Manufacturing Document Control Audit Checklist
Comprehensive document control system audit checklist.
- Industry: Manufacturing
- Frequency: Annually
- Estimated Time: 30-45 minutes
- Role: Quality Auditor
- Total Items: 22
- Compliance: ISO 9001, FDA 21 CFR Part 11
Document Approval
Approval process
- Document approval process defined?
- Approval authorities defined?
Revision Control
Version control
- Document revisions controlled?
- Change history maintained?
Distribution
Document access
- Current versions available at point of use?
- Obsolete documents controlled?
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?
Related Manufacturing Checklists
- Manufacturing Equipment Calibration Checklist
- Manufacturing Final Inspection Checklist
- Manufacturing First Article Inspection FAI Checklist
- Manufacturing Fixture Verification Checklist
- Manufacturing Drill Press Safety Inspection Checklist
- Manufacturing EDM Machine Safety Inspection Checklist
- Manufacturing Electrical Safety Program Audit Checklist
- Manufacturing Emergency Action Plan Drill Evaluation Checklist
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Why Use This Manufacturing Document Control Audit Checklist?
This manufacturing document control audit checklist helps manufacturing teams maintain compliance and operational excellence. Designed for quality auditor professionals, this checklist covers 22 critical inspection points across 8 sections. Recommended frequency: annually.
Ensures compliance with ISO 9001, FDA 21 CFR Part 11. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Manufacturing Document Control Audit Checklist cover?
This checklist covers 22 inspection items across 8 sections: Document Approval, Revision Control, Distribution, 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 annually. Each completion takes approximately 30-45 minutes.
Who should use this Manufacturing Document Control Audit Checklist?
This checklist is designed for Quality Auditor 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.