C
Copacetic
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.
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.