Cleanroom Gowning Checklist
This checklist standardizes cleanroom gowning checklist to improve throughput, quality, and safety in manufacturing environments. Use it to document controls, capture deviations, and assign corrective actions with sign-off. Includes GMP-style documentation and hygiene controls where applicable.
- Industry: Manufacturing & Industrial
- Frequency: Per Batch
- Estimated Time: 30-45 minutes
- Role: EHS Manager
- Total Items: 45
- Compliance: OSHA 29 CFR 1910.132 (PPE), GMP principles (as applicable)
Planning & Documentation
Confirm work orders, batch records, and required documents.
- SOP followed with no skipped steps?
- Any issues found that require escalation?
- Corrective action assigned and tracked?
- Time spent on this section
- Notes
Safety & PPE
Verify PPE, hazard controls, and safe work permits.
- SOP followed with no skipped steps?
- Any issues found that require escalation?
- Corrective action assigned and tracked?
- Time spent on this section
- Photo evidence
Process Execution
Verify SOP steps, parameters, and operator checks.
- SOP followed with no skipped steps?
- Any issues found that require escalation?
- Corrective action assigned and tracked?
- Output recorded
- Notes
Quality & Release
Verify inspections, records, and release/hold decisions.
- SOP followed with no skipped steps?
- Any issues found that require escalation?
- Corrective action assigned and tracked?
- Defects found
- Photo evidence
Equipment & Maintenance
Verify equipment readiness, defects tagging, and PM status.
- SOP followed with no skipped steps?
- Any issues found that require escalation?
- Corrective action assigned and tracked?
- Time spent on this section
- Photo evidence
Materials & Inventory Control
Verify staging, traceability, and correct material usage.
- SOP followed with no skipped steps?
- Any issues found that require escalation?
- Corrective action assigned and tracked?
- Lots/serials captured (count)
- Notes
Environmental & Utilities
Verify utilities, emissions/waste controls, and environmental logs.
- SOP followed with no skipped steps?
- Any issues found that require escalation?
- Corrective action assigned and tracked?
- Time spent on this section
- Photo evidence
Issues & CAPA
Document issues, assign owners, and verify corrective action.
- SOP followed with no skipped steps?
- Any issues found that require escalation?
- Corrective action assigned and tracked?
- Time spent on this section
- Photo evidence
QA, Corrective Actions & Sign-Off
Confirm completion, prioritize issues, and capture signatures for accountability.
- QA review completed?
- Any critical issues still open?
- Overall risk level
- Supervisor Signature
- Quality/EHS Signature
Related Manufacturing Industrial Checklists
- Personnel Hygiene Checklist
- Industrial Manufacturing Supplier Quality Audit
- Internal Quality Audit Checklist
- Customer Complaint Handling Checklist
- Industrial Manufacturing HazCom & SDS Availability Checklist
- PPE Compliance Checklist
- Industrial Manufacturing Lockout/Tagout (LOTO) Checklist
- Industrial Manufacturing Confined Space Entry Checklist
Related Quality Gmp Checklists
- Incoming Material Inspection Checklist - FREE Download
- In-Process Inspection Checklist - FREE Download
- Final Release & COA Checklist - FREE Download
- Nonconformance (NCR) Checklist - FREE Download
- CAPA Management Checklist - FREE Download
- Industrial Manufacturing Document Control Checklist - FREE Download
- Training Records Compliance Checklist - FREE Download
- Lot Traceability Checklist - FREE Download
- Change Control Checklist - FREE Download
- GMP Sanitation Checklist - FREE Download
Why Use This Cleanroom Gowning Checklist?
This cleanroom gowning checklist helps manufacturing & industrial teams maintain compliance and operational excellence. Designed for ehs manager professionals, this checklist covers 45 critical inspection points across 9 sections. Recommended frequency: per batch.
Ensures compliance with OSHA 29 CFR 1910.132 (PPE), GMP principles (as applicable). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Cleanroom Gowning Checklist cover?
This checklist covers 45 inspection items across 9 sections: Planning & Documentation, Safety & PPE, Process Execution, Quality & Release, Equipment & Maintenance, Materials & Inventory Control, Environmental & Utilities, Issues & CAPA, QA, Corrective Actions & Sign-Off. It is designed for manufacturing & industrial 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 Cleanroom Gowning Checklist?
This checklist is designed for EHS Manager professionals in the manufacturing & industrial 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.