PCQI Food Safety Plan Documentation System Full Pack Documents

A complete, audit-ready FDA Food Safety Plan documentation system for facilities required to maintain a written Food Safety Plan under FSMA's Preventive Controls for Human Food rule (21 CFR Part 117, Subpart C). Built by food safety documentation professionals. Used by PCQIs, QA Managers, and Compliance Officers.

What's Included (18 Files)

• Food Safety Plan Master Manual, Hazard Analysis Procedure, Preventive Controls Procedure, Monitoring/Corrective Action/Verification Procedure, Recall Plan, Supply Chain Program SOP, PCQI Job Description, and Food Safety Team Job Description (9 Word files)
• Hazard Analysis & Preventive Controls Workbook, Monitoring & Verification Records, CAPA Log & Product Disposition, Supplier Approval & Verification Records, FSP Review/Reanalysis/Validation Log, 142-question Internal Audit Checklist, External Documents Register, Legal & Regulatory Requirements Register, and Setup Guide (9 Excel files)
• 107+ pages | Instant download

Full Regulatory Coverage — 21 CFR Part 117

Every clause of 21 CFR Part 117 Subparts A–G addressed, including FASTER Act 2021 (sesame as 9th major allergen), FSMA Section 204 Traceability Rule, EMA assessment, allergen cleaning validation vs. verification, Environmental Monitoring Program (Zone 1–4), and all 5 supplier verification methods per 117.410(b)(1)–(5).

Designed For

PCQIs starting a new Food Safety Plan, food safety managers documenting an existing FSMA-compliant system, QA Directors preparing for an FDA facility inspection, compliance officers implementing the FSMA Preventive Controls rule, food manufacturers and processors subject to 21 CFR Part 117 Subpart C, contract manufacturers, co-packers, and food safety consultants.

Implementation

1. Download all 18 files   2. Replace 6 tokens using Find & Replace (Organization Name, Site Address, PCQI Name, Effective Date, PCQI Title, Approver Name)   3. Sign your Food Safety Plan, brief your team, and begin implementation. Ready for FDA inspection.

Estimated time savings: 100+ hours compared to building documentation from scratch.

This kit is a documentation template system for operational use. It does not constitute legal, regulatory, or professional advice. Purchasers are responsible for reviewing, customizing, and validating all documents against their specific facility, products, processes, and applicable regulations. Instant digital download — all sales are final.