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IATF 16949 Internal Audit question - Auditor's responsibility

John H

Starting to get Involved
#1
I recently completed an internal process audit. A certified operator did not complete all required Control Plan quality checks and was not able to complete certain measurement checks/did not know how. I deemed that work order as suspect product and informed the quality manager as well as the manufacturing manager. The QM stated she would take care of the issue by quarantining the product. I decided to audit the control of suspect product. The QM never quarantined the product and it made it to the customer. At that point I stated she had to contact the customer and that the process of control of suspect product failed. Customer was never notified. During the same audit a temporary operator made product with no oversight - could not answer any questions related to the Control Plans - that also became suspect product. Same outcome - no reaction from the quality manager or operations manager and that customer was never notified as well. I was blamed for not quarantining product even though I was the auditor and I informed the correct parties - quality manager and manufacturing manager. Any thoughts?
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Based on your description of the dysfunctional approach to systems at your organization (Customer Complaint & SCAR, false data), with special emphasis to the apparent total disregard to prevention of recurrence of negative events, it seems to be hopeless. You are doing your job well, as an internal auditor, uncovering issues of significance, of relevance, but the people with the authority and responsibility to ensure the system is being followed don't seem to care. I can only think the cultural organizational mismatch towards process discipline comes from the top.

Once again, I ask: How come your IATF CB auditor never finds these "atrocities"? Is s/he this incompetent?
 

John H

Starting to get Involved
#3
You ask a very interesting question. From my perspective the CB auditors (new auditor this year) are surface auditors figuratively speaking. Handful of years ago two witness auditors were with the CB auditor and major non-conformances were written. Is it typical for CB auditors to only touch the surface? It just seems like everything is rushed - if it looks ok - move on to next area. If you are open to questions - can you give your opinion on variable x-bar and range Control Charts - the company I work for has it setup as fixed for both the specification (which is expected) and the UCL & LCL. I have never heard of the UCL and LCL being fixed but I am also not an expert. Is this a somewhat common practice - are there benefits to this? It seems that issues would significantly out weigh the benefits. I also have another questions on training for Control of Suspect Product - do you know of any articles I can read through for the best approach on how to train operators on this subject?
 

Randy

Super Moderator
#4
I don't do 16949 but I do audit. CB's auditors very seldom have enough time to get really down to the grassroots because of the total amount of a MS (& organization) that has to be sampled during an audit, and that's a fact of life. You make a basic plan that covers the "required stuff" that has to be seen every audit, and then work out from there. On a 1 day (8 hour) annual audit, how much do you think can be looked at and how deep can one go? (One day annual audits do happen as do 1.5 and 2 day audits). Even during a recertification audit (which is 2/3rds the duration a completely new certification) how much and how deep can you go in 2 days, when a percentage of the time must be set aside for opening & closing meetings, planning and report writing? At times you do have to get down and dirty so to speak, there's no way around it, and when that happens your plan can go down the toilet really complicating that audit and most likely the next with trying to squeeze everything in, reducing the amount of time across the MS and therefore reducing sample size and so on. It's challenging and it's tough. No excuses, just fact that most outsiders don't know.

Interesting, 2 witness auditors? My last AB witness audit was not too long ago for 5 days during a RC14001 recertification (headquarters of a multi-site) and I only had one auditor, excellent person, non-intrusive, a couple OFI's for our internal procedural stuff, and nothing negative to report.
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#5
Good day @John H .
You have received good feedback thus far. If it helps, remember that the requirement of an internal auditor is to ...
"...provide information..." (ISO 9001 9.2).

I can only hope you do not have responsibilities related to quality performance/customer satisfaction beyond your duties as an internal auditor. If you do not, then you are doing your job and your conscience should be clear. If you DO have those additional responsibilities, then...well, it sounds like a heart to heart with sr. Leadership and/or a potential move to an organization that has Top Management taking responsibility for the QMS (as is required by the standard).

Hope this helps.
Be well.
 

Jim Wynne

Staff member
Admin
#6
If you are open to questions - can you give your opinion on variable x-bar and range Control Charts - the company I work for has it setup as fixed for both the specification (which is expected) and the UCL & LCL. I have never heard of the UCL and LCL being fixed but I am also not an expert. Is this a somewhat common practice - are there benefits to this? It seems that issues would significantly out weigh the benefits.
If the control limits are fixed, they're not control limits, statistically speaking. Control limits are mostly useless unless they're calculated from the data, and the data has been collected in a canonical manner.

I also have another questions on training for Control of Suspect Product - do you know of any articles I can read through for the best approach on how to train operators on this subject?
It's a relatively simple matter:
  • Do containment--makes sure you locate all of the potentially suspect product, including whatever might have been shipped or might already have reached a customer;
  • Segregate and identify (mark) all suspect material;
  • Notify customers, if necessary;
  • Review the segregated material for disposition.
For the future, it's best not to mix questions on different topics. Starting a new thread for each topic, in the appropriate forum, will render the best results.
 

John H

Starting to get Involved
#7
If the control limits are fixed, they're not control limits, statistically speaking. Control limits are mostly useless unless they're calculated from the data, and the data has been collected in a canonical manner.


It's a relatively simple matter:
  • Do containment--makes sure you locate all of the potentially suspect product, including whatever might have been shipped or might already have reached a customer;
  • Segregate and identify (mark) all suspect material;
  • Notify customers, if necessary;
  • Review the segregated material for disposition.
For the future, it's best not to mix questions on different topics. Starting a new thread for each topic, in the appropriate forum, will render the best results.
Well understood. Thank you for your reply.
 
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