Reactive
Risk is managed after it materialises. Quality is a series of responses to things that already went wrong.
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.
Everything is urgent and nothing is anticipated. The people are usually competent and often exhausted, because the system routes every problem to the same small group at the moment it becomes a crisis. Risk is not ignored here — it is priced entirely in hindsight. The tell is that nobody can answer "what are we most exposed to?" without first asking "what happened recently?", because the two questions have collapsed into one.
- ·Risk assessments happen only when a regulator, auditor, or customer asks for one
- ·The same problems recur; effort goes to firefighting, not prevention
- ·There is no shared method for deciding what to worry about first
WHY ORGANISATIONS STOP HERE
Reactive works, right up until it does not, and that is exactly why it persists. Firefighting produces visible heroics and a defensible record: problems were found and fixed, inspections were survived. What it cannot produce is a reason to spend attention on something that has not gone wrong yet, so the first preventive investment always loses the argument against the fire currently burning.
- Adopt a single, simple risk-assessment method (e.g. a risk matrix) and use it on your top recurring problems
- Start a risk register — even a spreadsheet — so risks are named, owned, and visible
- Read ICH Q9(R1) and translate its principles into one page for your team
- ·Problems drive activity; the calendar does not
- ·Investigations stop at the first plausible cause
- ·Quality is judged by whether the last inspection passed