U.S. Preventive Controls for Human Food Management System (21 CFR 117)
U.S. Preventive Controls for Human Food Management System (21 CFR 117)
An editable 21 CFR Part 117 documentation system for any U.S. food facility, built around a written food safety plan and not tied to one sector.
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By document type
| Category | Files |
|---|---|
| Manuals | 1 |
| Policies | 1 |
| Procedures & SOPs | 16 |
| Plans & Programmes | 30 |
| Forms & Records | 52 |
| Checklists & Audit Tools | 24 |
| Registers, Logs & Matrices | 7 |
| Job Descriptions & Organisation | 2 |
| Training & Awareness | 1 |
| Guides & Work Instructions | 5 |
| Tools & Workbooks | 2 |
| Other Documents | 14 |
Key documents
| Reference | Document | Format |
|---|---|---|
| FSP-MAN-001 | Food Safety and Preventive Controls Manual | Word |
| FSP-001 | Food Safety Plan Template | Word |
| PC-001 | Process Preventive Controls Procedure | Word |
| PC-003 | Food Allergen Preventive Controls Procedure | Word |
| F-007 | Preventive Control Monitoring Record | Word |
| XLS-002 | Hazard Analysis Worksheet | Excel |
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Overview
A U.S. food facility under 21 CFR Part 117 has to show its hazard analysis, the preventive controls it chose, how it monitors and verifies them, and how it would recall a product. This system builds that record around a food safety plan template with an owner signature section, and a cross-reference matrix that maps each Part 117 section to the package documents, forms and records.
It starts with the regulatory framework and an FSMA applicability assessment, then the manual, policy, food safety team and PCQI statement. Prerequisite programmes cover CGMP, hygiene, sanitation, allergens, suppliers, receiving, storage, pest control, chemicals, glass, foreign material, maintenance, calibration, water, waste and traceability. The food safety plan core covers process, sanitation, allergen and supply-chain preventive controls, with monitoring, corrective action, verification, validation, reanalysis and recordkeeping.
The files map 21 CFR Part 117 section by section and treat 21 CFR Part 1 Subparts H, J, L, O and S and Part 121 as related requirements, with 21 CFR 101, 111, 113, 120 and 123 as boundaries. FDA draft guidance is used as nonbinding reference. AGS is independent and is not affiliated with the FDA. Regulations are referenced by citation, and no regulation text is included.
What this system covers
- Framework: regulatory framework, FSMA applicability assessment, food safety and preventive controls manual, policy, food safety team and PCQI statement.
- Prerequisite programmes: CGMP, hygiene, sanitation, allergens, suppliers, pest control, foreign material, maintenance, calibration, water and traceability.
- Food safety plan: a plan template, hazard analysis, and process, sanitation, allergen and supply-chain preventive controls.
- Supply chain and recall: a supply-chain programme and a written recall plan with a contact and notification structure.
- Verification: monitoring, corrective action, verification, validation, reanalysis and recordkeeping.
- Wider protection: food defence, food fraud, emergency management, internal audit and management review.
- Tools: forms, checklists, training modules, Excel workbooks for the master register, hazard analysis, cross-reference and gap assessment, a hazard library, an inspection readiness guide, an implementation guide, a 30-day roadmap and a reference library.
Who it's for
U.S. food manufacturers, processors, packers, warehouses, co-packers and private-label makers, and start-ups preparing a first food safety plan. It suits small and medium facilities in any sector, and an existing facility can start with the gap assessment workbook.
Each sector system in this range carries its own preventive controls manual, for example the U.S. Bakery HACCP & Preventive Controls Management System (21 CFR 117) and the U.S. Ready-to-Eat Foods Preventive Controls Management System (21 CFR 117). For Codex HACCP, see the FSMS CodexHACCP-2023.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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