World's Funniest Audit Experiences

I wanted to start a thread that was a little more on the light-hearted side. Call it a "sharing of your weirdest experiences" during an audit.

I believe, due to personal experiences, that these most likely occur when a customer comes in to assess your Quality System.

So... here is my offering, one of my personal favorites:

I was given a deviation under element 4.5 from a customer because, at the customer's request, I was unable to provide a "controlled signature sheet" so that he could verify that the signature on various documents was, in fact, THAT PERSON'S SIGNATURE! Yupper, he was looking for a sheet that had the person's typed name, with a signature next to it and initials as well.

I recall him asking me, "How do you know that this is so-and-so's signature?" I imagine he wasn't pleased with my response of, "I've worked with these people for years and I know who's signature is who's." He told me that "he didn't know." I told him that at any time, he was welcome to ask the appropriate person if that was their signature and that they would be happy to verify it for him.

Well, despite my obvious challenge to his "deviation" it still showed up in his report.

My response to him was that "no corrective action is required at this time" because "in no place in the ISO Standards is there a requirement for controlled signature and/or initial sheets" but that "documents must be approved by appropriate authority" blah, blah, blah.

It might be that you "had to be there" to appreciate the humor in our interaction that day, but, we continue to maintain the business in spite of my not "correcting" our lack of a "controlled signature sheet" as somehow, somewhere it is "required" by the Standards.

It was one of my funniest experiences... going back and forth in a serious, professional manner, all the while laughing inside at how funny his assertion was...

Hope you enjoyed my experience, do you have any "World's Funniest Audit Experiences?"

How about having an employee faint when approached by the registrar for a Q&A session, before even a word was spoken? Happened here.

ALM

[Kevin Mader]

ALM,

I had the same request, but for me it did not result in a deviation. It did make the report as a general comment (perhaps unwarranted as well). I believe that this auditor was asking for this "sheet" because of his background in auditing for the FDA. As an auditor akin to GMP guidelines, he was looking for similar items as part of our ISO surveillence audit. He made comments about the use of White Out as well. In the Medical world, seemingly ridiculous request actually have merit. Remember that these folks are acting against a Regulatory requirement, and there are many legal implications. Perhaps the similarity of the different standards can cloud an auditors mind and occasionally they ask for something that they needn't ask for. Still, it does cause folks some surprise to say the least.

Now to the funny part: as I stated earlier, the auditor had collected several bits of objective evidence where white out was used. He threw this down on the conference table in front of the President at the closing meeting. He mentioned that this was a deviation in his mind. My President looked at me with total bewilderment. Being from a background with a Medical Device company, I was aware of GMP guidelines. I queried the auditor, reminding him that in fact, he was applying the wrong standard here. He didn't back down at first, so I referred it to the Lead Auditor, who stated that I was right. The President breathed a sigh of relief. A little later, perhaps 10 minutes, I happened to notice that the audit report had an error in it. The Lead Auditor looked at my finding and went ahead to correct the mistake with his WhiteOut pen. I queried: "Is that a GMP approved WhiteOut pen?" I never saw the President swallow harder in my life. We all had a pretty good laugh though (perhaps not so funny to the auditor who brought the whole issue up). That was one for me!

Back to the group...

[Marc]

In May 1994 a client went thru their ISO9001 registration audit. I had written a document control database where document changes were recorded. All except 1. When I came to help the company the quality manual was a mess. I updated it. In the document control database I wrote "...the changes in the quality manul were so extensive that the reader will have to compare the old version to the revised version to determine the changes..." The point of this was that there were so many radical changes it would have taken 100 pages to describe every change to the original manual and to what effect? The original one wasn't used anyway.

The registrar AGA (American Gas Association) and the auditor was an ex-GM person. The auditor wrote the company up saying '...it is not easy for me to tell the changes in the two quality manuals..." I asked where it said it has to be 'easy' to tell all the changes. The auditor hemmed and hummed, etc, and finally said (as we thumbed thru ISO9000) "...well, it's implied..." Horse sh_t.

This was at the very beginning of the audit. The auditor kept the 'minor' on that but after I challanged him he did 'take it easy' the rest of the audit. This is when I learned much of this is opinion and interpretation. I now tell every client "Be ready to fight."

Lock her up, Marc...

It appears that this thread isn't generating as much interest as I hoped it would.

Seeing as I have had about a half-dozen experiences that I would call "funny" or "odd," (over the last 4 years or so) I hoped I could laugh at some others' experiences.

;-)

ALM

[Marc]

I think we can leave the thread open. You never know what will pop up. Through the years I have had this site up I have often been surprised by what does and what does not 'go'.

(Previously posted in one of the ISO forums)

Andy Bassett wrote:

They attach no value to the idea of controlling the input from their suppliers and dodge the issue by sending out bland questionnaires that are filed without even being reviewed and then thrown onto the Approved Vendor List.

My apologies for getting off-topic slightly, but I encountered the single most interesting questionnaire that I have ever received.

I am one of those who, as much as I hate it, reviews each and every bland questionnaire thrown my way.

Well, it is a good thing that I do because for the first time ever, I received a questionnaire that was designed to check and see if the person completing it... is READING IT!

A sample of the questions sprinkled throughout the survey...

a) All of you equipment is out of calibration and none of it is identified as being part of your non-existent calibration system. (YES NO)

b) Your documentation is approved for use by anybody in the company, even those not remotely responsible for said documentation. (YES NO)

c) The quality inspection procedures are available at all points of use and do not detail how inspection is to be carried out at all. (YES NO)

These are just a few examples. After doing a double-take, I burst out in a fit of laughter right there in my office.

I'd hate to be the Manager at a company who just ran down the list circling "yes" to all of the questions, stuffing it back into the envelope and into the mail!

Guess what? I have a feeling that I will be revising OUR questionnaire very, very soon.

I'm STILL laughing about it. I wrote in the final comments that it was the best questionnaire I have ever received.

ALM

[Marc]

Ah yes! The Jr High School "Read all instructions and questions before you start the test" and the last instruction/question is "The point of this test was to see if you would read the instructions and questions as directed before starting the test. You do not have to take this test. You can goof off for a while while the ones who didn't read ahead as directed take the test."

[BRoyal]

I once had an internal auditor asked me how I knew that a year was up. Had to do with the retention of records.

When I explained, he wanted to know where that was documented.

He had me.

Ben Royal