Batch quality to release

Step by step

1. Batch planning Production Manager

   Production Manager creates a batch for a named product, records the lot number, quantity, site and line, and advances the batch from Planned when production begins.

   • Identifies the product and manufacturing lot
   • Updates Products, Batches

2. Testing QC Analyst

   QC Analyst records results against the batch and its product specification. The outcome and analyst note explain the observed result.

   • Connects requirement and result to the lot
   • Updates Quality specifications, Test results, Batches

3. Deviation review QA Manager

   QA Manager investigates exceptions against the same batch, including any equipment context.

   • Preserves the investigation and asset context
   • Updates Deviations, Equipment, Batches

4. CAPA follow-up QA Manager

   QA Manager follows linked actions and the effectiveness check when a deviation requires corrective work.

   • Tracks action and effectiveness
   • Updates Capa actions, Deviations

5. Quality review QA Manager

   QA Manager examines the lot's results, open exceptions, relevant changes and calibration state; unresolved lots remain Quarantined.

   • Records the batch state after evidence review
   • Updates Batches, Test results, Deviations, Change controls
   ApprovalA person approves before the work moves on.

6. Batch release QA Manager

   Qualified Person records the release decision and its rationale. For a Release decision, QA Manager marks the reviewed batch Approved; the workflow then changes every Approved batch to Released and writes a receipt. Other decisions stay outside Approved.

   • Captures judgment, posting and operation outcome
   • Updates Release decisions, Batches, Operation receipts
   ApprovalA person approves before the work moves on.

Production Manager

, QC Analyst, QA Manager and Qualified Person work through this process; Admin maintains the product and specification reference data.