Who is responsible for CAME Amendment - Part M AMC M.A.704 (6)

[Paulius]

Dear all

Yesterday I and CAMO postholder were discussing who’s responsibility to amend CAME. According Part M AMC M.A.704 (6) Unless otherwise agreed by the approving competent authority, the person responsible for the management of the quality system or for the organisational review should be responsible for monitoring and amending the exposition, including associated procedures manuals, and the submission of proposed amendments to the approving competent authority.

but

AMC M.A.712(b) Quality System 2. An essential element of the quality system is the independent audit.


So how it be, who should be responsible for the CAME the QM or CAMO postholder.

If QM, in this case we would have nonconformity to AMC M.A.712(b) (2).

I need your advice.

[Shell Management]

It is clearly a job for the QA Manager as anyone with a clue about ISO 9000 would know.

[Ghostdancer]

The CAME is owned by the CAMO. I would suggest that the CAMO is responsible for the processes and procedures defined in the document, and the Quality Manager's role is one of administration and verifying compliance with the Regulations.

In the UK, the submission of the CAME and amendments is generally expected to be made by the Quality Manager of an Organisation.

In my current company, the CAME is endorsed by the CAMO Manager as the manual owner, approved by the Quality Manager, and authorised by the Technical Director. The manual is then submitted for Approval by the Quality Manager to the Regulator.

[Shell Management]

@ghostdancer

I think you have misunderstood what independence is. The QA Manager is part of the CAMO, he owns their quality system, which includes both owning the procedures and owning the independent audit programme. Department heads should never own the procedures as they will naturally write out as many defences as they can to aid production.

[Ghostdancer]

Nope. No misunderstanding.

The CAME is owned by the CAMO. The Quality Manager is totally independant of the CAMO and reports directly to the Accountable Manager. See TGL 44 IEM OPS 1.035, Quality System Organisation Examples, the diagrams are explicit.