QSM-07: Quality Management System Manual for Facilities Registered in the Emerald Ash Borer Approved Facility Compliance Program (EABAFCP)
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Table of contents
- Contact
- Review
- Endorsement
- Amendment Record
- Distribution
- Introduction
- 1.0 Scope
- 2.0 References
- 3.0 Definitions, abbreviations and acronyms
- 4.0 EABAFCP Registration
- 5.0 EABAFCP Quality Management System Manual
- 5.1 General Requirements
- 5.2 Administration
- 5.3 Staff Training
- 5.4 Phytosanitary Control Points
- 5.5 Records and Documentation
- 5.6 Supplier List
- 5.7 Transportation of Non-Compliant Regulated Articles
- 5.8 Movement Certificates
- 5.9 Heat Treatment
- 5.10 Facility Non-Conformance
- 5.11 Clean-Up and Disposal of By-Products
- 5.12 Pest Notification
- 5.13 Internal Audits
- 6.0 Quality Management System Manual
- 7.0 Audits and Reviews
- 8.0 EABAFCP Non-Conformance
- 9.0 Cancellation, Reinstatement and Voluntary withdraw
- Appendix 1: Application to Register in the Emerald Ash Borer Approved Facility Compliance Program
- Appendix 2: EABAFCP Movement Certificate Log
- Appendix 3: Classification of Non-Conformance
- Appendix 4: EABAFCP - Audit and Facility Status Flow Chart
Contact
For further information and clarification, please contact the Canadian Food Inspection Agency.
Review
This QSM procedure will be reviewed every 5 years, unless otherwise needed.
Endorsement
Approved by:
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). The Classification of Non-Conformance was added in Appendix 3. The Compliance form for the transport of regulated articles was added in Appendix 4. The EABAFCP Audit and Facility Status Flow Chart can now be found in Appendix 4. |
| 2 | Isabelle Gosselin | March 2014 | Changes were made throughout the document to clarify the EABAFCP requirements. The frequency of survey per year has been updated. The system audit was removed. The Appendix 4 "Compliance form for the transport of regulated articles" was removed and all reference to the form was also removed through the document. |
Distribution
- CFIA Directive mailing list (Areas, Regions, PHRA, USDA other federal government departments)
- Provincial Government (via Regions)
- National Industry Organizations (Canadian Nursery and Landscape Association, The Hardwood Lumber Bureau, Canadian Lumber Standard Accreditation Board, other industry representatives)
- CFIA website
- North American transport industry representatives
- Facilities applying to EABAFCP and registered facilities.
Introduction
The Quality Management System Manual for Facilities 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". It outlines the requirements that facilities must meet to be approved as an Emerald Ash Borer Approved Facility Compliance Program (EABAFCP) facility. The EABAFCP enables facilities in good standing to ship regulated articles out of regulated areas without a pre-shipment CFIA inspection and allows facilities in non-regulated areas to receive regulated articles during certain low-risk times of the year. The EABAFCP is a systems based risk mitigation program, which is audited by the CFIA. A flow chart outlining audits and facility status is provided in Appendix 4.
1.0 Scope
The Quality Management System Manual for Facilities in the EABAFCP outlines the requirements to comply with the EABAFCP. Facilities not registered in the EABAFCP should refer to Directive D-03-08 for regulatory guidelines.
2.0 References
- CFIA Directive D-03-02, "The Canadian Heat Treated Wood Products Certification Program (CHTWPCP)".
- CFIA Directive D-03-08, "Phytosanitary requirements to prevent the introduction into and spread within Canada of the Emerald Ash Borer, Agrilus planipennis Fairmaire".
- QSM-08 – CFIA Quality Management System Manual for Auditors for the Emerald Ash Borer Approved Facility Compliance Program (EABAFCP)
- CFIA PI-07, Technical Heat Treatment Guidelines and Operating Conditions Management Plan
- ISPM No. 5, Glossary of Phytosanitary Terms, FAO (updated annually)
- ISPM No. 15, Guidelines for Regulating Wood Packaging in International Trade, Publication, FAO, 2009.
- ISO (International Organization for Standardization) 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 or in the International Plant Protection Convention (IPPC) (ISPM No. 5) Glossary of Phytosanitary Terms at http://www.ippc.int/en/.
4.0 EABAFCP Registration
To apply to the EABAFCP the facility must submit a completed application form (see Appendix 1) 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. Contact information for local CFIA offices is available on our Web site.
A facility that is approved for registration will be issued a facility registration number by the CFIA.
Once approved a facility must maintain a current copy of its manual, and make it available to the CFIA, immediately upon request.
5.0 EABAFCP Quality Management System Manual
The Manual must outline the procedures and processes implemented by a facility to mitigate the phytosanitary risk of Emerald Ash Borer spread associated with the movement of regulated articles.
The Manual must include all of the elements of a facility's operations that relate to Emerald Ash Borer risk mitigation. Details of these requirements are described below.
A quality management system that follows International Organization for Standardization guidelines or a similar management system and is amended to include the required elements of the EABAFCP can be used as a Manual.
5.1 General Requirements
5.1.1 Facility Identification
The Manual must provide the facility name, address and contact information of all facility locations where regulated ash articles are received and processed.
5.1.2 Organization of Manual
A table of contents page may be required at the CFIA's discretion to improve the organization of the Manual.
5.1.3 Manual Modifications
The Facility must have a CFIA-approved and up-to-date copy of the Manual with an assigned version number and date of revision. Subsequent changes must have a new version number and replace previous versions. When the Manual is altered, the updated version must be sent to the CFIA for approval prior to implementation. Where repeated updates are required, an amendment log must be kept to document changes. A copy of the amendment log must be attached to the Manual. Facility employees must be informed of the procedure changes and the changes made to the Manual once they have been approved by CFIA.
5.2 Administration
5.2.1 Certification Manager
The Manual must identify a Certification Manager (CM) and an alternate to the CM. The CM is the official contact with CFIA and is responsible for developing the Manual, enacting changes and updates, providing training to employees with roles and responsibilities under the EABAFCP and conducting optional internal audits. The CM will also be responsible to meet with CFIA and assign staff to accompany and assist during audits. The CM and alternate must have expertise in tree genus identification. This expertise could be obtained from experience or education and must be described in the Manual (e.g., number of years of experience, courses taken, etc).
5.2.2 Staff Responsibilities
The Manual must identify the staff members responsible for ensuring that the facility meets the EABAFCP requirements. Position titles and a description of responsibilities in relation to the EABAFCP must be documented.
5.3 Staff Training
The Manual must describe the training procedures of staff responsible for procedures that mitigate the spread of Emerald Ash Borer in accordance with the EABAFCP. This includes the specific training elements and the intervals between training sessions. The training records must include the names of the employees trained. An example of a training record must be appended to the Manual.
Information on the signs and symptoms of Emerald Ash Borer, a copy of the facility's Manual, and D-03-08 must be accessible to all facility staff that contribute to meeting the EABAFCP requirements.
5.4 Phytosanitary Control Points
Phytosanitary control points are critical processing steps where regulated articles must be processed in accordance with EABAFCP and D-03-08 in order to mitigate the spread of Emerald Ash Borer. These may include stages where regulated articles are received, segregated, processed and shipped.
Facilities are encouraged to conduct internal inspections following critical processing steps (e.g., inspection of lumber to ensure all bark and wane are removed). If the facility does internal inspections, the Manual must identify all phytosanitary control points and outline how the facility will conduct the internal inspections of the points to verify that regulated articles are processed in accordance with EABAFCP. The facility could develop a flow diagram to identify control points. Inspection and audit records at these control points should be current and complete, as specified in Section 5.5.
Staff must fully understand their roles and responsibilities regarding phytosanitary control points.
5.4.1 Receiving Regulated Articles
The Manual must document how incoming regulated articles are identified upon receipt. Procedures may include signing off on incoming shipping documents, and applying unique markings for loads of regulated articles. The facility must record incoming regulated articles.
5.4.2 Segregation
Facilities in non-regulated areas must have procedures in place to ensure regulated articles are segregated from non-regulated articles throughout the whole production process. This includes receipt of articles at the facility to distribution of finished products or disposal of by-products. Segregation methods may include physical barriers such as fencing designating areas identified with specific signage or other identification as described by the facility. A site plan must be included with the Manual to identify the location of these specific areas.
5.4.3 Processing Procedures
The Manual must indicate the processing procedures used to generate compliant regulated articles and the procedures used to confirm that the processing conditions are met. For example: inspection procedures to confirm bark chips are less than 2.5 cm in two (2) dimensions, inspection procedures for lumber to ensure bark and sapwood have been removed to a depth of 1.0 cm past the cambial layer, and verification of charge reports to ensure heat treatment has been attained to the prescribed treatment schedules. An example of a verification record must be appended to the Manual.
Treatment measures to generate compliant products are outlined in Appendix 6 of D-03-08.
5.4.4 Traceability of Regulated Articles
Facilities in non-regulated areas may be required to show the origin of lumber for export certification requirements for some countries. For these specific situations, it is mandatory that procedures be instituted to allow the confirmation to origin. CFIA may refuse to issue a Phytosanitary Certificate if the origin can not be confirmed.
5.4.5 Other Control Activities
Other control activities implemented by the facility that may impact the integrity of the EABAFCP must be included in the Manual.
5.5 Records and Documentation
Facilities are required to maintain records that track all activities related to the EABAFCP for a minimum of three (3) years. Examples of these records include incoming shipping documents (requirement for sources of incoming ash outside of a regulated area only), movement certificates and log journals, inspection records for incoming regulated articles in non-regulated areas, training records, sales records for regulated articles sold, audit reports and corrective actions.
5.6 Supplier List
Facilities that do not further process the regulated articles (e.g., firewood brokers) must maintain a list of suppliers from where regulated articles will be sourced. Changes made to the suppliers list must be communicated to the CFIA. Facilities that do process the regulated articles should keep a suppliers list of sources from non-regulated areas. Contact your local CFIA office for more information.
5.7 Transportation of Non-Compliant Regulated Articles
Regulated articles must be transported under the conditions outlined in D-03-08, Section 2 for domestic movement and Section 3 for imports. The Manual must outline how the facility will meet the requirements for transport of regulated articles.
Facilities using their own vehicles to transport non-compliant regulated articles must outline the procedures (e.g., cleaning of trailer after unloading regulated articles) used to mitigate the risk of Emerald Ash Borer spread.
5.8 Movement Certificates
Facilities registered in EABAFCP will be issued a Movement Certificate to allow the movement of regulated articles. The Manual must indicate the specific procedures and employees responsible for the care and control of the Movement Certificates. Specific information such as the movement certificate number, article, quantity, date of shipment, origin/destination of shipment, must be maintained for each shipment transported under the authority of the movement certificate. Appendix 2 contains a suggested template for how this information can be recorded.
Most importantly, the Manual must include the procedure surrounding what final inspection is done to signify that the shipment meets the conditions on the Movement Certificate (i.e.: How does the employee responsible for control of the Movement Certificate know that the entire shipment is compliant?).
5.9 Heat Treatment
Facilities not registered under the Canadian Heat Treated Wood Products Certification Program (CHTWPCP) but intending to use heat treatment to generate compliant articles must meet the treatment requirements outlined in The Technical Heat Treatment Guidelines and Operating Manual (PI-07).
Alternately, the CFIA will recognize specific treatment schedules developed by a recognized CFIA heat treatment evaluator. A list of CFIA recognized heat treatment evaluators is available on our Web site.
In all cases, the Manual must describe the kiln layout, including dimensions, direction of air flow, and location of all sensors. An example of the charge report, showing calculations used to confirm that heat treatment requirements are met must also be included in the Manual.
5.10 Facility Non-Conformance
The facility must specify an internal system for addressing and recording non-conformances.
A non-conformance record must include the following information:
- Description of the non-conformance
- Date of occurrence
- Employees involved
- Corrective actions taken
- Signature of approval by the Certification Manager
Examples of non- conformances are listed in Appendix 3.
An example of the facilities' non-conformance record must be included in the Manual. The CFIA must be notified within 24 hours of a non-conformance that affects the ability of the facility to meet the requirements of EABAFCP.
5.11 Clean-Up and Disposal of By-Products
Facilities in non-regulated areas must specify that processing, treatment, clean-up and disposal of regulated articles will be completed by March 31, which is the end of the low-risk period. Procedures to contact CFIA once the final clean-up is completed must be outlined in the Manual. Clean-up and disposal activities will be verified by CFIA.
5.12 Pest Notification
Live Emerald Ash Borer or signs of Emerald Ash Borer damage, may be encountered by facility staff during the processing of regulated articles. All facilities must clearly specify in their Manual a commitment to notify the CFIA immediately if Emerald Ash Borer in any life stage or signs of Emerald Ash Borer are found on regulated articles sourced from a non-regulated area.
5.13 Internal Audits
Facilities are encouraged to conduct internal audits on a routine basis. Internal audits are internal checks that verify all procedures are carried out as outlined in the facilities' Manual. The internal audits should include an audit of all the phytosanitary critical control points and should be recorded. If internal audits are conducted, a copy of the internal audit log must be included in the manual.
Internal Audit reports must be made available to the CFIA during audits.
6.0 Domestic Firewood Movement
Movement certificates for non ash slabwood and firewood are required for movement out of a regulated area. Movement certificates may only be granted to facilities under the EABAFCP. Facility procedures must include how ash is segregated and excluded from other tree genera.
For movement of firewood within a regulated area, no restrictions apply.
7.0 Audits and Reviews
A flow chart outlining audits and facility status is provided in Appendix 4.
7.1 Manual Review
Prior to registration, a review of the Manual will be conducted by the CFIA to verify that all prescribed elements in D-03-08 and section 5 of this document are addressed.
7.2 Evaluation Audit
An Evaluation Audit is a systemic examination conducted by CFIA, to verify that a facility is capable of consistently meeting the EABAFCP requirements as outlined in the facility's Manual. Once CFIA approves the Manual and a facility receives good standing in the Evaluation Audit, the facility will be approved for registration under the EABAFCP.
7.3 Surveillance Audit
Surveillance Audits are verifications that the processes and procedures described in the facility's Manual are implemented to consistently mitigate the phytosanitary risks of Emerald Ash Borer spread. The audit frequency is outlined in table 1.
Facilities located in non-regulated areas may only operate under the EABAFCP during the low risk season (October 1 – March 31). For these facilities, the clean-up surveillance audit prior to the start of the high risk season will focus on ensuring that all regulated articles have been processed/treated/disposed of as per Appendices 5 and 6 of D-03-08. These audits must be completed by March 31. However, where the final clean up/processing activities can not be completed due to harsh winter environmental conditions, the CFIA will review each situation on a case by case basis and will adjust the date of the final surveillance audit accordingly.
Facilities in regulated areas are subject to surveillance audits throughout the year.
Table 1: Audit frequency
| 1st year | 2nd year and after | |
|---|---|---|
| Evaluation audit (prior to October 1st) | 1 | 0 |
| Surveillance audit (≈ October) | 0 | 1 |
| Surveillance audit (≈ January) | 1 | 0 |
| Clean-up surveillance audit | 1 | 1 |
| (Total) | (3) | (2) |
| 1st year | 2nd year and after | |
|---|---|---|
| Evaluation audit | 1 | 0 |
| Surveillance audit | 2 | 2 |
| (Total) | (3) | (2) |
8.0 EABAFCP Non-Conformance
When CFIA audits identify that a registered EABAFCP facility is not in conformance with their Manual, QSM-07 or D-03-08, the facility must implement corrective actions. CFIA will provide a Corrective Action Request to the registered facility identifying the details of the non-conformance. Examples of non-conformances are listed in Appendix 3.
9.0 Cancellation, Reinstatement and Voluntary withdraw
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.
Cancelled EABAFCP facilities will have their Movement Certificates removed immediately and the facility will be removed from the CFIA list of approved EABAFCP facilities.
To be reinstated as EABAFCP approved facility status, cancelled facilities must submit a new application and a revised Manual. The facility must also receive a good standing on the Audit. Once the facility has demonstrated to the CFIA on-going compliance with the requirements of D-03-08 and QSM-07, the CFIA may reduce the audit frequency.
Facilities that voluntarily withdraw from the EABAFCP need to provide a written notification to the CFIA.
Individuals or companies that do not comply with the Plant Protection Act and Plant Protection Regulations may be subject to additional penalties including prosecution.
A facility in a non-regulated area may become inactive during the high risk season and be reinstated in the EABAFCP as an active approved facility 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 this case, a new application and a revised Manual are not required. However, a surveillance 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 Borer spread.
Appendix 1: Application to Register in the Emerald Ash Borer Approved Facility Compliance Program
Part A: Applicant/Permit Holder Information
- Facility name and address
- Location of the receiving facility
- Contact name / Certification Manager
- Telephone(s)
- Fax.
- Anticipated sources (counties and states/provinces from which the ash may be sourced)
Part B: Facility Consent
The facility must agree to permit the inclusion of its name on the public List of EABAFCP Approved Facilities, which will be posted on the CFIA website.
Signature:
Part C: Declaration
I, the owner/ authorized signatory of the above named facility have read and understood all the conditions and obligations stated herein and have read and hereby agree to comply with the requirements of the Emerald Ash Borer Approved Facility Compliance Program.
Further, I am and shall be responsible for and shall indemnify and save harmless and defend at its own costs Her Majesty the Queen in right of Canada, including the CFIA and its employees and agents, Her Heirs, Successors and Assigns from and against all claims, demands, losses, damages, costs, including solicitor and own-client costs, expenses, actions suits or other proceedings whatsoever, brought or prosecuted in any manner which heretofore or hereafter may be made by whomever; however and whenever caused by, arising out of, attributed to or with respect to any failure, inadvertent or otherwise, by act or omission, to fully comply with the said conditions and requirements.
Name and title of Certification Manager:
Signature:
Date:
Part D: Approval (To be completed by CFIA)
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Description for Part D: Approval (To be completed by CFIA)
Appoved as:
- Box Sawmill
- Box Disposal
- Box Firewood Producer (domestic only)
- Box Other:
Comments:
Names of Auditors:
Manual Approval
Signatures:
Date:
Evaluation Audit Approval
Signatures:
Date:
Final Approval
Name of CFIA RPO (responsible for EABAFCP):
Signatures:
Date:
Name of CFIA Area Program Specialist (responsible for EABAFCP):
Signatures:
Date:
EABAFCP registration number:
Appendix 2: EABAFCP Movement Certificate Log
| Entry | Date | Number of the associated bill of lading or invoice | Source | Destination | Authorization (Initials) | Movement Certificate Number |
|---|---|---|---|---|---|---|
| 1 | ||||||
| 2 | ||||||
| 3 | ||||||
| 4 | ||||||
| 5 | ||||||
| 6 | ||||||
| 7 | ||||||
| 8 | ||||||
| 9 | ||||||
| 10 |
Appendix 3: 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. |
|
| 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. |
|
| 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 Borer spread is very high. |
The facility is cancelled from EABAFCP. |
|
Table Notes
- Table note *
-
All non-conformances could be assigned a higher or lower level depending on the associated risk of the specific situation.
Appendix 4: EABAFCP - Audit and Facility Status Flow Chart
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Description for EABAFCP - Audit and Facility Status Flow Chart
This flow chart consists of two processes. One entitled Application Process the other entitled Audit Process.
The fist box of the Application Process is called Facility applies: submits Manual. The chart points you to the Manual Review box. If you fail the Manual review you are re-directed to the Gaps Identified box, which returns to the start of the Application Process Facility Applies submits Manual box.
If you pass the Manual review component, you are then directed to the Facility Evaluation Audit box. If you fail the Facility Evaluation Audit you are however, re-directed to the Facility addresses audit failure box, which then returns you to the Facility Evaluation Audit component. Having passed the Facility Evaluation Audit you continue to the Facility Approved box.
Having passed the Facility Approved you are brought to the to the Audit Process of the flow-chart and directed to the Surveillance Audits, Systems Audits and the Cleanup Audits (non-regulated areas only) processes.
Depending on the outcome of the Surveillance Audits, Systems Audits and the Cleanup Audits (non-regulated areas only) processes, you are directed to either the Critical non-conformance box, which leads you to the Facility cancellation box, which in turn brings you to the start of the Application Process to Facility applies submits Manual box. Alternatively, if the outcome of the Surveillance Audits, Systems Audits and the Cleanup Audits (non-regulated areas only) processes was Major non-conformance, you are directed to the CAR implementation and approved within 10 days box, which leads to the Follow up Audit box. Which in turn leads you back to the Surveillance Audits, Systems Audits and the Cleanup Audits (non-regulated areas only) processes. However, if the outcome of the Surveillance Audits, Systems Audits and the Cleanup Audits (non-regulated areas only) processes was Minor non-conformance, you are brought to the CAR implemented and approved by next audit box, which also leads to the Follow up Audit box. Which in turn leads you back to the Surveillance Audits, Systems Audits and the Cleanup Audits (non-regulated areas only) processes.
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