Technical investigation and lifecycle.
Understanding why a device fails in the field, fixing it for good, and keeping the design under control through changes and obsolescence.
You are probably in one of these situations.
A failure that is not understood always comes back. The goal is to find the root cause, demonstrate it, then prove the fix holds over time.
- The same failure keeps coming back from the field with no known cause.
- A critical component has an end-of-life notice.
- A process or a supplier is drifting, and scrap is going up.
What I actually do.
Failure analysis
Field returns analysed, failure reproduced, root cause demonstrated (8D).
Fix
Fix verified by testing, then effectiveness measured in the field.
Obsolescence
End-of-life notices tracked, replacements assessed, last-time buys sized.
Design changes
Impact on safety, EMC and performance, tests to repeat identified.
Statistical control
Control charts and capability, to see a drift coming.
Deliverables
| Ref. | Deliverable |
|---|---|
| D1 | Failure analysis report (8D) |
| D2 | Corrective plan and verification report |
| D3 | Obsolescence management plan |
| D4 | Design change impact assessment |
| D5 | Capability study and control charts |
Methods and standards
| 8D | Team problem solving, from description to prevention |
|---|---|
| FMEA | Failure mode, effects and criticality analysis |
| Ishikawa, 5 whys | Structured cause finding |
| SPC | Statistical process control, capability |
| MSA | Measurement system analysis |
| IEC 60601-1 | Reference for the electrical safety impact of changes |
Frequently asked questions
Do you need the failed parts?
Ideally. Otherwise the analysis starts from service history and device logs.
Do you find replacement components?
Yes, with a comparison of characteristics and the list of tests to repeat.
A project to move forward? Let's talk.
Three lines are enough: the topic, the stage, the deadline. Reply within two business days.
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