Continual improvement of a SOMS based on ISO 18788
What the exam tests
This domain tests nonconformity and corrective action, improvement opportunities, and the PDCA loop. It asks whether you can distinguish correction from root-cause action and show effectiveness.
Core rules and concepts
- When a nonconformity occurs, control it, correct it, evaluate the need for action, determine root cause, implement corrective action, and verify effectiveness.
- Correction fixes the immediate problem; corrective action addresses the cause. Retraining alone is often a correction, not a root-cause fix.
- Improvement can be reactive from incidents, complaints, audits, and nonconformities, or proactive from data trends, technology, and lessons learned.
- Changes to the SOMS must be planned and risk-assessed so improvements do not create new risks.
- Management review and performance data should feed improvement priorities.
Worked example
Incident reports arrive late at three sites. The correction is to remind staff. Root-cause analysis finds no mobile reporting option and fear of blame. Corrective actions: a mobile form, a no-blame reporting policy, and supervisor training. Effectiveness is checked by measuring report timeliness for three months and auditing a sample. Reasoning: the cause was systemic, so retraining alone would not prevent recurrence.
Traps
Calling retraining a root-cause fix. Closing corrective actions without verifying effectiveness. Confusing correction with corrective action. Ignoring positive improvement opportunities. Failing to update risk assessments after changes. Treating complaints as a public-relations issue rather than improvement input.