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

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 2

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 3

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

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 5

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 approved sampling plan must exist Sampling plan requirements are separated into two groups: ―(1) itemized and (2) non-itemized (bulk) TermDefinition ItemizedCountable and defined at a unit level Non-itemized (Bulk) Not countable (Instead, are defined as a bulk lot of material). Examples include liquids, powders, reels, etc.

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