Long shot- Any Quality Managers here? (Medical devices pref)
Discussion
Seeking any insight from any Quality Managers (and to be honest MDs etc) of manufacturing/engineering operations who have gone through a site closure...
I am the QM and our site will cease production end of Q3 and finally close doors end of Q4 once the decommissioning of the equipment etc is complete. Production will be transferred to Meh-heeeee-co, and Engineering ownership to the States.
Anyhow, from a QA point of view, am I missing anything in terms of my focus for the closure, going with (in no particular order):
Records
- Design History Files etc
- Calibration/equipment qualifications and decommission
Manufacturing risk for remaining units
- disaffected employees etc; sad to consider it as we have a good bunch, but must nonetheless
Materials risk
- suppliers not so engaged as they know future business from us is out of question)
Registations with notified body (i.e. BSI)
- Already given them notice, so no further inspections
Appreciate this may have a minimal target audience... but any thoughts would be appreciated
I am the QM and our site will cease production end of Q3 and finally close doors end of Q4 once the decommissioning of the equipment etc is complete. Production will be transferred to Meh-heeeee-co, and Engineering ownership to the States.
Anyhow, from a QA point of view, am I missing anything in terms of my focus for the closure, going with (in no particular order):
Records
- Design History Files etc
- Calibration/equipment qualifications and decommission
Manufacturing risk for remaining units
- disaffected employees etc; sad to consider it as we have a good bunch, but must nonetheless
Materials risk
- suppliers not so engaged as they know future business from us is out of question)
Registations with notified body (i.e. BSI)
- Already given them notice, so no further inspections
Appreciate this may have a minimal target audience... but any thoughts would be appreciated

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