Manufacturing Process Audit Review Checklist Form
Manufacturing Process Audit Review Checklist Form
Process documentation and current work instructions
Current approved process documentation is available
Current work instructions are accessible at the point of use
Document revisions and approvals are identifiable
Training and operator qualification records
Training records are available for relevant operators
Operator qualifications match assigned process tasks
Required training updates or renewals are documented
Equipment readiness, maintenance, and calibration
Equipment readiness is checked before use
Preventive maintenance records are available and current
Calibration status is documented for applicable equipment
Material identification, traceability, and storage
Materials are identified with appropriate status and details
Material traceability is maintained through the process
Storage conditions and segregation practices are followed
In-process controls and inspection records
Defined in-process control checks are performed
Inspection results are recorded and identifiable
Measurement methods and acceptance criteria are available
Nonconformance identification, containment, and corrective-action records
Nonconforming material or product is identified
Containment actions are documented where applicable
Corrective-action records include follow-up or effectiveness review
Workplace organization, housekeeping, and safe operating practices
Work areas are organized and materials are appropriately placed
Housekeeping practices are maintained in the audited area
Safe operating practices and applicable safeguards are observed
Process-change control and approval records
Process changes are documented and traceable
Required reviews and approvals are recorded before implementation
Relevant instructions or training are updated after changes
Production records, lot traceability, and record completeness
Production records identify the relevant process and output
Lot or batch traceability information is recorded
Records reviewed are legible, complete, and retrievable
Audit closeout
Audit findings are documented
Owners are assigned to follow-up items
Follow-up actions are recorded
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