Do processes that are audited need to be documented?

M

Meggsy

#1
We are a fairly new quality system - recently certified to ISO 9001. We have documented procedures for the mandatory processes - Document Control, Internal Audits, etc, but that's about it. At our certification audit, the auditor was fine with this as we have a list of processes that we want to document, and we told him how we were prioritising these.

The issue is that it will take a while to standardise these processes (3 different locations doing things differently), and in the meantime, I need to coordinate Internal Audits on these processes. I am happy for the locations to do the audit based on how they do the job there, however the current procedures are not documented, just informal instructions that they've been following for years. I am not happy to waste time now documenting all of these informal processes for the 3 locations, when we know that they're only going to be standardised, and probably changed, in the future (I should be spending my time doing that instead).

Does this count as an audit, if we are not auditing against a document? If not, how are we supposed to satisfy the requirements to do Internal Audits, if it's going to take us forever to document the processes? I am really confused.

Please no 9001 purist answers, I am looking for a real solution as to how I can get this work in my company.

Thanks,
~M
 
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Randy

Super Moderator
#2
OK...This isn't an ISO 19011 thing to begin with, but we'll go on.

You didn't want a 9001 Purist answer, but you claim to have a QMS in place, so use it to your benefit...It works for you, you don't work for it....

Look at ISO 9001:2008- 4.2.1 Quality system documentation - The quality management system documentation shall include... d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

Now ask some questions like...

Are we doing what is necessary to be done without the documentation?

Is the difference in the way the 3 different locations perform the processes in question causing problems?

If the processes are working why do I need to change them?


If you can show effective control, continuity and achievement of planned results without standardization and documentation then you need to ask..."Where's the value?"

Don't document stuff just to look pretty and dress-right-dressed, document when control is lacking and planning isn't fulfilled or when there is a real potential for these things to happen.
 

Stijloor

Staff member
Super Moderator
#3
We are a fairly new quality system - recently certified to ISO 9001. We have documented procedures for the mandatory processes - Document Control, Internal Audits, etc, but that's about it. At our certification audit, the auditor was fine with this as we have a list of processes that we want to document, and we told him how we were prioritising these.

The issue is that it will take a while to standardise these processes (3 different locations doing things differently), and in the meantime, I need to coordinate Internal Audits on these processes. I am happy for the locations to do the audit based on how they do the job there, however the current procedures are not documented, just informal instructions that they've been following for years. I am not happy to waste time now documenting all of these informal processes for the 3 locations, when we know that they're only going to be standardised, and probably changed, in the future (I should be spending my time doing that instead).

Does this count as an audit, if we are not auditing against a document? If not, how are we supposed to satisfy the requirements to do Internal Audits, if it's going to take us forever to document the processes? I am really confused.

Please no 9001 purist answers, I am looking for a real solution as to how I can get this work in my company.

Thanks,
~M
Look at the attachment.

Stijloor.
 

Attachments

M

Meggsy

#5
Thanks for the responses. I read this as you don't need to have documentation before doing the audit, and based on audit results, it's possible that you may never need the documentation? However, still keep doing the audits to ensure that the process continues to work properly. Is that right?

Thanks again :)
 

Stijloor

Staff member
Super Moderator
#6
Thanks for the responses. I read this as you don't need to have documentation before doing the audit, and based on audit results, it's possible that you may never need the documentation? However, still keep doing the audits to ensure that the process continues to work properly. Is that right?

Thanks again :)
Yes, you need to know what the purpose is of the process and you must verify its effectiveness based on objective evidence.

Stijloor.
 

Big Jim

Super Moderator
#7
If you can do the task effectively without written instructions, you don't need a written procedure (except for the required six that you already have documented).

It is that simple. Or as Randy often says, "it ain't rocket science". And he would know.
 
O

outoftown

#8
We are a fairly new quality system - recently certified to ISO 9001. We have documented procedures for the mandatory processes - Document Control, Internal Audits, etc, but that's about it. At our certification audit, the auditor was fine with this as we have a list of processes that we want to document, and we told him how we were prioritising these.

The issue is that it will take a while to standardise these processes (3 different locations doing things differently), and in the meantime, I need to coordinate Internal Audits on these processes. I am happy for the locations to do the audit based on how they do the job there, however the current procedures are not documented, just informal instructions that they've been following for years. I am not happy to waste time now documenting all of these informal processes for the 3 locations, when we know that they're only going to be standardised, and probably changed, in the future (I should be spending my time doing that instead).

Does this count as an audit, if we are not auditing against a document? If not, how are we supposed to satisfy the requirements to do Internal Audits, if it's going to take us forever to document the processes? I am really confused.

Please no 9001 purist answers, I am looking for a real solution as to how I can get this work in my company.

Thanks,
~M
I think you are confused because you are auditing the manufacturing process, but this is not one of the required procedures. You audit purchasing even though there is no requirement for a procedure, right? You can count working with the locations as an audit if it meets your audit intent. If you can write nonconformities and assign the actions to the management in the area you are auditing, this could be shown as audit evidence. You do not need procedures to do your audit. Use the standard. However, it may be difficult to audit to the proper manufacturing process if the optimum manufacturing process is not yet in place. Audits may help with the standardization.

The six mandatory procedures, if they are written as divisional or corporate type documents, could apply to all locations. Findings can be written for any location not following the general requirements as covered in these documents. If you would rather not have 3 unique sets of these documents tailored for each location, it might be a good idea to establish the procedure or work instruction as it is done at the main location. An auditor at location B or C would write a nonconformity if the documents are not followed at location B or C, and the corrective action would be to either change the way B or C does it, or change the procedure/work instruction to something everyone agrees to, or create a separate procedure/work instruction. If your audits are spread out over the calendar year, this will not be too overwhelming.


HTH
Good luck
Outoftown
 
Last edited by a moderator:
R

Richard Pike

#9
We are a fairly new quality system - recently certified to ISO 9001.
At our certification audit, the auditor was fine with this as we have a list of processes that we want to document, and we told him how we were prioritising these.

Please no 9001 purist answers, I am looking for a real solution as to how I can get this work in my company.

Thanks,
~M
So you got your Certification based on the fact that you were able to demonstrate that you have relevant processes in place (even if not-documented). (no problem with that - in fact - marvelous)

One of these Processes would have been "Internal Auditing" and in fact you would have had a "documented" process (procedure) for this as well as some form of Internal Audit history conducted by qualified Internal Auditor/s.

I'm sorry I really don't understand your question?

Your CB Auditor was happy with the way you had conducted your Internal Audits prior to his/her Certification Audit! i.e They were considered adequate and effective!

Why do you now want to second guess the way you have committed to conduct audits (via your documented audit process) and the way your Auditor was happy with?

PS. you say we (i assume you mean your Organizations Senior Management) WANT to now document certain processes. The question is WHY? What to you hope to achieve by doing so?

PS If you are asking - how to Document Processes - without destroying forests or a buying bigger hard drive - then that is an entirely different question. The immediate obvious answer is to use basic Process Flow Charts but any (non-ISO purist) Management Rep should already be fully aware of this methodology.

So again - with all due respect - what is the question?
 
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