Document Change Approval

#1
Auditors tend to bring up the statement that "You can not approve your own work". I am having a hard time pinning that down in ISO or the FDA standard. In some situations the subject expert is both the Document Owner and the Approver. Is this justified if we explain in our document procedure that this may be the case in some situations? I would just like to be sure as it seems to come up a lot like it is a golden rule although I am sure it is a best practice if you have a situation where you may have a secondary person with the same level of knowledge to evaluate the document before it becomes official, otherwise it is just a paper exercise to have someone approve just to keep from getting hit for not approving your own work. Thanks for your feedback.
 
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Zero_yield

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#2
It's a great rule of thumb. The only place I can think of in ISO 13485 that explicitly says anything like that is 8.2.4 - "auditors shall not audit their own work" - which isn't exactly what we're talking about here.

For most of our document changes, the approvers are the owner, the owner's manager, and a QA signature. There's no particular requirement it has to be that way, and it's probably a little overkill (but we love overkill around here).
 

John C. Abnet

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#3
Auditors tend to bring up the statement that "You can not approve your own work". I am having a hard time pinning that down in ISO or the FDA standard. In some situations the subject expert is both the Document Owner and the Approver. Is this justified if we explain in our document procedure that this may be the case in some situations? I would just like to be sure as it seems to come up a lot like it is a golden rule although I am sure it is a best practice if you have a situation where you may have a secondary person with the same level of knowledge to evaluate the document before it becomes official, otherwise it is just a paper exercise to have someone approve just to keep from getting hit for not approving your own work. Thanks for your feedback.
@Zero_yield is spot on. The reference to the similar term is indeed clause 8.2.4 and is in the context of INTERNAL AUDITING. Hopefully your organization slightly misunderstood the verbiage / intent and the 3rd party auditor did NOT actually use the term "can not approve your own work".

The verbiage, as stated, would imply the "auditor" (was this internal?...2nd party?....3rd party?....) is experiencing mission creep.

Hope this helps.
Be well.
 

Zero_yield

"You can observe a lot by just watching."
#4
Also, for full transparency - we actually have a requirement in our internal procedures that says that no one is allowed to approve their own work.

If you've got an internal auditor saying that, you may be in the same boat. They might be referencing an internal / local / corporate procedure.
 

Hi_Its_Matt

Involved In Discussions
#5
I sure hope people can approve their own work! Having said that, I also think there should be very few cases where a document/record is approved by only one person, either.

Generally, if Person A creates a record, or wants to make some document change, there should be at least one other person who reviews that record/document. I work at a very small (<20 people) design consulting company, and I can think of only a handful of records/documents that are genuinely approved by only one person.
 

Enternationalist

Involved In Discussions
#6
In 13485, "Approval" is always accompanied by the verb "verify" or "review" in some form. The obvious spirit of the concept is - check work is good and correct before approving it. It doesn't take much of a mental leap to see how an author reading over their own work isn't exactly a rigorous check. We've all written up something, thought it was great, passed it onto someone only to have them point out glaring errors 5 minutes later.

There's no explicit requirement, but you need to be able to justify that work has been adequately reviewed or verified. In most cases, this is most simply and effectively done by having a different person look at your work.

If you're a solo operator, I would think it worth establishing other objective methods to ensure work is reviewed sufficiently. For example, maybe you make a systematic checklist to ensure commonly-missed things are checked that might otherwise go unnoticed by a solo author. Maybe you implement automated systems to check for you. It's up to you to define what's necessary, but most of the time it'd be a cop-out just to say "Yeah, I checked my own work".
 
#7
Auditors tend to bring up the statement that "You can not approve your own work". I am having a hard time pinning that down in ISO or the FDA standard. In some situations the subject expert is both the Document Owner and the Approver. Is this justified if we explain in our document procedure that this may be the case in some situations? I would just like to be sure as it seems to come up a lot like it is a golden rule although I am sure it is a best practice if you have a situation where you may have a secondary person with the same level of knowledge to evaluate the document before it becomes official, otherwise it is just a paper exercise to have someone approve just to keep from getting hit for not approving your own work. Thanks for your feedback.
The one who approves a document about an area / activity will have indepth knowledge and background about that area / activity and more particularly the knowledge about how that area / activity interacts with other areas of the organization. This has to be established and clearly defined, documented and communucated within the organization by the top mnagement. Please note that approving of a document is also an authority given by the top management to a particular personnel, based on many factors, like education, training, skill and experience within the organization.
 
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