Major NC or Not - Procedure Not Implemented and Repetitive mistakes/failures

[Shiv]

Hello All!

I am back after a long time and wish to pose this question I had in mind for sometime. Recently I was part (as an observer only) of a Audit Team in an industry which was being audited for ISO 9001 – 2000 certification.

I observed that Corrective and Preventive Actions were not being carried out for repetitive mistakes/failures occurring in some product line at this industry. It was rather surprising to me that Certification was granted to this industry inspite of the above non-compliance.

On expressing my surprise to one of the aduitors , I was informed that the organization had procedures in place but had not implemented them, which does not make a major non-conformance.

I am not convinced with this explanation or is there something I am missing?

 

[Claes Gefvenberg]

On expressing my surprise to one of the aduitors , I was informed that the organization had procedures in place but had not implemented them, which does not make a major non-conformance.

Strange...? What about the first line in 4.1?

ISO9001:2000, Clause 4.1The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

Major or not, it's pretty basic.... Of what possible use could a procedure be without implementation?

/Claes

 

[gpainter]

In the second paragraph I would say I would have to read their procedure to see what they say. Based on the third paragraph, I would say a minor N/C. Most auditors do not want to issue a Major! I would agree with Claes as going against 4.1, which would cause me to verify the implementation of other procedures which would result in the show stopper if there were others not implemented.

 

[The Taz!]

In the second paragraph I would say I would have to read their procedure to see what they say. Based on the third paragraph, I would say a minor N/C. Most auditors do not want to issue a Major! I would agree with Claes as going against 4.1, which would cause me to verify the implementation of other procedures which would result in the show stopper if there were others not implemented.

I have to agree that the old Oxymoron "Management Responsibility" may be the real culprit or Root Cause in this case. There can be too much lip service.

In addition, their Quality Manual should state WHAT they do. . . do they say it and not do it?? IMHO, In that case, I could see a possible Major waiting in the wings.

 

[Sam]

Hello All!
On expressing my surprise to one of the aduitors , I was informed that the organization had procedures in place but had not implemented them, which does not make a major non-conformance.

After reviewing the ISO series, including ISO 19011, I find no rational for major or minor findings. As I see it a non-conformity is a non-conformity.
Now, the RAB may have some different thoughts, but I haven't taken the time to review.
With TS it is more specific; rational for majors and minors is spelled out in the "Rules". Recommendation for registration is not made until all NC's are cleared. Under these rules a "major" finding would have been issued.

 

[Bev D]

While ISO makes no definition or provision for major or minor findings most registrars have operational definitions for them and threshold limits that prevent registration - or revoke it - until the nonconformances are cleared.

Generally - a major would be a missing element or teh systemic failure of an element particularly if it put shipped part quality at jeopardy. (Such as the lack of an effective recall system for calibration that results in expired or uncalibrated gages being used for final acceptance of product and when the gages are calibrated they are found to be out of tolerance - now that's major in almost anyone's book of rules...)

In this particular case, I would most certainly question why they don't issue corrective actions for 'mistakes' or other types of repetitive failures. But ISO doesn't require formal corrective action on all problems or even on all recurring problems. The company must simply have a rational basis for making the decision dependent on the severity of the effect. (you can't fix everything at once...) So that would be line of inquiry - how severe are these repeatign problems? how severe are they in relationship to the other problems that do get formal corrective action? (and of course we must recognize that not all corrective actions have to be Root Cause Corrective Action that prevents re-occurrence...depending on the relative severity, containment (detect and scrap or repair) might be the best decision at the time.

The "lack of implementation" on the otherhand is troublesome. Did they write and issue the document - then fail completely to execute it? Or is it just a draft that has yet to be issued adn tehy have a Correctivea ction procedure that is documented and implemented and executed? If the latter, no problem. If the former, problem. I would search for a systemic problem and if I found several isseud procedrues that were being comletely ignored, I would not only issue a major, I would not grant registration, as that finding woud be an indication of a systemic faliure to implement adn control a QMS...let alone one that is complaint to ISO....

 

[WALLACE]

Shiv,
What approach was used by the auditors? I'm surprised that, according to what I read into your post, there was no apparent process approach to this particular audit.
Diging deeper is, or should be, part of the certification process in general and, I find it hard to believe the registrar would have certified the organization in question.
Maybe I'm missing something here?
Wallace.

 

[The Taz!]

Shiv,
What approach was used by the auditors? I'm surprised that, according to what I read into your post, there was no apparent process approach to this particular audit.
Diging deeper is, or should be, part of the certification process in general and, I find it hard to believe the registrar would have certified the organization in question.Maybe I'm missing something here?
Wallace.

I wonder just who this registrar is. . . wonder if it is PJ. . .