What to expect during an ISO 9001 audit

John Broomfield

Leader
Super Moderator
All the CEO has to say:

“It is not about “passing an audit”. It is about knowing our system and defending your part of the system while helping the auditor to find any genuine weaknesses in our system. After all we want to expose any weaknesses for corrective action before they impact our customers. By the way, the best time to do that was yesterday or today.”

Obtain value from your auditor.
 

John Predmore

Trusted Information Resource
share with my team in preparation of the our stage 2 audit

I met with factory personnel a few days ahead of the audit date and gave them these tips, verbally, and then posted this list on the bulletin board.
I call it Top Ten List - Be Prepared for an Audit (with thanks to David Letterman for the format idea).
  • Straighten-up your work area. Before the audit, dispose of post-it notes, handwritten instructions, and other temporary-looking job aids. If loose tidbits of information are vital, they would be better captured in official documents.
  • Reflect on your role in the QMS. The auditor may ask your understanding of the Quality Management System or the Quality Standard, or what is our company’s Quality Policy. Not necessary to memorize it, but you should know roughly what is says and what it means in terms of your work. The auditor may ask how your work contributes to product quality, or what is the consequence if your work is not performed properly.
  • Remind yourself not to be nervous. You know your job better than the auditor does. The Quality Management Rep will be present during an interview and can provide coaching if you are stuck, or may guide the auditor to another employee better qualified to answer a question which lies outside your responsibility.
  • Pause before you answer. Make sure you understand the question. You are allowed to ask the question be rephrased if you don’t understand.
  • This test is Open Book. It is allowable to respond you don’t know, but then explain how you would get the answer. You are allowed to consult work instructions or your supervisor to answer a question, if that is what you would do if you didn't know. You should be familiar with records you access, where documents are kept, and proper operation of your equipment/ tools.
  • Don’t volunteer more information than asked for, which opens a door for more scrutiny. Auditors are trained to ask open-ended questions, which invite you to spill the beans. Don’t hand over the entire folder if a single piece of paper answers the question. Loose lips sink ships.
  • Be patient with the process. The auditor will have an agenda to follow, and may only speak to you for a few minutes. The auditor will take notes, including your name, your title, and details you spoke about.
  • Silence runs down the clock. Silence is your friend. The auditor will likely pause in the conversation to ponder your answer or consider his next question. Resist the urge to keep talking to fill the silence.
  • There are no trick questions. Be truthful. Be respectful. Be cooperative. A certified auditor follows an ethical code of conduct.
  • Smile. Smiling makes you appear confident, and makes you feel more confident. Keep calm and carry on.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I met with factory personnel a few days ahead of the audit date and gave them these tips, verbally, and then posted this list on the bulletin board.
I call it Top Ten List - Be Prepared for an Audit (with thanks to David Letterman for the format idea).
  • Straighten-up your work area. Before the audit, dispose of post-it notes, handwritten instructions, and other temporary-looking job aids. If loose tidbits of information are vital, they would be better captured in official documents.
  • Reflect on your role in the QMS. The auditor may ask your understanding of the Quality Management System or the Quality Standard, or what is our company’s Quality Policy. Not necessary to memorize it, but you should know roughly what is says and what it means in terms of your work. The auditor may ask how your work contributes to product quality, or what is the consequence if your work is not performed properly.
  • Remind yourself not to be nervous. You know your job better than the auditor does. The Quality Management Rep will be present during an interview and can provide coaching if you are stuck, or may guide the auditor to another employee better qualified to answer a question which lies outside your responsibility.
  • Pause before you answer. Make sure you understand the question. You are allowed to ask the question be rephrased if you don’t understand.
  • This test is Open Book. It is allowable to respond you don’t know, but then explain how you would get the answer. You are allowed to consult work instructions or your supervisor to answer a question, if that is what you would do if you didn't know. You should be familiar with records you access, where documents are kept, and proper operation of your equipment/ tools.
  • Don’t volunteer more information than asked for, which opens a door for more scrutiny. Auditors are trained to ask open-ended questions, which invite you to spill the beans. Don’t hand over the entire folder if a single piece of paper answers the question. Loose lips sink ships.
  • Be patient with the process. The auditor will have an agenda to follow, and may only speak to you for a few minutes. The auditor will take notes, including your name, your title, and details you spoke about.
  • Silence runs down the clock. Silence is your friend. The auditor will likely pause in the conversation to ponder your answer or consider his next question. Resist the urge to keep talking to fill the silence.
  • There are no trick questions. Be truthful. Be respectful. Be cooperative. A certified auditor follows an ethical code of conduct.
  • Smile. Smiling makes you appear confident, and makes you feel more confident. Keep calm and carry on.

As a final check, I would look at any areas that you think are weaker than others. Writing memos to file or opening CAPAs can help you if an item is in question. If a supplier audit is late, open a CAPA for it. Thats your QMS working. If the auditor asks why there wasn't an audit performed if you show him your processes caught it already that can help you.
 

Emmyd

Involved In Discussions
Funny story from a prior job - it was our initial certification audit and I had done lots of prep work in the plant (approx 275 employees) to get everyone ready for the audit. When the audit time came around, our auditor was auditing our second shift welding department. He ended up talking to all the welders on that shift (about 15 people). When he asked a certain question regarding how the employee knew he/she was making parts as intended, every single one of the people got this glassy stare, spoke in a monotone voice and answered the question the exact same way. It was like robots took over! I pulled the supervisor (who was tagging along) aside and asked what had happened to the people. He said "we locked them in a room until they could all answer this question." He had effectively brainwashed them! That was definitely NOT in my prep! It was beyond freaky, but we did pass the initial audit with only a couple of minor NC's.

Good luck with your audit!
 

Ooi Yew Jin

Starting to get Involved
For me, NC and OFI are expected in the audit and sometime we spending a lot of times to argue for reducing the number of NC and OFI in the audit. Audit from either first, second or third party should help to further improve the system, process or product/service. However, sometime management may think too many NC and OFI is not good as we are not control well.
Be open minder, we should accept the comments, findings, recommendations..... and think positive to keep improve. I believed everyone desires act for the good to the company for this.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
For me, NC and OFI are expected in the audit and sometime we spending a lot of times to argue for reducing the number of NC and OFI in the audit. Audit from either first, second or third party should help to further improve the system, process or product/service. However, sometime management may think too many NC and OFI is not good as we are not control well.
Be open minder, we should accept the comments, findings, recommendations..... and think positive to keep improve. I believed everyone desires act for the good to the company for this.

An auditor who finds no areas for improvement may feel they have not done their job. When I audit suppliers I always try to ffind some things to improve.
 

Michael_M

Trusted Information Resource
When I audit suppliers I always try to find some things to improve.

I disagree with this. If the system is working within the stated requirements, 'finding' something just to find something creates unnecessary complications. OFI are opinions and may or may not work within the system you are auditing. Discussions are fine so long as both parties know that they are discussions and not requirements. Early on, I mistook OFI for fix "by next year or else".

If there is nothing to find, report that. If you find something, report that.
 

Jim Wynne

Leader
Admin
An auditor who finds no areas for improvement may feel they have not done their job. When I audit suppliers I always try to ffind some things to improve.
Speaking with experience on both sides of this fence, when audited by a customer, OFIs were almost never welcome or useful. As an auditor myself, I audited within the scope of the audit and left everything (and everyone) else alone.
 

hoda ali

Registered
Things may have changed, but I do not remember any requirement in any standard (AS9100 may now - I don't have a copy to check) which required any employee to recite the quality policy verbatim. As I stated above, and even attached an example of, I also printed out the company quality policy, like you on standard business card stock and gave them to employees. See post #6 in this thread. In many companies they put up banners. In some every bulletin board had a copy.

What I remember being acceptable was for an auditor to ask "What does your company Quality Policy mean to you?" (this was in the TS 16949 days). I remember this because (caution - war story ahead...) I was working with what was a Borg-Warner facility which was way out in the boonies. I knew most of the employees, including most of their personalities. The auditor came to one guy who was a "griper". He always had a "bad" attitude. The auditor came around to the "What does your company Quality Policy mean to you?" question. The guy answered "It doesn't mean sh!t to me". The auditor was a bit taken aback, but due to the nature of the question he couldn't write a nonconformance. And no - The guy wasn't fired or anything. He was a known malcontent, but he really was a nice guy and he did his job well.


Never saw that. IF they know their job and how to do it, their responsibilities, documentation which affects them, they know the answer unless the auditor asks a question which is outside the employee's job and responsibilities. I have seen asshat auditors do stupid thins like ask "OK, you do this and then you do this and you give it to Joe (or Sally or - well you get the idea). What does Joe do with it?" I taught that the correct answer was the auditor would have to as Joe, that what Joe did wasn't his/her job. This also is where an "escort" comes into play, as well. Many times an employee freezes up. It is acceptable for an escort to tell the auditor that they will have to go and ask Joe.

Just some more thoughts...

thanks , really good advice
 
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