1. SAAMF Roadshow Durban CSIR NML Eddie Tarnow Metrologist: Torque & Automotive 14 June 2006 ISO/TS 16949:2002 certification – Meeting the requirements of clause 7.6

2. Slide 2 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Control of devices

3. Slide 3 © CSIR 2006 www.csir.co.za Clause 7.6 Selection of appropriate test & measuring equipment Has an analysis been conducted to determine the measurement accuracy required? What uncertainty is acceptable? Have the instrument accuracy specifications been correctly interpreted? (especially taking into account environmental tolerance)

4. Slide 4 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Control of devices

5. Slide 5 © CSIR 2006 www.csir.co.za Clause 7.6 Calibration of test & measuring equipment Is a full calibration conducted, or just a partial? Is the instrument calibrated according to the manufacturer’s recommended procedure? Has the instrument been adjusted to get it to within spec? Or have correction factors simply been determined? Have the results been recorded/reported “as found” as well “as left? (before adjustment & after adjustment) Has the instrument been calibrated at the same points as previous calibration, thereby providing a useful history? Has the calibration service provider evaluated the results for conformance to accuracy specification and reported a statement to that effect?

6. Slide 6 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Control of devices

7. Slide 7 © CSIR 2006 www.csir.co.za Clause 7.6 Verification/validation of test & measuring equipment Definition: Verification – check that nothing has changed since the calibration Definition: Validation – check to see the instrument is indeed fit for purpose Has the required accuracy been proven by the calibration? (validation) Is there evidence that the instrument accuracy remains within the specification? (If compared to last cal & no adjustment performed, verification)

8. Slide 8 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Control of devices

9. Slide 9 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Measurement traceability Definition: Measurement traceability – unbroken chain of comparisons between the UUT and the national measurement standard, each step of which has an estimated uncertainty associated with it. Can the last step of the traceability chain be identified/described? (Is the identity of the standard used known and unique?) Was the calibration service provider SANAS accredited & was the calibration performed within the laboratory’s published accreditation schedule best measurement capability (BMC)? Is there an uncertainty of measurement reported with the results?

10. Slide 10 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Control of devices

11. Slide 11 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 To adjust or not to adjust during calibration Is there record of adjustments having been made during the calibration? If adjustment has been performed, are the results before AND after the adjustment reported? Does the calibration service provider have the technical ability to perform adjustments? Advantages of adjusting to within spec eliminates the need to apply corrections, facilitates ease of use for the operator, instrument can be used in other applications, can reduce the cost of calibration, simplifies the estimation of uncertainty of measurement when using the instrument

12. Slide 12 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 To adjust or not to adjust during calibration continued… Disadvantages of adjusting to within spec adjustment immediately invalidates (destroys) previous history, (this can be managed) can increase the cost of calibration (some calibration service providers refuse to perform adjustments or do not have the technical ability – typically a problem if not using the authorised agents as the calibration service provider) the natural drift of the instrument may be disturbed (the instrument may become more stable if left undisturbed for a long period of time)

13. Slide 13 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Control of devices

14. Slide 14 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Calibration status Can the calibration status, (valid or invalid calibration), easily be determined by the user? (How easily can the user inadvertently use an “out-of- calibration” instrument? Who’s responsibility?) On what basis is “Valid Calibration” status assigned to an instrument? Is the calibration expiry date indicated on the calibration label? If partially calibrated, is there indication to the user to prevent accidental usage for another application? How will the quality system prevent the use of an “un-calibrated” instrument?

15. Slide 15 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Control of devices

16. Slide 16 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Calibration integrity Is the calibration validity protected in some way? (Can the user accidentally or intentionally interfere with the calibration?) Who is responsible for ensuring calibration integrity? (Cannot always be the calibration service provider as the user may have access to adjustments) Which methods of calibration integrity protection are employed? Integrity seals over adjustment access points or chassis opening points? Password protection – who keeps the password?

17. Slide 17 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 cont. Control of devices cont.

18. Slide 18 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Evaluating the impact of an “out-of-calibration” instrument Is there communication from the calibration service provider regarding an “out-of-calibration” instrument and any subsequent adjustment? Was the error larger than the required uncertainty of the measurement or test? Was the instrument out of cal at a point directly applicable to the measurement function being used or was it on another range, function? Has a risk profile of the measurement been drawn up? Will an erroneous measurement have major consequences which cannot be rectified? What actions have been implemented to reduce the risk such as:- reducing the calibration interval, performing in-between-calibration verification checks

19. Slide 19 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 cont. Control of devices cont.

20. Slide 20 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6 Measurement software validation Is there evidence that the software is fit for its intended purpose? (proof that the software produces the correct measurement/test results) Has this been “validated” by comparing software generated results with results obtained by means of manual measurements? How is the integrity of the software protected? can a different version be inadvertently installed over the original version? is a copy of the original version kept in a safe place? is a particular version easily uniquely identifiable? (traceability) if changes are made, are these adequately documented and controlled? (can the user of the software make changes?)

21. Slide 21 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6.3 Laboratory requirements.

22. Slide 22 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6.3 Internal Laboratory requirements Laboratory scope Is there evidence of a laboratory scope listing the methods or tests/measurements which can be performed by the laboratory? Are the uncertainties, (Best Measurement Capabilities), for these methods or tests/measurements quoted? Is the technically responsible person, who confers validity to the tests/measurement reports, identified?

23. Slide 23 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6.3 Laboratory requirements.

24. Slide 24 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6.3 Internal Laboratory requirements Competence of laboratory personnel Since the responsibility of assessing whether or not the metrologist is competent is an internal one:- Have criteria for the required competence been drawn up? Is there evidence that the metrologist’s competence has been assessed against these criteria? Was the metrologist’s competence assessed by means of physically witnessing a measurement/test AND comparing the results obtained with results of known accuracy? To what extent have audit sample measurements, or participation in proficiency testing schemes, provided proof of acceptable measurement capability? Does the metrologist have a training file containing records of relevant training and experience? Is there sufficient depth of staff and is a designated “ stand-in” identified in the quality system?

25. Slide 25 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6.3 Laboratory requirements.

26. Slide 26 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6.3 Internal Laboratory requirements Testing of the product Are the uncertainties of measurement in the test adequately estimated? Do decisions of conformance or non-conformance take the estimated uncertainty of measurement into account?

27. Slide 27 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6.3 Laboratory requirements.

28. Slide 28 © CSIR 2006 www.csir.co.za ISO/TS 16949: Clause 7.6.3 External Laboratory requirements Acceptability to the customer If the external laboratory is NOT SANAS accredited, does it meet all the requirements of ISO/IEC 17025? If it is SANAS accredited and, or, meets the requirements of ISO/IEC 17025, does it meet the technical requirements of the customer? (Does the scope of the laboratory cover the measurements/tests required by the customer) SANAS accreditation does not by default mean the laboratory technically meets the requirement of the customer!!

29. Questions??