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

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:

Project Coordinator

Greg Stubbings, Chief Plant Health Officer

Amendment Record

Number of amendment:Amended by:Date of submission for approval of amendment:Summary of amendment and number of amended page(s):
1 Mireille Marcotte February 2012 Changes were made throughout the document to clarify the EABAFCP requirements. Approved facilities no longer need to re-submit an application form every year (see section 4.0). Appendix 3 and Appendix 4 were updated to reflect the changes made in QSM-07 and this document. The Classification of Non-Conformance was added in Appendix 6.

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

3.0 Definitions, abbreviations and acronyms

Definitions for terms used in the present document can be found in the Plant Health Glossary of 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 compliance 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 Surveillance and Systems Audits 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. Surveillance audits are conducted once a month for the first three (3) months that the facility is approved under the EABAFCP. Following this initial period, facilities that demonstrate consistent conformance are subject to quarterly Surveillance Audits, i.e. regular intervals of once every three (3) months. 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).

5.5 Systems Audit

The Systems Audit is a comprehensive audit of the organization structure, processes, and resources of the facility used to adhere to the requirements of the EABAFCP. The Systems Audit focuses on the phytosanitary control points. Systems audits are conducted once a year.

For facilities that operate only during the low risk season, a systems audit must be completed prior to the resumption of processing.

The findings of this audit will be recorded using the checklist outlined in Appendix 4. 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 Surveillance 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 will increase to once per month for three (3) months. 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 Manuel are not required. However, a system 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

CFIA Audit Report for the EABAFCP

Click on Image for Larger View
Appendix 2: Audit Report
Audit Report

Appendix 3: EABAFCP – Manual Assessment Checklist

Facility Name:
Audit Report No.:
Date:

The required elements listed in the table below must be described in detail in the facility's Manual.

Required Elements from QSM-07CNCRemarksCorrective Actions
5.1 General Requirements        
Facility identification and address        
Table of contents and page numbers        
Distribution list        
Date and version number        
Amendment log        
Procedures to inform staff of amendments to the Manual are specified.        
5.2 Administration        
Name, title, and contact information of Certification Manager        
Name, title, and contact information of employee designated as back-up Certification Manager.        
Experience or expertise in identifying tree genera for Certification Manager and alternate is described in the Manual.        
Titles, roles and responsibilities of each staff member involved in EABAFCP.        
5.3 Training        
Adequate training program is documented.        
An example of a training record is appended.        
5.4.1 Phytosanitary Control Points – Receiving Regulated Articles        
Procedures that verify and maintain identity of all ash regulated articles that enter the facility (for facilities in non regulated areas only) are documented.        
5.4.2 Phytosanitary Control Points – Segregation        
Procedures that indicate how ash logs from regulated areas are segregated from ash logs from non regulated areas are specified (for facilities in non regulated areas only).        
Procedures that indicate how regulated ash lumber is segregated from mitigated ash lumber are specified.        
Procedures that indicate how bark, chips and other waste from regulated articles are segregated from non regulated ash waste products (for facilities in non regulated areas only) are specified.        
Segregation process for firewood is documented.        
5.4.3 Phytosanitary Control Points – Processing Procedures        
Risk mitigation procedures for chip production (grinding / chipping to less than 2.5 cm in diameter) are documented.        
Risk mitigation procedures for heat treatment of lumber are documented.        
Risk mitigation for lumber production (milling to exclude all bark and sapwood) are documented.        
5.4.4 Phytosanitary Control Points – Traceability        
Procedures to trace ash products from origin until made compliant are documented (for facilities in non regulated areas only).        
5.4.5 Phytosanitary Control Points – Other Control Activities        
Procedures to ensure that regulated articles are secured from unauthorized movement are documented.        
5.5 Records and Documentation        
Procedures to maintain and retain (for 3 years) all records required under EABAFCP are documented.        
5.6 Suppliers List        
Procedures to maintain a supplier's list are documented (if applicable).        
5.7 Transportation of Non-compliant Regulated Articles        
Procedures for vehicles that ship non-compliant materials through or to non-regulated areas to ensure that they are accompanied by a Transport Compliance Form are documented.        
5.8 Movement Certificate        
Procedures outlining the care and control of movement certificates (employees responsible, specific information recorded, final inspection to authorize the facility issuance of the Movement Certificate recorded, and location) are documented.        
5.9 Heat Treatment        
Procedures specifying how the general operating requirements set out in PI-07 or in site specific schedules are met and maintained. (i.e. air flow rate, operation of fans, wet/dry bulb sensors locations, process for determining initial wood core temperature) to meet the phytosanitary standard of 56/30 are documented.        
A description of the heat treatment chamber with the location of heat sensors and dimensions of the kiln (e.g. a schematic) is provided in the Manual.        
The Manual indicates the specific heat treatment option(s) from PI-07 or a site specific kiln schedule to be used to heat treat ash lumber.        
The Manual indicates the method of recording the recognized heat treatment process and demonstrates how the records relate to the specific phytosanitary requirements with respect to minimum time and temperature.        
Documented procedure for verifying the measuring system (temperature sensors) is provided.        
Appendix contains example of records of verification (calibration schedules, etc.)        
A process is specified for determining the moisture content after each treatment (Option F in PI-07).        
5.10 Facility Non-conformance        
Internal system developed for reporting and correcting instances of non-conformance.        
A non-conformance corrective action record is appended.        
Procedures to notify CFIA within 24 hours of any major or critical non-conformances are indicated.        
5.11 Clean-up and Disposal of By-products        
Procedures to ensure all clean-up and disposal of regulated articles will be completed prior to March 31 (for facilities in non regulated areas only) are included.        
5.12 Pest Notification        
Procedures to notify CFIA if Emerald Ash Borer in any life stage is found in materials from non-regulated areas are included.        
5.13 Internal Audits        
Procedures for internal audits are documented (if applicable).        

Audit Team Members:  Date:

CFIA Auditor:  CFIA Office:

Signature:  Telephone:

Distribute copies to Area Program Specialist and Regional Program Officer

Appendix 4: EABAFCP – Evaluation, Surveillance, and Systems Audit Checklist

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

Required Elements from QSM-07CNCLevel of NC (Major, Minor, Critical)RemarksCorrective Actions
5.1 General Requirements          
The facility's Manual is maintained and distributed as per Manual procedures.          
Procedural changes and other updates are documented and described in the amendment log.          
All previous CARs have been addressed adequately.          
5.2 Administration          
Certification Manager or alternate as listed in the Manual is available for the audit.          
Certification Manager and alternate demonstrate expertise in tree genus identification.          
Certification Manager demonstrate knowledge of the D-03-08 requirements and of how their Manual meets these requirements.          
The Manual is accessible to all facility employees named in the manual.          
5.3 Training          
Copy of current training regime is on file.          
Training records are completed with employee name, date, and specific training topics.          
Employees are trained according to the frequency outlined in the Manual.          
Employees fully understand their roles and demonstrate the ability to fulfill their responsibilities as listed in the Manual.          
Employees are able to correctly identify signs, symptoms, and presence of Emerald Ash Borer.          
5.4.1 Phytosanitary Control Points – Receiving Regulated Articles          
Procedures for all incoming regulated ash materials (e.g. documentation, records, people responsible, etc.) are followed as per Manual.          
5.4.2 Phytosanitary Control Points – Segregation          
Procedures that verify and maintain identity of all regulated articles that enter the facility are followed as per Manual (for facilities in non regulated areas only).          
Procedures that indicate how ash logs from regulated areas are segregated from ash logs from non regulated areas (for facilities in non regulated areas only) are followed.          
Procedures that indicate how regulated ash lumber is segregated from mitigated ash lumber are followed.          
Procedures that indicate how bark, chips and other waste from regulated articles are segregated from non regulated ash waste products (for facilities in non regulated areas only) are followed.          
Segregation process for firewood is implemented.          
5.4.3 Phytosanitary Control Points – Processing Procedures          
Risk mitigation procedures for chip production (grinding / chipping to less than 2.5 cm in diameter) are followed.          
Risk mitigation procedures for heat treatment of lumber are followed.          
Risk mitigation for lumber production (milling to exclude all bark and sapwood) are followed.          
Charge reports indicate lumber has been heat treated to the standards of PI-07. Mandatory kiln requirements have been met (probe placement, air flow speeds, etc.)          
5.4.4 Phytosanitary Control Points – Traceability          
Procedures to ensure traceability of lumber are followed according to Manual (for non regulated areas only).          
5.4.5 Phytosanitary Control Points – Other Control Activities          
Procedures to ensure that regulated articles are secured from unauthorized movement are followed.          
5.5 Records and Documentation          
The appropriate control documents are completed and the 3 year retention period is respected (e.g. shipping records, movement certificates, Compliance Form for Transport of Regulated Articles, invoices, audit report, correctives actions, etc.) as per Manual.          
Movement Certificates for incoming and outgoing articles are verified and accompany incoming/outgoing loads and journal logs are accurately completed.          
Inspections/records are complete and accurate.          
Appropriate disposal/clean-up documentation is complete and accurate.          
5.6 Suppliers List          
Suppliers list is maintained.          
5.7 Transportation of Non-compliant Regulated Articles          
Procedures for vehicles that ship non-compliant materials through or to non-regulated areas are accompanied by proper documentation and adhered to.          
5.8 Movement Certificate          
Facility is tracking all information related to the receipt and distribution of regulated ash materials as described in the Manual.          
5.9 Heat Treatment          
Procedures specifying how the general operating requirements set out in PI-07 or in site specific schedules are met and maintained. (i.e. air flow rate, operation of fans, wet/dry bulb sensors locations, process for determining initial wood core temperature) to meet the phytosanitary standard of 56/30 are followed.          
Description of heat treatment chamber is accurate (e.g. Probe placement is verified, dimensions are verified, etc).          
Heat treatment documents indicate the specific PI-07 options (or site specific schedules) used.          
Charge records demonstrate and verify that the charges meet the PI-07 or site specific charge requirement (i.e. Minimum wet bulb run time, final wet bulb run time, and total heat treatment time is verified).          
Facility demonstrates that the verification of temperature sensors is done regularly.          
Moisture contents have been verified for all charges where option F is utilized.          
5.10 Facility Non-conformance          
The internal system developed for reporting and correcting instances of non-conformance is followed as per Manual.          
The CFIA has been notified within 24 hours of any major and critical non-conformances.          
Non-conformance reports are available.          
5.11 Clean-up and Disposal for facilities in non-regulated areas. Must be completed by March 31 or later with weather condition exemption issued by CFIA.          
Facility is free of all regulated articles as a result of clean-up or disposal.          
Employees understand their responsibilities in relation to disposal/clean up.          
Procedures to generate by-products are followed to effectively mitigate the risk of Emerald Ash Borer spread.          
Procedures to effectively store, distribute, or dispose of non-compliant products are followed as applicable.          
5.12 Pest Notification          
The facility has notified the CFIA if Emerald Ash Borer in any life stage is found in materials from non-regulated areas (e.g. No infested material from non-regulated areas is found during the audit).          
5.13 Internal Audits (Optional)          
Record of internal audits (which should occur at the same frequency as the surveillance audits) are available.          

Audit Team Members:  Date:

CFIA Auditor:  CFIA Office:

Signature:  Telephone:

Distribute copies to Area Program Specialist and Regional Program Officer

Appendix 5: Corrective Action Request (CAR)

Click on Image for Larger View
Appendix 5: Corrective Action Request (CAR)
Corrective Action Request (CAR)

Appendix 6: Classification of Non-Conformance

Type of Non-ConformanceConsequences of Non-ConformanceNon-exhaustive list of examples
Minor*
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.
  • Employees with 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
Major*
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, Compliance Form for the Transport of Regulated Articles) related to EABAFCP are missing or incomplete
  • Movement certificates not accompanying each load
  • 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
Critical*
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

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