View Full Version : What is the scope of a CAR (Corrective Action Request)?
davis007 29th June 2007, 03:43 PM Back story:
About 2 years ago our R&D department started sampling a potential customer with a product. The first shipment that arrived at the customer, and had an issue with performance parameter X. This issue was not one on our radar at the time. As this was being handled by R&D a CAR (which for us a customer complaint always trigers) was assigned to R&D. The R&D department "corrected" the problem by making a new lot of material as a replacement. Up until this point no specifications were written on the product.
About 1 year ago, the customer placed a comercial order for the material. Again no specs, so manufacturing wrote some specs. on what we belived were key performance issues, based on our experiance with other products of this type. These were reviewed by R&D, but no information was given to Production about the earlier issues, and no specs around manufacturing requirements or the performance characteristic in question were included or comunicated to production.
The order was shipped and the first part used by the customer. The remainder was stored for ~6 months and when used this material had the orginal issue that the first sample material exhibited. The customer issued a complaint.
Now for the questions then on with the story:
1. Which department should be assigned to head up working on the CAR?
2. Based on above what would you belive the failure in our system is? More than one is possible I think.
3. How should the original CAR be handled at this point? Should it remain closed, let sleeping dogs lie, or reopen it?
The CAR we issued was assigned to the R&D department as we felt the main issue was related to the original product design, no FMEA, only the most rudamentary design requirements from the customer obtained, etc. In the meantime, production produced a new lot of material and shipped it to the customer. This lot had one of the components changed.
R&D returned the CAR with the comment that the issue was resolved by production when the formulation was changed. The short term action was a new lot of material was produced and the long term action was change in formulation.
More questions:
1. Do you think the response from R&D is adequate? Yes I paraphrased but the some total in each section (short term and long term actions) was 2 sentences.
2. The case I give above is only one of several I could have choosen, this one picks on R&D but other examples would have pointed the finger and many other stories would have highlighted similar issues with other departments.
The reason for this post is two fold.
1. Answers to the questions will help me gauge if I am on the right track with my frustrations, and how well I understand the intent of a CAR.
2. The second is can anyone tell me of some trainning material that I could use to educate the company about how the CAR system fits with a continuous improvement effort?
Sidney Vianna 29th June 2007, 04:02 PM I understand that you trying to divide the problem in bite-size pieces, but it seems to me that this is a classical case of being too close to the trees to see the forest.
The fundamental problem here is that your organization allows for underdeveloped products to be offered commercially. It seems to me that your R&D Group did not perform a thorough design and engineering cycle of the product in question, throwing a patched design package over to manufacturing, who did their best to assemble the units. As you stated, specifications were not solidified. Chances are, the product design was not adequately verified nor validated.
Your organization did not learn from the initial problem, which generated a customer complaint and allowed for the same problem to recur.
If I were in your situation, the CAR would be addressed to top management to allow underdeveloped products to be offered (apparently without customer’s awareness).
From the tone of your email, it seems to me that you have the typical organization dysfunction of departmental feuds. Until your top management understand that a new product introduction process is a multifunctional, multidisciplinary, multi-departmental effort, you are bound (as an organization) to make the same mistakes over and over. To me, until your top management understands the risks of the flawed business model they have in their hands, corrective actions will address the symptoms and never reach the underlying causes of the problems.
And good luck.
davis007 29th June 2007, 04:25 PM The fundamental problem here is that your organization allows for underdeveloped products to be offered commercially. It seems to me that your R&D Group did not perform a thorough design and engineering cycle of the product in question, throwing a patched design package over to manufacturing, who did their best to assemble the units. As you stated, specifications were not solidified. Chances are, the product design was not adequately verified nor validated.
Yes I agree. Just having some issues explaining that to others so that we can correct the problem.
Your organization did not learn from the initial problem, which generated a customer complaint and allowed for the same problem to recur.
If I were in your situation, the CAR would be addressed to top management to allow underdeveloped products to be offered (apparently without customer’s awareness).
Good idea but getting top management involved is like pulling I teeth. The typicl response is we do not care just make sure all the audits (customer etc.) go perfectly.
From the tone of your email, it seems to me that you have the typical organization dysfunction of departmental feuds. Until your top management understand that a new product introduction process is a multifunctional, multidisciplinary, multi-departmental effort, you are bound (as an organization) to make the same mistakes over and over. To me, until your top management understands the risks of the flawed business model they have in their hands, corrective actions will address the symptoms and never reach the underlying causes of the problems.
And good luck.
Again you hit the nail on the head. Top managements refusal to get involoved other than at the lip service level, has in part created some of these riffs. There are some who want to see change, as this company has a great product and could really be great. top management says this but i never see action. Then there are the majoraty that think quality systems are a waste of time, root cause is garbage, and any attempt to get departments to work together is a waste.
Good luck to me indeed.
Sidney Vianna 2nd July 2007, 12:44 PM Top managements refusal to get involved other than at the lip service level, has in part created some of these riffs. Initiate a CAR against TOP management against ISO 9001:2000 paragraph 5.2 and don't let them off the hook easily.
JaneB 4th July 2007, 12:55 AM ... getting top management involved is like pulling I teeth. The typical response is we do not care just make sure all the audits (customer etc.) go perfectly.
Oh dear. Oh dear, oh dear. It just isn't possible - literally. Theirs is the key responsibility - it cannot be foisted off on you with this impossible to achieve tasks (ie, get perfect audit results with an uninvolved top management & thus a dysfunctional system).
Top managements refusal to get involoved other than at the lip service level, has in part created some of these riffs. There are some who want to see change, as this company has a great product and could really be great. top management says this but i never see action.
Yes, they need to walk the talk, not just talk it. Talk + no action = zip commmitment.
Sidney's given good advice, & your frustration is very justifiable. Can you apply the advice without too much professional risk? As in, not a career limiting move/politically dead unwise to issue a CAR against top management - because that's really where the issue is & where it needs to be solved. The results of the problem are only too plain: unhappy customer and very rightly so.
One strategy might be to raise the CAR using an approach along the lines of 'look, guys, we've got a recurrent problem we need to fix. I am doing this because otherwise we're heading straight for a nonconformity on this come next audit time". Normally I don't favour using the external auditor as the 'bad guy', but if it is what needed to make it happen in a particular context, I would.
Stijloor 4th July 2007, 01:44 AM Oh dear. Oh dear, oh dear. It just isn't possible - literally. Theirs is the key responsibility - it cannot be foisted off on you with this impossible to achieve tasks (ie, get perfect audit results with an uninvolved top management & thus a dysfunctional system).
Yes, they need to walk the talk, not just talk it. Talk + no action = zip commitment.
Sidney's given good advice, & your frustration is very justifiable. Can you apply the advice without too much professional risk? As in, not a career limiting move/politically dead unwise to issue a CAR against top management - because that's really where the issue is & where it needs to be solved. The results of the problem are only too plain: unhappy customer and very rightly so.
One strategy might be to raise the CAR using an approach along the lines of 'look, guys, we've got a recurrent problem we need to fix. I am doing this because otherwise we're heading straight for a nonconformity on this come next audit time". Normally I don't favour using the external auditor as the 'bad guy', but if it is what needed to make it happen in a particular context, I would.
Hello Friends,
As long as the Quality Manager = ISO (or ISO/TS) Coordinator = Management Representative = Audit Team Leader = Organizational Spokes Person = Quality Systems Coordinator continues to bail out Top Management when it's surveillance or recertification audit time, nothing will change. But, then again, that's why these good people were hired-to cover anyone else's a$$es. I guess this picture will fit many of our friends here on The Cove. At least, we've got many shoulders to cry on... :soap:
Stijloor.
JaneB 4th July 2007, 03:03 AM As long as the Quality Manager = ISO (or ISO/TS) Coordinator = Management Representative = Audit Team Leader = Organizational Spokes Person = Quality Systems Coordinator continues to bail out Top Management when it's surveillance or recertification audit time, nothing will change.
True, alas. The more often you see/hear of situations like this, the more you appreciate why the focus on 'top management' throughout the Standard. But it can be decidedly tricky in some organisations for the internal person to be the deliverer of bad news, particularly when it's 'excuse me, but you aren't doing it right' to the top person/people. Easier as an outsider, eg, external auditor or consultant.
For me as consultant, the worst that can happen is that they don't get me back - and I won't want to anyway, since the organisation doesn't want to change. For the QM, it can be much worse. Shouldn't be, isn't in a healthily functional organisation, but alas, it happens.
Another strategy to try is to partner with your external auditor to help your management understand. (That's assuming they're willing to listen & wish to, of course!)
Wes Bucey 4th July 2007, 01:21 PM One of the major difficulties the "Quality nerds" in most organizations face is how to present 'an opportunity for improvement' to top management without EVER implying "it's YOUR fault, management!" [and thus inviting instant dismissal from the organization.]
Factually, most of the folks in the Quality profession are ill-suited and ill-prepared to deal with the politics in most organizations. It's one of the main reasons Quality folk are relegated to staff jobs and rarely find their way to a line officer position.
Just like their brethren working in the organization, most outside consultants may be loaded with technical knowledge, but also lack the political skill to influence top management to implement improvements in the QMS.
As the story has unfolded in this thread, it seems obvious to me the root cause of this debacle is a basic failure of the organization to understand and implement Contract Review to understand the true requirements of the customer and determine whether the organization has the capability and capacity to perform the contract according to the requirements. FMEA (Failure Mode and Effects Analysis) is worthless unless and until the organization understands the requirements.
Corrective Action (versus a mere "correction") still requires the knowledge of the real requirements before planning or implementing a process change to meet those requirements.
So, what can the OP do today [or tomorrow] to be the "tail that wags the dog" and start the organization on the road to eliminating the dysfunction?
Start by getting a grounding in "Change Management." With that grounding, you can find a "champion" in management who is open to YOUR answer to his question ("What's in it for me?") who will lead the charge in ostensibly "helping improve the organization" while scratching his own "itch" for power or recognition within the organization. Without such a champion in the management ranks, the low level employee will have GREAT difficulty getting an audience with the folks who have the power to dictate a change.
:topic:For those who call me a cynic, I respond I have never seen a completely altruistic "champion" - the very least one can expect is the champion will take the glory for the improvement and shift the blame if it falls through.
davis007 5th July 2007, 10:36 AM As the story has unfolded in this thread, it seems obvious to me the root cause of this debacle is a basic failure of the organization to understand and implement Contract Review to understand the true requirements of the customer and determine whether the organization has the capability and capacity to perform the contract according to the requirements. FMEA (Failure Mode and Effects Analysis) is worthless unless and until the organization understands the requirements.
Wes:
I agree. From were I sit the organization is dysfunctional. For example the extent of our contract review is a quotation. Yep that right everyone gets a quote. you want specs with that? For some of our customers we have very well defined specs and formal contracts, these were all put in place BY OUR CUSTOMERS.
That is reality.
In ISO land:
According to our auditor we have one of the best ISO systems going. No findings the last three audits, only 2 suggestions. In our previous audits by customers only minor findings. This is all due to the hard work of our qualtiy systems manager. That person is very adept at getting the paper work in order prior to an audit and steering, questions toward areas were we have control. I have wittnessed documents being prepared, signed off on, and placed in our records, while an auditor is here.
In the real world:
We are a small private company, the owner flys in once every two weeks or so and throws the place into a tizzy as we prepare for the visit by cleaning. The COO spnds about 75% of his time here but goes on the floor maybe once a month for 5-10 min. Both of these people give great lip service to continuous improvement, in front of a customer. Yet I can not get them to read a CAR and understand why the response is or is not acceptable.
I have decided to leave. I have another job waiting. I give up.
Wes Bucey 5th July 2007, 10:53 AM I have decided to leave. I have another job waiting. I give up.Good! When all else fails, look out for yourself and family!
Mike S. 5th July 2007, 01:13 PM One of the major difficulties the "Quality nerds" in most organizations face is how to present 'an opportunity for improvement' to top management without EVER implying "it's YOUR fault, management!" [and thus inviting instant dismissal from the organization.]
Factually, most of the folks in the Quality profession are ill-suited and ill-prepared to deal with the politics in most organizations. It's one of the main reasons Quality folk are relegated to staff jobs and rarely find their way to a line officer position.
I hate to say it, but I think you are right. :(
chaosweary 5th July 2007, 06:37 PM For something like this while talking to management I usually pull RMA data along with some slightly exaggerated numbers for cost of labor, and customer costs. Management doesn't want a sermon about continual improvement. They want to hear, how they can make money or how they can save money. Point out how much R&D cost them (its overhead anyway and usually an expensive sore spot for many companies). You must explain it in terms of a business process using their terms, not quality speak. There are many COPQ costs of poor quality examples at the cove. Try to use these indicators without using the word "quality". You may have better luck in the future with your next company and its a real "hoot" if you can get the internal financial audit folks on your side!
JaneB 5th July 2007, 10:00 PM For something like this while talking to management I usually pull RMA data along with some slightly exaggerated numbers for cost of labor, and customer costs. Management doesn't want a sermon about continual improvement. They want to hear, how they can make money or how they can save money. Point out how much R&D cost them (its overhead anyway and usually an expensive sore spot for many companies). You must explain it in terms of a business process using their terms, not quality speak. There are many COPQ costs of poor quality examples at the cove. Try to use these indicators without using the word "quality". You may have better luck in the future with your next company and its a real "hoot" if you can get the internal financial audit folks on your side!
Well said & excellent approach.
It isn't just managers who need to hear things in terms they can understand & relate to - it's a basic communication principle.
The more 'quality' talks in standard business language (most usually money), usually the better. I know these things are obvious to many quality professionals - but managers often need considerable help & education to understand.
JaneB 5th July 2007, 10:04 PM I have decided to leave. I have another job waiting. I give up.
Sounds like an excellent idea given what you say about the organisation. There's no point in continuing to beat your head against a brick wall. Life's too short. Much better to seek a better opportunity elsewhere.
A client told me recently of a proverb in his home town of Vasto (on Italy's Adriatic coast) that goes like this:a person who washes a donkey's head wastes both soap and water - ie, some things are a total waste of time.
May your next position be more rewarding :)
Jennifer Kirley 5th July 2007, 11:52 PM Sounds like a very big growth experience.
I also am glad to hear that you have found a new place to land, because really there is only so much a person can do. Top management is free to make decisions contrary to good advice, and they often do.
That said, I also quite agree that good advice is a relative term. We all here are pretty much sold on the idea that investing in holistic quality practices is profitable, but people outside our discipline will not automatically understand.
Such people will need plain talk in terms they already understand. They'll need unambiguous choices and the sense that not only do they get to decide, they are quite capable of making the best decision.
The threads on quality costs could help, especially since they contain links to articles and a couple of calculators to help you form your message. You might also consider reading The Change Agent's Handbook. It's likely available at your area book store, or on Amazon.com for sure.
It's probably too late for your current position, but you can take these experiences with you to your next post if you are careful not to allow yourself a grudge. Just ask yourself "What's the best way to communicate with my audience?" and be ready with supportable facts and the patience for the message to be digested. These matters sometimes take time. Small gains in the right direction still lead to the goal, yes?
Best wishes to you. :cfingers:
JP Frisbee 20th July 2007, 12:55 PM As for question number 3, I would keep the original CAR closed. I would initiate a new Surveillance type, audit, investigation, etc. and issue a new CAR. I would also identify it as a Repeat Finding. Identify all parties involved with the issue. I spend considerable time training and describing what to do for completing a CAR. Most people do not have a clue on how to complete one.:confused: I give to them the documents I attached at http://Elsmar.com/Forums/showthread.php?t=22670&goto=newpost
which gives them additional info and guidance on how to do a good root cause analysis and how to complete the CAR form itself. Offer to be there if they have questions along the way. If this is the first one they have “really” done, offer to work with them in completing it. Good luck.:bigwave:
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