Effective Date (of Documents) issue outlined in 21 CFR Part 820.4

[Aphel]

Hello,

Maybe this is a simple - and perhaps often discussed topic - but I really need some clarification regarding the "effective date" issue outlined in ?820.40

Under 820.40 there is the requirement for an effective date...
My question to you is - how do you handle this exactly?

A document becomes formally reviewed, then in becomes formally approved - but what about the effecive date?

Do I have to note the effective date with same date as the approval date?
Do I have to note the effective date when before distributing the document?
If the effective date is another one as the approval date - do I have to include the name of the person who writes down the effective date?
What is correct - what is not correct?

Any guidance on that is appreciated!

Thanks for your support!

BR
Aphel

 

[mihzago]

It depends really on your needs.
Do you want your document to be effective the moment you approve it or some time after (for whatever reason, maybe to allow time for distribution or training)?
I have a note on all my documents stating that the approval date is the effectivity date.
you can also specify that in the procedure.

 

[lfrost]

Aphel,

We also used to note the effective date on all of our procedures. Then, found that it was really cumbersome to do so. Though a consultant, he suggested that we state in our document control procedure, that we state the approval date and effective dates are the same. We then have the procedure approved and conduct training sessions for those departments affected by the procedure change.

This system tends to not be as cumbersome as stating the effective date on each procedure after the training has been completed. Trying to guess when the procedure will be effective after training was very difficult as many of the departments felt that because the procedure was not in effect, then they didn't need to train their departments to the procedure change. Now they fulfill the training of their departments as quickly as they can, because they know that when the time for auditing the process the procedure covers is going to happen the next time their department is audited. One of the things I look at is the training documentation the department has for the procedure. Then I am able to pick-out those who have "slipped into" the "old way of doing it."

 

[Ronen E]

Hello,

Maybe this is a simple - and perhaps often discussed topic - but I really need some clarification regarding the "effective date" issue outlined in ?820.40

Under 820.40 there is the requirement for an effective date...
My question to you is - how do you handle this exactly?

A document becomes formally reviewed, then in becomes formally approved - but what about the effecive date?

Do I have to note the effective date with same date as the approval date?
Do I have to note the effective date when before distributing the document?
If the effective date is another one as the approval date - do I have to include the name of the person who writes down the effective date?
What is correct - what is not correct?

Any guidance on that is appreciated!

Thanks for your support!

BR
Aphel

Hi,

There is an unwritten convention that the effective date is the approval date unless a different effective date is called out. You can explicitly state it in your document control procedures for clarity, and avoid extra work and/or confusion.

If there is a reason to bring a change into effect at a time other than the approval, you could add it as an option, in which case I recommend that the reasons are explained in the change description / justification, and when the change is decided upon the cut-off date/event is captured and clearly presented. If it is critical and/or a slip is probable, it should also be managed to ensure switch over at the right date (or other cut-off point such as lot change etc.). You could edit your forms / templates etc. to allow for fields for capturing all these, as relevant to your operations / procedures. If the effective date is something you can only tell retrospectively (e.g. you don't know when exactly a lot change will occur) you could allow for means to capture and document it as it happens - again, the documentation should be set up for that and the implementation has to be managed, unless it is something very routine and your staff are already used to it.

Cheers,
Ronen.

 

[Aphel]

Hello!

Thanks to all of you for your comments!!!

Following your guesses - would it be ok from your point of view to handle document control (e.g. a work instruction) like the following way:

(1) Initial Createn/Update --> (2) formal review --> (3) Training for employees --> (4) formal approval (incl. effectiveness) --> (5) distribution of approved documents


Best regards,
Aphel

 

[Ronen E]

Hello!

Thanks to all of you for your comments!!!

Following your guesses - would it be ok from your point of view to handle document control (e.g. a work instruction) like the following way:

(1) Initial Createn/Update --> (2) formal review --> (3) Training for employees --> (4) formal approval (incl. effectiveness) --> (5) distribution of approved documents


Best regards,
Aphel

I wouldn't recommend it unless approval and distribution follow immediately at the end of training (which is not longer than 1 day), and you have good controls in place to ensure a very timely implementation. Otherwise you are risking implementation beginning before full approval and distribution, or confusion like "why don't we yet have that form that they said we need to complete?..."

Either way, your SOPs have to be extra clear about the process and the controls.

Cheers,
Ronen.

 

[Ajit Basrur]

Hello!

Thanks to all of you for your comments!!!

Following your guesses - would it be ok from your point of view to handle document control (e.g. a work instruction) like the following way:

(1) Initial Createn/Update --> (2) formal review --> (3) Training for employees --> (4) formal approval (incl. effectiveness) --> (5) distribution of approved documents


Best regards,
Aphel

I would not recommend this flow as the "Training" is conducted before "Document Approval" and thus it is inferred that training is conducted on unapproved documents.

You could swap no 3 and 4.

 

[TWA - not the airline]

I would not recommend this flow as the "Training" is conducted before "Document Approval" and thus it is inferred that training is conducted on unapproved documents.

Ajit,

I'd also recommend using approved documents for training, but I have to say that I've seen a lot of change procedures that force you to do just that: in order to change a work instruction you need to close the change and for that you need documented training...What people do in that case is to train on a draft document that is archived with the training documentation so that in case an auditor asks you can show that the draft and the final version are identical.

 

[Ajit Basrur]

Ajit,

I'd also recommend using approved documents for training, but I have to say that I've seen a lot of change procedures that force you to do just that: in order to change a work instruction you need to close the change and for that you need documented training...What people do in that case is to train on a draft document that is archived with the training documentation so that in case an auditor asks you can show that the draft and the final version are identical.

This is very true, TWA but to avoid any probing questions, its always best to train on the approved version of the procedure / work instruction.

 

[Aphel]

Hi all,

I totally agree with your hints...

I only would do training after the work instruction was approved.

Regarding the effective date - for me this is the point in time when a change of the work instruction becomes effective and is obligatory for the manufacturing department...
Considering these thoughts - from my point of view it not possible to have the approval date and the effective date on the same day...only in the case - if the training is finished on the day of approval...

Am I right with my guesses? :

BR
Aphel