CFIA oversight of authorized seed crop inspection (SWI 142.3.1)

This document describes the Canadian Food Inspection Agency's (CFIA) oversight of the inspection of pedigreed seed crops by Licensed Seed Crop Inspectors (LSCI) operating under the supervision of Authorized Seed Crop Inspection Services (ASCIS).

ASCIS and LSCI are private entities and individuals licensed by the CFIA to provide pedigreed seed crop inspection services. LSCI conduct the inspections and complete Seed Crop Inspection Reports which are verified by the ASCIS before being submitted to the Canadian Seed Growers' Association (CSGA) through the CSGA's SeedCert software package. The CSGA issues a crop certificate for the inspected seed crop based on the submitted Seed Crop Inspection Report.

The CFIA, as the authority for seed certification in Canada, is responsible for overseeing the ASCIS implementation of its quality management system (QMS) and the LSCI delivery of pedigreed seed crop inspection.

Updated: April 2, 2024

On this page

• 1.0 Scope
• 2.0 Definitions, references and acronyms
• 3.0 General requirements
• 4.0 Licensing of Licensed Seed Crop Inspectors
  • 4.1 LSCI training
  • 4.2 Evaluations of candidate LSCI
  • 4.3 Licensing the LSCI
  • 4.4 Post-licensing training and support
• 5.0 Licensing of Authorized Seed Crop Inspection Services
  • 5.1 Application
  • 5.2 Recommendation for licensing the ASCIS
  • 5.3 Licensing the ASCIS
• 6.0 Ongoing CFIA oversight of LSCI
  • 6.1 Check inspections
  • 6.2 Check inspection frequency
  • 6.3 Comparison of Check Inspector and LSCI Seed Crop Inspection Reports
  • 6.4 LSCI non-conformances
• 7.0 Ongoing ASCIS oversight by the CFIA via annual audits
  • 7.1 ASCIS audit scope
  • 7.2 Creating a check inspection summary
  • 7.3 Assessing previously-issued ASCIS and LSCI CARs
  • 7.4 ASCIS non-conformances
  • 7.5 Determining ASCIS audit scope for the next year
  • 7.6 Closing the audit
• 8.0 Corrective Action Requests (CARs)
  • 8.1 CAR timelines
  • 8.2 CARs issued to LSCI
  • 8.3 CARs issued to ASCIS
  • 8.4 Closing CARs
• 9.0 ASCIS or LSCI regulatory non-compliances
• 10.0 Annual renewal of an LSCI or ASCIS licence
• 11.0 Revocation of an LSCI or ASCIS licence
  • 11.1 Procedures for the revocation of an LSCI or ASCIS licence
• 12.0 Re-Instatement of an LSCI or ASCIS licence
• 13.0 Fees
• Appendix 0 Work flow and forms
• Appendix I Pre-licensing QMS manual review checklist
• Appendix II Summary of QMS manual review
• Appendix III ASCIS audit checklist
• Appendix IV [Redacted] Examples of the classification of non-conformances and non-compliances identified in an ASCIS audit
• Appendix V Corrective Action Request (CAR) form for LSCI
• Appendix VI Corrective Action Request (CAR) form for ASCIS
• Appendix VII Summary report of ASCIS audit
• Appendix VIII [Redacted] Record of invigilation of a written evaluation
• Appendix IX Checklist for the comparison of Check Inspector and LSCI Seed Crop Inspection Reports

1.0 Scope

This specific work instruction (SWI) details the procedures for CFIA oversight of LSCI and ASCIS activities.

2.0 Definitions, acronyms and references

For the purposes of this SWI, the definitions given in Seed Program Regulatory Authority (SPRA) 101 Definitions, Acronyms, and References for the Seed Program apply.

3.0 General requirements

General requirements for ASCIS and LSCI oversight are described in Quality System Procedure (QSP 142.3) – CFIA Oversight of Authorized Seed Crop Inspection.

4.0 Licensing of Licensed Seed Crop Inspectors

Information regarding the LSCI licensing process is found in Quality System Procedure (QSP) 142.2 Licensing of Authorized Seed Crop Inspection Services and Licensed Seed Crop Inspectors.

4.1 LSCI training

LSCIs and ASCISs should refer to QSP 142.2 Section 5.1 LSCI training and evaluation for information regarding the training process.

CFIA trainers should refer to Instructions for trainers of candidate Licensed Seed Crop Inspectors (RDIMS 3810122 accessible only on the Government of Canada network).

4.2 Evaluations of candidate LSCI

LSCIs and ASCISs should refer to QSP 142.2 Section 5.1 LSCI training and evaluation for information on the evaluation process.

CFIA trainers should refer to Instructions for trainers of candidate Licensed Seed Crop Inspectors (RDIMS 3810122 accessible only on the Government of Canada network).

4.2.1 Written evaluation

Each licensing group has a written theory evaluation, offered in person or using an online testing platform. Candidates are required to bring their own current copies of reference materials, which may be in either electronic or paper format. Candidates will be informed of their marks via email. If the candidate is not successful, it is their responsibility to contact their trainer to request a re-evaluation.

4.2.2 Practical evaluation

As indicated in QSP 142.2 Section 5.1, the licensing process of third party LSCIs for groups 1 and 4 includes a practical (in field) evaluation. For non-third party LSCIs, there are practical evaluations for groups 2 and 4. The evaluator will arrange a date and location with the candidate. The candidate will have access to all documents normally available to seed crop inspectors during the performance of their duties.

The evaluator will inform the candidate of their mark. If the candidate is not successful, it is their responsibility to contact their trainer to request a re-evaluation.

4.3 Licensing the LSCI

Once the candidate has passed both the written and practical evaluations, the Seed Section issues a licence to the LSCI and notifies the LSCI and the CSGA.

4.4 Post-licensing training and support

The availability of post-licensing training and support will vary by region and, when necessary, will be focused on ASCIS Lead Inspectors who can then distribute the information to the LSCI under their supervision. If there are updates to the training materials for LSCI, the Seed Section will distribute the updated materials to the Lead Inspector of each ASCIS.

This additional training may be attended by LSCI who are not Lead Inspectors, if space is available and if the trainer consents.

5.0 Licensing of Authorized Seed Crop Inspection Services

5.1 Application

The application process is described in QSP 142.2 Section 6.1 Application for licensing an ASCIS. The application package must include a copy of the QMS manual of the ASCIS as well as any related procedures documents or forms referred to in the QMS manual.

5.1.1 Application review

The application must be complete, signed and dated. If the application is incomplete, the Seed Section will contact the applicant to obtain the missing information.

5.1.2 ASCIS Quality Management Systems (QMS) manual review

The CFIA's ongoing oversight of the ASCIS assesses the ASCIS's ability to correctly implement its QMS. Therefore, it is essential that the initial review and assessment of the QMS be thorough and comprehensive.

Note: the reviewer must be an ASCIS auditor.

The QMS manual must describe the procedures followed by the ASCIS that result in the submission of unbiased, accurate, and comprehensive Seed Crop Inspection Reports. Appendix I is a checklist for review of a QMS manual, which must be completed by the reviewer before the ASCIS can be licensed. This checklist is not static and updates will occur from time to time as required.

If the QMS manual does not satisfactorily meet all the criteria in the checklist, the reviewer contacts the applicant and requests revisions. As deficient sections are amended, the reviewer should update the checklist. The QMS manual is considered complete only when it meets all of the criteria described in the checklist. The final version of the QMS should indicate the date that it was accepted by the CFIA.

All documentation that is received or created by the reviewer during the manual review process, including forms and checklists, should be added to the CFIA electronic folder for that ASCIS.

In some situations, the QMS manual may encompass procedures un-related to seed crop inspection. In this case, the ASCIS need not provide the full manual, but must provide sufficient sections of the QMS manual to demonstrate that the ASCIS is able to meet the objective of delivering seed crop inspection services to the standards expected by the CFIA and the CSGA.

5.2 Recommendation for licensing the ASCIS

When the reviewer is satisfied that the QMS manual meets the requirements of the program, the reviewer completes and signs the Summary of QMS Manual Review (Appendix II) and sends the form to the Seed Section.

5.3 Licensing the ASCIS

The Seed Section will review the Summary of QMS Manual Review and issue the licence to the ASCIS. The name of the ASCIS will be added to the list of licensed ASCIS and the CFIA auditor and the CSGA will be notified.

The ASCIS must apply separately to the CSGA for eligibility to submit Seed Crop Inspection Reports.

6.0 Ongoing CFIA oversight of LSCI

The oversight process for LSCI is outlined in QSP 142.3 section 5.0 Oversight of licensed seed crop inspectors.

6.1 Check inspections

Check inspections are conducted by CFIA seed crop inspectors. The check inspection process is described in QSP 142.3 section 5.1. Check inspectors should refer to OG-OO 54400 Check inspection of fields inspected by LSCIs (RDIMS 17760575 accessible only on the Government of Canada network) for procedures on conducting check inspections.

When an LSCI inspects a crop kind for the first time (or a new crop kind in a plot), they must notify the CSGA by completing the notification form in SeedCert. Durum wheat and wheat are considered different crop kinds and require separate notifications

6.2 Check inspection frequency

Check inspections are conducted at a frequency that is established by the auditor during the annual ASCIS audit. LSCI in their first year of licensing are subject to a Normal frequency.

All LSCI are check inspected at a rate of 20% for their Group 6 (Plot) seed crop inspections.

As percentages are used to calculate the number of fields for check inspection, the resulting number is rounded up to the nearest whole number.

These check inspections are subject to CFIA fees charged to the ASCIS.

6.2.1 Additional check inspections

The CFIA may wish to complete additional check inspections in the following circumstances:

• there are specific concerns regarding an LSCI (for example, newly licensed or poor performance history)
• there are specific concerns regarding an ASCIS, for which additional check inspections of the LSCI reporting through the ASCIS is a reasonable course of action
• the Seed Section requests check inspections be conducted on specific crop kinds or in specific geographic areas for additional oversight
• the minimum number of fields (5) required to maintain check inspector status cannot be met based on the required check inspection rates and field numbers

These additional check inspections are not subject to CFIA fees and should not be invoiced to the ASCIS.

6.2.2 Changes to the check inspection frequency

The check inspection frequency may remain the same from year to year, or may be increased 1 level (for example, from normal to tightened) or decreased 1 level (for example, from normal to reduced), depending on the numbers and types of non-conformances assigned to that LSCI. Table 2 describes the criteria for changing the check inspection frequency level.

Where multiple Minor or Major non-conformances of the same type are noted in the same season, they are considered as only 1 non-conformance. If multiple levels of non-conformance are issued to an LSCI for the same criteria, the auditor will apply the highest level. For example, if an LSCI has 2 Minor and 1 Major non-conformance for criteria 8.2, they will receive 1 Major non-conformance.

Based on check inspection data, the auditor will calculate each LSCI's frequency and follow the instructions to update the ASD-Auditors Calculation of Check Inspection Frequency (RDIMS 12518191 accessible only on the Government of Canada network) in the ASCIS Master folder (RDIMS 40907055 accessible only on the Government of Canada network).

If a LSCI is working for more than 1 ASCIS, the number of Minor and Major non-conformances is calculated independently for each ASCIS for which the LSCI conducts inspections in the current crop season. The auditor will calculate the LSCI's frequency per ASCIS and update the ASD-Auditors Calculation of Check Inspection Frequency (RDIMS 12518191 accessible only on the Government of Canada network). The LSCI's frequency for the following year can only be calculated by Seed Section once all the check inspection frequencies for each ASCIS are received as the highest check inspection frequency will be assigned to the LSCI for the following year. Therefore, an auditor may not be aware of a check inspection frequency from another ASCIS at the time of the audit and should communicate to the LSCI and ASCIS that this will be determined at a later date.

The "LSCI and CI names" tab is updated in the master tracking sheet template (RDIMS 3695396 accessible only on the Government of Canada network) by Seed Section / PASO each year. The names and inspector numbers of newly licensed LSCIs are not added to this spreadsheet until the following year. Regional contacts must add these names to their local spreadsheets manually in the year of licensing.

Check inspection frequencies are not changed during the season. However, unresolved Critical non-conformances can lead to the initiation of the licence revocation process during the seed crop inspection 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 3 check inspections in a single crop inspection season. If the LSCI works for more than 1 ASCIS, their number of inspections completed in total for all ASCISs is used to determine this eligibility.

The ASCIS is ultimately responsible for the actions of the LSCI under its supervision and is required to provide re-training or other support to the LSCI to improve their delivery of seed crop inspections as necessary.

6.3 Comparison of Check Inspector and LSCI Seed Crop Inspection Reports

CFIA check inspectors should refer to operational guideline OG-OO 54400 for procedures to conduct comparisons.

6.4 LSCI non-conformances

Descriptions of Minor, Major, and Critical non-conformances of an LSCI are found in Table 3.

If the LSCI has numerous non-conformances assigned to them, the check inspector may recommend to the CFIA auditor that the LSCI receive re-training within the current seed crop season and additional support or oversight by the ASCIS.

Minor and Major non-conformances are communicated to the ASCIS. Critical non-conformances are communicated to both the LSCI and the ASCIS.

Critical non-conformances are issued regardless of the final pedigree status granted to the inspected crop. CFIA compares to the published CSGA standard including variants, but CSGA may use additional information to assess the report.

7.0 Ongoing ASCIS oversight by the CFIA via annual audits

CFIA auditors conduct annual ASCIS audits by interviewing staff, reviewing records and observing procedures. These audits can be either full or partial and must be completed by December 15.

In a full audit, the auditor reviews all components of the QMS using the audit checklist in Appendix III.

In a partial audit, the auditor must review at minimum:

• all criteria listed as 'required for partial audit' on the audit checklist
• half of the remaining optional criteria on the audit checklist (ensuring that all optional criteria are reviewed at least once every 2 years)
• the summary of non-conformances identified in check inspections of each LSCI reporting to the ASCIS during the current seed crop inspection season
• components of the ASCIS QMS where Major and Critical non-conformances were noted in the previous audit and addressed in CARs
• any outstanding CARs from the previous audit
• components of the QMS manual which have changed since the last audit or initial QMS manual review to ensure that they remain in conformance with CFIA guidelines
• training plans and records
• the ASCIS list of their LSCI and their licence scopes

In either case, the audit is conducted according to standard audit protocols using the checklist provided in Appendix III. If non-conformances are identified, CARs are issued. More information on CARs can be found in Section 8.0.

7.1 ASCIS audit scope

At the end of its first year of licensing, the ASCIS must be subject to a full audit by the CFIA auditor. In the years following the first audit, an auditor may conduct either a full or a partial audit, depending on the performance history of the ASCIS in the previous audit as noted in Table 4. The auditor must review the summary report from the previous audit to determine if the upcoming audit will be full or partial.

7.2 Creating a check inspection summary

In preparation for the audit, the auditor must review the summary of the check inspections for each LSCI reporting to the ASCIS. Each year, the auditor must combine the check inspection data for the LSCI reporting to that ASCIS from each check inspector's tracking sheets (found in the electronic ASCIS folder) into 1 master tracking sheet that contains check inspection results for all LSCI reporting to that ASCIS. This master sheet should be saved in the ASCIS folder following the naming convention (RDIMS 8386390 accessible only on the Government of Canada network). From this master sheet, the auditor can generate a summary of check inspection results for each LSCI for the year using the 'Summary Data' tab, where each row summarizes the check inspection results for a single LSCI over the entire seed crop inspection season. When the summary is complete the auditor must provide a summary of the non-conformances to the ASCIS.

The auditor should provide the summary to the ASCIS at the end of the season and not later than at the time of the annual audit. The auditor should review the summary of non-conformances and ensure that the descriptions are clear and consistent.

The auditor should also review the 'Additional comments' column in the 'Check Inspection Data' tab of the checklist as this data is not rolled up in the check inspection summary. Check inspectors may indicate non-conformances to be assigned to the ASCIS in this column and these should be addressed during the audit.

7.3 Assessing previously-issued ASCIS and LSCI CARs

The auditor must review the non-conformances that were issued to the ASCIS in the previous audit to determine whether they were closed by their resolution dates. Non-conformances that were previously issued to the ASCIS should be filed in the CFIA electronic folder for the ASCIS.

Non-conformances issued to ASCIS during the previous year's audit that were not closed by their resolution dates may be addressed as escalating non-conformances, depending on their severity. Major non-conformances are to be escalated to Critical non-conformances if they have not been resolved by their resolution date. Unresolved Minor non-conformances are escalated to Major non-conformances. Unresolved Critical non-conformances may not be escalated further, but may lead to revocation of the ASCIS licence as per Section 11.0.

Non-conformances that are escalated are issued on new CARs, and should indicate in the comments section that the non-conformance has been escalated as the non-conformance was not closed by the resolution date. The file numbers of the original and new CARs should be cross-referenced on the forms.

The auditor must also review the critical CARs that were issued to LSCIs in the current season. The check inspector who issued the CAR to the LSCI is responsible for follow up as per Section 8.4, and should keep the auditor informed. In some cases, the resolution date will not have passed at the time of the audit and the CAR can remain open. If the resolution date has passed and the CAR has not been resolved, this may lead to revocation of the LSCI license as per Section 11.0.

7.4 ASCIS non-conformances

For an ASCIS, a non-conformance is a failure to follow the procedures of its QMS Manual or meet the standards in QSP 142.2 and the conditions in their ASCIS licence. Descriptions of Minor, Major, and Critical non-conformances of an ASCIS are found in Table 5.

CARs for Critical non-conformances must be issued immediately according to Section 8.0 and resolved as soon as possible. CARs for Major and Minor non-conformances must be issued during the current audit and resolved, at the latest, before the end of the next seed crop inspection season. It is the responsibility of the CFIA auditor to inform the check inspectors of the numbers and types of non-conformances identified in the audit that may affect the activities of the LSCI in the upcoming season.

7.4.1 Assigning LSCI non-conformances to the ASCIS

The ASCIS is responsible for resolving systemic problems that affect all LSCI under their supervision. Where the same non-conformances are noted in multiple LSCI at 1 ASCIS and the root cause can be ascribed to the actions of the ASCIS, a non-conformance is assigned to the ASCIS based on the conditions outlined in Table 6.

There are some types of non-conformances for which this table does not apply.

7.4.2 Roll-up of multiple non-conformances assigned to the ASCIS

Multiple non-conformances may indicate a trend in deficiencies that might have little significance when isolated cases are found but may be indicative of a systemic failure if they occur in significant numbers. If 3 Critical non-conformances are assigned to an ASCIS in a single audit, the auditor should inform Seed Section that they are initiating the process to revoke the ASCIS licence. For the purposes of an audit of an ASCIS, there is no roll-up of Major or Minor non-conformances to assign a Critical non-conformance.

7.5 Determining ASCIS audit scope for the next year

The scope of the next audit to be conducted is dependent on the number and type of non-conformances noted against the ASCIS. If 2 or more Critical non-conformances have been identified during the audit, the scope of the next audit will be full, otherwise it will be partial, as indicated in Table 4. The determination of audit scope should be made after the non-conformances from the previous audit and non-conformances assigned to the LSCI reporting to the ASCIS have been 'rolled up' according to Section 7.4.2 as much as possible.

7.6 Closing the audit

The audit is to be completed and the audit report received by Seed Section by December 15 of each year. If there are extenuating circumstances such that this deadline will not be met, the auditor should inform Seed Section as far in advance as possible.

The final audit report package which is provided to the ASCIS should include:

• the summary report (Appendix VII)
• summary of LSCI non-conformances
• notification of LSCI check inspection frequency for next season
• CARs issued to ASCIS if non-conformances identified (Appendix VI)

If one or more of these documents has been provided during the course of the audit it is not necessary to provide it again.

All relevant documents are saved in the RDIMS folder for the ASCIS.

8.0 Corrective Action Requests (CARs)

A Correction Action Request (CAR) form documents non-conformances and communicates them to the LSCI or ASCIS. The corrective action plan (CAP) developed by the ASCIS or LSCI, and accepted by CFIA, is intended to:

• correct the immediate problem (for example, make amendments to Seed Crop Inspection Reports that had missing or incorrect data)
• identify and correct the root cause of the problem so that the problem does not occur again in the future (for example, forms were inadequate to record the data correctly)
• amend the procedures and/or the QMS manual to put in place the required changes to the procedures (for example, revise the forms)
• provide training or re-training as necessary to personnel responsible for the activity (for example, train on using the new forms)
• put in place check methods to determine if the amended procedure meets the objective of preventing the occurrence of the non-conformance (for example, review 10% of the new forms to verify that they are completed correctly)

The CAP resolution date should be reasonable, should occur as soon as possible and preferably before the end of the next seed crop inspection season.

If the resolution date for a non-conformance has not passed and if additional non-conformances of the same type are identified, the auditor or check inspector will not issue an additional CAR.

Each Critical non-conformance must be reported on a single, unique CAR so that follow-up actions can be more easily tracked.

Auditors may report multiple Major and Minor non-conformances on a single CAR where each type of Major or Minor non-conformance is listed and described only once, but the number of occurrences of that non-conformance is noted on the CAR.

Appendix V contains the template for CARs assigned to the LSCI, and Appendix VI contains the template for CARs assigned to the ASCIS. CAR files are saved in the CFIA electronic folder for the ASCIS.

CARs should only be changed or deleted by the auditor and only if there is evidence to justify the change. If the ASCIS or LSCI provides sufficient evidence for withdrawal of the CAR, the auditor must indicate this in the notes section of the CAR form. The auditor must also ensure that the information in the check inspection tracking sheet is updated.

CARs can be closed if the LSCI or ASCIS has implemented their CAP. Both resolved and unresolved non-conformances issued in the current seed crop inspection season will be considered when calculating the check inspection frequency or audit scope for the next seed crop inspection season.

If a CAR is closed and the non-conformance recurs, the closed CAR should be referenced on the new CAR to ensure that the CAP from the previous CAR is taken into consideration when developing the CAP for the new CAR.

8.1 CAR timelines

When a Critical non-conformance is identified during the seed crop inspection season or during an audit, CAR timelines are as follows:

• within 2 business days of the identification of the non-conformance, the check inspector or auditor issues the CAR to the LSCI or ASCIS (issuing by email is recommended)
• within 2 business days of CAR issuance, the LSCI or ASCIS must acknowledge receipt in writing (email, text message, fax, or hard copy)
• within 3 business days of acknowledging receipt of the CAR, the LSCI or ASCIS must provide a corrective action plan (CAP) to CFIA in writing (email, text message, fax, or hard copy)

The CFIA contact reviews the proposed CAP and resolution date to ensure that it meets the requirements in Section 8.0, including addressing the immediate non-conformance, addressing the root cause, and implementing measures to prevent similar non-conformances in the future. Where applicable, CFIA will request that the ASCIS has the seed crop re-inspected as part of the corrective action plan. If the proposed CAP does not meet all elements, the CFIA contact will ask for a revised CAP. CFIA will confirm in writing once the CAP has been accepted.

If an ASCIS/LSCI wishes to appeal a non-conformance, they must complete the Request for Appeal of Non-conformance form (QSP 142.2 appendix G). This dispute process is separate from the CAR process and the CAR with CAP process must continue even if a dispute is initiated.

If the LSCI or ASCIS does not respond to CFIA in the timelines required, refer to section 11.1.

8.2 CARs issued to LSCI

If a Critical non-conformance is identified by the check inspector, the check inspector will issue a CAR to the LSCI, with copy sent to the Lead Inspector for the LSCI and the auditor of the ASCIS to which the LSCI reports. The CAR with accepted CAP are saved in RDIMS by the check inspector. The Critical non-conformance is recorded in the check inspection tracking spreadsheet with the RDIMS number for the CAR.

Most CARs issued to LSCIs are issued by check inspectors during the season, but there may be situations where the auditor identifies an issue during the audit requiring a CAR to be issued to an LSCI.

8.3 CARs issued to ASCIS

Although the auditor may issue CARs to the ASCIS during the seed crop inspection season, for example when non-conformances involving conflicts of interest or inappropriate refusals of inspections are identified, the majority of CARs will be issued to the ASCIS during the annual audit. If possible, CARs issued at the audit should be resolved during or immediately after the audit but it may not be possible to address all of the non-conformances or to confirm their resolution until the next seed crop inspection season is underway or even finished.

The CAP requested during the audit can be developed following the audit as long as it is developed within 2 weeks of the issuance of the CAR.

8.4 Closing CARs

Once the proposed resolution date has passed, the check inspector or auditor must follow up to confirm the CAP was implemented as described. Follow up will vary depending on the CAP; some examples include confirming that the LSCI submitted a corrected report in SeedCert, requesting copies of training records, or confirming that changes were made to the quality manual. CARs with longer term corrective actions should be discussed between check inspector and auditor to determine appropriate follow up.

The check inspector or auditor does not consider the efficacy of the CAP when closing the CAR. However, the auditor or check inspector may issue another CAR if the same non-conformance continues to occur following the CAR resolution date. In this case, the auditor and/or check inspector should reference the original CAR on the second CAR. When the CAR can be closed, CFIA completes the form and documents the resolution date. Documentation of formal disagreements with CARs or non-conformances should be saved in the electronic folder for the ASCIS.

9.0 ASCIS or LSCI regulatory non-compliances

A regulatory non-compliance is a failure to meet legislative, regulatory or legal obligations and is subject to a range of enforcement actions depending on the type of non-compliance.

Following are examples of regulatory non-compliances:

• false or misleading information was provided in the ASCIS or LSCI licence application
• false or misleading information was provided to a CFIA inspector

When a regulatory non-compliance is identified during an audit, the auditor should note the non-compliance in the report and complete the remainder of the audit in the usual manner. The auditor should not take action on the non-compliance during the audit as they are on-site at the ASCIS for the purpose of conducting an audit and any other actions are out of scope during the time of the audit. After the audit, inspection and enforcement actions can be initiated as appropriate.

10.0 Annual renewal of an LSCI or ASCIS licence

LSCI and ASCIS licences are renewed annually by the Seed Section. The renewal of the LSCI licence is not dependent on the renewal of the licence of the ASCIS to which the LSCI reports.

Licences are not renewed if:

• the licensee indicates they do not wish the licence to be renewed
• the licence revocation process has been initiated by a CFIA auditor or check inspector
• the licensee does not meet the conditions for renewal (for example, completion of 20 inspections in 2 years)
• the licensee has a critical CAR that was not closed by the resolution date

ASCIS licences are renewed based on the recommendation of the auditor following the annual audit using the Audit Summary Report found in Appendix VII. ASCIS licences are not renewed if:

• the ASCIS has assigned their licence to another entity
• the ASCIS does not have insurance
• the ASCIS has not paid their check inspection fees
• the ASCIS has not provided access to CFIA for audits
• the ASCIS has not provided a CAP for CARs assessed during their audit
• the licensee has a critical CAR that was not closed by the resolution date
• the ASCIS has not completed the renewal form and/or accepted the minimum number of inspections for the coming crop inspection season

If an ASCIS chooses to withdraw prior to the audit the auditor must complete the following steps:

• the LSCI summaries
• invoicing for Check Inspections
• the ASCIS audit summary with a statement indicating why the audit was not complete

11.0 Revocation of an LSCI or ASCIS licence

The Seed Section will notify the ASCIS or LSCI of the revocation of its licence by registered mail, and the CSGA, and CFIA auditor by electronic mail.

Section 11.1 outlines the procedures for the revocation of an LSCI or ASCIS licence that should be followed by the CFIA auditor in charge of the ASCIS to which the LSCI reports. Throughout this process, the auditor should be available to the LSCI or ASCIS to respond to questions. The auditor should retain the records leading to the revocation of a licence for 7 years and make them available to the National Manager of Seed Section if the ASCIS or LSCI seeks re-licensing at a future date.

If an ASCIS is no longer conducting inspections, an audit will be completed during the first year and the licence will be revoked the second year. In order to reinstate an ASCIS licence, the ASCIS must first re-apply for licensing.

11.1 Procedures for the revocation of an LSCI or ASCIS licence

Prior to recommending a revocation of an ASCIS or LSCI licence, the CFIA auditor must provide written notification by email to the LSCI or ASCIS that they have unacknowledged, unresolved or 3 Critical non-conformances and that without resolution, these non-conformances may lead to the revocation of the LSCI or ASCIS licence. The CFIA auditor requests confirmation to ensure that the email has been received.

The auditor should include documentation to verify the non-conformances and CARs issued, dates, check inspection reports, etc.

The grounds for revoking the licence must be documented and the records retained according to the CFIA's records retention policy.

The auditor gives the LSCI or ASCIS a date for follow up and records the contact date and content of the interaction in the LSCI or ASCIS file. If possible, the LSCI, ASCIS or their representative should sign and date the record. The auditor will send a copy to the Seed Section.

The auditor will then follow up on the agreed date by phone or in person. If the LSCI or ASCIS is working to resolve the issue, but it is not yet resolved, it is acceptable to extend the deadline for resolution and set a second date for follow up. The auditor should document the contact and date the record. If possible, the LSCI, ASCIS or their representative should sign and date the record. If the deadline for resolution was extended, the auditor should follow up on the second date by phone or in person. It is not appropriate to extend the deadline more than once.

The auditor will follow up on the agreed date by phone or in person.

If no action has been taken, or if actions are inadequate to resolve the CARs, then the auditor will inform the National Manager by email of the situation and recommend revocation of the LSCI or ASCIS licence. The auditor will attach copies of previous correspondence with the LSCI or ASCIS documenting that the above noted procedures have been followed.

The National Manager will then issue a notice of revocation of the licence to the ASCIS or LSCI by registered mail, and the CSGA, and CFIA auditor by electronic mail, as the entity is no longer licensed.

12.0 Re-instatement of an LSCI or ASCIS licence

Refer to QSP 142.2 Section 6.5 for information on re-instatement.

13.0 Fees

The CFIA will charge fees to the ASCIS for check inspections of their LSCI, based on the total number of check inspections completed for the LSCI for that ASCIS. The fees charged should not exceed the number of check inspections that would be required based on the check inspection frequency assigned to the LSCI. The auditor is responsible for billing each ASCIS for which check inspections have been performed. The CFIA maintains the authority to conduct additional check inspections over and above the assigned frequency, but no fees will be charged for these additional check inspections.

Check inspections are invoiced based on the CFIA Fees Notice, Part 14, Table 1, Item 1. The invoice amount is a fixed fee based on 6 quarter hours per check inspection.

Appendix 0 Work flow and forms

Appendix I Pre-licensing ASCIS Quality Management System manual review checklist

This checklist is to be completed during the pre-licensing ASCIS QMS manual review according to Section 5.1.2 of SWI 142.3.1. Each criterion is to be marked as Satisfactory (S) or Not Satisfactory (NS).

ASCIS Name
ASCIS Mailing Address
ASCIS Telephone
ASCIS Email
Name of ASCIS Quality Manager
ASCIS Quality Manager Email
ASCIS Quality Manager Telephone
Name of CFIA Auditor
CFIA Auditor Email
Date of Review

Additional Comments:

Appendix II Summary of ASCIS QMS manual review

ASCIS Name
ASCIS Mailing Address
ASCIS Telephone
ASCIS Email
Name of ASCIS Quality Manager
Email of ASCIS Quality Manager
Telephone of ASCIS Quality Manager
Name of CFIA Auditor
Email of CFIA Auditor
Date QMS manual received
Date QMS manual review complete

Part reserved for CFIA use
Version # of approved QMS manual
File #
Recommended for licensing: Yes/No
MRRS Code: 32a10.01
Time spent on activity
Comments

CFIA Auditor

Name (Print)

Signature

Date

ASCIS Quality Manager

Name (Print)

Signature

Date

Appendix III ASCIS audit checklist

The checklist is used to document the assessment of:

• the ability of the ASCIS to implement its documented quality management system
• whether changes to the QMS manual meet the criteria in QSP 142.2

Non-conformances are recorded as Minor, Major or Critical.

ASCIS Name
ASCIS Mailing Address
ASCIS Telephone
ASCIS Email
Name of ASCIS Quality Manager
Telephone of ASCIS Quality Manager
Email of ASCIS Quality Manager
Name of CFIA Auditor
Email of CFIA Auditor
Date of Audit

9.0 LSCI Non-conformances assigned to the ASCIS

Non-conformances issued to ASCIS based on non-conformances issued to LSCI. Refer to the Check Inspection Tracking Sheet – Worksheet "ASCIS Rollups." Detail each applicable non-conformance. Do not include LSCI non-conformances for Check Inspection Checklist items 3.4, 3.7, 7.2, 4.4, 11.1 to 11.7 and 13.1 to 13.5. These are already captured in the ASCIS Audit Checklist.

Additional Comments (other observations, opportunities for improvements):

Appendix IV Examples of the classification of non-conformances and non-compliances identified in an ASCIS audit

[Redacted]

Appendix V Corrective Action Request (CAR) form for LSCI

CFIA oversight of pedigreed seed crop inspection has identified a critical non-conformance. The details of the Corrective Action Request (CAR) are given in Part 1.

Acknowledge receipt of this CAR by completing Part 2 and responding in writing (email, text message, fax, or hard copy) within 2 business days of the date of CAR issuance.

A Corrective Action Plan (CAP) must be developed by the LSCI or ASCIS. Complete Part 3 and respond in writing within 3 business days of the date of acknowledgement.

Critical Corrective Action Request

Part 1 – Completed by CFIA (within 2 business days of identifying the non-conformance)

Name of LSCI:
LSCI number:
LSCI contact info (e-mail/phone number):
ASCIS:
Check inspector name:
Check inspector number:
Check inspector e-mail:
Check inspector phone number:
Date of CAR issuance:
Description of non-conformance (including number from checklist – Appendix IX):

Sequence number of report(s):
Name of CFIA auditor copied:
Name of ASCIS lead copied:

Part 2 – Completed by LSCI or ASCIS Lead Inspector (within 2 business days of the date of CAR issuance)

LSCI acknowledgement of receipt (signature, digital signature, or confirmed via email or text message):
Date of acknowledgement:

Part 3 – Completed by LSCI or ASCIS Lead Inspector (within 3 business days of the date of acknowledgement)

Corrective Action Plan (CAP):
Proposed resolution date:

Part 4 – Completed by CFIA once CAP has been accepted

CAP acceptance date:

Part 5 – Completed by CFIA when non-conformance is resolved and CAR is closed

Resolution date:
Date completed CAR sent to LSCI and ASCIS:
Completed CAR saved as RDIMS file number:

Appendix VI Corrective Action Request (CAR) for ASCIS

Template in RDIMS 18988459 (internal access only)

Corrective Action Request

Name of ASCIS:
ASCIS #:
Quality Manager Name:
E-mail/phone number:
Quality Manager Signature:
Date of Receipt:

To be completed by CFIA

• Description of non-conformance (include number from checklist – Appendix III)
• Reference
• Level – Minor Major Critical

To be completed by Quality Manager

• Corrective Action Plan (CAP)
• Proposed Resolution Date

To be completed by CFIA (on resolution of non-conformance)

• Resolution Date
• Auditor Initials verifying resolution

(insert more rows as necessary)

Notes:

Auditor
Name:
Signature:
Inspector #:
Email:
Phone Number:
Date of Issuance:
Original sent to ASCIS
Saved as file #:

Appendix VII – Summary report of ASCIS audit

This form is prepared by CFIA auditor and provided to the audited ASCIS and Seed Section.

Summary report of ASCIS audit

Name of ASCIS:
Address of ASCIS:
Date of Audit:
Name of ASCIS Quality Manager:
Name(s) of other ASCIS personnel present at audit:
Name of CFIA auditor:
Name(s) of other CFIA personnel present at audit:

Audit Scope:
Full

Partial

N/A Audit not complete – provide details

If Partial audit – specify all optional QMS criteria that were selected for the current audit

If Partial audit – specify all optional QMS criteria to be selected for the next audit

Comments

Summary audit observations – list key observations and comments

Note: seed Section will confirm that all fees owed to the CFIA have been paid prior to renewal of licence.

Appendix VIII Record of invigilation of a written evaluation

[Redacted]

Appendix IX Checklist for the comparison of Check Inspector and LSCI Seed Crop Inspection Reports

To be completed by CFIA Check Inspector. S = Satisfactory; NS = Not Satisfactory. If a non-conformance category is not applicable, mark as Satisfactory.

LSCI name:
LSCI number:
ASCIS name:
Field sequence number:
Plot (Y/N):

Check Inspector name:
Date comparison completed:
MRRS Code:
Time Spent on Activity: