This Technical Specification defines the requirements for the change control of Sealed Manufacturing Routes for A|D|S Product Standards subject to Qualification Testing in accordance with TS202. This specification is applicable to the manufactures of all qualified parts listed in TS200. This is to ensure that the quality and the performance of the qualified products are maintained.
It is the responsibility of the manufacturer to inform A|D|S of any changes they wish to make to the Sealed Manufacturing Route, prior to implementation, by submission of a completed Manufacturing Change Request (MCR).
The MCR submitted by the manufacturer shall include:
- Changes being requested.
- The actual reason for change.
- Supporting risk assessment regarding implementing the change.
- Supporting test data relevant to the controlling Technical Specification for the product.
- An MCR reference number obtained from the A|D|S MCR Register, prior to submission.
The manufacturer shall make no changes to a standard product’s Sealed Manufacturing Route, including transfer of manufacture to a new site, without the approval of an MCR by the A|D|S Technical Standards Committee (TSC).
Definitions of the terms used in this Technical Specification are defined in Section 3.
- Edition:
- Issue 4
- Published:
- 01/01/2010
- Number of Pages:
- 12
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