Change Control

[RR1]

Take the following example: A member of staff decides to be very helpful and change one of your more obscure procedures such as "How to access the old LIMS system" . They decide that the current procedure was not written accurately so wanted to re-write, ( because they were bored!!!)

They downloaded/ accessed the controlled version

Made what they classified as a 'minor' modification ie correcting what they considered was the correct route to access the LIMS and so gave this a minor version control change.

Printed the new document and got a colleague to review and sign.

3 mths later you needed to access the this LIMS system. You went to the procedure and tried to follow this- but there omissions/ errors or things that had changed since you last reviewed, so you could not perform this.

As the Q.M -you should have been made aware of this change that was going to be made, so you could ensure the appropriate staff grade was overseeing this, and was properly controlled.

This would have been achieved if ALL changes (whether processes/ documents or templates) had to go through some form of change control.

The document revision may also have impact on other dept forms as well as other related SOP's.

I could of course write to my inspector to clarify his comment (which was not a non-conf, just a mention during inspection).........but far too scared!!!!- will talk to my Q.A instead.

Edited October 12, 2009 by RR1

[Malcolm Needs ☆]

Take the following example: A member of staff decides to be very helpful and change one of your more obscure procedures such as "How to access the old LIMS system" . They decide that the current procedure was not written accurately so wanted to re-write, ( because they were bored!!!)

They downloaded/ accessed the controlled version

Made what they classified as a 'minor' modification ie correcting what they considered was the correct route to access the LIMS and so gave this a minor version control change.

Printed the new document and got a colleague to review and sign.

3 mths later you needed to access the this LIMS system. You went to the procedure and tried to follow this- but there omissions/ errors or things that had changed since you last reviewed, so you could not perform this.

As the Q.M -you should have been made aware of this change that was going to be made, so you could ensure the appropriate staff grade was overseeing this, and was properly controlled.

This would have been achieved if ALL changes (whether processes/ documents or templates) had to go through some form of change control.

The document revision may also have impact on other dept forms as well as other related SOP's.

I could of course write to my inspector to clarify his comment (which was not a non-conf, just a mention during inspection).........but far too scared!!!!- will talk to my Q.A instead.

No, that's not Change Control; that's Document Control.

Two things though. Firstly, you need to have a level of security that does not allow these "helpful" people to change the document without permission and, secondly, you should always have a master copy of the document that had been changed (this is acutally a legal requirement I think).

[RR1]

Our doc control system does have both features, however I still feel document revisions should still be discussed prior to changes.

how did everyone (HBB) complete the following question on the BCR:

3.7.16 Is there a documented system in place to describe change control? (This should demonstrate assessment and management of the impact of any procedural or equipment changes on the validation status of existing processes, and to ensure that training and documentation is available prior to the implementation of a change).

YES / NO

3.7.17 Does this system control changes to:

Documentation (SOPs and records)?

YES /NO

[Malcolm Needs ☆]

Yes and yes.

[jayjay]

.7.16 Is there a documented system in place to describe change control? (This should demonstrate assessment and management of the impact of any procedural or equipment changes on the validation status of existing processes, and to ensure that training and documentation is available prior to the implementation of a change).

YES / NO

So have you a policy and procedure which describes how to manage change control? If so the answer is yes?

3.7.17 Does this system control changes to:

Documentation (SOPs and records)?

In your change control procedure do you identify all documents which need updating or new documents which you will be required to write

I agree with Malcolm staff should not be able to change documents without authorisation. This is what a good document control system would not allow.

[RR1]

Thanks Joan and Malcolm for your advice. I plucked up the courage and asked my inspector today.

Reply from them below (and yes, I did mention I would be posting this on BBT!!!!):-

"I raised a comment that allowing staff to make handwritten amendments to controlled documents which were then picked up at the standard two yearly review is not good document practise, as the master copy of the document held with QA will be different from that in the laboratory. I suggested verbally that you develop a simple document change/modification form for staff to suggest changes which can then be quickly reviewed, assessed and approved, if appropriate, at any point during the lifecycle of that document. You could then re-issue the updated document. How you control this is up to you, the form and process controlling it, can be added to the document control SOP or the change control SOP, whatever is easiest and best for your operations and resources."

*************************************************************

Please note ( before Malcolm says anything!)- my lab doesn't allow these amendments, it's unfortunately written into the integrated dept doc control policy, and the lab had to deviate from the policy because it was obviously incorrect.. These things are sent to try us!

Edited October 13, 2009 by RR1

[jayjay]

you develop a simple document change/modification form for staff to suggest changes which can then be quickly reviewed, assessed and approved, if appropriate, at any point during the lifecycle of that document

This seems very reasonable but is not saying you need to run your formal change control but developing a change/modification form which would be part of your document control system

[RR1]

you develop a simple document change/modification form for staff to suggest changes which can then be quickly reviewed, assessed and approved, if appropriate, at any point during the lifecycle of that document

This seems very reasonable but is not saying you need to run your formal change control but developing a change/modification form which would be part of your document control system

Nice to know I have all you folk to point me in the right direction!

[Malcolm Needs ☆]

you develop a simple document change/modification form for staff to suggest changes which can then be quickly reviewed, assessed and approved, if appropriate, at any point during the lifecycle of that document

This seems very reasonable but is not saying you need to run your formal change control but developing a change/modification form which would be part of your document control system

This is exactly what is available in QPulse5, and it works brilliantly (except, of course, when any of my own suggestions are rejected!!!!!!!!!!!).

:eek:

[RR1]

How you control this is up to you, the form and process controlling it, can be added to the document control SOP or the change control SOP, whatever is easiest and best for your operations and resources."

The comment does however also state that this process can lie within the doc control procedure OR change control procedure.

Malcolm!...not everyone has QPulse, so don't rub it in!!!!

[Malcolm Needs ☆]

How you control this is up to you, the form and process controlling it, can be added to the document control SOP or the change control SOP, whatever is easiest and best for your operations and resources."

The comment does however also state that this process can lie within the doc control procedure OR change control procedure.

Malcolm!...not everyone has QPulse, so don't rub it in!!!!

It also says easiest; I'm all for that in all things, as long as the "easiest" is also fit for purpose.

Sorry to rub it in about QPulse5, but it is good!!!!!!!!

:nana:

[RR1]

Would it be correct to link my change control system to my Quality incident/ deviation system? After all, a raised QI might require as a corrective/ preventive action a change to be introduced.

Also if all these QMS systems were linked it would be easier to track everything if the QI system was raised as the 'first' introduction for the change ( prior to the change request).

I'm just trying to improve my QI process map and thought about introducing a link in this process.

All thought on this are very welcome!

[Malcolm Needs ☆]

It is bureaucracy gone insane.

[RR1]

A colleague of mine recently told me of a Laboratory that received a non-conformance because they had stopped using a notice board, and had not done a Change Control!!!!!!!!!!!!!!!!!!!!

:eek::eek:

That does seem a little over the top, unless of course the notice board was used for significant communication such as handover between shifts, in which case that could have caused problems if staff didn't know of this change.

Change control is difficult, especially getting cooperation from everyone, but it does make a lot of sense, and I think we all need to be very positive about these systems instead of attacking them. We seem to be making these more complicated than necessary, i'm sure there are simpler ways to manage this...just need to visualise how to do this,.

[Malcolm Needs ☆]

A colleague of mine recently told me of a Laboratory that received a non-conformance because they had stopped using a notice board, and had not done a Change Control!!!!!!!!!!!!!!!!!!!!

:eek::eek:

That does seem a little over the top, unless of course the notice board was used for significant communication such as handover between shifts, in which case that could have caused problems if staff didn't know of this change.

Change control is difficult, especially getting cooperation from everyone, but it does make a lot of sense, and I think we all need to be very positive about these systems instead of attacking them. We seem to be making these more complicated than necessary, i'm sure there are simpler ways to manage this...just need to visualise how to do this,.

I know that you are not going to believe this, so sit down. I AGREE WITH YOU!

Change Control is very important, but this kind of idiocy brings the entire system into disrepute.

In this case, by the way, the board was not used for change-over and notification of the change had been made and minuted in the Laboratory Meetings.

:cries:

[RR1]

Malcolm, i'm seriously becoming concerned...are you sure you're alright????!!!

Regarding the stated non-conformance I am sure that the reply to MHRA could state what actions had been taken and that this was not used for any significant communications. This does not require a complete overhaul of the sites CC procedures.

The CC SOP could also state how to assess if something needs to go through full change control or to just make a minor note of insignificant changes that are also checked by someone else ( this could be noted in the deviation system for example- as a quality improvement, wouldn't take more than 5 mins.)

Edited October 26, 2009 by RR1

[bmsjbatt]

Would it be correct to link my change control system to my Quality incident/ deviation system? After all, a raised QI might require as a corrective/ preventive action a change to be introduced.

Also if all these QMS systems were linked it would be easier to track everything if the QI system was raised as the 'first' introduction for the change ( prior to the change request).

I'm just trying to improve my QI process map and thought about introducing a link in this process.

All thought on this are very welcome!

Hi Rashmi,

I first included QI notes for just this purpose it allows you to make the change to the methodology before you finalise the SOP, and obviously small comments can be noted during the modification

[RR1]

Hi Jo,

Are your QI notes the same form you record all deviations etc on or are these a separate specific document ( quality improvement note) ?

thanks

[bmsjbatt]

Hi Rashmi,

My QI note is used from a variety of view points, e.g. it can be used when someone carrying out an audit identifies a potential better way of working, it is not a N/C but is an area that may be improved, e.g having to handwrite a 4th label for 25% of specimens received, so next time labels are ordered get 4 labels printed, saving time and the potential for illegible details. That is a QI.

or response to a low NEQAS score, (not low enough to require intervention by NEQAS, but below your departments KPI).

and any method experimentation, to improve because of change in reagant etc, so a QI can form part of method validation. or even part of a wider change control, because as you work through a Quality Improvement it becomes clear that it is going to need a more significant change to occur and so use your Change control procedure, but don't discard the QI note, keep it with the rest of the documentation.

Hope this makes things clearer,

QI Note.doc

[RR1]

I like your form Jo!, so you could use this for document (SOP) improvement suggestions too? could you combine your non-conf +QI to make one form instead or it easier handling as two separate forms?

Thanks

[bmsjbatt]

Hi Rashmi,

I prefer to keep them separate, it seems to help my audit team that way, it helps them differentiate between a good idea that has come out of an audit as opposed to a true N/C from an audit.

although the QI note can be used as part of a N?C corrective / preventative action