World's Funniest Audit Experiences

#1
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
 
Elsmar Forum Sponsor

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#2
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

Hunkered Down for the Duration
Staff member
Admin
#3
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."
 
#4
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

Hunkered Down for the Duration
Staff member
Admin
#5
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'.
 
#6
(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

Hunkered Down for the Duration
Staff member
Admin
#7
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."
 
B

BRoyal

#8
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
 
D

David Guffey

#9
This is an expose on myself.

Early in my auditing life with an aerospace OEM, I was a team member on a second party audit at a major computer OEM. Wanting to establish myself, I asked for something as I expected to see it. Needless to say, I was properly challenged. I could not point to any requirement in any standard to defend my position. I could not point to any internal requirement at this supplier to defend my position. You can guess where they shoved this "finding".

My lead auditor was a blessing. He let all of this transpire, fully knowing what the results would be. What a teacher he proved to be. For, never again have I cited something just because I wanted to see it that way. And, I have always shared this with my auditor students to demonstrate the importance of knowing and adhering to a standard.

Want the kicker? After all that, this supplier did think that what I had pointed out was a good idea and they put "it" into practice.

Oh, to be humbled...
 
L

Laura M

#10
Didn't notice this thread until todays earlier post...I have lots of stories, but this is my favorite. Can any one top this?

Initial assessment -3000+ company, so there were 4 auditors. As management rep, I was on call with my guides to page me if NC's are sited. My boss stayed away except for a periodic walk by and "how we doing?"(which was fine with me, because he couldn't answer one question correctly in my opinion, but that's another story...)
Anyway, we were in a N/C material review area. One of my internal auditors noticed a rather small unidentfied box of material on the floor while the auditor was interviewing employees of the dept. She happened to be wearing a long skirt, and "straddled" the box. Along comes the boss - motions "come here" and she wouldn't budge. She just shook her head no. He kept insisting.. face turning red.. getting mad.. and she didn't move. Probably another one of those "you had to be there" - but we always told him, trust us, we know how to handle the audit! Not much arguing after that! ;)
 
Thread starter Similar threads Forum Replies Date
Jim Wynne The World's Funniest Joke Funny Stuff - Jokes and Humour 13
Marc The German Enigma Machine of World War II After Work and Weekend Discussion Topics 0
S World Quality Day 2019, November 14 - Build Quality Awareness in the organization ASQ - American Society for Quality 0
D What foreign language proficiency would give the biggest edge to medical device regulatory affairs professionals in the world today or in future? Career and Occupation Discussions 6
P List of ISO certificate registrars around the world - ISO certification databases ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna World Accreditation Day 2019 - consistent accreditation? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
Sidney Vianna Ombudsmen & ombudswomen of the world, REJOYCE! ISO 37002 is coming to facilitate standardized whistleblowing Other ISO and International Standards and European Regulations 0
Sidney Vianna Interesting Discussion World wide energy demand will peak in the early 2030's Sustainability, Green Initiatives and Ecology 0
M FDA News FDA Safety communication – Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings Medical Device and FDA Regulations and Standards News 0
Sidney Vianna ISO 13485 Certificates Distribution around the World - 2018 ISO 13485:2016 - Medical Device Quality Management Systems 4
F WHO (World Health Organisation) Requirements - Africa Other Medical Device Regulations World-Wide 0
M Forced NOT to meet End Customer Expectations - Corrupt Third World Country ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F In a Medical Device Manufacturer World Why ISO 9001 At All? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Looking for Cross Functional Matrix of Medical Device Regulations around the World Other Medical Device Regulations World-Wide 5
S Could the term "GMP" be used in a Medical Device world? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Marc The Most Remote and Beautiful Landscape in the World Is in Westfjords, Iceland Coffee Break and Water Cooler Discussions 0
Bev D Bev D at 2015 ASQ World Conference in Nashville Misc. Quality Assurance and Business Systems Related Topics 5
L Lean in the ISO9001:2015 World Lean in Manufacturing and Service Industries 1
M Guidance for Medical Device Registration in Med Dev Regulations World-Wide Other Medical Device Regulations World-Wide 24
Ajit Basrur Six countries that make up half the world?s population Coffee Break and Water Cooler Discussions 8
Ajit Basrur World Populations Funny Stuff - Jokes and Humour 3
Hershal Veggies around the world Coffee Break and Water Cooler Discussions 19
S Stated Accuracy of Portable CMM Arm and Real World Use Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
Ajit Basrur World's oldest living man residing in Chhattisgarh (India) ? Coffee Break and Water Cooler Discussions 0
M TSCA (Toxic Substances Control Act) and Other World Toxicity Laws Miscellaneous Environmental Standards and EMS Related Discussions 1
Marc Scary Bridges around the World Travel - Hotels, Motels, Planes and Trains 11
Ajit Basrur China breaks world record for car sales in 2013 ! World News 1
Ajit Basrur This is the world?s best-designed pizza box ! Coffee Break and Water Cooler Discussions 2
M ISO 9000 World Conference and Draft changes to new revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Ajit Basrur The World's Best Multinational Workplaces Coffee Break and Water Cooler Discussions 0
Marc Scientists discover world's earliest known brain World News 0
C Change Control in a SCRUM World Misc. Quality Assurance and Business Systems Related Topics 3
G How can Total Quality help a company or business compete in the world market? Preventive Action and Continuous Improvement 2
G WCM (World Class Manufacturing) and ISO 9001:2008: Differences and similarities Lean in Manufacturing and Service Industries 3
T Is "World Class" Quality possible by Accident? Coffee Break and Water Cooler Discussions 18
J The end of the world is nigh!!! Coffee Break and Water Cooler Discussions 41
T World Class Supplier Quality Alert System CAR/SCAR By Email Quality Assurance and Compliance Software Tools and Solutions 2
AnaMariaVR2 Why modern maps put everyone at the centre of the world Coffee Break and Water Cooler Discussions 0
A How is Segregation of Duties defined in the IT World? IEC 27001 - Information Security Management Systems (ISMS) 4
Richard Regalado Phishing and Pharming Scams All-over the World After Work and Weekend Discussion Topics 1
Ajit Basrur World Hepatitis Day - July 28 Hospitals, Clinics & other Health Care Providers 1
H What kind of training would you recommend to start on the process improvement world? Training - Internal, External, Online and Distance Learning 8
G Rookie to the ISO 9001:2008 World - Required Procedures and Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Real World Example of Document Control Failure Needed Document Control Systems, Procedures, Forms and Templates 5
Bev D World Class Rolled Throughput Yields - 2012 Six Sigma 1
S Your guess for who will be in the 2012 World Series Coffee Break and Water Cooler Discussions 10
Crusader Real World Continuous Improvement Examples for Accounting Personnel? Quality Tools, Improvement and Analysis 3
G ISO 9001 Worldwide Certification for a company with multiple world wide locations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Electronic IFU's on Class III and IV Medical Devices World Wide Other Medical Device Regulations World-Wide 1
Richard Regalado Our Beautiful World courtesy of NASA - Photos of Earth Coffee Break and Water Cooler Discussions 3

Similar threads

Top Bottom