Key Tenents
Program Design
The program consists of a set of aligned practices designed with all sizes and types of organizations in mind. The Components are outlined in two sections:
1) Core Components which apply to all participants and include a required core set of product and quality considerations
2) Conditional Components which are applicable based on an Assessment of internal operations and include four subsections focused on potential impact areas. These include:
A) plant characteristics
B) market scope and trade considerations
C) regulatory environment
D) stakeholder/value chain transparency and engagement.
For conditional components, only those relevant to an organization’s operations would be expected to be developed, implemented, and verified. The core components, and the applicable conditional components based on the assessment, are confirmed through an independent verification process.
Section 1 – Core Components
This is comprised of a basic Quality Management System (QMS). This QMS includes a core set of product and quality considerations that comprise basic management activities to be implemented and verified for all program participants. The core components include required actions relating to documentation, training, and maintaining plant product integrity [1]. Importantly, this section is not intended to be prescriptive. Organizations of any size and complexity will develop and implement these activities based on their own operations, business objectives, and organizational needs.
Section 2 – Conditional Components
This is a set of additional required actions contingent upon the organization’s assessment of its activities as it utilizes PBI. This section is fit for purpose and scalable to meet the complexity, size, and scope of participating organizations, their use of PBI, and as appropriate for their products [2]. The verification will include a review of an organizations process to complete the assessment.
The assessment is a set of evaluative, principal-based questions designed to assist an organization in developing and implementing appropriate activities based on the utilization of PBI methods in developing products, the regulatory environment in the country/region(s) of development and commercialization, nature of the crop utilized, market scope, and value chain and stakeholder engagement and feedback. Using the assessment, a set of applicable conditional components are identified by the participant to implement from research and development through commercialization operations as appropriate. Those additional activities would integrate into and strengthen existing quality systems.
This assessment should be conducted at the timing most appropriate to the organization’s operations. The assessment should be done at the beginning of the research and development process, or when a PBI derived plant product may be integrated into the product pipeline, so timely decisions and actions specific to the product’s development and intended use can be taken. Organizations should conduct activities based on specific characteristics and intended use of the product after the initial assessment and then conduct an additional assessment to review its management approach/plan as deployment or intended use may be more fully determined. If assumptions or inputs to the assessment change, an additional assessment should be completed.
Verification Process
PBI MP 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. A Verification Guide[3] has been developed to provide guidance to program participants undertaking these verifications.
The verification is at an organization level and each program participant will work with their verifier to determine the sites/operations which will need to be included in the verification process. These will include headquarters and additional on-site activities related to PBI work that may be relevant to the program. The verifier will verify and document, by examination of objective evidence[4], if the organization has established and implemented appropriate measures consistent with the program objectives. 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.
Note: For those organizations also participating in the Excellence Through Stewardship program, only one audit would be conducted to cover the required activities for both programs. GSG staff will work with these companies to ensure a seamless transition to work with both programs.
[1] For the purposes of this document, “product integrity” means establishing and maintaining the specific identity of a plant materials and the purity of that plant material product using appropriate quality management measures.
[2] Product(s) may refer to a specific product being developed, a product line, or a group of similar products. Product, within the context of the PBI MP, is not limited to products that have been commercialized. Examples of products may include donor plants including a characteristic obtained by PBI provided by a tech developer (multinational or start-up) under license to breeding/seed companies. Seed company will multiply, process and sell seeds containing a specific trait obtained through PBI. Products can be breeder seeds, basic seeds, commercial seeds. Research institutions may use PBI during their research programs, they will handle PBI-derived products including seed and plant material. This is differentiated from “harvested crops” which may then be and end use, exported, or further processed. This also includes clonally propagated plants.
[3] The Verification Guide has been developed by the PBI Working Group.
[4] For the purposes of this document, objective evidence refers to Information an organization can show to prove, or demonstrate, that certain systems, policies, or programs are in place.
