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Do Work Instructions need to be approved by someone other than the author?

S

sunflower613

#1
Hi All,

This is my first post, though I've been lurking in the shadows for a few months now and have found this forum immensely helpful. So thank you!

We have an enormous amount (probably hundreds) of work instructions and manuals. They are all stored in a Document Management System, so Document Control from that point of view is all good. My issue is with the approval of the documents for issue. Typically this hasn't been done in the past, and I'm trying to work out the most efficient way to get this happening.

Someone has suggested that work instructions can just be approved for use by the document author, not by a manager. The reason being that the higher level process should have inspections built in, and if a work instruction was wrong it would be picked up in the inspection process. We therefore only need document approval by a manager at the higher process level.

Thoughts? Would this make it past an Auditor for ISO 9001?
 
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Pancho

wikineer
Super Moderator
#2
We have an enormous amount (probably hundreds) of work instructions and manuals. They are all stored in a Document Management System, so Document Control from that point of view is all good. My issue is with the approval of the documents for issue. Typically this hasn't been done in the past, and I'm trying to work out the most efficient way to get this happening.

Someone has suggested that work instructions can just be approved for use by the document author, not by a manager. The reason being that the higher level process should have inspections built in, and if a work instruction was wrong it would be picked up in the inspection process. We therefore only need document approval by a manager at the higher process level.

Thoughts? Would this make it past an Auditor for ISO 9001?
Hi Sunflower, and welcome!

ISO 9001 does not require a particular approval procedure. It does require your organization "to define the controls needed (a) to approve documents for adequacy prior to issue", and "(b) to review and update as necessary and re-approve documents".

Thus, it is your organization, not the standard, that defines who approves. It may be the same person as the author, or it could be a different person. It could be an operator, the process owner or the big kahuna. But whoever your company gives authority to a approve documents, that person should be able and capable to ascertain that the document is adequate for issue.

The documented procedure required by §4.2.3 must define these controls. Your auditor will verify that it does, and that your team follows what your procedure says.

Cheers!
Pancho
 

somashekar

Staff member
Super Moderator
#3
Hi All,

This is my first post, though I've been lurking in the shadows for a few months now and have found this forum immensely helpful. So thank you!

We have an enormous amount (probably hundreds) of work instructions and manuals. They are all stored in a Document Management System, so Document Control from that point of view is all good. My issue is with the approval of the documents for issue. Typically this hasn't been done in the past, and I'm trying to work out the most efficient way to get this happening.

Someone has suggested that work instructions can just be approved for use by the document author, not by a manager. The reason being that the higher level process should have inspections built in, and if a work instruction was wrong it would be picked up in the inspection process. We therefore only need document approval by a manager at the higher process level.

Thoughts? Would this make it past an Auditor for ISO 9001?
The one who approves must be the one who knows about it based on his past work experience and knowledge, and has the authority to approve such level of document. You identify within your organization what positions can approve them.
The word author, I take it as one who writes or drafts a document. (S)he could be the one who could approve as mentioned above OR authoring on behalf of an other person who has the authority. If you can see this clearly, approval of document becomes clear as well ~~~
Good luck and welcome to the Cove ...
 

sagai

Quite Involved in Discussions
#4
Actually in this context, you "only" have to have a procedure documented for the document management and for the record management, so you should comply with your own internal QM SOP in ISO9001 world.
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G

gregqc

#6
One suggestion: Watchout for a single signoff. Ours requires that the areas affected by the work instruction, procedure, etc, has a say in the approval. I speak from experience where one department had approval and gave task to other departments that did not know and were not consulted on the procedure. I got caught in the middle.

Everyone who has a part in carrying out the work show have approval authority.:bonk:
 
H

Hodgepodge

#7
One suggestion: Watchout for a single signoff. Ours requires that the areas affected by the work instruction, procedure, etc, has a say in the approval. I speak from experience where one department had approval and gave task to other departments that did not know and were not consulted on the procedure. I got caught in the middle.

Everyone who has a part in carrying out the work show have approval authority.:bonk:
Good point. Your example highlights the reason the process approach is a requisite for quality management systems.
 
S

samsung

#8
One suggestion: Watchout for a single signoff. Ours requires that the areas affected by the work instruction, procedure, etc, has a say in the approval. I speak from experience where one department had approval and gave task to other departments that did not know and were not consulted on the procedure. I got caught in the middle.

Everyone who has a part in carrying out the work show have approval authority.:bonk:
:yes::agree1:Good point. All the users of the document or those affected by it should be the prime candidates in the approval process since the document is a compilation of their needs and if they are not involved in approval process, it's likely that they will not use it.
 
T

Tom W

#9
Not to hijack this thread but what about an actual signature or signatures on the document. Is it neccessary to have actual signatures on the work instruction or is it enough to say if released in the system they are approved...and then maintain an approval page somewhere else (not in the actual document)?

I am having old school thoughts that a signature is required just because it looks right....but is it really neccessary?
 
T

treesei

#10
I am having old school thoughts that a signature is required just because it looks right....but is it really neccessary?
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I don't think it's necessary. We document the approval, but whether it is in the form of a signature depends. I would imagine small companies with relatively simple document system/usage may go the old world way, but keeping a separate approval record will not hurt. Furthermore, in the automated document control system, the approval could be simply a click on an "Approve" buttom. The system records the person and the time the bottom was clicked; however there is never a "signature".
 
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