Proactive
Risk is assessed before problems appear. QRM is integrated across the quality system and informed by data, not just judgement.
What a stage is not
The stages are SPEQ’s organising device for building a risk-based quality system, not a regulator’s mandated sequence. Real programmes overlap and revisit them, and no inspection asks which stage you are in.
Attention has started moving before failure. Signals are read as signals — a drifting trend, a supplier’s changed answer, a near-miss nobody had to report — and they change what gets watched. The register stops being a record of what went wrong and becomes a hypothesis about what might, which is a different document written by a different habit of mind.
- ·Risks are identified from trends and near-misses, not only from failures
- ·Risk assessments are informed by monitoring data, not opinion alone
- ·The organisation acts on leading indicators before they become findings
WHY ORGANISATIONS STOP HERE
The stall here is organisational rather than technical. Proactive work is, by construction, work whose value cannot be demonstrated: the failure that did not happen leaves no evidence, so the budget for preventing it competes against costs that are measurable. Organisations reach this stage and slide back not because the method fails but because nobody can point at what it bought.
- Feed process, complaint, and deviation trends into risk reassessment automatically
- Use knowledge management so lessons from one area update risk elsewhere
- Adopt Q12 lifecycle thinking — let demonstrated control earn regulatory flexibility
- ·Leading indicators are monitored and trigger preventive action
- ·Risk and knowledge flow between the PQS elements
- ·Preventive actions outnumber corrective ones