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Case Study 3: Validation of Product Release Test Apparatus

In 1995, a major medical device manufacturer was cited by the US FDA for lack of process validation. The device was a Class III life support device. The company lacked sufficient internal resources to accomplish the validation with in a reasonable period of time. Additionally, their product design required some unique, custom assembly processes. These processes had been developed in-house. No one had ever tried to validate these unique processes. To do so would require the creation of totally new test and validation methods.

Medical Development Services, Inc. was requested by the manufacturer to supply personnel to work on a team with internal resources to accomplish the validation of all manufacturing processes. MDS was given the challenge of developing complete validation techniques for the unique processes. One such process involved a test apparatus that was used to certify the leak rate of the product.

For validation of the test apparatus, MDS first developed a unique test method for challenging the test apparatus. MDS then completed a study of the test method against known standards to determine the accuracy and reproducibility of the test method. After demonstrating excellent accuracy and reproducibility of the test method, the method was used to conduct a gage reliability and reproducibility (gage R&R) study of the test apparatus. Upon successful completion of the gage R&R, MDS wrote the Installation Qualification, Operation Qualification, and Performance Qualification protocols. The manufacturer's technicians then executed these protocols. The data was supplied to MDS. MDS wrote the validation reports. The manufacturer's personnel as well as MDS personnel approved the validation reports. The FDA reviewed the total work and found the work to be a model of how validation work should be done.

To accomplish this project, MDS personnel worked primarily at home. MDS personnel made trips to the manufacturer's facility two to three times per week. Some in-process documents were shipped via the Internet. Final documents were reviewed in Design Reviews that were held at the manufacturer's facility.

This project is hybrid between full Digital Work and traditional work methods. It shows the flexibility of the MDS business model to address specific customer needs.