saamf roadshow durban csir nml eddie tarnow metrologist: torque & automotive 14 june 2006 iso/ts...

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

© CSIR 2006 www.csir.co.za

ISO/TS 16949: Clause 7.6

Control of devices


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)



Control of devices


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?



Control of devices


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)



Control of devices



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?



Control of devices



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



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)



Control of devices



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?



Control of devices



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?


ISO/TS 16949: Clause 7.6 cont.

Control of devices cont.



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


ISO/TS 16949: Clause 7.6 cont.

Control of devices cont.



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?)


ISO/TS 16949: Clause 7.6.3

Laboratory requirements.



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?




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?




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?



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!!

Questions??

saamf roadshow durban csir nml eddie tarnow metrologist: torque & automotive 14 june 2006 iso/ts...

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