Defining Responsibilities - Author and Owner Policies

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bonnieblue

#1
hello again everyone,
for most document types (procedures, manuals, etc) the line between document author and document owner is usually pretty clear. how do you guys handle this for policies?

i am thinking we may need to have one person (the process owner) sign as the author of the policy and all the other members of the leadership team sign off as approvers. do this sound reasonable? or should only the CIO be the approver and everyone else simply indicates they have reviewed the policy (and contributed to its completeness)?

thanks in advance!
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: Policy author and owner

Hi bonnieblue...

I have to call out the standard answer here before telling you what works for me: it really comes down to what works best for your organization.

In my system the author is never nearly as important as the process owner. We never have anyone sign as the "author" because the fact is two people have ghost authored 90% of our documents... we have an "originator" sign off in our system who is usually, but not always, the process owner. The originator is never called out on the document itself, but the process owner always is.

As far as policies, it depends on what your definition of policy is... my system has very few stand alone "policies".
I see a policy as a rule or a statement of belief, not a process like a procedure or work instruction. So the owner is, in reality, everyone.

Taking the example of the Quality Policy in my system - there is no assigned owner and there is no "author". The approvers of the Quality Policy are the executive team, and this is evidenced by all of them signing off on the Document Control Record. The originator was me, because I put it into the system, but the policy was written long before the document control system existed.
The policy itself is not signed, nor does it point out the author (who is lost in antiquity).
 
B

bonnieblue

#3
Re: Policy author and owner

thanks for the quick reply, scott. let me give see if I can clarify a little more. We are an animal Pharma company, so the FDA does require we list the people responsible for review and ownership of the document and their titles/roles.
typically we define the author as the person who uses the process or performs the task on a day to day basis and the owner is the leadership team member who has overall responsibility for the process (also read, the person who will be responsible for answering to the auditors about why we did it this way). so, as the documentation mgr, I author the document control procedure, but the quality and compliance director is the owner because she is responsible overall for our compliance program. Document control is defined as under our quality policy. But for the quality policy (or asset mgmt or security, etc), would she author it and CIO would be the owner?
 
P

Polly Pure Bread

#4
Re: Policy author and owner

But for the quality policy (or asset mgmt or security, etc), would she author it and CIO would be the owner?
hi bonnieblue,
what do you mean by CIO? do you mean CEO?
 
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P

Polly Pure Bread

#5
Re: Policy author and owner

The Approver can also be a Reviewer but the Author cannot be the Reviewer and Approver of document he/she wrote.
 
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bonnieblue

#8
cio = chief information officer
ceo = chief executive officer

it's the "same person cannot approve as authored" part that's getting me...
 
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