Which ISO 9001 Clause applies to "Procedures are outdated"?

[Sidney Vianna]

Internal audits are revealing the dichotomy betwixt the process documentation and the process actual, documents are getting updated.

That’s a good thing, but in a true process approach system, process owners should be controlling/documenting the changes to process. Internal audits should not be the primary mechanism for that, just like product inspection is not what makes a product conforming to requirements.

I know that in a workforce reduction mode, process owners see their resources stretched, but, still it would be preferable to have process owners responsible for managing change within their sphere of control, rather than relying on audits to identify the mismatch.

 

[Jim Wynne]

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

First, you shouldn't be writing NC statements against the standard. We should be able to assume that our processes are designed and executed in accordance with the requirements of the standard. If the documented process for supplier evaluation isn't being followed, the nonconformity should reference the documented supplier evaluation requirements.

The other thing is that it might not be so important in the grand scheme of things that the documented procedure isn't being followed. The important thing is why it's not being followed. Oftentimes procedures aren't faithfully observed because they're defective, illogical, unnecessarily vague or onerous and/or don't represent the most efficient way to accomplish the task at hand. In other cases, people responsible for executing the process are ill-trained or just negligent, perhaps purposefully so. Find out why the process isn't working as designed and fix it.

 

[Jim Wynne]

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Don’t forget that between to actual process (aka work) and the out of date documented procedure you have the actual undocumented procedure.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

There are senses in which "procedure" and "process" are synonymous. What is the difference between "undocumented procedure" and "undocumented process"? We need to be more careful about differentiating between the document and the actual work being done. The map is not the territory.

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

The argument could be made that there is no way to gauge the effectiveness of the process in the absence of documented requirements.

 

[normzone]

Yeah - when I have somebody complaining about why they need documentation for a given process when "everybody knows how to do it", I just ask what the consequences of that process not happening reliably would be.

Too often I've had employees tell me they've never seen the process documentation before when I ask their input regarding it being fact/fantasy.

 

[Jim Wynne]

Yeah - when I have somebody complaining about why they need documentation for a given process when "everybody knows how to do it", I just ask what the consequences of that process not happening reliably would be.

Too often I've had employees tell me they've never seen the process documentation before when I ask their input regarding it being fact/fantasy.

It's at least theoretically possible for people who have never seen and never will see the documentation to do the work as they were trained to do it. While work instructions must be available, that doesn't mean that they must be read. People should understand why the process has been designed and structured as it has been, the potential consequences for not doing it that way, and be able to suggest improvements.

 

[John Broomfield]

Jim,

You asked "What is the difference between "undocumented procedure" and "undocumented process"?""

Process is work by machine, human or animal or by a combination of these "workers".

Document the process and you have a documented procedure or the beginnings of one.

So I see no difference between a documented process and a documented procedure but a process is not a procedure.

It is very helpful for us to see clearly the difference between process and procedure because it can focus our attention on the work itself.

John

 

[AndyN]

Jim,

You asked "What is the difference between "undocumented procedure" and "undocumented process"?""

Process is work by machine, human or animal or by a combination of these "workers".

Document the process and you have a documented procedure or the beginnings of one.

So I see no difference between a documented process and a documented procedure but a process is not a procedure.

It is very helpful for us to see clearly the difference between process and procedure because it can focus our attention on the work itself.

John

John:
I seem to recall that a (previous) ISO definition was that a procedure was a way to carry out a process... Now, I'm not fully in agreement, since I'm not certain that everything is considered a process, but hey, what do I know?

 

[John Broomfield]

Andy,

Only work is process and we both know what work is surely?

We've both seen functions and departments (such as HR) called processes. This may be because some departments are named for their process such as Engineering or Training.

In resisting ISO 9000's process approach many of us convinced ourselves that process was just a fancy name for a procedure so this confusion may be two decades old.

I try always to use both terms correctly because our failure to distinguish clearly between process and procedure must be very confusing for newbies.

Cheers,

John

 

[Jim Wynne]

So I see no difference between a documented process and a documented procedure but a process is not a procedure.

It is very helpful for us to see clearly the difference between process and procedure because it can focus our attention on the work itself.

If this is the case, what is the difference between a documented process and a documented procedure? If there is such a thing as a documented procedure (where the word "procedure" is meant to refer to a document) what is an undocumented procedure, if not a process that's not documented?

 

[John Broomfield]

If this is the case, what is the difference between a documented process and a documented procedure? If there is such a thing as a documented procedure (where the word "procedure" is meant to refer to a document) what is an undocumented procedure, if not a process that's not documented?

Jim,

In my experience when people say “undocumented process” they usually mean that it is a process that may or may not conform to an undocumented procedure.

I may first seek clarification by asking if they mean the way the work is done is undocumented.

John