Module spotlight: Deviations & Non-Conformance Reports
When something does not go to plan, the response has to be structured and traceable. Deviations and NCRs capture the problem and connect it to the action that fixes it.
By MoniDoseQMS Team
Things go wrong — a process drifts, a product fails a check, a step is missed. What separates a strong quality system from a weak one is how that is handled. Deviation management and non-conformance reports capture the event in a structured way and connect it to the corrective action it should trigger.
What you can do
- Log deviations with severity, priority, and type (manufacturing, quality control, equipment, material, human error, and more)
- Raise non-conformance reports with detection dates and module links
- Link each record to the products, processes, or equipment involved
- Drive a CAPA directly from a deviation or non-conformance
Why it matters
ISO 13485 §8.3 requires control of nonconforming product, and §8.5 requires improvement. Capturing deviations and NCRs in a connected system means problems are not just recorded — they are routed to resolution and held in a traceable chain from event to corrective action.