Regulatory Authority Standard: Requirements for the Formal Recognition of Conformity Verification Bodies Providing Services in Support of the Seed Certification, Phytosanitary Certification of Seed and Seed Import Programs

SPRA Standard 231

Table of Contents

• Date
• Contact
• Review
• Endorsement
• Distribution List
• Introduction
• 1.0 Scope
• 2.0 References
• 3.0 Definitions and Acronyms
  • 3.1 Definitions
  • 3.2 Acronyms
• 4.0 General Requirements
• 5.0 Specific Requirements
  • 5.1 Organizational Requirements
  • 5.2 Organizational Commitment
  • 5.3 Services
  • 5.4 Service Management
  • 5.5 Human Resources
  • 5.6 Operators, Graders and Analysts
  • 5.7 Records
  • 5.8 Reporting
  • 5.9 Confidentiality and Security
  • 5.10 Facilities
• 6.0 Accreditation of Verification Bodies
  • 6.1 Application
  • 6.2 Evaluation
  • 6.3 Accreditation
  • 6.4 Audit
• 7.0 Suspension and Cancellation of Accreditation

Date

Version 2.0 of the Requirements for the Formal Recognition of Conformity Verification Bodies Providing Services in Support of the Seed Certification, Phytosanitary Certification of Seed and Import Programs was issued August 15, 2010.

Contact

The contact person for this Regulatory Authority Standard is the Senior Specialist, Seed Design and Delivery Office, Seed Section.

Review

This Seed Program Regulatory Authority Standard is subject to periodic review. Amendments will be issued to ensure the standard continues to meet current needs.

Endorsement

This Seed Program Regulatory Authority Standard is hereby approved.

Distribution List

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

Introduction

The Canadian Food Inspection Agency (CFIA) is the national authority for the Canadian seed certification system. Seed certification is a process whereby seed of varieties is multiplied pursuant to strict rules and controls so that the resulting seed conforms to specified requirements. These requirements include varietal purity standards established by the Canadian Seed Growers' Association (CSGA) and the physical purity, germination and disease standards set out in the Seeds Regulations. Phytosanitary certification of seed refers to the certification of seed for export as meeting the plant health phytosanitary import requirements of the importing country. The legislative authority for this is the Plant Protection Act and Regulations.

The process of seed certification involves planting known seed stocks, Crop inspection and certification of seed crops, harvesting, processing, sampling, testing, grading and labelling of the seed. In many seed certification schemes, the sampling and testing of seed are performed by employees of the certification agency. In Canada, industry personnel are accredited by the CFIA to perform these activities.

There are four designated activities essential to the formal recognition (accreditation) that recognized personnel of the seed industry are competent to perform:

• initial assessment of quality systems;
• evaluation of personnel;
• recommendation for acceptance;
• subsequent audit.

These activities are required to support the decision of the CFIA to grant and renew registrations of establishments, accreditations of graders and laboratories, and licences of operators and samplers.

1.0 Scope

This Seed Program Regulatory Authority (SPRA) standard sets out the requirements that an organization and its staff shall meet to be formally recognized (accredited) by the CFIA as competent to conduct conformity verification services in support of the Canadian seed certification, phytosanitary certification of seed and seed import programs.

NOTES

1. This standard applies to third party organizations that carry out all or part of the following verification services: assessments, evaluations, recommendations for acceptance and the auditing of establishments, laboratories, operators, samplers and graders participating in the Canadian seed certification, import and export programs.
2. Third party conformity verification organizations shall be referred to as verification bodies in this document.
3. The final decision for registration, accreditation and licensing remains with CFIA.

2.0 References

The publications referred to in the development of this SPRA standard are those identified in SPRA Standard 113.

3.0 Definitions and Acronyms

3.1 Definitions:

Assessment - the review of a quality management system upon which a recommendation for registration is partially based; this assessment may include both a review of documentation and an inspection of facilities and processes.

Assessor - an individual accredited by a verification body to assess quality systems against standards.

Audit - the process of verifying the continuing conformity to a documented quality system and compliance with the Seeds Regulations.

Establishment - a premise that has been registered as an Approved Conditioner, Bulk Storage Facility, Authorized Importer or Authorized Exporter.

Evaluation - the process of evaluating and individuals competence to complete specific tasks resulting in accreditation.

Evaluator - an individual accredited by a verification body to assess the level of knowledge and practical skills of personnel in relation to a standard.

Event reports - a report issued pursuant to section 5.8.9 of this standard describing an incident that may have severe repercussions on the integrity of the seed certification, import or export programs.

Executive Director - the functional head of the verification body.

Laboratory - a seed testing laboratory accredited by CFIA to test seed for certification and import purposes.

Registrar - the National Manager, Seed Section, Field Crop Division for establishments, operators, samplers and graders, the Director, Saskatoon Laboratory for laboratories and the National Manager, Grains and Oilseeds Section, Plant Health Division for the Canadian Phytosanitary Certification Program for Seeds.

Verification body - a third party impartial body having the organization, staffing, competence and integrity to perform conformity verification services to specified criteria. Verification services are understood to include such functions as assessing, evaluating, recommending for acceptance and subsequent audit of seed establishments, seed laboratories, operators of establishments, seed samplers and seed graders, and includes testing of seed. A conformity verification body may perform one or more of these tasks.

3.2 Acronyms

CFIA - Canadian Food Inspection Agency

CSGA - Canadian Seed Growers' Association

IEC - International Electrotechnical Commission

ISO - International Organization for Standardization

RSE - Registered Seed Establishment

SPRA - Seed Program Regulation Authority

SWI - Specific Work Instruction

4.0 General Requirements

Unless otherwise specified, ISO 17020: 1998 General Criteria for the Operation of Various Types of Bodies Performing Inspection shall apply to the verification body. In the case of laboratory assessments, the applicable provisions of ISO/IEC Guide 58 Calibration and testing laboratory accreditation systems - General requirements for operation and recognition shall apply.

5.0 Specific Requirements

5.1 Organizational Requirements

The verification body shall:

1. be legally identifiable;
2. be capable of conducting work on a national basis within Canada in both official languages;
3. be responsible for its verification activities;
4. have documented policies and decision-making procedures that distinguish between activities for which it has received formal recognition and any other activities in which the body is engaged;
5. not offer consultancies or other services that may compromise the objectivity of its accreditation process and decisions;
6. be soundly supported financially;
7. be free from commercial or any other influence that might affect its integrity.

5.2 Organizational Commitment

The verification body shall:

1. administer the procedures under which it operates in a non-discriminatory manner;
2. comply with all relevant legislation as stated in SPRA Standard 113;
3. develop, implement and make available to the Registrar(s), documented verification, audit and operating procedures based on ISO 9001 Quality Management System Requirements - Model for quality assurance in production, installation and servicing for the delivery of all services, including those for training, assessment, evaluation, accreditation and audit of assessors;
4. audit its activities to verify that they comply with the requirements of the quality system. The quality system shall also be reviewed to ensure its continued effectiveness. Audits and reviews shall be carried out systematically and periodically and recorded together with details of any corrective actions taken;
5. afford CFIA representatives such reasonable co-operation as necessary for the purpose of audits of the verification body;
6. comply with this standard and with such other requirements as may be determined as essential for the effective provision of services in support of the seed certification, phytosanitary certification of seed and seed import programs;
7. claim or infer official recognition only in respect to activities for which it has been accredited;
8. pay such fees for application, assessment, evaluation, audit, surveillance and other services as shall be determined by the CFIA from time to time, in consultation with the verification body;
9. demonstrate the ability to communicate effectively with the Registrar(s) and with the seed industry nationally;
10. not use its recognition in such a manner as to bring the CFIA into disrepute;
11. make it clear in all contracts that its recognition or any of its inspection reports by themselves in no way constitute nor imply product or system approval by CFIA;
12. endeavour to ensure that no audit or inspection report or any part thereof shall be used by industry or be authorised by industry for use for promotional or publicity purposes, if the Registrar(s) considers such use to be misleading;
13. update staff, assessors and evaluators on changes to inspection or certification requirements and quality system procedures within ten working days of the change being implemented and, in co-operation with the CFIA, update industry within an appropriate time frame agreed to by both parties;
14. in making reference to its accreditation status in communication media (such as documents, brochures, websites, advertising etc.) use only a phrase indicating they are accredited to provide CFIA with verification services in support of the program(s) for which it is accredited;
15. upon withdrawal of accreditation, take steps to ensure that no further use or reference to accreditation occurs.

5.3 Services

5.3.1

The verification body or its agent may be recognized to provide all or part of the following services in support of the registration of seed establishments, accreditation of laboratories and graders, including seed import release agents, and the licensing of seed samplers and operators of registered seed establishments:

1. review and respond to applications for the registration of seed establishments, the accreditation of seed laboratories and graders, and the licensing of operators and seed samplers;
2. assess establishments, laboratories and individuals pursuant to protocols essentially equivalent to the protocols used by the CFIA and approved by the Registrar(s);
3. evaluate the level of knowledge and, where applicable, practical skills of candidates for accreditation/licensing;
4. make recommendations to the Registrar(s) concerning the registration of establishments, the accreditation of laboratories and graders, and the licensing of seed samplers and operators;
5. audit establishments, laboratories and individuals that are recommended by the verification body and registered, accredited or licensed by the Registrar(s), to confirm ongoing compliance with the established standards, the Seeds Act and the Plant Protection Act. For the purposes of determining compliance with the Seeds Act and Regulations, samples must be taken based on internationally accepted sampling protocols.
6. report to the Registrar(s) by September 30 each year on the performance of establishments, laboratories and individuals recommended by the verification body and registered, accredited or licensed by the Registrar(s) in the previous seed year. Section 5.8.7 provides further detail.

5.3.2

Assessors and evaluators shall be accredited by the verification body and must meet the appropriate standards. The verification body must maintain objective evidence of ongoing compliance with those standards.

5.3.3

The verification body shall not delegate its responsibility for recommending establishments, laboratories, operators, samplers or graders for registration, accreditation or licensing to another body.

5.4 Service Management

The verification body shall:

1. appoint a person(s), however named, who is qualified and experienced in the areas for which the verification body has received accreditation;
2. ensure adequate technically qualified persons are available, some of whom are trained in the practice and principles of quality assurance. One or more of these staff shall be nominated to supervise the verification body in the absence of the Executive Director;
3. ensure that the establishments, laboratories, operators, graders, samplers and analysts are aware of the requirement to afford such accommodation and co-operation as is necessary to enable the CFIA to verify compliance with the requirements for accreditation;
4. ensure that evaluations of personnel for the purpose of licensing or accrediting are conducted in accordance with the following principles:
   1. practical evaluations (those not considered to be theory evaluations) will be invigilated and involve tight documentation control so as to prevent the inappropriate dissemination of evaluation material;
   2. where appropriate, evaluations will cover the range of species as requested by the candidate;
   3. where the candidate is dissatisfied with the results of the evaluation, a system will be in place to review the evaluation and allow for re-evaluation (re-write);
   4. in order to be approved by the Registrar, an evaluation must assess all required knowledge and skills components to the required level of performance and to the standards specified in the Seeds Regulations;
5. ensure that there is a clear line between the scope of services the verification body is accredited for under this SPRA standard and authorized to provide, and other activities/businesses the verification body may be responsible for when performing assessments and audits.

5.5 Human Resources

5.5.1

Individuals having responsibility for managing or coordinating the delivery of specific verification services shall:

1. be qualified in appropriate disciplines as described in Section 5.5.7;
2. have at least two years experience in the practical application of the specific service for which they manage or coordinate delivery.

5.5.2

Assessors responsible for monitoring industry quality systems not meeting the requirements of Section 5.5.7 shall be supervised by qualified assessors.

The proportion of unqualified assessors to qualified assessors shall be such as not to degrade the work undertaken. Unqualified assessors must be supervised by qualified assessors.

5.5.3

Evaluators shall have:

1. an additional year of experience to what is required of assessors in practical delivery of activity(ies) for which they are evaluating personnel;
2. training and experience in the evaluation process;
3. access to suitable facilities for the conduct of evaluations of knowledge and practical skills.

5.5.4

All staff, evaluators and assessors shall have written notification from the Executive Director of the verification body and be aware of the extent and any limitations of their responsibilities.

5.5.5

The proficiency, qualifications and training of assessors and evaluators must be documented in a register maintained as part of the verification body's quality system.

5.5.6

The verification body shall:

1. document instructions related to staff and assessors' duties and responsibilities regarding its verification activities related to the seed certification, phytosanitary certification of seed and, seed import and export programs;
2. ensure that all assessors and evaluators meet the general requirements and proficiency levels outlined in Section 5.5.7;
3. ensure assessors are provided with an up-to-date set of procedures giving audit instructions and all relevant information on verification arrangements.

5.5.7

General requirements for verification body - Human Resources

5.5.8

Verification proficiency levels

Proficiencies are defined as:

• Recall (R) - remembers the basic components and knows how to access the details through manuals, standards, procedures and legislation (open book evaluation).
• Comprehension (C) - understands concepts and can communicate them (closed book and asked to describe an area of proficiency).
• Application (A) - demonstrates proficiency in the work situation (evaluated on making decisions).
• Problem Solving (P) - able to assess unusual or undocumented situations and propose a solution that complies with the standards (evaluated on making decisions where there may be numerous answers).

The basic proficiency level is recall followed by comprehension, application, and problem solving in increasing order. A person achieving the proficiency level of problem solving shall also be able to exhibit proficiency in application, comprehension, and recall.

5.6 Operators, Graders, Samplers and Analysts

5.6.1

The verification body shall ensure and be able to demonstrate that operators, graders, samplers and/or analysts are competent to perform the activities for which they have been recommended for accreditation or licensing.

5.6.2

While it may not be possible for operators, graders, samplers and/or analysts to be totally free from commercial interest, the verification body shall be aware that commercial, financial or other pressures or conflicts might cause them to act in other than an impartial manner to pass defective product.

5.6.3

All operators, graders, samplers and/or analysts who meet the appropriate requirements shall be individually recommended by the verification body to the Registrar as meeting the proficiency requirements. The verification body shall maintain a register of these people and send a copy to the Registrar. The verification body shall ensure that it is informed of changes, and shall only submit the names of new operators, graders, samplers and/or analysts that meet the appropriate requirements.

5.7 Records

The verification body shall:

1. maintain a system to record performance, testing and audit results;
2. retain all verification records for a period of at least five years from date of issue in the case of all laboratories, establishments and personnel;
3. retain all reports as detailed in Section 5.8 for a period of at least five years from date of issue;
4. ensure all verification records are kept confidential and secure at all times;
5. ensure all assessment and audit results are uniquely identified, dated, and traceable and specify which function is being undertaken (e.g., initial assessment, surveillance audit etc.);
6. maintain records of staff, assessor and evaluator training that include:
   1. the training programs attended;
   2. the date of appointment as an assessor, signing officer, auditor, etc.;
   3. performance history;
   4. current status for all processes;
   5. appropriate refresher programs;
   6. educational qualifications;
   7. date of most recent updating of record.

5.8 Reporting

5.8.1

Reporting shall be consistent nationally and coordinated from one nominated point in the verification body.

5.8.2

The verification body shall nominate and document staff who are responsible for reports

5.8.3

The verification body shall ensure that at all times all reports are kept confidential and secure.

5.8.4

The verification body shall report annually to the Registrar(s) as described in Sections 5.8.7 and 5.8.8.

5.8.5

The verification body shall produce annually a directory of laboratories, establishments, operators, graders, samplers and analysts recommended to CFIA for registration, accreditation or licensing.

5.8.6

In addition, the verification body shall meet the reporting requirements outlined in the other SPRA standards and supporting documents that apply to those activities for which they have been formally recognized.

5.8.7

Annual Seed Industry Report

An annual seed industry report will be based on the seed year (July 1- June 30) and shall be submitted in writing by September 30 to the National Manager, Seed Section who will forward copies as appropriate. The Executive Director of the verification body shall be responsible for the report.

The report shall provide information for the seed year immediately prior and shall identify:

1. the number of audits of registered seed establishments performed by assessors;
2. statistics related to product sampling undertaken by the verification body as part of an audit program; including the detailed results of monitoring sample testing. This summary should include the number of pedigreed seed samples taken at each type of establishment and for each crop species, the number and percentage of samples that met grade and the number and percentage of samples that did not meet grade;
3. a detailed summary of critical and major non-conformances identified during audits. Specifically, the number and class of non-conformances by establishment type will be reported. For critical and major non-conformances, a summary of the percentage of audits conducted showing specific non-conformances will be provided to show industry compliance levels.

5.8.8

Annual Verification Body Operational Report

An annual report will be based on the seed year and shall be submitted in writing by September 30 to the National Manager, Seed Section who will forward copies as appropriate. The Executive Director of the verification body shall be responsible for the report.

The verification body shall report to the Registrar(s) on its operation during the previous seed year. This report shall contain the following information:

1. officers: names and status;
2. verification body management changes;
3. a summary of internal audits and reports, including the results of these audits;
4. a list of verification procedures introduced/changed (including training programs) and a brief description of the changes made;
5. detailed summary of non-conformances within the verification body identified during internal audits and corrective actions taken;
6. disputes: background, outcomes, legal action and settlements;
7. the number of audits of assessors conducted, a summary of the number and type of non-conformances noted and the number of assessors suspended/cancelled.

5.8.9

Event reports

The verification body shall report to the Registrar(s) within 24 hours any critical non conformities that come to its attention.

5.8.10

Annual Canadian Phytosanitary Certification Program for Seeds (CPCPS) report.

An annual CPCPS report shall be submitted in writing within one month of the end of each calendar year.

The Executive Director of the verification body shall be responsible for the report. The report shall provide information for the calendar year immediately prior and shall identify:

1. the number of audits of companies participating in the CPCPS program performed by assessors; and
2. a detailed summary of critical and major non-conformances identified during audits. Specifically, the number and class of non-conformance by each company will be reported.

5.9 Confidentiality and Security

5.9.1

The verification body shall ensure confidentiality and security of seed testing, seed certification, export and import information.

5.9.2

The verification body will, in the course of its duties, receive information such as market information, which is of a confidential nature. This confidentiality shall be respected at all times and be subject to a clear understanding among the Registrar(s), the verification body and the client.

5.9.3

The verification body and those providing services to them shall be made aware of the need for confidentiality and security in their work. The distribution of confidential information shall be limited to those persons whose job requires that they have such information.

5.9.4

All persons engaged in verification activities shall be issued with distinct identification.

5.9.5

The verification body shall verify all marks of conformity belonging to the CFIA or the government are used in a manner deemed appropriate.

5.10 Facilities

5.10.1

The verification body shall:

1. maintain suitable and adequate facilities to permit all necessary activities associated with verification services to be carried out (e.g., offices, typing, and record storage etc.);
2. have computer and data collection, storage and retrieval systems that are compatible with CFIA systems;
3. be able to provide information to CFIA in a format that is accessible and compatible with CFIA's own information system.

5.10.2

In addition, the actual site where an audit is performed by the verification body shall comply with the following:

1. Safety - undue risk of personal injury is not acceptable;
2. Hygiene - the site shall be sufficiently clean and not present a contamination risk to products;
3. Security - inspection material shall not be subject to any risk of substitution or of mixing with other products;
4. Space - an adequate area shall be available for inspection;
5. Lighting - shall be adequate for proper inspection, (e.g. a minimum of 1000 lux);
6. Services - labour and other necessary facilities shall be available.

6.0 Accreditation of Verification Bodies

6.1 Application

An application for accreditation as a verification body pursuant to this standard shall be made to the appropriate Registrar(s) at least ten weeks prior to its proposed starting date. The application shall include a clear statement as to the scope of the accreditation requested and such documents, including operating procedures, personnel proficiency assessment process and internal audit reports, that will enable the Registrar(s) to determine if the requirements of this standard have been met.

6.2 Evaluation

The Registrar(s) shall review the application referred to in Section 6.1 against the requirements established by this standard, shall prepare a record of evaluation indicating the extent of fulfilment of the requirements and shall notify the applicant. Where this desk audit indicates essential fulfilment of the requirements of this standard, an initial systems audit will be recommended.

6.3 Accreditation

Where the Registrar(s) confirms that the requirements set out in this standard have been fulfilled, the Registrar(s) shall recommend to the President of the CFIA that the verification body be formally recognized as competent to perform specific activities by entering into an agreement pursuant to subsection 14(1) of the Canadian Food Inspection Agency Act to accept specific recommendations from the verification body. [The Registrar(s) shall make public this decision and agreement.]

The Registrar(s) may grant a provisional accreditation to a verification body where a verification body does not fulfill all of the requirements set out in this standard, in order to facilitate the transition to full accreditation. A provisional accreditation shall be valid for a period of six months and may be renewed three times. The above noted agreement shall specify those requirements that are not immediately applicable, including those services identified in Section 5.3 that the verification body will not be providing initially.

6.4 Audit

The verification body shall agree to submit to such audits as determined by the Registrar(s) to be necessary for continuing confidence in the terms of accreditation.

7.0 Suspension and Cancellation of Accreditation

Accreditation of a verification body will be considered for suspension, in full or in part, for a specified period if:

1. an audit identifies a system failure that casts doubt on the ability of the verification body to adequately discharge its duties;
2. agreed corrective actions are not implemented within the prescribed time period;
3. assessment protocols are altered such that they no longer meet the minimum standards used by the CFIA;
4. applicable fees are not paid; or
5. requested by the verification body.

Accreditation of a verification body will be considered for cancellation, in full or in part, if:

1. requested by the verification body; or
2. an audit identifies systematic, ongoing failure to adequately discharge its duties.

Establishments, laboratories, operators, graders, samplers and analysts recommended to the Registrar(s) by a verification body and registered, licensed or accredited by CFIA will only be affected by cancellation of the accreditation of a verification body, in so far as they will have to pay annual renewal and quality surveillance fees directly to CFIA.