Deviation Investigation Checklist - FREE PDF
Investigate manufacturing deviations per quality system requirements.
- Industry: Pharmaceutical
- Frequency: Per deviation
- Estimated Time: 4-40 hours
- Role: QA / Deviation Investigator
- Total Items: 30
- Compliance: FDA 21 CFR 211, ICH Q10, EU GMP
Pre-Inspection Setup
Verify conditions before proceeding.
- Proper authorization obtained?
- Required documentation available?
- Safety precautions in place?
Inspection Items
Detailed inspection per FDA 21 CFR 211.
- Overall condition acceptable?
- Regulatory compliance verified?
- Safety features functional?
- Documentation current?
Deficiencies & Corrective Actions
Document findings and required actions.
- Inspection Result
- Deficiencies Description
- Corrective Actions Required
- Follow-up Date
- Inspector Signature
Initial Setup & Documentation
Complete initial documentation and preparation
- Inspector / Assessor Name
- Date
- Location / Area
- Inspection Type
- Previous findings reviewed?
Safety & Compliance Verification
Verify all safety requirements are met
- All safety protocols being followed?
- Emergency exits clear and accessible?
- First aid supplies available and stocked?
- All hazards identified and controlled?
- Required PPE being worn correctly?
Operational Standards Check
Verify operational standards and procedures are maintained
- Standard operating procedures being followed?
- All equipment in proper working condition?
- Maintenance schedule current?
- All staff training current and documented?
Quality Assessment
Evaluate quality standards and performance metrics
- Quality standards met for all items checked?
- Any deficiencies or non-conformances identified?
- Root cause analysis completed for issues?
- Continuous improvement opportunities identified?
Related Pharmaceutical Checklists
- Pharmaceutical Gmp Batch Record Review Checklist
- Pharmaceutical Cleanroom Environmental Monitoring Checklist
- Pharmaceutical Aseptic Processing Checklist
- Pharmaceutical Equipment Cleaning Validation Checklist
Why Use This Deviation Investigation Checklist?
This deviation investigation checklist helps pharmaceutical teams maintain compliance and operational excellence. Designed for qa / deviation investigator professionals, this checklist covers 30 critical inspection points across 7 sections. Recommended frequency: per deviation.
Ensures compliance with FDA 21 CFR 211, ICH Q10, EU GMP. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Deviation Investigation Checklist cover?
This checklist covers 30 inspection items across 7 sections: Pre-Inspection Setup, Inspection Items, Deficiencies & Corrective Actions, Initial Setup & Documentation, Safety & Compliance Verification, Operational Standards Check, Quality Assessment. It is designed for pharmaceutical operations and compliance.
How often should this checklist be completed?
This checklist should be completed per deviation. Each completion takes approximately 4-40 hours.
Who should use this Deviation Investigation Checklist?
This checklist is designed for QA / Deviation Investigator professionals in the pharmaceutical 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.