TS 16949 Registrar Audit Failure Modes
- Thread starter Marc
- Start date
M
Mustang
Our Failure Modes
Ok, here it goes:
1. Not all records being maintained in the system are being fully completed as required. (the auditor has a problem with forms with blank spaces. Not sure how to answer this, since flogging employees is not allowed.)
2. Lack of adequate objective evidence of a defined process for the measurement to ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. (the auditor says almost everyone is struggling with this. Another puzzling one.)
3. Lack of evidence of the documentation of the process sign-off requirement or statement from the customer that it is not a requirement as defined in the Customer Specific Requirements documents (even though the wording indicates they would tell us if they wanted it, the auditor wants us to get clarification)
4a. Lack of adequate objective evidence of a Supplier Performance Report being issued to suppliers as required in the Supplier development Manual (one of those things that became difficult to maintain when the responsible person was "downsized")
4b. Lack of adequate objective evidence of supplier quality management system development or customer approval to utilize a supplier of production and/or service material or components who is not registered (we have a signed warrant from the customer indicating our use of this supplier, but the auditor was not satisfied. He wants a letter.)
5. The Job Books (part specific binders sent to the floor for the run) do not always contain the latest revision of the Control Plan, Customer Specification or Engineering Change Notice. (we got caught with a rev level discrepancy)
6a. Not all monitoring and measuring devices are calibrated by the required due date (pin gages, calibration being changed to 3-year cycle, but we did not document the reasoning to his liking)
6b. Lack of objective evidence of an assessment of the validity of previous measuring results when the equipment is found to be out of tolerance (our CMM was minutely out of tolerance, well within our accuracy level. We just did not formally document that).
Nothing was earth-shattering, and no real surprises. A few disappointments, as some of this was supposed to be addressed by management prior to the audit, but what can you do?
Ok, here it goes:
1. Not all records being maintained in the system are being fully completed as required. (the auditor has a problem with forms with blank spaces. Not sure how to answer this, since flogging employees is not allowed.)
2. Lack of adequate objective evidence of a defined process for the measurement to ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. (the auditor says almost everyone is struggling with this. Another puzzling one.)
3. Lack of evidence of the documentation of the process sign-off requirement or statement from the customer that it is not a requirement as defined in the Customer Specific Requirements documents (even though the wording indicates they would tell us if they wanted it, the auditor wants us to get clarification)
4a. Lack of adequate objective evidence of a Supplier Performance Report being issued to suppliers as required in the Supplier development Manual (one of those things that became difficult to maintain when the responsible person was "downsized")
4b. Lack of adequate objective evidence of supplier quality management system development or customer approval to utilize a supplier of production and/or service material or components who is not registered (we have a signed warrant from the customer indicating our use of this supplier, but the auditor was not satisfied. He wants a letter.)
5. The Job Books (part specific binders sent to the floor for the run) do not always contain the latest revision of the Control Plan, Customer Specification or Engineering Change Notice. (we got caught with a rev level discrepancy)
6a. Not all monitoring and measuring devices are calibrated by the required due date (pin gages, calibration being changed to 3-year cycle, but we did not document the reasoning to his liking)
6b. Lack of objective evidence of an assessment of the validity of previous measuring results when the equipment is found to be out of tolerance (our CMM was minutely out of tolerance, well within our accuracy level. We just did not formally document that).
Nothing was earth-shattering, and no real surprises. A few disappointments, as some of this was supposed to be addressed by management prior to the audit, but what can you do?
E
engjane
Our deficiencies
Well the two big ones were:
- Not adhering to information in the CP / on specs
- Not making everyone aware of measurables, goals and process technique - this may be due to the fact that we only trained in the 3 weeks before the audit and the QMS was only updated in the few weeks before the audit! No time to practise.
Minors were - negative measurable trends, unrealistic goals, better use of software/spreadsheets to standardise techniques, more documented evidence for internal audits and more analysis of dock audits (which is being pushed by DC's layered audits aswell!)
Overall I think we had an easy time in the audit - hopefull this is a reflection on our systems! Im sure the surveillance audits will not be as easy though - more time to go into detail!
Well the two big ones were:
- Not adhering to information in the CP / on specs
- Not making everyone aware of measurables, goals and process technique - this may be due to the fact that we only trained in the 3 weeks before the audit and the QMS was only updated in the few weeks before the audit! No time to practise.
Minors were - negative measurable trends, unrealistic goals, better use of software/spreadsheets to standardise techniques, more documented evidence for internal audits and more analysis of dock audits (which is being pushed by DC's layered audits aswell!)
Overall I think we had an easy time in the audit - hopefull this is a reflection on our systems! Im sure the surveillance audits will not be as easy though - more time to go into detail!
A
Al Dyer
Sorry, I just posted a message asking Mustang to give us the details in another thread.
Very helpful in getting into the minds of what auditors are looking for these days. Again, congradulations Mustang!!!
Al...
Very helpful in getting into the minds of what auditors are looking for these days. Again, congradulations Mustang!!!
Al...
We passed TS today!
We passed TS today with several minors as follows.
Interfaces between sites – Sales/Design/Manufacturing. There were clear weakness with how we all work together on Contract Review, Internal Audit, CARs, Mgmt Review, Customer specification control between our plants and the remote sites. A good finding, this is where the big costly problems are happening.
Other things were:
There was a very, very strong focus on metrics, performance, and management responsibility and commitment.
There was also a keen focus on interfaces between processes…and that’s where our problems are.
All in all, I feel it was what TS was supposed to be. Looking for good business results and looking at the interaction of processes.
As always thanks to the Cove for all the education over the years. A big chunk of our system was born here.
It’s Miller time!
We passed TS today with several minors as follows.
Interfaces between sites – Sales/Design/Manufacturing. There were clear weakness with how we all work together on Contract Review, Internal Audit, CARs, Mgmt Review, Customer specification control between our plants and the remote sites. A good finding, this is where the big costly problems are happening.
Other things were:
- Poor capability without clear reaction plans in place.
- Control plan too focused on customer specs, missing “process” control information.
- 5 or 6 snakes and ladders type of things, missing a clear link from the procedure to the WI and/or form.
- A key supplier not identified (surprised us all)
There was a very, very strong focus on metrics, performance, and management responsibility and commitment.
There was also a keen focus on interfaces between processes…and that’s where our problems are.
All in all, I feel it was what TS was supposed to be. Looking for good business results and looking at the interaction of processes.
As always thanks to the Cove for all the education over the years. A big chunk of our system was born here.
It’s Miller time!
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Raffy
Quite Involved in Discussions
On our end:
1. Effectiveness of an auditor is not evaluated.
2. No basis in planning for frequency of audit.
3. Auditors auditing the same organization, e.g. QA Audits his department, though they are not directly in charged, that is QA Lab Chemist audits Doc Control under QA Department.
4. Unupdated Skills Map.
Raffy
1. Effectiveness of an auditor is not evaluated.
2. No basis in planning for frequency of audit.
3. Auditors auditing the same organization, e.g. QA Audits his department, though they are not directly in charged, that is QA Lab Chemist audits Doc Control under QA Department.
4. Unupdated Skills Map.
Raffy
J
jmp4429
Just went through our surveillance audit. The two we got written up for were:
1. Lack of tracking of supplier expedited freight. We were tracking expedited freight that we paid for, but not instances of suppliers having to expedite freight to make our delivery requirements.
2. Specs on the control plan did not always match our work instructions. I knew we would get hit on this, we’ve written it up as an internal minor twice now. The trouble is that one group within our quality department creates the control plans, and another group creates the work instructions.
There was one thing that kind of surprised us on this one. We have been allowing the work instructions to call out a *tighter* tolerance than the control plan, which our auditor in the past has told us was OK. Now based on input from a second auditor, they are telling us that this is no good. I have mixed feelings about this. I may get into this in another thread, if I get bored.
Issues they found and generously issued a verbal ‘warning’ about were:
1. We use first-time “Verification” stickers on some test equipment that does not require calibration. Some eejit bought the stickers that have a due date as well as the verification date, and just wrote in a date a year out from the verification. There is no recall system in place for this, so the stickers were ‘expired.’
2. Some parts on one of our assembly lines require an off-line cleaning step. There was no work instruction to tell the operators which parts require cleaning. We do have a Kanban system in place for the cleaning station, which is what we were using to tell the operators those parts needed to be cleaned.
3. The control plans did not list the packaging or lot control requirements.
4. We were doing 100% visual sort on some supplied parts that have had problems recently. The parts are a flexible part, and the sorters use a tool to hold the part still while they inspect it. The tools were not clearly identified, and since they were used during inspection, the auditors wanted to see them treated like a “gage.”
1. Lack of tracking of supplier expedited freight. We were tracking expedited freight that we paid for, but not instances of suppliers having to expedite freight to make our delivery requirements.
2. Specs on the control plan did not always match our work instructions. I knew we would get hit on this, we’ve written it up as an internal minor twice now. The trouble is that one group within our quality department creates the control plans, and another group creates the work instructions.
There was one thing that kind of surprised us on this one. We have been allowing the work instructions to call out a *tighter* tolerance than the control plan, which our auditor in the past has told us was OK. Now based on input from a second auditor, they are telling us that this is no good. I have mixed feelings about this. I may get into this in another thread, if I get bored.
Issues they found and generously issued a verbal ‘warning’ about were:
1. We use first-time “Verification” stickers on some test equipment that does not require calibration. Some eejit bought the stickers that have a due date as well as the verification date, and just wrote in a date a year out from the verification. There is no recall system in place for this, so the stickers were ‘expired.’
2. Some parts on one of our assembly lines require an off-line cleaning step. There was no work instruction to tell the operators which parts require cleaning. We do have a Kanban system in place for the cleaning station, which is what we were using to tell the operators those parts needed to be cleaned.
3. The control plans did not list the packaging or lot control requirements.
4. We were doing 100% visual sort on some supplied parts that have had problems recently. The parts are a flexible part, and the sorters use a tool to hold the part still while they inspect it. The tools were not clearly identified, and since they were used during inspection, the auditors wanted to see them treated like a “gage.”
B
Bill Ryan - 2007
Just out of curiosity - what was the second auditor's reasoning? There are many times where "tightened tolerances" are warranted and possibly necessary.jmp4429 said:
Bill Ryan said:
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, but logically why should you be able to tighten and not be able to loosen.
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.
J
jmp4429
Howard Atkins said:
I don’t disagree with that at all, if we need the tighter tolerances to assure good product, it should be on the CP and FMEA. I’m still not convinced it’s a nonconformance, though.
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.
Say the CP requires a pressure gage to read between 10 and 30 psi. If the work instructions call this out, and the operator reads 8 psi, they’re probably going to think “good enough.” (I know, I know. What can you do?)
If the work instructions call out 15 to 25 psi, and the operator reads 8, they’ll call quality.
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.
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