Can I audit processes I've established but do not implement or maintain?

Mark Meer

Trusted Information Resource
#1
There is a QMS requirement that internal audits "shall ensure objectivity and impartiality", and that "auditors shall not audit their own work".

Here's the situation: Years ago, I authored procedures for purchasing & supplier control based on our input quality system standard requirements (ISO 13485), and our own internal needs. I developed all supplementary training work instructions and forms, and was one of the persons responsible for authorising the documents for use.
I then delegated persons to train and implement so, for the last few years, I've not been involved with the process, with the exception of monitoring vis-a-vis internal audit outputs and management reviews.

Question: Can I justify performing an internal audit, given that I'm not involved in any of the actual activities at this point, but despite the fact that I am the original author of the current documents being used? Would this be a violation of the "objectivity and impartiality" or "not audit own work" requirements?

According to our ISO requirements, internal audits are intended to (paraphrased) (a) check conformity to the QMS standard, and internal & regulatory requirements; and (b) confirm effective implementation and maintenance. Perhaps I could do (b), but not (a)?
 
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Mark Meer

Trusted Information Resource
#3
As an external auditor, I would have no problems with that setup. Actually, you as the process designer and subject matter expert would be in a prime position to ascertain if the process is working as intended.
That is my feeling as well...but am still not sure.

On the one hand, as you say, given that I established the process, and am very well-versed in all the requirements, I'm in arguably one of the best positions to audit. Also, as manager of the overall quality system, I have an invested interest in improvement, and ensuring things are operating correctly & efficiently.

However, on the other hand, the original Standard's requirements were presumably instated because people are sometimes not critical or bias to processes they have a hand in -- they can have "blind spots" that a completely impartial auditor would (presumably) not have.

Given that all the activities ultimately stem from procedures I developed, it may be difficult to argue impartiality...and insofar as I'm double-checking the procedures to confirm that all Standard, regulatory, and internal requirements are still covered, I would technically be auditing my own work. Tough to make a case that the ISO requirements are not being violated, despite the case for great qualification otherwise.
 
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#4
Question: Can I justify performing an internal audit, given that I'm not involved in any of the actual activities at this point, but despite the fact that I am the original author of the current documents being used? Would this be a violation of the "objectivity and impartiality" or "not audit own work" requirements?
Objectivity? Impartiality? You might be too hard on your written work! As far as not auditing your own work? It's NOT your work is it? Make certain you demonstrate the former 2 requirements by careful planning (checklist preparation or similar) and the second won't be a problem.
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Given that all the activities ultimately stem from procedures I developed, it may be difficult to argue impartiality...and insofar as I'm double-checking the procedures to confirm that all Standard, regulatory, and internal requirements are still covered, I would technically be auditing my own work. Tough to make a case that the ISO requirements are not being violated, despite the case for great qualification otherwise.
Mark, authorship of the procedure is different from deploying it and performing the activities required. I don’t agree you would be auditing your own work in the context of the ISO standard.

As for the possibility of the process itself, as designed, failing to address some of the legal and voluntary requirements, you would think the external auditors would be doing their jobs.

Seems to me you are overthinking this.
 

John Broomfield

Staff member
Super Moderator
#7
Mark,

It seems to me that you’ve designed a process and written it’s procedure so others can work the process as specified by your procedure.

You are independent enough to audit the process (the work itself), but audit should not replace verification and validation of the process design.

And you are not independent enough to audit the effectiveness of the design as made manifest by your procedure.

What you could do is obtain independent verification and validation of the design and invest in monitoring of the process against your procedure.

But I could not truly audit (as in being impartial) a process that I had designed but you may be professional enough to still be an objective auditor.

John
 
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