posted 27 May 1999 09:16 AM               

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.

posted 07 June 1999 10:44 AM               

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,

posted 28 March 2000 11:27 AM               

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posted 28 March 2000 12:40 PM               

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,

posted 28 March 2000 12:41 PM               

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

posted 28 March 2000 06:54 PM               

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,

posted 30 March 2000 08:27 PM               

The particular CAR system included OHS incidents and hazards, customer complaints, nonconformances, improvements, security breaches, etc., etc.

For the managers I focussed on them adopting an empathetic apporach - if you wrote this CAR, would you be satisfied with the responses and actions?

In the circumstance where your auditor is coming, and you can't find any other means to motivate people, steer the auditor to focus on the problems you are experiencing. He/She will raise a NCR and hopefully this will spark the necessary crisis meeting and actions. It also serves to steer auditors away from anything else you don't want to deal with until you get the time!

Let the challenge motivate you, don't throw in the towel just yet - if I used that approach, I'd spend all my time fishing, golfing, surfing and sunbathing.

You must get executive buy-in. The CAR problems may just be a symptom of a far worse disease!

posted 31 March 2000 01:16 PM               

quote:

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Originally posted by ISO GUY:
I hate to say it the owners of the company don't really care about conforming to the standards, they just want the Certificate that says we are ISO certified. They see QA as an expense because " We do not make any money for the company", they don't understand that we are trying to save the company money...

...As far as pointing out the problems in our CAR system ( I don't want to get fired) I will let the Registrar find out for themselves. Well now that I sund like I am not making any sense at all I am out of here.

---

To your post (I hope I got the quote thing right):

It sounds like your management doesn't know how the ISO tool benefits their organization. Why is this? What are their individual theories based on? What are their expectations? Do you have any of these answers?

I suppose many organizations try for ISO because they want to "keep up with the Jones's." Get the certificate, mount it on the wall for all to see, let Marketing run to trade shows and wave flags of success. But does it have to be this way?

People need education and understanding about things. Superficial thinking is a serious disease in this country, as well as many other places in the world. What have we done to cure this disease? I think that Quality folks need an extra measure of patience. People need time to grasp what is important and we must present it in a way people will understand.

My thoughts: We need to understand the problems. Next, we theory. We must know the inputs and learn to control them. We must continually work to improve the process.

The questions I started with are to begin the process of understanding why management is content on playing lipservice to ISO. Maybe it was something they read and didn't agree with? Maybe Scapegoat 1 or 2 painted an awful picture, or one they can't understand? What can you do to change that?

If you gain a better understanding of the problem(s), you may be able to address them successfully, thus increasing the likelihood that they will return the favor by helping you to address the issues with your CARs. Collaboration is necessary.

You aren't alone ISOGUY. The war is not lost! If you let the registrar discover the CAR problem, you may risk what you fear of losing.

Regards,

posted 03 April 2000 12:55 PM               

quote:

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Originally posted by Spaceman Spiff:

Periodically we get rejection of 1 piece. Since the distributors are all jumping on the ISO bandwagon, I am getting requests for corrective action based on a single returned unit, some may be a year old (our warranty period) and others may have seen field use. It is very difficult to determine the exact root cause of the problem (especially if they've been in service). I hate to use the old "informed the operators" as a boilerplate answer. Anyone out there have any comments?

---

One thing to consider --> You have to set some threshold where you do not react.

If you do not get the unit, have a canned letter which states that without the unit no investigation can proceed.

posted 03 April 2000 02:02 PM               

The key is to be able to say what is a repetition and what is not. Now - this is all and well for me to say, so I will put in a cavat. Let's say you make air bags. A freak failure is not well tolerated by the public or government - thus the product makes a difference.

posted 07 April 2000 02:44 PM               

That's at least where we relate 4.13 Nonconforming product control to - 4.14 Corrective action (nonconforming product occurances recorded under 4.13 need to be placed in the correction AND/OR preventative system(S)If the Volume/Cost/ or potential current or future risk of reoccurance involved is "significant" enough for corrective action to be warranted...

I have in fact reported to our customers "at appropriate times" that the single occurance appears as an isolated situation and no further action is planned "until/unless" the risk involved becomes a costworthy or a risk worthy issue.

I have seen closure criteria mechanisims that allow closing single or low level nonconformance items using a time/delivery standard (for example only - 500 pcs delivered over a three month period with no further occurances would allow one to close becsuse that single or low level defect volume was a "freak" "flyer" etc. that in reality does not need documented correction.

posted 07 April 2000 03:49 PM               

Thanks,