Several times ago, I’m find a question that makes me surprised. It’s a question from Peters from Poland at Elsmar.com forum at June 2007.
The question is like this. “Internal Audit Nonconformance/NC is not closed, is it a nonconformity at CB assessment? “ He also explained like this. “These were some minor nonconformity from latest internal audits. Some (only some!) corrective actions began but are not finished and closed. Lead Auditor from CB had doubts that he can accept this. He was not sure it conforms to the requirements. We couldn't find in rules any information about such problem. Do internal audit nonconformities have to be closed before certification audit? Organization began corrective actions but these actions are not closed. Is there any requirement in Rules that this situation is nonconformity in certification audit?”
Several in the cove have answered this question.
Stijloor from North Caroline as the forum moderator’s was response like this. “No not necessarily. The corrective action may have to be monitored for a while to demonstrate its effectiveness before a CAR can be (finally) closed. Your CAR log should show the status of the CAR. Inactions (delays, etc.,) are bad”. He also told, “Now, if the Certification Body's auditor issues nonconformity, then it must be closed within a pre-determined time limit. In other words, a certificate of registration can not be issued unless all NC's have been closed to the satisfaction of the CB”.
Trainerbob from Michigan, USA response like this, “There should be no problem with a third party auditor and a corrective action for an internal audit problem as long there seems to be a reasonable plan in place to eliminate the problem and verify the effectiveness of it. If there is no reasonable plan in place to solve the problem, then the third party auditor would probably have a probably have a problem. As Stiljoor said there is a difference between a corrective action from an Internal Audit and a third party audit. Your third party auditor or his/her organization will have guidelines that they use for the closing of non-conformances found during their audits.
Spartan Kim as Shy poster at Elsmar.com response like this, “I agree with Stijloor and would say the requirement is implied. If an internal audit nonconformance is about a requirement of a standard that is not being done, then that certainly would create a new nonconformance at registration audit time from the registrar. But a departure from an internal, documented process that shows progress in meeting the target completion date (as opposed to no progress for days or weeks) should not create a new nonconformance from a registration audit”.
Sidney Vianna from Long Beach, California response like this, “I don't have my copy of the IATF rules handy, at this moment. So, I can not answer for sure if under the IATF rules that would be a nonconformity or not. But, if this was an ISO 9001 audit, conducted under the requirements of ISO 17021, I would have to ask you further questions. For example, are ALL corrective actions emanating from your internal audit process unresolved/open? If that were the case, how can an external auditor assess the effectiveness of your corrective action process? Further, since results of internal audits and status of corrective actions should be part of your management review, can an external audit assess if your management review activities are done? If we were to assume that a percentage of your corrective actions, originated from your internal audit were "closed" and the external auditor can verify the process is working, I would emphatically agree that there is no requirement mandating all corrective action requests to be closed, prior to the certification audit. However, if NONE of the actions have been closed, verified for implementation and effectiveness, myself as an auditor could not attest that a key process of the QMS, namely the corrective action process, is effectively implemented”.
Howste from Utah response like this, “The Rules are not specifically mentioned what you are talking about. Originally Posted by TS Rules 3rd Edition, the audit team shall record all findings of nonconformity when detected and identify the nonconformities to the client. The identified nonconformities shall not be closed during the audit. If there are still nonconformities present in the system, and the audit team finds them, they must record them. So if a corrective action has been initiated, and correction has taken place, there would be no nonconformity - even if the full corrective action is not complete. If the corrective action has been initiated, and the nonconformity still exists, it must be a nonconformity”.
Arios from Juarez-Chihuahua-Mexico response like this, “Corrective Actions derived from internal audits may still be open provided that the issue does not compromise registration. If for instance you have an internal audit finding and a Corrective Action open because the Management Review meetings have not been performed, then to me is a big issue and I would not take the Corrective Action as a waiver for not meeting a requirement in the management standard.
Raffy from Manila-Philippine response like this, “Hi peters, two years ago we also have the same problem as they are some NC from the internal audits were not closed. This was noted by our CB during our pre-assessment audit and likewise suggests that these items should be immediately addressed by our organization. As regards to the problem, during the certification audit, there also some NC that were not closed and status were not indicated, that's why it was called out against the requirement of the clause 8.2.2 & 8.5.2.1 of ISO/TS16949. Lesson learned, there should be a status of each NC and these should be tracked and monitored. If these are not yet finished and remain Open. Escalation Process must be immediately implemented”.
And I was resuming that stated opinion like this, “I think that is no problem if you have a complete planning about the corrective action. That is including the monitoring of your corrective action progress. And I think that was an excessive finding if that is as a nonconformity. It should be an observation finding not a minor or major finding”.
The question is like this. “Internal Audit Nonconformance/NC is not closed, is it a nonconformity at CB assessment? “ He also explained like this. “These were some minor nonconformity from latest internal audits. Some (only some!) corrective actions began but are not finished and closed. Lead Auditor from CB had doubts that he can accept this. He was not sure it conforms to the requirements. We couldn't find in rules any information about such problem. Do internal audit nonconformities have to be closed before certification audit? Organization began corrective actions but these actions are not closed. Is there any requirement in Rules that this situation is nonconformity in certification audit?”
Several in the cove have answered this question.
Stijloor from North Caroline as the forum moderator’s was response like this. “No not necessarily. The corrective action may have to be monitored for a while to demonstrate its effectiveness before a CAR can be (finally) closed. Your CAR log should show the status of the CAR. Inactions (delays, etc.,) are bad”. He also told, “Now, if the Certification Body's auditor issues nonconformity, then it must be closed within a pre-determined time limit. In other words, a certificate of registration can not be issued unless all NC's have been closed to the satisfaction of the CB”.
Trainerbob from Michigan, USA response like this, “There should be no problem with a third party auditor and a corrective action for an internal audit problem as long there seems to be a reasonable plan in place to eliminate the problem and verify the effectiveness of it. If there is no reasonable plan in place to solve the problem, then the third party auditor would probably have a probably have a problem. As Stiljoor said there is a difference between a corrective action from an Internal Audit and a third party audit. Your third party auditor or his/her organization will have guidelines that they use for the closing of non-conformances found during their audits.
Spartan Kim as Shy poster at Elsmar.com response like this, “I agree with Stijloor and would say the requirement is implied. If an internal audit nonconformance is about a requirement of a standard that is not being done, then that certainly would create a new nonconformance at registration audit time from the registrar. But a departure from an internal, documented process that shows progress in meeting the target completion date (as opposed to no progress for days or weeks) should not create a new nonconformance from a registration audit”.
Sidney Vianna from Long Beach, California response like this, “I don't have my copy of the IATF rules handy, at this moment. So, I can not answer for sure if under the IATF rules that would be a nonconformity or not. But, if this was an ISO 9001 audit, conducted under the requirements of ISO 17021, I would have to ask you further questions. For example, are ALL corrective actions emanating from your internal audit process unresolved/open? If that were the case, how can an external auditor assess the effectiveness of your corrective action process? Further, since results of internal audits and status of corrective actions should be part of your management review, can an external audit assess if your management review activities are done? If we were to assume that a percentage of your corrective actions, originated from your internal audit were "closed" and the external auditor can verify the process is working, I would emphatically agree that there is no requirement mandating all corrective action requests to be closed, prior to the certification audit. However, if NONE of the actions have been closed, verified for implementation and effectiveness, myself as an auditor could not attest that a key process of the QMS, namely the corrective action process, is effectively implemented”.
Howste from Utah response like this, “The Rules are not specifically mentioned what you are talking about. Originally Posted by TS Rules 3rd Edition, the audit team shall record all findings of nonconformity when detected and identify the nonconformities to the client. The identified nonconformities shall not be closed during the audit. If there are still nonconformities present in the system, and the audit team finds them, they must record them. So if a corrective action has been initiated, and correction has taken place, there would be no nonconformity - even if the full corrective action is not complete. If the corrective action has been initiated, and the nonconformity still exists, it must be a nonconformity”.
Arios from Juarez-Chihuahua-Mexico response like this, “Corrective Actions derived from internal audits may still be open provided that the issue does not compromise registration. If for instance you have an internal audit finding and a Corrective Action open because the Management Review meetings have not been performed, then to me is a big issue and I would not take the Corrective Action as a waiver for not meeting a requirement in the management standard.
Raffy from Manila-Philippine response like this, “Hi peters, two years ago we also have the same problem as they are some NC from the internal audits were not closed. This was noted by our CB during our pre-assessment audit and likewise suggests that these items should be immediately addressed by our organization. As regards to the problem, during the certification audit, there also some NC that were not closed and status were not indicated, that's why it was called out against the requirement of the clause 8.2.2 & 8.5.2.1 of ISO/TS16949. Lesson learned, there should be a status of each NC and these should be tracked and monitored. If these are not yet finished and remain Open. Escalation Process must be immediately implemented”.
And I was resuming that stated opinion like this, “I think that is no problem if you have a complete planning about the corrective action. That is including the monitoring of your corrective action progress. And I think that was an excessive finding if that is as a nonconformity. It should be an observation finding not a minor or major finding”.
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1 comment:
The weight of the problem will depend on the effect of the product to your client. This will be the deciding factor for the call out.
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