ISO 9001 Registrar Audits: Failure Modes

[howste]

I agree that preventive action is an important part of continual improvement. The reason I said that CAPA does not equal continual improvement is it's possible to make improvements while your system still fails. To use your metaphor, if you are sealing up craters at a rate of one per month while new craters are opening up daily, the organization overall still is not continually improving.

 

[Marc]

Don't miss these threads!

https://elsmar.com/elsmarqualityforum/threads/4036/

https://elsmar.com/elsmarqualityforum/threads/6532/

 

[Sam]

I agree that preventive action is an important part of continual improvement. The reason I said that CAPA does not equal continual improvement is it's possible to make improvements while your system still fails. To use your metaphor, if you are sealing up craters at a rate of one per month while new craters are opening up daily, the organization overall still is not continually improving.

Howste, I agree and it was stated more clearly in QS.
However it appears ISO cannot even agree what constitutes CI amongst themselves.
Referring to para in the TS2 yields the following inconsistencies:

8.5.1 - The organization shall continually improve the effectiveness of the quality management system through the use of . . . corrective and preventative actions . . .

8.5.1 - (see examples in annex b of ISO 9004-2000) Inconsistent with the philosphy of CI. The first step is to identify the "PROBLEM" as opposed to identifying an "opportunity for improvement" or better known as a "PA".

8.5.1.2 - . . . . manufacturing processes are capable and stable . . . (Now were getting somewhere).
Also referring to the guidance document that states that "In reference to NOTE 2, corrective action is not continual improvement.
The confusion that leads to "continual" chaos.

IMO, CA addresses problems. PA addresses improvement. Continual application of PA equals CI.

 

[Tanahy]

seems this thread started before i register to the cove, i was reading it and i see its kinda left, and i am still confused!
do you agree that PA=CI? or what?
can't we be some flexible and say PA is one of the helpful tools support CI? I think if improvement is meant for >>>Quality... we may be doing PA and still not improving, or not doing ALL the improvement we can do... I think also that when I do PA so i am preventing a nonconformity... is preventing all the nonconformities can be called CI? so what about this:

PA is a very important process that contributes in the continual improvement of quality. but it doesnt equal CI
?
any opinions?

 

[RoxaneB]

PA is a very important process that contributes in the continual improvement of quality. but it doesnt equal CI? any opinions?

In my opinion, Preventive Action does not equal Continual Improvement. It can be related and possibly be used as one of many tools to help demonstrate CI, but PA is not the be all and end all of Continual Improvement.

Why? Because Preventive Action is basically you addressing a potential problem. Do you only improve because of the possibility of a problem? Or do you improve because you want to be more effective and efficient?

Think of it like this...was the wheel invented because there would possibly be problems if we did not have such technology or was it invented to help improve how humans moved objects and covered distances?

Preventing a problem, potential or otherwise, is not an improvement in my mind. It is simply avoiding a problem. If I choose to walk around large puddle because I do not know how deep it is, is not an improvement...it is simply me avoiding getting my shoes wet. However, if realize that my shoes have remained dry because of my decision and now make it my practice to always walk around puddles in an effort to save my shoes, well, my process has changed, I'm saving money by not having to always buy shoes and have just demonstrated improvement.

There are many other ways, however, to demonstrate continual improvement within an organization:

• Opportunities for Improvement (audit results)
• Employee suggestions (including initiation, analysis, actions and feedback)
• Projects initiatied to help meet quality/production/operation goals and a clear improvement over the years can be demonstrated
• Improvement on Key Indicators
• Initiation of communications tools with Customers/Employees/Community/Suppliers.
• ...and so on...

 

[Rooch]

QMS vs Processes

My interpretation is that CI addresses the QMS, and PA addresses processes. The QMS is much more than processes.

 

[Marc]

Re: ISO 9001:2000 Registrar Audits: Failure Modes

Thread bumped for potential new input.

 

[qualityboi]

Re: ISO 9001:2000 Registrar Audits: Failure Modes

Design – 4.1B sequence and interaction not defined. Basically our design group likes to do things their own way because they are smarter than the rest of the company, also they don’t like to document or tell anyone how they conduct business.
Training – 6.2.2 no records of training for inspectors
Records – 4.2.4 not easily retrievable (calibration records)
Measurement of Process – 8.2.3 No process metrics for receiving
Nonconforming Product – 8.3 Non-conforming product unmarked in receiving
Management Review – 5.1 Evidence of management review is incomplete

4 of these are from a site next to the corporate site that is being certified under the corporate umbrella, 2 of these are for the certified corporate site.