An ISO/TS16949 Registration Maintenance Diary

[Icy Mountain]

I've been a bit neglectful of this thread, mostly due to limitations on my time to wade into quality stuff above and beyond turning the crank on my system. A little summary on the past 12 months:

Internal Audit in November 2009 (Production Processes):
One finding regarding the upkeep of metrics on team boards.
No big deal. I implemented a monthly QA checklist to keep track of a few things like daily ESD equipment signoffs, calibration sticker checks, metric updates, etc. that seem to be repetitive findings that could turn into major findings. I run this checklist the 3rd Monday of every month. If your board is not updated through the previous month, immediate correction is required.

ISO9001:2009 and ISO/TS 16949:2009 Awareness Training.
Ran through the "new" standards in February in a 10 minute training session. Along with a few other items, as listed by our registrar, this will allow us to update our certificates.
1) Obtain a copy of ISO 9001:2008 (do you already have a copy?)
2) Update any references to ISO 9001:2000 with ISO 9001:2008 in your Quality Manual, Procedures and Work Instructions.
3) Review the changes in ISO 9001:2008 with the organization (and have a training record of this review).
4) Management needs to review the quality system to ensure it is still in compliance with the revisions in ISO 9001:2008 (and have a record of this review).

Internal Audit March 2010 (Administrative Processes)
No findings.

 

[Icy Mountain]

DNV Periodic Audit 2010:

One finding:

ISO 9001:2008 / ISO/TS 16949:2009 Clause 7.6. Control of monitoring and measuring equipment
Requirement: The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Failure: Not all test equipment used to determine product acceptance is calibrated or verified prior to use.
Evidence: The ABC123 product tester #1 is used to perform an automated test, telling the operator whether or not the product passed the tests performed.
1) There is no objective evidence that this equipment is verified as accurate in its' ability to determine product acceptance.
2) Neither procedures nor records indicate specifically which test equipment is to be verified accurate during the team areas' routine preventive maintenance (the time at which it was presented that this equipment is verified accurate.)
NOTE: There is a specific assembly area in which the organization's one TS customer's product is assembled, and that assembly area has no such issue. This uncalibrated equipment is applicable solely to non-automotive customers.

Immediate Correction/ Containment of Specific Nonconformity

Checked ABC123Tester #1 against ABC123 specifications using calibrated equipment to assure that product is properly tested. Checked all other legacy equipment (ABC456 Tester) in the Team B area in the same manner.
Checked Production Teams C, D, E, F, J and Service to assure that there are no other testers or test equipment not validated by annual calibration traceable to NIST. Service Team also has an ABC456 Tester.

See attached "Prelimary Procedures Legacy Equipment.pdf"
See attached "Equipment Validation Report.pdf"

Root Cause

Not all test equipment used to determine product acceptance is calibrated or verified prior to use. 1Why?
Equipment is verified but procedures and records are not sufficient to provide objective evidence. 2Why?
Team B legacy equipment was designed and installed prior to quality system and PDCP implementation. 3Why?
Current documented processes require equipment calibration or validation procedures to be released along with product.

Sorry, I just couldn't make it to 5.:truce:

Corrective Action:

Survey all production Teams and Service for evidence of any test equipment that is not validated via scheduled traceable calibration to NIST.
Document validation procedures for any equipment found (See WI - Legacy Equipment Validation (06-24-10).pdf attached). Add specific equipment to Preventive Maintenance List or calibration database (See WI Preventive and Predictive Maintenance (06-24-10).pdf attached). Add records of validations to Records Matrix and document scheduled validations (See Records Matrix (06-24-10).pdf attached).

Specific evidence of Procedures Manual Changes (See 00 Table of Contents (06-24-10).pdf attached) and equipment validation records (See Test Equipment Validation Survey (06-16-10).pdf attached).

Procedures Manual Changes released 6/24/2010 via ECO 3334.

The Corrective Action plan has already been accepted and I sent off my evidence of Corrective Action today. Now, I shall go on vacation for the next 11 days.

 

[Icy Mountain]

In other news, while the TS rules require that the lead auditor change every 3 year re-certification/surveillance cycle, there is no rule that after that 3 year period that the lead auditor from a previous cycle cannot return.

One of the best auditors in the business, fair, practical, pragmatic, yet firm will be returning to assist us in maintaining our registration beginning with our second re-certification audit in May of 2011. Welcome back, RJ!

Have I really been doing this for five years?

 

[Icy Mountain]

Evidence of Corrective Action accepted and audit closed July 7 (I been busy).

 

[Adkins]

Are you aware if there is a list of TS subscribing customers? We have about 3,000 customers and just received a nonconformity on one customer specific requirement. I had no clue that we shipped to this customer. I now have a list of all our OEMs and I want to make sure I can locate all TS subscribing customer specifices.

 

[niklas]

We had our first re certification of ISO / TS i november. Result from that was 6 minor - and we are very happy for that.
Now we working on actions and we can soon get are updated certificates

 

[Adkins]

I am still looking for a reply that addresses my original question. If you have looked yourself and been unable to find one, I would like to know I'm not the only one in this boat.


Are you aware if there is a list of TS subscribing customers? We have about 3,000 customers and just received a nonconformity on one customer specific requirement. I had no clue that we shipped to this customer. I now have a list of all our OEMs and I want to make sure I can locate all TS subscribing customer specifices.

 

[howste]

I'm not aware of anyone that keeps an updated list of TS subscribing customers. A CB that I work for used to try to maintain a current list of TS customers and their customer-specific requirements documents, but it got too difficult to maintain and they stopped maintaining it.

 

[qusys]

I'm not aware of anyone that keeps an updated list of TS subscribing customers. A CB that I work for used to try to maintain a current list of TS customers and their customer-specific requirements documents, but it got too difficult to maintain and they stopped maintaining it.

Could the link of IAOB be usefull for this?

www.iaob.org <http://www.iaob.org>.

 

[Adkins]

The list contains the big ones but there are many more. I think I was looking for a magic wand and fairy dust to keep track of the updates. The list is a pain to keep up to date. I have been working on ours since 2003. Every so often a new customer creeps up.