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  #65  
Old 14th June 2007, 01:00 PM
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Re: An ISO/TS16949 Registration Maintenance Diary

We assign another designate.

My former president (during the implementation project) and current investor/CEO absolutely cannot/will not tolerate the standard organizational chart that would allow your solution.

We have a couple of gate keeping functions in the QMS that are assigned very specific authority and responsibility. The job descriptions for them were already written, we just needed to make them generic enough that we don't have to change the Procedures Manual every time a title changes or we want to move the responsibility to another individual who may not necessarily be the "Director of Engineering". Think of this like the Management Representative, they don't have to have a specific title, or fit in the org. chart except "executive management" but they do need to be clearly identified somehow.

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  #66  
Old 14th June 2007, 01:12 PM
Helmut Jilling Helmut Jilling is offline
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Re: An ISO/TS16949 Registration Maintenance Diary

Quote:
In Reply to Parent Post by Icy Mountain View Post

There is a lot of point if your standard customers are 95% of your business and your TS customer is 5%. I have a number of customers that couldn't care less whether I am registered or not, TS or ISO, etc. I run my ISO9001 system for them. I have several product lines that cannot be encumbered by the additional TS requirements (like manufacturing process audits or product audits) because my customers won't pay for them.

Sure, but you can just write that into your procedure. TS would in effect be a customer specific requirement for the automotive specific product. The rest of the product would not apply certain procedural requirements. But, you don't have to maintain a separate cert or system (as your previous post explains very well.)

If you prefer to run two systems, that would be OK too, but then you may need two certs.

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  #67  
Old 14th June 2007, 01:14 PM
Helmut Jilling Helmut Jilling is offline
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Re: An ISO/TS16949 Registration Maintenance Diary

Quote:
In Reply to Parent Post by Icy Mountain View Post

We assign another designate.

My former president (during the implementation project) and current investor/CEO absolutely cannot/will not tolerate the standard organizational chart that would allow your solution.

We have a couple of gate keeping functions in the QMS that are assigned very specific authority and responsibility. The job descriptions for them were already written, we just needed to make them generic enough that we don't have to change the Procedures Manual every time a title changes or we want to move the responsibility to another individual who may not necessarily be the "Director of Engineering". Think of this like the Management Representative, they don't have to have a specific title, or fit in the org. chart except "executive management" but they do need to be clearly identified somehow.

I think this approach as described would be a fine solution.

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  #68  
Old 14th June 2007, 01:22 PM
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Re: An ISO/TS16949 Registration Maintenance Diary

Quote:
In Reply to Parent Post by hjilling View Post

Sure, but you can just write that into your procedure. TS would in effect be a customer specific requirement for the automotive specific product. The rest of the product would not apply certain procedural requirements. But, you don't have to maintain a separate cert or system (as your previous post explains very well.)

If you prefer to run two systems, that would be OK too, but then you may need two certs.
I actually only run one system, applying the extra TS requirements only to the processes/products as required by the customer. I actually have a customer that wants me to have an ISO9001 cert. as they are not "automotive". The extra $$$ for the ISO cert is a drop in the bucket compared to the cost of maintaining TS registration.
Quote:
In Reply to Parent Post by hjilling View Post

I think this approach as described would be a fine solution.
Thank you, the check is in the mail.

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  #69  
Old 21st June 2007, 01:25 PM
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Re: An ISO/TS16949 Registration Maintenance Diary

Periodic Audit #4 for the last two days. Results:
Positive Indicators:
Scorecards from customers are acceptable. PPM & delivery.
Internal metrics meeting company goals: KPI’s such as PPM, warranty, scrap, On time delivery, productivity, cycle count & financial data show positive trends.
Internal audit, corrective action system, & CI projects.
Team scoreboards , visual controls, & teamwork.
New product & technology, & marketing developments
Employee recognition, & communications

Main areas for improvement:
NC#1 Design change validation (7.3.6)
Requirement: Design changes shall be reviewed , verified , and validated, and approved before implementation. Records of results of reviews and necessary actions shall be maintained.
Failure: Not all design changes are fully recorded & validated , including actions before releasing to production.
Evidence: Units with incorrect error message drove an ECO 123 and change in Final test. The ECO does not describe the actions required before releasing to production, (e.g. validation of final test, work instruction update). The production line did not have record of authorization or updated instruction for final test on line. The test equipment was validated by EE and work instruction is currently being revised, but authorization of new final test was not on the line. The operator was testing it according to the ECO criteria for proper simulation.

NC #2 Work instruction availability
Requirement: Shall prepare work instruction & be accessible at work station
Failure: Work instructions are not always up to date with ECO requirements
Evidence: Final test work instruction was not updated for the ECO 123 test to simulate AGSP error codes. Note: an 8D was in place at this time and on line testing was being performed correctly.

OFI #1 Improve documenting target completion dates for action items on team meeting minutes

ARRGH!!! Two findings generated by the same Corrective Action that was implemented to detect the one failed diode out of 125,000 that we used last year.

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  #70  
Old 21st June 2007, 01:41 PM
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Re: An ISO/TS16949 Registration Maintenance Diary

For NC #1, We have a software simulator for the customer's computer. Said simulator was developed and validated for use in the original development of the product over 2 years ago. This was a brilliant idea to use it at final test to detect error codes generated by the product based on a defect rather than the actual error being physically evident. The validation of this software can be demonstrated in about 60 seconds by actually creating the conditions that cause the "error" and watching the display on the laptop turn on the little red light next to "ERROR". If only I had written down that we've done that, I would have a validation record.

For NC #2, We used the aforementioned software simulator to actually detect and diagnose the original defect. Of course we left it on the test bed with instructions to the technician to make sure that no red lights come on during the execution of the "official" final test. If only I would have left a copy of the 8D (that the customer accepted) with the technician at the test bed, I would have had a documented work instruction.

PS-My camping rig pulls out of the driveway at 9AM tomorrow for 75 hours of uninterrupted riverside relaxation on the Mohican River (Icy adult beverages and aluminum canoe included).

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Last edited by Icy Mountain; 21st June 2007 at 01:45 PM. Reason: added PS
  #71  
Old 18th July 2007, 01:47 PM
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Re: An ISO/TS16949 Registration Maintenance Diary

Audit findings answer emailed to RJ today. Since these two findings point at the same process change there is some overlap in the answer. I'll start with the second as it covers the first as well.

We have had a long running debate on how to cover both documented instructions, review, and approval when the change needs to be immediate but the simple fact that drawing and work instruction changes can take several days if they are to be done correctly and completely. Resorting to some complex process to allow the dreaded "mark-up and initial" was never the answer. Enter the ECO! By taking a few extra minutes to detail changes required on the ECO description page (which also contains our review and approval signatures), we end up with a reviewed, approved, work instruction modification. Since the ECO is systematic, we know that the follow-up of actually modifying and distributing the revised work instruction or drawing will be done, whereas it is very easy to forget to update Drawing XYZ from rev A to B when you just mark it up, initial and date.

In addition, with a little more effort, the person actually responsible for the ECO can jot down a few results of validating the change, sign, date, and include a copy with the ECO. All of us that write and execute change orders do validation testing to make sure that they will work. The vast majority of validation results are already recorded in lab notebooks or personal files corresponding to the ECO. Now, we're going to make a copy to include with the permanent ECO record. Actually, this will be a great defense for the age old management question: "Did you actually bother to see if it worked before you made this change?"

PS-My camping rig pulls out of the driveway at 2AM Saturday for 7 days and 7 nights of beachfront fun on the eastern shores of Lake Michigan.

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  #72  
Old 19th July 2007, 09:54 AM
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Re: An ISO/TS16949 Registration Maintenance Diary

Response received from my DNV auditor in less than one hour (gotta love those DNV guys). Audit closed!

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