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.

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!

Hi Everyone

Really love the site.

Here’s my chuckle

During the registration audit, in one of my past lives, we had a lead auditor in who was very personable and you just couldn’t help but like the guy. Employees just naturally warmed to him and he kept exclaiming about how knowledgeable our employees were.

We were walking through an area on our way to check the second shift of a line we had interviewed earlier. He saw a guy walking and said that he would like to ask him about our quality policy. Before I could stop him, he had the man cornered and was asking about the quality policy. As I vainly tried to interrupt, the man pulled a business card out of his wallet and reads our quality policy to the auditor. The auditor quickly asks (as I am doing everything but standing on my head to try to interrupt the conversation) if the employee can tell him what that means to him.

The guy answers and says that “it is important that we all do our job correctly so that the next guy on the line and the customer always get what they need when they need it.” The auditor asks if the man feels that is what really happens, and the response is “Oh sure, this is a great bunch to work with, they are really great.”

The auditor asked the man to sign the interview sheet and we walked away as he repeated once again how knowledgeable our employees were. I just did not have the heart to tell him he’d just interviewed one of our customers’ truck drivers, in for his daily pick-up.

[quote=chandra]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…
[/quote]

Well, I hope I dont sound like a party crasher, but in all the places I had worked, they had a “Signature catalog” document that includes all of that information.

So… in my experience, one day an auditor from a buyer went to the quality control laboratory. He was quite an agressive and annoying little man. He entered the laboratories slamming doors and then, almost shouting, he pointed to “Mr. Somebody” (names had been edited to protect the involved parties), and the next dialog started:

Angry auditor: Hey you, over there… yes, you… I want you to answer some questions…
Mr. Somebody:Ye…yeah, s…ssure…
Angry auditor: Do you know how reagent must be separated and storaged?
Mr. Somebody: (insecure)But… I… I dont…
Angry auditor: So you dont know?.. then, look at this and tell me what it is (showing a black and white copy of a NFPA 704).
Mr. Somebody: (nervous)I…Its the thingye that shows how dangerous are things? right?
Angry auditor: Thingye… huh? then wich color should be here? (pointing the left side).
Mr. Somebody: (sweating heavily and ice cold)Red?
Angry auditor: NO!!, it is blue… and here? (pointing to the upper side)
Mr. Somebody: (hyperventilating)Blue?
Angry auditor: NOOO!! ITS RED!!!
Mr. Somebody: (almost blacking out).

Angry auditor: (with a fiery red face)THIS…This is the kind of ignorant people that works in your quality control lab?
Quality assurance director: (stone cold)No, he works in packeting, just came by for some results…
Angry auditor: (now ivory white) Yeah…? well… he should be capacitated for being here…
Quality assurance director:So… we need a SOP for just being at the entrance of the laboratory?
Angry auditor: (looking at last were mr. somebody was standing and that he was dressed in a different way that the ones really working on the laboratory)Well…I… umm.
Quality assurance director:So you say…
Angry auditor: (mumbling) …anyway… it is a deviation…

[quote=chandra]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.[/quote]

this is also happened to me. when i try to registered for new product, the NADFC (National Agency of Drug & Food Control) asking me bout controlled signature sheet, they told me to write the name below the signature…and i think they right…becoz they (the auditor) dont know who is the person that sign the document…probably to prevent someone from copying other person signature…maybe…i dont know also…

but this is my funny story when i was audit by the NADFC :
back then that was the first time i was having experience being audit and i still dont know anything. the funny is NADFC give some advice that against the rule that they made…funny right…
and may i ask you all something…is it right/proper if the auditor say in front of auditee like this : “THIS IS FATAL…VERY FATAL”.
one thing i know becoz i already join auditor training that the auditor should not say something like that in front of the auditee…if auditor see something wrong, they will tell us “what was the “right” is” or give us some advice to fix the “wrong”. right?:rolleyes:
funny huh…

I do not find his audit observation all that odd. In fact, a signature log, with all employees’ (who sign documents) full signature + inital signatures is indeed a standard requirement. This signature log is used for precisly the reason that he (the auditor) stated. Hence, unless you have such a complete signature log you are, in fact, out of compliance with GDP.

It’s a little frightening that most of these posts are from Quality Personnel. The records we create are legal documents which are admissible in a court of law as evidence of compliance with the federal Food, Drug and Cosmetic Act and the codification of that law (or 21 CFR) + I’m sure multi other international laws. GDP for these records is therefore expected. So, if you think a signature card is silly, try opening a bank account without one. Insist it’s ok for the bank to not have it on file. Same for whiteout… whip it out next time you’re trying to get a car loan or a home mortgage and see how well that gets accepted. I’m not a lawyer, but I believe the alteration of a record by obliteration (white out or other) could be construed as fraud since it is hiding the original entry.