GAMP 5 - Good Automated Manufacturing Practice M6: Appendix M6 Supplier Quality Planning

Quality planning defines how a supplier, external or internal, meets the quality requirements of a new project, service or software release, setting out the approach, the tools, the controls, who does what, and the deliverables and ensuring the risk-based application of the supplier QMS; quality agreements and other contractual documents define the responsibilities and measures at an objectives level so that suppliers serving many customers can address them within their own QMS, and the output may be held in IT tools, a quality plan, a project plan, a service level agreement or a release plan, with medical device software considering IEC 62304. Planning considerations cover the life cycle approach, risk management including customer input for customer projects, organization and third-party governance, specification and whether customer requirements enter the core product or become custom development, design and configuration records and configuration management, traceability, build with source code management, coding standards and code review tools, testing with risk-based planning, tester independence, tools and automation, defect management and regression, release management with acceptance criteria and authorization, installation and deployment verification, data migration and verification, acceptance responsibilities and leveraging of supplier testing, IT tools and their assessment and data integrity controls, records and document ownership and management, deliverables, project change management and transition at handover, handover to the support organization with knowledge transfer, reporting of progress, issues, risks and quality metrics, project audits, and training; and for projects involving multiple organizations, roles, dependencies, timescales, joint activities and deliverable responsibilities are made clear to all parties.