Closing Out Corrective Actions and Verifying their Effectiveness

T

tracey

Well everything came to a halt yesturday. The owners found out about the CAR's not being addressed and saw to it that there were. They wanted to know why I hadn't come to them.

I explained to the Engineer manger, as I have done before, that if he wanted to take a different approach to reviews we could do that. It was decided by all, including the manager, that this was the way they wanted it to be done. They feel that having these meeting will eliminate problems in the later stages of design.

It was also decided that I would send monthly updates on the Satatus of Correcctive Actions. Thanks to the cove members...this shouldn't happen again.

Tracey;)
 
B

Bill Ryan - 2007

The owners found out about the CAR's not being addressed and saw to it that there were.

Appears to me to be a textbook example of the "Quality Message" being driven from the top-down. I would think your life will be much "easier" from here on in to know you have the owners' support (and, thusly, the manager's "buy-in").

Even though we strayed from your original posting somewhat(thank goodness that doesn't happen much here .:rolleyes: ), I hope all the responses were somewhat helpful.

Bill
 

Mike S.

Happy to be Alive
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Freddiem11 said:

It seems to be a waste of valuable resources to write a nonconformance finding on not having design review meetings, even though your procedure says to. Your system seems to be stuck in the say what we do, do what we say thinking. Question is, what value do the review meetings have on improvement of your organization? There is no ISO requirement to have meetings, the intent is to review design inputs and changes. Our engineers do this almost exclusively through e-mails and phone-cons. Your system may be bogging down these brilliant folks with meeting requirements.

Secondly, Corrective action timelines need to be flexible, if not, effective implementation is destined to fail. It is not uncommon for corrective actions to take months or sometimes years to implement,depending on their nature. Who sets the due date and why did they choose it? Consider extension requests.
Hi Fred,

Welcome to the Cove.:bigwave:

While I agree with a few points you made I have to disagree with a few as well.

If the procedure says you will hold DR meetings and you don't do it IMO it is quite proper to write the CAR. The corrective action might be that mgt. determines the meetings are not needed, so the procedure is changed so that the need for meetings is deleted, which is fair. But someone who was responsible for the process at some time decided meetings were the way to go, so they must either change the procedure or follow it, otherwise all procedures might start being ignored.

As for CAR timelines... A manager is supposed to be a responsible LEADER. If he/she truly needs more time to do an investigation, etc. he/she should have the minimal courtesy to respond to the QM as to what the situation is and what the new expected timeline is, but ignoring the QM or just saying "I'll get to it tomorrow" day after day is unprofessional and not a sign of an effective manager, IMO.
 
F

Freddiem11

Mike S. said:

Hi Fred,

Welcome to the Cove.:bigwave:

While I agree with a few points you made I have to disagree with a few as well.

If the procedure says you will hold DR meetings and you don't do it IMO it is quite proper to write the CAR. The corrective action might be that mgt. determines the meetings are not needed, so the procedure is changed so that the need for meetings is deleted, which is fair. But someone who was responsible for the process at some time decided meetings were the way to go, so they must either change the procedure or follow it, otherwise all procedures might start being ignored.

As for CAR timelines... A manager is supposed to be a responsible LEADER. If he/she truly needs more time to do an investigation, etc. he/she should have the minimal courtesy to respond to the QM as to what the situation is and what the new expected timeline is, but ignoring the QM or just saying "I'll get to it tomorrow" day after day is unprofessional and not a sign of an effective manager, IMO.

Mike, points well taken. However, I did not pick up from Tracey's situation that the CAR was being blown off, but rather was a re-curring CAR that did not get implemented iaw the initial timeframe. Many poor procedures were developed simply to meet the requirements of the 1994 std, it will take some time and system maturity to weed out these procedures that were developed simply as prescriptions to any noncompliance to ISO 9001. We are still weeding. Question is, if they start having the meetings as required, are they adding any value to design reviews or a just a ticket punch. There can be multiple causes to any system problem. Find the best one to act on, and decide this as a team, not one person responsible for the process.

Tracey, here's something you might want to try. My CAR status report bang list includes every manager in our organization. The report is not just a list of CARs and due dates, but the CARs are hyperlinked to the actual nonconformance report file (CAR) in the database. This not only gets hightened awareness, but managers now know that when a CAR in their area is issued, the entire management will see the issue and be familiar with any actions needed. You will shift accountability where it belongs, with the responsible manager. Most don't like this high level of visibility, so they take action.

Fred
 
S

Sirlard

I was a little late in reading this thread and it sounds like Tracey has the backing of upper management now. When I wrote our Corrective and Preventive Action Procedure I included the following clause: “The Department Manager assigned for taking action must respond, by the due date. Extensions of the due date will be granted if justified. Copies of overdue CAR’s are given to the Assistant General Manager for intervention.” It was my intent to give this old toothless dog a little chance to have some bite. So far, only a years time, I have not had to invoke the intervention portion of the clause. The Assistant General Manager is our top dog.
 
M

M Greenaway

Well said Fred.

I agree, many non-compliances found during internal audit are trivial, and arise due to the fact that the procedure is poorly written or unnecessarily detailed. Such findings do not warrant any attention what so ever, no wonder the CAR system is failing - the issues are trivial.

This state of affairs has come about through two poor practices - 1) writing detailed procedures badly for everything and 2) auditing soley for compliance to procedures.

The answer ? Simple...

Adopt the ISO9001:2000 process approach, bin all your text based procedures, process map to sufficient depth to define the important cornerstones of your business processes, and audit for compliance to the standard itself.
 

Mike S.

Happy to be Alive
Trusted Information Resource
M Greenaway said:

I agree, many non-compliances found during internal audit are trivial, and arise due to the fact that the procedure is poorly written or unnecessarily detailed. Such findings do not warrant any attention what so ever, no wonder the CAR system is failing - the issues are trivial.

The answer ? Simple...

Adopt the ISO9001:2000 process approach, bin all your text based procedures, process map to sufficient depth to define the important cornerstones of your business processes, and audit for compliance to the standard itself.

Help me here. Is this a general discussion or are you guys (Fred and Martin) saying Tracey's CAR's were trivial and should not have been addressed? If I remember correctly the owner wrote one and the other was for design review not being conducted. Are these trivial in your view?

If your process map says that at some point a test/inspection is to be done but you discover in internal audit it is not being done, is this trivial in your view?
 
M

M Greenaway

Mike

I was speaking generally from my own past experiences.

I think the point is perhaps that we need to audit more deeply, not just look for the right tick in the right box, in order to give our findings more weight.

The example of missed inspection might simply be a one off example of incompleted records, we might be able to ascertain that the inspection was actually done - now an NC raised just because one person missed a signature on a piece of paper is largely trivial in my mind. The process of inspection is there to verify the product in some way, by looking at the process we could determine that the process was successfully completed, and real quality, as it is important to the customer, has been assured.
 

Mike S.

Happy to be Alive
Trusted Information Resource
Martin,

Okay, I understand your perspective better now. I would never suggest we should do a formal CAR for every example of an undotted "i" or uncrossed "t" or trivial or one-off findings of a minor nature. Doing so would quickly exhaust the paper supply in many companies, not to memtion the reserve of patience of one's co-workers.

The example I gave of inspection not being done (in my mind) was not just a case of someone forgetting a signature on the inspection doc. (which I would do a simple verbal reminder about) but rather someone actually not performing (at all) an inspection that the process map says is required (presumably for good reason). In the latter case, I'm not so forgiving and would do a CAR. :bigwave:
 
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