Where & How to Capture Details of Periodic Reviews of Change Control & CAPAs

[v9991]

Change Control/Non-Conformance systems have a specific review requirement to follow-up with the open/pending records and also to ensure closure of CAPA.

1)Where & How to capture the details of periodic reviews? Should the status/progress be updated on respective record, OR should there be different record maintained for the same?

* * * *

Justification/Investigation data for non-conformance - Deviations
2) Is it adequate to provide a "review comments", as a justification for Incidents(Non-conformance)/Deviations/Change control.

Most of the systems, which I have come across, just provide an option where the comments are reported by related departments; and at the most provide a summary report.

Most of the times, (especially where investigation reports are not missing/relevant), the review comments from respective departments lack the reference or basis of approval.

 

[Stijloor]

Change Control/Non-Conformance systems have a specific review requirement to follow-up with the open/pending records and also to ensure closure of CAPA.

1)Where & How to capture the details of periodic reviews? Should the status/progress be updated on respective record, OR should there be different record maintained for the same?

* * * *

Justification/Investigation data for non-conformance - Deviations
2) Is it adequate to provide a "review comments", as a justification for Incidents(Non-conformance)/Deviations/Change control.

Most of the systems, which I have come across, just provide an option where the comments are reported by related departments; and at the most provide a summary report.

Most of the times, (especially where investigation reports are not missing/relevant), the review comments from respective departments lack the reference or basis of approval.

Any comments, suggestions?

Thank you very much!

Stijloor.

 

[Ajit Basrur]

Change Control/Non-Conformance systems have a specific review requirement to follow-up with the open/pending records and also to ensure closure of CAPA.

1)Where & How to capture the details of periodic reviews? Should the status/progress be updated on respective record, OR should there be different record maintained for the same?

* * * *

Justification/Investigation data for non-conformance - Deviations
2) Is it adequate to provide a "review comments", as a justification for Incidents(Non-conformance)/Deviations/Change control.

Most of the systems, which I have come across, just provide an option where the comments are reported by related departments; and at the most provide a summary report.

Most of the times, (especially where investigation reports are not missing/relevant), the review comments from respective departments lack the reference or basis of approval.

Ans 1
The Periodic Reviews can be handled seperately and not as part of the Qqualification / Validation documents.

Ans 2
Comments section could be provided to input any notable findings.

 

[v9991]

Ans 2
Comments section could be provided to input any notable findings.

for implementing any change, the change control is forwarded to all concerned departments for evaluations and the response is noted through review comments (attachments/summary reports/justifications where applicable)

My query was regarding the
Auditor/compliance related perception on treating 'comments' recorded from respective departments as adequate.
To what extent the references/traceability are advisable for these comments.

(viz., for a comment, is it adequate to write something like "proposed changes are acceptable/approvable" (assuming that all follow up actions are adequately addressed);
Here my point is that, shouldn't the user be add the "basis/justification for writing the above comment of approval" + "add the reference of data which is reviewed/supporting the approval")

 

[Ajit Basrur]

for implementing any change, the change control is forwarded to all concerned departments for evaluations and the response is noted through review comments (attachments/summary reports/justifications where applicable)

My query was regarding the
Auditor/compliance related perception on treating 'comments' recorded from respective departments as adequate.
To what extent the references/traceability are advisable for these comments.

(viz., for a comment, is it adequate to write something like "proposed changes are acceptable/approvable" (assuming that all follow up actions are adequately addressed);
Here my point is that, shouldn't the user be add the "basis/justification for writing the above comment of approval" + "add the reference of data which is reviewed/supporting the approval")

If you attach your form, that would help understand what exactly you are trying to say !

From what you write, the approver in the change control has to either approve / reject the proposal. If its a "No", he has to justify the rejection of the proposal. This justification is provided in a box next to his decision of Approve / Reject.

 

[Chennaiite]

Change Control/Non-Conformance systems have a specific review requirement to follow-up with the open/pending records and also to ensure closure of CAPA.

1)Where & How to capture the details of periodic reviews? Should the status/progress be updated on respective record, OR should there be different record maintained for the same?

I have come across a tracking sheet which I regard as effective for following the progress of CA or Change Management. This sheet basically is the list of Problems or Changes (basic information) along with planned and actual dates of all stages that make up the CA or Change implementation. With the help of this sheet, it is easy to understand the status of ongoing CA or Changes at any point of time and hence periodic reviews can be made for fixing the priority. I don't have this format offhand.

Justification/Investigation data for non-conformance - Deviations
2) Is it adequate to provide a "review comments", as a justification for Incidents(Non-conformance)/Deviations/Change control.

I don't know what you mean by 'justification' contextually. Of course, the root cause analysis got to be based on facts (one of the TQM principles), Changes shall have reasons, Deviation shall have details that would enable to make decision to accept or reject.

Most of the systems, which I have come across, just provide an option where the comments are reported by related departments; and at the most provide a summary report.

Most of the times, (especially where investigation reports are not missing/relevant), the review comments from respective departments lack the reference or basis of approval.

Here again, the related department shall only study the content of the changes and identify risks that are relevant to their function preferably with the help of a risk evaluation guidelines. Final approval to implement the Change is got to be done by authorized personnel identified by your Top Management. The basis of approval is the risk identified by the cross-functions.

What I have shared could be a good practice and not necessarily the Standard requirement. This might help you.

 

[v9991]

Here's the document I am talking about...
Pl. refer to the Sec.III "CC review process" of identified departments.

I haven't seen other systems where such justification/basis provided by respective departments. they simply state that "proposed changes are acceptable"; at the most provide some textual assessment comments which does not necessarily capture the 'reason/justification'.

My query is whether, "Justification / Reference" field (highlighted in red-background) is required or not?

So what is the take of auditor/system-compliance on the above phenomenon.

 

[Ajit Basrur]

v9991,

This is what I was saying

My is the following -

1. Change "Initial Review Comments" to "Approve / Reject"

2. Justification (if Proposal is "Reject")

 

[v9991]

As indicated, my query was the "justification/reference for the review comments of independent department"

I think I got the point you have made; I get a feeling that this may not be required after-all!!.

Anyways, thank you all for your time & comments.