ISO 9001 Registrar Audits: Failure Modes

[Aaron Lupo]

Here is a list of findings that I have seen most often when doing upgrade audits from 94 to 2000.

4.2.2 C Processes are not defined in the Quality Manual. If there are multiple sites involved the interface between the sites are not identified.

4.2.3 b) Document control procedure does not address periodic review and re approval of documents.

4.2.4) Control of records procedure does not address retention time or disposal of quality records.

5.1) Top management (those who have responsibility for profit and loss) do not communicate the importance of meeting customer, and statutory requirements. No records, resp defined, etc..

By far the requirement most often missed are 8.2.1 or 5.4.1) Top management has not established measurable objectives, goals (8.4), and corrective action (8.5.1) is not issued when goals are not met. (8.2.3)

5.5.3) There is no evidence that Top Management communicates 5.4.1 to all levels

- Most often floor employees do not know what the goals are, if they are meeting their goals, how they contribute to meeting the goals

5.6.3) is obvious and completely missed, no action items with responsible person and target date for completion. No follow-up from previous mgt reviews.

6.2 a & d) records of competence, qualification is initial training, competence is continued evaluation after they are initially qualified

7.1 No evidence of items a - d for new or changes to processes

7.5.1 a)

8.2.1) Customer perception is from the customer's point of view. The fact that clients are not complaining or still buying product is not customer perception. Internal measures of OTD and scrap is not customer perception.

8.4 d) there is no data to measure and monitor supplier performance

 

[Marc]

I split this thread off because I think it has merit as a 'Special' thread.

What ARE the failure modes / writeups you're seeing? In the old days, this was 'it': https://elsmar.com/level2/failure.html

Let's update that page here.

 

[howste]

I'm attaching an interesting article on this topic. It's a survey of companies that have been transitioned to ISO 9001:2000, and includes summary information about the top areas that companies have had trouble.

 

[Claes Gefvenberg]

Thank you Howste,

That was interesting and I intend to go through that text very thououghly. Still: Since that survey was based solely on US data I suggest that we try to roll our own here, where we have participants from all over the globe.

In our transition audit we had no NC's, so fortunately I'm unable to add to the list.

/Claes

 

[gpainter]

we had two:
1. Control plans not being revised as stated in CA Plan.
2. Work orders not being revised as stated in CA Plan.

 

[howste]

...we had no NC's, so fortunately I'm unable to add to the list.

Yes Claes, It's too bad you didn't have any NC's. Hopefully others here that are transitioning will have the same "misfortune."

 

[Cari Spears]

Here is a list of findings that I have seen most often when doing upgrade audits from 94 to 2000...

...By far the requirement most often missed are 8.2.1 or 5.4.1) Top management has not established measurable objectives, goals (8.4), and corrective action (8.5.1) is not issued when goals are not met. (8.2.3)

...5.6.3) is obvious and completely missed, no action items with responsible person and target date for completion. No follow-up from previous mgt reviews...

Well, it wasn't our transition audit, but...

We received two minors at our first 9k2k surveillance audit. The following are the exact wordings:

CAR #1 - 8.1c) No objective evidence to indicate the supplier has continually improved the effectiveness of the quality management system.

CAR #2 - 8.4) No objective evidence to indicate the supplier has analyzed data for the basis of improvements.

Though he cited 8.1 & 8.4 - he could have also cited 5.6.3.

In a nutshell, what he found was that we have objectives and metrics established, we are monitoring them and reviewing them at Mgt Rev meetings, but #1 - our indicators are not showing continual improvement (positive trends toward our established goals) and #2 - we're not showing effective management review outputs (like action items) when goals are not met (negative trends away from our established goals).

 

[Douglas E. Purdy]

Uh Oh!

Did Top Management take this as a wake-up call even though they were minors?

 

[Cari Spears]

Yes. The auditor, during the closing meeting, also made sure that they understood that theses minors could turn into majors. As we've discussed in other threads - it does sometimes take an outside person (auditor, customer rep, consultant, etc.) to validate what I've been saying around here.

We really took our time in choosing our objectives and targets, deciding what to monitor and how to measure them, etc. However, day-to-day operations (is that going to ship today?!) put things we talk about in Mgt. Rev. on the back burner. This is a seriously rush environment, we often joke that we'd save more red ink if we stamped routers and follow up sheets "Not Rush" instead of "Rush".

Just a little side note - our registration audit should have been: 1/2 day desk audit off site, 1 day for the upgrade, and 1 day for our regularly scheduled surveillance audit. Because of scheduling conflicts - our two on-site days were split and performed about a month apart from each other. We had the 1 day registration in September '03, and our surveillance in November '03. We've been monitoring and measuring things throughout 2003 in order to determine "where we are" in order to set obtainable goals. We hardly had time to "improve" in the 5-6 week interval between the reg. and surv. audits. However, as I mentioned above, this is something that I need to work on (using our metrics that we're spending all this time to compile) with our management team, so (frankly) I'm glad the auditor wrote these up.

 

[Marc]

Can I drag any more responses out of you folks?