TS 16949 Registrar Audit Failure Modes

[Jim Wynne]

I would think that it is because 7.5.1.2- Work Instructions shall be derived from.. the control plan...The CP comes before the WI, it depends what is the meaning of derived

"Derived from" doesn't mean "verbatim copy." It means that there should be no conflict between the two with regard to customer requirements. If work instructions weren't different somehow from the control plan, there would be no need for separate work instructions. The question is one of control of the working specifications, I think, if the working specifications are different from the customer specifications

... logically why should you be able to tighten and not be able to loosen.

Because loosening would probably violate customer requirements. If the drawing says 100 +/- 10 and the control plan says 100 +/- 15, then there's a problem, assuming that there isn't a subsequent operation that addresses the final condition of the product. But if the control plan or WI says +/- 5, and the additional control doesn't add unnecessary expense, the customer's requirements are being met. No harm, no foul.

If there is a reason for the tolerances to be tightened then it should have been reflected in the FMEA and the CP! This has nothing to do with using narrowed tolerances but the justification for them.

This is an interesting point, and I think in most cases it's probably correct to assume that tolerances tightened beyond the customer requirements should be subject to some sort of review, and the FMEA process seems to be the correct place to do it. That being the case, it does seem that the tightened tolerances should be "flowed down" from the FMEA, and not arbitrarily assigned at a subsequent level. So I'm agreeing with Howard here, and probably the auditor, as there seems to be a system disconnect with regard to control of working specifications.

 

[Helmut Jilling]

The reason the WI’s have tighter tolerances is not that the process requires it, but to make sure our actuals really fall within the tolerance of the CP. ...

That’s the reason we had the tighter tolerances on the WI’s, and I had no idea it would be considered a nonconformance. The auditor’s reasoning was “The control plan is like your Bible, you have to follow it.”

My thought was “The Bible says don’t drink alcohol in excess, but if a family doesn’t believe in drinking alcohol at all, they are going to ****.” I kept my little mouth shut though.

I really don’t mind that we got the minor, as some of the WI specs just didn’t match. But I was surprised to hear from the auditor that we would have gotten it just for the too-tight specs.

I believe the auditor may be wrong. If, having different specs were an oversight or error, then the Engineering Process is not in control, then it should be a NC. However, it sounds like you intentionally chose to tighten the spec for valid reasons. (Jim Wynne's post clearly explains in more detail on this.) Certainly, you can purposefully make it tighter, and that should not be an NC. The PPAP manual even mentions that as a "does not need to inform the customer" item.

That leaves the variable as to whether it has to be in the CP to be in the WI. The standards do not go to that level of detail. IF it is in the CP, it has to be in the WI. But if it is tighter in the WI, that is not necessarily an NC. Though, the CP, would be the more appropriate palce to tighten, maybe even in the FMEA level.

Bottom line, I would not write an NC. The auditor cites a valid principle, that the CP is the document that defines how you are going to control the process. However, I think he is misapplying the principle.

(The CP is not my Bible, however, that book has a lot more significance).

 

[GinaHill]

Re: TS 16949:2000 Audit Failure Modes

We just completed our TS audit with two minor non-conformances & recommedation for certification. Our two non-conformance were:

1. The evidence presented on machine availablility improvements did not sufficiently breakdown causes to be able to directly correlate Preventive Maintenance activities as the reason for improvements.
Did not identify any changes to downtime based on preventive maintenance program solely.

2. Objective evidence did not indicate the routine use of manufacturing process capability parameters on process control plans.
Scrap and rework was evident at every process throughout the plant on all shifts.

 

[Lars_]

Re: TS 16949:2000 Audit Failure Modes

Just finished our Phase 2 audit last week. It was a quite heavy one with 8,5 man days of auditing (we are 900 employees, working 24/7). I would say that most of the pressure was put on FMEA/CP and KPI's.

The auditors came up with 18 minors found under the following clauses:

General requirements:
4.1a
Records retention:
4.2.4.1
Process efficiency:
5.1.1
Planning of product realization
7.1
7.1.1
7.1.4
Design and developement:
7.3.1.1
7.3.3.2
Supplier quality management system development:
7.4.1.2
Control of production and service provision:
7.5.1.1
7.5.1.1
7.5.1.4
7.5.1.4
Identification and traceability:
7.5.3.1
Knowledge of basic statistical concepts:
8.1.2
Monitoring and measurement of manufacturing processes:
8.2.3.1
Manufacturing process improvment:
8.5.1.2
Problem solving:
8.5.2.1

They also wrote down 9 OFI's, 10 positive indications and a recomendation for certification.

 

[Ionel Golban]

Re: TS 16949:2000 Audit Failure Modes

Originally posted by Marc

TS 16949:2000 Audit Failure Modes
I just realized I had not addressed TS 16949 specific failure modes.
If you've gone through a TS 16949 audit, please take a minute and let us know what 'failure modes' were identified!

Marc, it was a colossal idea !!!

My English is not very well, so please forgive me for any spelling errors ... speaking and writing English has never been one of my strong suits.
Anyway I'll try to go on.

We passed a surveillance TS-audit (next year follows a recertification) a month ago, with three minors as follows:

1. For a process -"Logistik"- was used three terms (words) in three different documents (the words used was not identical but in rumanian language the same meaning– subject to interpretation-deficient translation - not a excuse) ;
2. At a reworkplace near by the SMD-mountingline, in a box was found some components (condensers) with uncertain status. (We use these condensers only for a produkt and, at that moment, was not in work. That is not a excuse)
3. We can not demonstrate that the equipments mentenance system is work out on the basis of our experience. (not a systematic documentation of different events)



During the audit, among a lot of questions (normal), was one strange: why I did not do an audit of risk (or a risk-audit) ?


Can any one explain what is this? I never heard anything about such a thing ! Can any one help me ?

 

[tony s]

Re: TS 16949:2000 Audit Failure Modes

Hi folks,

After nine months of preparation for ISO/TS 16949, we have finally received a recommendation from our registrar. Surprisingly, no NCs were found but with a lot of OFIs.

Actually, we failed the first stage (readiness review) audit. This was due to the 12 months key indicator trend for employee motivation. The auditor was looking for metrics on how we measure employee motivation. I know most of the Cover’s don’t agree with this but the auditor insisted that he needs to satisfy his checklist which was based on the Readiness Evaluation Work Sheet – page 31 of the IATF Guidance to ISO/TS 16949:2002.

We got the auditor’s approval on the second attempt on the first stage by showing him improvements on the absenteeism and tardiness rates on data that we gathered one and a half year ago up to present. Very easy. Since he only wanted some metrics, so we gave him metrics. Though we don’t see any value on doing that.

During the stage 2 audit, the auditor transformed from a stick-to-the-book person into a very considerate with a very practical approach auditing style. He later confessed that he himself do not agree in measuring employee motivation, he just need to satisfy the checklist given to him by their German’s office.

Regards to All,

tony s

 

[Ajit Basrur]

Re: TS 16949:2000 Audit Failure Modes

This prompts me a question - is there any website which lists NCs like FDA's Warning letters (affectionately called as 483's) for other segments like Automotive ?

 

[luciano]

Re: TS 16949:2000 Audit Failure Modes

Dear all
Some findings form our TS surveillance audit last month;

1. Control plans do not always comprise all tests and verifications.

2. No instruction for Visual inspection line #10 2 sec, 60cm for visual defects; in case of any suspicious issues discussion and decision with line leaders and quality engineer.

3. Key devices are not determined and resources are not always timely available. (There is no analysis e.g. in the line which are key devices regarding availability/uptime. Furthermore there is no personnel yet for repair in case of software failures/problems e.g. at the transponder station.

4. Conditionally approvals shall be done as required.( Label #2224 is conditionally approved without limit for time or quantity)

5. PPAP shall be done according to requirements.( Some MSA’s for new purchased gages and test equipment prior to SOP had not been documented timely)

6. Annex A, N, H, K to …… Contract not translated yet.

7. Not all tests, checks and controls that are implemented are discussed for their risk.- Step 80.10 shows "Poka Yoke" with detection of 2 in the P-FMEA; however additional 100% visual and as well sampling inspection by quality inspectors (5pcs/shift) are done.

8. Lead time for customer 8Ds as is not measured yet. (Measured as KPI) see 5.1.1.

 

[LUV-d-4UM]

Re: Our Failure Modes

We just completed the ISO-TS16949 surveillance audit. The finding was this: the Top Management did not conduct Layered Process Audit once a week as per Chrysler's specific requirement. My company does not supply widgets. We supply liquid materials to Chrysler and we do not even make this product once a week. When I attended the LPA at Chrysler we were told this does not apply to us, yet they did niot grant us a waiver. Another opportunities for improvement was that we are not documenting Preventive Actions.
Is there any advice from the experts?

Thank you.

 

[Helmut Jilling]

Re: Our Failure Modes

We just completed the ISO-TS16949 surveillance audit. The finding was this: the Top Management did not conduct Layered Process Audit once a week as per Chrysler's specific requirement. My company does not supply widgets. We supply liquid materials to Chrysler and we do not even make this product once a week. When I attended the LPA at Chrysler we were told this does not apply to us, yet they did niot grant us a waiver. Another opportunities for improvement was that we are not documenting Preventive Actions.
Is there any advice from the experts?

Thank you.

The layered audit one can be a little tough. Once per week does not sound right, as the LPA format has different frequencies for different layers. Some typically down to each shift. Check the requirements.

However, in the weeks the product does not run, you obviously should not be expected to audit an LPA. That would seem to be just obvious, even to an auditor.

The preventive actions, well, they are a requirement. I might prod a client a time or two, but I have written nonconformities when it is clear the organization is not doing any formal PAs. There is much written here at the Cove about PA,s if you would liek to wade in...