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Quality by Design: Incoming Acceptance Activities of Purchased Materials

Components and raw materials have to be carefully selected, using the requirements of the device as a guide. Components should be chosen so that they will not be over-stressed and will be compatible with the internal device environment, as well as the external environment that the device is expected to encounter during manufacture, distribution and use. The components should then be appropriately tested, alone and as part of the device, utilizing the specifications established for the component and the device. New components or components used in an unusual application will usually need extensive evaluation. This evaluation should include parameter and life testing as well as compatibility testing for both the internal and external environment. Well-known industry standard components that are used in their normal application and that are not over-stressed will need only minor testing, which is usually an integral part of the verification of the device design. A record of any component verification testing should be maintained. This record should include the component identity and the testing methods that were used, as well as the actual test data and results.

Having Qualified Suppliers is a Fundamental Step

A major factor in obtaining high quality components and raw materials for the manufacture of orthopaedic devices is the selection of competent suppliers. Although a manufacturer's knowledge of supplier operations may be limited and information about the operations difficult to obtain, the cGMP-QS Requirement that a manufacturer is responsible for quality remains undiminished. To the maximum extent feasible, selection and qualification of these suppliers by audits, performance analysis, acceptance criteria being met, etc., should be an integral part of the quality management system. If a company does not have the capability to test components for conformance to specifications, then supplier test data or outside lab results are acceptable provided that components are tested and inspected in a statistically valid manner to show their acceptability for use in the finished device. Any outside test results should be accompanied by relevant raw data used for the test so that judgments of authenticity may be made by the finished device manufacturer. Excluding a supplier whose components are unreliable from supplying components may help prevent problems with the products.

Acceptance Procedures

Written instructions are necessary to assure that components, manufacturing materials, etc. are properly identified, processed and stored when received. Written inspection and test procedures are necessary to prescribe the acceptance activities performed, the dates when acceptance activities are performed, the results, the use of a signature of the individual(s) conducting acceptance activities for the proper authority and, where appropriate, the equipment used. A device manufacturer shall establish and maintain procedures to ensure that all purchased and otherwise received product conform to specified requirements and establish and maintain procedures for acceptance activities. The manufacturer shall assure that all lots of components or other products are accepted, sampled, tested and/or inspected using written procedures. The design verification procedures (originally coming from the design process) usually may be used to develop production test procedures. The procedure should specify items to which it applies, product characteristics to be inspected/tested, acceptance/rejection criteria, validated test method(s), data forms, sampling plans and the necessary test inspection equipment and tools.

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