Purpose of the Supplier Process Control SOP

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

2. Purpose of the Supplier Process Control SOP • The MD&D Supplier Process Control SOP defines the requirements for creating and maintaining a supplier process control plan • The supplier control plan • Documents required controls for a supplier’s process • Documents agreement between MD&D and the supplier • Is adhered to throughout the life of the product • Is updated as process steps or controls are modified A control plan is used to ensure controls are in place to minimize variation and ensure conforming product

3. Scope of the Supplier Process Control SOP • The supplier control plan SOP begins with activities associated with receiving in raw materials; through all in‐process steps, sub‐tier operations, and inspection; and ends with shipping product to MD&D • The supplier control plan reflects • Process inputs and outputs which are monitored, and • Monitoring and control methods that will be used • The Control Plan does not replace the information contained in detailed operator instructions or production/workflow documentation, rather it is to be consistent with those types of documents

4. Key ResponsibilitiesAdditional detailed responsibilities can be found in the SOP MD&D • Ensure SOP requirements are met (in procedures & by suppliers) • Communicate CTQs (Critical to Quality), specs and risks to suppliers • Ensure supplier controls are adequate • Approval of supplier control plans • Suppliers • Create and maintain control plans • Maintain associated documentation (reaction plans, etc.) • Ensure MD&D approval of control plans

5. Key Requirements • The supplier can use their own Control Plan format if it includes the items in the MD&D Control Plan Template • A multi‐disciplined team, from both the supplier and MD&D, is established to develop the Control Plan • The control plan must be maintained throughout the product’s lifecycle, reflecting all steps used from receipt of raw materials through shipment to MD&D • Controls should be appropriate to ensure the materials used are as specified. This is particularly important for devices that are implantable or for components with significant tissue/patient contact.

6. Key Requirements (continued) • The control plan shall control risks identified in the risk management documentation with the type of control based on the severity of the risk to the patient • Throughout the life of the product (component or finished device), evaluations are to be done to assess ongoing manufacturing capability. Where long-term capability is achieved, and risk to the patient/customer understood, an evaluation may be completed to reduce the sample size and/or frequency of the control. It is suggested though, that the control remain in the control plan albeit at a reduced frequency, lower sample size or different measurement method. • The information in the control plan should align with all other necessary engineering documents (such as raw material specifications, prints, functional requirements/tests, etc.).

7. Supplier Control Plan -Consolidates and Summarizes the Following: Engineering Drawings DFMEA and PFMEA Monitoring and Controls Process Flow Diagram

8. Major Steps in Supplier Control Plan Development*A complete list of steps can be found in the SOP. The MD&D Control Plan template contains instructions for each section of the template. Obtain relevant documentation (drawings, PFMEA, Process Flow Diagram, supplier control plans for similar processes) Develop or obtain component PFMEA and Process Flow Diagram to confirm process steps Evaluate each process step (from PFD/PFMEA) and document all sections (process step, characteristic, specification, evaluation method, sampling plan, control method, reaction plan) Review, approve and store the control plan (with revision control) The development of the supplier control plan will be an iterative process during product or component development.

9. Supplier Control Plan Overview Characteristics (and specifications) to be monitored & controlled Process Step Identification From Process Flow or PFMEA Product Characteristics – important product features after the process has been performed Process Characteristics – variables in the operation that, when controlled, will reduce variation in the Product Characteristics

10. Supplier Control Plan Overview (continued) How will you monitor the characteristics? (Who, When, How) The Evaluation method is a trigger for the Reaction Plan Sampling should be based on the variation in the process.

11. Supplier Control Plan Overview (continued) How is the process controlled? Focus on processcontrol (prevention), over product control (detection) Common Controls: Control Charts, Error Proofing, Final Inspection and Test, Parameter/Tool Change Logs Consider dominant sources of variation (setup, materials, etc.)

12. Supplier Control Plan Overview (continued) What to do about out-of-spec or out-of-control Detailed Reaction Plans are often found in reference documents or work instructions Typical reactions are contain, record, inform, investigate, adjust