Canada Organic Regime operating manual
Part A Assessment and designation of conformity verification bodies (CVB)
These requirements apply to the conformity verification body's (CVB) accreditation services provided for the purposes of the SFCR. Participation in the COR accreditation program is not intended to prevent CVBs from carrying out other business activities, especially those involving the accreditation of CBs not covered by the SFCR.
Operations resulting from these other activities should neither constitute an infringement nor result in conflicts of interest with the accreditation activities performed by the CFIA.
Further consideration shall be given to address COR requirements that shall be additional to those required by ISO/IEC 17011.
To outline the process under which the CFIA shall enter into an agreement with a CVB and maintain it.
A.2 Requirements for entering into an agreement
Only entities that meet the requirements set out in ISO/IEC 17011 may enter into agreement with the CFIA to assess, recommend for accreditation and monitor certification bodies.
A.3 Initial assessment and designation of the CVB also for reassessments
A.3.1 Application and documents screening
- A.3.1.1 Any applicant seeking information from the CFIA regarding the conditions under which CFIA shall enter into an agreement with a CVB may consult the CFIA website and access information from the CFIA organic products homepage.
- A.3.1.2 Upon request, the CFIA sends to the applicant an information package which contains a list of documents to be provided to initiate an assessment.
- A.3.1.3 The applicants may be either private or government entities.
- A.3.1.4 The applicant shall submit to the CFIA the documents listed in section A.8.
- A.3.1.5 The CFIA (COR team) reviews for adequacy the information supplied by the applicant and sends acknowledgement of receipt within 5 working days after reception of the application and proceeds with the assessment.
- A.3.1.6 The application and accompanying documents are reviewed by the COR Lead Auditor to completeness of the application within 15 working days.
- A.3.1.7 When information is missing, the COR Lead Auditor informs the applicant of the necessary additional documentation and indicates that no further processing of the application shall take place until all required information is submitted.
- A.3.1.8 The applicant is required to respond to the clarification questions and document requests within 30 working days or the file shall be closed.
- A.3.1.9 When the COR Lead Auditor determines that the information is complete, the process of document and record review starts.
A.3.2 Document and record review
- A.3.2.1 The COR Lead Auditor or other designated CFIA staff shall review all relevant documents and records supplied by the applicant to evaluate its system, as documented, for conformity with the ISO/IEC 17011 requirements as referenced in the SFCR and the additional requirements specified in the COR operating manual.
- A.3.2.2 Upon completion of the document review, the COR Lead Auditor prepares document review report which indicates any nonconformities (NCs) and opportunities for improvement (OFIs) with the requirements and requests for further information, if necessary.
- A.3.2.3 In some cases, when the number of NCs are very high the COR Lead Auditor may decide to cease the document review and shall notify the applicant accordingly.
- A.3.2.4 The document review report is sent to the applicant, with a request to take necessary actions to conform to the applicable requirements.
- A.3.2.5 The CVB has 60 working days to submit evidence of corrective actions for all NCs.
- A.3.2.6 On receipt of the corrective actions COR Lead Auditor reviews the submission and assesses the extent to which the required NCs have been addressed.
- A.3.2.7 Once the COR Lead Auditor assesses that all the amended documents confirm with ISO/IEC 17011 and COR operating manual an on-site assessment (audit) shall be arranged.
A.3.3 On-site assessment
- A.3.3.1 The on-site assessment is conducted by the COR audit team.
- A.3.3.2 The COR audit team prepares and sends to the applicant all the information and documentation needed for the on-site assessment including audit plan and assessment criteria in advance.
- A.3.3.3 During the on-site assessment, the COR audit team shall require access to the following information: organizational setup, personnel, management system documents, internal audit reports, management review reports, accreditation procedures, accreditation records, certification bodies' files, personnel files for the purpose of verifying training records and performance monitoring. The applicant shall ensure this information is available and easily retrievable whether in hard copy or electronic form. Any findings during the on-site audit shall be classified as a NC or an OFI.
- A.3.3.4 The on-site audit shall end with an exit interview where the NCs and OFI shall be presented and discussed.
- A.3.3.5 The applicant shall be given time period of 30 working days to provide corrective actions on the identified NCs from the date of the exit interview. OFIs are to be addressed at the applicant's timeframe.
- A.3.3.6 The COR audit team shall draft out an assessment report which shall include the findings from the on-site assessment.
- A.3.3.7 The draft assessment report shall be provided to the applicant within 30 working days after the on-site audit is completed. It includes the NCs, if any, and OFIs.
- A.3.3.8 The applicant reviews the report content, verifies the accuracy of the facts and submits any corrections to CFIA.
- A.3.3.9 The final assessment report shall be reviewed and approved by the CFIA National Manager responsible for COR and a copy shall be sent to the applicant.
- A.3.3.10 COR Lead Auditor shall verify the implementation of the corrective actions submitted by the applicant before providing recommendation to the CFIA for decision on entering into an agreement with the applicant.
- A.3.3.11 In case the CFIA decides not to enter into an agreement with the applicant, the CFIA shall notify the applicant of its right to request a decision review of the designation process by the CFIA management.
A.3.4 Witness audit
- A.3.4.1 The witness audit shall be conducted as a means of verifying that the applicant is satisfactorily implementing its procedures.
- A.3.4.2 During the witness audit, the COR audit team shall examine the applicant's auditor's preparation for the audit and the implementation of the CVB's auditing procedures.
- A.3.4.3 The COR audit team and the CVB auditor(s) shall have a closing meeting to discuss any findings identified during the audit in a manner that they are understood and acknowledged by the CVB.
- A.3.4.4 The COR audit team shall draft a witness audit report that shall be shared with the CVB within 30 working days after the witness audit is completed.
- A.3.4.5 The CVB shall review the report content, verify the accuracy of the facts and submit any corrections to CFIA.
- A.3.4.6 The final witness report shall be approved by the CFIA National Manager before being released.
- A.3.4.7 The witness report shall be issued separately both during the initial and reassessment year and the surveillance years.
A.3.5 Decision review process
- A.3.5.1 Any applicant organization can request a review of a designation decision. The request shall be made within 30 working days of notification of the decision in writing to CFIA Executive Director responsible for the Canada Organic Regime. The Executive Director shall review the request and notify the applicant of his decision.
- A.3.5.2 The decision of the Executive Director in this regard shall be final.
A.3.6 Agreement signature
- A.3.6.1 Based on the results from the final assessment report, the CFIA shall enter into an agreement with the applicant.
- A.3.6.2 The agreement between the CFIA and the CVB expires on the fifth year and shall require renewal every 5 years following the initial assessment.
A.4 Monitoring and surveillance of CVB
A.4.1 The CFIA shall monitor the ongoing compliance of the CVB with the regulations and the Agreement.
A.4.2 The CVB shall submit an annual update report in accordance with A.10.
A.4.3 Under the COR agreement cycle as outlined in section A.9, the CFIA shall conduct CVB on-site surveillance assessment in the first, third and fifth year. In the second and fourth year there shall be a document review based on the CVB annual report.
A.4.4 During the 5 year agreement cycle, the COR audit team shall conduct 1 witness audit per CVB every year following A.3.4. The COR team may choose to witness a CVB audit at the CB office, CVB witness audit or CVB verification audit.
A.4.5 The surveillance assessments are conducted following a review of the annual report. During the surveillance assessment the COR audit team shall review the compliance with the agreement and certain elements of the COR.
A.4.6 Following the surveillance assessment the COR audit team shall draft out a surveillance report which shall include the findings from the on-site assessment.
A.4.7 The draft surveillance report shall be provided to the applicant within 30 working days after the on-site audit is completed. It includes the NCs, if any, and OFIs.
A.4.8 The applicant reviews the report content, verifies the accuracy of the facts and submits any corrections to CFIA.
A.4.9 The final report shall be reviewed and approved by the CFIA National Manager responsible for COR and a copy shall be sent to the CVB.
A.4.10 The CVB shall review the report content, verify the accuracy of the facts and submit any corrections to CFIA.
A.4.11 The final surveillance report shall be reviewed and approved by the CFIA National Manager responsible for COR and a copy shall be sent to the CVB.
A.4.12 If any NCs are found during the surveillance the CVB shall be given up to 30 working days to respond.
A.4.13 At any time and upon its own discretion, the CFIA may carry out additional assessments for any NCs with the agreement, regulations and CFIA requirements. The CFIA shall advise the CVB of this possibility.
A.4.14 The CFIA may conduct unscheduled assessments or visits as a result of valid complaints or changes to the regulations.
A.5 Renewal of the agreement between CFIA and CVB
A.5.1 All the CVBs shall undergo full reassessment on the fifth year of the agreement signature. The procedure for the agreement renewal is the same as the one for initial CVB assessment outlined in A.3 and includes resubmission of all required documentation, on-site assessment and witness audit.
A.5.2 The CVBs shall submit all required documentation 8 months prior to the agreement expiration date to allow for the reassessment to be completed in timely manner.
A.6 Breach of the agreement, suspension and early termination
A.6.1 The CVB understands that its failure to meet any of the terms of the agreement is considered by the CFIA a breach of the Agreement and as a result, the CFIA could take actions including suspension measures and termination of the agreement.
A.6.2 If during monitoring of the compliance with the agreement, the CFIA notices NCs, it shall issue a report to the CVB outlining the NCs and the period in which a corrective action plan should be submitted to the CFIA for approval. Upon receipt of the report, the CVB signs it.
A.6.3 Following the report, the CFIA shall provide a notice to the CVB which specifies the period within which the CVB shall have to provide to the CFIA a corrective action plan with defined timeline for approval.
A.6.4 If the CVB fails to provide a corrective action plan within the specified period in the notice, the CFIA shall suspend the CVB.
A.6.5 If the CVB provides to the CFIA a corrective action plan within the specified period in the notice, the CFIA shall verify the adequacy of the proposed corrective action and approve it if it is satisfactory to the CFIA.
A.6.6 If the CFIA is not satisfied with the adequacy of the proposed corrective action, the CFIA shall send a notice for revision to the CVB to revise their corrective action plan with a specified period.
A.6.7 The CVB shall submit to the CFIA a revised corrective action plan for approval within the period specified in the notice for revision.
A.6.8 The CFIA shall review and approve the revised correction action plan if it is satisfactory. The process is on-going until corrective action plan is approved by the CFIA.
A.6.9 The CVB shall implement the corrective action plan as approved by the CFIA. The CVB could be subject to suspension if failing to do so.
A.6.10 The CFIA shall verify the implementation of the corrective action plan and submit a report to the CVB.
A.6.11 If the CVB fails to implement the corrective action plan within the prescribed time period to the CFIA's satisfaction, the CFIA shall submit a report to the CVB outlining the NCs.
A.6.12 The CFIA shall send a notice of suspension to the CVB, outlining the grounds for suspension, the required corrective measures and the period within which those measures shall be implemented to avoid termination of the agreement.
A.6.13 During the suspension period, the CVB is not authorized to accept new applications for accreditation and conduct initial assessment and reassessment for accreditation however; the CVB shall continue conducting its surveillance activities as planned.
A.6.14 Furthermore, the CVB shall provide to the CFIA an updated list of the CBs under their supervision and a list of pending applications for accreditation within 5 working days after receipt of the notice of suspension.
A.6.15 The CFIA may lift the suspension after it has conducted an assessment to verify that the CVB has implemented the corrective measures within the period specified in the notice of suspension.
A.6.16 The CFIA may, at its sole discretion, terminate the agreement in the event the CVB does not implement the corrective measures within the period specified in the notice of suspension.
A.6.17 Each party may decide to terminate the agreement for any other reasons. That party shall give to the other party a minimum of 60 days notice prior to the termination of the agreement.
A.6.18 In the event that the agreement is terminated, CFIA shall notify the affected CBs and give them some time to find another assessed CVB to continue their accreditation.
A.7 Complaints against CVBs
A.7.1 Every complaint concerning a CVB's accreditation activities shall be submitted to the COR Lead Auditor in writing and accompanied by justifying evidence or documents.
A.7.2 The COR Lead Auditor shall acknowledge the complaint within 5 working days in writing.
A.7.3 The COR Lead Auditor shall designate a person from CFIA to follow-up on the complaint or decide to follow-up on the complaint.
A.7.4 The designated person shall gather all required information and prepare a report which is submitted to the COR Lead Auditor at the conclusion of the process.
A.7.5 The complainant shall be informed that the CFIA took appropriate action to correct the situation. However, the nature of the action shall remain confidential. If no further issues arise, the CFIA shall close the file.
A.7.6 The CFIA maintains the record of each complaint, the corrective and preventive actions taken and the effectiveness of such action.
A.8 CVB documents required for initial assessment
A.8.1 CVB documents to be submitted along with the application for designation
- A.8.1.1 The corporate charter
- A.8.1.2 Any government act, regulation or decree that gives the CVB the legal authority to accredit prior to becoming a CVB under the COR.
- A.8.1.3 The corporate structure showing graphically and quantitatively relations of control by shareholders, companies or other groups of the organization.
- A.8.1.4 The general bylaws.
- A.8.1.5 A list of directors, comprising:
- A.18.104.22.168 Members of the board of directors (including specific function, duration of mandate, and affiliation).
- A.22.214.171.124 Board members of a sponsoring organization (if applicable).
- A.8.1.6 The addresses of all locations where the CVB does business and summary of activities from each location.
- A.8.1.7 A copy of the compliance mark (body's name such as it appears on accreditation certificates and any property rights related to it prior to becoming a CVB under the COR).
- A.8.1.8 A copy of the liability insurance for directors and employees.
A.8.2 Description of CVB decision making structures
- A.8.2.1 A description of individuals or Internal bodies making decisions covering:
- A.126.96.36.199 Assessment of applicants
- A.188.8.131.52 Accreditation of applicants
- A.184.108.40.206 Appeals
- A.220.127.116.11 Complaints
- A.8.2.2 A description of sharing of responsibilities between head office and affiliates (if applicable).
- A.8.2.3 An organization chart related to the general administration of the program including names of persons occupying managerial positions in both head office and affiliates (when it applies).
A.8.3 Information on CVB's operations
- A.8.3.1 A complete list of all CBs including the name and address of every one to which the CVB has granted accreditation for production of organic products prior to becoming a CVB under the COR.
- A.8.3.2 A copy of the board of Director's latest annual report to members or stockholders.
A.8.4 CVB standards, policies and technical procedures (quality manual)
- A.8.4.1 The quality manual related to the accreditation program.
- A.8.4.2 The templates for assessment questionnaires used by auditors.
- A.8.4.3 The templates for audit reports.
- A.8.4.4 Lists of documents included in the file on each CB having requested accreditation.
- A.8.4.5 Copy of IAF evaluation of the CVB or other third party assessment against ISO/IEC 17011 standard (if available).
A.8.5 CVB's human resources management
- A.8.5.1 A complete list of employees associated with the CVB to work on COR accreditation including the status and position held by each one.
- A.8.5.2 A copy of the standard contract with these employees.
- A.8.5.3 The selection criteria for persons making accreditation decisions or in charge of overseeing those who make them.
- A.8.5.4 The name of person or list of the members of the internal body committee, etc. assigned either to make accreditation decisions or to oversee those who make them (with their experience or specific training).
- A.8.5.5 The selection criteria for assessors and experts.
- A.8.5.6 A copy of the standard contract with contract assessors.
- A.8.5.7 A complete list of contract assessors (including their training and years of experience, their commercial or financial affiliation).
- A.8.5.8 A copy of the standard contract used with any subcontractors (if applicable).
A.8.6 Information, material and forms forwarded to accreditation applicants
- A.8.6.1 A detailed CVB fee schedule for the various services offered (to be available for review during the on-site assessment by CFIA).
- A.8.6.2 Copies of information documents about the COR accreditation program within the CVB that would be provided to potential clients.
- A.8.6.3 A copy of the application forms to be filled out by applicants.
- A.8.6.4 A list of documents that shall be supplied to the CVB by an applicant's CB.
A.8.7 Documents concerning rights and obligations of designated CVBs
- A.8.7.1 A copy of the contract (template) between the CVB and the CB, to be signed, when the CB is granted accreditation by CVB prior to becoming a CVB under the COR.
- A.8.7.2 An example of an accreditation certificate issued by the CVB prior to becoming a CVB under the COR.
A.9 Canada Organic Regime assessment cycle
The following table outlines the types of audits that the CFIA shall conduct of its designated CVBs in the first 5 years after the COR became effective. This same sequence of events shall be logically extended to cover those years subsequent to those shown below.
|Initial AssessmentTable Note 1||On-site surveillanceTable Note 1||Document review||On-site surveillanceTable Note 1||Document review||Re-assessmentTable Note 1|
|One witness audit||One witness audit||One witness audit||One witness audit||One witness audit||One witness audit|
- Table note 1
Scheduled on-site surveillance visit may be replaced by a visit as part of a peer review. The CFIA may conduct unscheduled assessments or visits as a result of valid complaints or changes to the regulations
A.10 Annual information from the designated CVBs
This section lists those documents or information that the designated CVBs shall submit annually to the CFIA as a part of the on-going monitoring of the designated CVBs.
The information shall be submitted before the end of the first quarter of the calendar year and shall cover the previous 12 months.
- A.10.1 A list of all CBs under their supervision including those transferred from other CVBs with information concerning their corporate entity, name, business addresses; and a description of the certification services that the CBs undertake.
- A.10.2 The number of CBs who have applied for assessment
- A.10.3 Total number of surveillance audits
- A.10.4 Total number of witness audits
- A.10.5 Total number of verification audits
- A.10.6 Total number of reassessment audits
- A.10.7 Total number of complaints under COR
- A.10.8 Total number of appeals under COR
- A.10.9 Copy of the internal audit report
- A.10.10 Copy of the Management's review
- A.10.11 Information on the personnel change
- A.10.12 Information on policy change
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