AS9100 Revision A - Timely and effective corrective actions not achieved

R

Raptorwild

#1
What are some specific actions to be taken where timely and/or effective corrective actions are not achieved? I really am looking for help on this one.
Thanks
Paula :bigwave:
 
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E

energy

#2
Just assuming

Raptorwild said:
What are some specific actions to be taken where timely and/or effective corrective actions are not achieved? I really am looking for help on this one.
Thanks
Paula :bigwave:
Take all the Corrective Actions not addressed to your satisfaction and write another CAR. These are usually scrutinized by your Customer Auditors or Registrar Auditors (If you are registered) and it will highlight the need to respond to your CA's a little more seriously. Write it with the names of the Department Managers responsible for seeing to it that actions are taken. Don't get discouraged. Just keep plugging away. Been there. If your feeling real frisky, send it to the Company President as it is ultimately his/her responsibility to see that these Corrective Actions are completed within the time frame agreed to. :frust: :smokin:
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#3
escalate, elevate

Remember, the status of cas/pas MUST be part of the input into management reviews. So, MOST definitely, bring delinquent/innefective issues to top management's attention. Depending on their response/interest, you will have a pretty good feel for how serious/commited they are.

As a side comment, many times I see unresolved ca's linger ad nauseum because the people responsible for correcting the problem do not agree that the problem exists. Unfortunately, poorly qualified internal auditors many times issue non-value added cars which do not get anybody's attention.
 
E

energy

#4
Persistance

Sidney Vianna said:
As a side comment, many times I see unresolved ca's linger ad nauseum because the people responsible for correcting the problem do not agree that the problem exists. Unfortunately, poorly qualified internal auditors many times issue non-value added cars which do not get anybody's attention.
Agree. Sometimes, upper Mgt isn't aware that things are being ignored. Unless you are meeting with the Honcho regularly and have complained about the lack of cooperation, they are in the dark. I found that Top Management also looks for things like this to remind people who is in charge. Why not use this to your advantage? I've been asked "Why haven't you come to me with this sooner?" As for "non-value added CARS", can violation of their Corrective Action Procedure be considered that? Or, are we thinking that the original CARS fit that description?JMHO :smokin:
 
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R

Raptorwild

#5
Car

The standard states that: "A documented procedure shall be established to define requirements for h. specific actions where timely and/or effective corrective actions are not achieved."

I dont like to write a procedure where defined and specific words are used, because every situation is different.
What if I state in the procedure that: "In the event that timely and/or effective corrective action is not achieved, the corrective action is reviewed and may be elevated or forwarded to top management for implementation." :) ???? Hey I think I just answered my own question...maybe...I need more input...please :)

Energy, I like the idea of generating another CAR and when I asked a few other Lead Auditors they also frowned on that idea but never really could come up with a better solution.

Thanks Paula :bigwave:
 
#6
When corrective actions are deemed to be ineffective, we generate another CAR referencing the original. When CAR's are not addressed in a timely manner, we close the original CAR and generate a new one to the next level within the organizational structure.

Remember, the status of cas/pas MUST be part of the input into management reviews.
Good point. A strategically assembled and presented monthly summary of C/A status is very effective.

Unfortunately, poorly qualified internal auditors many times issue non-value added cars which do not get anybody's attention.
Our internal auditors meet with the client after the audit and review the observations to determine if any warrant the generation of a CAR.
They issue CAR's in response to audit findings at the request of the client (our Management Rep./Director of Quality).

A good question and corresponding advice!
 
S

srqaeng

#7
In a past life when my company was QS-9000 I wrote this into my CPAR Process" If corrective actions are not addressed thoroughly or in the prescribed time period, the Corrective Action is issued to the Executive Vice President for action" He was very involved in the process and held the CPAR responses as a priority in the comapny.
 
M

mjones2

#8
There should be some form of escalation procedure written in to the Corrective Action Procedure.

For examples:
CAR’s open longer than 30 days require an extension signed by the Quality Manager.
CAR’s open longer than 60 days require an extension signed by the General Manager.
CAR’s open longer 90 days require extension signed for the Vice-President of Sales and Marketing.

(Effective June 21, 2007 for new CAR’s). CAR’s that are currently open will have an extension by the General Manager, and further extensions be granted at the General Manager discretion).
 
I

ISO Druid

#9
Having worked full time for several Registrars performing as (AE) lead auditor on AS9100 audits (including the 1st DOD pilot program in the US) I can share with you what passed muster and what got the organization a nonconformity write-up.
Writing a new CAR or multiple extensions ... proved to be ineffective and in a few cases were written as major non-conformances since these indicated there was a system breakdown ... especially in some cases effecting product quality ... and in some cases product shipped to the customer.
Escalation is correct ... if its effective. If management takes effective action for delinquent corrective action responses ... what I've seen internally - from process changes, engineering change, to disciplinary action ranging from re-training (but not repetitive as a response ... if we see "re-trained" over and over ... obviously not effective), re-assignment, suspension and even firing (internal) ... supplier - management meeting with supplier to discuss the issues ... walking them through the process, even sending a team in to resolve the non-conformance, rating reduction, re-audit, reduced or suspended business, in some cases ... disapproved status.
Opening a new CAR, as we were trained, only served to show the corrective action system was ineffective. There was (fortunately) a pre-audit I performed where the Quality Manager was told by by upper management to close out corrective actions deeming them "nit pickey" ... upon review of the corrective action requests however ... not the case ... contamination issues in the clean room and end product. I met with management and here is the actual audit report verbiage (RE: 8.5.2), by the way ... multiple (major) product non-conformances were noted in the audit reports ("leakers"). In my debriefing with Management we did discuss that had this been the actual certification/surveillance audit it would have been considered a major nonconformity including re-audit and possible lose of certification. There were at least 50 open corrective actions and yes, they also were re-writing their corrective actions ... not effective.
There are valid reasons for corrective action extensions such as allowing for another DOE or another test to complete, procurement of new equipment, etc.
Re-worded to maintain confidentiality but here are the non-conformances documented in the audit report ...
1. Verification for corrective action effectiveness apparently does not verify re-occurrence via effectivity review such as metrics. Emphasis of closing out CARs should not only be on reducing the number of CARs but rather on effective closure.
2. An effective corrective action is required to prevent re-occurrence of the non-conformance.
3. Target implementation dates on CARs are not being effectively completed by responsible departments. Quality is having to complete the forms.
4. There does not appear to be a documented process for escalating overdue or ineffective CARs to upper management. Upper management of the organization is ultimately responsible for assuring the quality management system is effective.

Since this was a consultant/contractor pre-audit, the following suggestions were added to the report:
1. 50 CARs were noted as open. Consider trending these by root cause, department, product, process to determine possible preventive action areas for combining the corrective actions. Please do not take this as a suggestion to close out CARs by moving them to a fewer number of PARs.
2. The responsible department should be responsible working their assigned corrective actions.
3. Customer audit non-conformances must be taken seriously (e.g.: housekeeping, contamination in clean rooms).
4. CAR effectiveness should be included as site quality goals and objectives.
5. Be more realistic in tracking CAR metrics such as number of overdue CARs. Due dates for root cause, corrective action plan, implementation and verification should be tracked.
6. A Fishbone/Pareto analysis conducted by the lead auditor of several CARs in the system revealed that the majority of root causes fell into categories MAN (employee training, human error) and MATERIAL (supplier issues). The third highest occurrence of root causes fell under EQUIPMENT. By focusing on employee and material related corrective/preventive actions the organization may be able to reduce CARs significantly and effectively while also considering equipment issues.

A little long winded but hopefully helps ....
 
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