Single Point of Failure in GMP Operations
What is a single point of failure?
A single point of failure is one element, a person, a system or a step, whose failure stops the whole process because nothing else can take its place. Engineers remove single points of failure from equipment with redundancy. In operations, the most common single point of failure is a person.
What does a human single point of failure look like?
One person approves a step and has no qualified deputy. One person knows how to run an investigation, a report or a recovery. One inbox holds every scheduling conversation. The process works every day, until that person is away.
How does HDI find single points of failure?
The screening asks what happens when the person responsible for a critical process is unavailable for three working days: nothing, a slowdown, a near standstill or a full stop. It also asks whether important processes depend on the knowledge of specific people. If they do, the result cannot fall below the High Risk band. The audit then confirms each single point of failure in the workshop, process by process.
Related terms
- Bus factor: a bus factor of 1 is a human single point of failure.
- Key-person risk: the business risk it creates.
- Operational resilience in GMP: what removing it achieves.