Please review and critique our new Document Control Procedure

[wooden nickle]

Please help, we are a small start up medical device specification developer. We intend to have contractors manufacture our devices for us. Our Quality Department has developed the attached Document Control Procedure for us to follow. Please critique and advise. Thank you all in advance for your help.

[rickpaul01]

Hi,
In appendix 3, what are the 4 classes?

[yodon]

I've always found that it's easier to separate (management of) quality system docs from product docs. This is especially important to consider when discussing record retention.

I wouldn't recommend naming names for approvals - just stick to roles. That way if the people change, you don't have to rev the doc.

I've never been a big fan of a document list. It's pretty common practice (but not required). To me, it's always been more a trap for not keeping updated. But if it works for you, it's fine.

You say you're a spec developer but you have a considerable amount of manufacturing documents (e.g., routers) described. May not be necessary. You don't need to define your CM's procedures / documents; only ensure that they comply with regulations. There is an 'interface' with the DMR & DHRs so you have to address those; but you shouldn't need to go deeper.

I did see a rather humorous typo in 6.1.6: you said documents would be on the "sheared" intranet. I don't know if your intranet has gotten too wooly and needs shearing.

[dbulak]

Looks good. You have a master log which is good. Check 6.1.6, not sure about "sheared." Maybe shared?

[wooden nickle]

Appendix 3 defines who must sign off on the submitted document.