Calibration Purchasing Information - TS 16949 Audit Finding

[AndyN]

It certainly can! I'm thinking that since you seem to get what you want from your calibration supplier, e.g. they give you all those things in their cal. reports (don't they?), the 'where appropriate' comes into play.

By the auditor saying you don't have sufficient data in your calibration purchasing document, without looking at the effectiveness (did you get what you wanted from your supplier) is an easy - but inadequate - reason for writing an nc. (IMHO)

 

[Caster]

However, I know from long experience that if an auditor is bound and determined to write a certain number of findings, and they are coming up dry, that they will hit three areas, throw sampling out the window, and go through everything until they find something:

Purchasing Information (specifically contracted service POs)
Control of Monitoring and Measuring Devices
Control of Documents

I find they have a fourth pet gotcha- training aka competence. You can always find somthing looking at a temp, new hire, secretary, or if they are brave, the plant manager or owner.

In my experience the useless "what is the quality policy" gotcha is finally dying away.

IMHO the reason ISO/TS is so devalued by executive management is because of these "missing cal stickers and wrong rev number" type auditors.

Nothing of substantial value to the business is ever found by these folks, making ISO/TS compliance just a pure cost burden.

 

[Sidney Vianna]

Nothing of substantial value to the business is ever found by these folks, making ISO/TS compliance just a pure cost burden.

I think you have a very valid point there. However, there are circumstances when a 3rd party CB auditor reports some real business issues as NC's, which points to serious mismanagement or identifies some really hard issues to correct. These instances are, many times, followed by requests from the certified organizations for an "auditor reassignment", or a registrar switch altogether.

Maybe you could also share with us the type of value added findings your internal audits generate. It might be educational for many external auditors and other internal auditors.

 

[Icy Mountain]

It certainly can! I'm thinking that since you seem to get what you want from your calibration supplier, e.g. they give you all those things in their cal. reports (don't they?), the 'where appropriate' comes into play.

By the auditor saying you don't have sufficient data in your calibration purchasing document, without looking at the effectiveness (did you get what you wanted from your supplier) is an easy - but inadequate - reason for writing an nc. (IMHO)

My opinion exactly (shared by other certified lead assessors that shall not be named).

I find they have a fourth pet gotcha- training aka competence. You can always find somthing looking at a temp, new hire, secretary, or if they are brave, the plant manager or owner.

He wrote this one. We got it overturned on appeal.

In my experience the useless "what is the quality policy" gotcha is finally dying away.

Ask this one here and they will point to their laminated copy AND THEN give you and example of what one of the 5 points means to them in their day-to-day operations.

IMHO the reason ISO/TS is so devalued by executive management is because of these "missing cal stickers and wrong rev number" type auditors. Nothing of substantial value to the business is ever found by these folks, making ISO/TS compliance just a pure cost burden.

And that is why this auditor will not be inside my building again.

I think you have a very valid point there. However, there are circumstances when a 3rd party CB auditor reports some real business issues as NC's, which points to serious mismanagement or identifies some really hard issues to correct. These instances are, many times, followed by requests from the certified organizations for an "auditor reassignment", or a registrar switch altogether.

I would rather have a serious mismanagement issue to correct any day. Doing a 5 Why on a "I looked at 1,000 records and found 1 unsigned" issue is nearly impossible. As anyone here who has read my registration diaries can attest, I am not shy about this issue. Sidney, you know that I will take a huge, systemic finding, say "thank you" to the auditor, then crush the non-conformance into oblivion and welcome the auditor back so that I can show off our thorough elimination of the issue. On the other hand, I will ask for "auditor reassignment" in a heartbeat for anyone who comes in with their "I can always write something in this section" checklist and proceeds to write (or attempt to write) half-baked findings that create nothing but busywork for me. On the gripping hand, Sidney, you know exactly who my registrar is and I have no intention of switching.

 

[Sidney Vianna]

On the other hand, I will ask for "auditor reassignment" in a heartbeat for anyone who comes in with their "I can always write something in this section" checklist and proceeds to write (or attempt to write) half-baked findings that create nothing but busywork for me.

I wholeheartedly agree with that position. CB auditors must realize that they are auditing a system and not should not be doing "quality control" checks of the data being offered for assessment.

I said it many, many times, if there is a clear conclusion that a non-conformity does not represent a systemic problem, we can not have true corrective action. At best, we will have a correction of the NC situation.

On the other hand, that myth of "auditor luck" which people believe that the auditor found the only nonconforming record out of a million possibilities is just a myth. Good auditing techniques teach us that, upon discovery of an nonconforming situation, the auditor should expand the sample to determine if the situation is systemic or not. But, remember that, due to time constraints, sometimes that auditor can not really expand the sample. Sometimes, the auditor will write up a corrective action request, based on a limited sample. My expectation would be for the organization to perform a thorough assessment of the situation and sample a "large" percentage of the subject at hand. If the organization's assessment shows that the deficiencies do not really amount to a systemic breakdown, I would be satisfied with correction (if warranted) and void the expectation for a true corrective action.

 

[Icy Mountain]

I said it many, many times, if there is a clear conclusion that a non-conformity does not represent a systemic problem, we can not have true corrective action. At best, we will have a correction of the NC situation.

If the organization's assessment shows that the deficiencies do not really amount to a systemic breakdown, I would be satisfied with correction (if warranted) and void the expectation for a true corrective action.

I believe that this describes at least 3 (if not all 4) of the findings in my re-cert audit. Sidney, are you qualified for the electronics sector?

 

[Sidney Vianna]

Sidney, are you qualified for the electronics sector?

Sure, but I am not Automotive grade...

 

[Raffy]

Our procedure states that a Calibration Service Provider (CSP) must be accredited to ISO17025.
This is the scenario, the measuring instrument was calibrated by a CSP accredited to ISO9001: 2000.
Originally, the measuring instrument was sent to our accredited CSP which was an ISO17025 accredited, since they are not capable in calibrating the said instrument they outsourced calibration and send the latter to another calibration service provider, which was accredited to ISO9001: 2000. Our Accredited CSP is aware of our procedure on ISO17025.
In my understanding, our vendor (Accredited CSP) violates our requirement that a CSP must be accredited to ISO17025. Our vendor said that even though their vendor is not an ISO17025 Accredited. The measuring instrument was calibrated according to the equipment’s manufacturer, i.e. ASTM F328-97 & JIS 9921 B-1997. And the standards and equipment used in the calibration are traceable to NIST, Z540-1, MIL-STD 45662A & FTSCPAC CCA “7P1”.
Is this acceptable? If yes, Please advise and explain. If no, can we file a claim that they pay as back to have it calibrated by other CSP accredited to ISO17025? Please advise.
Thank you very in advance for the usual prompt attention you will give in this request.
Best regards,
Raffy

 

[howste]

I have an ISO/TS16949 audit finding regarding the Purchasing Information as regards the purchase of calibration services. I am using an external laboratory to calibrate electronic (e.g. Fluke meters) and mechanical (e.g. torque wrenches). Apparently, my Purchase Orders do not contain enough information to specify this service.

Does anyone out there have some bullet-proof language for purchasing this kind of calibration service in an ISO/TS 16949 system.

Here's my first pass:

• Calibration or verification to manufacturer's specifications for the attached equipment list, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.
• Supplier shall supply calibration record for each piece of equipment in any form or type of medium;
• Supplier shall identify the the equipment to allow the calibration status to be determined (e.g. via calibration sticker or reference to Model and Serial Number).
• Supplier shall apply safeguards to prevent adjustments that would invalidate the measurement results.
• Supplier shall supply notification of any equipment found out of tolerance and provide as-found as-left data for such equipment.
• Supplier shall be third party registered as meeting the requirements of ISO 9001:2000 with the scope of calibration, repair, and testing of process instruments and equipment, measuring instruments and equipment, and test equipment.
• Supplier shall be accredited to ISO / IEC 17025:1999 by A2LA with a scope including the required measurements.

Looks like I missed this thread when it was fresh. I would add that all calibration services provided must be included in the supplier's ISO 17025 scope of accreditation. It seems that the scopes listed may be too generic to ensure that all services provided would fall into them.

Either that, or specify that the supplier must notify you if any items in the attached equipment list were not included in the supplier's ISO 17025 scope of accreditation

 

[howste]

Our procedure states that a Calibration Service Provider (CSP) must be accredited to ISO17025.
This is the scenario, the measuring instrument was calibrated by a CSP accredited to ISO9001: 2000.
Originally, the measuring instrument was sent to our accredited CSP which was an ISO17025 accredited, since they are not capable in calibrating the said instrument they outsourced calibration and send the latter to another calibration service provider, which was accredited to ISO9001: 2000. Our Accredited CSP is aware of our procedure on ISO17025.
In my understanding, our vendor (Accredited CSP) violates our requirement that a CSP must be accredited to ISO17025. Our vendor said that even though their vendor is not an ISO17025 Accredited. The measuring instrument was calibrated according to the equipment’s manufacturer, i.e. ASTM F328-97 & JIS 9921 B-1997. And the standards and equipment used in the calibration are traceable to NIST, Z540-1, MIL-STD 45662A & FTSCPAC CCA “7P1”.
Is this acceptable? If yes, Please advise and explain. If no, can we file a claim that they pay as back to have it calibrated by other CSP accredited to ISO17025? Please advise.
Thank you very in advance for the usual prompt attention you will give in this request.

Best regards,

Raffy

Sounds like it doesn't meet requirements to me. Did you verify their scope of accreditation before contracting with them for the work?

Probably the only way you could get a refund from them would be if you specified that the work be done within the scope of their ISO 17025 accreditation.

By the way, here are the clauses of ISO 17025 that relate to subcontracted calibrations. I've highlighted in blue some text that may be useful to you...

4.5 Subcontracting of tests and calibrations
4.5.1 When a laboratory subcontracts work, whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent subcontractor. A competent subcontractor is one that, for example, complies with this International Standard for the work in question.
4.5.2 The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing.
4.5.3 The laboratory is responsible to the customer for the subcontractor’s work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used.
4.5.4 The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question.

5.10.6 Testing and calibration results obtained from subcontractors
When the test report contains results of tests performed by subcontractors, these results shall be clearly identified. The subcontractor shall report the results in writing or electronically.
When a calibration has been subcontracted, the laboratory performing the work shall issue the calibration certificate to the contracting laboratory.