A common challenge that medical device manufactures face in maintaining a high level of supplier quality is the lack of adequate and appropriate change control reporting to manage changes made to products or processes. In order to ensure that no unnecessary changes are made, all changes are evaluated appropriately, and that resources are used efficiently, a systematic approach and robust change control notification contract must be developed. Ensuring that all involved parties understand and follow the encompassed requirements is essential to the success of the manufacturer.
- Developing a vigorous change control contract
- Identifying the scope of changes that must be reported
- Tactics to ensure supplier behavior alignment with contract
Associate Director, US Quality Assurance