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Can You Internally Audit a Process You Own?

chetws

Starting to get Involved
#22
People. Stop. Lets get back on track with the OP... @chetws
I can help, I think. I too work in a small 60-70 person company and wear several hats every day. I own the audit process and I do 98% of auditing. I do not have an assistant like you do. Sooooo, I trained my co-worker next to me to audit effectively. He typically only audits me and helps satisfy the objectivity requirement.

So my suggestion is choose just 1 person who has no involvement at all in your process. Train them to audit your process. And you're done. Annnd, NO, you cannot audit your process that you own if you are the one tasked with performing the process.

Heck, even I could audit you for that matter.... Over the phone, and send evidence I suppose. Anyone agree or disagree with that? Has anyone done that??

OMG, I opened another can of worms!
It's nice to see someone out there feels my pain. Your situation, Crusader, pretty much mirrors mine. As you know from experience, working for a smaller company means that getting just one person to audit one process can be a monumental task. In the past, our internal audits were not done according to schedule. The person that has traditionally assisted the ISO manager isn't very easy to work with when it comes to scheduling as she has other things to do as well. Now she wasn't entirely at fault for the audits not done, as my predecessor was very lazy about this as well. Thus, I would like to do as many of the internal audits as possible to ensure the job gets done.

I am the owner of the QA process, but I don't do a lot of the day to day work in the lab (unfortunately as that's the part of QA I like the most). That primary responsibility is the plant chemist. Now I do work in the lab if he's on vacation, jury duty, etc, but the plant chemist really does the bulk of the job. Perhaps I could audit the work he has prime responsibility for (the QA lab), and then he could audit the 9001 clauses that I am directly responsible for, such as internal auditing and corrective actions. I would rather work with the plant chemist being that we work together a lot better. This looks possible as long as I can audit QA. It sounds like you do a similar thing at your company.

Thank you much :)
 

chetws

Starting to get Involved
#23
This is out of hand. It is an old topic which has been discussed many times in discussion threads here over the years anyway. Some contentious posts have been removed from view.
Hi Marc,

I did search old posts on this topic, but old posts didn't address specific situations like mine. I agree that there were a few posts that were surprisingly contentious, but I very much appreciate that you didn't lock the thread the thread over that like many other forums would have.

Keep in mind that what sounds like an old, tired, rehashed topics to seasoned veterans is fresh and new to those of us starting out. I don't know anyone who works as a QMS manager to bounce ideas off of and ask "what if" type questions to figure out how to improve my companies QMS, so this forum is a valuable resource. Plus, there's a lot of interpretation involved with ISO 9001. Reading the several points of view on this thread were helpful to getting a feel for how the standard is typically interpreted. While the contentious posts were unfortunate, I very much appreciate (and learned a lot) from the many thoughtful posts.
 
#24
Hi Marc,

I don't know anyone who works as a QMS manager to bounce ideas off of and ask "what if" type questions to figure out how to improve my companies QMS, so this forum is a valuable resource.
you can ask me since we are in very similar situations....I too will start mixing chemicals since our chemist recently left the company.
 

Marc

Captain Nice
Staff member
Admin
#25
Hi Marc,

I did search old posts on this topic, but old posts didn't address specific situations like mine. I agree that there were a few posts that were surprisingly contentious, but I very much appreciate that you didn't lock the thread the thread over that like many other forums would have.

Keep in mind that what sounds like an old, tired, rehashed topics to seasoned veterans is fresh and new to those of us starting out. I don't know anyone who works as a QMS manager to bounce ideas off of and ask "what if" type questions to figure out how to improve my companies QMS, so this forum is a valuable resource. Plus, there's a lot of interpretation involved with ISO 9001. Reading the several points of view on this thread were helpful to getting a feel for how the standard is typically interpreted. While the contentious posts were unfortunate, I very much appreciate (and learned a lot) from the many thoughtful posts.
The discussion was reported. My review - In my opinion it was getting personal and somewhat contentious, so I did what I felt best to control it. It's an internet forum. Contentious discussions occur from time to time.

I reviewed your starting post and don't see a problem with it. It has been discussed before, but many topics, especially those related to calibration and document control, are asked about again, often many times. Not typically an issue.

I will say that your situation isn't unusual. We have discussed auditing in small companies, some as small os only 3 people. The responses in this discussion to this point do, I feel, give you good information for your consideration.
 

atitheya

Involved In Discussions
#26
I am the QA and the QMS manager for a small manufacturer with less than 40 full time employees. Thus I own the QA process and the Internal Audit process. There is an assistant auditor who normally audits the QA process being that I own that process. The problem is that we have no one to audit the Internal Audit process because the assistant auditor audits the QA process, while I audit all the others. There isn't an uninvolved third auditor to audit the internal audits. There will not be a third auditor ever because, as those of you who work at a small company know, everyone wears multiple hats and is already spread thin. I'm lucky to have one person available to audit one process at all.

My question: is it possible to internally audit a process you own given the lack of personnel at a small company?
Ask your top management to audit the Internal audit process and other such processes where you feel you or your assistant auditor should not be auditing.
 
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