Batch Record Review
Complete per batch.
- Industry: Manufacturing
- Frequency: Per batch
- Estimated Time: 30-60 minutes
- Role: Quality
- Total Items: 30
- Compliance: cGMP, FDA
Record Review
Review batch record.
- Record complete?
- All signatures present?
- No unexplained deviations?
Pre-Shift Verification & Setup
Initial verification before operations begin
- Operator / Inspector Name
- Date
- Shift Number
- Production Line / Area
- Previous shift handover notes reviewed?
Safety Protocols & Compliance
Verify all safety measures are in place per OSHA standards
- LOTO procedures verified for all equipment?
- All machine guards in place and secured?
- Emergency stop buttons tested and functional?
- Required PPE worn by all operators?
- Safety signage visible and current?
Equipment & Operational Readiness
Verify equipment is calibrated and operational
- Equipment calibration current and documented?
- All gauges and instruments reading correctly?
- Lubrication schedule maintained?
- Any abnormal sounds, vibrations, or leaks?
Quality Control Standards
Verify product quality meets specifications
- Current specifications/work instructions available?
- First article inspection completed?
- Measurement tools calibrated and in tolerance?
- Reject/scrap rate within acceptable limits?
Housekeeping & Work Environment
Workplace cleanliness and environmental conditions
- 5S standards maintained (Sort, Set, Shine, Standardize, Sustain)?
- Spill containment and cleanup supplies available?
- Ventilation adequate in work area?
- Waste properly segregated and disposed?
Documentation & Records
Complete all required documentation and reporting
- Production logs updated with current data?
- Any non-conformances documented on NCR?
- Corrective actions identified and assigned?
- Supervisor Signature
- Additional Remarks
Related Manufacturing Checklists
- In-Process Inspection
- Gauge Calibration
- Internal Quality Audit
- Supplier Quality Audit
- Customer Return Analysis
- Laboratory Testing
- Reliability Testing
- Control Plan Review
Related Quality Assurance Checklists
- Quality Control Inspection Checklist - FREE Download
- Incoming Material Inspection - Quality Assurance Checklist - FREE Download
- Final Inspection - FREE Download
- Non-Conformance Report - FREE Download
- Corrective Action Tracking - FREE Download
- Scrap Tracking Log - FREE Download
- Rework Verification - FREE Download
- In-Process Inspection - FREE Download
- Gauge Calibration - FREE Download
- Internal Quality Audit - FREE Download
Why Use This Batch Record Review?
This batch record review helps manufacturing teams maintain compliance and operational excellence. Designed for quality professionals, this checklist covers 30 critical inspection points across 7 sections. Recommended frequency: per batch.
Ensures compliance with cGMP, FDA. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Batch Record Review cover?
This checklist covers 30 inspection items across 7 sections: Record Review, Pre-Shift Verification & Setup, Safety Protocols & Compliance, Equipment & Operational Readiness, Quality Control Standards, Housekeeping & Work Environment, Documentation & Records. It is designed for manufacturing operations and compliance.
How often should this checklist be completed?
This checklist should be completed per batch. Each completion takes approximately 30-60 minutes.
Who should use this Batch Record Review?
This checklist is designed for Quality professionals in the manufacturing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.