Corrective Actions - Specifically closing out and verifying effectiveness

[SheilaK]

Corrective Actions

We are struggling with corrective actions - specifically closing out and verifying effectiveness.
Any suggestions, works for us stories, etc. would be greatly appreciated.

 

[barb butrym]

It is action specific. Very hard to pin down with out specifics.

If you are asking how to document it in your procedure...I'd say someone who was involved in writing the CAR (or knowledgeable of the situation) would check on the effectivity (ie.. did it work?). I would leave a blank on the form for 'followup activity' and who ever followed up, would fill in what they did, and their recommendations.

for instance...if the CA was to write a procedure...the follow up would be to review the released procedure to ensure it covered the issues, and verify it is distributed to the appropriate places and implemented (perhaps an internal audit, or a quick check during follow up). IF the CA was to train someone, the follow up would be to review the training record, and audit the activity and see if there is a change/improvement/understanding of the requirement etc by those involved. verify activity records to see if any reoccurance at the next internal audit (or change the audit schedule to add an audit at an appropriate time ). I could go on for hours here .... with scenarios, but I am sure you get the picture. Use the systems you have available to you.

A session on 'how to respond' to CAR and measure effectivity is in order. It's a common sense thing, some people do it well, some don't.

 

[barb butrym]

Perhaps, now that i think about it.....your struggle may be with the identification of the root cause, if you don't have that right, its hard to follow up for effectivity. And it could also be that you are doing CARs on random ocurrances, that can not be fixed long term....

how about some examples for us?

 

[SheilaK]

okay...an example of the problem I am facing with CAR's ... we hold a meeting, determine root cause...recommend actions - using action plan...forward plan to functions responsible for completing tasks, most cases first task must be completed - notify me, so I can forward information so next task can start...third...fourth etc. We have communication gap in that I'm not always notified...then jobs are moving through the manufacturing process...differently (due to early changes) and not being monitored - hence we cannot determine effectiveness and close out the CAR - too many 'open' issues worsens the situation.

 

[Kevin Mader]

Sheila,

Your committee issues the corrective action to be deployed by the responsible authority? Are the responsible folks part of this meeting (I get the impression that they are not)? I am wondering if the committee is close enough to the problem to properly assess the root cause and have the body of knowledge to correct it. Perhaps the communication gap you are speaking of is manufactured by your CA process (ie. folks are being told what to do and are not contributing as part of a team, causing them to rebel). You may find that the folks closest to the problem have a better handle on how to correct the issue at hand and only need guidance through the CA process from management. This should improve the effectiveness of the CA program I think. The question Barb asks is the same one used by myself and I am sure many others. Did your actions fix the problem? If there are no more repeat issues, then I'd have to say your CA was probably effective.

Regards,

Kevin

 

[Aaron Lupo]

We have a similar problem at the company I work for. Going back about 2 months ago I had the Corrective Action dumped on me. It used to be the whole QA departments responsibility (lucky me). Thats not the problem, the problem is nobody feels it is necessary to respond to them This would not be a problem if we didn't have multipile facilities. If we only had one I would do the "hand holding" of the responsible people to see that they did what they said they were going to do, and also see that it is effective. I don't have the time to call all the facilities to see that they have it done only to be told umm well h we don't have it done yet because umm well uh duh we don't have time. Then ontop of this the Managers have a monthly "meeting", well this last meeting they were all just DUMB founded that there is so many open CAR's, and they didn't know that it was this bad. My response to that of course would be thats a load of BS and I know this for a fact because I am the Internal Auditor (lucky me) and when I send them the reports it states that they have numerous CAR's that are not responded to or need follow up. I also tell them this during the audits. The reason I feel that we have such a big problem is that our "Executive Commitee" does not stress the importance of the Corrective and Preventive Action system, so the managers don't give a hoot either. Well our Registrar is coming early 2000(no agenda from them yet and we have asked them to send it numerous times) and when they look at the Corrective Action System we have in place if they are not blind, they will see that it does not really exist except in name only. But hey whats an Internal Auditor to due we have no authority and nobody listens to us anyways so I just make sure I document everything so I know that I tried. Ok enough of my complaining if anybody has any suggestions please tell me. Thanks.

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[This message has been edited by ISO GUY (edited 03 May 2000).]

 

[Aaron Lupo]

Kevin, our Managment Rep. has tried to get or EC to respond to these issues, but our EC like I said before just does not care. It seemd like I have walked into a situation that is almost hopeless. The last time our registrar was here they just glanced at Element 4.14, and I have a feeling they will do the same this time. Most of our open CAR's are the responsibility of one department. These could be closed out if they would issue a blanket response for a problem that is on going that unless the company buys new equipment, will always be there. I am in the process of implementing a Cost of Quality associated with each CAR/Complaint, but with all things that are new to people they take time to get up and running. I think if our EC sees how much these problems are costing us they will act on them. It also does not help when the QA Manager makes the comment infront of other Managers that "CAR's are not really that important" well I guess that says it all.

 

[Kevin Mader]

ISOGUY,

I feel your pain!! As Andy points out in his post, we have all probably been there. It is a frustrating position you find yourself in. Hopefully it will improve for you as it has for me.

Andy gives good advice; make the invisible, visible. Maybe as Andy has done, by attaching it to a newletter, or perhaps, create a report for your EC (your CoQ may help). Keep it simple. If not, they probably won't read it, and that would only add to your frustration.

You mentioned a blanket CA would close out a number of your outstanding CARs. I would reduce all those CARs to just one, blowing out the excess baggage and decide to deal with the one. But you also stated that in order to eliminate the Cause, the organization would have to buy an expensive piece of machinery. In theory, you could close the doors of this organization forever by closing out this CAR by spending all you had. Just so that you know, you may as an organization have to 'manage the problem', that is to control it, in the best way without ever totally eliminating it (it would be pointless to issue a CAR with that knowledge). Remember, a CA in theory TOTALLY eliminates the problem from ever occurring. This isn't always possible. All systems produce some level of nonconformance. Assess the risk, and manage the nonconformance (I don't know if you make medical devices or landing gear for planes. If so, you may still be stuck to find a solution).

The problem with ISO is not the Standard. It is in how the organization views the Standard in their own culture. The EC must realize that this is a tool to help the organization to succeed. It is only a tool in the philosophy for managing. ISO will not save a company by itself. It never has, it never will. Using the tool wrong can do damage to an otherwise healthy organization. They must rise to the role of Leadership and help to implement the tool correctly. Your task: finding a way to help them realize the value of ISO without getting labeled as an "I told you so!" I hope we can help.

Regards,

Kevin

 

[Kevin Mader]

Where is you Management Rep? The rep should be able to get the executive levels to respond to this dilemma. Otherwise, April will serve senior management with a nasty right hook!

Speculation on my part, but 137 is a rather large number, especially for only 3 months! I suspect that your CAR system is burdened with nonconformances that are probably not System threatening or have High risk to contribute to nonconforming product. Folks may not be responding because they believe that many of the CARs are a farce.

My suggestion: review the CARs already issued in to piles. Eliminate the CARs that don't belong, prioritize the rest, create an action plan to resolve the CARs. You may not get a bulk of them done before the audit, but at least you will have demonstrated a structured approach to the problem, deployed your plan, and are in the midst of resolving open issues.

Regards,

Kevin

 

[Andy Bassett]

Hello ISO Guy

In the beginning, i used to write posts like that, but the best advise you are likely to get is 'start preparing your CV'. No buy-in form the employees, no support from the managers, the all too frequent 'Project from Hell'.

I can only suggest one thing that i presume you may already have tried.
Today i was just finishing a 'Monthly Newsletter' for a company which had on the backside 8 simple bar charts, one of the graphs showed open CAR's against closed CAR's, Dept by Dept. This will be distributed monthly, to all management and staff. We will see what the result is.

Regards



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Andy B