Areas to analyze:
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Specific Points of Analysis:
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Suppliers / Supplies
Raw Materials
Crisis Management
Product Recalls
Complaints
Audit Traceability
Document Traceability
Allergens
Microbial Control
Sanitation
Cross Contact /
Contamination
Packaging and Label
Issues
HACCP
Organization
Pest Control
Safety
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All floors free of garbage, pests, debris, etc.
Tools in appropriate areas
Cleanliness of equipment, floors, sinks, QA
critical equipment, etc.
Operators following GMPs
Traceability of Batch Records and floor
protocols
GDP of documents on floor
Standing water
Calibration dates
Finished product specifications and raw
material storage
Propped doors, openings that are not allowed,
broken windows/ doors/ equipment.
Environment and equipment maintenance
Glass and brittles
CCP checks
Safety all around
Findings: Actionable items for operators to drive and follow up on!
Building/ Area: ____________ Auditor(s): _________________ Date: _________
Production Attendee: _______________________
Finding
Major/
Minor
Resolved
during
audit?
(Yes/ No)
Comments/Follow Up Required
Production sign & Date: ________________________________________________________________
Quality sign & Date: ___________________________________________________________________