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ISO/TS 16949:2002 certification – Meeting the requirements of clause 7.6. SAAMF Roadshow Durban CSIR NML Eddie Tarnow Metrologist: Torque & Automotive 14 June 2006. ISO/TS 16949: Clause 7.6. Control of devices. Clause 7.6. Selection of appropriate test & measuring equipment.

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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

SAAMF Roadshow Durban

CSIR NML

Eddie TarnowMetrologist: Torque & Automotive

14 June 2006

slide2

ISO/TS 16949: Clause 7.6

Control of devices

© CSIR 2006 www.csir.co.za

slide3

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

slide4

ISO/TS 16949: Clause 7.6

Control of devices

© CSIR 2006 www.csir.co.za

slide5

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

slide6

ISO/TS 16949: Clause 7.6

Control of devices

© CSIR 2006 www.csir.co.za

slide7

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

slide8

ISO/TS 16949: Clause 7.6

Control of devices

© CSIR 2006 www.csir.co.za

slide9

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

slide10

ISO/TS 16949: Clause 7.6

Control of devices

© CSIR 2006 www.csir.co.za

slide11

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

slide12

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

slide13

ISO/TS 16949: Clause 7.6

Control of devices

© CSIR 2006 www.csir.co.za

slide14

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

slide15

ISO/TS 16949: Clause 7.6

Control of devices

© CSIR 2006 www.csir.co.za

slide16

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

slide17

ISO/TS 16949: Clause 7.6 cont.

Control of devices cont.

© CSIR 2006 www.csir.co.za

slide18

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

slide19

ISO/TS 16949: Clause 7.6 cont.

Control of devices cont.

© CSIR 2006 www.csir.co.za

slide20

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

slide21

ISO/TS 16949: Clause 7.6.3

Laboratory requirements.

© CSIR 2006 www.csir.co.za

slide22

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

slide23

ISO/TS 16949: Clause 7.6.3

Laboratory requirements.

© CSIR 2006 www.csir.co.za

slide24

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

slide25

ISO/TS 16949: Clause 7.6.3

Laboratory requirements.

© CSIR 2006 www.csir.co.za

slide26

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

slide27

ISO/TS 16949: Clause 7.6.3

Laboratory requirements.

© CSIR 2006 www.csir.co.za

slide28

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