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

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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.

Endorsement

Approved by:


Joanne Rousson, Project Coordinator


Date


Greg Stubbings, Chief Plant Health Officer


Date

Number of amendment Amendment Content and Pages Entered by Date
       
       

Distribution List

  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

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 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)

ISPM No. 5, Glossary of Phytosanitary Terms, FAO (updated annually)

ISPM No. 15, Guidelines for Regulating Wood Packaging in International Trade, Publication, FAO

ISO Guide 8402, Quality Systems Terminology

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 the facility must submit a completed application form (Appendix 1 of QSM-07) and a copy of the facility's Quality Management System Manual (referred to herein as the Manual) to the local CFIA office for review and approval. The CFIA reviews and compares the Manual to the requirements specified in Directive 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 become registered EABAFCP facilities. The regional program officer (RPO) will approve the application and submit a copy of the application form and Manual to the Forestry Division Policy and Programs for final approval and issuance of an EABAFCP registration number. The Forestry Division Policy and Programs will add the contact information of the facility to the public EABAFCP approved facility list.

Registered facilities must re-submit an EABAFCP application every year to CFIA to remain registered in the program and to be issued import permits. Local CFIA offices must forward a copy of updated registration forms to the Forestry Division Policy and Programs.

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, the EABAFCP program will be overseen by a RPO.

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.
  • 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.

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.

A detailed audit and facility status flow chart is outlined in Appendix 3 of QSM-07.

5.1 Quality Management System Manual Review

CFIA will review the Manual of facilities applying to EABAFCP. The Manual outlines the specific process and procedures implemented by a facility to mitigate the phytosanitary risk of EAB 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 Directive D-03-08 and QSM-07. CFIA staff must use the checklist in Appendix 3 to evaluate the quality 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 quality 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 EAB spread. The checklist in Appendix 4 should 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). CFIA staff must use the checklist in Appendix 4 to conduct the Evaluation Audit.

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 EAB 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 review 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 similar to Evaluation Audits, but are conducted when the facility is an approved EABAFCP facility. Systems audits are conducted once a year.

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).

5.6 Internal Audits

Facilities are encouraged to conduct optional internal audits. These audits should occur at the same frequency as Surveillance Audits but at a different time. The internal audits must include an audit of all the phytosanitary critical control points. The facility must document internal audits in a log that is audited by CFIA. Alternatively, the facility may administer an internal quality audit conducted on a routine basis to ensure quality control. Facilities are responsible for creating and maintaining this log.

6.0 Domestic Movement Requirements

For movement of regulated articles between adjacent regulated areas, facilities must be registered in the EABAFCP or receive per shipment inspections in order to be granted Movement Certificates. Please contact CFIA for further details.

For movement of regulated articles between non adjacent regulated areas, 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. Facilities located in non-regulated areas that source regulated articles from regulated areas are permitted to receive regulated articles in the low risk season only.

7.0 Domestic Movement of Firewood

Refer to section 7 of QSM-07.

8.0 Non-Conformance

When a facility exhibits a non-conformance with the procedures and processes outlined in their quality manual, QSM-07, or Directive D-03-08, the facility must implement corrective actions. CFIA will provide a Corrective Action Request Report (Appendix 5) identifying the non-conformance, corrective actions necessary, and scheduling an audit to verify it has been corrected.

Movement Certificates are issued once CFIA is satisfied that the facility has addressed the corrective actions. The CFIA may increase a facility's audit frequency until the corrective actions have been satisfactorily implemented. The consequences of the three different types of non-conformances are outlined below. Examples of non-conformances are outlined in Appendix 9 in Directive D-03-08.

8.1 Minor Non-Conformances

The Corrective Action Request (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

CFIA must immediately cancel facilities that are unable to address the necessary corrective actions, have a total failure of their quality management system, or voluntarily withdraw. CFIA will cancel the Movement Certificates of cancelled facilities. The local CFIA office must notify Forestry Division, Policy and Programs Branch 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 non-compliant with 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 quality manual; and
  3. receive good standing on an audit.

The audit will include a review of the required elements of the quality 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 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.

Appendices

Appendix 1: Supplies Required to Conduct EABAFCP Audits
Appendix 2: Audit Report
Appendix 3: EABAFCP – Manual Assessment Checklist
Appendix 4: EABAFCP – Evaluation, Surveillance, and Systems Audit Checklist
Appendix 5: Corrective Action Request (CAR)


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 Directive D-03-08, QSM-07, QSM-08 and movement certificates.
  • Required safety equipment.

Appendix 2

Audit Report

CFIA Audit Report for the EABAFCP

Part A – Facility Information

Legal name and address of Auditee:

Authorized Representative:

Audit Date:

Telephone No.:

Fax No.:

Audit Report No.:

Part B – Observations & Non-Conformances

Describe and reference any Corrective Action Request (CAR):

Notes:

Number of Major Non-Conformances:

CAR No.:

Number of Minor Non-Conformances:

CAR No.:

Follow-up Action required:

Date action required by:

Part C – Results of Audit

Notes:

Compliance without CAR:   Suspension:

Compliance with CAR:   Cancelled:

Follow-up Action required by Facility (Yes/No):

Distribution List:

Facility:   Specify:

CFIA office:   Specify:

Part D – Acknowledgement of Report by Facility

Authorized Representative:   Date:

Part E – Approval of Audit (CFIA Use Only)

Audit Team Members:   Office:

CFIA Lead Auditor:   Date:


Appendix 3

EABAFCP – Manual Assessment Checklist

Facility Name:

Registration Facility No.:

Audit Report No.:

Date:

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

Required Elements C NC Remarks Corrective Actions
General Requirements        
Facility identification and address        
Table of contents and page numbers        
Distribution list        
Date and version number        
Amendment log        
Administration        
Name, title, and contact information of Certification Manager        
Name, title, and contact information of employee designated as back-up Certification Manager        
Titles, roles and responsibilities of each staff member involved in EABAFCP        
Procedures to inform staff of amendments to the quality manual        
Training        
Adequate training regime is documented        
A copy of the training record is appended        
Phytosanitary Control Points – Receiving Regulated Articles        
Procedures for all incoming regulated articles (e.g., documentation, records, people responsible, etc.)        
Procedures to inspect all incoming articles for all life signs of EAB        
Phytosanitary Control Points – Segregation        
Procedures to verify and maintain identity of all regulated articles that enter the facility        
Segregation of waste and by-products from regulated articles using adequate barriers        
Segregation and prevention of co-mingling of by-products and non-conformant products with compliant articles        
Phytosanitary Control Points – Mitigation Procedures        
Treatments and procedures for regulated ash articles (including documentation)        
Internal inspection procedures to ensure that mitigation treatments have been verified; example of record appended        
Risk mitigation procedures for chip production (grinding / chipping to less than 2.5 cm in diameter)        
Risk mitigation procedures for heat treatment of lumber        
Risk mitigation for lumber production (milling to exclude all bark and sapwood)        
Phytosanitary Control Points – Traceability        
Procedures to trace final ash products from origin to destination        
Phytosanitary Control Points – Firewood        
A verifiable ash segregation process is implemented        
Certification Manager and alternate are experts in tree species identification        
Phytosanitary Control Points – Other Control Activities        
Regulated articles are secured from unauthorized movement        
Further processing or destination of secondary by products (e.g., fuelwood, slabwood, and wood chips)        
Records and Documentation        
Maintenance and retention (for 3 years) all records required under EABAFCP and those relating to all regulated articles        
Transportation of Regulated Articles        
Procedures for vehicles that ship materials through or to non-regulated areas to ensure that they are accompanied by a Transport Compliance Form        
Procedures that ensure that transporters contracted to ship regulated articles to this facility are aware of when a Compliance Form for the Transport of Regulated Articles must be used        
Suppliers List        
Procedures to maintain a supplier's list        
Heat Treatment        
Specifies how the general operating requirements set out in PI-07 or in their site specific evaluation are met and maintained. (i.e., facility air flow rate, operation of fans, wet/dry bulb sensors descriptions and locations, the strategy for changing air flow direction and if applicable, the process for determining initial wood core temperature)        
Description of the heat treatment chamber with the location of heat sensors (e.g., a schematic)        
Identify the phytosanitary heat treatment option(s) selected from PI-07 or provide a CFIA recognized heat treatment evaluator's kiln schedule        
Includes (for each option selected) 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        
Specifies the species to be treated, dimensions of the wood being treated and the size of the stickers        
Indicates which records are maintained to verify that each heat treatment has met the technical specifications outlined in Directive D-03-02, the PI-07, and specifies the type of information to be maintained        
Documented procedure for verifying the measuring system (temperature sensors)        
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) and how the facility deals with non-conforming treatments        
Facility Non-Conformance        
Internal system developed for reporting and correcting instances of non-conformance        
A non-conformance corrective action record        
CFIA is notified within 24 hours of any major or critical non-conformances        
Clean-up and Disposal for facilities in non-regulated areas.        
All clean-up and disposal of regulated articles will be completed prior to March 31        
Notification to CFIA if EAB in any life stage is found in materials from non-regulated areas.        
Procedures outlining the care and control of movement certificates (employees responsible, specific information recorded) and where kept.        
Procedures for internal audits (e.g., occur at same frequency as surveillance audits but at different time periods)        

Audit Team Members:   Date:

CFIA Lead Auditor:   CFIA Office:

Signature:   Phone:

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 C NC Level of NC
Major, Minor, Critical
Remarks Corrective Actions
General Requirements          
The current revision of the Manual is in place and other revisions are not in circulation          
Changes to the Manual (staffing changes, location, procedures, etc.) are documented and described in the amendment log          
Administration          
Certification Manager or alternate as listed in the Manual is available for the audit          
Certification Manager is aware of the Directive D-03-08 requirements and of how their Manual meets these requirements          
The Manual is accessible to all facility employees named in the manual          
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 quality manual          
Employees fully understand their roles and demonstrate the ability to fulfill their responsibilities as listed in the quality manual          
Employees are able to correctly identify signs, symptoms, and presence of EAB          
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          
Procedures to inspect all incoming materials for all life signs of EAB are recorded and followed as per quality manual          
Phytosanitary Control Points – Segregation          
Procedures to verify and maintain identity of all regulated articles that enter the facility are followed as per Manual          
Procedures for segregation of waste and by-products from regulated articles using adequate barriers is carried out as per Manual          
Segregation and prevention of co-mingling of by-products and non conformant products with conformant articles is followed          
Segregation procedures are followed as per the Manual and site plan specifications          
Segregation is adequate to reduce the risk of co-mingled products          
Physical barriers/signage is sufficient to prevent unauthorized movement of regulated articles          
An effective identification system is in use to segregate regulated articles from non regulated articles          
Phytosanitary Control Points – Mitigation procedures          
Regulated ash articles are treated or processed as outlined in the Manual (chipping to 2.5 cm, milling to exclude all bark and sapwood, etc.)          
Inspection procedures to ensure that the mitigation treatments or procedures have been verified are followed as per quality manual          
Logs have been processed to create bark free lumber and the underlying sapwood has been removed to a depth of at least 2.5 cm          
Chips/sawdust has been ground to 2.5 cm in 2 dimensions or less          
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.)          
Phytosanitary Control Points – Traceability          
Procedures to ensure traceability of lumber are followed according to Manual          
Phytosanitary Control Points – Firewood          
A verifiable ash segregation process is implemented          
Certification Manager and alternate are experts in tree species identification          
Phytosanitary Control Points – Other Control Activities          
Procedures for further processing or destination of secondary products are followed (e.g., fuelwood, slabwood, and wood chips)          
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 accurately completed          
Inspections/records are complete and accurate          
Appropriate disposal/clean-up documentation is complete and accurate          
Transportation of Regulated Articles          
List of vehicles or companies used for transportation is accurate and current          
Drivers are aware of their responsibilities and their responsibilities are outlined in the quality manual          
Procedures for vehicles that ship regulated materials through or to a non-regulated areas are accompanied by a Compliance Form for the Transport of Regulated Articles and these conditions are adhered to          
Facilities transporting regulated articles using contract shippers have a record of the shipper's Compliance Form for Transportation of Regulated Articles and the shippers adhere to the Compliance Form          
Suppliers List          
Suppliers list is maintained          
Heat Treatment          
Demonstration of how the general operating requirements of PI-07 or the facility's site specific evaluation are met and maintained. (i.e., facility air flow rate, operation of fans, wet/dry bulb sensors descriptions and locations, the strategy for changing air flow direction and if applicable, the process for determining initial wood core temperature)          
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)          
For each charge, documentation specifies the species that was treated, dimensions of the wood treated and the size of the stickers          
Facility demonstrates that the verification of temperature sensors is done regularly          
Moisture contents have been verified for all charges where options B, C, D, and F are utilized          
Facility Non-Conformance          
The internal system developed for reporting and correcting instances of non-conformance is followed as per quality manual          
The CFIA has been notified within 24 hours of any major and critical non-conformances          
Audit reports are available          
All CAR are corrected          
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 EAB spread          
Procedures to effectively store, distribute, or dispose of non-compliant products as applicable          
Pest Notification          
The facility has notified the CFIA if EAB 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)          
Movement Certificate          
Facility is tracking all information related to the receipt and distribution of regulated ash materials as described in the quality manual          
Internal Audits (Optional)          
Record of internal audits which occur at the same frequency as the surveillance audits          

Audit Team Members:   Date:

CFIA Lead Auditor:   CFIA Office:

Signature:   Phone:

Distribute copies to Area Program Specialist and Regional Program Officer.


Appendix 5

Corrective Action Request (CAR)

Part A – Facility Information

CAR No.:

Facility name & address:

Contact name & information:

Part B – Dexcription of Non-Conformance & Related Observations

Date:

Non-Conformance Type (Critical, Major, Minor, Other):

Description:

Auditor's printed name & signature:

Date:

Part C – Description of Corrective Actions

Date for completion of corrective action:

Facility representative's Signature & date:

Approval of Part C:

Auditor's printed name and signature:

Date:

Part D – Verificaton of Corrective Action

Verification of corrective action (Acceptable/Not Acceptable):

Follow up visit findings/Additional comments:

CAR closed (Yes/No):

Auditor's printed name & signature:

Date: