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An ISO/TS16949 Registration Maintenance Diary

So, another registrar that adds an hour to the schedule for each nonconformity. Do you feel it's justified?
Justification doesn't have anything to do with it:

AUTOMOTIVE CERTIFICATION SCHEME FOR ISO/TS 16949:2002 said:
Annex 3 Audit days for certification to ISO/TS 16949:2002, Requirements on audit days

3. On-site review of corrective actions arising from previous audits will be additional to the specified audit days.
 
Elsmar Forum Sponsor
Maybe I should complain some more. The rules say that my total number of surveillance days should be 3.5 over the next two years. Then it says the surveillance audits should be equal duration and rounded up to the nearest half day. So, each audit should be 1.75 days, rounded up to 2, so that leaves .75 days or 2 hours during the 2 days to cover the previous 4 (nitpicking non-) findings. You know I'm going to have to pay an overnight expense and 4 more hours for that last 1/2 day.
 

howste

Thaumaturge
Super Moderator
When I do 3rd-party TS audits, I don't get paid for the additional time to close minor nonconformities. I may work a longer day for a day or two to get them done, but that's just part of the gig. I've never stayed an extra day and the client has never had to pay for it.
 
I have received notice from my registrar, DNV, that I am scheduled for 2.5 days of surveillance audit the week of 4/20/09, another 2 days the week of 4/19/10, with our recert audit the week of 4/18/11. We are also scheduled to have the original auditor that we vetted perform the surveillance, replacing the auditor that performed the recertification audit (see above).

In other news, AIAG just socked me $225 for: ISO/TS 16949:2002 Automotive Certification Scheme - Rules for Achieving IATF Recognition (Third Edition), Advanced Product Quality Planning & Control Plan (Second Edition), and Potential Failure Mode and Effects Analysis (Fourth Edition).

Not to be outdone, I just spend $195 at ASQ for: ANSI/ISO/ASQ Q9001:2008 Quality Management Systems – Requirements and ANSI/ISO/ASQ QE19011S-2008 Guidelines on Quality and/or Environmental Management Systems Auditing – U.S. Version with Supplemental Guidance Attached.

What a racket.
 

Stijloor

Staff member
Super Moderator
In other news, AIAG just socked me $225 for: ISO/TS 16949:2002 Automotive Certification Scheme - Rules for Achieving IATF Recognition (Third Edition), Advanced Product Quality Planning & Control Plan (Second Edition), and Potential Failure Mode and Effects Analysis (Fourth Edition).

Not to be outdone, I just spend $195 at ASQ for: ANSI/ISO/ASQ Q9001:2008 Quality Management Systems – Requirements and ANSI/ISO/ASQ QE19011S-2008 Guidelines on Quality and/or Environmental Management Systems Auditing – U.S. Version with Supplemental Guidance Attached.

What a racket.
Icy,

Now, considering all this great wisdom for such little money...consider it a steal! :lol:

Stijloor.
 
I have my brand new copy of ISO9001:2008 and here are the changes I will be making to the operation of my quality management system: none.

Here are the changes that I will make to my procedures manual the next time I open an engineering change order:
  • 6.3 Change the wording in our procedure to include "information systems" after "such as communications." Our IT guy has always had acceptable answers so I'll not write another useless procedure.
  • 8.1 Add "to requirements" after "Demonstrate conformity of our products/services. Why not make it clear(er)?
  • 8.2.2 Under my Supporting Document Reference section for Measurement, Analysis and Improvement, change ISO/TS16949:2002 and ISO19011:2002 to ISO/TS16949 and ISO19011, respectively. I'm not sure how I missed this little piece of future proofing the first time around.
I already had "determine" for all the places where "identify" has been changed and "statutory" where it has been added :magic:

Also, after a careful reading of the changes in clause 2, I know why I didn't get dinged by my ultra-picky auditor for my outdated ISO9000:2000 copy of the vocabulary: "For dated references, only the edition cited applies." I'm missed that, too, and the old version said the same thing in a lot more words.
[Tongue-in-cheek]Now, the old version also encouraged us to seek out and apply the most current version. Since we are no longer encouraged to do so, and the new statement says "only", should I assume that I will be N/C'd for using a newer version of the vocabulary.[/tongue-in-cheek]
 
Update time:

Internal Audit and Management Review both during the week before Christmas. Three OFIs and two CAs from Internal Audit and a few clarifications as action items from Management Review not worth going into here.
OFIs:
Standard finding for typographical errors and/grammar in procedures.

Workplace Organization in our Service area.

While verifying corrective action on the Section 7.6 finding on anti-tamper from post 90 above comes the suggestion that we remove the anti-tamper stickers from the outside, where they must be removed to change the batteries, and put them over the adjustment screw inside so that they don't need removed to change the batteries. And that's why our internal auditor gets the big bucks.

The single NC was a two-fer regarding supplier monitoring:
One, Materials Team purchasing from unapproved suppliers; and two, inadequate controls to prevent Materials Team from purchasing from unapproved suppliers. This finding was on seldom used supplier that makes bench parts like backers, lights, etc. and not a production parts supplier. Corrective Action:
Training session with all Materials Team to go through our Product Realization - Purchasing procedures again.
Rework the Purchase Order Form so that it prints "SUPPLIER NOT APPROVED - DO NOT USE" in big letters if the supplier is not approved.
Spend the last three months going through our approved supplier list with a fine-tooth comb, updating ISO certs, performing supplier evaluations on those that had slipped through and explaining to our Finance Team that "just because there is a typo on the Supplier Evaluation Form (real excuse) does not mean that you don't send it to new suppliers or fail to tell me that you are entering a new supplier into our system."

Finally, another Management Review in March with the standard atta-boys and investigations in detail on a couple of items Management found interesting. During our Audit of Internal Audit (my VP of Sales finds that to be evidence that this Quality stuff is nuts), we found a couple more dated references to ISO9001 and TS16949 in the Measurement, Analysis and Improvement Procedure. Dagnabit, I thought I got all those in the last post. I have somewhat of a reprieve: my DNV auditor's schedule requires that we move our surveillance audit to the third week in May, boo-hoo.:crybaby:
 
DNV's Periodic Audit of our recertified Quality Management System for 2009 is now complete.

We had 3 days with a wonderful auditor from DNV. Some of the positives noted included:
Our production folks are extremely knowledgeable and are very versed in getting from the physical work they are doing back to the drawings, procedures and polices that tell them how and why to do it.
Our Product Development Control Process is commendable. The records for our most recent product release are so clear and organized that one of our new engineers ran through it for the auditor, since all of our project managers were out of the building.
All of the findings from all 2008 audits were reviewed and found to be effectively closed.

Only one finding against Document Control, Control of Non-Conforming Product and Corrective Action (a 3-fer!).

Corrective Action Finding
We have a Supplier Action Request Form, with database. We use this to document single defects or returns even if we did not require corrective action as well as to document larger issues where we require Corrective Action. That's why it's call supplier "ACTION". There is a box to fill in a due date if corrective action is required. Unfortunately, somewhere along the line, our traffic manager started putting dates in the box even when the only action was a credit for the defective part.

Control of Non-Conforming Product
Some time ago, our Materials Team was urged to use their team meeting to review, update and close Supplier Action Requests in a timely manner. They found this to be such a good idea that they added a Part Action Form to track every single defective part until we had a resolution, whether it was credit, replacement, and/or corrective action. Unfortunately, the form comes with no instructions so the control is kind of fuzzy and records are a mess.

Document Control
I hope you can see this one coming. The new Part Action Form is not controlled, obviously. The instructions and form called out in the Control of Non-Conforming Product procedure is a Return to Supplier Form, a predecessor and very similar to the new Part Action Form.

The fix is rather simple:
  • Tighten up the procedure to use the Supplier Action Form only when Corrective Action is required.
  • Modify the Control of Non-Conforming Procedure to call the new Part Action Form when we do not request corrective action and include instructions.
  • Create a Part Action Form Database and add this form to our released forms.
  • Training all around for the users of the SAR Form and the PA Form.

A very good audit overall considering that since our recert 1 year ago:
  • The only training, coaching, or realignment of people to procedures has been to answer the findings from the recert audit and the two internal audits (see above).
  • The quality manager (me) was on medical leave for 3 months.
  • We do no special clean up before audits. We just do what we do.
 
Here's the original wording for the finding above:

ISO 9001:2000 / ISO/TS 16949:2002
8.3 / 4.2.3 / 8.5.2
Control of Nonconforming Product / Document Control / Corrective Action
Finding:
Requirement: a) Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. b) Documents shall be controlled. c) A documented procedure shall be established to define requirements for corrective action.
Failure: a) Part Action Forms are not always being completely filled-out (e.g.: Return Information section). Procedures do not clearly describe the process for handling supplier rejects. b) Documents are not always controlled. c) Supplier Action Responses are not always being received by the response due date stated on the Supplier Action Request, including root cause. Corrective Action Procedures do not clearly define the process for issuing and verifying supplier corrective actions.
Evidence: a) Based on a review of Part Action Forms. Reference Measurement, Analysis & Improvement Procedure Rev 4/15/09. b) Part Action Form is not a controlled document. c) SAR #'s 2009-0615, 2009-0668, 2009-0672 show no evidence of response from the supplier and these SAR's have been closed. Reference Measurement, Analysis & Improvement Procedure Rev 4/15/09.

I'll leave the summary above stand as my answers are in the form of a novelette.
 
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