I am conducting internal audits and when performing the one for management responsibility, I questioned the auditee about responsibility and authority and benchmarking. This "manager" had written procedures (which I knew he had) but at the time of the audit did not remember he had written them. I pointed out that the procedures existed and he pretty much made a joke about it, stating that these were pretty good procedures he had written.

Can I write a non-conformance for him not knowing he has procedures he should be following? Note: I could not prove that the procedures were not being followed.
If I can write a non-conformance for this what section would it be under?

Thanks,
Carla

Personal opinion:

IF the procedure is being followed, and IF when asked how he operates, this "manager" describes the process that is defined in the procedure, then for me, this indicates that the quality policy and management system are indeed well understood and implemented within the organization.

Nowhere in ISO9001:2000 does it state that anyone needs to be able to cite chapter and verse of the procedures, rather that they exist, are respected, and are periodically reviewed for suitability, applicability and effectiveness.

However, if you wanted to make a point, I would report a "remark" (not an NC) against chapter 5.3 phrase d: "Top management shall ensure that the quality policy is communicated and understood within the organization".

Other opinions?

Bruce

I agree with Bruce.

You could not say that the documented system was not being followed, and you could not say that the system was ineffective. These are the two crucial issues in an audit (effectiveness probably more so than compliance).

You might argue that the document was 'not available at the point of use' if you want to argue that the managers inability to locate the document means that it was un-available. But it is a pretty minor issue in itself.

You might use it as an audit trail to see if he can locate other applicable documents that he might use. If he is unable to locate any quality system documentation it might give more weight to an NC.

Just goes to show that no-one actually uses procedures !

I agree with the other comments also. The one issue I would look at is how can the procedure be reviewed for applicability if the approval authority doesn't know it exists? If you have evidence that the procedure is being followed I would hesitate in writing an NC. I would look at it more as the system is working but you need a little tune up to ensure the procedures maintain their applicability.
:bigwave:

Originally posted by Carla


Can I write a non-conformance for him not knowing he has procedures he should be following? Note: I could not prove that the procedures were not being followed.
If I can write a non-conformance for this what section would it be under?

Thanks,
Carla

No, if you have nothing that supports your n/c. You should have objective evidence that the procedure is not being followed then how can you write the n/c what would you to support it? It is very difficult to wite an n/c with no evidence. JMHO

I believe you can write a nonconformance against this.

ISO 9001: 2000 4.1 General Requirements: "The organization shall establish, document, implement and maintain a quality managment system..."

In this case a procedure has been established and documented, but not implemented effectively. I would not have a problem if someone could not recite the procedure from memory, but not knowing of the existance of procedures that relate to one's job is an indication of lack of implementation and maintenance.

If this is someone responsible for management and involved in management review, there may also be a nonconformance against 5.6.1 "Top management shall review the organization's quality management system..." How can the system be reviewed if management does not know it exists?

It may not be a huge nonconformance, but it is something that should be documented and corrected.

Tom

I would consider the procedure implemented effectively if the guy is doing what it says in the procedure. Just because he cannot put his hand on it does not mean it isnt effectively implemented.

Also with regard to management review you could know the system exists without knowing every single procedure in it.

Still dont think its an NC.

Originally posted by Carla

Can I write a non-conformance for him not knowing he has procedures he should be following? Note: I could not prove that the procedures were not being followed.
If I can write a non-conformance for this what section would it be under?
Thanks,
Carla

Here we go. :vfunny: I agree with M. Greenway on this one. Believe it?
Carla, You couldn't prove that the procedures were not being followed. Put your pen away, even though you are bent on writing an N/C. You're job isn't to issue N/C's. It's to ensure compliance to the standard/procedure. If you can't find something to write up, don't feel bad. You still did your job.:ko: :smokin:

Right on Jim.

I was also going to suggest that the procedure was not required.

.....and energy agreed with me !! that has really made my day :bigwave:

Well **** MI is freezing over today, could there be a connection with Energy agreeing with M G ???????

:biglaugh:

Marc,
I was referring to the city in Michigan, not using my sailor language!!!!!:o

Its a good point worth re-stating that the role of the auditor is to report on compliance as well as any non-compliance.

Thankfully we dont get measured for effectiveness on the number of NC's issued yet (unlike our wonderful police force or traffic wardens).

Interesting post and responses.

My first inclination is to say yes you can write a non-conformance based on the idea of how can the manager review the documents for continued suitability. However, after reading the responses, and recognizing that this is an internal audit, The rules may be a little more relaxed.

If the system is fairly new, then just make a note to watch this area in the future. If the manager is not taking things seriously then he/she will not review and revise procedures as things change. If the manager is just in a learning curve, the audit may help them to remember that the procedure(s) do exist and need to be checked over periodically.

If the system is older, and/or this manager is a troublesome type, you may want to write a minor along the lines that Tom outlined above just to get his attention. I wouldn't try to beat him/her up with it, but just point out that they need to be aware of the procedures and be able to: 1) locate them during an outside audit and 2) be able to keep them up to date. Then commend him/her on how well the area is run and keep up the good work.

Whatever you decide, do it to improve the system, the training and systems awareness.

JMHO

James

Originally posted by JRKH
Interesting post and responses.

point out that they need to be aware of the procedures and be able to: 1) locate them during an outside audit and

James

We recently had one of our auditor teams write an N/C because the engineer accessed the database where the procedures reside, and opened the wrong one. A misclick, if you will. I don't have to tell you what happened to that N/C.:vfunny: :ko: :smokin:

Well, I just got caught by this one in real life.

An internal auditor from "Headquarters" was here last week. One of the people he audited was following the procedure at 100% (by the auditor's own admission), but this person admitted that he had never seen the actual procedure itself.

We got a major NC, with the corrective action to improve our "training".

Call me older and wiser now...

:bonk:

Bruce,

How can this person be doing a perfect job according to proceedure without even reading it or being trained in it?

It seems at the very least there should be a matrix of who has read the procedure, who has been trained in the procedure. Maybe just some kind of sign-off that the procedure was written following his/her actions because they were the correct way to do it?????

Of course Training is an easy way for an auditor to find a problem, but if the job is being performed correctly, there has to be an assumption that the person knows how to do it?

The President of a company has procedures and processes to follow, can the auditor go up to the President and tell him/her that they have not been correctly trained.

The one thing that should be included in the process of deciding compliance in this situation should be PPM or scrap rates. If a person is trained or know what they do will usually have a lower scrap rate than a new hire.

What happens when the General Manager or President come out to the floor to run a machine during a crisis period, do they need a special certificate to put a blank in the back of every machine?

One time as a management rep I was called out to the floor to load machines under such a situation. Did I know how to do it? NO. Did I learn within 5 minutes what to do? YES Was I formally trained to do the job? NO Was the experience succesful? YES

Was I invited back? NO

I truly believe that product quality can be quantified by experience and training, but there are limits and situations. Sometimes a temp is hired because 2 people don't show up for work. Do they go through a two week training program and get a certificate to show an auditor? NOOOO

What happens if an


OK, off the soapbox, just a subject that hits home!:bigwave:

Bruce:

What was the N/C written against? What “shall” was violated? Was there a procedure? –Yes! Did the operator follow the procedure? – Yes! Is there evidence that the procedure was being followed? – Yes! The question is how did the auditee know what to do? It sounds to me like it was through training. Unless there is a problem with the training records, I cannot see ANY justification for an N/C of any type! I’m not even sure I see an observation. I would fight this until the auditor was removed!:mad:

You're right on it db (sorry if it messes up your reputation here).

We got a major NC, with the corrective action to improve our "training".

Looks to me like the auditor was out to lunch!!!! The operator was obviously well training if s/he didn't need the procedure. Plus it was a procedure and not a work instruction.

:frust:

Bruce

I cannot believe the incompetence of your internal auditor - perhaps that is where your companies training is really lacking.

db has said it all really with 'where is the shall', but auditing should also consider effectiveness - by the auditors own admission your training was 100% effective !

Did the auditor actually quote a non-compliance, or did he just suggest the corrective action (which is another no-no) ?

Originally posted by M Greenaway
Bruce

I cannot believe the incompetence of your internal auditor - perhaps that is where your companies training is really lacking.

db has said it all really with 'where is the shall', but auditing should also consider effectiveness - by the auditors own admission your training was 100% effective !

Did the auditor actually quote a non-compliance, or did he just suggest the corrective action (which is another no-no) ?

Just to clarify the situation, the person who was audited was not an "operator" (as someone seems to have assumed) but a "design engineer". The procedure was written to describe the universally-accepted-but-never-before-formalized "how we work". This engineer's manager was heavily involved in creating the procedure, and she *lives* it in the daily work of her group. This is how the engineer was completely conformant to it without knowing it.

The NC was written against chapter 4.18 of the 1994 standard. As this was our first internal audit, I have a feeling that our auditor needed to show something, especially since they had had such a hard time in his site (US corporate headquarters). In general "They" think that "We" are barely literate savages (*), and "They" could never imagine that "We" could do something better than them.

Moreover, as inappropriate as this specific action might have been, this auditor is still light-years ahead of most of the headquarters people that I need to deal with.

Sigh, such is life...

:frust: :bonk: :mad:

(*) It has really been an eye-opening experience to be on the receiving end of US arrogance and prejudice. But that's a topic for another thread. :smokin:

I think you are right in that the auditor is "trying to show something". I agree also with the observation that there is no shall which was violated. The fact that the NC was written on an internal audit still remains. The report has probably been filed neatly into a slot somewhere waiting for your CAR. The point that your engineer knew nothing about the procedure is certainly valid. He is working in an area where the manager considered it important enough to write a procedure, but not important enough to tell the employees it existed. Even without a shall, doing an internal audit I would recognize there is something not quite right here. My guess is that Jim is right, you probably don't need a procedure. I also agree that we tend to write way too many procedures that aren't really necessary.

Why not take the opportunity to review your practice of writing "how we work" procedures? If you find you do need the procedures, review your practice of not informing the employees you have them.

The US auditor works for the same company as you and isn't the enemy. The intent of an internal audit is to help identify areas for improvement. There has to be some validity in the statement that something needs some sort of improvement here. Who cares if the auditor cites the wrong or non-existant requirement? If it makes sense to fix it, why argue and upset the auditor and the corporate office?

After all, you surely must realize any arguement on your part would be futile. It may be an international standard, but the only intelligence in it came from our side of the pond. Why else do you suppose you Europeans are trying to write a new version?

Dave

eye-opening experience to be on the receiving end of US arrogance and prejudice.
And we know how much the French folks love us!!!!!!:bigwave: :truce: :vfunny:

I have a feeling that our auditor needed to show something,
It sounds like you're right, especially when it comes to auditing engineers. In my experience and IMO there are a lot of auditors out there that don't have a clue as to how engineers and engineering departments operate.
It does sound like an easy fix, and if that is the worse they could find I would take it as a good sign. :p

Originally posted by Bruce Epstein
Well, I just got caught by this one in real life.

An internal auditor from "Headquarters" was here last week. One of the people he audited was following the procedure at 100% (by the auditor's own admission), but this person admitted that he had never seen the actual procedure itself.

We got a major NC, with the corrective action to improve our "training".

Call me older and wiser now...

:bonk:

Bruce,

Wasn't this employee taught how to behave as an auditee? There are cardinal rules to follow. Number One:Only answer the questions. That's all. Did the auditor ask if he/she ever read it? If he/she was working to the procedure, as the auditor observed, why would the auditor ask if they read it? Did the employee "volunteer" the comment that he/she never read it? Just curious.

:ko: :smokin:

Originally posted by Bruce Epstein


(*) It has really been an eye-opening experience to be on the receiving end of US arrogance and prejudice. But that's a topic for another thread. :smokin:

Wow US arrogance!! Pretty strong words! I hope that was just a joke. :(

Originally posted by ISO GUY

Wow US arrogance!! Pretty strong words! I hope that was just a joke. :(

This type of joke has been posted before, by Mr. Epstein. I'm keeping my powder dry because it may be one of those things we can't really understand in this medium. It may very well be a case of the pot calling the kettle arrogant and prejudiced.

What's the best selling book in Paris these days? Anybody know? 11 septembre, l’effroyable imposture. Top of the list at www.amazon.fr.
Even with my dismal understanding of French, I can guess what the title implies. Selling like hotcakes.
:ko: :smokin:

At the risk of dragging this topic even further off track:

just in case it wasn't already clear, I have taken the extraordinary step of adding the name of the country that issued my passport into my user profile (you'll find it in the Biography section).

Then you will understand why I take the liberty of being so hard on the US and Americans. (I am just as rough on my adopted countrymen.)

In fact, a large part of my job consists of helping to smooth down the ruffled feathers caused by the incompatibilities between the two cultures, and by the inability of each to really understand the other.

Try living as an immigrant (yes, that's what my family and I are, not "expatriates") somewhere for a while and you will see for yourself.

And, knowing that someone will ask for a clarification of the terms I used, here are my definitions:

"expatriate": someone sent to an "exotic" location for a closed-end, short-term assignment; often does not bother to learn the local language, lives in an expatriate ghetto, sends the kids to the local International school on company expense....

"immigrant": someone who, voluntarily or involuntarily, finds himself in a country other than his country of origin. Tries to integrate into the local society, with the intent of remaining "for the foreseeable future".

Bruce

P.S. In addition to the "understanding humo(u)r" thread, perhaps we need one in "understanding when someone is just blowing off steam as opposed to blowing smoke". :vfunny:

Originally posted by energy


What's the best selling book in Paris these days? Anybody know? 11 septembre, l’effroyable imposture. Top of the list at www.amazon.fr.
Even with my dismal understanding of French, I can guess what the title implies. Selling like hotcakes.
:ko: :smokin:

Just goes to show that the Americanization of France is succeeding :( The rest of the top 10 includes such masterpieces of modern literature as "Men are from Mars", the latest John Grisham, "Lose Weight without Dieting", and a comic book.

Seriously, I believe that the success of Amazon is that the French can now secretly buy all the trash books that they wouldn't be caught dead purchasing at their local bookshop.

And, for those whose French is not up to energy's level, [look - I gave you a compliment!]:bigwave: , the book he refers to tries to make the case that no airplane crashed into the Pentagon. In other words, a fairy tale. :vfunny:

Bruce

Anyway, dragging this thread out of the muck and back to the subject at hand, I am guilty as charged about not having sufficiently "coached" the entire department about how to respond to an auditor.

I won't make that mistake twice...

Bruce

Bruce I think you'll find that there are a good number of us that have qualified for immigrant status at one time or another. I have lived in Scotland, Italy and Canada and been placed in other countries with no purpose of integrating in with the locals. Even with Canada being so close I couldn't wait to get back to the states.

Originally posted by Bruce Epstein
Anyway, dragging this thread out of the muck and back to the subject at hand, I am guilty as charged about not having sufficiently "coached" the entire department about how to respond to an auditor.
I won't make that mistake twice...
Bruce

Bruce,

It sounded like that was what happened. It's happened to me during an OSHA compliance aidit. An individual, after being told to answer just the question, confessed all his life's sins. Resulted in 2 minor write ups having nothing to do with the original question. Sometimes people try to impress others how smart they are. They don't realize that there are those who are smarter. Your engineer may have enjoyed the opportunity to demonstrate how well they comply without having to read "no stinkin procedure!":vfunny: :ko: :smokin:

I conducted an audit last week on the manufacturing shop floor. The reflow profile is found to be out of specification on 5-Oct-01 and 26-Oct-01 but there was no evidence that action plans were initiated to rectify the deviation. Question is, is it proper to issue non compliance and requesting CA when it happened last year? I did not manage to find any deviation for this year. Pls. advise.

Johnny,

Sounds like we are in the same game...reflow profiling...SM components....aaarrrggghhh!

As far as issuing a NC for this, I wouldn't have thought so at all, but you have uncovered a defect opportunity and it will happen again, believe me.

How is this measured?
How frequently?
To what spec?
etc;

AND is this documented ?

Presumably, you take measurments (using a mole?) once or twice a day and compare this to a capability index. This is recorded on a chart (run chart/control chart).

So why did it take this long to find...thats the issue.
If someone is plotting this data, it is immediately apparent that the process is drifting.

So, no I wouldn't issue a NC, but I would find out IF the operators understand the reasons for monitoring and the impact of error.
As you are aware, with SM equipment, if it is not set up right, you can build things wronger, quicker.
The reflow profile is critical to quality, OK, you have quite a big process window with some paste, but it was drifting for a reason or maybe the wrong profile was used.

I had a similar exp with our flowsoldering guys. I didn't beat them up over this because upon investigation, they were not aware........but now they are.

Regards,

Chris May