OPS.18:8 - Common Anti-Patterns and How to Avoid Them

Misuse	Working repair
Treat statistical stability as product conformity.	Compare output with its requirement and obtain the applicable capability or acceptance result.
Use a chart signal as proof of a specific cause.	Contain as required and investigate the actual mechanism.
Let an error budget authorize every kind of loss.	Preserve independent safety, human, clinical and acceptance conditions.
Accept a lot because the process chart looks normal.	Apply the lot’s qualified acceptance plan and risks.
Resume normal work when the reporting window resets.	Verify the actual restart conditions and obtain the authorized continuation decision.
Reuse an old monitor after the population or failure modes change.	Requalify the affected observation and detection method for the new use.