Handling deviations during qualification
A test that fails or cannot be executed as written is a deviation. Record it, assess it, decide, and let the report show the whole story.
Qualification rarely runs exactly to plan. Sensors fail, doors are left open, a set point cannot be reached. Each event is a protocol deviation to be recorded at the time, assessed for impact on the validity of the test, and resolved — by repeating the test, by accepting the result with justification, or by declaring the requirement unmet.
Failure to meet acceptance criteria
- Confirm the data are valid (sensor calibration, placement, timing).
- Investigate cause: equipment, environment, protocol design.
- Options: remediate and repeat; restrict use (exclude a location); reject the system.
- Record the decision, the rationale and the approvals.
A qualification report with no deviations recorded is more suspicious than one with several well-handled ones.
Frequently asked questions
- Can a failed mapping position simply be excluded from storage?
- Yes, if the exclusion is documented, physically enforced (signage, blocking) and included in the monitoring and periodic-review scope.
References
- [1]EudraLex Volume 4, Annex 15: Qualification and Validation (2015)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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