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Which ISO 9001 Clause applies to "Procedures are outdated"?

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Sidney Vianna

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Staff member
Admin
#12
The other side of this point is that I have seen a deviation of processes and procedure which has improved the effectiveness of the process but was not properly documented.
I agree. Sometimes, the mismatch between the deployed process and the documentation defining the process is because the process evolved and the documentation revision is lagging behind.

That is what I wrote in this post, over 8 years ago.

Failure to follow established procedures signify failure to implement PROCESSES, as devised. ISO 9001 is about process control & improvement. Documented procedures exist to describe how the process is supposed to work. Thus, and obviously, if you are not following a documented procedure, chances are, you are deviating from the intended way the process is supposed to be executed. Unless it is one of those instances where the documented procedure has not been revised to catch up with the intended process.
 

Tagin

Trusted Information Resource
#13
Hello Readers,
I am doing my first internal audit in this company, During the audit , I found out that the supplier evaluation procedure is not up to date. We are not currently perform some of the activity which are written on procedure.
So I am writing the NCR for this finding and can't figure it out which ISO clause should i mention in the Non-conformance. Should it be 7.5.2 (c)?

Thank you for your help !

Regards
I would think that it would be 6.3b Planning of Changes ("The organization shall consider: b) the integrity of the quality management system;").

At one time, the procedure matched the process.
Then, the process was intentionally changed but the documentation was not changed, which broke the integrity of the qms.
Hence 6.3b.

4.4.2a ("maintain documented information to support the operation of its processes") applies too, but since this NC was due to a process change that was not properly planned, I think 6.3b is the one to mention.

Another way to look at it is: if this happened in one process change, what corrective action will prevent it from occurring in another process change in the future?
I think the answer is: better planning of process changes; i.e., 6.3 Planning of Changes.
 
#14
Hello Readers,
I am doing my first internal audit in this company, During the audit , I found out that the supplier evaluation procedure is not up to date. We are not currently perform some of the activity which are written on procedure.
So I am writing the NCR for this finding and can't figure it out which ISO clause should i mention in the Non-conformance. Should it be 7.5.2 (c)?

Thank you for your help !

Regards
Since this is your first audit, if I were your audit manager (IA Process owner) I'd be debriefing you along the lines of:

How did you determine the evaluation procedure is not up to date?
Which activities are not being performed? Why is that?
What is the effect of not doing these activities?

Before you worry about which clause of a standard to apply (which, frankly, management don't know or care to know about), let's make a compelling case for management to resolve the exact nature of what you have found. Simply "not following procedures" isn't going to capture anyone's attention...
 

normzone

Trusted Information Resource
#15
I'm involved in a similar situation at this time - significant reduction in force, so not all of the layers of management referenced in the documentation exist any more, and not all of the work referenced in said document is being done.

That said, some more efficient methods of getting the corn through the goose have evolved, so there are upsides to the challenge as well.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#16
That said, some more efficient methods of getting the corn through the goose have evolved, so there are upsides to the challenge as well.
What are the methods used to capture this organizational knowledge of more efficient methods? Because, there is always a risk to lose this knowledge if and when the reduction in force affects more employees.
 

normzone

Trusted Information Resource
#17
Internal audits are revealing the dichotomy betwixt the process documentation and the process actual, documents are getting updated.
 

John Broomfield

Staff member
Super Moderator
#18
Internal audits are revealing the dichotomy betwixt the process documentation and the process actual, documents are getting updated.
norm,

Don’t forget that between to actual process (aka work) and the out of date documented procedure you have the actual undocumented procedure.

We quite often make the mistake of thinking the way we carry out the process is the process when it’s actually the procedure.

So, if the process is effective and working in accordance with the undocumented procedure is the documented procedure necessary?

John
 
#19
norm,

Don’t forget that between to actual process (aka work) and the out of date documented procedure you have the actual undocumented procedure.

We quite often make the mistake of thinking the way we carry out the process is the process when it’s actually the procedure.

So, if the process is effective and working in accordance with the undocumented procedure is the documented procedure necessary?

John
I've found it common that the documents and the practices are different. Too many people draw process flows which are the "logic" of the process and not what actually happens. Again, this is often done in isolation of the people who have to deal with the issues of an ineffective process.

The need for documentation doesn't come from a process being effective. It comes from understanding the context of the organization and the need to retain knowledge!
 

John Broomfield

Staff member
Super Moderator
#20
I agree with you.

Our documented procedures could help us to manage organizational knowledge by giving the process team members the authority to mark them up so they accurately reflect their process.

Instead our documented procedures tend to become relics.
 
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