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Introduction

This Verification Guide provides an overview of the verification processes to be used in conjunction with the Verification Checklist (Appendix A). The processes outlined in this document should be adapted to the specific needs of the organization, its structure, the activities being verified, the product(s) involved and the relevant product markets.  Individual situations will vary according to the needs of each organization.

 

I. Verification Objectives and Scope

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Participation in the PBI Management Program is encouraged for all companies and institutions involved in research, development, or commercial activities for plant breeding innovation products. Program participants commit to an independent third-party verification of the implementation of management programs and quality management systems consistent with the objectives of the program. This is in addition to the routine practice of self-assessment of the effectiveness of quality management systems.

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The Verification Guide was developed to provide guidance to program participants undertaking these verifications. Verifications are at a systems level; the verifier is expected to verify and document, by examination of objective evidence, if the program participant has established and implemented appropriate management and quality management systems consistent with the PBI Management Program objectives. The verifications are not designed to measure the technical merit or operational performance of the systems once the systems are verified as appropriately designed and implemented. 

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The Verification Components included are: 

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Core Component 1: Quality Management Systems/ Product Integrity

Core Component 2: Product Characterization

Conditional Component 1: Crop/Plant Biology

Conditional Component 2: Market Scope

Conditional Component 3: Regulatory Environment

Conditional Component 4: Stakeholder Engagement and Feedback

 

Core Components are relevant to all program participants while one or more Conditional Components may be required based on factors included in the Program Assessment (see PBI Assessment Guide). For example, an organization may limit its business to research and development whereas another organization may have multiple integrated functions bridging from laboratory to breeder and distribution.

 

This Verification Guide introduces the subject of the verification, including how to prepare for the verification. The Guide also provides example verification checklist questions and objective evidence for each component that a verifier may observe during the verification. For each of the checklist questions, the verifier will confirm that related systems, procedures, and/or work instructions are in place.

 

II. Verification

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A. INTRODUCTION

An organization level verification is systematic and independent; verifying by examination of processes that applicable elements of the system are appropriate, documented, and implemented in accordance with program objectives. Other key characteristics include:

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• Verification will be conducted by 3rd-party independent verifiers trained on the program objective by the Global Stewardship Group (GSG).

• Participating organizations will be verified on a 3-year cycle basis.

• Verifiers will use the Verification Checklist (sample verification checklist questions are included in Appendix A) to conduct the verifications. These include questions on each program focus area and are designed to show if a participating organization is meeting its commitments outlined by the program.

• Verifier and participating organization will assess the organization’s PBI related operations and develop an appropriate plan for the verification. Verification will cover both headquarters and, as appropriate, a representative sample of additional auditable operations (i.e. laboratories, green houses, field sites, etc.).

• Where applicable, a single program audit, which will cover joint and unique characteristics of each program, will be sufficient to cover multiple Global Stewardship Group (GSG) programs (i.e. ETS and PBI Management). GSG Staff will work with each participant that is enrolled in multiple programs to ensure their existing ETS audit plan and the PBI MP verification requirements are aligned. 

 

 

Steps in the Verification Process:

 

 

 

 

 

 

 

B. VERIFICATION PROCESS

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1. CONDUCT INTERNAL REVIEW

Prior to scheduling the verification, the organization should conduct an internal review of its relevant operations based on the programs’ focus areas. An organization should consult the Verification Checklist in Appendix A when conducting the internal review or audit. Additional considerations when conducting the internal review:

 

1. Current regulatory and statutory environment for organizational activities

2. Internal process performance metrics

3. Location/site physical changes or staff changes

4. New product/service launches

5. Recent product failures and/or recalls

6. Significant changes to location/site quality management system

7. Third party verification  

 

In addition to the Verification Checklist organizations may refer to the Internal Audit Checklist – Appendix B for additional considerations.

 

   2. VERIFICATION PLANNING AND SCHEDULING:  

Following completion of the internal review and filling gaps identified during the review process, an organization can begin planning for the program verification. Utilize the Verification Planning/Scheduling Checklist included in Appendix C to assist in preparing for and scheduling your verification. Additional considerations when planning and scheduling your verification:

 

      2.1 Availability of appropriate staff at site/location on the audit day

      2.2 Processes taking place on the audit day

      2.3 Logistics for both staff and auditor including necessary travel arrangements

      2.4 Preferred communication methods between staff and auditor

 

 

   3. VERIFICATION PREPARATION

The verifier will contact the program participant to initiate a pre-verification consultation to ensure there is a common understanding of the process and to jointly determine the specific scope and checklist for the verification. The consultation discussions must include:

 

      3.1 Documents and records to be examined prior to the assessment

      3.2 Site safety requirements (if applicable)

      3.3 Significant business factors currently affecting the organization

      3.4 Previous verification/audit results and follow-up (if applicable)

      3.5 A verification/audit plan including the roles/responsibilities of each party and the language used during the verification

      3.6 All matters related to confidentiality and information sharing

 

The purpose of the initial contact is to:

 

• Establish communication channels with the program participant’s representative;

• Confirm the authority of the verifier to conduct the verification;

• Verify the Checklist version to be used, including scope of the verification based on the organization’s activities;

• Provide information on the proposed timing and verification team composition (if applicable);

• Request access to relevant documents, including records;

• Determine applicable site safety rules and orientation requirements;

• Make arrangements for the verification; and

• Agree on the attendance of observers and the need for guides for the verifier.

           

The verifier should prepare a verification plan that provides the basis of the agreement between the verifier and the program participant. This plan should be reviewed and accepted by the program participant before the on-site verification activities begin. The plan should confirm the following:

 

• The verification objectives;

• The verification criteria and any reference documents;

• The verification scope, including identification of the organizational and functional units and processes to be verified;

• The dates and places where the on-site verification activities are to be conducted;

• The expected time and duration of on-site verification activities, including meetings with the program participant’s management;

• The roles and responsibilities of the verifier, the verification team members and accompanying persons (if applicable);

• The allocation of appropriate resources to critical areas of the verification;

• Identification of the program participant’s representative for the verification;

• The working and reporting language of the verification where this is different from the language of the verifier and/or the program participant;

• The verification report topics;

• Logistical arrangements (travel, on-site facilities, etc.);

• Matters related to confidentiality; and

• Any verification follow-up actions.

 

Prior to the on-site verification activities, the program participant’s documentation identified during the initial meeting may be reviewed. The documentation may include relevant management system documents and records, and previous verification reports.  The review should consider the size, nature, and complexity of the organization, and the objectives and scope of the verification. 

 

The verifier and program participant should specify document confidentiality, retention, and destruction requirements in the formal agreements between these parties. The verifier should review, handle, and retain program participant documents exclusively and in strict accordance with those agreements.

 

4.VERIFICATION EXECUTION

On the day of the verification the verifier will hold an opening meeting and review the verification plan with the organization’s participants. Any changes to the plan will be agreed upon and the schedule adjusted accordingly. After any pertinent adjustments the verifier will allow time for questions by the participant then execute the plan according to the agreed upon schedule. During the verification the verifier will:

 

4.1.      Utilize checklists to collect organizational information as appropriate

4.2.      Examine procedures, protocols, and any other relevant documentation related to the scope and objectives of the verification

4.3.      Interview organizational staff and examine processes in real time as they occur (if applicable)

4.4.      Discuss findings and observations as they occur and provide real time feedback during the verification

4.5.      Conduct a closing meeting to discuss all findings and observations and share with the organization’s participants

4.6.      Agree upon verification report receipt date and resolve any differences of opinion prior to the closing of the audit day

 

1. Opening Meeting

The verification should commence with an opening meeting to:

• Confirm the verification plan, scope and timelines;

• Provide a short summary of how the verification activities will be undertaken;

• Provide an opportunity for the program participant to provide relevant site and/or organizational overviews;

• Confirm closing meeting times (e.g., daily and overall);

• Confirm communication channels; and

• Provide an opportunity for the program participant to ask questions.

 

2. Collecting Information and Sampling for Objective Evidence

During the verification, information relevant to the verification objectives, scope and criteria should be collected by appropriate sampling and should be verified. Only information that is verifiable may be used as verification evidence and this should be recorded. The sources of information chosen may vary according to the scope and complexity of the verification and the organization. 

 

Verifiers will use their existing procedures for collecting objective evidence. Records, procedures and processes that are used to document, establish and/or verify systems relevant to the subject of the verification will be sampled. If more than one site or geographic location is involved, these sites or locations should also be visited for the purpose of collecting objective evidence. 

 

Verification evidence should be evaluated to determine whether quality management systems for the outlined activities are in place. The determination should be summarized by the verifier to indicate locations, functions or processes that were verified. If included in the verification plan, individual verification determinations and their supporting evidence should also be recorded.

 

There must be sufficient objective evidence to confirm the establishment and implementation of the program participant’s management programs and quality management systems. Determinations and their supporting verification evidence should be recorded and then reviewed with the program participant to obtain acknowledgement that the verification evidence is accurate and that the determinations are understood. Every effort should be made to resolve any differences of opinions concerning the verification evidence and/or determinations, and unresolved points should be recorded.

 

3. Closing Meeting

A closing meeting, chaired by the verifier, should be held to present the verification findings and conclusions so that they are understood and acknowledged by the program participant. Minutes of the meeting, including records of attendance, should be kept.  Any differences of opinion regarding the verification findings and/or conclusions between the verifier and the program participant should be discussed and, if possible, resolved during the closing meeting. 

 

The program participant should have the opportunity in the closing meeting to ask for clarification around verification findings and to respond with additional objective evidence as appropriate. If differences of opinion are unresolved, the divergent opinions should be recorded. The verifier should indicate that a detailed verification report will be prepared and sent to the program participant within a specified number of days.

 

   5. VERIFICATION REPORTING

The verifier will send a draft verification report no later than the agreed upon timeline to the organization’s participants. Additional considerations for verification reporting:

 

      5.1 Review the report’s findings and observations

      5.2 Communicate to the verifier any discrepancies or differences of opinion, if any that are contained in the report

      5.3Continue to communicate with the auditor until all matters are resolved and the parties have reached agreement on the findings and observations outlined in the report

 

   6. VERIFICATION FOLLOW UP AND CLOSURE

The organization will consider all findings and observations in the report and implement improvements as needed.

 

1. Implement corrective measures as needed

 

   7. PROGRAM RECOGNITION

The verifier, after ensuring any needed corrective measures have been undertaken by the organization in order to be successfully verified has been completed, will formally close the verification. With agreement from the organization the verifier will submit a summary report to the Global Stewardship Group (GSG). Formal recognition by the GSG will occur once all required verifications have been completed and appropriate verification reports submitted.