Operational Readiness Review (ORR)
Structured operational readiness review template for the transition from project to operations: readiness dimensions (SOPs, training, materials, maintenance and calibration, live quality system), a weighted scorecard, an open-gap register, and a documented go/no-go recommendation.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A structured, evidence-based review answering one question before start-up: is the operating organisation — people, procedures, materials, maintenance and the live quality system — ready to run the facility, not merely the equipment ready to be run? Qualified equipment in an unready organisation is the failure this review exists to catch, and which gaps block start-up is the organisation’s own call.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
ICH Q10 makes management responsible for resources, training and a functioning quality system before commercial operation; 21 CFR Part 211 requires qualified personnel, approved procedures and controlled materials from the first batch; and EU GMP Annex 15 frames qualification and validation as a prerequisite to routine use. None of them sets your readiness criteria or decides which open gap is tolerable at start-up — that judgement is the organisation’s. The readiness-dimension structure and scorecard are SPEQ practitioner synthesis.
WHERE NEXT
- FILL IT INHow to Conduct an Operational Readiness Review →The procedure this template records, one step at a time.
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