Seeking advise on how to stop the trend that is happening at my site where CAPAs are starting to fall pass their required due dates. Do any of you guys use score cards etc. that indicate how your key quality systems programs are performing?

Cheers.

Maybe it’s an Irish thing.... I have recently resigned from a company due to problems with the CAPA system. CAPAs all over ran and when they were filled out it was a 2 minute effort to basically complete the paper trail.
As problems kept repeating and the effort to bury my head in the sand (the preferred option in the company) apparently didn’t work I brought the attention to senior management. The ranted and raved issued memos detailing our new disciplined approach, root cause investigation to be carried out within 48 hrs, target for CAPA closure 30 days – 3 months later not a single CAPA was completed.
After reaching a point where I began to question my own competence to do the job, lack of management commitment encouraged me to look at new pastures. I am now with a new company for 4 weeks, basically just observing processes and culture for now and preparing suggestions. One worrying item I recently saw was another management email saw, stating that all CAPA were to be closed by the end of business – so much for measures of effectiveness and root cause investigation – long live the paper exercise:confused:

Seeking advise on how to stop the trend that is happening at my site where CAPAs are starting to fall pass their required due dates. Do any of you guys use score cards etc. that indicate how your key quality systems programs are performing?

Cheers.

It MUST start from the top of your organization. If the head person doesn't really care then you are in for a stressful life including high blood pressure and the risk of stroke.

Get a meeting with the person and go over the costs of failures since the head of any company is interested in $$. Also go over the present pass due Corrective Actions and ask for help or guidance.

If it doesn't work, change jobs or companies since your vocational life will be dismal.

PS - When I was a Quality Manager in a confrontational atmosphere, I had extremely high blood pressure and I was only 32 years old.

It's a common problem, IMO.

It might help to examine the CAPAs critically. Would fixing the problems

(a) add some kind of value to their owners, or
(b) is the result merely going to satisfying some "shall"?

If the CAPA's owner thinks the answer is choice b), it may help to develop some compelling arguments that would draw a connection between the solution and recognizable value.

The suggestion of tying the problem to quality costs is a good one. Use the Search function in the blue tool bar above this thread, and use the key words "quality cost calculator" to find a selection of threads to read on this subject.

However, one should always be prepared to confront the poor-cousin dynamic, where "quality" is viewed as product attributes and not doing things well.

Sometimes CAPAs can be, or seem, complicated or burdensome. It might help to negotiate a stepped plan to deal with containment, then address long-term systems factors that enable the nonconformances. Be prepared to check in on the process and take notes for your files, showing progress is being made and that customer needs are receiving focus. This is, of course, a lot more work than simply administering data and dates in a stuff-in, stuff-out manner. Real improvement is not necessarily so tidy.

In the end, it was accurately noted that management holds responsibility for fostering a culture of dedication to doing things well. If they diggedly fixate on short term profits at the expense of long term, robust organizational health, it may indeed be a good idea to bail. Just be aware that there's no utopia. People will have foibles; we are all subject to one or more of the same seven human vices shown by those timeless Greek tragic plays.

Seeking advise on how to stop the trend that is happening at my site where CAPAs are starting to fall pass their required due dates. Do any of you guys use score cards etc. that indicate how your key quality systems programs are performing?

Cheers.

I tend to view the issue of overdue CAPAs a little differently than most. I've had this issue in past places I've worked and found that it was because I was trying to write too many. Blaming management for lack of support is too often an easy out. Most upper managers do want to see good, effective corrective actions implemented. And the the best corrective actions are usually analyzed by a team.

Are you trying to implement a corrective action for every nonconformance? If so, there are probably too many corrective actions. Try grouping nonconformances into catagories, products, areas, etc... Change your reporting to Pareto on the top nonconformances for each month and then write your corrective actions again one or two of those, (the significant or repeated events as I like to call them). Leading a cross-functional team in a meeting to attack those one or two issues at a time will give you much better corrective action response and you'll see the improvement in your nonconformance metric.

Trying to come up with a scorecard to measure corrective action response may lead to faster responses, but also ineffective ones. I think it's best to keep the metric focus on the nonconformance trends.

Good Luck.

I believe this is an issue in the majority of organizations out there. What I have done in the past is begin to assign an auditor from the internal audit team to manage CAPA's as they develop. This way you have someone managing the CAPA rather than hoping someone will step in take responsibility and manage it. In addition at the same time you are creating a stronger internal auditor.
:)

hope this helps!

I believe this is an issue in the majority of organizations out there. What I have done in the past is begin to assign an auditor from the internal audit team to manage CAPA's as they develop. This way you have someone managing the CAPA rather than hoping someone will step in take responsibility and manage it. In addition at the same time you are creating a stronger internal auditor.
:)

hope this helps!


IF Top Management is committed, and
IF Top Mgt. has a metric of overdue CAs at weekly or monthly meetings,
IF Top Mgt. makes noise obout these, then they will simply be solved.

IF it does not matter to Top Mgt. then it won't matter to anyone else...

Negotiate.

Negotiate.

This implies that those involved have options.

Assuming that the CAR's and PAR's are valid and correctly and accurately documented, there should not be options. Maintaining and improving Quality Management System requires Management's unwavering commitment and immediate action when required. It seems that this is time for action and not negotiations.

Stijloor.

IF Top Management is committed, and
IF Top Mgt. has a metric of overdue CAs at weekly or monthly meetings,
IF Top Mgt. makes noise obout these, then they will simply be solved.

IF it does not matter to Top Mgt. then it won't matter to anyone else...

If top mgt has a metric of overdue CAs and makes noise about them, they will be successful in driving the metric toward reducing overdue CAs. But it won't mean the problems are getting solved or that nonconformances are reducing.

We had a few related indicators:

CAs and PAs open
CAs and PAs open > 90 days (warranted some attention to understand why)
CAs and PAs open > 90 days with actions pending - these were flagged at Management Review and actions assigned with follow-ups done with the managers. After 90 days the expectations for any open CA/PA was that it would be in the verification stage and, in some cases, that may be 6 months (i.e., due to our schedule). If it was open > 90 days with actions still pending, or in some cases root cause analysis hadn't even been done, the support was there to address the situation.

If top mgt has a metric of overdue CAs and makes noise about them, they will be successful in driving the metric toward reducing overdue CAs. But it won't mean the problems are getting solved or that nonconformances are reducing.

An excellent observation. :agree1: We have to be careful about how we characterize our requirements, being ever mindful of self-fulfilling prophecies and the tendency to get what we ask for. If the requirement is to complete the paperwork within a given amount of time, it's not a difficult thing to have done. On the other hand, if the requirement is to solve the problem, it becomes immediately evident that (A) time limits in and of themselves aren't particularly helpful, and (B) the problem must actually be solved before the case is closed.

If there are many unresolved CA issues, it's almost always due to either conflicting priorities (a failure of leadership) or unnecessary formalization of the process in some cases, which comes about as a result of the misbegotten belief that all nonconforming conditions require formal CA.
The emphasis has to be on solving problems, not filling out paperwork.

Assuming that the CAR's and PAR's are valid and correctly and accurately documented, there should not be options. Very well stated.If top mgt has a metric of overdue CAs and makes noise about them, they will be successful in driving the metric toward reducing overdue CAs. But it won't mean the problems are getting solved or that nonconformances are reducing.Excellent point.
As we can see, the processes associated with CAR/PAR generation, CAR/PAR processing and tracking, as well as CAR/PAR monitoring have all to be effective. Chronic delinquency of CAR/PAR is explicitly required to be a part of the management review process. In that event, top management has to demonstrate it's firm commitment and seriousness about the CAPA system. If there are significant delinquencies, they must enquire the reason for that and provide RESOURCES to change the situation. Otherwise, lack of discipline will mestastasize like wild fires fed by the Santa Ana winds.

If top mgt has a metric of overdue CAs and makes noise about them, they will be successful in driving the metric toward reducing overdue CAs. But it won't mean the problems are getting solved or that nonconformances are reducing.

Here is an idea...

Make top management's salaries, bonuses and other spiffy perks contingent upon successful completion of CAR's and PAR's. A good way to get management's attention is to affect their wallet and/or pocket book.

Stijloor.

Here is an idea...
Make top management's salaries, bonuses and other spiffy perks contingent upon successful completion of CAR's and PAR's. A good way to get management's attention is to affect their wallet and/or pocket book.Since they (top management) make the rules, why would they subject themselves to a financial risk? Very likely, if such goal was implemented, the measure of "successful completion" would be paperwork completed, like Jim very appropriately mentioned in The emphasis has to be on solving problems, not filling out paperwork.I know of companies that have tied people's bonuses to their performance in supporting the CAPA process, but at the end, some issues might require capital investments or resources that only top management could allocate.

Since they (top management) make the rules, why would they subject themselves to a financial risk?

Actually, when I wrote this post, I had their 'bosses" in mind. Corporate people (if applicable). Could be the Board, or the Owner. I realize, that such a measure may not be feasible in all cases, but when appropriate, it sure would get people's attention.

Very likely, if such goal was implemented, the measure of "successful completion" would be paperwork completed, like Jim very appropriately mentioned in I know of companies that have tied people's bonuses to their performance in supporting the CAPA process, but at the end, some issues might require capital investments or resources that only top management could allocate.

"Paperwork completion" could happen, but in a good quality system, only the absence of recurrences would be the ultimate proof of successful completion. But that would require a longer-term view, something that does not get rewarded in (some) businesses.

Stijloor.

Since they (top management) make the rules, why would they subject themselves to a financial risk? Very likely, if such goal was implemented, the measure of "successful completion" would be paperwork completed, like Jim very appropriately mentioned in I know of companies that have tied people's bonuses to their performance in supporting the CAPA process, but at the end, some issues might require capital investments or resources that only top management could allocate.

I've always thought that if you have to hit someone over the head to get his attention, there's something wrong somewhere that will diminish the effectiveness of the blunt instrument. While leadership involves the provision of unequivocal consequences for straying from the chosen path, there first has to be a clearly circumscribed path, and people need to understand why straying is considered unacceptable behavior. Another function of leadership is to have people who do things the right way because it's the right thing to do, and not because they're afraid of being hit over the head.

The answer to your question maybe lies in the response to another question "Why is the relevant department manager not interested in resolving the corrective action?" After all it's their issue and not yours.
You should discuss it with them directly once, or even twice to understand their view on CAR's and indeed your management system however, after that Hmmm!

Make the CAR reporting system an important part of the next Management Review. Highlight overdue issues, time open & who owns the issue and then ask your boss what he is going to do about it.

You will soon learn your position and potential value within the company.

Steve

If top mgt has a metric of overdue CAs and makes noise about them, they will be successful in driving the metric toward reducing overdue CAs. But it won't mean the problems are getting solved or that nonconformances are reducing.


Top Mgt gets what they truly want. When I see that Top Mgt truly is committed to improving this, the rest will fall into place. If they are not, the rest will likely stay messy.

Sometimes, a particularly influential Quality Mgr. can make some progress on their own, but it truly comes together only when it is clear that Top Mgt wants it too.

Andy Nutt is on the money!:cool:

We must be so careful to make anything worthy of a corrective action something that management will get some benefit from. Too many times CAR's are written with the best intentions, but frankly, making a corrective action because it's an 'ISO requirement' or something equally banal is not going to get support, neither is having a lot of 'correctable' issues which bog the whole process down.

Thanks, Andy for those very practical insights!:agree1:

Top Mgt gets what they truly want. When I see that Top Mgt truly is committed to improving this, the rest will fall into place. If they are not, the rest will likely stay messy.

Sometimes, a particularly influential Quality Mgr. can make some progress on their own, but it truly comes together only when it is clear that Top Mgt wants it too.

I do understand your point and I definitely agree on some level. It has just been my experience that the majority of top mgt truly do want good corrective actions, they just don't know the difference between a good one and a bad one or how to go about this and so they really rely on us to lead.

....Are you trying to implement a corrective action for every nonconformance? If so, there are probably too many corrective actions. Try grouping nonconformances into catagories, products, areas, etc...
My point in my earlier post was that whenever I hear of problems with overdue CAPAs, my first instinct is to ask what can "we" do better and perform the 5-why analysis on ourselves. When we do this I've often found that we write and issue too many. And ones we do issue are not tied to a clear metric that we can see will improve if we implement the CAPA. It helps if we can make better use of Pareto and separate the significant few from the insignificant many and try to do less with more. Focus the whole team on just a few issues at a time, then you'll see more of the magic happen.
:magic:

I do understand your point and I definitely agree on some level. It has just been my experience that the majority of top mgt truly do want good corrective actions, they just don't know the difference between a good one and a bad one or how to go about this and so they really rely on us to lead.


My point in my earlier post was that whenever I hear of problems with overdue CAPAs, my first instinct is to ask what can "we" do better and perform the 5-why analysis on ourselves. When we do this I've often found that we write and issue too many. And ones we do issue are not tied to a clear metric that we can see will improve if we implement the CAPA. It helps if we can make better use of Pareto and separate the significant few from the insignificant many and try to do less with more. Focus the whole team on just a few issues at a time, then you'll see more of the magic happen.
:magic:

Andy hits the nail on the head again. :agree1: I'll go a step further and say that if you're having trouble getting management's attention, Andy's advice regarding Pareto analysis should be followed, but it's important when doing any Pareto analysis to quantify things in terms of dollars, and not just the numbers of occurrences. Experience shows that when you do Pareto without regard for cost, you might find a chart that shows 10 instances of a relatively insignificant (in terms of dollars lost) issue, and only two of a very costly problem. Without cost data, the assumption will be that the tallest bar on the chart should be the initial target. Just counting occurrences isn't necessarily useful. Show management that effective corrective action saves money, and they'll listen.

I do understand your point and I definitely agree on some level. It has just been my experience that the majority of top mgt truly do want good corrective actions, they just don't know the difference between a good one and a bad one or how to go about this and so they really rely on us to lead.


My point in my earlier post was that whenever I hear of problems with overdue CAPAs, my first instinct is to ask what can "we" do better and perform the 5-why analysis on ourselves. When we do this I've often found that we write and issue too many. And ones we do issue are not tied to a clear metric that we can see will improve if we implement the CAPA. It helps if we can make better use of Pareto and separate the significant few from the insignificant many and try to do less with more. Focus the whole team on just a few issues at a time, then you'll see more of the magic happen.
:magic:


I agree both points are fair and valid.

This has become a problem with us as well. So much so that we received an NC from our registrar auditor for it last year. Luckily, our Top Management became involved and supported the decisions made to reduce the problem (it will never be totally eliminated). Our actions:
1. It seemed there was some confusion on how to complete the CARS so we did company-wide training on Corrective Actions, their importance, and how to complete the form.
2. Hold weekly CAR meetings. First item of business: date extensions for any open CARS. We then discuss all open CARS to see if we can come up with solutions together as a multi-disciplinary team. Also, each week a few days prior to the meeting we post a notice of each CAR, who it is assigned to and the due date. Typically most of the ones that are overdue are either on my desk completed before the meeting, an extension date has been requested, or help for completion has been requested.

Our on time completion of CARs has increased over 40%!

This has become a problem with us as well. So much so that we received an NC from our registrar auditor for it last year. Luckily, our Top Management became involved and supported the decisions made to reduce the problem (it will never be totally eliminated). Our actions:
1. It seemed there was some confusion on how to complete the CARS so we did company-wide training on Corrective Actions, their importance, and how to complete the form.
2. Hold weekly CAR meetings. First item of business: date extensions for any open CARS. We then discuss all open CARS to see if we can come up with solutions together as a multi-disciplinary team. Also, each week a few days prior to the meeting we post a notice of each CAR, who it is assigned to and the due date. Typically most of the ones that are overdue are either on my desk completed before the meeting, an extension date has been requested, or help for completion has been requested.

Our on time completion of CARs has increased over 40%!


Your on time completion increase is very good. I am curious to know your thoughts on the CAR responses. Are you seeing what you feel are good CA responses? Or are you seeing a lot of "the operator has been retrained" type of responses?

Thanks.

Andy,
If the responses are unacceptable they are sent back to the person who completed them. This went on for awhile at first until everyone really got the hang of it (several years ago we all went through a 7 step problem solving class so all were already familiar).

My door is always open for any questions and I usually help anyone who is having a hard time. And, there is also the weekly meetings that we use a team to really get into the root cause and corrective actions.

-Billie Jean

I believe this is an issue in the majority of organizations out there. What I have done in the past is begin to assign an auditor from the internal audit team to manage CAPA's as they develop. This way you have someone managing the CAPA rather than hoping someone will step in take responsibility and manage it. In addition at the same time you are creating a stronger internal auditor.
:)

hope this helps!

We did something very similar....we had created a CAPA team in the Quality Assurance department. If a nonconformance Owner wasn't sure if a CA/PA was necessary, they would consult the CAPA team. If it was deemed that a CA/PA was needed, then someone within the CAPA team was assigned as the QA Approver and was responsible for driving the CA/PA to on-time closure.

It is interesting to me that every post so far (I think) looks at this question from an internal CAPA response standpoint. Yet at my company internal CAPA request response is far better than we get from our suppliers. I’m not the most popular QE in the company with our suppliers (and some Purchasing people) because I put forth the time and effort to follow-up on past due CAPAs issued to vendors. Apparently many vendors are not accustomed to customers actually following up on such things! :confused:

It is interesting to me that every post so far (I think) looks at this question from an internal CAPA response standpoint. Yet at my company internal CAPA request response is far better than we get from our suppliers. I’m not the most popular QE in the company with our suppliers (and some Purchasing people) because I put forth the time and effort to follow-up on past due CAPAs issued to vendors. Apparently many vendors are not accustomed to customers actually following up on such things! :confused:

Mike,
I commend you for following through on the external CAPAs....it shows that your dedicated. We had a separate Nonconformance procedure for our vendors and would make sure that our CAPA timeline was realistic....taking into account that many of our vendors are not in the U.S. Also we would make sure that we had our electronic system notify the QA approver when the NC or CAPA was within 5 days of being due....this reminder would avoid an overdue status.

You might want to look at a risk based system. It helps determine the systemic issues verses ones that you want to trend for possible CA's. As Andy Nutt indicated in his reply if you flood the system you'll be hard press to get the commitment. Having a Risk Base system where you get buy in helps. However as indicated in a few responses it must be a commitment from the top to do this I suggest an Executive /Management Corrective Action Board that reviews open and completed CA's

Fifi2006, The statistics you collect relative to these past due CAPAs should make their way to the Management Review.

Traditionally, (except for critical findings or issues requiring immediate Corrective Action) it is very difficult to move these things along. You must have a good tracking and control system to monitor these actions. This is not a new characteristic, and is one that is likely to continue for a long, long time. It mandates however, continuous attention and exposure to upper management when these actions become past due.

One more thing. Make absolutely sure the CAPA gets to the right person for investigation and resolution, very important.

Good Luck

Bob