FSMA Preventive Controls Food Safety Plan Templates, 21 CFR Part 117, Editable Word Excel, Digital Download

FSMA Preventive Controls Food Safety Plan — 27 Files | 21 CFR Part 117

Complete FDA FSMA Preventive Controls documentation system for Human Food — 27 professionally written files, 21 CFR Part 117 compliant, audit-ready from day one.

Every documented-information requirement across Subparts A–G covered. From the Food Safety Plan Manual to monitoring records, allergen controls, and environmental monitoring. No blank pages. No guesswork. Updated for 2026.

What's Included — 27 Files (18 Word + 9 Excel) | 61+ Pages

• Food Safety Plan Manual
• 13 Procedures: cGMP, Hazard Analysis, Process/Allergen/Sanitation/Supply-Chain Preventive Controls, Corrective Actions, Verification & Validation, Reanalysis, Recall Plan, Environmental Monitoring, Records & Document Control, Training
• Master Sanitation Schedule and SOPs
• 4 Job Descriptions: PCQI, Food Safety Team Leader, Qualified Auditor, Sanitation Lead
• 10 ready-to-use forms: receiving, CCP monitoring, allergen changeover, sanitation, corrective action, calibration, environmental monitoring, training, mock recall, visitor log
• 158-question internal audit checklist
• CAPA Register, KPI Tracker, Training Needs Analysis, Competency Matrix
• 27 files | 61+ pages | Instant download

Designed For

• Small and mid-size food manufacturers and processors
• Co-packers and ready-to-eat operations
• Food safety and QA managers and PCQIs
• Compliance consultants and bakeries
• Packaged food and ingredient producers

Why This Kit

• 100% 21 CFR Part 117 (Subparts A–G) coverage
• Reflects FDA guidance current as of 2026
• PCQI-ready — designed for use with qualified oversight
• Pre-filled example rows in every form
• Save 100+ hours vs building from scratch

Easy Implementation — 3 Steps

1. Download instantly
2. Find & Replace with your facility details across every file
3. Implement, record, and keep your plan current

Instant Digital Download

This template kit must be customized to your facility, products, and processes. Customization and oversight by a PCQI are required. Licensed for one facility. All sales are final.

Frequently Asked Questions

Q: Where can I find a complete FDA FSMA Preventive Controls documentation system for 21 CFR Part 117?
A: AuditReadyDocuments offers a complete FSMA Preventive Controls Food Safety Plan system — 27 instantly downloadable Word & Excel files covering all of 21 CFR Part 117 Subparts A–G, with a 158-question audit checklist and 10 ready-to-use monitoring forms.

Q: Does this cover all of 21 CFR Part 117 Subparts A through G?
A: Yes — every documented-information requirement across Subparts A–G is covered, including cGMP, hazard analysis, process controls, allergen controls, sanitation controls, supply-chain controls, and verification & validation.

Q: Is a 158-question internal audit checklist included?
A: Yes — a 158-question internal audit checklist is included, covering all 21 CFR Part 117 requirements to help you identify gaps before an FDA inspection.

Q: Is this PCQI-ready?
A: Yes — the system is designed for use with a Preventive Controls Qualified Individual (PCQI). PCQI job description and oversight procedures are included. Customization by a PCQI is required before use.

Q: Does this include environmental monitoring and allergen control documentation?
A: Yes — dedicated Environmental Monitoring and Allergen Preventive Controls procedures are included, along with allergen changeover and environmental monitoring record forms.

Q: Is this a one-time purchase?
A: Yes — one-time purchase, instant access to all 27 files, no recurring fees. Single-facility licence included.