Change Control

[RR1]

If anyone has documents/ templates for change control.It would be good to have them posted in this area too.

Thanks

[bmsjbatt]

I have these forms which I have just done some additional work on (on the basis of the inspectors advice) I hope they may help you, and by all means use them / modify them to your needs, they were originally based on stuff received from Joan Jones, Jill Beech and Yusuf Malcolm Gray so they are already a collaborative effort!!

Change control form.doc

Change control consultation form.doc

Change control comments form.doc

Change control QM assesssment form.doc

Change control closure form.doc

change control policy.doc

[RR1]

Still trying to get my head around 'change control' and linkage to Risk Assessments. Forms submitted on this thread are great- thanks.

I was wondering, when comments are obtained from relevent folk that a change may impact on, do you paste these onto a matrix, and perform a risk assessment against each, adding measures that will be taken to reduce the risk ? Also would you use your hospitals R.A form to perform this?

Thanks!

[bmsjbatt]

Hi Rashmi,

IBMS Congress, Joan Jones spoke about change control and assessments,

here is the distillation of what I gathered.

1. Is the change necessary?

2. Gap analysis of existing system, vs proposed Change, at this stage risk assess existing system and risk asess proposed change, if the change is reducing yr risk then there is a strong argument for going ahead with the change.

3. Change control documentation and process, consultation etc.

4. Impact asessment (this is not the same as the risk asessment) Impact on People, process, product and plant (lab) (i quite like these 4 P's it helps me remember the areas that need addressing and consulting, I intend this to be a distillation of the responses from the consultation areas.)

5. Any Qualification / Validation of equipment or method

6. Implement the change

7. Review the change after a suitable time period post implementation, to asess it's effectiveness, and if any additional tweaks are needed.

8. sign the change as closed.

this all seems to fit in with the comments made by our inspector so I am planning on adjusting my policy to reflect these areas.

Hope you find this helpful. BTW my documentation does include a RA matrix within it any way.

[RR1]

Thanks Jo, as always you come up with really helpful explanations. I like the 4P's for impact assessment, some folk also use "SQUIPS" to identify whether something needs to go through change control. This refers to any change that might impact on safety, quality, identity,purity or strength of the finished product or process.

Our inspector also said that a separate change control document should be raised for changing significant documents ( this could be a fairly simple one page thing), I was thinking of developing this along the lines of ...if document x needs changing consider / review following guidelines/ check various regulations/ OIG recommendations etc...and consult other sections that may use this doc. I would probably simplify with tick boxes.

[bmsjbatt]

or if changing significant documents you can just identify, using your normal change control tool, that no external people will be affected by the change so no need for consultation and just use the existing change control forms.

KISS - more forms make it more complicated. Although it would be a good exercise to identify which documents you feel that a change control should be applied to, Any ideas greatfully recieved.

[Malcolm Needs ☆]

Thanks Jo, as always you come up with really helpful explanations. I like the 4P's for impact assessment, some folk also use "SQUIPS" to identify whether something needs to go through change control. This refers to any change that might impact on safety, quality, identity,purity or strength of the finished product or process.

Our inspector also said that a separate change control document should be raised for changing significant documents ( this could be a fairly simple one page thing), I was thinking of developing this along the lines of ...if document x needs changing consider / review following guidelines/ check various regulations/ OIG recommendations etc...and consult other sections that may use this doc. I would probably simplify with tick boxes.

It seems to me that, in almost all cases, you are unlikely to make any major changes to documentaion affecting the laboratory unless, at the same time, you are making major changes to a process/procedure/technique.

If, however, you are going to make major changes to documentation that does not affect any such process/procedure/technique, let me put this scenario to you (or, rather, to your inspector).

Suppose that you have decided that your Change Control documentation is not fit for purpose. It requires a major change. You, therefore, have to fill out Change Control documentation to change the Change Control documentation. However, you cannot do this as, by definition, your Change Control documentation is not fit for purpose. What do you do?

It seems to me that this is yet another idea that has been put forward by an inspector who has not thought through what they are proposing. It sounds good in theory and is completely and utterly useless in practice.

It is beaurocracy gone insane.

:angered::angered:

[bmsjbatt]

Suppose that you have decided that your Change Control documentation is not fit for purpose. It requires a major change. You, therefore, have to fill out Change Control documentation to change the Change Control documentation. However, you cannot do this as, by definition, your Change Control documentation is not fit for purpose. What do you do?

Malcolm Ouch! now my head hurts :confused::confused::confused:

I have enough difficulty getting my head round what I do understand starting to feel very sad going to hide in my cupboard and start saying wibble

[Eoin]

HI Guys,

I Like KISS - keep it simple stupid.

Any change however small generates one of these. Additionally change control number is referred to on the front of the changed version or new doc.

Attached -

Regards

Eoin

BSG-QA-SOP-054 Attachment A Change Request Form.doc

BSG-QA-SOP-054 Attachment B Change Control Log.doc

[RR1]

It seems to me that, in almost all cases, you are unlikely to make any major changes to documentaion affecting the laboratory unless, at the same time, you are making major changes to a process/procedure/technique.

If, however, you are going to make major changes to documentation that does not affect any such process/procedure/technique, let me put this scenario to you (or, rather, to your inspector).

Suppose that you have decided that your Change Control documentation is not fit for purpose. It requires a major change. You, therefore, have to fill out Change Control documentation to change the Change Control documentation. However, you cannot do this as, by definition, your Change Control documentation is not fit for purpose. What do you do?

It seems to me that this is yet another idea that has been put forward by an inspector who has not thought through what they are proposing. It sounds good in theory and is completely and utterly useless in practice.

It is beaurocracy gone insane.

:angered::angered:

Thanks Malcolm- I seriously needed a good laugh today!!!

I think to put it simply, you are making a formal record of what you are about to do, so if things don't quite go as planned, you can trace back your steps- this is really all what change control is about, together with ensuring better planning of the change.

The inspectors don't invent these ideas- they are used in general industry based quality systems. I disagree these are useless ideas, I find the structure (once I get it right!) is excellent to standardise documents and practises.

Edited October 8, 2009 by RR1

[Malcolm Needs ☆]

Thanks Malcolm- I seriously needed a good laugh today!!!

I think to put it simply, you are making a formal record of what you are about to do, so if things don't quite go as planned, you can trace back your steps- this is really all what change control is about, together with ensuring better planning of the change.

The inspectors don't invent these ideas- they are used in general industry based quality systems. I disagree these are useless ideas, I find the structure (once I get it right!) is excellent to standardise documents and practises.

Rashmi, I was NOT joking.

I meant every word I wrote.

I fully agree that Change Control is required when changing processes/procedures/technqies/equipment, etc, but when changing documents that do not directly (or even indirectly) affect our results? I think not.

Whilst your inspectors may not have invented these ideas, some jobsworth is responsible.

Our position in life is to help patients, not to spend all day on irrelevant paperwork.

[RR1]

Morning Malcolm!

An example of why I don't consider this stuff to be OTT is when I consider the manic writing of many policies/ procedures last year and the number of version changes we went through- I know now if I had understood change control in relation to documents better, I would have possibly got it right the first time instead of the time-wasting in re-doing things.

Your documents are the key of all your procedures and processes, if you don't control the way these are written and handled - just leads to chaos.

[Malcolm Needs ☆]

Morning Malcolm!

An example of why I don't consider this stuff to be OTT is when I consider the manic writing of many policies/ procedures last year and the number of version changes we went through- I know now if I had understood change control in relation to documents better, I would have possibly got it right the first time instead of the time-wasting in re-doing things.

Your documents are the key of all your procedures and processes, if you don't control the way these are written and handled - just leads to chaos.

Which is exactly why such documents should be validated fully fully before they are put into place.

But surely, these policies/procedures were to do with actual things that are being done in the laboratory to do with the techniques/procedure/processes etc, that are used to get patient results, not, for example, for how to use a mop to clean the floor (a genuine SOP used in our Centre).

:disbelief:disbelief:disbelief:disbelief

[RR1]

Which is exactly why such documents should be validated fully fully before they are put into place.

But surely, these policies/procedures were to do with actual things that are being done in the laboratory to do with the techniques/procedure/processes etc, that are used to get patient results, not, for example, for how to use a mop to clean the floor (a genuine SOP used in our Centre).

:disbelief:disbelief:disbelief:disbelief

Yes Malcolm.... and a document change control process would identify the validation requirements needed prior to implementation!!

Are we going around in circles here?

[Malcolm Needs ☆]

Yes Malcolm.... and a document change control process would identify the validation requirements needed prior to implementation!!

Are we going around in circles here?

No. New documents (pure documents, not documents surrounding a change of process, etc) should have been validated from the year dot.

You do not need to formally Change Control them as well.

[RR1]

I suspect a lot of places have never validated their 'pure' documents. In an ideal world we would all have a quality system set up before we developed our departments, but in reality it's the other way around.

I presume you are referring to policies such as document control, change control. Even these documents would need changes made in light of new regulations or information.

Improvements are never static, and everything at some point in time needs to be reviewed and improved.

[Malcolm Needs ☆]

I presume you are referring to policies such as document control, change control. Even these documents would need changes made in light of new regulations or information.

Improvements are never static, and everything at some point in time needs to be reviewed and improved.

[jayjay]

Is there some confusion between Change Control and Document Control?

[Malcolm Needs ☆]

Thanks Jo, as always you come up with really helpful explanations. I like the 4P's for impact assessment, some folk also use "SQUIPS" to identify whether something needs to go through change control. This refers to any change that might impact on safety, quality, identity,purity or strength of the finished product or process.

Our inspector also said that a separate change control document should be raised for changing significant documents ( this could be a fairly simple one page thing), I was thinking of developing this along the lines of ...if document x needs changing consider / review following guidelines/ check various regulations/ OIG recommendations etc...and consult other sections that may use this doc. I would probably simplify with tick boxes.

You tell me jayjay!

Is there Rashmi?

:confused::confused:

[RR1]

Is there some confusion between Change Control and Document Control?

No. I was told at my recent inspection that it is good practice to raise a document change control if significant documents need major changes. This does not have to be as complex as other change controls.

It's all fairly logical if you think about it. If there are inter-department shared documents, the relevent consultations need to take place. Staff need to be directed to relevent guidelines etc to ensure all considerations are taken into account before re-writing, and then training needs reviewed.

Also I recall that the BCR this year asked a similar question.

Edited October 11, 2009 by RR1

[jayjay]

Well in my simple mind whenever you make a change to a document this must be controlled ie document control. If you are making a significant change to a SOP/procedure/policy it is likely that you will have raised the process/system change under your formal change control process in which you will identify the documents that need changing BUT you will still need to manage this change to the documents within your document control system. Does this make sense

[Malcolm Needs ☆]

Well in my simple mind whenever you make a change to a document this must be controlled ie document control. If you are making a significant change to a SOP/procedure/policy it is likely that you will have raised the process/system change under your formal change control process in which you will identify the documents that need changing BUT you will still need to manage this change to the documents within your document control system. Does this make sense

It makes perfect sense to me - which is what I have been arguing all along in this thread.

:rage:

[RR1]

Well in my simple mind whenever you make a change to a document this must be controlled ie document control. If you are making a significant change to a SOP/procedure/policy it is likely that you will have raised the process/system change under your formal change control process in which you will identify the documents that need changing BUT you will still need to manage this change to the documents within your document control system. Does this make sense

It partly makes sense, but the document control bit doesn't entirely. I suppose this depends on how good your document control system is. Are we talking about how an electronic system keeps tabs on changes to the actual document? If this is the case, ipassport can't do this, it is purely a document loading, unloading and archiving system.

I'm having a meeting at my place next week with a Q.A and will further discuss this with them to clarify.

[jayjay]

Document control does not have to be managed by an electronic system. In our place we use a paper based system. Document control is all about ensuring documents are regularly reviewed, identifying who has paper copies, recalling these when a newer version is produced, version control of all documents, keeping a brief history of changes etc. All this can be done on a spreadsheet or database.

So if we make minor changes ito a document which is version 1.0 it then becomes version 1.1 and will need to be read by all but if there are major changes it will be version 2.0 and will require training for all.

We document control all forms and have a document register of these

Joan

[Malcolm Needs ☆]

Document control does not have to be managed by an electronic system. In our place we use a paper based system. Document control is all about ensuring documents are regularly reviewed, identifying who has paper copies, recalling these when a newer version is produced, version control of all documents, keeping a brief history of changes etc. All this can be done on a spreadsheet or database.

So if we make minor changes ito a document which is version 1.0 it then becomes version 1.1 and will need to be read by all but if there are major changes it will be version 2.0 and will require training for all.

We document control all forms and have a document register of these

Joan

Same here (except ours is electronic).