What does a good business practice Process Audit look like for AS9100D?

Audit Coordinator

Involved In Discussions
#1
Hello,
We currently are going through our surveillance audit for AS9100D upgrade. Yesterday, she examined our internal audits. Our previous way of doing process audits did incorporate the use of a checklist but not with yes/no answers - answers required had to be more in depth. Since the transition, I have changed our audits to a more open audit format, just listing the pertinent clauses at the top of the audit that an auditor should consider investigating,creating an audit trail, using turtles or following the inputs and outputs etc.

Well, she didn't like either approach and didn't suggest how we should go about auditing (they can't consult after all). So I'm at a loss of what a good process audit should look like. If anyone can share what their template looks like, perhaps I can make it work here. I'm not getting any support from my manager as she knows less than myself on these matters - she's new (two months) at first time being a Quality Manager.
Thanks for any help you can provide, members! :cfingers:
 
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John Broomfield

Leader
Super Moderator
#2
Hello,
We currently are going through our surveillance audit for AS9100D upgrade. Yesterday, she examined our internal audits. Our previous way of doing process audits did incorporate the use of a checklist but not with yes/no answers - answers required had to be more in depth. Since the transition, I have changed our audits to a more open audit format, just listing the pertinent clauses at the top of the audit that an auditor should consider investigating,creating an audit trail, using turtles or following the inputs and outputs etc.
Well, she didn't like either approach and didn't suggest how we should go about auditing (they can't consult after all). So I'm at a loss of what a good process audit should look like. If anyone can share what their template looks like, perhaps I can make it work here. I'm not getting any support from my manager as she knows less than myself on these matters - she's new (two months) at first time being a Quality Manager.
Thanks for any help you can provide, members! :cfingers:
Dear Audit Coordinator,

Apart from making sure your organization is effective in fulfilling its objectives you are also sampling the organization’s processes to see how well they fulfill their process objectives.

Your auditors are selected for their attributes (see ISO 19011) and then trained and coached for competence in planning audits, engaging auditees, sampling evidence of conformity, effectiveness and, where necessary, invoking corrective action and verifying the evidence of effective corrective action.

As audit coordinator you determine or deploy an objective (or two) for each audit before briefing the auditor. You may ask to see their audit plan before they engage the auditee until you are confident in their audit planning competence. Expect to see timings, what they will sample (you may ask why and how) and who they will talk too and for how long.

Do not look for clauses or closed questions.

Make sure they have the confidence to audit managers for their effective planning, resourcing and supervision of process teams. Try not to allow managers to delegate their supervisory responsibilities to your auditors!

Coach then to engage auditees by showing a genuine curiousity in what they do, how and why. They should take notes openly so the auditee can help them capture the facts correctly. Encourage them to let the auditee see any nonconformity for themselves when compared with the requirement.

Require them to report each nonconformity clearly, correctly and completely by stating:

A. The nature of the nonconformity.
B. The evidence of the nonconformity.
C. The applicable requirement.​

They may also record any reasons stated by the auditee for disagreeing with any nonconformity.

Show then how to report their audit against its objective with the findings (including the positive facts) and conclusion that addresses the audit objective.

With process audits, reserve referring to clauses from the standard until reporting item C. above in the Corrective Action Request form. Your system audits will already have confirmed conformity of the management system to AS9100D and any other applicable standards.

Your question suggests to me that you need more training before you master auditing so you can train others.

Forgive me if I’m wrong,

John
 
#3
Hello,
We currently are going through our surveillance audit for AS9100D upgrade. Yesterday, she examined our internal audits. Our previous way of doing process audits did incorporate the use of a checklist but not with yes/no answers - answers required had to be more in depth. Since the transition, I have changed our audits to a more open audit format, just listing the pertinent clauses at the top of the audit that an auditor should consider investigating,creating an audit trail, using turtles or following the inputs and outputs etc.
Well, she didn't like either approach and didn't suggest how we should go about auditing (they can't consult after all). So I'm at a loss of what a good process audit should look like. If anyone can share what their template looks like, perhaps I can make it work here. I'm not getting any support from my manager as she knows less than myself on these matters - she's new (two months) at first time being a Quality Manager.
Thanks for any help you can provide, members! :cfingers:
Firstly, you don't need to do anything. It's NOT your auditor's job to LIKE anything you do. It's simply a case of what you do being effective. The question becomes, show me that your audits are EFFECTIVE. You might want to ask yourself, how do I know my audits are effective? Forget doing something different for someone who isn't a good CB auditor. If you want to improve your audits, THAT'S your goal.
 

Audit Coordinator

Involved In Discussions
#4
Thanks Andy, I feel I have more confidence with pursuing what will really be effective regardless of what some picky CB auditor wants. We will be auditing in a process oriented way but I still want to put the clauses that will be applicable to each process on the top of the form, just to be sure that all my auditors don't overlook items that need to be touched upon. We will be auditing to a turtle, and the CB seems to accept that instead too.
Last year, the same CB auditor loved my audit templates but did ask me to put what clause the questions drew from and this year, she had dove off the other end - and completely doesn't wish for us to have any pre-made questions to ask. So fine!

The first response from John, above, I feel went off into another tangent as I didn't ask anything about auditor training as our auditors have all been through process audit training and the upgrade standards training as well.

I really dislike the variability that happens between different CB auditors of what they feel is acceptable- makes me crazy! :frust:
 
#5
Last year, the same CB auditor loved my audit templates but did ask me to put what clause the questions drew from and this year, she had dove off the other end - and completely doesn't wish for us to have any pre-made questions to ask. So fine!

I really dislike the variability that happens between different CB auditors of what they feel is acceptable- makes me crazy! :frust:
Good grief! Are you kidding? No, wait! I've heard similar things from others...:bonk:

PM me your email and I'll share a template which has been used by folks who prefer it to the (odious) turtle...
 

John Broomfield

Leader
Super Moderator
#7
Thanks Andy, I feel I have more confidence with pursuing what will really be effective regardless of what some picky CB auditor wants. We will be auditing in a process oriented way but I still want to put the clauses that will be applicable to each process on the top of the form, just to be sure that all my auditors don't overlook items that need to be touched upon. We will be auditing to a turtle, and the CB seems to accept that instead too.
Last year, the same CB auditor loved my audit templates but did ask me to put what clause the questions drew from and this year, she had dove off the other end - and completely doesn't wish for us to have any pre-made questions to ask. So fine!

The first response from John, above, I feel went off into another tangent as I didn't ask anything about auditor training as our auditors have all been through process audit training and the upgrade standards training as well.

I really dislike the variability that happens between different CB auditors of what they feel is acceptable- makes me crazy! :frust:
Audit Coordinator,

Your frustration seems to be result of you being eager to please your CB’s auditors.

Instead, explain how your audits benefit your organization and satisfy the requirements of the standard.

By explaining and defending the effectiveness and conformity of your audits, with evidence, you’ll probably find that your CB’s auditors are remarkably consistent.

Best wishes,

John
 

Audit Coordinator

Involved In Discussions
#8
Audit Coordinator,

Your frustration seems to be result of you being eager to please your CB’s auditors.

Best wishes,

John
Well I sure wouldn't want to "displease" them after all, the internal audit program received a minor nonconformance.....:mad:but that's all water under the bridge. This auditor cannot even be consistent. She's the one last year that asked me to align each question with the appropriate clause. And now she doesn't even want to see any questions. THEN, she has the gall to ask me if my auditors asked the questions if the employees were aware of the requirement that they know the ethical standard and if they know what their role is in product safety. Sounds like that's asking questions to me - so what, we just can't have those questions written down like on a short checklist? Come on, which way is it!
So, I'm just going to send my auditors out on the floor with the standards and blank sheet of paper.
I need to find a new career. :truce:
 

John Broomfield

Leader
Super Moderator
#9
Well I sure wouldn't want to "displease" them after all, the internal audit program received a minor nonconformance.....:mad:but that's all water under the bridge. This auditor cannot even be consistent. She's the one last year that asked me to align each question with the appropriate clause. And now she doesn't even want to see any questions. THEN, she has the gall to ask me if my auditors asked the questions if the employees were aware of the requirement that they know the ethical standard and if they know what their role is in product safety. Sounds like that's asking questions to me - so what, we just can't have those questions written down like on a short checklist? Come on, which way is it!
So, I'm just going to send my auditors out on the floor with the standards and blank sheet of paper.
I need to find a new career. :truce:
Audit Coordinator,

I feel your pain. But you must stay true to yourself instead of being blown around by asking for an auditor’s opinion.

Never ask an auditor for their opinion; it may be taken as evidence of your lack of confidence (which is at the heart of quality assurance).

You’ve provided evidence that the CB’s auditing is focusing on matters other than the requirements and evidence of effectiveness.

Either ask for your CB to replace your auditor or stop playing their game.

No need to find a new career.

John
 

Audit Coordinator

Involved In Discussions
#10
John,
The good news is that this CB auditor just did her last audit - she's retiring now so she won't be putting anyone else through this anymore including us!
I just want to say that I really appreciate those who gave advice or their opinions here. I don't feel so all alone in this business and it's comforting to know I have somewhere to turn for suggestions. support, and what not.
:thanx:
 
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