Approval of Documents - Is Verbal Approval good enough?

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Big Jim

Super Moderator
#22
I'm in the process of writing up our Control of Documents procedure, and I'm puzzling over how detailed we need to be when it comes to approving our documents 4.2.3(a).

We're not a huge company (~50 employees), with four departments.

When a document needs to be updated/changed/created, the manager of a department, with input from his/her subordinates, will come up with a version of what they want the document to look like. The manager then communicates this information to the QMS guy (me). I formalize the change (basically meaning I type it into the computer), and then when I'm done, I show it to the manager (this could be done as an e-mail attachment or by presenting him/her with a printed hard copy of the document - we haven't formalized this part and don't intend to), and then the manager tells me verbally that it looks good (ie that I have made the understood the changes he/she wanted me to make and that I made the changes accordingly - in other words, I think it can be said that they approve of the change - verbally). Once I have this verbal approval, I proceed with the rest of the 'Control of Documents' procedure (archiving the old version of the document, placing the new version in a network share accessible to the employees, updating a document that shows the revision history (including a comment about who approved the current version of the document), etc.

So I guess my question is, is this sufficient (especially the verbal approval part)? I mean, there's no real 'record' that the verbal approval actually occured. All I do is make a note of who approved the change in an excel spreadsheet that lists all of our documents.

Do we need to incorporate some kind of electronic/digital signature document approval procedure as part of our Control of Documents procedure? I'd rather not get into that if I don't have to.

Thanks in advance for your replies, Elsmar Cove community!

FrameReader
What you have in mind is appropriate. Something that has been missed by many other posters is that there is no requirement for keeping records associated with element 4.2.3.

Anywhere in the ISO 9001:2008 where records are required, it is clearly specified and element 4.2.4 is referenced. You won't find it in 4.2.3.
 
J
#23
There are many good responses on this thread and I'm sure it will be of use to many who have similar questions.

Several posters have mentioned keeping things appropriate to the size of the company which is very good advice indeed. But one should also be aware of potential changes (growth hopefully)
The OP says his company is about 50 souls. To me this is a size that is on the cusp of needing more detailed controls (again depending on the particulars of the company).
Once you start getting much over 50 people communication can get more complicated very quickly. Particularly if business is good. Many times a company this size still has people wearing multiple hats and they are very busy.
So while in the initial start up of a system one might try to keep it as simple as possible, relying on the fact that the company has grown and prospered well with the current team, one should also bear in mind that as the company continues to prosper, more control may be needed fairly quickly.

When I took my job as QM the company was about 30 souls and much was done "verbally". It worked fine, but I could see that the company was going to grow, so I tried to anticipate the needs for greater control and greater 'documentation". When I left we were nearly 100 souls and the systems were much more detailed than at the beginning.

So - I've taken a long time to say - Don't just consider the short view of how you document these things, but consider the longer view as well. Assume tha tthe company will grow and organize your system to be able to grow with it without undue changes.

Peace
James
 
K

Ka Pilo

#24
I'm in the process of writing up our Control of Documents procedure, and I'm puzzling over how detailed we need to be when it comes to approving our documents 4.2.3(a).

We're not a huge company (~50 employees), with four departments.
Why not get the approval in writting?
When a document needs to be updated/changed/created, the manager of a department, with input from his/her subordinates, will come up with a version of what they want the document to look like. The manager then communicates this information to the QMS guy (me). I formalize the change (basically meaning I type it into the computer), and then when I'm done, I show it to the manager (this could be done as an e-mail attachment or by presenting him/her with a printed hard copy of the document - we haven't formalized this part and don't intend to), and then the manager tells me verbally that it looks good (ie that I have made the understood the changes he/she wanted me to make and that I made the changes accordingly - in other words, I think it can be said that they approve of the change - verbally). Once I have this verbal approval, I proceed with the rest of the 'Control of Documents' procedure (archiving the old version of the document, placing the new version in a network share accessible to the employees, updating a document that shows the revision history (including a comment about who approved the current version of the document), etc.
In theory, verbal approval is the same as written approval.The difference is that verbal is not suported by any documentation, while written clearly shows that the approver have approved a specific document. In ISO 9001 view point, which one shows "control of org's QMS documents" and "control documents that are used as QMS records?"
So I guess my question is, is this sufficient (especially the verbal approval part)? I mean, there's no real 'record' that the verbal approval actually occured. All I do is make a note of who approved the change in an excel spreadsheet that lists all of our documents.
What evidence you can show that the approval has actually been done?

Do we need to incorporate some kind of electronic/digital signature document approval procedure as part of our Control of Documents procedure? I'd rather not get into that if I don't have to.

Thanks in advance for your replies, Elsmar Cove community!

FrameReader
It's all up to you as long as provision of evidence that what was planned, has actually been done.
 

Big Jim

Super Moderator
#25
What evidence you can show that the approval has actually been done?
But remember that the standard does not require that you maintain evidence (records) that it is actually being done.

True, it may make the work of the auditor a bit more difficult, because when records are not needed, and he must determine that you are meeting the requirement, he is compelled to determine what your practice is. And that is done with interviewing and observing how it is done.
 
Likes: db
K

Ka Pilo

#26
But remember that the standard does not require that you maintain evidence (records) that it is actually being done.

True, it may make the work of the auditor a bit more difficult, because when records are not needed, and he must determine that you are meeting the requirement, he is compelled to determine what your practice is. And that is done with interviewing and observing how it is done.
Approval should be recorded prior to the release and use of the document. All approvals should come prior to release.

ISO 9001 4.2.3 a)
to approve documents for adequacy prior to issue,
 
S

samsung

#27
Approval should be recorded prior to the release and use of the document. All approvals should come prior to release.

ISO 9001 4.2.3 a)
The above statement 'to approve documents for adequacy prior to issue' should not be construed to mean 'keep record of'. It does require 'approval' which can be in verbal form as well if the person concerned doesn't disapprove or deny it.
 
K

Ka Pilo

#28
The above statement 'to approve documents for adequacy prior to issue' should not be construed to mean 'keep record of'. It does require 'approval' which can be in verbal form as well if the person concerned doesn't disapprove or deny it.
Assuming that the approval in a verbal form is acceptable, the question became: How can you show that it precede the document’s release date?
 

sagai

Quite Involved in Discussions
#29
Assuming that the approval in a verbal form is acceptable, the question became: How can you show that it precede the document’s release date?
even more, how the verbal approver can recall all her/his verbal approval for each release of the documents in case auditor request?

There are several obvious cases when verbal approve can not be acceptable and not because of any standard but rather because you shall run a "money safe" business for example project plan, resource assignments, appointments, budgets, project/product risk related records, etc.

br.
Sz.
 
K

Ka Pilo

#30
Perhaps the appropriate statement is
Any form of approval is acceptable as long as the procedure indicates what constitutes the evidence that the document is approved.
 
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