Supplier Overview of Johnson & Johnson MD&D Supplier Quality Standard Operating Procedures (SOPs) MDD-013 Supplier Business Reviews
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1 Supplier Overview of Johnson & Johnson MD&D Supplier Quality Standard Operating Procedures (SOPs) MDD-013 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 J&J 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 J&J MD&D Operating Companies to participate in a single business review 2
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 3
4 Responsibilities At a minimum, the supplier s Account Representation and Quality Manager should be present for the Business Review The supplier should involve additional functions in the Business Review, as needed The supplier is responsible for preparing for the Business Review The supplier is responsible for any supplier-owned action items resulting from the Business Review 4
5 Business Review Structure The Business Review Structure covers four primary areas: Organizational Quality Business General 5
6 Organizational Topics Organizational changes: Staffing/structure changes impacting J&J MD&D Certifications: Review latest copy of applicable certificates or registrations Training: Review supplier s training program, including cross training and replacement of key positions 6
7 Quality Topics Review of Quality Agreements: Review applicable quality agreements and/or other agreements between the supplier and J&J MD&D Audit Observations: Any observations or findings derived from J&J 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 CAPA: Review applicable corrective and preventive action plans Compliance Update: Review progress on relative to applicable 2 nd /3 rd party quality system assessments 7
8 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: Review Field Actions and Complaints 8
9 Business Topics General Business Discussion: Review important issues not covered in other parts of the meeting Continuous Improvement: Review supplier scorecard (if applicable) and performance/actions relative to J&J MD&D metrics Business Continuity Plan: Review organizational health and business continuity planning J&D Owned Equipment: Discuss/review J&J MD&D owned assets Capacity Forecast: Discuss projected demand changes vs. capacity 9
10 Business Topics (continued) Inventory Levels: Discuss inventory levels/targets (for select products) Production Schedules: Discuss impact of items such as shutdowns J&J MD&D Sustainability Standards: Discuss supplier sustainability efforts Financials: Review financials including outstanding items and aging inventory Contract Review: Review supply agreement (if applicable) Conflict Minerals: Review Conflict Minerals Compliance, if applicable 10
11 General Discussion Topics Open Action Items: Review open items from previous Business Review Records Review: Review records retention, where applicable, and alignment between J&J and supplier revisions for key documents J&J MD&D Projects: Review active J&J MD&D projects J&J MD&D SOPs: Review supplier s awareness of applicable SOPs Supplier Feedback: Capture feedback from the supplier 11
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