Canadian Partners in Quality (C-PIQ)
3. Production Controls

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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. However, please note that from October 01, 2013 to April 30, 2015, establishments may choose to participate in an 18-month Pilot Project that will allow C-PIQ establishments to perform Lot Verification on product graded within the establishment and originally destined for the domestic market, which has not undergone In-Line Verification. This will provide establishments with the flexibility to complete an order for export to the US on short notice. The Pilot Project is restricted to product originally destined for the domestic market that is fully compliant with Canadian requirements (grade, size, packaging and labelling), as well as meeting US import requirements for quality (grade, size and maturity).

In order to participate in the Pilot, the establishment must have procedures for Lot Verification in their Company QA Manual which adequately describe how product will be segregated (either in time or operationally), identified and tracked. These procedures must be approved by the local CFIA Inspection Office prior to implementation. Establishments implementing Lot Verification will be required to comply with Section 3.4, including notification requirements explained in section 3.4.5.

Please note the 18-month period for the Pilot Project includes the time required for revision and submission of Company QA Manual, as well as CFIA review and approval of said manual. The validity and outcome of the Pilot Project will be evaluated following the 18-month timeframe for either permanent acceptance into the C-PIQ Program, or for its removal from it.

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;
  • Color;
  • 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.

For each product and process, this analysis must address each of the eight steps
Description of Process Analysis Steps Process Analysis
1. Identify what quality factors, if not controlled during the process, might cause the packed product to fail requirements at the end of the process. Factors to be Controlled


2. Identify where in the process each of the factors will be controlled. These are called control points. Control Points


3. Identify where in the process samples may be taken to evaluate factors that will be controlled. These are called sampling sites. Sampling Sites


4. Establish limits for each quality factor at each sampling site. Limits


5. Establish and document the monitoring procedures for each quality factor for compliance with the limits (at sampling site) Monitoring Procedures


6. Identify and document corrective actions which will be taken every time a limit is not met at a sampling site. Corrective Actions


7. Identify and document what records will be completed and maintained in order to demonstrate compliance with the documented quality system. Records


8. Identify the verification procedures in place to ensure that all processes are followed in accordance with the Company QA Manual and confirm that any corrective actions implemented were effective. Verification Procedures

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. The Fresh Fruit and Vegetable Regulations, US Import Requirements and the CFIA Commodity Manuals should serve as references.

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 (Appendix 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 (Appendix 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 Fresh Fruit and Vegetable Regulations.

Lot Verification is to be performed only by identified individuals within the establishment who have received training on requirements established within the Fresh Fruit and Vegetable Regulations, US Import Requirements and defect evaluation. 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 Fresh Fruit and Vegetable Regulations, US Import Requirements and the CFIA Commodity Manuals 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 Fresh Fruit and Vegetable 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 (Appendix 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 can be done by way of fax and must contain:

  • the name of the C-PIQ establishment;
  • produce description (type, size, color);
  • 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.

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