Implementing a change for a particular Process - Document & Change Control

[AnandR]

Good Morning!

Document Change Control (DCR) was raised for implementing a change for a particlaur process. After obtaining the DCR approval, the change was communicated and implemented. However, remarks was made in the DCR by MR (Management Representative) that the particular process will be updated later to reflect the change beacuse the process is being reviewed for making other changes.
Questions, is can the approved changes mentioned in the DCR be implemented before getting reflected in the process?

Thanks
Anand

 

[The Specialist]

Good Morning!

Document Change Control (DCR) was raised for implementing a change for a particlaur process. After obtaining the DCR approval, the change was communicated and implemented. However, remarks was made in the DCR by MR (Management Representative) that the particular process will be updated later to reflect the change beacuse the process is being reviewed for making other changes.
Questions, is can the approved changes mentioned in the DCR be implemented before getting reflected in the process?

Thanks
Anand

So:
· the change control was raised
· the changes were approved
· an action plan for implementation was devised
· an impact assessment was carried out

The change has NOT yet been implemented?
The change control has NOT yet been ‘finally’ approved

There is no (absolute) right answer to your question… the change may be implemented, however justification will need to be made clear, impact assessment must be carried out, necessary testing must be carried out and an approval of the agreed scope of works must be sought.

This change may be considered a ‘temporary’ change and controlled as such.
A ‘temporary’ procedure will need to be written, attached to the change control and made available to operators/line-staff or whomever may be effected by the change.

This will constitute a ‘temporary’ deviation from current process/procedure.

A clear time-line for implementation of the full change (as mentioned by the MR) must be agreed and a further change control raised to include full scope, which will be cross-referenced.

The key here is to understand the impact of the change and assess the risks of implementation. Close all ‘gaps’ identified in the impact/risk assessment process.

This action is ‘justifiable’ if done correctly!

 

[The Specialist]

I will give you an example of a similar ‘temporary’ change I initiated quite recently:

Deionised water was being used in our analytical laboratory (daily). The water has an in-line monitoring device which monitors the resistivity/conductivity of the water at point-of-use. The procedure for use of this water is to check the resistivity/conductivity for conformance to specification prior to use in assay.

I discovered during a lab ‘walk-about’ that the monitoring device was outside of its calibration date and issued a ‘do not use’ notice to the Lab manager and hung a notice on the user point.

I then raised an NCR and conducted a review… (not applicable to your post, so will not bore you with the detail!)

The lab manager was desperate to continue using the water and approached me to find a solution.

I tested the water, using a calibrated hand-held device, and told him that it could be used, following a temporary procedure, whereby the water would be tested prior to use, using the hand-held device.

I raised a change control, detailing the ‘temporary’ deviation from procedure and attached a signed single-page instruction (counter-signed by a QP) to the change control.

A copy of both the change control and temporary procedure was attached to the DI water user-point and all lab staff were made aware of the procedure.

In the proceeding two weeks, I had the device calibrated and the lab reverted back to the ‘normal’ procedure and the change control was closed.


In your instance, a similar approach can be taken… rather than revert back to the existing procedure though; you would fully implement the New procedure.


Does this help?

 

[AnandR]

Thanks Sir. In my case I implemented the change by making the remarks in the DCR informing related process will be later. I also sent an email to departments heads informing the new change can be followed. There has been no negative impact with the change I did. But, I was issued an NC during audit.