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Slide 15
InstMC FS2016 V1.3
Nicol Instrument Engineering Limited
Data quality
Shall be credible, traceable, documented,
justified.
Based on field feedback from similar devices
used in a similar operating environment.
Engineering judgement can be used to
assess missing reliability data or evaluate
the impact on reliability data collected in a
different operating environment.
Device certificate failure rates can be a starting point.
But may not be sufficient for your application.