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Author Topic:   Rank of Findings
Dor Marchan
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Posts: 6
From:Singapore
Registered: Sep 1999

posted 13 September 1999 09:08 PM     Click Here to See the Profile for Dor Marchan   Click Here to Email Dor Marchan     Edit/Delete Message   Reply w/Quote
Hi there,

Please adivse the following statistics:

1. Rank of Findings per Element in ISO 9002
2. Usual/Common findings for the top 5 (if
possible)in rank.
3. Typicaly planned hours spent by auditors
in their audit per element.

Thanks in advance...regards, Dor Marchan

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Marc Smith
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From:West Chester, OH, USA
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posted 15 September 1999 01:23 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
1 and 2 - I'm not sure what you mean by 'rank, but try Elsmar.com/failure.html

3 - It depends upon company size and the intent of the audit. If you are looking at a 'compliance audit' (verification - are all the required ISO/QS systems defined in your documentation), you're not looking at but a day or two. If you want to validate your procedures (like in a registration audit) and you have 20,000 employees, it will take a lot longer than if you have 150 employees.

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Brenda Mundroff
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posted 16 September 1999 12:24 PM     Click Here to See the Profile for Brenda Mundroff     Edit/Delete Message   Reply w/Quote
Are there guidelines issued by the RAB on how
much time should be spent based on number of
employees in the scope? Or is it based on
functions performed?

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barb butrym
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posted 16 September 1999 06:06 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
For a registration or surveillance audit..........
Based on the Lead Auditor experience, the scope of the audit, functions performed and logistics the Lead auditor plans the audit in the RAB required time frame. No other way to say it......

RAB says how many man-days based on size, scope, and # facilities (a matrix). The auditor manages the audit. Areas that sometimes pull extra time ...design, doc control, calibration, process, inspection...anything global.

For Internal audits (since this is the thread topic)........

I typicall do internal audits in 1 -2 hour chunks per team....any more than that taxes resources and becomes ineffective...if an area cannot be covered in that time frame, add more auditors to spread out, or do it in 2 parts.

[This message has been edited by barb butrym (edited 16 September 1999).]

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Marc Smith
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posted 16 September 1999 06:10 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Barb: QS9000 has required audit days. You say the RAB prescribes "RAB required time frame" (in audit days?) - is that (the required days and basis) specified in documentation anywhere?

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Dor Marchan
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From:Singapore
Registered: Sep 1999

posted 16 September 1999 06:34 PM     Click Here to See the Profile for Dor Marchan   Click Here to Email Dor Marchan     Edit/Delete Message   Reply w/Quote
Hi again,
I'm here in Singapore. We will be having an ISO 9002 audit next week...
Maybe, I'll rephrase my inquiry regarding the rank of findings....
There are 19 elements for ISO 9002 (please correct me if I'm wrong) and of course, auditors will have audit findings. During that audit, perhaps, element 4.1 may have 2 finings, other element is 1 finding, and oither element have no finding at all, and so on...I'm interested on the rank (per element) on findings. Is it element 4.9 that have the highest findings? Or is it 4.5 or 4.16, etc..??
Please advise...thank you in advance.
Regards,
Dor Marchan

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Marc Smith
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posted 16 September 1999 08:21 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I'm still not clear on what you mean by Rank. If you have 2 findings in 4.1 and 1 in 4.9 and 4 in 4.14 and they're all minors - no problem.
They don't rank findings per se except to say you had the most findings in this element, the next highest in that element. If you get 3 findings in 4.1 and 1 in 4.9, there is nothing saying you had the most findings in 4.1 but 4.9 is more important.

If you mean what are the most common failure modes, that's in the link I posted.

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Dor Marchan
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From:Singapore
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posted 16 September 1999 09:17 PM     Click Here to See the Profile for Dor Marchan   Click Here to Email Dor Marchan     Edit/Delete Message   Reply w/Quote
Hi again Mark,
Among the 19 elements in ISO 9002, which element had the most number of non-compliances (or findings - we call it here as findings)? Which element is 2nd to it? Which element is 3rd to it? which elemnt is next?
Please advise...
Regards,
Dor

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Dor Marchan
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From:Singapore
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posted 16 September 1999 09:20 PM     Click Here to See the Profile for Dor Marchan   Click Here to Email Dor Marchan     Edit/Delete Message   Reply w/Quote
Hi again Mark,
Among the 19 elements in ISO 9002, which element had the most number of non-compliances (or findings - we call it here as findings)? Which element is 2nd to it? Which element is 3rd to it? which elemnt is next?
Please advise...
Regards,
Dor

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Marc Smith
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posted 16 September 1999 11:44 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I don't know of any specific numbers - someone may have some but I don't recall any. Document Control and Calibration were the biggies in the past. Sorry I can't help beyond that and the link I gave above.

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Dor Marchan
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posted 17 September 1999 02:00 AM     Click Here to See the Profile for Dor Marchan   Click Here to Email Dor Marchan     Edit/Delete Message   Reply w/Quote
Thank you for your reply...
Yes, I also heard that Document and Data Control (4.5), Process Control (4.9) and Control of Inspection, Measuring and Test (4.11) are the top three. However, I just want to have a more concrete evidence.

Is there anyone there who made a survey regarding this topic??

Regards,
Dor Marchan

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barb butrym
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posted 17 September 1999 07:43 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
yes Marc...there is a matrix of man days ....I have one somewhere from RVA/UCAS..let me go and find it (no small task...LOL)

On the rank issue, there are as many takes on that as there are auditors......each system has its own built in weakness...the larger more global elements will always have a tendency to have more as there are more cooks in the kitchen and more opportunities to have an 'opps' happen...so in that I agree the elements you called out are more likely to have findings...but if you have a grip on that and know it needs more attention to detail, then you naturally decrease the opportunity for findings in that element...companies and consultants have strong points as well...that skew the stats. All in all its a question without an answer.

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waberens
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From:Akron,Ohio,USA
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posted 17 September 1999 11:03 AM     Click Here to See the Profile for waberens   Click Here to Email waberens     Edit/Delete Message   Reply w/Quote
Appendix H of the "Quality System Reguirements" QS-9000 Third Edition has the table for on-site auditor days. Also includes how to adjust for special situations.
Recently received a reprint from "The Registrar" a publication of Quality Systems Registrars,Inc. Top 10 areas of noncompliance are: 4.5 Document and Data 292; 4.6 Purchasing 196; 4.11 IMTE 187; 4.10 Inspection and Testing 87; 4.14 Corrective and Preventive Action 82; 4.9 Process Control 71; 4.16 Control of Quality Records 67; 4.13 Control of Nonconforming Product 64; 4.1 Management Responsibility 58; 4.17 Internal Quality Audits 55. It also adds that for ISO 9001 design control is a major pitfall.
Bill

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Marc Smith
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posted 17 September 1999 11:22 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Yeah - I know QS does - ISO technically doesn't but Barb says registrar accreditation folks do.

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waberens
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posted 17 September 1999 02:43 PM     Click Here to See the Profile for waberens   Click Here to Email waberens     Edit/Delete Message   Reply w/Quote
If you go to the RAB site you can find their table of assessment times. It lines up with QS-9000 tables for the most part.
www.rabnet.com/content/qr_crit1.htm

Look in Annex 1 Assessment Times

Sorry, I do not know how to make this a hotlink. Oh, I guess it links automatically if the right options are turned on.


Bill

[This message has been edited by waberens (edited 17 September 1999).]

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Marc Smith
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posted 17 September 1999 04:13 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Thanks for the link! That pretty well says it all about audit days!

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David Guffey
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From:St. Joseph MI, USA
Registered: Oct 1999

posted 21 October 1999 04:04 PM     Click Here to See the Profile for David Guffey   Click Here to Email David Guffey     Edit/Delete Message   Reply w/Quote
Dor, may I repectfully suggest you not get hung up by worrying about "rank"? Even if I had ten findings in Document and Data Control, what you and your company does has no relativity to mine. So, it's not important.

Of the 19 elements (or 18 if Service is descoped), just do your best to ensure your company is ready. Then if there are findings, address them with sincerity and vigor. Over time, you and your company will improve and a good, value-adding auditor will continue to peel away the onion. Don't loose sleep over it.

[This message has been edited by David Guffey (edited 21 October 1999).]

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Dor Marchan
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From:Singapore
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posted 21 October 1999 08:29 PM     Click Here to See the Profile for Dor Marchan   Click Here to Email Dor Marchan     Edit/Delete Message   Reply w/Quote
Hi David,
Thank you for your advise.
Actually, our ISO audit is finished last 22-23 Sep 99 and guess what..... ZERO noncompliance!
Our consultant (NOVO Quality Services) was speechless. They only said that in their consulting and auditing experience, 3M-Singapore is the first company that they consulted to have 0 noncompliance. And when they asked who was the auditor, they were more surprised becuase the lead auditor is the current representative of PSB to ISO. (And she is really stringent.)
But, of course, we are prepared and ready. Most of our system in computerized and everyone is committed.
Now, we are including other areas and product lines for the surveillance audit on March 2000. Plus, we are going for ISO 14000 and OSHAS18000 on July 2000.
Other than that, I'm also going to propose to our management to have our technical center to be ISO Guide 25 (or to be ISO 17025) certified. I guess they would...
That's all I can say...again, thank you.
Regards,
Dor Marchan

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