Audit of the Corporate Audit Program

C

Copacetic

#1
:bigwave:Hypothetically...of course.

Imagine a corporate level audit program in an organization (>30,000 employees) which has a handful of recognized medical device products and a lot more products that will probably be considered medical devices by the FDA in coming years. As such, the corporation is less mature than one might imagine in understanding the requirements of the QSR. They are mature enough to have implemented the audit program, but not mature enough to have a comprehensive corporate quality organization, so the audit group has a small, relatively simple (15 or so SOPs) quality system to standardize the audit process and audit deliverables.

In this audit group there is divided opinion about the need to conduct internal audits of the corporate audit process (i.e the small audit delivery quality system).

Some members believe that a quality system without an internal audit process is deficient.

Some members believe that there is no need to conduct internal audits of a corporate level auditing function. The arguments being that "large, multi-national medical device organizations do not conduct audits of their corporate audit function" and "the FDA does not audit their inspection program".

I'm not sure I buy either of these arguments against auditing a corporate audit quality system, but I am assured by experienced personnel that this is the case.

These arguments to me seem both hypocritical and contrary to common sense.

I would be intrigued to hear the opinions of forum members on this topic.
 
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Q

qualityboi

#2
Re: Audit of Corporate Audit Program

The corporate audit program should be audited to ensure you get objective data for the health and management of the process. In our company we have Supplier Quality (SQE) do an annual audit of the corporate audit program. Now some folks might say that the registrar's audit should be sufficient, however, the registrar really does not know the internal workings of a company. I suggest in the spirit of improvement that the corporate audit program get audited by another competent auditing team such as either Supplier Quality or Internal Financial Audit (they are trained to do similar type audits). Even if your registrar does not require it, it is good to have an objective view in order to continually improve.
 
C

Copacetic

#3
Thank you for your response, Qualityboi :thanks:

The quality system is not audited by a registrar - it was put in place primarily to meet FDA requirements. It was designed to meet ISO 13485 requirements, too in case the need to register arises, but that is not the case yet. The quality system covers audit provision only so there are no supplier audits of the quality system either because no products/components are produced under the QMS and although auditing could be considered service provision, customers have not (yet) considered it necessary to audit the audit provision QMS.

I totally agree with your suggestion to use another audit organization (like Supplier Quality or Internal Financial Audit) to conduct audits in the name of continuous improvement. That's the philosophy I have proposed and the one that has been shot down by a colleague who came from several similarly sized corporations with significantly more maturity in the medical device field. I don't think internal audits are the whole answer to this, but the results are an important input to the Management Review process.

The corporation does not have a Supplier Quality audit group yet - I'm sure it will exist somewhere down the road, but right now each business unit that produces medical devices behaves like a separate company and has its own supplier quality program. I had proposed that an experienced auditor from one of these business units conduct our internal audit and that was rejected on the basis that "we audit you - you audit us" creates a conflict of interest. I agree that this might be an issue, but I believe the risk is much lower than not conducting an internal audit at all.

The corporation does, however, have an Internal Financial Audit entity and it's certainly an option I will explore. They have appropriate auditing technique experience and training. Again because the most of the corporation's products are not medical devices, their experience in this arena is limited, but they may be the best internal option.

The use of an external consultant to conduct our internal audit is also under consideration but, of course, that would be expensive and the debate over the need to audit the audit process arose because of questions over the true value of such an audit. Where I get stuck is how you can determine the effectiveness of the QMS during Management Review if the processes of the QMS have not been independently evaluated.

Again, thanks for your input and I really look forward to reading more thoughts on this topic.
 
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