Manufacturing Batch Production Record Review Checklist
Comprehensive batch production record review checklist.
- Industry: Manufacturing
- Frequency: Per batch
- Estimated Time: 30-45 minutes
- Role: Quality Assurance
- Total Items: 23
- Compliance: GMP, FDA 21 CFR 211, ISO 13485
Documentation Completeness
Record review
- All pages present and numbered?
- All required signatures present?
- All entries dated?
Process Verification
Manufacturing steps
- Process parameters within specifications?
- Yield within acceptable range?
Deviations
Deviation review
- Deviations properly documented?
- Deviations resolved before release?
Machine Guarding
OSHA 1910 Subpart O
- Machine guards in place?
- E-stop buttons tested?
- Safety interlocks functional?
- Light curtains operational?
Chemical Safety
OSHA 1910.1200 HazCom
- SDS sheets available?
- Containers labeled?
- Secondary containment?
Ergonomics
Ergonomic assessment
- Workstation heights OK?
- Lifting aids available?
- Anti-fatigue mats present?
Quality Control
Product quality
- Tools calibrated?
- Defect rate acceptable?
- First article approved?
Environmental Controls
Ventilation and monitoring
- Ventilation operating?
- Noise within limits?
- Lighting adequate?
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Why Use This Manufacturing Batch Production Record Review Checklist?
This manufacturing batch production record review checklist helps manufacturing teams maintain compliance and operational excellence. Designed for quality assurance professionals, this checklist covers 23 critical inspection points across 8 sections. Recommended frequency: per batch.
Ensures compliance with GMP, FDA 21 CFR 211, ISO 13485. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Manufacturing Batch Production Record Review Checklist cover?
This checklist covers 23 inspection items across 8 sections: Documentation Completeness, Process Verification, Deviations, Machine Guarding, Chemical Safety, Ergonomics, Quality Control, Environmental Controls. 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 30-45 minutes.
Who should use this Manufacturing Batch Production Record Review Checklist?
This checklist is designed for Quality Assurance 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.