ISO 9001 Registrar Audits: Failure Modes

[David Hartman]

Can I drag any more responses out of you folks?

Drag away O' Mighty Cheech Wizard!

We ended up with 5 Minors and 5 Opportunities for Improvement (I will define the Minors).

1. Procedure XXX does not define what metric is used to monitor or gage the effectiveness of the process.

2. Procedure YYY requires update to clearly define the process steps.

3. Procedure ZZZ defines two specific metrics for gaging the effectiveness of this process, these were not the metrics being used.

4. Procedure for Disaster Recovery was not under document control [One we overlooked/missed].

5. The QMS does not define the controls over subcontractor used for Owner's Manual printing and distribution.​

 

[The Taz!]

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.

He actually referred to your company as "the supplier"????"

 

[Cari Spears]

Yeah, he does in all of our findings. I never thought much of it.

 

[krishkaar]

Audit NCS - ISo 9001:2000

With one of the clients, NCs are :
1. the Organisation has no planned continual improvement processes identified. Mere Corrective and preventive actions do not amount to Continual improvement?
2. the QMS does not address how the 'investors' will be satisfied?

Comments please.

 

[howste]

With one of the clients, NCs are :
1. the Organisation has no planned continual improvement processes identified. Mere Corrective and preventive actions do not amount to Continual improvement?
2. the QMS does not address how the 'investors' will be satisfied?

Comments please.

I'd be interested in more details on both of these. Here are my thoughts:

1. I agree that CAPA does not equal CI. As such, the NC is probably valid, but I don't necessarily agree with the first sentence of the NC. The ISO standard pretty much defines the continual improvement process. It is accomplished "through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review." If those activities are effective, then the requirement is being met. To show that these processes are effective requires demonstrated improvement, most likely in the are of the quality objectives. If there is no improvement then the requirement is not being met.

2. I don't understand this one at all. The ISO 9001:2000 standard does not include 'investors' anywhere in it, and there are no requirements that we satisfy their needs. ISO 9004:2000 does talk about investors, but it's not auditable, so how can there be an NC?

 

[Sidney Vianna]

Monday morning quarter backing

Interesting posts and discussions. As ususal, it is always hard to second guess the write-ups. We never know all the background, context,etc . . ., but I would like to make a couple of points.

The third-party auditor should not write up the finding use the word supplier. The word to be used is ORGANIZATION. One of the changes from 1994 to the 2000 Edition. Makes me wonder if this auditor is still wearing his/her second-party auditor hat

Written up for failing to demonstrate continual improvement of the QMS. OK, but let's remember that for many reasons, organizations MIGHT not be able to improve the QMS, such as a recessionary period, merger, acquisition, employee strike, etc . . . The key question is if management is aware and addressing the reasons behind the lack of improvement. An analogy I make is non-conforming product. Tha Std. accepts that an organization might produce a nonconforming product. However, once identified, it needs to be controlled, possibly segregated, dispositioned, etc . . .Unless an organization chronically fails to improve the effectiveness of the QMS and Management seems to be indifferent or oblivious to it, I would not be trigger happy writing this up. Further, if an organization fails to improve it's performance, much worse than being written up in an audit, is the realization that it would not last long in a very competitive market.


The finding concerning lack of evidence for investor satisfaction: Howste, you are right. However, let's imagine that the organization in question was a venture capitalist investiment entity. The investors are the customers, in that scenario. So, somehow the organization should monitor their customers.

You see, as ISO 9001 expands it's coverage, especially in the Service Sector, certain scenarios, never dealt with in the past will pop up.

 

[Cari Spears]

...Written up for failing to demonstrate continual improvement of the QMS. OK, but let's remember that for many reasons, organizations MIGHT not be able to improve the QMS, such as a recessionary period, merger, acquisition, employee strike, etc . . . The key question is if management is aware and addressing the reasons behind the lack of improvement...

. . .Unless an organization chronically fails to improve the effectiveness of the QMS and Management seems to be indifferent or oblivious to it,...

...Further, if an organization fails to improve it's performance, much worse than being written up in an audit, is the realization that it would not last long in a very competitive market...

Thank you

 

[krishkaar]

NC on 'Invester'

The auditor was highlighting the requirements of 'setting objectives at all functional levels-' and this he advised to the top management-
"your investor must be interested in your managing the busines. What steps are you taking to satisfy them".
The proprietor said-
increased sales growth, more new products and reduced wastage / scrap are the steps taken which according to him must satisfy the investor.
Auditor: You must take care of your - Customers, Investors, Statutory / regulatory Authorirties, Employees and Suppliers'.
He suggested some steps for ensuring measurements of perfromance and satisfaction.
May be the auditor's suggestion could be taken as- a review in the MRM highlighting the various issues towards these and drawing conclusions???

 

[krishkaar]

Audit comment on 'Corrective action vs Continual Imp.

Here again, look at the size of the organisation - small and more customer driven - literally.
Because the 'supplier organisation is a Job-worker. he has only TWo customers.
His QMS and the implementation is very effective in so far as taking corrective / preventive actions. This is also accepted by the Auditor.

The proprietor's defence is that every Corrective / Preventive action has changed his way of working and shop-floor practice for the better. And a revision in Objectives also, wherever appropriate.
(This is not acceptable to the Auditor. Hence the suggestion.)
Why then a separate continual improvement 'Project'?

 

[Rachel]

I don't really get how preventive action isn't the same as continual improvement. If the goal of PA is to identify potential issues (*before* they become issues) and resolve them - to be proactive and all that - then how in the world could anyone say that isn't continual improvement? The whole PA process amounts to finding craters in your system and sealing them before anyone or anything falls in. How is that not continual improvement???


Someone ... book me for being clueless.
-R.