Silence before the storm. Multiple companies use ISO9000 and ISO9001 which enforces model of development, the most common model is V-model. It essentiall confirms "goodnes" of design by verification and validation, most manageres are confident product would be reliable if tests are passed. Mass production start, product is released and soon comes failure rate significantly cuting into profit margin and damaging brand reputation.
Disaster? Mass production start, product is released and after some time failure rate significantly cuts into profit margin and damage brand reputation.
Why? - was test performed on statistically significant quantity of DUTs? - was test performed on multiple batches of components? - was any combination of components worst case? - was test performed at typical input voltages only and with typical load only? - was sensitive nodes monitored during test to establish real margin to failure? - do accelerated test ignore fact multiple phenomena have various acceleration factors? (for example CAF, dendrites, electromigration, leakage current, penetration of IC by humidity, seals penetration have different acceleration factors); - does worst case calculation cover multiple worst case conditions at once? - is there disconnection between DFMEA and PFMEA? - was mudule designed with full understanding of system and all user cases predicted? - is test team and design team the same? - were any tests performed to capture glitches in full factorial stimuli environment? - are undocumented quirks of surrounding electronic modules in the system known? - is software capable to serving multiple interrupts (reaction to stimuli) at once;
You have been set up
Most tests are performed at about 10 DUT quantity (depending on industry), which very roughly translates to confidence level 90%, which very roughly translates to up to 10% failure rate. Above covers only bottom of "bathtube", not sides. Why? Typically modules are checked thoroughly before official tests so early failure are not oficially seen. Typically duration of tests is lesser than ageing of electrolytic capacitors or build up of electostatic charge what might completly fail 100% of modules at customers. Unfortunately V-model and verification/validation on about 10units set you up in real world scenario for about 1% failure rate (from 0.01% to 10%) which is both damaging and dificult to spot.
Peer review
This is where we can help, extremly experienced staff of external reiewers not tangled by internal politics can point concerns and issue early. Is spotted early most issues / concerns can be fixed at 0 or very little cost.
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