CAR from 3rd party AS9100D auditor - Root cause dilemma

[AndyN]

Short explanation. Had transition AS9100D audit, finished last Friday. We had not audited to the new standard. Received a minor nonconformance for not auditing to the new standard. Internal CA issued for me to address.

Can I ask how the wording of the non-conformity was phrased? I cant find a requirement "to audit to AS9100D"...

 

[Audit Coordinator]

This thread has been fascinating to me as I am a ISO9001, IATF16949 quality guy and have zero experience in the implementation and maintenance of the AS standard.

Looking as an outsider it seems you know exactly what happened and have the evidence to prove it i.e. your previous QM made the decision to stay with the old standard until the end of the financial year and then transition to the new standard in the next financial year. This was the incorrect decision, as you were going to be audited against the new standard before this transition took place.

So as far as I can see you have two failures here , one in planning and one in communication. I don’t think you have a failure in understanding the requirements as they were known and ignored, so I believe your best route for your non-conformance and corrective action(s) is to go down the planning and communication route. Would you get away with a small amendment to your internal audit procedure to say that they must be conducted to an new standard, to cover all new requirements X months before CB transition?

As always, please feel free to shoot be down in flames if you disagree or I am fundamentally missing something.

Hi Scanton,
I appreciate your input. I had to submit my responses yesterday to my Quality Manager and she approved it so I submitted it to the CAR system coordinator. Thanks to all the help I received here, it was a very professional answer and I believe will be accepted by the CB auditor.

I think when you state, "I don’t think you have a failure in understanding the requirements as they were known and ignored" I presume you mean they were ignored by the old QM, as I only listened to him and he convinced me that what we were doing was going to be acceptable.

NOW, I love your suggestion about the amendment! It just so happens that I am creating a new internal audit procedure right now and so it's the perfect time to put that in there and submit that too in the CAR for the preventive action field as an attachment of evidence. What a great idea and it couldn't have come at a better time

Now on to the next project, getting all my auditors and auditors "wanna be" trained and retrained to the new standards and get some audits completed before she returns for the follow up in June. Then I off for two months for surgery to have my left hip replaced!

You all are just the best love you and this forum!

 

[Audit Coordinator]

Can I ask how the wording of the non-conformity was phrased? I cant find a requirement "to audit to AS9100D"...

Hi Andy,
No problem. Here is the exact wording:
During an AS9100D surveillance audit conducted the week of April 16, 2018, the following minor finding (JG-01) was made: Statement of nonconformity: Requirement 9.2.1: The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system (a) conforms to: 1. the organization's own requirements for it quality management system, and 2. the requirements of the AS9100D (this international standard). Objective evidence: No evidence was provided to show that all requirements of the Purchasing process (ie: 8.4.3) and all QMS requirements of AS9100D Section 4, 5 and 6 were audited. Internal audit procedure QP9-005 details use of Internal Audit Record QF1-1600. This Audit Record is currently not in use.

 

[Bob Z]

Short explanation. Had transition AS9100D audit, finished last Friday. We had not audited to the new standard. Received a minor nonconformance for not auditing to the new standard. Internal CA issued for me to address.

I am the audit coordinator. Last year, January thru May, our Quality Manager, myself, and two others completed the transition classes. No mention in this class as to when we were supposed to change over our audits to the new standard. Quality Manager and the other two auditors completed audits to the old standard (including self). No mention to me about auditing to the new standard from the Quality Manager although I asked him and he told me that we could start auditing to the new standard with the new FY2019 audit schedule which started this month. Quality Manager retired in February.

Now, I am struggling with how to address the root cause and preventive action for the CA. I don't think it is appropriate to blame the old QM but it was lack of communication or incorrect communication that caused this issue. I was enlightened about two weeks ago that the QM knew we were supposed to upgrade last year - don't know if he neglected to tell me due to vindictive reasons as he was very frustrated with the lack of manager support for QA or what. :mg:

So, how does one report such a root cause and how does one go about responding to the preventive action being that this type of thing only comes around every 10 years?

I'm not well experience with all things quality as I've only been working in quality six years and have learned everything I know from reading and this forum. I do know that we usually try to keep people's names out of the CA and direct towards system failures and such.

Thanks in advance especially for this self taught, up from the ranks employee.

In my opinion, yes, you need to identify the root cause and the Corrective Action. That said, I think keeping it simple and understandable is the key. ie. Root cause: Lack of proper training and communication from former QM. Corrective Action: All involved staff trained to new standards. Date, & VOE of training. That is how I would approach it. However, I have only been through 1 audit myself and not in a managerial role. So this is just my opinion.

 

[dsanabria]

Short explanation. Had transition AS9100D audit, finished last Friday. We had not audited to the new standard. Received a minor nonconformance for not auditing to the new standard. Internal CA issued for me to address.

I am the audit coordinator. Last year, January thru May, our Quality Manager, myself, and two others completed the transition classes. No mention in this class as to when we were supposed to change over our audits to the new standard. Quality Manager and the other two auditors completed audits to the old standard (including self). No mention to me about auditing to the new standard from the Quality Manager although I asked him and he told me that we could start auditing to the new standard with the new FY2019 audit schedule which started this month. Quality Manager retired in February.

Now, I am struggling with how to address the root cause and preventive action for the CA. I don't think it is appropriate to blame the old QM but it was lack of communication or incorrect communication that caused this issue. I was enlightened about two weeks ago that the QM knew we were supposed to upgrade last year - don't know if he neglected to tell me due to vindictive reasons as he was very frustrated with the lack of manager support for QA or what. :mg:

So, how does one report such a root cause and how does one go about responding to the preventive action being that this type of thing only comes around every 10 years?

I'm not well experience with all things quality as I've only been working in quality six years and have learned everything I know from reading and this forum. I do know that we usually try to keep people's names out of the CA and direct towards system failures and such.

Thanks in advance especially for this self taught, up from the ranks employee.

You have describe the root cause very nicely (copy Paste) do a gap analysis and audit the difference.

 

[Sidney Vianna]

do a gap analysis and audit the difference.

That's correction, not corrective action.

 

[dsanabria]

That's correction, not corrective action.

Actually it's neither - its a way to get over the hump and then use any quality tools (such as 5 why, 8D...) to implement an effective corrective action and one that will ensure that this does not happen again.

At the end of the day - they concepts intertwine with each other and a better process is developed and implemented.

 

[Sidney Vianna]

Actually it's neither

So what would you offer to be entered in field 20 of the CAR form?

 

[dsanabria]

So what would you offer to be entered in field 20 of the CAR form?

2 items -

First - how this was corrected

second one - What is the company going to do to prevent this from happening again i.e. better plan, training, schedule - effective auditing to all requirements according to the companies established requirements.

 

[Sidney Vianna]

First - how this was corrected

That is called CORRECTION....

second one - What is the company going to do to prevent this from happening again i.e. better plan, training, schedule - effective auditing to all requirements according to the companies established requirements.

That is called CORRECTIVE ACTION, to be entered in field 25 in the form. Which MUST address the identified ROOT CAUSE for the nonconformity.