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ISO/TS 16949:2002 certification – Meeting the requirements of clause 7.6

ISO/TS 16949:2002 certification – Meeting the requirements of clause 7.6

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ISO/TS 16949:2002 certification – Meeting the requirements of clause 7.6

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

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

  3. 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) © CSIR 2006 www.csir.co.za

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

  5. 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? © CSIR 2006 www.csir.co.za

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

  7. 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) © CSIR 2006 www.csir.co.za

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

  9. 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? © CSIR 2006 www.csir.co.za

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

  11. 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 © CSIR 2006 www.csir.co.za

  12. 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) © CSIR 2006 www.csir.co.za

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

  14. 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? © CSIR 2006 www.csir.co.za

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

  16. 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? © CSIR 2006 www.csir.co.za

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

  18. 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 © CSIR 2006 www.csir.co.za

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

  20. 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?) © CSIR 2006 www.csir.co.za

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

  22. 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? © CSIR 2006 www.csir.co.za

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

  24. 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? © CSIR 2006 www.csir.co.za

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

  26. 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? © CSIR 2006 www.csir.co.za

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

  28. 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!! © CSIR 2006 www.csir.co.za

  29. Questions??