Clean Room Inspection - FREE PDF
Inspect clean room environments for compliance and contamination control.
- Industry: Pharmaceutical / Electronics / Biotech
- Frequency: Daily / Per shift
- Estimated Time: 30-60 minutes
- Role: Clean Room Technician / QA
- Total Items: 32
- Compliance: ISO 14644, FDA, EU GMP Annex 1
General Assessment
Overall facility/store condition assessment.
- Overall appearance acceptable?
- Signage correct and visible?
- Lighting adequate?
Safety & Compliance
Verify safety requirements per ISO 14644.
- Safety hazards addressed?
- Emergency equipment accessible?
- Required PPE available?
- Staff training current?
Operations Review
Evaluate operational procedures and practices.
- Procedures being followed?
- Equipment functioning properly?
- Documentation complete?
Findings & Actions
Document findings and corrective actions.
- Overall Result
- Deficiencies Found
- Corrective Actions
- Inspector Signature
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?
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Why Use This Clean Room Inspection?
This clean room inspection helps pharmaceutical / electronics / biotech teams maintain compliance and operational excellence. Designed for clean room technician / qa professionals, this checklist covers 32 critical inspection points across 8 sections. Recommended frequency: daily / per shift.
Ensures compliance with ISO 14644, FDA, EU GMP Annex 1. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Clean Room Inspection cover?
This checklist covers 32 inspection items across 8 sections: General Assessment, Safety & Compliance, Operations Review, Findings & Actions, Pre-Shift Verification & Setup, Safety Protocols & Compliance, Equipment & Operational Readiness, Quality Control Standards. It is designed for pharmaceutical / electronics / biotech operations and compliance.
How often should this checklist be completed?
This checklist should be completed daily / per shift. Each completion takes approximately 30-60 minutes.
Who should use this Clean Room Inspection?
This checklist is designed for Clean Room Technician / QA professionals in the pharmaceutical / electronics / biotech 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.