02 — Capability · BC-1140.50
Quality Records & Audit Readiness
Maintain batch records, certificates and the plant's quality system evidence so that an internal, customer or regulatory audit is a review of what exists rather than a scramble to create it.
- Batch Records
- Certificates of Analysis
- Quality Documentation
In scope
- Batch and device history records
- Certificates of conformance and analysis for shipments
- Plant internal audits and audit response
- Document and procedure control at the plant
Out of scope
- Enterprise compliance program and regulatory affairs (see BC-140)
- Internal audit function (see BC-160)
Decomposes into · 4
- BC-1140.50.10Batch Record ManagementCompile and review the complete record of how each batch or serialized unit was made and tested before it is released.
- BC-1140.50.20Certificate IssuanceProduce the certificates of conformance or analysis a shipment needs, drawn from actual results and signed by someone accountable.
- BC-1140.50.30Plant Quality AuditsAudit the plant's own processes against its procedures and standards on a schedule, and host external audits with findings tracked to closure.
- BC-1140.50.40Plant Document ControlKeep procedures, work instructions and specifications at the current revision on the floor, with superseded versions withdrawn.