How to Conduct an Operational Readiness Review

An operational readiness review (ORR) confirms that a facility or system is ready to begin routine GxP operation — not just qualified equipment, but the SOPs, trained people, materials, utilities, and quality systems needed to run it. It is the final check that catches the readiness gaps qualification alone does not cover.

1. 1

   Define readiness criteria across all elements

   Define readiness criteria across every element that has to be in place, not only the equipment: qualified systems, approved procedures, trained and assessed people, calibrated instruments, established maintenance and cleaning programmes, agreed material supply and specifications, and the quality-system processes — deviation, change, complaint — able to receive events from this operation. Readiness fails at the least-considered element, which is rarely the equipment.

2. 2

   Verify each element against evidence

   Verify each element against evidence rather than against assurance. The distinction is practical: "procedures are complete" and "procedures are approved, issued at the point of use in their current version, and the people working to them have been trained against that version" are different claims, and only the second is a readiness state. Record the evidence examined so the review can be revisited.

3. 3

   Check the human and procedural readiness

   Check human and procedural readiness specifically, because it is the element that slips most and shows least. Are the right number of trained people available across the shift pattern, including cover? Have they practised the operation rather than been trained on it? Do the procedures match the equipment as installed, including the changes made late in commissioning? A readiness review that only reads documents cannot answer these.

4. 4

   Decide readiness and track gaps

   Reach a readiness decision and track the gaps that remain, with each gap carrying an owner, a date and an interim control where operation is proceeding anyway. Partial readiness is a legitimate position when it is stated; it becomes a problem when it is implicit, because nobody then knows which risks are being carried or by whom.

5. 5

   Document the review

   Document the review, the evidence, the decision and the accepted gaps. This record is the bridge between the project and the operation, and it is where accountability transfers — after it, the gaps belong to the operating organisation and its quality system rather than to the project, and that transfer should be explicit rather than a consequence of the project team dispersing.