Supplier Overview of Johnson & Johnson MD&D Supplier Quality Standard Operating Procedures (SOPs) Supplier Business Reviews
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 2 The common approach will allow multiple MD&D Operating Companies to participate in a single business review
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 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
Business Review Structure Business Review Structure (four areas) ―Organizational ―Quality ―Business ―General 5
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 6
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 2 nd /3 rd party quality system assessments (MD&D, FDA, Notified Body, etc.) Business Review Structure (continued) 7
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 Business Review Structure (continued) 8
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 Capacity Forecast: Discuss projected demand changes vs. capacity Inventory Levels: Discuss inventory levels/targets (for select products) Production Schedules: Discuss impact of items such as shutdowns Business Review Structure (continued) 9
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 Business Review Structure (continued) 10
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 11