Seed Program Quality System Procedure QSP 142.3
Authorized Seed Crop Inspection Service Monitoring and Auditing

Appendices

DATE

Version 2.0 of the Authorized Seed Crop Inspection Service Monitoring and Auditing was issued April 15, 2008.

CONTACT

The contact person for this Seed Program Quality System Procedure is the Chief, Seed Design and Delivery Office, Seed Section.

REVIEW

This Seed Program Quality System Procedure is subject to periodic review. Amendments will be issued to ensure the procedure continues to meet current needs.

ENDORSEMENT

This Seed Program Quality System Procedure is hereby approved.

Director, Production Division

Date

DISTRIBUTION

The current version of this document will be maintained on the Canadian Food Inspection Agency Internet site. The signed original will be maintained by the National Manager, Seed Section.

This Seed Program Quality System Procedure (QSP) outlines the principles and strategy for the standard assessment of authorized seed crop inspection services in delivering inspection of pedigreed seed crop production.

1.0 SCOPE

This QSP outlines procedures to verify that the authorized seed crop inspection service meets the specifications outlined in:

Canadian Regulations and Procedures for Pedigreed Seed Crop Inspection (CSGA Circular 6 and its amendments);
Inspection Agency Requirements for the Delivery of the Pedigreed Seed Crop Inspection Program (SPRA 141); and
The Organisation for Economic Cooperation and Development (OECD) Guidelines for Control Plot Tests and Field Inspection of Seed Crops.

2.0 REFERENCES

The publications referred to in the development of this QSP are identified in SPRA 111 References and the Canadian Food Inspection Agency (CFIA) Program Audit Protocol (2001).

3.0 DEFINITIONS, ABBREVIATIONS AND ACRONYMS

3.1 Definitions

For the purposes of this QSP, the definitions given in SPRA 101 Definitions for the Seed Program and those indicated below apply.

Applicant - a company/institution that applies for authorization to provide an officially recognized pedigreed seed crop inspection service.

Audit - a systematic and independent evaluation, by examination of objective evidence, to determine the degree of conformity of a body's planned activities and related results with the prescribed standards.

Auditor - an individual who has the appropriate qualifications and authorization to undertake audits as recognized by the CFIA.

Audit Criteria - the criteria against which an audit is conducted. These may include SPRAs, Seed Program QSPs, standards in Acts and Regulations administered by CFIA, the supplier's quality manual and/or procedures.

Audit Scope - the organizational activities and physical locations to be audited.

Audit Team - the group of (normally two) auditors, one of whom is the lead auditor, conducting an audit in accordance with this QSP and the CFIA Program Audit Protocol.

Auditee(s) - the individual(s) nominated by the management of the supplier as being directly responsible for the area(s) audited.

Authorized - having received written authorization from the National Manager, Seed Section.

Authorized Seed Crop Inspection Service - a program that has received written authorization from the National Manager, Seed Section.

Candidate - an individual seeking to become a licensed seed crop inspector.

Certificate - documents recognized by CFIA for inspection purposes that may include:

OECD labels and tags;
AOSCA labels and tags;
CSGA Crop Certificates and tags (Breeder and Select);
farmer proof of pedigreed seed purchase
CFIA labels and tags.

Complete Systems Audit - an audit carried out on all elements of a quality system that affect the ability of the system to comply with the SPRA standards and QSPs and with the requirements of Acts and Regulations administered by CFIA.

Critical Non-conformance - a significant deviation from the documented requirements such that compliance is absent and will have a consequential effect on the quality of the product or service.

Inspection Agency - an organization authorized to carry out pedigreed seed crop inspection for certification purposes and oversee the authorization of pedigreed seed crop inspection services, i.e. CFIA.

Licensed Seed Crop Inspector - an individual who has been licensed to conduct pedigreed seed crop inspection for an authorized seed crop inspection service.

Major Non-conformance - a significant deviation from the documented requirements such that the program integrity or compliance with the requirements is absent. This may result in the product or service not meeting the requirements.

Minor Non-conformance - a failure in the implementation of the documented quality system resulting in a decrease in confidence that the product or service meets the requirements of the activity.

Non-compliance - the deviation of performance or product from that required by regulation.

Non-conformance - the deviation of performance or product from a written standard.

Official Seed Crop Inspector - an individual employed by the CFIA who is qualified to conduct pedigreed seed crop inspection.

Partial Systems Audit - an audit carried out on specific components of a quality system that affect the ability of the system to comply with the SPRA standards and QSPs and with the requirements of an Act and Regulations. The partial system audit may be carried out in conjunction with the surveillance audit.

Surveillance Audit - an audit that examines elements of a quality system that are specifically related to the QSP for the delegated activity, including the verification of completed procedures and conducting an evaluation of the competency of personnel in relation to a SPRA standard and relevant QSPs.

Supplier - for the purpose of this QSP, supplier means:

an applicant;
an authorized body.

3.2 Abbreviations and Acronyms

AOSCA - Association of Official Seed Certifying Agencies

CSGA - Canadian Seed Growers' Association

OECD - Organisation for Economic Co-operation and Development

QSP - Quality Systems Procedure

SPRA - Seed Program Regulatory Authority

4.0 GENERAL REQUIREMENTS

This authorized seed crop inspection service monitoring and auditing QSP is designed to provide reasonable assurance that the operation of an authorized seed crop inspection service meets or continues to meet or exceed the initial authorization standard. This is accomplished by performing audits of the applicant/inspection service and the candidate/licensed inspector. The performance of each is to be rated by the auditor(s) and the frequency of subsequent audits will be determined from the performance. Detailed checklists to conduct the audit, and actions when a non-conformance or non-compliance is detected, are provided in this QSP. The framework under which the audits are to be conducted is given in this QSP and in the CFIA Program Audit Protocol.

Delegation of the inspection of pedigreed seed crops is given only where authorized seed crop inspection services have an audited quality system in place. Prior to any pedigreed seed crop inspection system being formally authorized, an initial complete system audit is to be undertaken to verify the implementation of the documented pedigreed seed crop inspection quality system. Subsequent complete and partial system audits will be conducted as required.

5.0 COMPLETE SYSTEM AUDIT - PARTIAL SYSTEM AUDIT

A complete system audit will establish the conformance of the pedigreed seed crop inspection service's performance to its quality system. A complete systems audit is carried out on each applicant prior to recognition as an authorized pedigreed seed crop inspection service. A complete systems audit may be required to reinstate an authorized pedigreed seed crop inspection service that has been suspended. The objectives of the complete system audit are elaborated in Appendix I. A partial system audit confirms the on-going conformance of the pedigreed seed crop inspection quality system. The normal audit level is one partial system audit per year. The audits are cost-recoverable.

6.0 INSPECTION PROGRAM AUDIT PLAN

The audit shall be planned and implemented according to this QSP, SPRA 141 Inspection Agency Requirements for the Delivery of the Pedigreed Seed Crop Inspection Program, and the principles outlined in the CFIA Program Audit Protocol. It must take place while the pedigreed seed crop inspection system is functioning. Partial system audits are carried out on each authorized seed crop inspection service according to the frequency established by Section 6.5 of this QSP.

6.1 Audit Team

6.1.1 Lead Auditor

The audit team should be led by an auditor who is qualified as required by SPRA141 Inspection Agency Requirements for the Delivery of the Pedigreed Seed Crop Inspection Program and the CFIA Program Audit Protocol. The lead auditor shall have successfully completed an International Organization for Standardization (ISO) accredited Lead Auditor training program.

6.1.2 Technical Expertise

Additional audit team members should be certified as Advanced level crop inspectors with the Licensed Inspector Monitoring specialization (once implemented) or Intermediate level crop inspectors, in the absence of the Advanced level program implementation. Where the lead auditor also meets these latter requirements, additional audit team members are unnecessary.

6.2 Preparing for the Audit

For the complete system audit, all portions of the quality system should be evaluated.

Using the checklist for the complete system audit in Appendix VII, Sections 1, 8, 9, 10, 13, 16 and 17 should be highlighted as the initial elements of the quality system to review for a partial system audit.

The reports from previous partial system and surveillance audits should be used to identify areas requiring the verification of implementation and effectiveness of previous corrective actions. In addition, the recurrence of non-conformances over time may result in their reclassification.

6.3 Conducting the Audit

Preparation and conduct of the partial system audit should be performed by following this QSP and the principles outlined in the CFIA Program Audit Protocol. Following the guidelines for a complete system audit found in Appendix VII, the audit should be initiated by looking at:

Section 1 - Management Responsibility
Section 8 - Product Identification and Traceability (where applicable)
Section 9 - Process Control
Section 10 - Inspection and Testing
Section 13 - Control of Nonconforming Product (where applicable)
Section 16 - Quality Records as they relate to required documentation
Section 17 - Audits

If all of these elements are in conformance, the audit may be suspended and the audit report generated. If one or more non-conformance is encountered in the above elements, the following elements should be incrementally considered:

Section 18 - Employee Training and Qualifications
Section 12 - Inspection and Test Status (where applicable)
Section 15 - Handling and Storage
Section 6 - Purchase Control
Section 5 - Documentation

If Employee Training and Qualifications, Inspection and Test Status and Handling and Storage are in conformance, the audit may be suspended. Any non-conformances must be classified according to Section 6.4.

Where the seed crop inspection service is using the ISO 9001 :2000 format, Appendix VII may be used to identify the equivalent required elements for audit.

6.4 Classification of Non-Conformances

Any non-conformances identified during the audit are to be classified using Appendix III. The non-conformances will be classified as indicated below.

"Critical"

An activity that is in direct contravention of either a required procedure and/or a condition of authorization;
An activity that is in direct contravention of the CSGA Circular 6 and its amendments.

"Major"

A required systems element not addressed;

"Minor"

An isolated incident of non-conformance within a system or with a procedural requirement that has no immediate or direct consequential effect on the quality of the pedigreed seed crop production;
Deficiency trends of little significance when isolated cases are found but that could lead to a negative impact on the quality of the pedigreed seed crop, and are considered to be a major non-conformance if more than three incidents are encountered.

Note: Where more than two minor non-conformance are identified within an audit, every three minors are to be classified as one major non-conformance. Where the same minor non-conformance has been identified in the two previous audits, it is to be reclassified as a major non-conformance. Where more than two major non-conformances are identified within an audit, every three majors are to classified as one critical non-conformance. Where the same major non-conformance has been identified in the two previous audits, it is to be reclassified as a critical non-conformance.

For critical or major non-conformances, the audit team must consult QSP 142.2 Authorized Seed Crop Inspection Program to determine if a suspension or cancellation of authorization is required. If so, the audit team will immediately inform the National Manager, Seed Section of their findings.

For all other major non-conformances and all minor non-conformances, a corrective action request must be given to the authorized seed crop inspection service in a manner that is consistent with the CFIA Program Audit Protocol.

Corrective action(s) for minor non-conformances are to be confirmed by the auditor as having been implemented during the next audit and, for major non-conformances, will be implemented in accordance with QSP 142.2 Authorized Seed Crop Inspection Program. The Corrective Action Request Form is found in Appendix VIII.

Where a corrective action is not implemented within the required or agreed upon time frame, the classification of the non-conformance is elevated one level and a new corrective action request is issued.

If a non-compliance with the Seeds Act and Regulations is discovered during the audit, refer to Appendix IX for guidance. The auditor must complete Appendix V and retain the completed document with the company's file at the CFIA office.

6.5 Establishing Audit Frequency

6.5.1 Application

This procedure is applied once an audit has been completed and when the auditor needs to calculate future audit frequency. This procedure also provides guidelines for appropriate corrective action time frames.

6.5.2 Responsibilities

The auditor has overall responsibility for the application of this procedure and any need for a subsequent partial systems audit as a result of any identified non-conformances is to be negotiated with the authorized seed crop inspection service at the exit interview.

6.5.3 Actions

Once the non-conformances have been classified, the audit frequency for the authorized seed crop inspection service can be calculated using Section 6.5.4.

The time frames for the next audit are to be used as guidelines when negotiating a timetable for corrective action on minor non-conformances.

6.5.4 Subsequent Audit Frequency

All authorized seed crop inspection services will initially be subject to audits at a "normal" frequency rate:

Normal - At least one partial system audit annually;
Tightened - At least one complete systems audit and any number of partial system audits as required, until all critical and major corrective actions have been implemented and verified by an auditor.
Reduced - One partial system audit every second year. This is granted based on exemplary performance (no non-conformances or non-compliances observed for two consecutive audits).

7.0 INSPECTOR SURVEILLANCE AUDIT PLAN

While the complete system or partial system audit concentrates on the quality system of the authorized seed crop inspection service, a surveillance audit is to review and verify that completed seed crop inspections were done in accordance with the relevant QSPs and SWIs. During the surveillance audit, which includes individual check inspections, the auditor is primarily concerned with the activity and competency of the licensed seed crop inspector. The identification of non-conformances will be based on a comparison of the licensed seed crop inspector's inspection reports, against those of a CFIA inspector. The audits are cost recoverable.

The surveillance audit or ‘check inspection' is directed by the regional seed officer and conducted by one or more auditors as described in Section 7.1. When the regional seed officer meets the requirements outlined in Section 7.1, he may conduct the audit. The intent is to have a CFIA inspector inspect randomly selected crops for which the licensed crop inspector has filed Reports of Seed Crop Inspection. The frequency of surveillance will be established according to Section 7.5.

Surveillance audits will be limited to the inspection activities pertaining to pedigreed seed crop inspection. The audits will not encompass any additional inspection activities requested by the client of the authorized crop inspection service unless specific arrangements have been made in consultation with the CSGA and Seed Section.

7.1 Audit Team

7.1.1 Lead Auditor

The lead auditor shall be certified as a crop inspector at the Advanced level with the Licensed Inspector Monitoring Specialization (once implemented) or Intermediate level, in the absence of the Advanced level program implementation.

7.1.2 Technical Expertise

In addition to the lead auditor, individuals that have been certified as Intermediate level pedigreed seed crop inspectors. The audit team must be familiar with the crop kind(s) for which the seed crop inspection service has been authorized.

7.2 Preparing for the Audit

Determination should be made if there are crop specific procedures to which conformance must be verified.

The reports from previous surveillance audits should be used to identify areas requiring the verification of implementation and effectiveness of previous corrective actions. In addition, the recurrence of non-conformances over time may result in their reclassification.

7.3 Conducting the Audit

Selection of crops for 'check inspection,' may be performed from the documentation submitted on crops inspected by the licensed seed crop inspector. This documentation will include all Reports of Seed Crop Inspection, rough notes, and a copy of the completed application form. No later than three days after completion by the licensed seed crop inspector, the selected 'check' inspections should be assigned to the auditing inspector. The auditing inspector must be provided with a copy of the completed application highlighting which crops they are to inspect and with blank Reports of Seed Crop Inspection. The surveillance audit should be conducted as soon as is practical after the original inspection. Upon receipt of the CFIA inspector's report, the General Verification of Submitted Documentation checklist in Appendix II is used to confirm the accurate completion of the Report of Seed Crop Inspection by the licensed seed crop inspector.

7.4 Classification of Non-Conformances

Any non-conformances identified during the audit should be classified using Appendix III. If further guidance is required for classification of non-conformance, the auditor may refer to QSP 142.4 Official Crop Inspector Certification Procedures, Appendix IV. The non-conformances will be classified as indicated below.

"Critical"

An activity that is in direct contravention of the CSGA Circular 6 and its amendments;
An activity that is in direct contravention of an accepted pedigreed seed crop inspection procedure and will have a consequential effect on the quality of the pedigreed seed crop.

"Major"

An activity that is in contravention of an accepted pedigreed seed crop inspection procedure and may have a consequential effect on the quality of the pedigreed seed crop;
A required company procedural requirement is not met.

"Minor"

An isolated incident of non-conformance within a system or with a procedural requirement that has no immediate or direct consequential effect on the quality of the pedigreed seed crop;
Deficiency trends of little significance when isolated cases are found but that could lead to a negative impact on the quality of the pedigreed seed crop, and are considered to be a major non-conformance if more than three incidents are encountered.

Note: Where more than two minor non-conformances are identified within an audit, every three minor non-conformances are classified as one major non-conformance. Where the same minor non-conformance has been identified in the two previous audits, it is to be reclassified as a major non-conformance. Where more than two major non-conformances are identified within an audit, every three major non-conformances are classified as one critical non-conformance. Where the same major non-conformance has been identified in the two previous audits, it is to be reclassified as a critical non-conformance.

Corrective action(s) for minor non-conformances are to be confirmed by the auditor as having been implemented at the next audit and, for critical and major non-conformances, prior to the reinstatement of a suspended crop inspector's licence, where applicable, or as soon as it is feasible to do so.

For critical and major non-conformances, the audit team must consult QSP 142.2 Authorized Seed Crop Inspection Program to determine if a suspension or cancellation of licence is required. If so, the audit team will immediately inform the National Manager, Seed Section of their findings. Where a suspension of licence is recommended, the authorized seed crop inspection service must indicate, to avoid its own suspension, who the replacement licensed seed crop inspector will be during the period of suspension.

For all other non-conformances, a corrective action request must be given to the authorized seed crop inspection service in a manner that is consistent with the CFIA Program Audit Protocol. The Corrective Action Request Form is found in Appendix VIII.

7.5 Establishing Audit Frequency

7.5.1 Responsibilities

The auditor has overall responsibility for the application of this procedure. Any need for follow up surveillance audits, as a result of any non-conformance identified, is to be negotiated with the licensed pedigreed seed crop inspector and the manager of the authorized seed crop inspection service at the exit interview.

7.5.2 Actions

Once the non-conformances have been classified, the audit frequency for the licensed seed crop inspector can be calculated using Appendix IV. The auditor must enter the number of non-conformances onto the worksheet and follow the process to calculate subsequent frequency.

The time frames for the next audit are to be used as guidelines when negotiating a timetable for corrective action on minor non-conformances.

7.5.3 Subsequent Audit Frequency

All licensed seed crop inspectors will be initially subject to audits at a "normal" frequency rate with revised audit frequencies calculated according to Appendix IV:

Normal
- where the inspector is inspecting one to five crops for hybrid corn or one to 15 crops for hybrid canola or other crop for which one inspection is required, audit level is 100%.
- where the inspector is inspecting 5-50 crops of hybrid corn or 15-150 crops of hybrid canola or other crop for which one inspection is required, the minimum inspection level is five crops for hybrid corn and 15 crops for canola; maximum of fifteen percent of crops inspected;
- where the inspector is inspecting more than 50 crops of hybrid corn or 150 crops of hybrid canola or other crop for which one inspection is required, one additional crop will be audited for each crop inspected over this level.
Tightened
- one additional crop for every non-conformance over the inspector's normal audit level.
Reduced
- where the inspector is inspecting one or two crops for hybrid corn or one to six crops for hybrid canola or other crop for which one inspection is required, the audit level is 100%
- where the inspector is inspecting 3-50 crops for hybrid corn, the number of audits required is 3; where the inspector is inspecting 6-150 crops for hybrid canola or other crop for which one inspection is required, the required number of inspections is 7
- where the inspector is inspection > 50 crops of hybrid corn or > 150 crops of hybrid canola, the inspection rate for hybrid corn is 3 + one crop for every crop in excess of 50 and for hybrid canola or other crop for which one inspection is required is 7 + one crop for every crop in excess of 150.

8.0 AUDIT REPORT PREPARATION AND DISTRIBUTION

8.1 Responsibilities

The lead auditor is responsible for preparing the audit report including Corrective Action Requests and recommendations for suspension or changed audit frequency. The lead auditor will provide written preliminary information on non-conformances and observations at the closing meeting.

8.2 Distribution

Within fourteen working days of the closing meeting, the lead auditor shall distribute the completed audit report to the:

Area Network Seed Specialist;
management of the authorized crop inspection service.

Where a recommendation for changed audit frequency is made, this will be communicated to the regional seed officer managing the program. Where a recommendation for suspension was made during the audit, the lead audit will provide a copy of the audit report to the National Manager, Seed Section.

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