Approval of Documents - Is Verbal Approval good enough?

[FrameReader]

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

 

[ScottK]

Re: Approval of Documents

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

Hi FrameReader.

IMO you need some record of the approval in order to comply with 4.2.3 a. If it's just a verbal OK there is no objective evidence that the document has been reviewed for adequacy, right?

I have the process owner sign something - whether it's the document itself or a document approval sheet.

Actually I prefer an approval sheet or change record becuase then you don't need to keep a paper copy of the documents itself if you want to keep your procedures on the intranet or something.

 

[SteelMaiden]

Re: Approval of Documents

Document what you do. The fact that you keep a spreadsheet is your record of who. Make sure that your procedure spells out the fact that the dept. managers are responsible for approving document to the MR and and the MR records the who and when in a spreadsheet. If you protect that spreadsheet you will have even tighter control, proving that the janitor cannot open the file and change the approval information accidently or on purpose.

 

[ScottK]

Re: Approval of Documents

Document what you do. The fact that you keep a spreadsheet is your record of who. Make sure that your procedure spells out the fact that the dept. managers are responsible for approving document to the MR and and the MR records the who and when in a spreadsheet. If you protect that spreadsheet you will have even tighter control, proving that the janitor cannot open the file and change the approval information accidently or on purpose.

I dunno - there's still no evidence that the document was actually reviewed... it's one person's word.
But I'm looking at this through FDA goggles too.
Our customers would write this up every time even if the registrar didn't.

 

[sagai]

Re: Approval of Documents

in 9001 word, an email is fine if it does readily available, but you shall mention your approach in your document management procedure description, remember about tha past talking is not an objective evidence br
Sz.

 

[Hydrazine]

Imho it may be a little dangerous not to have written records of everything that is going on. Auditors love to tell you things like "if it isn't recorded, than it doesn't exist".
Cheers,

 

[Quality-Geek]

As long as your process is documented and you can control your spreadsheet tightly, you're probably OK. Personally, I like having an actual signature. I've seen too many cases of "amnesia." I really don't like it when some flipping promoted-to-his-highest-level-of-incompetence-idiot "forgets" that he made a change and tries to get me in trouble. Getting a signature keeps me out of trouble, since I'm one of two people who can change any document in the plant.

And we're old-school... I haven't been able to talk management into buying Acrobat for everyone yet, so everything is printed and then scanned. I couldn't even scan effectively until a couple years ago! Right now digital sigs are not happening.

Scott, I like your approval sheet approach. It would save a ton of paper (and comply with ISO 14000 objectives and targets).

 

[somashekar]

My response has nothing to do with any standard requirement. In an very broader sense whoever approves, does that person stand by it ?
Even if it is the CEO who approves with a signoff, is he humble enough to admit an error if there is one ?
Even if he approves verbally, will he stand by it and admit an error if there is any ?
OR
Is he the one who will turn around when something goes wrong and says 'Who approved this s---' ?
If ethics run in the blood of your company then ...

All I do is make a note of who approved the change in an excel spreadsheet that lists all of our documents.

is ok ~~~

 

[harry]

My response has nothing to do with any standard requirement. In an very broader sense whoever approves, does that person stand by it ?
Even if it is the CEO who approves with a signoff, is he humble enough to admit an error if there is one ?
Even if he approves verbally, will he stand by it and admit an error if there is any ?
OR
Is he the one who will turn around when something goes wrong and says 'Who approved this s---' ?
If ethics run in the blood of your company then ...
is ok ~~~

Good point - Accountability!!

 

[JRKH]

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

I do not see a particular problem with your method on the surface of it. In fact I used just such an informal process in the system I set up. It was my initials on the documents most of the time...

As an auditor, I would be interested in knowing how you control and protect your documents, who can access and change the originals, who releases them etc. If the system is sufficiently controlled and I find no bad resvisons on the floor etc... then I don't think I'd have a problem with a "verbal" change between yourself and the manager/dept head.
As to the idea of someone not standing behind what they approved...If something like that were to come up during an audit, it would demonstrate that procedures were not being read and followed more than not being properly approved.
After all, if you follow your procedure, and get a verbal OK (but in reality there is something amiss), someone else should certainly catch the error when the new procedure is put into effect and they try to follow it.
An auditor should never even be aware os such an occurance.
And I've never had one go around asking, "did you approve this?"

Peace
James