ISO 9001-2000 Registration Nonconformances - What are the most common ones?

[gpainter]

To what areas of the 00 standard did your registration audit find the most Non Conformities? Please feel free to share details. Thanks!!!!!

 

[Jimmy Olson]

The only NC we had was under document control. From what i've heard from some other people, this seems to be the big hitter. This will be an interesting poll to follow.

 

[db]

Three of our clients went through registration in the last two weeks. One had nothing (not even an observation), one had a couple of minors in document and records, and the third had one for identifying training needs, and two for doc control (one print that was not in the system, and an observation when one form was called different things)

 

[Bill Ryan - 2007]

We tend to get nailed in the documentation of our inspection measurements and are a little weak in the calibration and R&R areas. We are also pretty weak in the "SPC area" with respect to the die casting side of the business.

Bill

 

[Marc]

Just 'bumping' this up - Not many folks 'voted' on this back then, and the discussion was limited - Maybe a few more folks would like 'vote' and discuss current registration failure modes.

Also, has much changed since this thread was started a couple of years ago?

 

[ccochran]

My Hit Parade

Howdy, folks:

Here is what I'm currently seeing as the most common nonconformities. To put it in perspective, I do 1-2 full system audits per month across a variety of industries:

*** Uncontrolled documents being used, especially memos, emails, photographs, and sticky notes with specific instructions on them. (Refer to 4.2.3: Documents required by the quality management system shall be controlled.)

*** Management review does not include all the required inputs. (Refer to 5.6.2: The input to management review shall include information on...a-g.)

*** Competency requirements are not determined for top management (Refer to 6.2.2: The organization shall...a) determine the necessary competence for personnel performing work affecting product quality.)

*** No assessment and recording of the effect of out-of-calibration gauges. (Refer to 7.6: In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.)

*** Preventive actions have been taken, but no records maintained. (Refer to 8.5.3: A documented procedure shall be established to define requirements for...d) records...)

I used to write up 6.2.2d quite a bit (The organization shall...ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives), but people have seemed to get the message on this.

Have a nice weekend,
Craig

 

[Govind]

Howdy, folks:

Here is what I'm currently seeing as the most common nonconformities. To put it in perspective, I do 1-2 full system audits per month across a variety of industries:

*** Uncontrolled documents being used, especially memos, emails, photographs, and sticky notes with specific instructions on them. (Refer to 4.2.3: Documents required by the quality management system shall be controlled.)

*** Management review does not include all the required inputs. (Refer to 5.6.2: The input to management review shall include information on...a-g.)

*** Competency requirements are not determined for top management (Refer to 6.2.2: The organization shall...a) determine the necessary competence for personnel performing work affecting product quality.)

*** No assessment and recording of the effect of out-of-calibration gauges. (Refer to 7.6: In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.)

*** Preventive actions have been taken, but no records maintained. (Refer to 8.5.3: A documented procedure shall be established to define requirements for...d) records...)

I used to write up 6.2.2d quite a bit (The organization shall...ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives), but people have seemed to get the message on this.

Have a nice weekend,
Craig

I think the poll in this thread is at 10,000-foot level. Average Auditors will obviously find more non-conformances in section 7.
Above average auditors who can interpret the requirements very well and relate to system implementation can find in sections 4,5,6 & 8.
I think recreating the poll based on 1994 Elements will give better insight for this exercise. This is more like 1000-foot level. 1994 elements are more specific. We can leave out the 1994 clause # if that would create some confusion.

Craig's observations are in alignment with many auditors’ experience. I have discussed these occurrences in the past.
#1 is Documentation & Data Control
#2 is Control of monitoring and measuring devices.

Items mentioned by Craig in 5.6.2, 6.2.2, 7.6, 8.5.3 are very good example of potential non-conformances in any organization. Most auditors do not pick up on these subtle NC. Particularly the one in 7.6. This requires knowledge of metrology and interpretation of requirements.

Also, Even organization exclude Special processes from the system when they actually do perform those processes. (Lack of understanding on the intent of special process).

Regards,
Govind.