FSMA Template Package List of Documents

Transcription

1 FSMA Template Package List of Documents FSMA PC Rule, Subpart B containing the following 47 Documents: 001 Air Purity and Ventilation (provided upon purchase) 002 Allergen Management Program (provided upon purchase) 003 Animal Food By-product (provided upon purchase) 004 Cleaning and Sanitizing Equipment (provided upon purchase) 005 Cleaning and Sanitizing (provided upon purchase) 006 Cold Storage, Freezing and Chilling (provided upon purchase) 007 Construction and Sanitary Facilities (provided upon purchase) 008 Control of Foreign Material Contamination (provided upon purchase) 009 Defect Action Levels (provided upon purchase) 010 Detection of Foreign Objects (provided upon purchase) 011 Drains (provided upon purchase) 012 Equipment (provided upon purchase) 013 Food Defense Risk Assessment (provided upon purchase) 014 Hold & Non-conforming Product (provided upon purchase) 015 Loading, Unloading and Transport (provided upon purchase) 016 Maintenance and Repair (provided upon purchase) 017 Management of Pest and Vermin (provided upon purchase) 018 Microbiological Specifications (provided upon purchase) 019 Monthly Internal Inspections (provided upon purchase) 020 Personnel Hygiene (provided upon purchase) 021 Plant and Grounds (provided upon purchase) 022 Preventative Maintenance (provided upon purchase) 023 Process and Manufacturing Controls (provided upon purchase) 024 Raw Materials (provided upon purchase) 025 Rework Program (provided upon purchase) 026 Specifications (provided upon purchase) 027 Storage and Warehouse (provided upon purchase) 028 Storage of Hazardous Chemicals and Toxic Substances (provided upon purchase) 029 Waste Management (provided upon purchase)

2 030 Water, Ice, Air Supply & Boiler (provided upon purchase) 031 Color-coding Program N/A - Added to Package 032 Complaint Management N/A - Added to Package 033 Formula and Ingredient Change N/A - Added to Package 034 Knife Control N/A - Added to Package 035 Label Verification N/A - Added to Package 036 Laboratory Facilities N/A - Added to Package 037 Organic & GMO N/A - Added to Package 038 Packaging N/A - Added to Package 039 Pallet Inspection Program N/A - Added to Package 040 Product Sampling & Inspection N/A - Added to Package 041 Product Development N/A - Added to Package 042 Regulatory and Outside Agencies N/A - Added to Package 043 Stock Rotation N/A - Added to Package 044 Tempering N/A - Added to Package 045 Thermometer Calibration N/A - Added to Package 046 Weight Control N/A - Added to Package 047 Wood Policy N/A - Added to Package FSMA PC Rule, Subpart C containing the following 29 Documents: 001 Control of Measuring and Calibration (provided upon purchase) 002 Corrective and Preventative Actions (provided upon purchase) 003 Environmental Monitoring Program (provided upon purchase) 004 Food Safety Plan (provided upon purchase) 005 Food Safety Plan Literature Registry (provided upon purchase) 006 Food Safety Plan Team Members (provided upon purchase) 007 Food Safety Plan - Training Log (provided upon purchase) 008 Food Safety Plan Verification Schedule (provided upon purchase) 009 Hazard Analysis - Raw Ingredients (provided upon purchase) 010 Hazard Analysis - Preventive Controls & HACCP (provided upon purchase) 011 Hazard Analysis - Preventive Controls & HACCP (provided upon purchase) 012 History of Modifications (provided upon purchase) 013 Master Sanitation Schedule (provided upon purchase) 014 Monitoring (provided upon purchase) 015 Preventive Controls Outline - Allergens (provided upon purchase) 016 Preventive Controls Outline - Process Controls (provided upon purchase) 017 Preventive Controls Outline - Supply Chain (provided upon purchase) 018 Preventive Controls Outline - Sanitation Example (provided upon purchase) 019 Process Flow Diagram Example (provided upon purchase)

3 020 Product Description (provided upon purchase) 021 Reanalysis (provided upon purchase) 022 Recall, Withdrawal and Traceability (provided upon purchase) 023 Records Controls and Review (provided upon purchase) 024 Requirements for PCQI and Qualified Auditor (provided upon purchase) 025 SSOP's (provided upon purchase) 026 Training - Preventive Controls Crew (provided upon purchase) 027 Verification and Validation Outline (provided upon purchase) 028 Verification and Validation Policy (provided upon purchase) 029 Pathogen Activation Tables N/A - Added to Package FSMA PC Rule, Subpart C containing the following Document: 001 Supply Chain Program (provided upon purchase) Soterian Systems Proprietary Forms containing the following 95 Documents: 001 Allergen Changeover Checklist Soterian Systems, LLC 002 Audit Plan & Schedule Soterian Systems, LLC 003 Breakdown History Log & PM Schedule Soterian Systems, LLC 004 Business Continuity Mock Drill Soterian Systems, LLC 005 Calibration Status of Equipment Soterian Systems, LLC 006 Chemical Usage Log Soterian Systems, LLC 007 COA Validation Schedule Soterian Systems, LLC 008 Color Coded Container Reference Chart Soterian Systems, LLC 009 Commercialization Checklist Soterian Systems, LLC 010 Contract Service Providers Spec Soterian Systems, LLC 011 Cooler Temp Monitoring Log Soterian Systems, LLC 012 Corrective & Preventive Action Form Soterian Systems, LLC 013 Corrective Action Monitoring Form Soterian Systems, LLC 014 Customer Complaint Form Soterian Systems, LLC 015 Customer Complaint Log Soterian Systems, LLC 016 Customer Complaint Trend Log Soterian Systems, LLC 017 Daily Sanitation & Pre-Operational Inspection Soterian Systems, LLC 018 Daily Sanitizer Log Soterian Systems, LLC 019 Daily Stock Statement Soterian Systems, LLC 020 Maintenance Major Change Review Soterian Systems, LLC 021 Document Change Form Soterian Systems, LLC 022 Dry Warehouse Allergen Zoning Soterian Systems, LLC 023 Emergency Supplier Approval Form Soterian Systems, LLC

4 024 Employee Training Matrix Soterian Systems, LLC 025 Equipment Approval Form Soterian Systems, LLC 026 Facility Self-Inspection Form Soterian Systems, LLC 027 Finished Product Evaluation Log Soterian Systems, LLC 028 Food Safety Risk Analysis Matrix Soterian Systems, LLC 029 Foodborne Illness Complaint Form Soterian Systems, LLC 030 Foreign Material Form Soterian Systems, LLC 031 Foreign Material Log Soterian Systems, LLC 032 Foreign Material Tracking Log Soterian Systems, LLC 033 Glass & Brittle Plastic Inventory List Soterian Systems, LLC 034 Glass Breakage Report Soterian Systems, LLC 035 Glass Inventory Log Soterian Systems, LLC 036 Hand Swab Test Log Soterian Systems, LLC 037 Health Questionnaire Soterian Systems, LLC 038 Incubator Temperature Log Soterian Systems, LLC 039 Ingredient Allergen Matrix Soterian Systems, LLC 040 Ingredient Tempering Log Soterian Systems, LLC 041 Internal Audit Nonconformity Report Soterian Systems, LLC 042 Internal Programs Audit Log (Annual Review) Soterian Systems, LLC 043 Internal Temp Oven Log Soterian Systems, LLC 044 Label Review Log Soterian Systems, LLC 045 Maintenance Downtime Release Form Soterian Systems, LLC 046 Maintenance Work Order Tracking Log Soterian Systems, LLC 047 Maintenance Work Order Soterian Systems, LLC 048 Master Ingredient & Vendor Approval Matrix Soterian Systems, LLC 049 Master Program Verification Schedule Soterian Systems, LLC 050 Master Sanitation Schedule Soterian Systems, LLC 051 Medical Checkup Report Soterian Systems, LLC 052 Micro Hold Log Soterian Systems, LLC 053 Microlab Submission Tracking Form Soterian Systems, LLC 054 Mock Recall Form & Checklist Soterian Systems, LLC 055 Monthly Self-Inspection Audit Soterian Systems, LLC 056 Package Material Lot Tracking Form Soterian Systems, LLC 057 Pest Control Corrective Actions Soterian Systems, LLC 058 Pest Control Trend Log Soterian Systems, LLC 059 ph Meter Calibration Report Soterian Systems, LLC 060 Pre-Requisite Programs Soterian Systems, LLC 061 Preventive Maintenance Checkpoints (Daily) Soterian Systems, LLC 062 Preventive Maintenance Checkpoints for Building & Civil Work Soterian Systems, LLC 063 Preventive Maintenance Schedule Soterian Systems, LLC 064 Product Contact Packaging Log Soterian Systems, LLC 065 Product Development Checklist Soterian Systems, LLC 066 Product Sensory Evaluation Form Soterian Systems, LLC 067 QA Hold Log Soterian Systems, LLC

5 068 QA Hold Tag Soterian Systems, LLC 069 QA Retain & Testing Log Soterian Systems, LLC 070 Environmental Testing Trend Analysis Soterian Systems, LLC 071 Receiving Log Soterian Systems, LLC 072 Restroom Checklist Soterian Systems, LLC 073 Re-Work Tracking Log Soterian Systems, LLC 074 Scale Calibration Log Soterian Systems, LLC 075 Scale Inventory Log Soterian Systems, LLC 076 Scales-Equipment Accountability Log Soterian Systems, LLC 077 Shipping Log Soterian Systems, LLC 078 Specification Form Soterian Systems, LLC 079 SQF Team Program Review Soterian Systems, LLC 080 Supplier Emergency Contact Information Form Soterian Systems, LLC 081 Thermometer Tracking & Calibration Log Soterian Systems, LLC 082 Tool Inventory Log Soterian Systems, LLC 083 Truck Driver Log Soterian Systems, LLC 084 Truck Inspection Form Soterian Systems, LLC 085 Validation Report Soterian Systems, LLC 086 Vehicle Internal Temperature Log Soterian Systems, LLC 087 Vendor Performance Matrix Soterian Systems, LLC 088 Verification Validation Matrix Soterian Systems, LLC 089 Visitor Log Soterian Systems, LLC 090 Wood & Pallet Inspection Log Soterian Systems, LLC 091 Job Description Template Soterian Systems, LLC 092 Dairy Temperature Tracking Log Soterian Systems, LLC 093 Management Review Record Soterian Systems, LLC 094 HACCP Deviation Report Soterian Systems, LLC 095 Daily Knives Record Soterian Systems, LLC