Supplier Qualifications
A major factor in obtaining high quality components is the selection of suppliers. Although a manufacturer's knowledge of supplier operations may be limited and information about the operations difficult to obtain, the GMP requirement that a manufacturer is responsible for quality remains undiminished. To the maximum extent feasible, selection and qualification of suppliers by audits, performance analysis, etc., should be part of a quality system. If the manufacturer 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 final device and is certainly worthwhile as a cost reduction effort.
It is important to remember that raw components acquire cumulative value as they are processed through receiving, assembly, test, inspection, and as they ultimately become part of the finished device. If a component fails during assembly, or as part of the device, additional costs will be incurred for fault isolation, removal, replacement, inspection, testing, etc. When field failures occur, the ultimate cost of the component becomes even higher because its replacement requires travel, trouble-shooting, and retrofit. In addition, customer dissatisfaction, user injury, product liability action, medical device reporting, or regulatory action may result. Usually, the initial cost of a component is relatively insignificant compared to the later cost should the component prove to be defective or improper for the selected use. Many recalls occur because manufacturers fail to qualify components properly or to assure that a supplier's manufacturing methods and quality system are adequate.