Inspection and Testing PFMEA
Last year (as a result of the research on the Cove!), we created a number of new PFMEAs, including generic FMEAs for inspection and testing.
The potential failure modes and causes we identified of course would never all be applicable to a particular program or test but during the planning for the cross-functional meeting, I was able to reference examples for most of the scenarios!
This PFMEA was intended for internal planning rather than distribution to customers.
B.G. Wiehle
(PFMEA co-ordinator)
Failure modes and causes:
(A) Missed inspection or missed task in list of tasks.
• Wrong frequency or timing, including out-of-sequence.
• Lack of opportunity to do test (can't get parts, access equipment, manpower, communication).
• Operator / inspector error, including wrong assumptions.
• Missing tool/ fixture/ document.
• Changed requirements because of GP-12 or FPSC.
• Test never specified (requirement not documented).
(B) Wrong task completed.
• Wrong frequency
• Similar task substituted.
• Operator / inspector error.
• Missing or wrong criteria.
• Changed requirements because of GP-12 or FPSC added or removed.
(C) Wrong technique.
• Part loaded incorrectly, part test location incorrect.
• Wrong fixturing/ missing fixture.
• Data misinterpreted (gauge scale needs conversion, hard to read)
• Test run incorrectly.
• Wrong sample size.
• Wrong sample selection.
• Wrong sample preparation (cooling, aging, etc.)
• Wrong ambient conditions (temperature, humidity, dust, etc.)
• Test not appropriate for parameter being tested.
(D) Wrong or bad tool used (gauges, measuring equipment, read-outs, etc.).
• Out of calibration / calibrated incorrectly.
• Broken / poorly maintained / dirty.
• Replaced with different model.
• Sensor malfunction (if present)
• Wrong rev level (esp. attribute gauges)
• Reagent shelf-life expired or contaminated (if applicable).
• Low battery (if applicable).
(E) Wrong decision / determination made after inspection / test.
• Criteria too subjective / missing / wrong / still in development.
• Insufficient lighting / lack of contrast surface.
• Decision made by wrong (unauthorized) person (ie. operator or supervisor instead of inspector).
• Inexperienced inspector / operator, including new defects not previously identified.
• Operator / inspector disability (color-blindness, poor vision, illiteracy, innumeracy).
• Determination based on documentation / labeling error.
• Operator / inspector error, including time pressures, lack of commitment to quality, etc.
(F) Test samples / part being inspected not dispositioned properly.
• Defective/ failed parts returned to production.
• Passed parts returned to production downstream of a required operation or test.
• Parts being sorted placed in wrong container (during sorting).
• Parts replaced in wrong container.
• Set-up parts or parts generated during maintenance/ trouble-shooting not segregated as suspect parts.
(G) Test results not acted on (process not adjusted, parts not segregated).
• Operator / supervisor / lead-hand/ facilitator error. Lack of communication.
(H) Test / inspection not documented, or recorded incorrectly (if required).
• Operator / inspector error (including forgot, couldn't find form, didn't know how to fill in form, too long between test & record creation).
• Form missing place to record data due to new or changed requirements (document control issue).
• Record misplaced / sent to wrong location.