Revision of Risk Assessment document------change control form needed?

GOOD MANUFACTURING PRACTICE (cGMP) RISK ASSESSMENT
1

A risk assessment on a piece of equipment was approved by all parties.

After a while, it was noticed that there was an error in the document in the scoring and what were thought to be ‘medium risks’ requiring extra controls, were not necessary.

I want to revise the risk assessment, noting the reason for the change and deleting proposed controls, Then I will ask all parties to approve if they agree with my document.

QA say that I have to first raise a change control form to ask for permission to make the change. No physical changes were made. The risk assessment is not a formula or an SOP or even a qualification protocol…

Is this strictly necessary? are they being picky, or am I being lax!!!..

thanks

NK

2

The risk assessment is a controlled document so after approval, it DOES need to go through the controlled change process. Presumably your document control procedures require a change control form for initiating changes to controlled documents. If in doubt, re-read your document control procedures.

3

Thanks for that Yodon.

I am so used to defending my work against the critique of the QA dept, I never quite believe all their statements…

4

if your procedure states that to modify any document you must go through a change request, then you do.

whether the procedure is set-up in a way that makes the whole process cumbersome is another story.

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[quote=Niamh]Thanks for that Yodon.

I am so used to defending my work against the critique of the QA dept, I never quite believe all their statements…[/quote]

5

Any controlled document change requires a change control form. Yes, you need to initiate a change control form!

6

Dhara, what is the regulation that requires a change control form?

7

Hi, if only to revise the document (risk assessment), a “document change request form” or “document change notice” will do. This form is used when to raise new document/revising the document such as batch records, protocol, SOP…

Change control form is used when we have permanent change to be implemented.

For example: A change control is raised to change the process step mixing time from 30 min to 10 min. The affected document will be the manufacturing batch record. The change control will served as a “trigger system” to assign task such as revise the manufacturing batch record. So, the person in charge (usually is production) will revise the batch record, by initiate a “document change request form”.

Thanks and regards,
Kek