Change Control for new Equipment at new Project

Quality Assurance
1

Is it mandatory to raise Change Control for new Equipment at new Project ? Because there is no any change/addition, all are related to new.

Thanks

2

It is not mandatory to raise Change proposal for new equipment at the new facility unless the existing facility is discontinued and shifted to the entire new facility and new equipment. In that case, the Change proposal would be for the entire facility including new equipment.

3

Thanks sir for the valuable response.

4

Yes, Introduction of new equipment at new project, should be drive through change control. The reason for Change control will be introduction of new equipment at new project, and all other activities related to new equipment will be captured in CCR. This all liked to what your SOP says for new equipment introduction. accordingly all asset register and site master file will be updated, taking reference of CCR.

5

Thanks Sir for the valuable feedback.+

6

You definitively need to assess the risks of changing that equipment; how to do that and document it, depends on how your QMS (quality management system) is implemented.

If the former (initial) equipment introduction was controlled via a change control, this change control included an evaluation of risks involved in that activity (new equipment) and the actions (controls) that were needed to mitigate those risks, for example: area cleaning, equipment qualification, personnel training, etc.

If you are to change that equipment, whose risks were previously evaluated; you need to reassess risks involved with this new equipment; otherwise, you will not document either the purpose of the change nor the risks involved with it (some risks associated with former equipment may not exist anymore, some could be different, or there could be new risks)

Imagine if this new equipment you want to introduce requires to open a hole on the facility to install it, because it is significantly larger than the previous one, and that could impact other systems like existing manufacturing lines, or damage to utilities, lay out modifications, etc.

When there is a change in a project that is handled via change control; you need to update the risk asessment of that change control, and update the action plan accordingly to include additional actions to mitigate new risks (or eliminate actions that are not needed anymor due to change in the project). For example, a second revision/version of the change control, its risk assessment and action plan.

7

Many Thanks sir for the very descriptive explanations.

8

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