The Elsmar Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Elsmar Cove Discussion Forums Main Page
Welcome to what was The Original Cayman Cove Forums!
This thread is carried over and continued in the Current Elsmar Cove Forums

Search the Elsmar Cove!

Wooden Line
This is a "Frozen" Legacy Forum.
Most links on this page do NOT work.
Discussions since 2001 are HERE

Owl Line
The New Elsmar Cove Forums   The New Elsmar Cove Forums
  Auditing
  Oddest "requirements"

Post New Topic  Post A Reply
profile | register | preferences | faq | search

UBBFriend: Email This Page to Someone! next newest topic | next oldest topic
Author Topic:   Oddest "requirements"
ALM
Forum Contributor

Posts: 80
From:Philadelphia
Registered: Jun 1999

posted 24 June 1999 11:49 AM     Click Here to See the Profile for ALM   Click Here to Email ALM     Edit/Delete Message   Reply w/Quote
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

IP: Logged

Kevin Mader
Forum Wizard

Posts: 575
From:Seymour, CT USA
Registered: Nov 98

posted 24 June 1999 04:23 PM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
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...

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 27 June 1999 06:04 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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."

IP: Logged

ALM
Forum Contributor

Posts: 80
From:Philadelphia
Registered: Jun 1999

posted 22 July 1999 01:50 PM     Click Here to See the Profile for ALM   Click Here to Email ALM     Edit/Delete Message   Reply w/Quote
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

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 22 July 1999 04:27 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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'.

IP: Logged

ALM
Forum Contributor

Posts: 80
From:Philadelphia
Registered: Jun 1999

posted 30 July 1999 07:48 AM     Click Here to See the Profile for ALM   Click Here to Email ALM     Edit/Delete Message   Reply w/Quote
(Previously posted in one of the ISO forums)

Andy Bassett wrote:

quote:
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

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 30 July 1999 01:58 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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."

IP: Logged

BRoyal
Forum Contributor

Posts: 22
From:Charlotte, NC
Registered: Nov 98

posted 04 August 1999 05:45 PM     Click Here to See the Profile for BRoyal   Click Here to Email BRoyal     Edit/Delete Message   Reply w/Quote
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

IP: Logged

David Guffey
Forum Contributor

Posts: 49
From:St. Joseph MI, USA
Registered: Oct 1999

posted 21 October 1999 04:22 PM     Click Here to See the Profile for David Guffey   Click Here to Email David Guffey     Edit/Delete Message   Reply w/Quote
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...

IP: Logged

Laura M
Forum Contributor

Posts: 299
From:Rochester, NY US
Registered: Aug 1999

posted 21 October 1999 04:52 PM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
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!

IP: Logged

barb butrym
Forum Contributor

Posts: 637
From:South Central Massachusetts
Registered:

posted 22 October 1999 08:00 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
that one made me giggle...but i bet the auditor caught it, and did his own internal smile and let it ride.... You would be surprised what you see.....from that side

IP: Logged

Kevin Mader
Forum Wizard

Posts: 575
From:Seymour, CT USA
Registered: Nov 98

posted 22 October 1999 08:51 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Barb,

The old slight of hand......

You're probably right about the auditor taking notice, but keeping it to him/herself. I have received a few "gifts" over the last few years.

Regards,

Kevin

IP: Logged

Laura M
Forum Contributor

Posts: 299
From:Rochester, NY US
Registered: Aug 1999

posted 22 October 1999 09:37 AM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
Of the 4 auditors, the other 3 would have noticed. Not this guy....he didn't notice stuff that should have hit him between the eyes, and tried to find n/c that didn't exist.
Example. In a recent re-assessment he was looking through N/C material hold tag log verifying disposition. He sampled the current week, went back 1/week, then 1/month, then went page by page until he found one that didn't have disposition recorded - from 10 months prior (actually dated before his last assessment.) "AH HA" he says, "what about this one..." The internal auditor/guide pointed out that in an internal audit they already documented N/C disposition, and his task just verified that the dept. implemented C/A and the Internal audit system worked. "Gotcha back" Not that this is the right forum, but shouldn't he have sampled a few dates and moved on....verifying a system is working... and not gone page by page? I know some people may clean up stuff before an audit, so auditors should sample dates a few months earlier, but page by page for 10 months?

Here's a quote he said at initial assessment after 4 days of auditing..."I know there's a major in this place somewhere, I just can't find it."

Laura

IP: Logged

ALM
Forum Contributor

Posts: 80
From:Philadelphia
Registered: Jun 1999

posted 22 October 1999 09:45 AM     Click Here to See the Profile for ALM   Click Here to Email ALM     Edit/Delete Message   Reply w/Quote
Re: Your closing sentence, Laura:

Sounds to me like you need to complain to your registrar and find yourself a new lead auditor. That is totally unprofessional and I would have told him so right there at the closing meeting.

ALM

IP: Logged

Laura M
Forum Contributor

Posts: 299
From:Rochester, NY US
Registered: Aug 1999

posted 22 October 1999 10:14 AM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
You're right, and I tried...I was told to bite my tongue (because we passed) and as far as fornal complaint - even tho I was mgmt. rep for our site, I had to get approval from my mgmt, then divisional mgmt who selected the registrar. Too much bureaucracy. They wouldn't even let my comments on the "satisfaction survey" provided by the registrar go through. Of course the people making those decisions only showed up at the closing meetings while I spent a week with the guy!!
Too late now, I'm no longer there (for lots of reasons..don't mean to sound like that's why)
Don't get me wrong, I loved the QS process, and personal satisfaction knowing we did a good job. I would just assume the auditor did a better job to lend more integrity to the process.

IP: Logged

Kevin Mader
Forum Wizard

Posts: 575
From:Seymour, CT USA
Registered: Nov 98

posted 22 October 1999 05:15 PM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Laura,

I agree with ALM. A registrar with this view point is not interested in a working partnership. The 'gifts' given from time to time indicates to me that registrars realize that all systems produce some level of nonconformance, but in their view (risk assessment), an allowance was made. This gift often comes with the understanding that on the next visit, this won't be overlooked. In fact, working on these freebies indicates to them that you recognize this working partnership takes two. Your auditor seems to be on a mission of doom! I would consider ALM's suggestion.

Regards,

Kevin

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 22 October 1999 05:22 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Like barb, I'm compassionate. I'd ignore it once. Sometimes a person is in all good faith trying to protect someone or the company - whether right or wrong. If it happens again there's a problem.

[This message has been edited by Marc Smith (edited 22 October 1999).]

IP: Logged

Al Dyer
Forum Wizard

Posts: 622
From:Lapeer, MI USA
Registered: Oct 2000

posted 01 February 2001 06:49 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
I won't go into the gory details but:

We went through our first surv. audit and got a minor N/C.

We implemented and submitted our corrective action.

During this time our auditor retired and the newly assigned auditor reviewed our C/A and closed it out.

At the next surv. audit our new auditor "attempted" to write us up for the same N/C. He said that there was no way the N/C should have been closed in the first place.

I went to my office and retrieved the copy of the closed N/C with his name as the approver.

We didn't receive the N/C and the auditor was alot easier to work with during the post audit activities.

Point: Keep good records and challange the auditor (gracefully) when required.

ASD...

------------------
Al Dyer
Mngt. Rep.
ullysses3@excite.com

IP: Logged

SteelMaiden
Forum Contributor

Posts: 28
From:NC, USA
Registered: Jan 2001

posted 02 February 2001 11:14 AM     Click Here to See the Profile for SteelMaiden     Edit/Delete Message   Reply w/Quote
Guess I'd overlooked this thread in the past. Back to "something funny happened on the way to cerification"--

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.

IP: Logged

Jim Biz
Forum Wizard

Posts: 275
From:ILLINOIS
Registered: Mar 2000

posted 02 February 2001 12:15 PM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
Our first registration audit (after opting to forgo a pre-registration overview.)

It was our plan to have but 1 authorized set of documents - keep neatly controlled in a bullet proof free standing computer.

We issued Red stamped UNCONTROLLED copies through - the shop to make the information "readily" available. Of course we provided our external registrars with the same information.

They decided that our documents were not controlled because the paper was white & no red controlled stamp was on them.

We printed a single set that evening & then asked them to return the "uncontrolled" copies they were provided so they could be destroyed.

They spent the next two days running back & forth to the single controlled set. We would not allow it to be removed from the office. At the exit meeting they remarked with a broad smile that they should maybe have waited to make this point on the last day of the audit.

Regards
Jim

IP: Logged

ISO GUY
Forum Contributor

Posts: 81
From:Rochester, NY
Registered: Jan 2000

posted 02 February 2001 02:38 PM     Click Here to See the Profile for ISO GUY   Click Here to Email ISO GUY     Edit/Delete Message   Reply w/Quote
Well it has nothing to do with our registrar, but with one of our larger clients. The "Lead Auditor" of this company came to our site to audit us, and in my opinion made a fool of himself. Not only was he cocky but a real jacka$$ too. During the audit the "gentleman" had the nerve to make ethnic comments (one of which was directed at me), talk with a filthy mouth (I am no saint mind you but I do not use that language in the work place), and just act like a real jerk. He left by telling the President of our Company that the QA Dept. has no clue what they are doing. Then over the next week proceeded to call me at least once a day because he forgot to ask for the information while he was here or blamed it on the amount of time he had to do the audit. Then I hear a day or two later that the FDA had been into visit them before they came to see us, and pretty much told them their QA Dept was lacking (or as I would say sucked). But they are a big customer of ours so of course they are right and thats that.

IP: Logged

All times are Eastern Standard Time (USA)

next newest topic | next oldest topic

Administrative Options: Close Topic | Archive/Move | Delete Topic
Post New Topic  Post A Reply Hop to:

Contact Us | The Elsmar Cove Home Page

Your Input Into These Forums Is Appreciated! Thanks!


Main Site Search
Y'All Come Back Now, Ya Hear?
Powered by FreeBSD!Made With A Mac!Powered by Apache!