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Purpose of the Supplier Business Review SOP

Supplier Overview of Johnson & Johnson MD&D Supplier Quality Standard Operating Procedures (SOPs) Supplier Business Reviews. Purpose of the Supplier Business Review SOP.

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Purpose of the Supplier Business Review SOP

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  1. Supplier Overview of Johnson & Johnson MD&D Supplier Quality Standard Operating Procedures (SOPs)Supplier Business Reviews

  2. Purpose of the Supplier Business Review SOP • Establishes a consistent supplier Business Review process across the Johnson & Johnson Family of Medical Device & Diagnostics Companies (MD&D) • The Business Review process provides for periodic structured conversations with suppliers about their relationship with MD&D, for: • Identifying improvement opportunities • Communicating expectations • Monitoring projects, metrics and overall performance • The Business Review will result in a defined set of actionable follow-ups • The common approach will allow multiple MD&D Operating Companies to participate in a single business review

  3. Scope of the Supplier Business Review SOP • The SOP identifies both a standard process and metrics for Business Reviews • The process includes both the topics and the general process for running the Business Review

  4. Responsibilities MD&D • Ensure SOP requirements are met (in procedures & by suppliers) • Supplier Manager (SM) - execution of the Business Review, minutes • Supplier Quality (SQ) - participate in the Business Review, sign-off • SM and SQ - capture follow-ups in the Quality System • Suppliers • Account Representation and Quality Manager should be present • Preparation for the Business Review • Other J&J MD&D and supplier functions can participate, as needed

  5. Business Review Structure • Business Review Structure (four areas) • Organizational • Quality • Business • General

  6. Business Review Structure (continued) • Organizational Topics • Organizational changes: Staffing/structure changes impacting MD&D • Certifications: Latest copy of applicable appropriate certificate or registration (ISO, UL, etc.) • Training: Review supplier’s training program, including cross‐training and replacement of key positions

  7. Business Review Structure (continued) • Quality Topics • Review of Quality Agreements: Review existing quality agreements and other agreements between the supplier and MD&D • Audit Observations: Any observations or findings derived from MD&D audits, past Business Reviews or other audits or inspections • Product Quality Review: Review general issues related to product quality • Nonconformance report review: Review trends, pareto information • CAPA: Review corrective and preventive action plans for MD&D products • Compliance Update: Progress on applicable 2nd/3rd party quality system assessments (MD&D, FDA, Notified Body, etc.)

  8. Business Review Structure (continued) • Quality Topics (continued) • Change Control: Discuss planned component or related changes; consider if control plan or other updates are needed. • Sterilization Requirements and Monitoring: Review periodic activities for EMs who provide sterilized, or ready‐to‐be sterilized product • Sub-tier Supplier Performance: Review the supplier’s own supplier management program and performance of sub‐tier suppliers • Preventive Maintenance: Review PM program, spare parts, etc. • Additional Quality Metrics: Field Actions and Complaints

  9. Business Review Structure (continued) • Business Topics • General Business Discussion: Issues identified during the meeting • Continuous Improvement: Actions to address MD&D metrics • Business Continuity Plan: Organizational health and continuity plans • MD&D Owned Equipment: Discuss/review MD&D owned assets • CapacityForecast: Discuss projected demand changes vs. capacity • Inventory Levels: Discuss inventory levels/targets (for select products) • Production Schedules: Discuss impact of items such as shutdowns

  10. Business Review Structure (continued) • General Discussion Topics • Open Action Items: Review open items from previous Business Review • Records Review: Review records retention, where applicable, and alignment between MD&D and supplier revisions for key documents • MD&D Projects: Review active MD&D projects (NPD, CIPs, etc.) • MD&D SOPs: Review the supplier’s awareness of applicable SOPs

  11. Business Review Closure • Meeting minutes shall be documented with a list of action items, responsibilities and due dates • Operating Companies may review some portion of the topics in other venues (such as audits); will be noted in the minutes • Relevant documentation reviewed (such as a supplier presentation) will be attached to the meeting minutes

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