QSM-08: Quality Management System Manual for Canadian Food Inspection Agency Auditors to Administer the Emerald Ash Borer Approved Facility Compliance Program (EABAFCP)

Table of contents

• Contact
• Review
• Endorsement
• Amendment Record
• Distribution
• Introduction
• 1.0 Scope
• 2.0 References
• 3.0 Definitions, abbreviations and abbrs
• 4.0 EABAFCP Registration
• 5.0 Audits and Reviews
  • 5.1 Manual Review
  • 5.2 Evaluation Audit
  • 5.3 Surveillance Audit
  • 5.4 Clean-Up Surveillance Audit
• 6.0 Domestic Movement Requirements
• 7.0 Domestic Movement of Firewood
• 8.0 Non-Conformance
  • 8.1 Minor Non-Conformances
  • 8.2 Major Non-Conformances
  • 8.3 Critical Non-Conformances
• 9.0 EABAFCP Cancellation
• 10.0 Reinstatement in EABAFCP
• Appendix 1: Supplies Required to Conduct EABAFCP Audits
• Appendix 2: Audit Report
• Appendix 3: Corrective Action Request (CAR)
• Appendix 4: EABAFCP – Manual Assessment Checklist
• Appendix 5: EABAFCP – Evaluation and Surveillance Audit Checklist
• Appendix 6: Classification of Non-Conformance

Contact

For further information and clarification, please contact the Canadian Food Inspection Agency (CFIA).

Review

This QSM procedure will be reviewed every 5 years, unless otherwise needed.

Endorsement

Approved by:

Chief Plant Health Officer

Amendment Record

Distribution

1. CFIA Directive mailing list (Areas, Regions, PHRA, USDA other federal government departments)
2. Provincial Government (via Regions)
3. National Industry Organizations (Canadian Nursery and Landscape Association, The Hardwood Lumber Bureau, Canadian Lumber Standard Accreditation Board, other industry representatives)
4. CFIA website
5. North American transport industry representatives
6. Facilities applying to EABAFCP and registered facilities.

Introduction

The Quality Management System Manual for Auditors supplements CFIA Directive D-03-08 "Phytosanitary requirements to prevent the introduction into and spread within Canada of the Emerald Ash Borer, Agrilus planipennis Fairmaire." This document provides the procedures and checklists for CFIA staff to review EABAFCP applications and perform audits of EABAFCP registered facilities. The required elements and guidelines for facilities to register and participate in the EABAFCP are outlined in QSM-07 "Quality Management System Manual for Facilities Registered in the Emerald Ash Borer Approved Facility Compliance Program (EABAFCP)."

1.0 Scope

This document is to be used by CFIA staff to register a facility in the EABAFCP and to conduct audits of registered facilities.

2.0 References

• CFIA Inspection Procedure CFIA PI-07, "The Technical Heat Treatment Guidelines and Operating Conditions Management Plan."
• CFIA Directive D-03-08, "Phytosanitary Requirements to prevent the introduction and spread within Canada of the Emerald Ash Borer, Agrilus planipennis (Fairmaire)."
• CFIA Directive D-03-02, "The Canadian Heat Treated Wood Products Certification Program (CHTWPCP)."
• CFIA Directive D-01-12, "Phytosanitary Requirements for the importation and domestic movement of firewood."
• CFIA, Directive D-01-05: "The Canadian Wood Packaging Certification Program (CWPCP) for Export."
• CFIA QSM-07, CFIA Quality Management System Manual for Facility Participation in the Emerald Ash Borer Approved Facility Compliance Program (EABAFCP).
• ISO (International Organization for Standardization) Guide 8402, Quality Systems Terminology.
• ISPM No. 5, Glossary of Phytosanitary Terms, FAO (updated annually)
• ISPM No. 15, Guidelines for Regulating Wood Packaging in International Trade, Publication, FAO, 2009.

3.0 Definitions, abbreviations and abbrs

Definitions for terms used in the present document can be found in the Plant Health Glossary of Terms or in the International Plant Protection Convention (IPPC) (ISPM No. 5) Glossary of Phytosanitary Terms.

4.0 EABAFCP Registration

To apply to the EABAFCP a facility must submit a completed application form (Appendix 1 of QSM-07) and a copy of the facility's Quality Management System Manual (hereafter referred to as the Manual) to the local CFIA office for review and approval. The CFIA inspector reviews and compares the Manual to the requirements specified in D-03-08 and the QSM-07.

Once the Manual is approved, an evaluation audit will be conducted. Facilities awarded good standing on the Evaluation Audit will be approved under the program. The regional program officer (RPO) will approve the application and submit a copy of the application form and Manual to the Area Program Specialist for final approval. Forest Resources Section of the Plant Biosecurity and Forestry Division will issue an EABAFCP registration number and add the contact information of the facility to the public EABAFCP approved facility list online.

Once approved a facility must maintain a current copy of its manual, and make it available to the CFIA, immediately upon request.

5.0 Audits and Reviews

The CFIA reserves the right to conduct audits any time during regular business hours of facilities registered under the EABAFCP. In each region, a RPO will be responsible for the oversight of the delivery of facility audits. This includes ensuring the audit team members are adequately trained to deliver the audits; maintaining audit records; ensuring that audits are conducted in accordance with the program standards and maintaining a listing of all registered facilities within their regional jurisdiction. Audit team members must have successfully completed the CFIA Understanding Audit course, and have a minimum of one year experience in the de livery of Plant Health programs.

The CFIA auditor is responsible for:

• Assembling and leading audit teams
• Completing, maintaining, and saving copies of audit records
• Distributing the audit report within five (5) business days
• Following-up with Corrective Action Requests (CAR)
• Ensuring audits are conducted in accordance with EABAFCP standards
• Maintaining a list of all EABAFCP participating facilities in their regional jurisdiction, facility status, and other relevant information
• Assessing the conformance of registered facilities
• Issuing Movement Certificates to permit the domestic movement of regulated articles

Opening meeting – The CFIA auditor must arrange an opening meeting of the audit team with the Certification Manager (CM) and any other relevant staff of the participating facility, to discuss among other items, audit criteria, availability of staff, method of performing the audit, method of handling any non-conformance found during the audit, time and place of the closing meeting, and the distribution of the audit report.

Closing meeting – The CFIA auditor must meet with the CM to review the audit findings, discuss any non-conformances, and decide upon an action plan for correction. In addition, any critical non-conformances must be reported, resulting in immediate suspension of the facility from the EABAFCP.

Supplies required to conduct Audit are listed in Appendix 1. Audit reports will be completed and distributed according to the CFIA Audit Report in Appendix 2. The Audit Report number will be generated as follows: Calendar Year-Region-Facility-Audit Type-Report Number.

A detailed audit and facility status flow chart is outlined in Appendix 5 of QSM-07.

5.1 Manual Review

CFIA staff will review the Manual of facilities applying to EABAFCP as well as Manuals subsequently revised by approved facilities. The Manual outlines the specific process and procedures implemented by a facility to mitigate the phytosanitary risk of Emerald Ash Bore spread associated with the movement of regulated articles.

The Manual is reviewed to verify that it meets the requirements of the EABAFCP as outlined in D-03-08 and QSM-07. CFIA staff must use the checklist in Appendix 3 to evaluate the Manual. If the Manual does not adhere to EABAFCP requirements CFIA staff must identify the required improvements for the applicant.

5.2 Evaluation Audit

Following approval of the Manual, CFIA will conduct an Evaluation Audit. This audit is a systemic examination conducted by CFIA to verify that a facility is operating according to the procedures outlined in its Manual and that these procedures will mitigate the risk of Emerald Ash Bore spread. The checklist in Appendix 4 must be used to conduct the evaluation audit.

For the majority of facilities, the Evaluation Audit will only be conducted once. Subsequent Evaluation Audits are required to confirm that a facility cancelled due to non-conformance has implemented corrective actions to address non-conformances. A CFIA Audit Report will be completed and given to the facility as a record of the audit (Appendix 2).

5.3 Surveillance Audit

Surveillance Audits are continual verifications that the processes and procedures described in the facility's Manual are implemented to effectively mitigate the phytosanitary risks of Emerald Ash Bore spread. The audit frequency is outlined in table 1. The audit frequency can be increased for facilities that incur non-conformances at the discretion of the RPO and the CFIA inspector who oversee EABAFCP audits. Surveillance Audits will be completed using the checklist in Appendix 4. This checklist includes verification of heat treatment processes where specific treatment schedules approval has been authorized by CFIA. A CFIA Audit Report will be completed and given to the facility as a record of the audit (Appendix 2).

5.4 Clean-Up Surveillance Audit

CFIA will conduct a Clean-Up Surveillance Audit to confirm that facilities located in non-regulated areas are completely free of non-conforming regulated articles no later than March 31 each year. The Clean-Up Surveillance Audit must be completed by March 31 to ensure that the facilities are free of non-conforming regulated articles prior to the start of the high risk season. The deadline for a Clean-Up Surveillance Audit can be reviewed annually by CFIA for facilities located in areas that continue to experience winter climatic conditions associated with low-risk periods after March 31.

For facilities in non-regulated areas that incur a major or critical non-conformance, resolution to the non-conformance must be completed by March 31. The facility is responsible for notifying CFIA when it is ready to have a clean-up surveillance audit.

Clean-Up Surveillance Audits will be completed using the checklist in Appendix 4 that includes a section for verification of clean-up for facilities located in non-regulated areas. A CFIA Audit Report will be completed and given to the facility as a record of the audit (Appendix 2).

6.0 Domestic Movement Requirements

CFIA will issue a Movement Certificate to facilities in good standing to enable the movement of compliant regulated articles out of a regulated area. The Movement Certificate will be valid for the time period between two consecutive Audits. After completion of a successful Surveillance Audit, another Movement Certificate will be issued. Strict adherence to the conditions of the Movement Certificate is required.

7.0 Domestic Movement of Firewood

Refer to section 6 of QSM-07.

8.0 Non-Conformance

When a non-conformance is discovered, the facility must implement corrective actions. Any non-conformance discovered by the facility must be documented, in accordance with their Manual, and be presented to the CFIA. CFIA will provide a CAR Report (Appendix 5) identifying the non-conformance, corrective actions necessary, and scheduling an audit to verify it has been corrected. The CAR Report number will be generated as follows: Calendar Year-Region-Facility-Audit Type-CAR-Report Number.

Movement Certificates are issued once CFIA is satisfied that the facility has addressed the corrective actions. The CFIA may increase audit frequency until the corrective actions have been satisfactorily implemented. The outcomes of the three different types of non-conformances are outlined below. Examples of non-conformances are outlined in Appendix 6.

8.1 Minor Non-Conformances

The CAR must be implemented and approved by the CFIA by the next scheduled audit.

8.2 Major Non-Conformances

The CAR must be implemented and approved by the CFIA within ten (10) business days.

8.3 Critical Non-Conformances

A facility that incurs a critical non-conformance will be cancelled from the EABAFCP.

9.0 EABAFCP Cancellation

Facilities that are unable to address the necessary corrective actions or have a total failure of their quality management system will be notified in writing by the CFIA and will be immediately cancelled from the EABAFCP.

Facilities that voluntarily withdraw from the EABAFCP need to provide a written notification to the CFIA.

CFIA will remove the Movement Certificates from the cancelled facility. The local CFIA office must notify Forest Resources Section of the Plant Biosecurity and Forestry Division of the cancellation so that the facilities can be removed from the published list of approved EABAFCP facilities.

Individuals or facilities that are found to be in violation of the Plant Protection Act or regulations may be subject to additional penalties including prosecution.

10.0 Reinstatement in EABAFCP

To be reinstated as an approved EABAFCP facility, cancelled facilities must:

1. submit a new application,
2. submit a revised Manual, and
3. receive good standing on an audit.

The audit will include a review of the required elements of the Manual, the processes and procedures of the facility, as well as any other aspects of the program that the audit team deems appropriate. Surveillance Audit frequencies may be increased at the discretion of CFIA following the reinstatement in EABAFCP. When the facility demonstrates consistent conformance CFIA may reduce the audit frequency as appropriate. It is strongly recommended that the facility make a reinstatement request a month before the desired reinstatement date to their local CFIA office.

Facilities in non-regulated areas must become inactive during the high risk season and be reinstated in the EABAFCP as an active approved facilities during the low risk season. The facility must contact the local CFIA office to request reinstatement. It is strongly recommended that the facility make a reinstatement request a month before the desired reinstatement date. In these cases, a new application and a revised Manual are not required. However, an audit to verify suitability for reinstatement in the EABAFCP will be conducted and include a review of the Manual and the phytosanitary critical control points to mitigate the risk of Emerald Ash Bore spread.

Appendix 1: Supplies Required to Conduct EABAFCP Audits

• Facility records, such as Manual and previous audit reports.
• Wood identification materials, hand lens, and knife.
• Materials for specimen submission, such as specimen vials, 70% alcohol, and camera.
• Policy documents and forms such as D-03-08, QSM-07, QSM-08 and movement certificates.
• Required safety equipment.

Appendix 2: Audit Report

PDF (177 kb)

Emerald Ash Borer Approved Facility Compliance Program (EABAFCP)

Facility Name

Address

Facility #

Date (yyyy/mm/dd)

Quality Manager

CFIA Representative(s)

Telephone No.

Fax No.

Audit Report No.

Audit Objectives, Scope and Criteria

The objective of this audit was to ensure the conformance of the facility with their written Quality Plan as well as product compliance with the requirements of the current version of D-03-08, Phytosanitary Requirements to prevent the introduction and spread within Canada of the Emerald Ash Borer, Agrilus planipennis (Fairmaire).

The scope of this audit included (list the scope, for example: the offices, milling and storage areas of the facility, interviews with staff, review of records, etc.):

The Criteria used for this audit consisted of (list all document reviewed, for example CFIA references D-03-08, QSM-08, QSM-07, PI-07, Facility X Quality Manual, Facility records, etc.):

Audit Details

(For example, the audit consisted of an introductory meeting beginning at 00:00, record review, observations, interviews and the closing meeting finishing at 00:00, interview questions and results, etc.)

Areas Audited

(Identify the records reviewed, for example: tracking log, training records, shipping documents, invoices, previous CAR's, internal audits, etc. Identified the interviewees, for example: Quality Manager, Head Sawyer, stacker and loader driver, etc.)

Facility Status

• Box Approved
• Box Standard
• Box Modified
• Box Suspended

Audit Report Distribution

Copies have been distributed to:

Facility X

File

CFIA, District Office
CFIA, Area Network Specialist

Appendix 3: Corrective Action Request (CAR)

PDF (183 kb)

CAR #:

A – Facility Information:

Facility name & address:

Contact name & information:

B – Description of Non-Conformance & Related Observations:

Date:

Non-Conformance Type:

• Box Critical
• Box Major
• Box Minor
• Box Other:

Description:

Auditor's printed name & signature:

Date:

C – Description of Corrective Actions:

Date for completion of corrective action:

Facility representative's Signature & date:

Approval of Part C:

Auditor's printed name & signature:

Date:

D – Verification of Corrective Action:

Verification of corrective action:

• Box Acceptable
• Box Not Acceptable

Follow up visit findings/Additional comments:

CAR closed:

• Box Yes
• Box No

Auditor's printed name & signature:

Date:

Appendix 4: EABAFCP – Manual Assessment Checklist

PDF (216 kb)

Facility Name:
Audit Report No.:
Date:

Audit Team Members: Date:

CFIA Auditor: CFIA Office:

Signature: Telephone:

Distribute copies to Area Program Specialist and Regional Program Officer

Appendix 5: EABAFCP – Evaluation and Surveillance Audit Checklist

Note: The checklist is only a general guide for CFIA staff and that it is expected that details of what was reviewed and how will be included.

PDF (254 kb)

Facility Name:
Registration Facility No.:
Audit Report No.:
Date:

Audit Team Members: Date:

CFIA Auditor: CFIA Office:

Signature: Telephone:

Distribute copies to Area Program Specialist and Regional Program Officer

Appendix 6: Classification of Non-Conformance

Type of Non-Conformance	Consequences of Non-Conformance	Non-exhaustive list of examples
MinorTable Note * An isolated incident of non-conformance which has no direct impact on the integrity of the product and that remedial action can be taken within a time period defined by the inspector.	The corrective action request (CAR) must be implemented and approved by CFIA by the next scheduled audit or the facility may be cancelled from EABAFCP.	Positions of responsibilities under the EABAFCP are not listed in Manual Outdated Manuals of the facility are found in circulation Missing pages in manuals

4 Minors found = 1 Major

Type of Non-Conformance	Consequences of Non-Conformance	Non-exhaustive list of examples
MajorTable Note * The integrity of the program may be compromised due to a non-conformance.	Written authorization for the movement of regulated articles may not be issued. The CAR must be implemented and approved by CFIA within 10 business days or the the facility may be cancelled from EABAFCP.	Some records (invoices, movement certificate) related to EABAFCP are missing or incomplete Staff not trained as per facility's training plan Segregation procedures (e.g. signage) are not maintained Manual revisions have not been submitted to the CFIA prior to procedural changes Heat Treatment records incomplete to confirm Heat treatment to 56/30 is adequate Minor non-conformances have not been corrected Facility non-conformance mechanism not effective

3 Majors found = 1 Critical

Type of Non-Conformance	Consequences of Non-Conformance	Non-exhaustive list of examples
CriticalTable Note * The integrity of the EABAFCP has been compromised, there is a serious breakdown at a critical control point, or the risk of Emerald Ash Bore spread is very high.	The facility is cancelled from EABAFCP.	Segregation of compliant and non-compliant ash articles is not being maintained Ash lumber not fully debarked has been shipped out of a regulated area Movement certificates are found to not accompany each outgoing load Facility clean up not complete by March 31 annually or by pre-arranged date with the CFIA.

Table Note

Table Note *

All non-conformances could be assigned a higher or lower level depending on the associated risk of the specific situation.

Return to first table note * referrer