CAPA / Deviation

[scubasammy]

Yes, CAs and PAs are both corrective in nature, but CAs are immediate and PAs are preventative. For example, say a volunteer checks the wrong box on a donor form, a supervisor discovers the error immediatley and corrects the error by checking the right box and signing off on the correction. Now, say the same volunteer does this three more times but the issue isn't discovered right away. First, you need to correct the error and second you may need to re-train the volunteer. However, the volunteer only works once a month and won't be back for 28 days. Are you going to keep the deviation open for 28 more days? It's better to close out the deviaition and CA while keeping the PA open until completed. The only way to trend accuratly is by keeping count of all events and the timeline for each activity. BTW, I don't think the regulators expect your CAPAs to be completed in 30 days unless your SOPs state that this is the timeframe for closure. They will however react if deviations, CAPAs, etc are not closed in a timely and consistent manner.

[adiescast]

I think the original event should be closed out after the corrective action (quick fix) is put into place and the preventive action (long term fix) is decided on. Then there should be a separate monitor for the effectiveness of the preventive action. You could find a way to link them in your system so that the effectiveness monitor can be associated with the oriiginal problem. Maybe give them both the same ID number with a distinct sub number or letter to distinguish them.

Edited February 15, 2010 by adiescast
Flying Finger Disease

[RR1]

Thanks scubasammy & adiescast, I am sure I still get my CAs and PAs confused...just something I need to work on.

On our annual Blood Compliance Report, (BCR), our regulators last year asked how many CAPAs were still open after 1 mth, 3mths etc. I understand now that some folk close the CAs quickly, but does the definition of CAPA not include the PAs too?

[adiescast]

It does, but that doesn't mean that you are required to keep the report open until the whole thing is done. With some preventative actions, that could be a very long time. You just need to make sure the package stays together, so to speak, so that you can see the whole picture when you need to. The corrective action takes care of the initial problem, so that problem can be closed out. Then if you have to address a system problem that really caused the original problem, you do a preventive action and a monitoring. That one stays open until you are satisfied that the PA worked and the original problem will not resurface.

You can choose to make it all one package, but it will look on review like you are slow to respond to the original problem.

Does that help at all?

[Malcolm Needs ☆]

I had a telephone conversation with a friend of mine (who wants to remain anonymous - probably doesn't want to admit to anyone that he/she is really a friend of mine!!!!!!) about this. He/she knows a lot more about the subject than do I (which, come to think of it, is most of the world's population) and he/she said the following.

It's all to easy to get bogged down with what to label the different stages of incident reporting and error management. The interpretations above are valid, but other other QA experts might talk about;

Correction - putting right what went wrong

Corrective action - making sure what went wrong does not happen again

Preventive action - making sure you prevent other similar errors in other areas.

Eg. Fridge failure resulting in components stored at the wrong temperature for 6 hours

Correction - getting fridge fixed, discarding components, replacing lost components

Corrective action - ensuring alarms work and that staff understand procedures for actioning the alarm and dealing with the problem

Preventive action - ensuring all fridges, freezers and incubators have been serviced within the required timeframe, that all alarms work and that the procedures for dealing with alarms are robust when applied to all the equipment.

As you can see depending on who you're asking, correction and corrective measures can be interchangeable terms, as can corrective action and preventive action. In the UK regulations, the generic term "corrective measures" is used to incorporate correction and CAPA.

What's important is that you have a robust system for spotting errors and dealing with them.

Usually a regulator will be less concerned with how you manage your incident reporting system as opposed to whether you comply. There are as many ways to crack a nut as there are to comply with the regulations, and where there might be "best practice" a regulator will not give a non-compliance if your system works. The BCR might well ask how long the CAPAs have been open, but this information on it's own is unlikely to trigger an inspection. The regulator may well ask for further detail, but as long as you have a justifiable reason for doing so, this should satisfy them. They would be far happier that an incident is still open after 3 months because several procedures needed to be rewritten, validated, document controlled and trained to all staff than to have the same incident closed after one week when the member of staff responsible re-read the old SOP.

So, whether you split your documentation into sections and close down the incident in stages, or whether you close down the incident in one go, it is entirely the choice of the reporter.

I hope this helps.

Malcolm

:D:D:D:D

[RR1]

Thanks everyone, some very helpful responses given so far.

Malcolm, I like the term "corrective measures" given by your friend and the overall clarity of the response.

Regarding their opinion on the BCR question about CAPAs ,I would say that the question asked by the regulators is then possibly meaningless and it would be difficult to assess the efficacy of a sites CAPA system as everyone is closing these out at different stages. Obviously this needs standardising too!!

p.s...you have another friend????...wow!!! :tongue:

Edited February 20, 2010 by RR1

[RR1]

If a lab reports X number of deviations/ year and this number increases the following year/s (this is a hypothetical question!!!!), would this indicate:

1. The lab has serious issues and the CAPA is not being implemented effectively or

2. The lab is becoming more efficient at identifying and reporting incidents/ deviations?

Thanks

[Malcolm Needs ☆]

If a lab reports X number of deviations/ year and this number increases the following year/s (this is a hypothetical question!!!!), would this indicate:

1. The lab has serious issues and the CAPA is not being implemented effectively or

2. The lab is becoming more efficient at identifying and reporting incidents/ deviations?

Thanks

Surely, it could be either, or both.

The hypothetical person would have to examine what is happening in detail.

:confused::confused:

[RR1]

Excellent Malcolm, yes, you're right. The hypothetical person would have to show senior management the reason for the increase, and if this was due to CAPA not being effective then possibly another root cause would have to be looked for.

I suppose once CAPA systems are properly in place then the number of deviations will increase for the first couple of years as staff begin to report more of these, but these should also be low level ones rather than more serious types.

Also as the Q.S develops then the number of audit non-conformances, as a proportion of the deviations may also shoe an increase, but these may be due to refining the systems in place...or should these begin to decrease in number?

Would you expect to see an increase or decrease in the number of customer complaints ( I would have thought this would show a similar pattern) ?

[Malcolm Needs ☆]

Excellent Malcolm, yes, you're right. The hypothetical person would have to show senior management the reason for the increase, and if this was due to CAPA not being effective then possibly another root cause would have to be looked for.

I suppose once CAPA systems are properly in place then the number of deviations will increase for the first couple of years as staff begin to report more of these, but these should also be low level ones rather than more serious types.

Also as the Q.S develops then the number of audit non-conformances, as a proportion of the deviations may also shoe an increase, but these may be due to refining the systems in place...or should these begin to decrease in number?

Would you expect to see an increase or decrease in the number of customer complaints ( I would have thought this would show a similar pattern) ?

I agree with your proposition (in the same way that the number of reports to SHOT shot up [if you will excuse the intended pun] when people began to realise that the scheme really is anonymous).

Whether the hypothetical managers will realise this is a completely different matter!!!

:mad::mad::mad::mad:

[RR1]

Whether the hypothetical managers will realise this is a completely different matter!!!

:mad::mad::mad::mad:

Yes, that can be a bit of a problem. I gather that at some places the high number of incidents/ deviations being reported by the lab. is being taken by senior management as a negative indicator of practices rather than showing a positive, open reporting culture by the lab staff, who are willing to address issues rather than sweep these under the carpet...as has been done for many years.

As always these things are sent to try us!

[jayjay]

I think you are all trying to read too much into all os this and some common sense is required!! Yes SAE's may go up as people realise and recognise what these are. A good Quality system shoull see a decrease in these over time proving that the CAPA is effective. It is the tracking and trending that is the really important issue. Repeat, same type, SAEs is fairly obvious that the PAs are ineffective that the root cause has not been determined and managed

Thats my view anyway

Perhaps I am too simplistic

Joan

[Malcolm Needs ☆]

Yes, that can be a bit of a problem. I gather that at some places the high number of incidents/ deviations being reported by the lab. is being taken by senior management as a negative indicator of practices rather than showing a positive, open reporting culture by the lab staff, who are willing to address issues rather than sweep these under the carpet...as has been done for many years.

As always these things are sent to try us!

If this is true, the Professional Bodies representing the Laboratory Staff must, and will, be brought in to "level the playing field", and educate the senior managers.

:eek::eek:

[Malcolm Needs ☆]

I think you are all trying to read too much into all os this and some common sense is required!! Yes SAE's may go up as people realise and recognise what these are. A good Quality system shoull see a decrease in these over time proving that the CAPA is effective. It is the tracking and trending that is the really important issue. Repeat, same type, SAEs is fairly obvious that the PAs are ineffective that the root cause has not been determined and managed

Thats my view anyway

Perhaps I am too simplistic

Joan

No Joan, I think you are absolutely correct. What I am saying is that your common sense (and correct) approach is not always (seldom) taken by senior managers, who see an increase in non-conformances/an increase in QI's not as a phase that is required before these decrease, but as a "black mark" against the incumbent middle manager, and threaten sacking, which is what is happening in more than one Laboratory.

:eek::eek:

[RR1]

Tracking and trending of all the non-conformances, as Joan has mentioned, is probably the most important way forward to educate senior management. Trends should show a decrease in incident severity if CAPA performed is effective

However, when a lab begins to record deviations, this generally involves recording the most obvious problems in the first year and during subsequent years less obvious events are then noted, the numbers therefore may increase in the first 2-4 years of forming a deviation system.I would be more concerned in seeing a significant reduction of recorded incidents during this period than an increase,

as this may well indicate a system wide problem (specifically the reluctance of staff to record deviations -possibly due to resource issues etc?) though the trends for the increase should be different to the initial year.

Trending figures could then be used as Quality indicators to show senior management activity within the dept, and in theory a negative trend should indicate areas where resources are needed to improve the situation, in reality this is unlikely to happen until senior management throughout the trust 'buy into Quality' as is used in well run industry/organisations.

I think it is down to the Quality/ Blood bank staff to educate senior managers with all of this, until management understands the relevance of these systems to ultimately improve safety/ reduce wastage and thereby improve financial performance and reputation- in some ways you can't blame them totally in being dismissing of 'quality' and thinking this is all as just a paper exercise.

Edited February 28, 2010 by RR1

[bmsjbatt]

Yes, that can be a bit of a problem. I gather that at some places the high number of incidents/ deviations being reported by the lab. is being taken by senior management as a negative indicator of practices rather than showing a positive, open reporting culture by the lab staff, who are willing to address issues rather than sweep these under the carpet...as has been done for many years.

As always these things are sent to try us!

Rashmi, To try and get these senior managers on-side you may try liaising with your risk & safety team. beacause they have evidence that shows that under reporting of incidents is seen as a negative thing and may influence the NHSLA grouping that the trust is awarded, and thereby a real financial cost pressure, we have been able to use this to persuade managers that adequate reporting of errors and incidents is critical as this is the only way we can improve, and save money!!!

[RR1]

Hi Jo, thanks- I recall reading something similar on the NPSA website, this mentioned that an increased reporting of incidents is generally classified as showing improved performance, and a more open culture within the organisation.

[bmsjbatt]

Indeed, and in my experience our hospital managers are taught to respond positively to evidence based changes of practice, so use tools like NPSA etc to give you some leverage.

We were encouraged to have stronger links with our Trust Risk and Safety Team by our last MHRA inspector, in part because he was unhappy with us not having ownership of all of the resolution procedures especially ones outside our department, but we now have an excellent relationship whereby our Trust reporting process has been modified to satisfy our requirements.

[Gregor]

I currently work with various NHS, Private Healthcare, Medical Device and Clinical Trials consulting on their compliance activities. With a continued focus on the delivery of quality improvements based on the latest evidence based practice and a robust monitoring of performance. One of the key focus is CA/PA management.

The company is Gael Ltd http://www.gaelquality.com/healthsector_bloodservices.asp, I am sure if there was enough interest, they would be happy to run through a quick presentation of what they have delivered to date.

If this is of interest, please let me know.

[RR1]

Thanks for the info Gregor, many of us are aware of how good Q-pulse is in managing these activities but unfortunately have to make the best of what we currently have. We use iPassport for doc control only but I know this has features for assigning CAPA tasks- but it actually seems rather more laborious than placing CAPA on an excel spreadsheet.

I know many of these systems use email to remind folk of assigned CAPA tasks but this isn't of much use if your staff don't regularly read their email, sometimes it just helps to have a simple task list with due dates.