FSMA Preventive Controls Audit - FREE PDF
Audit FSMA Preventive Controls compliance for FDA-regulated facilities.
- Industry: Food Manufacturing
- Frequency: Annual / Quarterly
- Estimated Time: 4-8 hours
- Role: PCQI / Food Safety Manager
- Total Items: 31
- Compliance: FDA 21 CFR 117, FSMA PCHF
Preparation & Setup
Verify readiness and preparation.
- Area/equipment ready for operation?
- Supplies adequately stocked?
- Equipment functioning properly?
Safety & Compliance
Verify FDA 21 CFR 117 requirements.
- Required temperatures verified?
- Sanitation procedures completed?
- Safety hazards addressed?
Quality & Brand Standards
Verify quality and presentation standards.
- Presentation meets standards?
- Brand standards met?
- Guest/customer ready?
Issues & Corrective Actions
Document any issues found.
- Overall Result
- Issues Found
- Actions Taken
- 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?
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Why Use This FSMA Preventive Controls Audit?
This fsma preventive controls audit helps food manufacturing teams maintain compliance and operational excellence. Designed for pcqi / food safety manager professionals, this checklist covers 31 critical inspection points across 8 sections. Recommended frequency: annual / quarterly.
Ensures compliance with FDA 21 CFR 117, FSMA PCHF. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the FSMA Preventive Controls Audit cover?
This checklist covers 31 inspection items across 8 sections: Preparation & Setup, Safety & Compliance, Quality & Brand Standards, Issues & Corrective Actions, Initial Setup & Documentation, Safety & Compliance Verification, Operational Standards Check, Quality Assessment. It is designed for food manufacturing operations and compliance.
How often should this checklist be completed?
This checklist should be completed annual / quarterly. Each completion takes approximately 4-8 hours.
Who should use this FSMA Preventive Controls Audit?
This checklist is designed for PCQI / Food Safety Manager professionals in the food 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.