Predating Document Effective Date

QuinnM

Involved In Discussions
#1
Opinions…

A document has an effective date of 5-Jan-2017.

All approvers signed the document on 20-Feb-2017, after the effective date.

Would this be an issue for the FDA or EU (ISO 13485/MDD)?
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
What would happen if one or more "approvers" refused to do so for some reason?

In short - A document must be reviewed and approved prior to use.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Opinions…

A document has an effective date of 5-Jan-2017.

All approvers signed the document on 20-Feb-2017, after the effective date.

Would this be an issue for the FDA or EU (ISO 13485/MDD)?
Hello QuinnM and welcome to the Cove :bigwave:

A pedantic auditor might make a minor observation off that.
A reasonable auditor will likely treat the date the last approver signed off as the de-facto effective date.
 

v9991

Trusted Information Resource
#4
Opinions…
A document has an effective date of 5-Jan-2017.
All approvers signed the document on 20-Feb-2017, after the effective date.
as principle & practice, "Effective date" is assigned after approval & training. (beyond what Marc has pointed out, training before approving the procedure is not a good practice; especially not recommended (objectionable) for revision/changes to the SOP)


Opinions…
Would this be an issue for the FDA or EU (ISO 13485/MDD)?
Agree with Ronen; this would certainly be an issue (observation) for an auditor; from perspective of document-control & change management.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
I'm a bit prickly about document control. In DoD work, such a document would be close to fraud, will ring all sorts of bells and throw up red flags. A document simply isn't effective until review(s) and approval(s) are complete. After that it may be given an "effective date" and released. HOWEVER, no person(s) can use it until the person(s) has (have) been trained on it.

Were I an ISO 9001 auditor, if there was a "one off", you'd get a "gimme" (no problem - observation probably). But if it was a common practice it would be a major finding in document control, were I the auditor. It simply isn't the way a valid document control system works.
 

Ninja

Looking for Reality
Trusted Information Resource
#6
I'm not in Medical at all, so read this with that knowledge in case it makes a difference.

You do stuff (a process- rev A)
At some point the process must be changed for a valid reason (a process - rev B) {Day 10}
...but you're not sure rev B process works...
So you try it {Day 15}, and test it {Day 25}, and tweak it {Day 50}, and validate it {Day 75} until you have a process that works again.
Now you have to update your document, and do so {Day 85}
...and it gets approved... {Day 100}
...and distributed for use {Day 101}

Which day did you start "using the process" ? Pretty much Day 50
When did you confirm it was the right process to be using? Pretty much Day 75
When did you document it? Pretty much Day 85
When was the doc approved? Day 100
When was the approved document distributed for use? Day 101

Which one is the "effective date"?
If it is de-facto Day 100...what did you do with the stuff made by that exact same process earlier than that?

The document is "effective" when people have the ability to follow the approved document...Day 101.
The use of the process documented started Day 50.
The use of the documented process started on Day 101.

I guess the real question here is whether the documentation follows the process, or vice versa. Chicken and Egg-ish.

If I ran 5 days production as a final validation before locking it down in the approved doc...do I really have to scrap it all, after following the exact same process in all respects, just because the Document de-facto effective date is later?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
I can see this, Ninja, but then you are going to have to put in special controls as you "test and tweak". I know the process you describe is often used. In fact, I put such documents in "Level 5" of a document hierarchy back in the 1990's along with "Temporary Change" documents. Did that in the 1980's in DoD work.

Your description is of a "special circumstance" situation. Whether or not you have to "scrap it all" depends upon the contract language as well as communication/coordination with the customer(s). It is also often referred to as a "running process change". It often involves a contract change, and I have seen customers wanting a lower price since the original contract was for a specific part made by a specific process. This is where "why are you changing the process" can become an issue for discussion with the customer.

Then again, if a company is making drywall screws to sell to hardware stores a process change will likely not be an issue. How big of an issue it is depends upon the actual product. How about titanium joints for humans? How abut heart valves and artificial hearts? What about rubber ducks for children to play with in the bathroom?
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Were I an ISO 9001 auditor, if there was a "one off", you'd get a "gimme" (no problem - observation probably). But if it was a common practice it would be a major finding in document control, were I the auditor. It simply isn't the way a valid document control system works.
Yes, I agree, I addressed it as a one-off.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
I'm not in Medical at all, so read this with that knowledge in case it makes a difference.

You do stuff (a process- rev A)
At some point the process must be changed for a valid reason (a process - rev B) {Day 10}
...but you're not sure rev B process works...
So you try it {Day 15}, and test it {Day 25}, and tweak it {Day 50}, and validate it {Day 75} until you have a process that works again.
Now you have to update your document, and do so {Day 85}
...and it gets approved... {Day 100}
...and distributed for use {Day 101}

Which day did you start "using the process" ? Pretty much Day 50
When did you confirm it was the right process to be using? Pretty much Day 75
When did you document it? Pretty much Day 85
When was the doc approved? Day 100
When was the approved document distributed for use? Day 101

Which one is the "effective date"?
If it is de-facto Day 100...what did you do with the stuff made by that exact same process earlier than that?

The document is "effective" when people have the ability to follow the approved document...Day 101.
The use of the process documented started Day 50.
The use of the documented process started on Day 101.

I guess the real question here is whether the documentation follows the process, or vice versa. Chicken and Egg-ish.

If I ran 5 days production as a final validation before locking it down in the approved doc...do I really have to scrap it all, after following the exact same process in all respects, just because the Document de-facto effective date is later?
I do come from the medical field, so what I write applies mostly (if not only) to it.

I actually don't like the concept of a formal "effective date" (ie something printed on the document itself) at all. I'm fine with a declared effective date in change control documentation though. In my opinion and experience an effective date is more of a result than an origin, though it's useful to document a target effective date for purposes of orderly management. What I do find important is a documented understanding of when a document becomes effective, and in my opinion using the last approval signature's date for that purpose is simple, practical and typically regulatory-compliant. I can't remember a regulatory requirement that dictates imprinting a formal effective date. All quality systems I have been involved with (there were one or two :)) implemented that approach.

Coming back to Ninja's questions, in the medical industry products made for final validation are typically usable / sellable provided that the (documented) settings used in their making are within the eventually approved ones. Such products are usually quarantined until final approval and then released for use / sale. Products made prior to the final validation (usually smaller quantities) are typically scrapped / recycled / archived (depending on the particulars).

Cheers,
Ronen.
 
Last edited:

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#10
Good responses so far. :agree1:

I cannot understand why have both an "effective date" and an approved date. A document becomes effective at the time it is released, that is after all approvals are completed; as has been pointed out, one of the approvers may have asked for a change.

If you must have an effective date, it should be the date the revised document was released to users. So says the ex-Document Control Queen... (did it for almost four years)
:2cents:
 
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