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CFIA oversight of authorized seed crop inspection (SWI 142.3.1)

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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 14, 2023

On this page

1.0 Scope

This Specific Work Instructions details the procedures for CFIA oversight of procedures to be followed by the CFIA when overseeing 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 – internal access only).

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 – internal access only).

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 to the CSGA. 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 to the CSGA.

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 – internal access only) 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.

Table 1 Check inspection frequencies
Frequency Check inspection rate
Reduced 5%
Normal 10%
Tightened 15%

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:

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

As part of the annual audit of the ASCIS, the check inspection frequency for an LSCI may be adjusted by the auditor. 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 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 follow the instructions to update the ASD-Auditors Calculation of Check Inspection Frequency (RDIMS 12518191 – internal access only) in the ASCIS Master folder (RDIMS 40907055 – internal access only). 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.

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.

Table 2 Criteria for changing LSCI check inspection frequency level
Check inspection frequency change Non-conformances in previous year
Decrease from tightened to normal 4 or fewer Minor, and no Major or Critical
Decrease from normal to reduced 4 or fewer Minor, and no Major or Critical
Increase from reduced to normal 2 or more Major, or 1 or 2 Critical
Increase from normal to tightened 3 or more Major, or 1 or 2 Critical
Initiate revocation process 3 Critical

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.

Table 3 Types of LSCI non-conformances
Non-conformance Description
Minor An activity that is not in conformity with an accepted pedigreed seed crop inspection procedure but will not or is unlikely to adversely affect the quality of the pedigreed seed crop inspection when isolated cases are found but that cumulatively may result in a consequential impact on the quality of the pedigreed seed crop inspection
Major An activity that is not in conformity with an accepted pedigreed seed crop inspection procedure and may have or is likely to have an adverse impact on the quality of the pedigreed seed crop inspection
Critical An activity that is not in conformity with an accepted pedigreed seed crop inspection procedure and will have an adverse impact on the quality of the pedigreed seed crop inspection

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

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. The auditor conducts interviews with staff, reviews records and observes procedures.

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:

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.

The audit is to be completed and the audit report received by Seed Section by December 15 of each year.

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

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

7.1 Determining ASCIS audit scope

The scope of the audit to be conducted is dependent on the number and type of non-conformances noted against the ASCIS in the previous audit, and should be determined based on the criteria 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.

Table 4 Determining requirement for a full audit of an ASCIS
Audit Conditions Audit Scope
First year of licensing of the ASCIS Full audit
2 or more Critical non-conformances in the last audit Full audit

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.

7.2 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 with the name of the ASCIS, and the year, in the title. 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 this information 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.

A copy of the summary audit report (Appendix VII) is provided to the ASCIS, and the Seed Section. The auditor keeps the original paper copy of audit checklist on file and saves a copy in the CFIA electronic folder for the ASCIS.

7.3 Assessing open ASCIS and LSCI CARs

The auditor must review the non-conformances that were issued to each ASCIS and LSCI in the previous and current seed crop inspection seasons to determine whether they were closed by their resolution dates. Non-conformances that were previously issued to the ASCIS and its LSCI should be filed in the CFIA electronic folder for the ASCIS, and should be listed in the check inspection summary sheet for non-conformances issued to the LSCI.

Non-conformances issued to ASCIS that are 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 or LSCI 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.

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.

Table 5 Descriptions of ASCIS Minor, Major and Critical Non-Conformances
Non-conformance Description
Minor A deviation from the QMS such that confidence in the conformance with the QMS is decreased. Minor non-conformances have no immediate or direct impact on the quality of the Seed Crop Inspection Report.
Major A significant deviation from the QMS such that conformance with the QMS is in doubt. Major non-conformances indicate a lack of control in the QMS and may negatively affect the quality of the Seed Crop Inspection Report.
Critical A deviation from the QMS such that conformance is absent.

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.

Table 6 Conditions where LSCI non-conformances may be assigned to the ASCIS
Non-conformances assigned to LSCI reporting to an ASCIS Non-conformance assigned to the ASCIS
The same Critical non-conformance assigned to 2 or more LSCI or 10% of active LSCI, whichever is greater, reporting to that ASCIS 1 Critical
The same Major non-conformance assigned to more than 50% of LSCI reporting to that ASCIS 1 Major
The same Minor non-conformance assigned to 80% of LSCI reporting to that ASCIS 1 Minor

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.

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:

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:

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. 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:

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:

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:

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

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

LSCI – Pre-licensing
Action Reference
Applicant submits application for LSCI licence which is reviewed by Seed Section QSP 142.2 Appendix D
LSCI completes classroom and practical training and evaluations QSP 142.2
Appendix E
Seed Section issues LSCI licence Template in QSP 142.2
LSCI – Post-licensing
Action Reference
Check inspector conducts inspections of seed crops inspected by LSCI QSP 142.2
Check inspector issues CARs to the LSCI for Critical non-conformances during the inspection season SWI 142.3.1 Appendix V
Check inspector completes check inspection tracking sheet as time permits but before ASCIS annual audit Each inspector must save their own copy of check inspection tracking sheet.
Check inspector may complete and save a Seed Crop Inspection Report comparison report for each check inspection before ASCIS annual audit. This is optional. SWI 142.3.1 Appendix IX (or using tracking sheet)
ASCIS – Pre-licensing
Action Reference
Applicant submits application for ASCIS licence which is reviewed by Seed Section QSP 142.2 Appendix B
Reviewer reviews ASCIS QMS manual and completes checklist SWI 142.3.1 Appendix I
Reviewer completes recommendation for ASCIS licensing and sends to SeedSemence@inspection.gc.ca SWI 142.3.1 Appendix II
Seed Section issues ASCIS licence Template in QSP 142.2
Appendix C
ASCIS – Post-licensing
Action Reference
Auditor creates summary of LSCI non-conformances using ASCIS check inspection tracking sheet and applies them to ASCIS as appropriate SWI 142.3.1 Table 6
Auditor issues a list of LSCI Minor and Major non-conformances to the ASCIS SWI 142.3.1 Appendix V
Auditor determines LSCI check inspection frequencies for following year SWI 142.3.1 Table 2
Auditor visits ASCIS and assesses ASCIS using Audit Checklist SWI 142.3.1 Appendix III
Auditor identifies non-conformances and issues CARs to ASCIS SWI 142.3.1 Appendix VI
Auditor determines ASCIS audit scope for next year SWI 142.3.1 Table 4
Auditor completes Report of ASCIS Audit for Seed Section and ASCIS SWI 142.3.1 Appendix VII

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

1.0 Quality Management System manual
No. Reference QMS Criteria Review
(S/NS)
Comments
1.0

QSP 142.2
Section 4.3 ASCIS Responsibilities

QMS manual exists
2.0 General criteria – ASCIS and LSCI
No. Reference QMS Criteria Review
(S/NS)
Comments
2.1

ASCIS Licence

QSP 142.2

Section 3.1

Manual states that ASCIS operates and accepts requests for inspection only within the geographic area for which it is licensed (unless permitted by the CFIA)
2.2 ASCIS Licence Manual states that ASCIS will accept the minimum number of inspections for their Region before refusing service to a seed grower. (Not applicable to non-third party)
2.2.1

QSP 142.2

Section 4.3

ASCIS Licence

Manual states that ASCIS is committing to pay fees owed to the CFIA for check inspections
2.3 ASCIS Licence Manual states that ASCIS will notify the CFIA if there are changes in the ownership, majority control, technical or financial competence, location of the workplace, or any other changes in its status
2.4 ASCIS Licence A procedure stating that the ASCIS is committing to maintain appropriate insurance coverage
2.5 ASCIS Licence Manual states that ASCIS will notify the CFIA of any proceedings for bankruptcy or insolvency brought by or against the ASCIS
2.6

ASCIS Licence

LSCI Licence

A procedure stating that neither the ASCIS employees nor the LSCI represent themselves as agents, employees or partners of the CFIA
2.7

ASCIS Licence

LSCI Licence

A procedure stating that neither the licence of the ASCIS nor the licence of the LSCI is assigned to another entity
2.8 QSP 142.2
Section 4.3

ASCIS Licence

LSCI Licence

Manual has a procedure or method to identify conflict of interest with the ASCIS staff or LSCI, including how they handle conflict of interest when identified
2.8.1 [Redacted]
2.9

QSP 142.2
Section 4.3

ASCIS Licence

LSCI Licence

Manual states that ASCIS maintains the confidentiality of information on Seed Crop Inspection Reports and other confidential information
2.10

QSP 142.2
Section 4.3

Manual states that ASCIS will submit a list of their LSCI in SeedCert before June 15th. The list identifies the Lead and Alternate Lead for each region in which the ASCIS operates.
2.11

QSP 142.2
Section 4.3

ASCIS Licence

Manual states that ASCIS notifies CFIA and CSGA immediately via the ASCIS roster in SeedCert when their list of LSCI changes.
2.12

QSP 142.2
Section 4.3

Manual states that the Lead Inspector/Alternate Lead is an LSCI that possesses, as a minimum, the Group 1 Scope.
3.0 QMS manual
No. Reference QMS Criteria Review
(S/NS)
Comments
3.1

QSP 142.2
Appendix F
QMS Manual

QMS manual includes current information on:

  • mailing address
  • site location(s), if different from mailing address
  • phone number
  • email address and
  • website (if available)
3.2

QSP 142.2
Appendix F
QMS Manual

QMS manual includes:

  • organizational chart including reporting structure
  • list of employees currently filling those positions
  • name of Quality Manager
  • name of manager or owner with the ultimate responsibility for decisions at the ASCIS
3.3

QSP 142.2
Appendix F
QMS Manual

QMS manual describes the roles and responsibilities of positions related to seed crop inspection
3.4 [Redacted]
3.5

QSP 142.2
Appendix F
Section 3 QMS Manual

The final version of the QMS manual is approved by the QMS manager
3.6

QSP 142.2
Section 4.3

There is a procedure stating that the QMS manager maintains the QMS manual, that procedures are up to date and that obsolete documentation is removed from the system.
3.7

QSP 142.2
Appendix F
Section 3 QMS Manual

The QMS includes provisions for regular and systematic review of the QMS
3.8

QSP 142.2
Appendix F
Section 3 QMS Manual

There is a procedure stating that amendments to the QMS are tracked.
3.9 ASCIS Licence Manual states that CFIA is notified when significant changes to the QMS are planned
3.10 [Redacted]
3.11

QSP 142.2
Appendix F
Section 2 Management Responsibilities

A procedure exists to inform employees and LSCI to provide feedback to improve the QMS.
3.12

QSP 142.2
Appendix F
Section 3 QMS Manual

Quality manual is complete, unambiguous and consistent
3.13

QSP 142.2
Appendix F
Section 3 QMS Manual

QMS manual pages are numbered x of y, and all articles are identified with unique alphanumeric sequences
4.0 Procedures
No. Reference QMS Criteria Review
(S/NS)
Comments
4.1

QSP 142.2
Appendix F
Section 3 QMS Manual

QSP 142.2
Appendix F
Section 4 Procedures

Section 2 Management Responsibilities

There is a method for staff and LSCI to have access to the most recent versions of any internal, CFIA, or CSGA documents referenced in the QMS manual
4.2 [Redacted]
4.3

QSP 142.2
Appendix F
Section 4 Procedures

Each procedure clearly indicates any form(s) required to be completed and maintained by that procedure
4.4

QSP 142.2
Appendix F
Section 4 Procedures

Procedure exists for managing requests for re-inspection
4.5 [Redacted]
4.6 ASCIS Licence Manual states that the ASCIS is responsible to ensure that LSCI provides notice of their schedule prior to the inspection date and should be provided two (2) days prior to inspections. Where 2 days is not possible, the notice should be entered prior to the inspection being conducted.
4.6.1

LSCI Licence

ASCIS Licence

Manual states that the actual date of inspection is reported by the end of the day on which the inspection is conducted.
4.7

QSP 142.2
Section 4.3

Manual states that seed crop inspections will be conducted at an appropriate growth stage
4.8 ASCIS Licence A method exists to inform the CFIA of the pest control product application schedule when requested by CFIA
4.9

QSP 142.2
Section 4.3

Manual states that the Seed Crop Inspection Reports will be reviewed prior to submission to the CSGA
4.9.1 [Redacted]
4.9.2

QSP 142.2
Section 4.3

Manual states that ASCIS approves the report of crop inspection within 2 business days from the inspection date
4.10

ASCIS Licence

LSCI Licence

Manual states that the ASCIS and/or the LSCI reported to the CFIA the finding of a prohibited noxious weed within 48 hours of its observation during a seed crop inspection
4.11

ASCIS Licence

LSCI Licence

Manual states that neither the ASCIS nor the LSCI communicate to the seed grower an opinion as to the decision of the CSGA with respect to the results of an inspection
5.0 Corrective Action Requests (CARs) issued by the CFIA
No. Reference QMS Criteria Review
(S/NS)
Comments
5.1

QSP 142.2
Appendix F
Section 1

A procedure exists to respond to CARs issued by the CFIA to the ASCIS and Critical CARs issued to LSCI
5.2

QSP 142.2
Appendix F
Section 5 CARs

A procedure exists identifying a person who is assigned to coordinate follow-up activities for CARs
5.3 [Redacted]
5.4

QSP 142.2
Appendix F
Section 5 CARs

A procedure exists that describes when a non-conformance is identified, a response should include a time period to resolve the issue, addresses the root cause and a verification action to be implemented
5.5

QSP 142.2
Appendix F
Section 5 CARs

A procedure exists to address cases where corrective action is not completed within the time frame
5.6

QSP 142.2
Appendix F
Section 5 CARs

A procedure is in place stating where appropriate, CARs lead to an amendment to the QMS to prevent similar non-conformances or non-compliances from occurring in the future
5.7

QSP 142.2
Appendix F
Section 5 CARs

A procedure exists to respond internally to non-conformances identified during the ASCIS review of the Seed Crop Inspection Report
6.0 Records
No. Reference QMS Criteria Review
(S/NS)
Comments
6.1

QSP 142.2
Section 4.3

ASCIS Licence

Manual states that ASCIS retains records for minimum of 7 years
6.2

QSP 142.2
Appendix F
Section 6 Records

Manual states that records are stored in a manner that provides for their safekeeping and physical protection
6.3

QSP 142.2
Appendix F
Section 6 Records

Manual states that records are disposed of by a secure method and only by authorized persons
6.4

QSP 142.2
Appendix F
Section 6 Records

QSP 142.2
Appendix F
Section 8 Training and Qualifications

A procedure exists stating the following records are maintained:

  • revisions and amendments to the QMS manual and procedures
  • copies of ASCIS and LSCI licences
  • list of active LSCI
  • records of training and qualifications for staff and LSCI
  • CARs and follow-up actions and
  • any other document directly referenced in the QMS manual
7.0 Training and qualifications
No. Reference QMS Criteria Review
(S/NS)
Comments
7.1

QSP 142.2
Appendix F
Section 8 Training and Qualifications

Procedure exists stating that the personnel have been trained and are competent in the activities for which they are responsible, including, but not limited to:

  • Lead Inspector
  • Quality manager
  • Records clerk
  • LSCI-training records
7.2

QSP 142.2
Section 4.4 LSCI Responsibilities

LSCI Licence

Manual states that the LSCI will only inspect crop kinds for which they have been licensed and are competent
7.3

QSP 142.2
Appendix F
Section 8 Training and Qualifications

Methods or procedures exist to provide refresher training as required
7.4 [Redacted]
7.5

QSP 142.2
Appendix F
Section 8 Training and Qualifications

Procedure exists stating new LSCI are supervised by an experienced Lead Inspector
7.6

QSP 142.2
Appendix F
Section 8 Training and Qualifications

Procedure exists for LSCI inspecting a new crop kind for the first time are supervised
7.7

QSP 142.2
Appendix F
Section 8 Training and Qualifications QSP 142.1 Section 4.4

Procedure exists to inform CFIA when an LSCI inspects a new crop kind for the first time (including a new crop kind in a plot)
8.0 General conclusions
No. Reference QMS Criteria Review
(S/NS)
Comments
8.1 [Redacted]

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

space
Name (Print)

space
Signature

space
Date

ASCIS Quality Manager

space
Name (Print)

space
Signature

space
Date

Appendix III ASCIS audit checklist

The checklist is used to document the assessment of:

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

1.0 Quality system
No. Reference QMS Criteria Non-Conformance Comments
1.0

QSP 142.2
Section 4.3 ASCIS Responsibilities

QMS manual exists Critical required for partial audit
2.0 General criteria – ASCIS and LSCI
No. Reference QMS Criteria Non-Conformance Comments
2.1 QSP 142.2
Section 3.1
ASCIS Licence
The ASCIS operated and accepted requests for inspection only within the geographic area for which it is licensed (unless permitted otherwise by the CFIA) Critical required for partial audit
2.2 ASCIS Licence The ASCIS accepted the minimum number of inspections for their Region before refusing service to a seed grower (not applicable to non-third party) Critical required for partial audit
2.2.1

QSP 142.2
Section 4.3

ASCIS Licence

ASCIS paid fees owed to the CFIA for check inspections Critical required for partial audit
2.3 ASCIS Licence The ASCIS notified the CFIA of changes in the ownership, majority control, technical or financial competence, location of the workplace or any other changes in its status Major required for partial audit
2.4 ASCIS Licence The ASCIS maintained appropriate insurance coverage Major required for partial audit
2.5 ASCIS Licence The ASCIS notified the CFIA of any proceedings for bankruptcy or insolvency brought by or against the ASCIS Major required for partial audit
2.6

ASCIS Licence

LSCI Licence

Neither the ASCIS employees nor the LSCI represented themselves as agents, employees or partners of the CFIA Critical required for partial audit
2.7

ASCIS Licence

LSCI Licence

Neither the licence of the ASCIS nor the licence of the LSCI was assigned to another entity Critical required for partial audit
2.8

QSP 142.2
Section 4.3

ASCIS Licence

LSCI Licence

The ASCIS has a procedure or a method to identify conflict of interest and took appropriate action when conflicts of interest were identified with the ASCIS staff or LSCI Critical required for partial audit
2.8.1

QSP 142.2
Sections 4.3 and 4.4

ASCIS Licence

LSCI Licence

The LSCI and ASCIS were free of any conflict of interest with the seed growers or the seed crops which they inspected Critical required for partial audit
2.9

QSP 142.2
Section 4.3

ASCIS Licence

LSCI Licence

The ASCIS maintained the confidentiality of information on Seed Crop Inspection Reports and other confidential information Major
2.10

QSP 142.2
Section 4.3

The ASCIS provided a list of their LSCI in SeedCert June 15th. The list identified the Lead and an Alternate Lead for each region in which the ASCIS operates. Major required for partial audit
2.11

QSP 142.2
Section 4.3

ASCIS Licence

The ASCIS notified the CFIA and CSGA immediately via the ASCIS roster in SeedCert when their list of LSCI changed.

Minor
Major

required for partial audit
2.12

QSP 142.2
Section 4.3

The Lead Inspector/- Alternate Lead is an LSCI that possesses, as a minimum, the Group 1 Scope. Major required for partial audit
3.0 QMS Manual
No. Reference QMS Criteria Non-Conformance Comments
3.1

QSP 142.2
Appendix F
QMS Manual

QMS manual includes current information on:

  • mailing address
  • site location(s), if different from mailing address
  • phone number
  • email address and
  • website (if available)
Minor required for partial audit – changes only
3.2

QSP 142.2
Appendix F
QMS Manual

QMS manual includes:

  • organizational chart including reporting structure
  • list of employees currently filling those positions
  • name of QMS manager
  • name of manager or owner with the ultimate responsibility for decisions at the ASCIS
Minor required for partial audit – changes only
3.3

QSP 142.2
Appendix F
QMS Manual

QMS manual describes the roles and responsibilities of positions related to crop inspection Minor required for partial audit – changes only
3.4 [Redacted]
3.5

QSP 142.2
Appendix F
Section 3 – QMS Manual

The final version of the QMS manual was approved by the QMS manager Minor
3.6

QSP 142.2
Section 4.3

The QMS manager maintained the QMS manual and procedures up to date Minor
3.7

QSP 142.2
Appendix F
Section 3 – QMS Manual

The QMS manual has been regularly reviewed Major
3.8

QSP 142.2
Appendix F
Section 3 – QMS Manual

Amendments to the QMS documentation followed a procedure that tracks the changes Minor
3.9 ASCIS Licence The CFIA was notified of significant changes to the QMS

Minor

Major

3.10

QSP 142.2
Appendix F
Section 2 Management Responsibilities

Employees and LSCI were informed of changes to the QMS Major
3.11

QSP 142.2
Appendix F
Section 2 Management Responsibilities

The employees and LSCI were encouraged to provide input which contributes to the continual improvement of the QMS Minor
3.12

QSP 142.2
Appendix F
Section 3 – QMS Manual

The QMS manual and related documentation is complete, unambiguous and consistent

Minor
Major

3.13

QSP 142.2
Appendix F
Section 3 – QMS Manual

QMS manual pages are numbered x of y, and all articles are identified with unique alphanumeric sequences Minor
ed
4.0 Procedures
No. Reference QMS Criteria Non-Conformance Comments
4.1

QSP 142.2
Appendix F
Section 3 – QMS Manual

QSP 142.2
Appendix F
Section 4 Procedures

Section 2 Management Responsibilities

ASCIS Staff and LSCI have access to the most recent versions of any internal, CFIA, or CSGA documents referenced in the QMS manual

Minor
Major

4.2

QSP 142.2
Appendix F
Section 3 – QMS Manual

Obsolete documentation was promptly removed from all points of use Minor
4.3

QSP 142.2
Appendix F
Section 4 Procedures

Each procedure clearly indicates any form(s) required by that procedure. They are completed and maintained

Minor
Major

4.4

QSP 142.2
Appendix F
Section 4 Procedures

Requests for re-inspection were managed according to procedure Minor
4.5 [Redacted]
4.6 ASCIS Licence LSCI provides notice of their schedule prior to the inspection date and should be provided 2 days prior to inspections. Where 2 days was not possible, the notice has been entered prior to the inspection being conducted. Minor required for partial audit
4.6.1

LSCI Licence

ASCIS Licence

When seed crop inspections are conducted, the actual date of inspection is reported by the end of the day on which the inspection is conducted Major
4.7

QSP 142.2
Section 4.3

Seed crop inspections were conducted at an appropriate growth stage Major required for partial audit
4.8 ASCIS Licence The ASCIS informed the CFIA of the pest control product application schedule when requested Minor
4.9

QSP 142.2
Section 4.3

Seed Crop Inspection Reports were correctly reviewed prior to submission to the CSGA Major required for partial audit
4.9.1

QSP 142.2
Section 4.4

Seed Crop Inspection Report was submitted within 2 business days by the LSCI Major required for partial audit
4.9.2

QSP 142.2
Section 4.3

ASCIS approved the report of crop inspection within 2 business days. Major required for partial audit
4.10

ASCIS Licence

LSCI Licence

The ASCIS and/or the LSCI reported to the CFIA the finding of a prohibited noxious weed within 2 days of its observation in a seed crop inspection Major required for partial audit
4.11

ASCIS Licence

LSCI Licence

Neither the ASCIS nor the LSCI communicated to the seed grower an opinion as to the decision of the CSGA with respect to the results of a seed crop inspection

Major
Minor

required for partial audit
5.0 Corrective Action Requests (CARs) issued by the CFIA
No. Reference QMS Criteria Non-Conformance Comments
5.1

QSP 142.2
Section 4.3

QSP 142.2 Appendix F
Section 5 CARs

The ASCIS responded to CARs issued by the CFIA to the ASCIS and Critical CARs issued to the LSCI according to procedure:

  • follow-up activities were coordinated according to procedure
  • corrective actions addressed the immediate non-conformance or non-compliance and the root cause
  • a time period was agreed on for resolution
  • completion of the corrective action was verified
  • procedure was followed to address cases where corrective action is not completed within the time frame
  • where appropriate, CARs led to an amendment to the QMS to prevent similar non-conformances or non-compliances from occurring in the future

Major

Minor

required for partial audit
6.0 Records
No. Reference QMS Criteria Non-Conformance Comments
6.1

QSP 142.2
Section 4.3

ASCIS Licence

ASCIS retains records for minimum of 7 years Major
6.2

QSP 142.2
Appendix F
Section 6 Records

Records are stored in a manner that provides for their safekeeping and physical protection.

Minor
Major
Critical

6.3

QSP 142.2
Appendix F
Section 6 Records

Records were disposed of by a secure method and only by authorized persons Minor
6.4

QSP 142.2
Appendix F
Section 6 Records

QSP 142.2
Appendix F
Section 8 Training and Qualifications

Records include:

  • revisions and amendments to the QMS manual and procedures
  • copies of ASCIS and LSCI licences
  • list of active LSCI
  • records of training and qualifications for staff and LSCI
  • CARs and follow-up actions
  • any other document directly referenced in the QMS manual

Minor

Major

Critical

required for partial audit
7.0 Training and Qualifications
No. Reference QMS Criteria Non-Conformance Comments
7.1

QSP 142.2
Appendix F
Section 8 Training and Qualifications

Personnel were trained and demonstrate competence in the activities for which they are responsible, including but not limited to:

  • Lead inspector
  • QMS manager
  • Records clerk
  • LSCI
Major required for partial audit
7.2

QSP 142.2
Section 4.4 LSCI Requirements

LSCI Licence

The LSCI only inspected crop kinds for which they are licensed and are competent Critical required for partial audit
7.3

QSP 142.2
Appendix F
Section 8 Training and Qualifications

Procedures were followed to provide training as required Minor
7.4 [Redacted]
7.5

QSP 142.2
Appendix F
Section 8 Training and Qualifications

New LSCI were supervised by an experienced Lead Inspector Major
7.6

QSP 142.2
Appendix F
Section 8 Training and Qualifications

LSCI inspecting a new crop kind for the first time were supervised Major required for partial audit
7.7

QSP 142.2
Appendix F
Section 8 Training and Qualifications QSP 142.1 Section 4.4

The CFIA was informed when LSCI inspected a new crop type for the first time (including a new crop kind in a plot) Minor
8.0 General Conclusions
No. Reference QMS Criteria Non-Conformance Comments
8.1

QSP 142.2
Section 4.3

The ASCIS appropriately oversaw the activities of its LSCI

Minor
Major
Critical

required for partial audit
8.2

QSP 142.2
Section 4.3

The ASCIS offered reasonable cooperation for the CFIA audit of ASCIS and check inspections of its LSCI. Field maps were available. Accurate planned dates were entered 2 days in advance of inspections.

Minor
Major
Critical

required for partial audit
8.3

QSP 142.2
Section 4.3

QMS procedures were implemented correctly

Minor
Major
Critical

required for partial 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.

Item No. from LSCI Check Inspection Checklist % LSCI with the non-conformance Description Minor
Major
Critical
Comments
(insert more rows as necessary)

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

Note: the text below can be used as the body of an email (recommended) or can be copied into a letter to be sent by mail or fax. Updated contact information for LSCIs and ASCIS leads can be found in the SeedCert Oversight tab.

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.

Please 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

To be completed by Quality Manager

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

(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

Non-conformances
Type of non-conformance # of Minor N/C # of Major N/C # of Critical N/C
Non-conformances issued at previous audit and not resolved
Non-conformances issued at current audit including LSCI non-conformances assigned to the ASCIS

Comments

Summary audit observations – list key observations and comments

Section Scope Comments
2 General Criteria
3 QMS Manual
4 Procedures
5 Corrective Action Request(s) issued by CFIA
6 Records
7 Training and Qualifications
Additional comments and other observations:
Criteria Yes No
Licensee requests renewal
ASCIS has assigned their licence to another entity (if yes, the licence cannot be renewed)
ASCIS has insurance (if no, licence cannot be renewed)
ASCIS has provided CFIA access for audits (if no, cannot be renewed)
ASCIS has provided CAP for CARs from audit (if no, licence cannot be renewed)
Does the ASCIS or any LSCI have any Critical CARs that have not been closed by their resolution date?
CFIA auditor recommends ASCIS for renewal of their agreement

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

Recommendation
Recommendation for subsequent year audit scope Partial Box Full Box N/A Box
Name (print) of CFIA Auditor Signature Date
Name (print) of ASCIS Quality Manager Signature Date

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):

1.0 Seed tags
No. Non-conformance Level S/NS Comments
1.1 Failure to verify seed source (tags or crop certificate) Minor
2.0 Land use
No. Non-conformance Level S/NS Comments
2.1 Failure to verify previous land use Minor
2.2 Failure to verify previous land use for a sufficient number of years Minor
3.0 At the field
No. Non-conformance Level S/NS Comments
3.1 Failure to report that one or more characteristics in the variety description does not match the inspected variety Major
3.2 Inspect incorrect field Critical
3.3 Failure to correctly report land location Minor
3.4 Conducting inspection at inappropriate growth stage; distinguishing characteristics are somewhat visible although timing is not ideal Major
3.5 Conducting inspection at a growth stage where distinguishing characteristics are not visible Critical
3.6 Failure to report change in inspection acreage Minor
3.7 Conducting an inspection for which the inspector is not licensed
Note: Check inspector must also assess any potential conflicts of interest and report these to SeedSemence@inspection.gc.ca
Critical
3.8 Failure to correctly report impurities outside of counts (off-types, other crop kinds, weeds reported by count) Major
Minor
3.9 Failure to separate 2 fields when it was required as per CSGA's field definition Minor
4.0 Counts
No. Non-conformance Level S/NS Comments
4.1 Failure to report altered count area Major
4.2 Performing/reporting less than 6 counts or the required number of counts Major
4.3 Taking counts in a non-representative manner (clustering) Major
4.4 Performing inspection on incorrect plant population Critical
5.0 Weeds
No. Non-conformance Level S/NS Comments
5.1 Failure to correctly identify and report weeds by frequency Minor
5.2 Inaccurate reporting of general weed condition Minor
5.3 Reporting weeds by count as weeds by frequency Major
5.4 Failure to identify and /or report a Prohibited Noxious weed in the field or 3 metres isolation Critical
6.0 Plant disease
No. Non-conformance Level S/NS Comments
6.1 Failure to correctly report Smut in barley crop Minor
7.0 Isolation
No. Non-conformance Level S/NS Comments
7.1 Failure to correctly rate the condition of the isolation (good vs. poor) Major
7.2 Failure to report what was found in the isolation distance for open pollinated crops Major
8.0 Off-types/variants
No. Non-conformance Level S/NS Comments
8.1 Identifying plant morphological deviations due to environmental factors as off-type/variants Minor
8.2 Failure to identify and/or quantify off-types/variants Critical
Major
Minor
8.3 Unclear reporting and/or description of off-types/variants Minor
8.4 Identifying off-types/variants using only 1 distinguishing characteristic when 2 are required (for soybean, turf grass, or forage crops, or "tall" off-types/variants in any crop) Minor
9.0 Other crop kinds and weeds reported by count
No. Non-conformance Level S/NS Comments
9.1 Failure to identify and/or quantify crops and/or weeds reported by count Critical
Major
Minor
9.2 Unclear reporting and/or description of crops and/or weeds reported by count Minor
10.0 Production methods
No. Non-conformance Level S/NS Comments
10.1 Failure to report problem areas (for example, lodging or flooding) Minor
10.2 Failure to report planting issues in hybrid crops (for example, mix-up of male and female lines) Major
11.0 Reporting
No. Non-conformance Level S/NS Comments
11.1 Providing inappropriate comments on Seed Crop Inspection Reports Minor
11.2 Predicting CSGA decision verbally or on Seed Crop Inspection Report Major
11.3 Information is not supplied in a meaningful, understandable manner Minor
11.4 Omissions on Report of Seed Crop Inspection (for example, required comments) Minor
11.5 Failure to submit an inspection schedule to the CFIA Minor
11.6 Failure to notify the CFIA of inspections completed by the end of the day of the inspection(s) Major
11.7 Failure to submit initial report in SeedCert within 2 business days of the inspection Major
12.0 Other non-conformances observed
No. Non-conformance Level S/NS Comments
(insert more rows as necessary)
13.0 Non-conformances observed at check inspection which are rolled up to the ASCIS
No. Non-conformance S=0, NS=1, N/A = 0
13.1 An accurate map was supplied
13.2 LSCI reported the actual date of inspection at the end of the day of the inspection(s)
13.3 Pesticide application schedule provided by the ASCIS to the CFIA when requested by the CFIA
13.4 ASCIS has notified the CFIA of a Prohibited Noxious Weed observed by the LSCI
13.5 Final report approved by ASCIS within 2 business days of the inspection
Total numbers of non-conformances observed
Minor Major Critical
Total numbers of non-conformances observed

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