QSM-09: Non-Propagative Potato Program

Phytosanitary management system requirements for facilities receiving and handling regulated non-propagative potatoes and related potato articles, including associated soil.

On this page

• Introduction
• 1. Scope
• 2. References
• 3. Definitions, abbreviations and acronyms
• 4. Program approval process
  • 4.1 Application
  • 4.2 Program manager
  • 4.3 Evaluation of applications
  • 4.4 Approval process
  • 4.5 Registration status and re-application
• 5. Responsibilities of the approved facility
• 6. Preventive control plan
• 7. Training of employees
• 8. CFIA audits
  • 8.1 Authorization audit
  • 8.2 Surveillance audit
  • 8.3 Non-conformances
• 9. Enforcement measures
• 10. Internal audits
  • 10.1 Frequency
  • 10.2 Documenting the internal audit
  • 10.3 Corrective actions
• 11. Record keeping and document verification
• Appendix 1: terms and conditions
• Appendix 2: authorization checklist
• Appendix 3: audit checklist
• Appendix 4: audit report
• Appendix 5: corrective action request
• Appendix 6: list of required records and documents
• Appendix 7: required elements of the preventive control plan
• Appendix 8: guidelines for the transport and disposal of regulated articles and cleaning requirements

Introduction

General requirements for the importation and domestic movements of non-seed potatoes are prescribed in CFIA's Directive D-96-05, phytosanitary requirements for the importation and domestic movement of non-propagative potatoes (Solanum tuberosum) and related potato articles, including associated soil. D-96-05 introduces the concept of a phytosanitary management system as one of the options available to permit the movement of regulated potato articles in Canada.

A facility must be approved by the CFIA under the Non-Propagative Potato Program in order to be issued a permit to import or a movement certificate for the purpose of receiving and/or handling regulated articles as described in D-96-05.

1. Scope

The purpose of QSM-09 is to provide detailed information on the Non-Propagative Potato Program as described in D-96-05. QSM-09 outlines the requirements for a facility to apply for approval under the program, and for the CFIA to audit the facility. In particular, QSM-09 provides instructions and a template for the development of a preventive control plan (PCP).

QSM-09 is intended for use by both CFIA inspection staff and facilities seeking approval or already approved under the program.

2. References

• Canadian Food Inspection Agency Fees Notice, Canada Gazette, Part I
• D-96-05: phytosanitary requirements for the importation and domestic movement of non-propagative potatoes (Solanum tuberosum) and related potato articles, including associated soil
• Plant Protection Act (S.C. 1990, c.22)
• Plant Protection Regulations (SOR/95-212)
• PI-016 - Procedure for inspecting regulated articles for freedom from soil, plants, plant parts and related matter

3. Definitions, abbreviations and acronyms

Definitions for terms used in the present document can be found in the Plant health glossary of terms.

4. Program approval process

4.1 Application

Facilities wishing to participate in the program can apply for registration by submitting a service request through their My CFIA account. A copy of the facility's PCP should be included in the My CFIA application or forwarded to the local CFIA office.

4.2 Program manager

The person responsible for the facility's phytosanitary management system must be identified as the program manager in the application.

4.3 Evaluation of applications

The CFIA will review and assess the facility's PCP to the program requirements as specified in D-96-05 and QSM-09. An authorization audit of the facility will be conducted by the CFIA to ensure that they can or will be able to meet all requirements of the program.

4.4 Approval process

Provided the PCP meets the requirements and the authorization audit of the facility is satisfactory, the CFIA will approve the registration on the program and issue a confirmation of registration through the My CFIA account.

4.5 Registration status and re-application

For facilities handling regulated articles year-round, registration continues to be valid if a surveillance audit has been completed within the last 90 days, and all corrective actions (if any) have been addressed to the satisfaction of the CFIA.

If a company wishes to voluntarily withdraw their registration from the program, they can notify their local CFIA office or make this request through their My CFIA account. The company may re-register for participation under the program at any time.

5. Responsibilities of the approved facility

The approved facility must comply with all the requirements of D-96-05 and QSM-09, including:

• planning, drafting and maintaining the PCP
• implementing the provisions of the PCP
• circulating all updated versions of the PCP to the CFIA and the facility's staff
• obtaining the CFIA's approval before implementing any changes to the PCP
• conducting internal audits and making results available to the CFIA
• cooperating with the CFIA's inspectors
• applying corrective actions as discussed and mutually agreed with the CFIA and consequently updating the PCP to reflect corrections to administrative or operational procedures
• employing competent staff in sufficient numbers to carry out the requirements of the PCP
• training all staff members involved in receiving or handling the regulated articles in accordance with the provisions of the PCP. All staff involved must be aware of the phytosanitary requirements associated with the facility's approval
• identifying a program manager responsible for the facility's phytosanitary management system
• develop a contingency plan in case of an accidental spillage or overflow of the regulated articles
• ensure all third parties contractors comply with the requirements of D-96-05 and QSM-09.
• informing the CFIA of receiving schedules for regulated articles

6. Preventive control plan

The preventive control plan (PCP) should be designed so that full regulatory compliance is met through fulfillment of the provisions of the PCP. It is the facility's responsibility to develop its own PCP. The PCP will be used as a basis for the authorization and surveillance audits conducted by the CFIA, as well as internal audits conducted by the approved facility. A PCP must be kept up to date at all times, reflecting the facility's organizational and operational plans and the associated activities. Modifications to the PCP must be documented according to a protocol determined by the approved facility and described in the PCP. Approved facilities must seek CFIA approval prior to implementing any changes made to the PCP. Timelines for updating the PCP after findings of non-conformance are the same as the timelines for responding to a specific non-conformance (in other words, next audit for a minor, 2 weeks for a major etc.)

Appendix 7 outlines all expected elements to be found in the PCP of an approved facility. Note that some sections listed in Appendix 7 may not apply for some facilities.

In addition, Appendix 8 provides general guidelines for the movement and disposal of regulated articles and cleaning of facilities equipment. These elements should also be taken under consideration into the PCP.

7. Training of employees

Timely and effective training of all individuals involved in implementing the requirements of the PCP is essential. The approved facility must develop a training strategy and training plans must be documented and implemented. This includes relaying information contained in the PCP, D-96-05 and QSM-09, as well as any information pertinent to changes made to the PCP, D-96-05 and QSM-09. All program related training delivered and received must be recorded. Training records must indicate training dates, names of trainers and trainees, training type and content, and whether the training was completed satisfactorily. Training records must also include any additional training needs identified.

8. CFIA audits

CFIA will complete audits to verify that the facility conforms to the requirements of both the PCP and the D-96-05. CFIA audits may be scheduled and carried out during or after the period in which the facility is receiving potato articles from regulated areas.

The person identified as program manager must be present and available to help during all scheduled CFIA activities at the facility. This includes allowing the CFIA inspectors to examine records and documents, collect samples, inspect articles and equipment, observe processes and interview facility staff.

Audit findings will be compiled by the CFIA in a report. Non-conformances will be identified and recorded and a corrective action request (CAR) will be issued to the facility (appendix 5) for any identified non-conformances. The facility is responsible for the implementation and documentation of corrective actions to address non-conformances within the time frame specified in the CAR. Corrective actions will be verified by the CFIA.

8.1 Authorization audit

The CFIA authorization audit is conducted prior to any movement of regulated articles into the facility and is a scheduled systematic examination of a new applicant's facility, which verifies if the facility is capable of meeting program requirements. It includes a review of the PCP and its proposed implementation plan. This audit will be scheduled after the facility has applied for registration in the program and submitted a copy of their PCP to the CFIA. All non-conformances found during the course of the authorization audit must be addressed before the facility's registration is approved. Failure to address non-conformances and update the PCP accordingly will result in rejection of the application.

8.2 Surveillance audit

The CFIA surveillance audits are reviews of the organizational structure, procedures, processes and resources used by the approved facility to meet program requirements, including the verification that the PCP and the corrective actions, are implemented as planned. Surveillance audits also include the review of all internal audit reports and associated records produced by the approved facility.

The CFIA will conduct at least one surveillance audit during the period when the facility is receiving and handling regulated articles, with a minimum of one surveillance audit every 3 months. Ideally, the first surveillance audit will be performed within a week of receiving the first load of regulated articles. The last surveillance audit will be conducted immediately after the period during which regulated articles are handled by the approved facility. The purpose of the last surveillance audit is to verify proper cleanup practices in accordance with the PCP. For facilities handling regulated articles year-round, a specific schedule for clean-up of all equipment and areas used for receiving, conveying, storing and processing the regulated articles must be kept on record and will be used as a basis for at least one targeted CFIA surveillance audit per year.

Unsatisfactory findings during the surveillance audit will be dealt with in accordance with the non-conformance scheme as prescribed in section 8.3.

8.3 Non-conformances

During the course of a CFIA audit, any procedures, documentation, or articles that are found to be in contravention of the standards of the phytosanitary management system implemented by the facility are considered to be a non-conformance; this includes any deficiencies of the procedures in meeting the requirements of D-96-05 and QSM-09 or violations of the provisions of D-96-05, QSM-09 or the PCP.

Non-conformances can be classified into 3 types: critical, major, or minor. The classification of non-conformances is based on the evaluation of the associated phytosanitary risk and the resulting threat to the integrity of the phytosanitary management system of the approved facility. In the event of a dispute over the classification of a non-conformance, the CFIA's decision will be final.

For every non-conformance found during the course of a CFIA audit, a corrective action request (CAR) will be issued to the approved facility (appendix 5), and the implementation of corrective actions will be expected and monitored by the CFIA. The approved facility must seek approval from the CFIA prior to implementing remedial actions to address CARs.

The identification of non-conformances and/or the unsatisfactory management of the associated CARs may increase the CFIA audit frequency for a period to be determined by the CFIA and may result in suspension of a facility's registration.

9. Enforcement measures

In addition to the fulfillment of the provisions of D-96-05 and QSM-09, approved facilities must ensure they comply with the Plant Protection Act, the Plant Protection Regulations and any additional requirements that apply to the regulated area from which the potato article is originating. The CFIA may take enforcement measures including prosecution for any violations of the above requirements.

10. Internal audits

10.1 Frequency

The person identified as the program manager must conduct internal audits or designate and supervise employees to perform internal audits. In general terms, it is expected that internal audits be conducted at least twice during the period during which the approved facility is receiving and handling regulated articles, with a minimum of one internal audit every month. Internal auditors shall not audit their own work.

Internal audits do not need to be performed during the period when an approved facility does not receive or handle regulated articles subject to the program, unless otherwise specified in the PCP

Internal audits include, but are not limited to:

• the assessment of the adequacy and effectiveness of the facility's processes as outlined in their PCP in meeting the program requirements prescribed in D-96-05 and QSM-09
• the verification of whether the required program related documentation is sufficient, current and readily available to staff
• the verification whether the facility's phytosanitary management system is operating in accordance with the specified requirements, including the performance of all staff identified in the PCP
• the verification that effective corrective action plans have been developed and properly implemented for all non-conformances identified
• the evaluation of the competency of employees in carrying out duties and responsibilities as outlined in the PCP
• the verification that the facility's record-keeping activities comply with the provisions of the PCP and are sufficient to ensure proper traceability and segregation of the regulated articles
• the verification that actions are taken on all outstanding non-conformances or CFIA CARs

10.2 Documenting the internal audit

Records of every internal audit must be kept for a period of 10 years. An internal audit report must be prepared within 3 working days of performing the internal audit, detailing any non-conformances, remedial action plans, corrective actions implemented and opportunities for improvement that related to program requirements. Internal audit reports must be made available to the local CFIA office responsible for the surveillance audits. Internal audit reports and associated records will be review by the CFIA during surveillance audits.

10.3 Corrective actions

Activities or articles that are found to be in violation of the provisions of D-96-05, QSM-09 or the PCP are considered non-conforming. Non-conformances detected during internal audits must be documented in internal audit reports. Corrective actions must be implemented for each non-conformance detected by the approved facility. Remedial action plans and the implementation of corrective actions must also be documented in internal audit reports.

Non-conformances found during internal audits must be identified as being "critical", "major" or "minor", in accordance with section 8.3. The implementation of remedial action plans and the associated corrective actions must be prioritized based on the type of the non-conformance. Internal audit reports must include detailed instructions on how to prevent recurrences of the non-conformances, generally requiring that the PCP be amended, and staff be informed accordingly. It is the responsibility of the facility to inform CFIA of any critical non-conformances found during an internal audit no later than the next business day following the finding.

11. Record keeping and document verification

Record keeping is a key program requirement. The approved facility must keep records of all organizational and operational processes and procedures used to fulfill all requirements. Internal and CFIA inspectors will review these records to verify if the facility's phytosanitary management system as described in its PCP, including the corrective actions, is implemented as planned. As well, the verification of an approved facility's records will help the CFIA determine if a facility satisfies all requirements stated in D-96-05 and QSM-09. Records must be kept on the premises of the approved facility and must be available to the CFIA upon request at any time. Program required records must be kept for a minimum of 10 years. Program required records relate to receiving, rejecting, storing, handling, processing and shipping regulated articles, disposing of by-products, cleaning activities, training of staff, identifying and remedying non-conformances, internal and CFIA audit reports, tracking amendments to the PCP, etc. Consult Appendix 6 for list of all program required records and documents.

In addition, up-to-date copies of the following documents must be readily accessible for use by all facility staff and contractors involved in the management, processing or handling of regulated articles:

• Plant Protection Act and Plant Protection Regulations.
• D-96-05: Phytosanitary requirements for the importation and domestic movement of non-propagative potatoes (Solanum tuberosum) and related potato articles, including associated soil
• QSM-09: Non-Propagative Potato Program
• The PCP
• Any other regulatory documents that relates to the areas from which the imported or received potato article is originating

Appendix 1: terms and conditions

Applicant's statement

The facility must designate the person responsible for the facility's phytosanitary management system; this person must be designated as the program manager in the My CFIA application.

The facility has read and agreed to comply with all provisions of D-96-05 and QSM-09. In particular, they agree to:

• implement the provisions of the PCP and keep it up to date
• circulate all updated versions of the PCP to the CFIA and the facility's staff
• seek the CFIA's approval before implementing any changes to the PCP
• conduct internal audits and make the results available to the CFIA
• cooperate with the CFIA's inspectors
• apply corrective actions as discussed and mutually agreed to with the CFIA, and update the PCP accordingly
• employ competent staff in sufficient numbers to carry out the requirements of the PCP
• train all individuals involved in implementing the provisions of the PCP
• identify a program manager responsible for the facility's phytosanitary management system
• develop a contingency plan in case of an accidental spillage or overflow of the regulated articles
• ensure all third parties contractors comply with the requirements of D-96-05 and QSM-09
• inform the CFIA of receiving schedules for regulated articles
• contact the local CFIA office as soon as a date for receiving the first load of regulated articles has been confirmed

Appendix 2: authorization audit checklist

Download the authorization audit checklist (PDF 33.7 kb)

Text version

The following checklist should be used during the evaluation of the facility.

General information to be filled in

• Company name
• Facility address
• Contact person
• Title or position
• Phone
• Cell
• Fax
• Email
• CFIA evaluators
• Date of evaluation

General requirements

• The facility has developed its own manual
• The facility's management agrees to follow the requirements of the manual
• The facility has identified an employee that is responsible for the quality management program
• The employee that is responsible for the quality management program has the appropriate training and knowledge of the program
• The Manual includes an organizational structure including the names of all individuals involved in implementing the provisions of the manual
• The appropriate staff members have access to the manual. The appropriate staff members are up to date with the amendments to the manual
• The facility's Manual is up-to-date and has been approved by the CFIA
• Amendments to the Manual have been tracked and recorded by the facility
• The facility's operating procedures are accurately reflected by the procedures described in the manual
• The facility employs enough staff to carry out the procedures described in the manual

Training

• The manual includes all training plans pertinent to the implementation of the facility's procedures
• The facility has a training strategy that is documented in the manual
• The facility's training records include the name of the trainer and trainee, date of training and content of training

Internal audit

• The facility has an example of the internal audit checklist it uses in the manual
• The facility's internal audit checklist is adequate to assess their procedures

Receiving and handling of regulated article

• The manual clearly describes all process steps related to receiving and handling the regulated article
• The facility is able to implement the procedures in the manual for receiving and handling the regulated article
• The manual has an accurate diagram describing the flow of the regulated article within the facility
• The manual identifies the period and the volume of regulated article expected to be received
• The manual includes a sample copy of the receiving log
• The facility's receiving log meets all program requirements of QSM-09 and D-96-05
• The manual includes a description of the unloading area and the flow of the regulated article through the unloading process
• All machinery used in the unloading of regulated article is listed in the manual
• The facility is able to implement the procedure in the manual for unloading of the regulated article

Handling and disposal rejected loads

• The manual includes a procedure for cleaning the unloading area and equipment that meets the requirements of QSM-09 and D-96-05
• The manual includes a procedure for the handling and disposal of rejected loads
• The manual includes a copy of the log for tracking rejected loads that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedures in the manual for the handling and disposal of rejected loads

Storing, tracking and labelling

• The manual includes a diagram of the storage area
• The manual includes a procedure for tracking and labelling regulated article that will be stored in the facility
• The manual includes a sample copy of the log used for tracking stored material that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedures in the manual for the tracking and labelling of regulated article that will be stored in the facility

Grading

• All machinery used in the grading of regulated article is listed in the manual
• A procedure that clearly describes all process steps related to grading is included in the facilities manual
• The manual includes a procedure for cleaning the grading area and equipment that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedures in the manual for grading

Washing and brushing

• The manual includes a procedure that clearly describes all process steps related to washing and brushing of the potatoes
• The manual includes a list of all machinery used for washing and brushing
• The manual includes a procedure for cleaning the washing and brushing area and equipment that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedure in the manual for washing and brushing

Peeling and/or cooking

• The manual includes a procedure that clearly describes all process steps related to peeling and/or cooking
• The manual includes a list of all machinery used for peeling and/or cooking
• The manual includes a procedure for cleaning the peeling and/or cooking area and equipment that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedure in the manual for peeling and/or cooking

Packing and repacking

• The manual includes a procedure that clearly describes all process steps related packing and repacking
• The manual includes a list of all machinery used for packing and repacking
• The manual includes a procedure for cleaning the packing and repacking area and equipment that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedure in the manual for packing and repacking.

Sprout inhibition

• The manual includes a procedure that clearly describes all process steps related to sprout inhibition
• The manual includes a list of all machinery used for sprout inhibition
• The manual includes a procedure for cleaning the sprout inhibition area and equipment that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedure in the Manual for sprout inhibition

Collection within the facility

• The manual includes a procedure for collecting and storing wash water, liquid and solid wastes, culls, peels, other potato parts, soil, used containers, etc. from the various processes within the facility, that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedure in the manual for collecting wash water, liquid and solid wastes, culls, peels, other potato parts, soil, used containers, etc. from the various processes

Final disposition of by-products

• The manual includes a procedure for disposing of wash water, liquid and solid wastes, culls, peels, other potato parts, soil, used containers, etc. from the various processes within the facility that meets the requirements of QSM-09 and D-96-05
• The facility is able to implement the procedure in the Manual for disposing of wash water, liquid and solid wastes, culls, peels, other potato parts, soil, used containers, etc.
• The manual includes a sample copy of the log used for tracking disposal of wash water, liquid and solid wastes, culls, peels, other potato parts, soil, used containers, etc. that meets the requirements of QSM-09 and D-96-05
• The manual includes a list of places where all regulated articles such as wash water, liquid and solid wastes, culls, peels, other potato parts, soil, used containers, etc. will be disposed of

General

• The facility meets all program requirements

Appendix 3: surveillance audit checklist

Download the audit checklist (PDF 26 kb)

Text version

The following checklist should be used during the surveillance audit of the facility.

General information to be filled in

• Company name
• Facility address
• Contact person
• Title or position
• Phone
• Cell
• Fax
• Email
• CFIA auditors
• Date of audit

General requirements

• The facility's version of the manual matches the Manual the CFIA has on file for the facility
• The facility has identified an employee that is responsible for the quality management program
• The employee that is responsible for the quality management program has the appropriate training and knowledge of the program
• The organizational structure in the manual is up to date.
• The appropriate staff members have access to the manual
• The appropriate staff members are up to date with the amendments to the manual
• The facility's manual is up to date and has been approved by the CFIA
• Amendments to the manual have been approved by the CFIA before they were implemented.
• Amendments to the manual have been tracked and recorded by the facility
• The facility's operating procedures are accurately reflected by the procedures described in the manual
• The facility employs enough staff to carry out the procedures described in the manual

Training

• The appropriate staff members have been trained on the requirements of the manual
• The facility's training records for the staff members are up to date
• The facility's staff members understand their responsibilities as stated in the manual

Internal audit

• The facility has reported all critical non-compliances found in the internal audits to the CFIA in a timely manner
• The facility has implemented corrective action plans within the time limit given
• The facility has no outstanding corrective action requests
• The facility has responded appropriately to all corrective action requests in a timely manner
• The facility has conducted an adequate number of internal audits since the last CFIA audit and has made the results of the audits available to the CFIA
• The facility has completed the individual audit reports within 3 working days of the actual audits
• The facility has made all internal audit reports available to the CFIA
• iving and handling of regulated article
• The facility has followed the procedures in the manual in regard to receiving and handling of regulated article and informed the CFIA of the arrival of the first load of regulated articles
• The facility has adequately recorded all regulated article received
• All records are up to date and fully completed
• All records are signed by the appropriate staff

Handling and disposal of rejected loads

• The facility has followed the procedures in the manual in regard to handling and disposal of rejected loads

Storing, tracking and labelling

• The facility has followed the procedures in the manual in regard to storing, tracking and labelling

Grading

• The facility has followed the procedures in the manual in regard to grading

Washing and brushing

• The facility has followed the procedures in the Manual in regard to washing and brushing

Peeling and/or cooking

• The facility has followed the procedures in the manual in regard to peeling and/or cooking

Packing and repacking

• The facility has followed the procedures in the manual in regard to packing and repacking

Sprout inhibition

• The facility has followed the procedures in the manual in regard to sprout inhibition

Collection Within the Facility

• The facility has followed the procedures in the manual in regard to collection of wash water, liquid and solid wastes, culls, peels, other potato parts, soil, used containers, etc. from the various processes within the facility

Final disposition of by-products

• The facility has followed the procedures in the manual in regard to disposition of by-products
• All records are up to date and fully completed
• All records are signed by the appropriate staff.

General

• The facility meets all program requirements

Appendix 4: audit report

Download the audit report (PDF 79 kb)

Text version

Importation and domestic movement of non-propagative potatoes

Basic information

• Report number
• Date
• Name and address of the facility
• Facility representative: name, title, phone, fax, email
• Lead CFIA representative: name, title, office, phone, fax, email
• Other participants
• Time period covered by the report

Type of report

• Evaluation
• General surveillance
• Targeted surveillance (with a specific objective)
• End of receiving and handling period

Previous CFIA reports

• Date, report number, type

Compliance details

• List and reference any corrective action requests (CARs) related to this report
  • Number of critical non-conformances (with CAR number)
  • Number of major non-conformances (with CAR number)
  • Number of minor non-conformances (with CAR number)

Results

• Compliant or approved
• Suspended
• Not approved (evaluation)

Additional comments and observations

Signatures

• Lead CFIA representative (with date)
• Facility representative (with date)

Appendix 5: corrective action request

Download the corrective action request (PDF 18.2 kb)

Text version

Corrective action request (CAR) (D-96-05 and QSM-09)

Basic information

• Type of review
  • Evaluation
  • Surveillance audit
• CAR number
• Associated report number
• Facility name and address
• Facility representative (name and title)
• CFIA lead auditor
• Contact phone numbers

Details of the non-conformance

• Type of non-conformance (one per CAR)
  • Minor
  • Major
  • Critical
• Description of the issue
• CFIA auditor signature
• Date to be corrected

Corrective action plan

• Facility's plan to fix the issue
• Facility representative signature
• Expected completion date
• CFIA approval of the plan (signature and date)

Follow-up

• Was the corrective action completed and acceptable
  • Yes / No
• CFIA auditor signature and date
• Additional comments
• Final signature and date

Appendix 6: list of required records and documents

The following records, logs and documents must be kept for a period of 10 years.

Records to be kept up to date:

• staff and contractors responsibility list
• training records
• shipment reception log
• shipment rejection log
• logs and records associated with storing, handling, grading, processing, packing, shipping, sprout inhibiting and other activities
• logs and records for the collection and disposal of regulated articles and by-products
• cleaning records
• internal audit records
• records of internal and CFIA audit non-conformances and corrective actions
• PCP updates

Documents to be available at any time (electronic copies are acceptable):

• movement certificates
• corrective action requests
• permits to import
• bills, shipping slips, treatment certificates or any other document that relates to tasks required by the PCP
• previous versions of the PCP
• internal audit reports
• any documents sent by the CFIA (letters, reports, etc.)

Appendix 7: required elements of the preventive control plan

The following information must be included in the PCP of an approved facility under the program in accordance with the provisions of D-96-05 and QSM-09. Some requirements may not apply.

A. Format of the PCP

The front page of the PCP must display the following information:

• the facility's legal and business name
• the complete address (es) of the premises where the facility will be receiving and handling the regulated articles
• the suggested document title "[insert company name] Phytosanitary Management System PCP for the Non-Propagative Potato Program in order to receive and handle regulated potato articles as described in D-96-05 and QSM-09"
• the date and/or version number of the document

The following information should be recorded on each page of the PCP:

• on the lower left-hand side: version date and/or number
• on the lower right-hand side: "page X of Y" pagination

B. Generalities

B1. Management endorsement

Facility management must sign and date a statement in the PCP, indicating that they agree to operate in accordance with the terms of the PCP, D-96-05 and QSM-09. Facility's management must identify a Program Manager responsible for the facility's phytosanitary management system as a main contact for the CFIA, including at least one alternate person. Names of representatives must be clearly spelled out.

B2. Facility description and administrative structure

The PCP must briefly describe the facility's main business lines. All activities associated with program requirements prescribed in D-96-05 and QSM-09 must be described in detail. The PCP must list all employees involved in these activities, including a description of their respective responsibilities. The name of all individuals involved in implementing the provisions of the PCP must appear in the PCP; this includes all hired third-party contractors. An organizational chart must be included in an appendix to the PCP.

B3. Training of employees

All training plans pertinent to the implementation of the PCP requirements must be described in the PCP. This includes a description of the process by which the facility deals with and communicates changes to the PCP. Training records must be completed and kept. A template for training records must be included in an appendix to the PCP.

B4. Internal audits

The facility's plan for conducting internal audits must be described in the PCP. This includes a description of the audit frequency and the associated operational procedures. Internal audit reports must be completed and kept. A template for internal audit reports must be included in an appendix to the PCP.

B5. Updating the PCP

The PCP must describe how to update the PCP. All modifications to the PCP should be recorded in a tracking sheet to be included in an appendix to the PCP.

B6. Record keeping

The PCP must indicate that all records associated with the implementation of the PCP must be kept on the facility's premises for a period of 10 years, and that all records must be made available to the CFIA upon request.

C. Identification of all process steps associated with the regulated articles

All processing steps and activities related to receiving and handling regulated articles must be described and documented in the PCP.

The PCP must clearly identify the nature of the regulated articles being received and handled by the facility.

The PCP must contain a general diagram of the overall flow of articles and by-products (wash water, liquid and solid wastes, culls, peels, other potato parts, soil, used containers, etc.) throughout the facility, from receiving to shipping. The diagram should primarily focus on articles, installations and activities associated with receiving, handling, processing and disposing of the regulated articles.

By-products generated by the facility, such as rejected potatoes, culls, potato parts, soil, wash water and used containers are considered regulated articles and must be subject to specific collection and disposal instructions in the PCP as part of all processing steps. Appendix 5 outlines additional disposal requirements.

Specific to every processing step, the identification of equipment, areas, procedures, responsible staff members, the use of logs and the creation of a layout and/or flow diagram may be required in the PCP for clarification.

C1. Receiving and storing the regulated articles

The PCP must identify the period of the year when the facility plans to receive the regulated articles, including an evaluation of the volumes to be received and the origin of the articles. All documents related to sourcing and purchasing the regulated articles must be made available to the CFIA upon request. All loads of regulated articles received by the facility must be recorded in a log. A template of the reception log must be included in an appendix to the PCP. This log must include the following information for each load of regulated articles:

• reception date
• description of the articles
• quantity received
• load identification or tracking number, including a copy of the delivery bill
• packaging status (in other words bulk or packaged), including package size
• cleanliness status (in other words received as washed or not)
• origin of the articles, including the certificate of origin, phytosanitary certificate or movement certificate, if applicable
• status of load: accepted or rejected
• cleanliness of trailer after unloading
• notify the local CFIA contact person prior to or within one business day upon arrival of the first load of regulated articles

C2. Grading

The PCP must contain the following information:

• a list of grading equipment
• a grading procedure

C3. Washing and brushing

The PCP must contain the following information:

• a list of washing and brushing equipment
• washing and brushing procedures

C4. Packing and repacking

The PCP must contain the following information:

• a list of packing and repacking equipment
• packing and repacking procedures

C5. Peeling

The PCP must contain the following information:

• a list of peeling equipment
• peeling procedures

C6. Cooking

The PCP must contain the following information:

• a list of cooking equipment
• cooking procedures

C7. Sprout inhibition

The PCP must contain the following information:

• a list of sprout inhibition equipment
• sprout inhibition procedures. Sprout inhibition activities must be recorded in a log. A template of the sprout inhibition log must be included in an appendix to the PCP. This log must contain
  • the load/or lot identification
  • the sprout inhibition products used
  • the application rate
  • the date and time of treatment
  • the name of the person who performed the treatment

Should the sprout inhibition be performed prior to receiving the regulated potatoes, treatment information must be collected and records must be kept in association with the above log or independently. This includes treatment procedures as stated above, and any documents ensuring the identification and traceability of the sprout-inhibited lots.

C8. Other processing steps

The PCP must describe any other processes applied by the facility to the regulated articles. The PCP must indicate all mitigation measures implemented in order to reduce the phytosanitary risks associated with these other processes.

C9. Cleanup activities, including collecting and disposing of regulated articles and by-products

The PCP must describe cleanup activities including the collection and disposal of regulated articles and by-products generated at every processing step.

This includes a description of all procedures used for cleaning equipment and areas dedicated to unloading, storing, conveying, grading, washing and brushing, packing and repacking, peeling, cooking, sprout inhibition, or any other processing steps.

This also includes a description of all procedures used for collecting and disposing of all waste associated with the regulated articles being handled, processed or treated, such as rejected potatoes, culls, potato parts, soil, wash water, and containers and packages used to store and transport the regulated articles.

In addition, the PCP must contain a description of any other cleanup activities of equipment or areas, as well as any procedures used to ensure segregation of the regulated articles and possible by-products. This includes end-of-season cleanup activities for facilities not handling regulated articles year-round, and transitioning to a period when non-regulated articles will be received or handled.

Refer to Appendix 5 and PI-016 for more details.

C10. Final collection and disposal of

regulated articles and by-products Final collection and disposal of regulated articles and by-products can occur on the approved facility's premises or using third party service providers (see Appendix 5).

The PCP must clearly indicate how the facility will handle final collection and disposal of any regulated articles and by-products generated from the above processing steps (wash water, liquid and solid wastes, rejected potatoes, culls, peels, other potato parts, soil, used containers, etc.), including any other things potentially contaminated by contact with the regulated articles.

For the purpose of providing detailed instructions for final collection and disposal of by-products, the identification of equipment, areas, procedures, responsible staff members, the use of logs and the creation of a layout and/or flow diagram are required and must be identified in the PCP. All documents associated with the disposal of regulated articles and by-products including information such as destination, authorization, service providers, date, time, quantity, description of articles and by-products, bills of lading, conveyance, treatment, etc., must be collected and kept on file.

Appendix 5 specifies additional collection and disposal requirements.

Appendix 8: guidelines for the transport and disposal of regulated articles and cleaning requirements

The overall principle addressing the final disposal of regulated articles and by-products exiting the approved facility is outlined in the CFIA's directive D-96-05, section 2.9.5. The purpose of this appendix is to provide additional instructions pertinent to disposal options and cleaning. Guidance on what to include in the facilities PCP regarding cleaning and disposal can be found in Appendix 7 section C9 and C10 of this document.

It is the approved facility's responsibility to ensure that additional local disposal requirements are met. This includes and is not limited to environmental considerations in municipal bylaws and regional, provincial and federal legislations.

A list of disposal sites to be utilized must be included in the facilities PCP. All the specifications (records, procedures, diagrams etc.) regarding the movement and the disposal of regulated articles must be defined in the PCP. In all cases, disposal procedures and sites will be evaluated and approved by the CFIA.

The CFIA may be required to issue regulatory documents such as notice of prohibition of movement (CFIA/ACIA 0113) and/or movement certificates (MC) to control the movement and the disposal of regulated articles and by-products. If a MC is issued, all conditions on the issued document must be followed. In addition, all conditions and limitations applied to a disposal site must be clearly identified.

The requirements pertaining to the transport and disposal of regulated articles apply to:

1. movement of regulated articles
2. cleaning sites
3. commercial and private landfills sites
4. other disposal sites (such as retention lagoons and treatment facilities)

A. Movement of regulated articles

All means of transporting regulated articles must be leak-proof. The transporting vehicle, trailer or container is to be cleaned in an appropriate manner prior to the next load at an approved cleaning site. This applies to both the transport of regulated articles from the United States (U.S.) and within Canada.

B. Cleaning sites

The cleaning site location can either be one of the following:

• importing/receiving facility
  • vehicles, containers or mini totes containing or transporting regulated articles from the U.S. to Canada or from a regulated area in Canada can be cleaned directly at the importing or receiving facility
• third party location
  • in some circumstances, it may be more convenient to use a different cleaning site than the importing or receiving facility

C. Commercial and private landfills sites

The site has been granted a current valid permit or license from the appropriate municipal, regional and/or provincial authorities to operate or has been recognized as satisfactory by CFIA to contain any potential pests of concern.

The landfill site must have a clearly defined boundary and location (Global Positioning System (GPS) coordinates may be used).

The regulated articles and by-products presented for disposal must be entirely covered within a one-day period by a layer of any suitable covering material that will efficiently prevent the regulated articles from being exposed to the environment. The covering material could consist of domestic garbage, compacted soil or other standard covering materials. The final covering must be permanent and stable meaning that it should not be removed or moved, unless it has been discussed with CFIA and CFIA has provided written authorization.

The CFIA may authorize the disposal of regulated articles back to the place of origin. For disposal in regulated areas within Canada, provisions of deep burial may not apply. Please contact your local CFIA person for disposal options.

D. Other disposal sites (such as retention lagoons or treatment facilities)

Floating material and sediments should be contained and disposed of as solid waste.

Segregated clear water should be discharged into an approved collecting and treatment and/or disposal system (for example, a municipal sewage treatment system).

Liquid waste from retention lagoons cannot be used to irrigate agricultural land. Lagoons (natural or constructed) must be designed to prevent possible overflow.

The regulated articles generated following the emptying and/or the cleaning of a lagoon or treatment system must be disposed of in compliance with the disposal requirements outlined in this document.

For disposal sites within Canada, CFIA may be required to place additional regulatory restrictions on these sites.

General cleaning guidelines for processing and packing equipment

Each facility will have its own individual cleaning procedure which will be part of their PCP.

Some points to consider:

• the dismantling of equipment for effective cleaning may have to occur
• after cleaning up, all equipment and the facility itself must be free of soil
• closed piping that cannot be disassembled must be considered (in other words, may need to be flushed first before non-regulated articles/loads can be accepted through this system)
• bulk boxes comprised of wooden material may be difficult to clean effectively
• conveyor belts may need to be taken apart to clean effectively
• the washing of transport vehicles and containers will have to occur every time they leave a facility. Unless otherwise stated in the PCP and authorized by the CFIA
• the equipment of the processing and packing lines may only be cleaned once a week or a major clean up at the end of the season based on the use/reception intensity of the regulated articles
• roll-off and roll-on containers (which strictly carry only waste to disposal sites) will only be required to be cleaned at the end of the season

For more information on cleaning standards, refer to PI-016.