Seed Program Quality System Procedure (QSP 142.3) – CFIA Oversight of Authorized Seed Crop Inspection
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- 0.0 Introduction
- 1.0 Scope
- 2.0 References
- 3.0 Definitions
- 4.0 Roles and responsibilities
- 5.0 Oversight of licensed seed crop inspectors
- 6.0 Oversight of authorized seed crop inspection services
This version 4.2 of Quality Systems Procedure (QSP) 142.3 CFIA Oversight of Authorized Seed Crop Inspection was issued April 19, 2021.
The contact person for this document is the National Manager, Seed Section. Comments regarding the content of this document should be addressed to the National Manager at email@example.com.
This Seed Program Quality System Procedure (QSP) is subject to periodic review. Amendments will be issued from time to time to ensure the procedure continues to meet current needs.
This seed program Quality Systems Procedure is hereby approved by:
Director, Plant Production Division
The most up to date version of this document will be maintained on the CFIA website. The signed original will be maintained by the National Manager, Seed Section. A copy of the latest version is available upon request to firstname.lastname@example.org.
The Canadian Food Inspection Agency (CFIA) is obligated to provide comprehensive and effective oversight when pedigreed seed crop inspection is delivered by private individuals. In Canada, Licensed Seed Crop Inspectors (LSCI) operating under the supervision of Authorized Seed Crop Inspection Services (ASCIS) are authorized to conduct seed crop inspections and submit Reports of Seed Crop Inspection to the Canadian Seed Growers' Association (CSGA) to support CSGA certification of the seed crop.
Candidate LSCI and ASCIS are required to apply for a licence to inspect pedigreed seed crops and companies wishing to operate as ASCIS must apply for a licence to supervise LSCI. After licensing, the LSCI and ASCIS are subject to a range of oversight activities including, but not limited to, training, check inspecting, and auditing. The observed performance levels of the LSCI and the ASCIS determine the frequency and type of subsequent CFIA oversight activities. The performance ratings of the LSCI and the ASCIS are linked and each can influence the rating of the other. If the performance of either the LSCI or the ASCIS is consistently poor, then the licence(s) of either or both may be revoked.
The CFIA observes ASCIS and LSCI activities and reports on conformance with the program requirements and compliance with legal and regulatory requirements. Effective oversight, along with regular program review, will identify opportunities for program improvement.
This QSP provides the general framework for the CFIA to oversee the delivery of pedigreed seed crop inspections by LSCI and to evaluate, audit and report on the implementation of the quality management systems (QMS) of ASCIS supervising LSCI.
Procedures, instructions and checklists are found in Specific Work Instructions (SWI) 142.3.1 CFIA Oversight of Authorized Seed Crop Inspection Licensing procedures for ASCIS and LSCI are found in QSP 142.2 Licensing of Authorized Seed Crop Inspection Services and Licensed Seed Crop Inspectors. Procedures for seed crop inspection as conducted by CFIA inspectors and LSCI can be found in SWI 142.1.1 Pedigreed Seed Crop Inspection and QSP 142.1 Pedigreed Seed Crop Inspection, which in turn is based on the Seed Program Regulatory Authority (SPRA 141) Inspection Agency Requirements for the Delivery of Pedigreed Seed Crop Inspection.
Definitions for the seed program are contained in Seed Program Regulatory Authority (SPRA) 101 – Definitions, Acronyms, and References for the Seed Program.
4.0 Roles and responsibilities
4.1 Seed Section responsibilities
The CFIA is the authority responsible for the implementation and oversight of the seed certification system in Canada. The CFIA Seed Section is responsible for communications with the CSGA, the Organisation for Economic Co-operation and Development (OECD), the Association of Official Seed Certifying Agencies (AOSCA) and other national and international bodies that establish standards or regulations for the certification and trade of seed.
The Seed Section is ultimately responsible for evaluating the effectiveness of the program in achieving the objective of the production of high quality pedigreed seed in Canada. The Seed Section is responsible for the evaluation of the uniformity and the accuracy of reports and the analysis of data generated by its oversight activities.
The Seed Section has the overall responsibility for:
- receiving, processing, and tracking LSCI and ASCIS applications for licensing
- creating ASCIS folder in ASCIS Master folder (RDIMS #4097055) when applications are received
- licensing LSCI and ASCIS on behalf of the President of the CFIA
- providing up-to-date information to LSCI, ASCIS, the CSGA, and the CFIA Operations and Science Branches as appropriate
- renewing ASCIS and LSCI licences
- developing and implementing policies and procedures for the oversight of LSCI and ASCIS as appropriate
- responding to requests and comments from LSCI, ASCIS, the CSGA, the CFIA Science and Operations Branches, and other stakeholders in a timely manner
- managing issues and problems that arise
- maintaining the documentation required for the on-going implementation of authorized seed crop inspection
- reporting on the performance of the Authorized Seed Crop Inspection Program
Comments and suggestions related to authorized seed crop inspection received by the Seed Section from seed growers, LSCI, ASCIS, the CSGA or the CFIA Operations and Science Branches will be considered in the subsequent review of this and related QSPs and Specific Work Instructions (SWIs).
4.2 CFIA operations branch personnel responsibilities
Operations Branch managers are responsible for allocating sufficient resources for the appropriate oversight of authorized seed crop inspection in their regions and will include these oversight activities in their annual work planning. Managers will designate personnel in each region to be responsible for the overall implementation and oversight of authorized seed crop inspection in their region through:
- assigning auditors for the ASCIS in their region
- coordinating CFIA check inspections
- coordinating the training of CFIA seed crop inspectors to conduct check inspections
- coordinating the seed crop inspections that remain the responsibility of the CFIA
- coordinating the training of LSCI to conduct crop inspections
- assigning CFIA crop inspectors to provide additional training and guidance to LSCI and ASCIS Lead Inspectors when requested by the LSCI or ASCIS Lead Inspector, as resources allow
- assigning CFIA Lead and Alternate inspectors to communicate with the ASCIS Auditor(s) and the Lead/Alternate LSCI
- providing the Seed Section with information on LSCI training sessions
- conducting the initial review of the ASCIS QMS manual submitted by the candidate ASCIS, and providing feedback to the ASCIS during the review process of their QMS manual
- if the ASCIS QMS manual meets the requirements, recommending licensing of the ASCIS to the Seed Section
- receiving comments from LSCI, ASCIS, and the CFIA Operations staff and communicating these to the Seed Section
- co-ordinating and conducting any investigation and enforcement actions related to the LSCI and ASCIS in their region
- initiating CFIA invoicing of the ASCIS for check inspections
The CFIA operations branch auditorFootnote 1 assigned to an ASCIS is responsible for:
- conducting and/or co-ordinating audits of the ASCIS to evaluate their implementation of their QMS
- assigning Corrective Action Requests (CARs) to the ASCIS; including providing directions what the corrective action plan should be and conducting the related follow-up activities
- addressing LSCI and ASCIS CAR appeals
- issuing, changing or deleting a CAR if there is evidence to justify the change
- addressing Minor and Major non-conformances noted against LSCI by the check inspector
- identifying specific fields, crop kinds, or other targets for check inspection where necessary
- receiving and maintaining reports of the results of check inspections of LSCI under the supervision of the ASCIS
- providing to the Seed Section summary information on the check inspections of the LSCI under the supervision of the ASCIS, including a recommendation for the subsequent year's check inspection frequency for each LSCI
- providing information on the audit of the ASCIS to the Seed Section, including a recommendation for the subsequent year's audit frequency and scope, and a recommendation for renewal or revocation of the ASCIS licence
- providing a summary audit report to the ASCIS, the Seed Section, and other CFIA staff as required
- providing the Seed section with the name of ASCIS auditor when there is a change
- creating, maintaining and updating ASCIS sub-folders in ASCIS Master folder (RDIMS #4097055) with Audit information
- updating the ASD-Auditors Calculation of Check inspection frequency (RDIMS #12518191) in the ASCIS Master folder (RDIMS #40907055) annually after each audit
- providing the ASCIS and its Lead Inspector the contact information for CFIA Lead/Alternate Lead Contacts and audit team members responsible for responding to requests for information
- maintaining communications with the ASCIS for which they are responsible
The CFIA official seed crop check inspectorFootnote 1 is responsible for:
- prior to the check inspection, verifying that the LSCI is only inspecting crop kinds within the scope of their licence
- conducting check inspections of fields inspected by LSCI
- conducting additional check inspections, not invoiced to the ASCIS, as necessary to assess the competence of the LSCI
- comparing the results of the check inspection with the Report of Seed Crop Inspection submitted by the LSCI, and identifying non-conformances
- issuing CARs to the LSCI to address Critical non-conformances
- reporting the results of the check inspection comparison to the CFIA auditor
- notifying the CSGA if the check inspection identifies a significant issue that may cause CSGA to decline or demote the seed crop or that may require remedial action on the part of the grower in order to obtain a crop certificate
4.3 CSGA responsibilities
The CSGA is responsible for:
- determining the eligibility of the LSCI to submit Reports of Seed Crop Inspection to the CSGA
- maintaining a list of eligible LSCI and ASCIS
- communicating with the CFIA auditor, the ASCIS, and the Seed Section when significant or ongoing errors or inconsistencies are observed in the Reports submitted by the LSCI
5.0 Oversight of licensed seed crop inspectors
The CFIA's oversight of the LSCI is intended to verify whether the LSCI complies with the conditions of the licence issued to them. The oversight also verifies the conformance of the LSCI activities with the procedures described in the QMS of the ASCIS they report to as well as the procedures in the CSGA's Regulations and Procedures for Pedigreed Seed Crop Production (Circular 6) and the relevant CFIA QSPs and SWIs.
5.1 Check inspections
Check inspections by CFIA seed crop inspectors of fields inspected by the LSCI are conducted according to standard inspection procedures within three days either before or after the LSCI inspection. In some cases, the check inspector may perform the check inspection outside of this three day window if it can be determined that the crop has not been altered since the inspection by the LSCI or if the crop was not inspected at the appropriate growth stage. If the LSCI inspects a number of crop kinds, the check inspections are distributed to include as many of those crop kinds as possible.
The frequency of check inspections for each LSCI is determined by the previous performance of the LSCI. In their first year of seed crop inspection, LSCI are subject to the normal check inspection frequency. The frequency is increased or decreased depending on the number and type of non-conformances assigned to the LSCI in the previous season. In order for an LSCI to change to a lower check inspection rate, the LSCI must have completed at least 25 field inspections and have had at least three check inspections in a single crop inspection season.
The check inspector compares their check inspection report with the Report of Seed Crop Inspection prepared by the LSCI as soon as possible and assigns non-conformances to the LSCI as appropriate. Check inspectors should complete the assessment of Report of Seed Crop Inspection prepared by the LSCI after it is approved by the ASCIS lead/alternate lead inspector. Information on the numbers and types of non-conformances is provided to the auditor of the ASCIS to which the LSCI reports. The performance of the LSCI is considered in the audit of the ASCIS.
The results of check inspections should be discussed with the LSCI as soon as possible after the check inspection to improve the performance of the LSCI in the current crop season. If Critical non-conformances are identified, the LSCI, the ASCIS and the auditor are notified immediately through the issuance of a CAR. Major and Minor non-conformances are communicated to the ASCIS through the issuance of a CAR by the auditor at the end of the crop season.
5.2 CSGA reporting to the CFIA
The CSGA maintains its own records of the quality of the Reports of Seed Crop Inspection submitted by each LSCI. The CSGA will provide information to the CFIA on request.
6.0 Oversight of authorized seed crop inspection services
The CFIA's oversight of the ASCIS is intended to verify whether the ASCIS complies with the conditions of the licence issued to them. The oversight also verifies the conformance of ASCIS activities with the procedures described in their QMS as well as the procedures in CSGA Circular 6 and the relevant CFIA QSPs and SWIs.
In the first year of licensing, the ASCIS implementation of its QMS is audited by the CFIA prior to renewal of their licence. The audit includes, but is not limited to, a review of the QMS manual, an evaluation of the implementation of the QMS, a review of CFIA-issued CARs and a review of the summary of the performance of the LSCI under the supervision of the ASCIS.
The auditor may also choose to accompany one or more LSCI as they inspect seed crops to gather additional information. If the auditor does not have technical competence in seed inspection, then the auditor should be accompanied by an experienced CFIA seed crop inspector.
The auditor will schedule the audit to occur after the completion of seed crop inspections and will provide sufficient advance notice of the audit date to the ASCIS.
The frequency and scope of audits are based on the recommendation of the auditor. The scope of the annual audit may be limited to specific components of the QMS (partial audit) however each component of the QMS must be audited at least once every two years. In all cases, the ASCIS is subject to a full audit in the first year after licensing.
Audits will be completed and reports provided to Seed Section by December 15 of each year.
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