inspected and certified by the CFIA. In addition, the CFIA will audit the QA system weekly to confirm the establishment is maintained and operated in accordance with C-PIQ. The validation period will be for, the greater of, a minimum of 5 weeks or 25 export shipments to the United States (where a shipment is 25,000 pounds 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 provided a certain number of shipments are export shipments.
   • Before an establishment may be recommended for registration, 3 consecutive satisfactory audits must be obtained. More than 5 audits may be required where the Operator is unable to satisfactorily meet the requirements for validation. However, if more than 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 3 consecutive satisfactory audits after12 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.
7. A C-PIQ Audit Report will be completed by CFIA auditors after each visit, and once the establishment has successfully completed the validation period, an audit report will be issued recommending registration as a C-PIQ registered establishment. An Operator of a C-PIQ registered establishment will be required to sign a participation agreement and pay the C-PIQ registration fee. Once the participation agreement is signed, CFIA will provide the company with a certificate of registration for prominent display as long as the company meets the requirements for participation in the program.
8. Submission of the application for consideration and registration of an establishment under the Canadian Partners in Quality Program (C-PIQ) (Annex C) form is required only at the time of initial registration. Submission of this form is also required at the time of renewal of C-PIQ registration for payment purposes and processing of registration renewal. C-PIQ Operators are required to provide CFIA with any changes to the initial registration.
9. The participation agreement is signed annually and the C-PIQ establishment registration fee is submitted at time of signing the participation agreement. The participation agreement covers the period of September 01 to August 31 and states the responsibilities of both the CFIA as well as the management and personnel of the C-PIQ registered establishment.

1.3 Verification/audit process

The C-PIQ Program utilizes an audit based inspection process to verify compliance with the Company QA Manual. Product quality, monitoring and control procedures, and C-PIQ export document completion are the responsibility of the Operator of the C-PIQ establishment. The Operator may choose the type of monitoring system to implement as well as have some flexibility in the method and limits for monitoring. However, it is essential that the establishment is operated and maintained in accordance with (Annex A) and that the product meets quality requirements. Failure to do so may result in additional audits and enforcement action by the CFIA, as necessary, to maintain the overall integrity of the program.

The role of CFIA is to verify that:

• operational control is maintained by the company (actually doing what they say they are doing)
• operations comply with C-PIQ requirements
• product prepared in the establishment meets the quality (grade, size, maturity), and applicable packaging and labelling requirements

The C-PIQ Audit Report is a summary of the audit findings and corrective actions necessary, if any.

Non-compliance's observed by auditors are identified and categorized based upon the impact on program integrity and product quality. Continued failure by an Operator of a C-PIQ establishment to demonstrate satisfactory controls may result in the suspension or cancellation of registration. CFIA audit frequency is based upon the ability of the Operator to maintain effective control of their QA system.

Pre-validation audits are announced; in most cases verification audits are unannounced. All audits start with a brief meeting between company management and the audit team and conclude with another meeting following the verification process. The audit will be conducted by an audit team, one of whom will assume the role of lead auditor. During the audit, the team will observe, interview, ask questions, review records and inspect product. The results of the audit will become the objective evidence by which compliance will be determined. At the closing meeting, the lead auditor will outline the audit findings, request corrective action with time frames to address non-conformities, and provide an overall evaluation for the company. These findings will be confirmed in a C-PIQ Audit Report, a copy of which will be provided to the company.

1.4 Compliance and enforcement

The C-PIQ Program permits the Operator flexibility in the design and implementation of a quality assurance system. However, where the integrity of the C-PIQ Program is compromised, and where terms of the participation agreement have not been met, the CFIA will assess the non-compliance, and where appropriate, take enforcement action.

Enforcement action may include:

• the assessment of non-conformities and the request for corrective action
• warning letters
• suspension or cancellation of your C-PIQ registration and/or the SFC Licence

The Operator of the establishment will be advised in person and by way of a written C-PIQ Audit Report when there are grounds for suspension. Where the C-PIQ registration is suspended, the Operator must not issue C-PIQ export documents, and shipments marketed in export trade to the United States while the establishment is under suspension will require inspection by the CFIA.

The Operator will receive confirmation of the suspension by way of a written notice of suspension. This written notice of suspension will include a list of the non-conformities/ deficiencies leading to the suspension, a request for a comprehensive corrective action plan satisfactory to CFIA, and the date of suspension. A satisfactory corrective action plan must be provided to the CFIA and implemented within 30 working days from the date the notice of suspension is sent to the company.

The suspension will remain in effect until the required corrective actions have been taken and verified by the inspector as being effective in correcting the non-conformities and preventing a re-occurrence. Furthermore, in the case of a suspension issued in respect of a critical non-conformity, the suspension will remain in effect for a minimum of 7 calendar days. If a suspension is issued in respect of grading of product, traceability, lot identification or issuance of C-PIQ export documents or transfer documents, the suspension will remain in effect 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). The Operator will receive written confirmation of suspension being lifted. A failure to meet requirements during the period of suspension may result in an extension of suspension.

Failure to provide and implement the effective corrective actions by the date specified in the notice of suspension, will result in CFIA initiating procedures to cancel registration and the establishment's participation in the C-PIQ Program.

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.

As of the effective date of the cancellation of the establishment's participation in C-PIQ, all references to the C-PIQ Program or the establishment's participation therein must be removed from all of the establishment literature, packaging, etc.. in whatever format it may exist, and the C-PIQ certificate of registration and all unused C-PIQ export documents must be returned to the CFIA.

The Operator of an establishment, for which a C-PIQ registration has been cancelled, may reapply as a new applicant, but must comply with the same criteria and requirements that apply to any new applicant.

The CFIA reserves the right to cancel an establishment's participation in C-PIQ after a total of 3 suspensions, or not to accept a C-PIQ application from an establishment that has twice had a C-PIQ registration cancelled.

1.5 Special circumstances

C-PIQ is an alternative to traditional hands-on inspection by the CFIA for tablestock potato shipments exported to the United States. Therefore the Operator of an establishment choosing to be registered under the C-PIQ Program will not normally request and receive inspection and certification for shipments prepared by the establishment. However, under unusual circumstances, an Operator may request traditional inspection and certification (subject to current inspection fees), and still maintain C-PIQ status. An example of such circumstance may be a request by a receiver for government inspection to meet an importing country's requirement (other than the United States). Requests for hands on inspection will be dealt with on a case by case basis as resources permit.

Shipments for which an inspection has been requested must be fully prepared and accessible for inspection by the CFIA. It is the responsibility of the Operator to ensure that all monitoring procedures are followed as per the Company QA Manual for product for which inspection is requested.

2. General requirements for C-PIQ establishments

The written procedures and control measures contained in the Company QA Manual must address all of the following general requirements for C-PIQ establishments. The Industry Checklist for Development of Company QA Manual (Annex E) has been developed as a tool to assess the completeness of the Company QA Manual for compliance with C-PIQ Program requirements.

2.1 Quality policy statement

CFIA requires a company applying for participation in C-PIQ to have a strong commitment to quality, clearly evident to its staff. A statement describing the aims of the Company in this regard must be included in the Company QA Manual. Such a statement shall authorize the policies and procedures documented in the manual and may incorporate the requirements for the chief executive declaration outlined in the next section.

2.2 Declaration of commitment

This is a mandatory statement signed by the chief executive of the Company (the person in the top management position). It shall express the full support of Company management in directing appropriate staff in meeting the requirements of their QA system, and endorse the procedures outlined in the Company QA Manual. The declaration shall also include a statement of commitment that the quality system in place will be maintained at a level of integrity which will ensure that all products and processes meet all requirements of applicable Acts, Regulations, policies, foreign country import requirements (for exporters), and the Company itself.

2.3 Organization

Certain positions within the organization are key to the maintenance and operation of the C-PIQ establishment, and to the production of safe and quality food. The application for registration must include the name of the owner of the establishment, the name of the Operator of the establishment, and the person responsible for the supervision of the preparation of the product. The Operator must ensure that a QA system is established in accordance with the requirements of C-PIQ and appoint/designate a person that will have the responsibilities of a Quality Assurance Manager.

The Operator of an establishment must identify in the Company QA Manual the personnel responsible for:

2.3.1 Quality assurance manager

The Quality Assurance Manager, irrespective of other responsibilities, shall have defined authority for ensuring that a QA system is established, implemented and maintained in accordance with the C-PIQ Program, regulatory requirements and product standards, which should include

1. reviewing the QA system;
2. verification of monitoring and corrective action records; and
3. acting as the liaison with CFIA on matters relating to C-PIQ, corrective actions, and audit findings.

2.3.2 Other key quality assurance positions

Key quality assurance positions must be identified, including: grade/lot verifiers, and certificate controllers.

It is a requirement that the duties and responsibilities, as well as back-up personnel, for each key quality assurance position, be identified in the Company QA Manual. When specifying duties of key QA personnel, it is important to remember that the person responsible for verification of records may not be the same person as the one doing the actual monitoring. Changes to identified personnel or their duties must be reflected in an amendment to the Company QA Manual.

2.4 Maintenance of reference materials

The Company QA Manual must also include a list of Reference Materials such as pertinent Acts, Regulations and procedural documents. The Establishment must explain where these Reference Materials are available, as well as how and by whom they are maintained to ensure these are current at all times.

2.5 Training

It is the Operator's responsibility to ensure that staff is trained. As per SFCR 75 any person who is involved the manufacturing, preparing, storing, packaging or labelling of a food must have the competencies and qualifications necessary to perform their duties. Training must be provided to all required staff, as appropriate, upon hire and a minimum of once per season thereafter and cover the following topics:

1. the safe preparation and handling of food (all staff);
2. the quality assurance system implemented within the establishment;
3. U.S. import requirements;
4. defect identification and tolerances;
5. inspection procedures;
6. control and completion of documents, including C-PIQ Export Documents and Transfer Documents; and
7. traceability and lot identification.

Personnel that have responsibility for the training program within the establishment must be clearly identified in the Company QA Manual. Details pertaining to the employee training program shall also be included in the Company QA Manual outlining training frequency, training topics and materials, target audience, as well as records to be maintained. Training of personnel is to be documented and kept on file by the establishment.

2.6 Floor plan of facility and process flow diagram

Under SFCR section 59, a facility must be designed, constructed and maintained in a manner such that the movement of persons and things within, into and out of it is controlled and the movement must not present a risk of contamination to the food.

2.6.1 Floor plan

The establishment must provide the CFIA with a floor plan of the facility. The floor plan shall illustrate the general layout of the facility including:

1. receiving areas (for product and materials), sorting and grading areas, packaging areas (bulk or packaged product), storage areas and the shipping area;
2. lunchrooms, washrooms, mechanical rooms, offices, etc.;
3. location of major equipment;
4. flow of product to illustrate the movement of product through all production steps (receiving, washing, sizing, rough grading, finish grading, packaging (identify each package line), storage, shipping, etc.);
5. location and identification of all sampling sites.^Footnote 1

2.6.2 Process flow diagram

The Company QA Manual must also include a process flow diagram which illustrates the flow of the product through each step in the process from receiving to final shipping with particular attention to any cross-over of product lines which could negatively affect the quality of the product. The process flow diagram shall identify control points for quality, lot identification and other factors that need to be controlled, as well as sites where samples are taken and monitored.

This process flow diagram must be correlated to the floor plan to ensure a clear understanding of the process.

2.7 Calibration of equipment

In order to meet SFCR 53 (g) respecting calibration, the establishment must identify the equipment used to grade the product and monitor control points (i.e. thermometers, temperature gauges, sizing equipment, scales, electronic grading equipment, etc.) and document the procedures for calibration of equipment including:

• person(s) responsible;
• procedures for calibration, and record keeping;
• frequency of testing and tolerances for equipment; and
• corrective actions if equipment is found in non-compliance with requirements.

This information may be put in the form of a table for easy reference.

2.8 Facility and operational requirements - registered and maintain registration

The establishment must meet the Safe Food for Canadians Regulations and C-PIQ requirements for the operation and maintenance of C-PIQ registration as outlined in (Annex A) prior to and during registration. These basic requirements aim to provide environmental conditions favorable for the production of safe food and the preparation of quality product. It is the Operator's responsibility to ensure that the establishment is operated and maintained in accordance with the minimum requirements at all times throughout the registration period. The Operator of the C-PIQ establishment is responsible for all produce received into the establishment and for its compliance with C-PIQ and any applicable Acts and Regulations.

2.9 Traceability and lot identification

Traceability of product as it passes through the establishment is an important element in C-PIQ. This is to ensure that product destined for shipment to the United States has not been co-mingled or inadvertently certified as meeting US import requirements. Traceability applies to all product entering and exiting the establishment. The Operator of the establishment shall have a policy and procedure which permits the identification and traceability of all product from receiving to shipment. The establishment must maintain records to provide a clear link between the receipt of the product, any preparation or monitoring within the facility, and the ultimate disposition of the product. Lot identification must permit product to be traceable. The establishment may use shipping documents, manifests, purchase orders, etc. as part of their procedures for traceability, providing that the C-PIQ requirements of this section are met. Under SFCR Part 5 operators must ensure that traceability documents are kept for two years after the day on which the food was provided to them and they provided the food to another person. All traceability documents must be accessible in Canada.

2.9.1 Incoming product

C-PIQ traceability and lot identification requirements for incoming product do not apply to loose product off-loaded from vehicles directly into storage for either short or long-term storage. Traceability of loose product commences once the product enters the production line, at which time a record of receipt is required.

A record of receipt is required for each lot of packaged product entering an establishment, whether it is in bulk containers (bins, totes, sacks) or palletized.

The record of receipt should contain the following information:

• Date of receipt;
• Quantity;
• Type of product;
• Quality declared (if applicable);
• Source or origin;
• Ministerial exemption number (if the product is received in bulk from another province or country)^Footnote 2;
• C-PIQ Transfer Document number (if applicable).

For incoming product, the method of traceability must include unique identification of the lot on each bulk container or pallet of packaged product within the lot and provide a clear link to the record of receipt. For incoming product, each establishment may utilize any numbering system of lot identification that is suitable for their operation, as long as the total quantity of product from each lot is traceable.

If graded produce is coming from another C-PIQ establishment, product will already be identified with the unique pallet/bulk container identification number, but must be linked with the record of receipt.

Production records and sample site documents must be able to be linked to the record of receipt via the lot identification numbers. Culls/rejects must be accounted for by quantity through shipping records and must be identified while in the establishment with the words" Do Not Ship".

2.9.2 Finished product

C-PIQ requirements include lot identification of all product that has gone through the production line to the pallet or bulk container level and traceability through to the consignee or receiver of the product. Finished product identification is a method to identify individual containers or pallets of product with a unique identification number and tie them to a C-PIQ Export Document, C-PIQ Transfer Document and/or other shipping records.

Each bulk container (bins, totes, sacks) or pallet of finished product which has been graded or verified for grade within the establishment must be labelled with:

• the C-PIQ registration number of the establishment, as issued by the CFIA;
• the date of preparation and/or monitoring by the establishment; and
• a unique pallet/bulk container identification number.

An alternative to the date of preparation and/or monitoring is the use of a code, such as a Julian code, which represents the date. An Operator may wish to include additional information in the lot identification of finished product to identify growers, packing lines, hours of day packed, etc. for its own control purposes. If an Operator wishes to implement these additional requirements, the meaning of the identification system used must be clearly explained in the Company QA Manual, and the CFIA will audit against these additional requirements.

Example: The code may appear as A222160510NB06

In this example,"A" would denote the first pallet packed/monitored, "222" denote the C-PIQ registration number,"160510" denote the date of packing/monitoring of May 16, 2010, and the following additional information that the establishment would like to include: "NB" representing the code for the province, and "06" the grower number.

Each pallet of product intended to be exported to the United States or Puerto Rico must also be labelled with the CFIA C-PIQ Logo (Annex F) in addition to the C-PIQ registration number, date and unique pallet/bulk container identification number. The logo may appear in either black and white, or may be depicted in colour. If in colour, the logo and colours must be as per the official CFIA C-PIQ Logo.

Note: If graded product is loaded loose onto a truck, the appropriate lot identification requirements may be applied to the back of the truck door.

Product that is run through the production line but is not graded (i.e. product that is only sized or washed or run to remove debris) must also be identified at the end of the process with the following:

• the date of preparation; and
• a unique identifier on the container.

All lot identification on pallets must be a minimum of 6 inches (15.24 cm) in width and 4 inches (10.16 cm) in height. Lot identification must be clearly visible and legible, and securely affixed in the upper portion of the bulk container or pallet in a manner that cannot be easily removed or tampered with.

If any product is reworked, the establishment must document and control the removal of the original product identifier. A new lot identification mark must be affixed to this lot, and records must clearly link the new and old identification numbers.

Any product that has been monitored and found not to be in compliance with quality requirements must be identified in a manner that will ensure that the lot is not shipped.

2.10 Information and document control

2.10.1 Document control

The Export Document for C-PIQ Establishments (C-PIQ Export Document – CFIA/ACIA 5314) (Annex G) is a document to accompany each shipment exported to the United States.

2.10.1.1 Issuance of export documents

The completion of the C-PIQ Export Document is a joint responsibility of the C-PIQ establishment and CFIA. CFIA issues the C-PIQ Export Document to confirm that the establishment is operating under a CFIA recognized quality assurance program and is monitored and audited for compliance with the requirements of the program. The completion and the control of the C-PIQ Export Document is the responsibility of the C-PIQ establishment whereby they attest to the verification of quality and compliance with US import requirements.

2.10.1.2 Identification of staff

Each C-PIQ establishment must identify staff authorized to request and complete C-PIQ Export Documents, clearly identifying the names and titles of the authorized personnel in the Company QA Manual. These persons shall be trained in the control and completion of documents.

2.10.1.3 Control of export documents

The procedures adopted for the control and completion of Export Documents must be clearly identified in the Company QA Manual and be adequate to ensure control of the documents and the integrity of C-PIQ. The establishment must ensure that all C-PIQ Export Documents are controlled and completed accurately and truthfully, being used only for shipments of graded product eligible under C-PIQ. C-PIQ Export Documents are non-transferable. A C-PIQ establishment which permits another facility to use C-PIQ Export Documents which have been issued to their facility will be assigned a Critical Non-Conformity, will have their C-PIQ registration suspended or cancelled, and will lose the privilege to request, complete and issue C-PIQ Export Documents.

2.10.1.4 Requesting export documents

The C-PIQ establishment must submit a signed Request for Export Documents for C-PIQ Establishments (Annex H) to obtain C-PIQ Export Documents. The establishment must provide 24 hours advanced notice to CFIA for C-PIQ Export Documents. If the establishment is in good standing, CFIA will assess the request and provide the C-PIQ Export Documents. Additional documents may be provided upon request subject to adequate accountability of previously issued documents.

C-PIQ Export Documents provided by CFIA will include the following information:

1. a unique C-PIQ Export Document number;
2. the C-PIQ establishment name;
3. the C-PIQ registration number; and
4. the name, and signature of a CFIA inspector.

2.10.1.5 Completion of export documents

For each eligible shipment, the authorized establishment personnel shall complete each C-PIQ Export Document as per instructions in (Annex G). The original of the document shall be signed by the authorized personnel and accompany the shipment. A copy of each completed and signed C-PIQ Export Document must be sent to the local CFIA office within 24 hours of shipment. Should the C-PIQ Export Document not be sent to the local CFIA office in a timely manner repetitively, C-PIQ Export Documents may be issued by the CFIA on a load by load basis.

A C-PIQ Export Document is considered to be issued once it has been faxed to the local CFIA office and the original copy has been provided to the transporting vehicle. Prior to the completion of the C-PIQ Export Document, faxing to the local CFIA office and the shipment leaving the establishment, minor changes may be made. Such changes are to be made by authorized personnel only and must follow the procedure for all corrections to records, i.e., a single line through the incorrect entry; the correct entry in close proximity to the incorrect entry; and the initials of the person making the correction.

2.10.1.6 Cancellation of issued export documents

Once issued and a copy has been sent to the local CFIA office, alterations to the C-PIQ Export Document are not permitted. Subsequent changes will require the cancellation of the issued document and the issuance of a replacement document. A line must be drawn diagonally across the inspection document with the word Cancelled appearing above that line. A copy of all cancelled C-PIQ Export Documents shall be sent to the local CFIA office. The original shall be maintained on file by the establishment for review by CFIA audit staff.

The establishment is required to maintain copies of C-PIQ Export Documents, shipping and production records for a minimum of two (2) years as per the Safe Food for Canadians Regulations Part 5 Traceability 90 (1)(2)(3). The local CFIA office should be contacted with regard to any questions or inquiries related to the Export Document and its use.

2.10.1.7 CFIA control of export documents

CFIA will maintain a record of C-PIQ Export Documents issued to and completed by each establishment. A copy of the Request for Export Documents for C-PIQ Establishments form will be maintained on file at the local CFIA office. Upon receipt of the sent document, CFIA staff will note the C-PIQ Export Document number and the date the document was issued, cancelled or returned by the establishment. The sent copy of the C-PIQ Export Document will serve as CFIA's official record of the shipment.

2.10.2 Transfer documents

Produce prepared (packaged or bulk) in a C-PIQ establishment may be transported to another C-PIQ establishment for the purpose of inclusion on an Export Document for shipment to the United States provided the following conditions are respected:

1. both establishments are operating under C-PIQ and are monitored and audited by CFIA for compliance with C-PIQ Program requirements;
2. the produce meets the Traceability and Lot Identification requirements as identified in 2.9;
3. each shipment is documented with a C-PIQ Establishment Transfer Document (for movement of potatoes, intended to be exported to the United States, from one C-PIQ establishment to another C-PIQ establishment) (Annex I);
4. the C-PIQ Establishment Transfer Document shall be printed on the establishment's letterhead paper and provide the following information:
   1. a unique tracking number for each C-PIQ Establishment Transfer Document;
   2. full name, address and registration number of the C-PIQ establishment;
   3. shipper (full name and address; indicate "same" if shipper is same as originating C-PIQ establishment);
   4. receiving C-PIQ establishment (full name and address)
   5. marks on packages, including brand name;
   6. product/type/variety (potatoes round or long type; variety name where declared; yellow-fleshed where applicable);
   7. number and type of packages (e.g. 500 master container, 10/ 5 lb 2.27 kg poly bags);
   8. grade name of the produce;
   9. size of produce (e.g. 2" minimum; Chef; or 10 oz. minimum);
   10. lot identification numbers;
   11. date that the produce was packed and/or monitored;
   12. remarks;
   13. province of origin of product (a plant health requirement);
   14. signature and date that lot was shipped, attesting to origin of the product; authorization to sign on behalf of the establishment; the accuracy of the information provided; and legal implications of providing false, misleading or deceptive information;
5. produce shipped and included on the C-PIQ Establishment Transfer Document must, at all times, be controlled and identifiable;
6. for each movement of eligible produce between C-PIQ establishments, a C-PIQ Establishment Transfer Document must be completed, the original kept on file and a copy must accompany the shipment. Within 24 hours from the time the shipment takes place, the C-PIQ Establishment Transfer Document must be faxed to both the local CFIA office and the C-PIQ establishment where the produce is destined for ultimate shipment to the United States;
7. the issuance of the C-PIQ Establishment Transfer Document will be used in the calculation of shipping days for the frequency of audit.

Note: When a C-PIQ establishment transfers product intended for the domestic market to a C-PIQ establishment located in another province, this must be in accordance with the Safe Food for Canadians Regulations.

C-PIQ Establishment Transfer Documents may be used without a ministerial exemption for the interprovincial movement of finished bulk product between C-PIQ establishments for the purpose of inclusion in a C-PIQ Export Document for ultimate shipment to the United States.

Produce received from another C-PIQ establishment with a C-PIQ Establishment Transfer Document may be included on an Export Document for shipment to the United States provided the following conditions are met:

1. the information provided on the C-PIQ Establishment Transfer Document must clearly link the final Export Document to the receiving/ production/shipping samples and records in the originating establishment;
2. the C-PIQ Export Document must include the marks on packages, product type, declared grade, number and type of packages, and lot identification number of the produce packed in the originating establishment;
3. produce more than 3 days from the time of packing/monitoring must be examined to verify that the quality of the product has not deteriorated.

Should product received from another C-PIQ establishment, by way of a C-PIQ Establishment Transfer Document, not meet U.S. import requirements, the receiving C-PIQ establishment must notify the local CFIA office for further instructions.

2.10.3 Notification requirements

The operator of a C-PIQ establishment must provide written notification by way of fax to the CFIA of any returned export or domestic shipment of product, irrespective of the reason for the return, no later than 24 hours following the shipment's return. If the returned load is returned under a CFIA detention, then notification must be immediate. The operator shall maintain the load intact and hold all returned shipments for inspection by the CFIA.

Failure to provide written notification within 24 hours or failure to hold a returned shipment for inspection will be deemed to be a Non-Conformity, which results in an Unsatisfactory Audit.

2.10.4 Amendments to company QA manual

The Company QA Manual will require regular updates to document new procedures, changing requirements or specifications, particularly when improvements are made to the quality system. The C-PIQ establishment must document and include in the Company QA Manual the procedure for making necessary amendments to the manual. A list of holders of controlled copies of the Company QA Manual must be documented to ensure that amendments are issued to each for inclusion in the manual. A page listing all amendments made to the Company QA Manual must be present at the front of the manual.

It is the responsibility of the C-PIQ establishment to ensure that the Company QA Manual is amended to accurately document the operation of its quality assurance system, and ensure it remains current at all times. The C-PIQ establishment must submit to the CFIA any amendments which result in changes to a process, critical limit or duties of key staff, and receive CFIA approval prior to implementation. For all other types of changes, the establishment must only forward a copy of the amended Company QA Manual page to the CFIA.

2.11 Internal audits

The Operator of a C-PIQ establishment must implement procedures for Internal Audit (self-assessment). The Operator must complete, and document a minimum of one (1) full internal audit (all parts of the QA system) per shipping season. These audits are necessary to assure the integrity of the C-PIQ Program, the establishment's own QA system, and the production of quality product. The Company QA Manual must identify and set out a policy to conduct these internal audits on a regular basis. The CFIA will review this record as part of the audit process to ensure that the C-PIQ establishment is maintained and operated in accordance with the C-PIQ Program.

Internal Audits should include such things as:

• a review of the Company's own QA Manual;
• an inspection of facilities, equipment, chemical storage, etc.
• a review of sanitation, maintenance and calibration procedures and records;
• a review of the policies and procedures in relation to monitoring, corrective action and verification;
• the examination of product to confirm monitoring procedures are followed;
• a review of inspection records;
• a review of lot identification and traceability procedures;
• a review of issued C-PIQ Export Documents;
• a review of training and training records;
• a review of other records and procedures for control of records.

3. Production controls

3.1 Introduction

Each establishment is responsible for the development of its own quality assurance program in accordance with the nature of the operation, type of product and the physical layout of the facility. The procedures and control measures that are developed to ensure production and/or preparation of quality product must be documented in the Company QA Manual and must be consistent with C-PIQ principles and requirements. This places the quality control process fully in the hands of the C-PIQ establishment. Credibility of the establishment in controlling operations is critical in maintaining C-PIQ integrity. CFIA will monitor the compliance of the establishment against the establishment's documented quality assurance program. The establishment must demonstrate, on a consistent basis, that they have operational control.

An establishment may choose to implement a quality assurance program based on either In-Line Verification or Lot Verification. The Company QA Manual must clearly identify which method will be implemented and detail the procedures to be employed to ensure that the product meets applicable grades, standards and other requirements for quality.

An In-Line Verification QA system shall include the identification of control points and sampling sites, and the implementation of monitoring procedures to verify product quality as the product is being prepared. An establishment opting for In-Line Verification may also elect to use Lot Verification for graded product (packaged or bulk) that does not go through their grading line which enters the establishment from other facilities.

An establishment may not use both verification systems (In-Line Verification and Lot Verification) for product going through their own grading line.

Lot Verification is the examination (verification) by the establishment of a lot of graded (packaged or bulk) product, prior to shipment and inclusion on a C-PIQ Export Document, according to an established CFIA sampling plan.

Note: For any lot of produce to be included on a C-PIQ Export Document, the lot must have either gone through the In-Line Verification System or the Lot Verification System.

3.2 Quality factors

To verify compliance with requirements for quality (grade, size and maturity), the Operator must put in place monitoring procedures and controls, and corrective measures to be taken when the following quality factors are not met:

• Defects (internal, external, and decay);
• Size;
• Special lot tolerances;
• Cleanliness;
• Colour;
• Maturity;
• Weight or count;
• Temperature (product, warehouse, vehicle).

3.3 In-Line verification of product

The Operator shall identify and plan the production and monitoring processes which directly affect quality and shall ensure that these processes are carried out under controlled conditions. The process, factors, limits and procedures must be included in the Company QA Manual.

3.3.1 Process analysis and planning

The Company shall define and document, in writing, how each quality factor will be assessed. The analysis should take into account all the products and processes in the operation of the establishment. This program offers a measure of flexibility to the Operator in the number, size and frequency of samples to be monitored. However, for In-Line Verification, the establishment must identify one sampling site at the beginning of the preparation process, one sampling site for finished product, and at least one (1) sampling site during the preparation process, where the product will be monitored and monitoring records maintained in accordance with frequencies and limits set by the establishment.

3.3.1.1 Identification of quality factors

This first step is to identify what factors, if not controlled during the process, might cause the graded product (packaged or bulk) to fail the requirements at the conclusion of the process. Quality factors include such things as grade, size, cleanliness, maturity, and so on.

Refer to the Safe Food for Canadians Regulations, Canadian Grade Compendium Volume 2 – Fresh Fruit or Vegetables and US Import Requirements.

3.3.1.2 Identification of control points for each quality factor

A control point is a point or operation beyond which, if a quality factor is not controlled, non-conforming product may be produced. The control may be performed mechanically by equipment identified on the flow diagram, or may be performed by personnel of the establishment. For some quality factors, there may be more than one control point identified to control the same factor. The Company shall identify where each quality factor will be controlled.

3.3.1.3 Identification of sampling sites

A sampling site is a point in the process where samples will be taken and findings recorded to evaluate the quality factors being controlled. Please note that multiple quality factors may be evaluated at a same sampling site. For In-Line Verification, the establishment must identify one sampling site at the beginning of the preparation process, one sampling site for finished product, and at least one (1) sampling site during the preparation process.

3.3.1.4 Identification of limits for quality factors at each sampling site

At each sampling site, the Operator must establish limits for quality factors which, if exceeded, may mean that the process is not being satisfactorily controlled at that point. The limits are established by the Operator based upon such parameters as: type/ variety of product, grade, and intended market. Limits may be more stringent than those required by regulation, but must not be less. Limits identified by the Operator should not be so stringent that they cannot be met.

3.3.1.5 Identification of Monitoring Procedures for each quality factor at each sampling site

Once limits are established, the Operator must establish monitoring procedures to ensure that product meets the applicable quality standards.

The Company QA Manual must fully describe how each quality factor will be monitored for compliance with the limits. The monitoring procedures must include: who, what action, how often and the type of record to be kept. Work instructions may be posted at sampling sites to facilitate understanding by the responsible person(s) at those points and to ensure that the monitoring process is consistent regardless of who is doing the monitoring. Monitoring frequency and amount of product to be monitored are set by the Operator of the establishment as each establishment is different from each other.

3.3.1.6 Identification of corrective actions for each limit exceeded

The Operator shall identify and document what corrective actions will be taken when a limit is exceeded. These actions must ensure that non-complying product will not be shipped from the establishment. Actions are predetermined and must be implemented immediately every time the limit is exceeded. These predetermined actions must be implemented regardless of the market conditions or the degree by which the limit is exceeded.

3.3.1.7 Identification of records for each sampling site

In order to audit the monitoring procedures and corrective actions at sampling sites, the Operator shall identify and document what records will be completed and maintained, by whom, in order to demonstrate compliance with the limits. These records shall be available to auditors upon request.

3.3.1.8 Identification of verification procedures

Verification procedures must be identified to confirm that any corrective actions taken were effective. For example, if the limit for grade defects was exceeded at a sampling site No. 2 and more graders were put on the line as the corrective action, it is expected that the results of this corrective action be verified. This verification should take place within a short time frame (i.e. 10 minutes after the corrective action has taken place). If the verification procedure indicates that the corrective action was ineffective, another corrective action must be applied immediately, and subsequently verified.

In addition, verification procedures must be identified to confirm that monitoring procedures at sampling sites are being followed and effectively implemented as described in the Company QA Manual, and records of results appropriately maintained.

Verification procedures need to identify verification frequency as well as personnel responsible for verification, keeping in mind that the person doing the actual verification may not be the same person as the one doing the monitoring and/or corrective action procedures.

To assist in establishing appropriate sampling sites, the following "decision tree" may prove useful but is provided strictly as an illustration:

Has a quality factor been identified?
If not, identify the factor which must be controlled.

Has (have) the control point(s) for the quality factor in the process flow been identified?
If not, identify within the process flow where the quality factor is controlled.

Is there a sampling site following the control point?
If not, establish a sampling site following the control point.

Has a limit for the quality factor, at the sampling site, been identified?
If not, what, if any, are the limits for the factor established at the sample site?

Note: Operators should be aware that they may set their own limits at any sampling site other than the final/finished product sampling site. At the final/finished sampling site, the product must comply with regulatory or U.S. import requirements.

Have predetermined corrective actions been established if the sample does not meet the limits established?
If not, what corrective actions will be taken when a limit is not met?

Have verification procedures been established to ensure that corrective actions taken are affective?
If not, what procedures will be put in place to ensure that corrective actions are effective?

An example as to how the establishment should define and document each factor in their Company QA Manual is as follows:

Factor: Internal and external defects
Sampling site: Receiving Area Site No.1
Limit: 20% external defects, 5% internal defects, 2% decay, 25% total
Monitoring procedures:

• What: Inspection for internal and external defects and decay
• How: Inspect unloading of product, 2 × 50 lb samples will be taken
• Frequency: Once per received lot
• Who: Receiving Foreman
• Records: Results recorded on Incoming Product Inspection Summary

Corrective actions:

If lot exceeds allowable limit, Receiving Foreman has authority to reject lot and/or advise lead grader to slow line and/or add graders. Monitor subsequent sample at Site No. 2 to ensure it meets limits established for internal, external and decay.

Verification procedures:

A Manager verifies that corrective actions were implemented and effective, in that the sample at Site No. 2 meets limits established for internal, external and decay. QA Manager also ensures that appropriate measures were taken to control product that exceeded the allowable limits.

3.3.2 Process analysis worksheet

To assist companies with their analysis procedures, a Process Analysis Worksheet has been developed. While not mandatory, this worksheet can be an effective tool in the analysis of production processes and the identification of factors, limits and procedures. Worksheets may be constructed as per the example in (Annex J) and must document the monitoring procedures (who, what, how, how often, what record) for each factor, as well as corrective actions and verification procedures for each sampling site. Each quality factor must be addressed separately.

The corrective action and verification sections of the process analysis are critical to any QA system. Monitoring procedures without effective corrective actions to be taken when limits are exceeded will render the QA system ineffective. Detailed corrective actions are essential, and should have the general format of "If this happens, then this corrective action will take place." If "this" (the limit) is exceeded, then "who" will do "what" action and "when". Once a corrective action is taken, a verification step is necessary to ensure that the corrective action produced the desired result. If the corrective action was not effective, further corrective actions are required.

3.3.3 Finished product sampling

This is the final sampling site in the grading line and should serve simply to confirm that previous controls and corrective action procedures were effective and requirements were met. This is a mandatory control point in the C-PIQ Program. Monitoring procedures (rate of sampling, size of sample, etc.) are established by the Operator, but must be adequate to ensure compliance with product standards on an ongoing basis. Procedures should identify when the finished product will be sampled, by whom, the sample size, the records to be maintained for documentation of both sample findings and compliance results. Procedures should also clearly outline what corrective action will be taken should non-compliance be identified, including who is to be notified and what actions are taken to respond quickly to correct the problem. Non-complying product must not be shipped, must not be mixed with complying product and must be effectively controlled.

It is a C-PIQ Program requirement that a unique identification number be applied to each pallet, bulk container or bulk load (See section 2.9). All finished product (packaged or in bulk totes, bins or sacks, or bulk loads) in the establishment must be lot identified. The unique identifier must be recorded on the worksheet for each sample of finished product monitored.

When an out of tolerance sample is encountered at the finished product sampling site, the following corrective action must be implemented, and incorporated into the QA system and manual:

• Two (2) additional samples must be taken, graded immediately, results recorded.
• The two (2) additional samples must be within the tolerance, and the average of all three (3) samples (including the one found to be out of tolerance) must be within the stated limits (within tolerance).
• Should the above not be the case, all product (related to the packages sampled) packed since the last compliant sample, must be immediately segregated. This segregated lot will include all product graded and packaged until the appropriate corrective action is verified as being effective.
• A full inspection of the lot, according to CFIA Sampling Plan (Annex K), must be performed and documented to confirm whether the lot meets requirements or requires rework.

3.3.4 Verification of received lots

The Operator of an establishment that has opted for verification of product quality by In-Line Verification system may wish to also employ Lot Verification procedures for graded product (packaged or in bulk totes, bins or sacks) entering their establishment. To include product graded at another facility on a C-PIQ Export Document issued by the C-PIQ establishment, the Operator must include Lot Verification procedures in their Company QA Manual. (See Lot Verification of Product in section 3.4)

A lot of graded produce entering a C-PIQ establishment may not require further verification provided the lot is accompanied by:

• a CFIA inspection certificate (for the purpose of export to the United States);
• a C-PIQ Export Document; or
• a C-PIQ Transfer Document.

If a lot was inspected and certified by the CFIA for the purpose of export to the United States, it must be accompanied by a CFIA certificate, and each pallet must be identified with CFIA Official Seal Tape. A lot certified by the CFIA must not be included on a C-PIQ Export Document. The lot must be shipped using the original CFIA certificate within three (3) days of its issuance. After three (3) days, the establishment will need to do a full lot verification on the product before it may be included on a C-PIQ Export Document.

If a lot or shipment is received with a C-PIQ Export Document or a C-PIQ Transfer Document, the lot may be included in the receiving establishment's C-PIQ Export Document. Each pallet must be fully lot identified, including the registration number, the day/date of preparation or monitoring and unique number of the originating C-PIQ establishment.

If the product is received from a non-C-PIQ establishment, the receiving C-PIQ establishment must immediately identify the product upon receipt, as per lot identification requirements specified in section 2.9.1 for incoming product. If the lot is to be included on a C-PIQ Export Document, the lot must be monitored as per the procedures set out for Lot Verification of product and as documented in the Company QA Manual.

3.3.5 Storage area controls

An establishment must have a sampling site in the storage area. Product control and segregation is especially important for lots that fail or are suspected of failing quality requirements. Also, control of product that originated elsewhere is crucial as the quality assurance system must be able to track product from the time it enters a facility until shipped out. All product in storage, regardless of whether it is packed by the establishment or originated elsewhere, is subject to controls.

In order to ensure quality of product, the Operator must ensure that, prior to shipment, product previously monitored by the establishment's QA personnel is re-examined for quality factors. This up-to-date check must be done prior to shipment for all product that had previously been monitored more than three (3) days prior to the shipment date. The quality check is required for all product, whether previously monitored by In-Line Verification or Lot Verification QA systems. Although condition factors may be progressive in nature, and therefore are the reason for the quality check, product must be monitored for both condition and permanent defects, excluding size, as the grade tolerance is based on internal and external defects, not condition and permanent factors. Product may be inspected for defects at half the sampling rate called for in the CFIA sampling plan. If, after examining samples at half the sampling rate, the tolerances are exceeded, then the full sampling rate must be applied.

3.4 Lot Verification of product

An establishment may choose to implement procedures for verification of product quality by the assessment of final graded product (packaged or in bulk totes, bins or sacks) prior to shipment as per an established sampling plan. The entire focus of Lot Verification is assessment of product that has been graded and packaged and is prepared for sale. Lots to be assessed may be prepared in the establishment, or may originate in another establishment. Lot Verification should be considered as a last sampling site of a lot of finished product. The Company QA Manual must clearly describe the monitoring procedures (who, what, how, how often, what record) and limits for each quality factor, corrective actions for non-compliant lots and verification procedures.

A lot is defined as a quantity of produce that for any reason is considered separately. Therefore, different size designations, type (round/long) or package sizes are to be considered as different lots.

The CFIA sampling plan is to be used to determine the number of samples that must be examined from each lot.

The establishment must examine all required samples and maintain records of results to ensure that the final product is in compliance with the grade, size and maturity requirements in accordance with US Import Requirements for product exported to the United States or Puerto Rico. It should be noted that product shipped interprovincially must be in compliance with the quality, packaging and labelling requirements set out in the Safe Food for Canadians Regulations.

Lot Verification is to be performed only by identified individuals within the establishment who have received training on requirements established within the SFCR, US Import Requirements and defect evaluation as outlined in the Canadian Grade Compendium Volume 2 – Fresh Fruit or Vegetables. Training of personnel (including back-up personnel) in the application of the quality assurance system must be documented.

3.4.1 Performing lot verification

For inclusion on a C-PIQ Export Document, the product must meet the applicable quality requirements. These requirements will be dictated by the commodity, type, grade declared, standards, etc. The Operator of a C-PIQ establishment must not include a lot on a C-PIQ Export Document that has not been sampled, examined and verified to meet the requirements and does not contain the appropriate pallet identification on all pallets. Inclusion of a lot that has not been verified, or a lot that fails to meet the requirements is a Non-Conformity which results in an Unsatisfactory Audit.

Export Documents must never be issued for a load where samples are not randomly taken throughout the whole load and sampling complete.

The Company QA Manual must describe the procedures used for lot verification of finished product which addresses the following information:

3.4.1.1 Identification of Quality Factors

This first step is to identify what factors, if not controlled, might cause the packed product to fail the requirements. Quality factors include such things as grade, size, cleanliness, maturity, and so on. The, SFCR, Canadian Grade Compendium Volume 2 - Fresh Fruit or Vegetables and US Import Requirements should serve as references.

3.4.1.2 Identification of sampling site

The point where samples of final graded product (packed or bulk) will be taken prior to shipment to evaluate the quality factors being controlled and findings recorded must be identified in the lot verification procedure.

3.4.1.3 Identification of limits for quality factors

The Operator must establish limits for quality factors which are based upon such parameters as: type/ variety of product, grade, and intended market. Limits may be more stringent that those required by regulation or foreign import requirements, but must not be less. Limits identified by the Operator should not be so stringent that they cannot be met. If limits are exceeded, predetermined corrective measures must be implemented immediately.

3.4.1.4 Identification of monitoring procedures for each quality factor

Once limits are established for each quality factor, the Operator must establish monitoring procedures to ensure that product meets the applicable quality standards.

The Company QA Manual must fully describe how each quality factor will be monitored for compliance with established limits. The monitoring procedures must include: who, what action, when and the type of record to be kept. Refer to section 3.4.3 for more details regarding monitoring procedures for Lot Verification.

3.4.1.5 Identification of corrective actions for failed lots due to exceeded limits

The Operator shall identify and document what corrective actions will be taken when a lot exceeds the established limits. These actions must ensure that non-complying product will not be shipped from the establishment. Actions are predetermined and must be implemented every time the limit is exceeded. These predetermined actions must be implemented regardless of the market conditions or the degree by which the limit is exceeded.

3.4.1.6 Identification of records

In order to audit the monitoring procedures and any corrective actions taken for finished product, the Operator shall document monitoring results and corrective actions, if any, on a Detail/Work Sheet as per section to demonstrate compliance with the limits. These records shall be available to auditors upon request.

3.4.1.7 Identification of verification procedures

Verification procedures must be identified to confirm that monitoring procedures are followed in accordance with the Company QA Manual and that any corrective actions taken were effective. If the verification procedure indicates that the corrective action was ineffective, another corrective action must be applied immediately, and subsequently verified.

3.4.2 Detail/work sheet

The results of the monitoring of each identified lot must be recorded on a Detail/Work Sheet. The QA person monitoring the product must, at a minimum, address the following items and include the results or information on a Detail/Work sheet.

• Unique Detail/Work Sheet Identifying number
  • Each worksheet must bear a unique number created by the Operator.
  • The worksheet must be traceable to the receiving record, unique pallet/bulk container identification, shipping record, C-PIQ Export Document or C-PIQ Transfer Document.
• Lot size
  • Operator must identify the lot to be examined.
  • Number and kind of packages in lot must be recorded.
  • Number of samples to be examined based upon total number of packages or weight of the lot.
  • Sampling based upon CFIA sampling plan and procedures.
  • Intended market (Interprovincial or Export)
• To be specified if lot verification is also used for interprovincial shipments.
• Date and time inspection began
• Product and warehouse temperatures
  • Vehicle information, if applicable
  • Vehicle number
  • Cleanliness
  • General condition
  • Operation of refrigeration or heating units
• Marks on packages
  • Basic labelling information must be recorded.
  • Marketing, promotional, or nutritional facts not required.
• Colour (skin and flesh), statement of cleanliness and maturity (skinning and firmness)
• Lot identification number for each sample
• Minimum size, maximum size, and/or special tolerances for size
  • Size requirements relate to Canadian standards based upon grade declared on package or invoice.
  • Size requirements relate to U.S. import requirements.
  • Individual sample results and total lot results must be recorded.
  • Percentage of internal and external defects as well as decay
  • Weight of defective specimens in each sample must be recorded.
  • Percentage of each individual defect must be recorded.
  • Total percentage of defects
• Special lot tolerances for maturity (skinning) and sprouts must be computed.
• Declaration statement: Samples examined represented the lot, and lot meets or fails to meet the requirements of the Safe Food for Canadians Regulations or U.S. Import Requirements.
• Date and time the inspection completed
• Signature and date of the individual performing the monitoring
• Signature and date of the person designated to verify procedures were followed and record was completed (not later than next business day)

3.4.3 Procedures for end product monitoring

The procedures for end product monitoring are described in (Annex L) and refer to the procedures that should be followed in order to evaluate and record all necessary information on the Detail/Work Sheet.

3.4.4 Storage area controls

An establishment must have a sampling site in the storage area. Product control and segregation is especially important for lots that fail or are suspected of failing quality requirements. Also, control of product that originated elsewhere is crucial as the quality assurance system must be able to track product from the time it enters a facility until shipped out. All product in storage, regardless of whether it is packed by the establishment or originated elsewhere, is subject to controls.

In order to ensure quality of product, the Operator must ensure that, prior to shipment, product previously monitored by the establishment's QA personnel or another C-PIQ establishment is re-examined for quality factors. This up-to-date check must be done prior to shipment for all product that had previously been monitored more than three (3) days prior to the shipment date. The quality check is required for all product, whether previously monitored by In-Line Verification or Lot Verification QA systems. Although condition factors may be progressive in nature, and therefore are the reason for the quality check, product must be monitored for both condition and permanent defects, excluding size, as the grade tolerance is based on internal and external defects, not condition and permanent factors. Product may be inspected for defects at half the sampling rate called for in the CFIA sampling plan. If, after examining samples at half the sampling rate, the tolerances are exceeded, then the full sampling rate must be applied.

3.4.5 Notification requirements

The establishment must notify their closest CFIA inspection office minimum four (4) hours prior to the shipment of any exported lot verified by the establishment using the Lot Verification method. This notification must contain:

• the name of the C-PIQ establishment;
• produce description (type, size, colour);
• number of packages;
• pallet/bulk container identification numbers;
• date, time of shipment; and
• C-PIQ Export Document number if available.

The CFIA will only notify the establishment when a load is to be held for monitoring by the CFIA. Monitoring of a lot by way of this notification will be done at the discretion of the CFIA if, during normal verification audits, there is no or insufficient graded produce in storage for verification of product quality. During an audit period, a minimum of two (2) loads of produce must be verified provided the two (2) loads together total a minimum of 50,000 lbs. More loads may be required to be examined to reach this minimum weight. Failure to notify CFIA minimum four (4) hours prior to shipment or failure to hold a lot for monitoring will be considered a Non-Conformity.

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.).

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.