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GM1 to AMC 20-189 — PR management

ED Decision 2020/010/R

Typically, PR processes include the following aspects:

1.         PR Recording: a means to document problems resulting from the execution of life-cycle processes.

2.         PR Classification: a means to classify PRs prior to the time of approval of the product or of the ETSO article, as early in the life cycle as practical. While early classification may be preliminary, it will help to focus attention on PRs with a potential safety or functional effect, as well as process PRs that may impact the development or development assurance processes.

3.         PR Assessment: a means to assess the effect of having a PR remain open at the time of approval. The assessment of PRs classified as ‘Significant’, ‘Functional’ or ‘Process’ would typically be performed by a review board. The assessment of PRs classified as ‘Life-cycle data’ may be performed within the peer-review process instead of a review board.

4.         PR Resolution: a means to correct or mitigate PRs prior to the time of approval, as early in the life cycle as practical. The PR resolution process may depend on the classification of the PR; for example, shorter closure loops could be set for PRs classified as ‘Life-cycle data’.

5.         PR Closure: a means to close PRs, which includes the review and confirmation of the resolution of the problem, and indicated through a documented authorisation process (e.g. Change Control Board sign-off).

[Amdt 20/19]