Operational readiness

People, procedures, materials, and the quality system are made ready to run the asset routinely: SOPs, training and qualification, the live deviation/CAPA/change-control system, and the supply chain into the new line.

Purpose

Make the organisation ready to operate the asset in a state of control from the first commercial batch.

Work performed

• Author and approve the SOPs the asset runs on and train/qualify personnel to them
• Bring the deviation, CAPA, and change-control systems live on the new asset
• Confirm materials, supply chain, warehousing, and maintenance/calibration readiness
• Run an operational readiness review against a defined checklist before start-up

Who is involved

• Operations, quality, and the site training function
• Supply chain, warehousing, and maintenance/engineering
• Quality systems owners (deviation/CAPA/change control)

What quality owns

• Approval of SOPs and confirmation personnel are trained and qualified
• That the quality system (deviation/CAPA/change control) is live on the asset

What engineering owns

• Maintenance, calibration, and spare-parts readiness for the asset
• Handover of engineering documentation into the maintenance system

What operations owns

• Staffing, shift structure, and operator qualification for routine running
• Material flow, warehousing, and the day-one production plan

Management decisions

• The operational readiness go/no-go for start-up
• Resourcing of any readiness gaps before the first commercial batch

Deliverables

• Approved SOPs and completed training/qualification records
• Operational readiness review and gap register
• Live quality-system configuration for the asset

Evidence to retain

• Training and personnel-qualification records
• The operational readiness review and its go/no-go decision

Common risks

• A qualified asset with SOPs or trained staff not ready, stalling start-up
• Quality system not truly live, so early deviations are mishandled
• Supply-chain or maintenance gaps that surface in the first weeks

Gate criteria to advance

• SOPs approved and personnel trained and qualified for their tasks
• Deviation, CAPA, and change control live on the new asset
• Materials, supply chain, and maintenance readiness confirmed

Expensive if deferred

• Training and SOP readiness — gaps become first-batch deviations and lost start-up time
• A live quality system — mishandled early deviations are a shaky first-inspection signal

Business effect

A qualified asset with an unready organisation stalls at start-up; readiness gaps show up as early deviations and a shaky first inspection.

Greenfield vs brownfield

Greenfield stands up a whole new organisation and quality system; brownfield extends the existing site’s trained workforce and live quality system onto the new asset, so readiness is incremental rather than wholesale.