Supplier Overview of Johnson & Johnson MD&D Supplier Quality Standard Operating Procedures (SOPs) Cascade of Specifications and CTQs* to Suppliers *CTQ – Critical to Quality 1

Purpose of this SOP MD&D To cascade Critical to Quality (CTQ) requirements from the device level down to the component and dimensional/functional level, ensuring the supplier is aware of them and that they are integrated and controlled within the supplier’s manufacturing process The key expectation is that suppliers monitor and control the CTQs within their process Device Component Dimension/ Functional Supplier’s Process Supplier

Scope The SOP begins with known MD&D product specifications and critical (CTQ) characteristics required for the function of the device and ends with the capture of those characteristics in the supplier’s specifications and control plans This SOP is not about how to establish MD&D specifications and CTQs This SOP is about ensuring that known MD&D specifications and CTQs are integrated and controlled in the supplier’s process

Responsibilities MD&D Suppliers Ensure SOP requirements are met (in procedures & by suppliers) Communicate CTQs, specifications and risks to suppliers Ensure that specifications, CTQs and risks are captured in the appropriate quality system documents Suppliers Understand MD&D CTQ requirements Ensure that specifications and CTQs are captured in appropriate documentation Integrate robust practices for monitoring and controlling CTQs

Key Terms CTQs (Critical to Quality): Attributes that are critical to acceptable performance of a product, process, component, etc. Specifications: Attributes of products, processes, components, etc. defined to meet customer needs and expectations

Key Requirements - Prerequisites Prerequisite - In advance of cascading CTQs and specifications to suppliers, MD&D Operating Companies will identify product specifications and CTQs following procedures outside of this SOP. A team approach will be used, with suppliers involved where appropriate. Product specifications and CTQs will be captured in formal documentation (such as drawings) Specifications and CTQs shall be reviewed during development in technical review sessions or other stage‐gate milestones The team will establish CTQs and specs for the product/process CTQs/specs will be translated into any needed additional technical requirements. Suppliers will be involved in this process, as needed. Specs and CTQs will be established at the product/process, sub-assembly and component level, as needed. Completed specs will be reviewed to confirm which specs are critical. Documentation will indicate which dimensions are critical.

Key Requirements (continued) Documented specifications, technical requirements and CTQs, will be clearly communicated to suppliers for use in their internal specifications, product/process control plans, etc. This can be done using Requirements Reviews, drawings, etc. Applicable device features will be reviewed with suppliers in order to provide an understanding of functionality and risks This may include a review of the overall device and its performance. It is important that the supplier knows the device and the risks that the products the supplier is providing could pose to the functionality of the device. It is important that the most severe failure modes are communicated to suppliers.

Key Requirements (continued) Specs and CTQs will be translated into the supplier’s documents, including Control Plans and Risk Management documents (such as FMEAs), to ensure there are methods to monitor these items throughout the life of manufacturing. Specifications/CTQs, technical requirements, critical specifications, etc. must be reviewed periodically by the supplier, to ensure they are current Updates may be required Revisions must be communicated to the MD&D Operating Company, prior to implementation, for appropriate approval

CTQ Identification in Supplier Control Plans Op-Seq No. Process Name Machine Device Tools Characteristics Special Char Class Methods Product Process Product/Process Spec Eval Method Sample Plans Control Method Reaction Plan Size Freq Who 10 Incoming raw matl NA 416 AISI SS R2015-01 Cond. A Supplier Cert Each lot Rec. Insp. Lot Control PO # Q-tine pending disp. 0.130” +/-0.001” 0-1” mic. Per RSI-027 20 Screw Machine Setup ACME 0.750” Length ∆E +/-0.003” 5 pcs. At startup FA Inspector Cal. Main-tained Job does not run until insp. approve Critical dimensions or features should be indicated on the supplier control plan based on methods agreed to between the supplier and the MD&D Op Co