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Is it possible to have a General Change Control SOP and Form?

S

snaphardcore

#1
Hi everybody, I wanted to know your opinion:

Do you think it's possible to have a General Change Control SOP and Form to make changes the same way on all types of documents (SOP, Batch Records, Protocols, Forms, Design Changes, etc.) as well as a General Approval Process SOP for all types of documents. This would facilitate the Document Control change and approval process when all documents are treated the same instead of having a different process and change forms depending on the document. Also, if anyone already has an SOP or a Form like this, could you facilitate it? Thanks.
 
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Kales Veggie

People: The Vital Few
#2
Re: General Change Control

Hi everybody, I wanted to know your opinion:

Do you think it's possible to have a General Change Control SOP and Form to make changes the same way on all types of documents (SOP, Batch Records, Protocols, Forms, Design Changes, etc.) as well as a General Approval Process SOP for all types of documents. This would facilitate the Document Control change and approval process when all documents are treated the same instead of having a different process and change forms depending on the document. Also, if anyone already has an SOP or a Form like this, could you facilitate it? Thanks.
Sure, that is possible. On the other hand, think about the most effective and efficient way to manage document control. Creating a process that is the same for all types documents and works great for the document controller but is difficult for the users to use (which means they will not use it) is not a good solution.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Hi everybody, I wanted to know your opinion:

Do you think it's possible to have a General Change Control SOP and Form to make changes the same way on all types of documents (SOP, Batch Records, Protocols, Forms, Design Changes, etc.) as well as a General Approval Process SOP for all types of documents. This would facilitate the Document Control change and approval process when all documents are treated the same instead of having a different process and change forms depending on the document. Also, if anyone already has an SOP or a Form like this, could you facilitate it? Thanks.
Most of the examples on your list look like controlled documents, changes of which could be managed using one process if that works for you. The subject of design changes, which I take to mean product design, might be handled in design engineering process(es). They might not require the same kind of controls as controlled documents would because there is less need for circulating proposed changes for review and approval and drawings are usually kept in systems apart from procedures, forms, etc.

The Cove does have attachments that provide examples of change control protocols. I did a search using key word "change" in the Post Attachments List via the green button in the header, and was presented with this list of attachments.
 

Ajit Basrur

Staff member
Admin
#4
Hi everybody, I wanted to know your opinion:

Do you think it's possible to have a General Change Control SOP and Form to make changes the same way on all types of documents (SOP, Batch Records, Protocols, Forms, Design Changes, etc.) as well as a General Approval Process SOP for all types of documents. This would facilitate the Document Control change and approval process when all documents are treated the same instead of having a different process and change forms depending on the document. Also, if anyone already has an SOP or a Form like this, could you facilitate it? Thanks.
Absolutely ... you can have a SOP on "Change Control Systems" encompassing all types of change control like Documentation Change Control, Product Change Control and any other that is contained as different templates.
 
S

snaphardcore

#5
Actually I didn't mean all different Change Control processes into one SOP, I meant the same process for all different types of documents. Hence, there would only be one type of Change Control process to follow when making a change in any type of document. The only thing that changes is the people involved since the process owner would be from different departments.

In the end I think it could be achievable since the form would be used to allow the person to include any description or impacted documents related to the change. If a change is not approved, then a demotion of the document is in effect.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
It might be possible to use a single form and procedure for any of the changes you list. As long as the requirements of change control are met in the elements, including product realization, you get to define how it will be done. Simple is better, so long as it's effective. :cool:
 

Wes Bucey

Quite Involved in Discussions
#7
Hi everybody, I wanted to know your opinion:

Do you think it's possible to have a General Change Control SOP and Form to make changes the same way on all types of documents (SOP, Batch Records, Protocols, Forms, Design Changes, etc.) as well as a General Approval Process SOP for all types of documents. This would facilitate the Document Control change and approval process when all documents are treated the same instead of having a different process and change forms depending on the document. Also, if anyone already has an SOP or a Form like this, could you facilitate it? Thanks.
Nine years ago, I wrote this following post (note the link to a sample form.) Not much has changed in the intervening years.
the form, itself, is from January 2000
All our Engineering Change Orders (to pass muster with the FAA) go through a process to determine the "impact" of the change. I redacted a computer form (to remove company ID) and printed it to show the checklist we consider for the process. Some changes have little or no impact and are dealt with accordingly. Others may have great impact and go through a process similar to a new design.

A non-impact change might be "changing fasteners in a non-user-accessible portion of a device from phillips head to star drive to accommodate assembly machines." It is important to note there is a point where the change is so drastic, it is no longer viable to consider it a change, but a new design, effectively obsoleting the original design.

I hope this helps you put your own changes into proper perspective and to help you form a "justification" when you do not go through a new verification and validation of the revised design.

Any questions about the form can be addressed in this thread.
:applause:Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
generic ECO.doc (37.5 KB, 2895 views)
 
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