Purpose of the Receiving Inspection SOP

1. Supplier Overview of Johnson & JohnsonMD&D Supplier Quality Standard Operating Procedures (SOPs)Receiving Inspection Process for Components and Finished Devices

2. Purpose of the Receiving Inspection SOP • Define a consistent set of requirements for the inspection of incoming Components and Finished Devices for the Johnson & Johnson MD&D Operating Companies • Refers to the receiving inspection activities by MD&D • Does not impact how MD&D Suppliers and External Manufacturers receive items into their facility

3. Scope of the Receiving Inspection SOP • Applicable to components and/or finished devices intended for salable release • Applicable to all qualified components intended to be part of a finished medical device, and applicable to finished devices

4. Responsibilities • Responsibilities for Receiving Inspection (RI) activities must include, but are not limited to: • Performing receipt activities • Executing the receiving inspection activities • Executing the disposition of materials as required • Nonconformance initiation for components and/or finished devices being inspected at RI

5. Key Requirements • Approved Supplier Controls • Controls to prevent acceptance from unapproved suppliers • Packaging/Shipping requirement verification • Part number, quantity, method, damage • Component/Finished Device traceability • Identification & traceability maintained throughout the RI process • Document Verification – supplier documentation • Each Op Co will establish requirements for supplier documentation (e.g. Packing slips, Certificates) and verify presence and accuracy • Incoming component or Finished device inspection • Each Op Co must have a procedure which outlines incoming component or finished device inspection requirements

6. Requirements - Inspection Plan • An approved inspection plan must be created for each component or finished device that is to be inspected • The inspection plan will define what attribute(s) of the component or finished device will be inspected and the sampling plan • Established quality characteristics that have been identified as critical-to-quality (CTQ) should be included in the inspection plan If a component or finished device is being moved from dock-to-stock/ship direct status to a receiving inspection status then the choice of inspection strategy needs to be reconsidered, as the circumstances (e.g. NCs, CAPAs) may influence the strategy

7. Requirements – Sampling Plans • If sampling is performed as part of receiving inspection then an approvedsampling plan must exist • Sampling plan requirements are separated into two groups: • (1) itemized and (2) non-itemized (bulk)

8. Sampling Plans – Itemized • Sampling plans for itemized components or finished devices should use the latest version of national or international standard procedures, (e.g. ANSI/ASQ Z1.4, ISO2859, etc.) • When designing the sampling plan, the Op Co is to consider: • the criticality of the component or finished device, • the process capability associated with the characteristic inspected, • the risks to the consumer and producer, and • the defect class/risk level

9. Sampling Plans – Bulk • When sampling non-itemized or bulk components, the MD&D Operating Companies will define the requirements to collect and test a representative sample from the bulk • MD&D Operating Companies will communicate specific guidance and requirements when non-itemized or bulk components are to be sampled

10. Inspection Requirements • Inspection requirements must be detailed in the inspection plan • Inspection activities may take place at the supplier, at a contractor’s site, at the MD&D receiving site, or at another MD&D site • A list of inspection plan elements is included in the SOP • Includes verification of things such as correct identification of the purchased item, expiry information and packaging configurations

11. Additional Requirements • Additional specific requirements can be found in the SOP on the following: • cGXP requirements (current Good Manufacturing, Laboratory and Documentation Practices) • EH&S Requirements • Recording of Results • Lot Disposition • Increased Inspection Activities • Inspection of multiple lots from the same supplier lot