Medical device
Medical device reliability improvement study
A disposable device line showed intermittent seal failures in functional test during a validation extension. The team needed to prove the process was capable before releasing added capacity.
Challenge
Failure rate was low but trending upward. Complaint risk and validation timing left little room for trial-and-error parameter changes.
How they worked it
- Framed the seal-failure trend with 5W2H — affected stations, test method, and validation timeline before parameter trials. (5W2H Builder)
- Walked Exploration Cascade to isolate station vs. material branches, then Chi-Square on leak codes across assembly cells. (Exploration Cascade, Chi-Square Test)
- Verified the seal-force gage with variable Gage R&R before trusting functional-test and capability data. (Variable Gage R&R)
- Revised PFMEA for seal failure modes and updated the control plan with the validated temperature band. (PFMEA / DFMEA Lite, Control Plan Builder)
Approach
- Ran capability on seal force and visual leak indicators by station after MSA sign-off.
- Used DOE on temperature, dwell time, and ram speed to find a robust process window.
- Re-established SPC limits on seal force for ongoing monitoring.
- Exported validation summaries for the quality record and line-release package.
Tools used
Outcome
A narrow temperature band stabilized seal performance. PFMEA and control-plan updates supported line release without repeating full IQ/OQ scope.
Illustrative workflow based on typical medical device validation patterns — not a specific regulatory submission.
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