U.S. Frozen Food Preventive Controls Management System (21 CFR 117)
U.S. Frozen Food Preventive Controls Management System (21 CFR 117)
An editable food safety documentation system for U.S. businesses that make, freeze, store or distribute frozen food, built on 21 CFR Part 117.
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By document type
| Category | Files |
|---|---|
| Manuals | 7 |
| Policies | 2 |
| Procedures & SOPs | 31 |
| Plans & Programmes | 47 |
| Forms & Records | 60 |
| Checklists & Audit Tools | 20 |
| Registers, Logs & Matrices | 11 |
| Job Descriptions & Organisation | 1 |
| Training & Awareness | 27 |
| Guides & Work Instructions | 4 |
| Tools & Workbooks | 1 |
| Other Documents | 32 |
Key documents
| Reference | Document | Format |
|---|---|---|
| FZ-PC-001 | Frozen Food Preventive Controls Manual | Word |
| FZ-FRZ-001 | Freezing Control Program | Word |
| FZ-LIS-001 | Listeria Control Program | Word |
| FZ-CC-001 | Cold Chain Management Program | Word |
| FZ-016 | Freezing Monitoring Record | Word |
| FZ-XLS-001 | Frozen Food Food Safety Workbook | Excel |
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Overview
Freezing preserves food, but it does not kill pathogens. A par-fried or breaded product can look cooked when it is not, and a temperature excursion or a re-freeze can undo the controls upstream. This system is built on that principle and puts the jurisdiction question first: does the product fall under the FDA or USDA FSIS?
Each freezing method has its own procedure, including IQF, plate, air blast, cryogenic, spiral and tunnel freezing, with a freezing validation programme. Frozen storage, temperature control and excursion handling, cold chain, transport and thawing follow, with a structured re-freezing risk assessment in place of a blanket rule. For products that are not ready to eat, a separate procedure validates the cooking instructions on the pack. The documents are explicit about what the package does not supply and why.
The files reference 21 CFR Part 117 as shown on the eCFR at the end of August 2026, to be checked before use. 9 CFR 417, 430, 416, 381, 303 and 412 mark the boundary for meat and poultry products, and 21 CFR 123, 120, 113, 114 and 101 the other boundaries. FDA guidance is referred to by subject, and you record the editions you use. AGS is independent and is not affiliated with the FDA or USDA FSIS. Regulations are referenced by citation, and no regulation text is included.
What this system covers
- Manuals and jurisdiction: a food safety manual, HACCP manual and preventive controls manual, with an FDA and USDA jurisdiction assessment.
- Freezing: a freezing programme, freezing validation and a procedure for each freezing method.
- Storage and cold chain: frozen storage, temperature control and excursions, cold chain, transport, thawing and re-freezing.
- Pre-freeze processing: cooking, thermal processing, pasteurisation, blanching, cooling, and post-lethality and ready-to-eat controls.
- Hazards: allergen control and programmes for Listeria, Salmonella and STEC.
- Product release: traceability, recall, complaints, shelf life and validation of consumer cooking instructions.
- HACCP and assurance: HACCP core, flow models, HACCP, cold chain and freezing validation models, a hazard library, scientific support, inspection readiness, an FSMA gap assessment, a compliance matrix, a reference library, an implementation guide, forms, checklists, training modules and an Excel workbook.
Who it's for
Frozen food manufacturers, processors, packers, and storage and distribution businesses: vegetables, fruit, meals, pizza, dough, seafood, meat and poultry products, bakery, sauces, potatoes, snacks and meal kits. PCQIs, QA managers and senior management each have a defined role.
For a Codex-based HACCP system for the same sector, see the HACCP Frozen Foods Management System. Makers of chilled meals may prefer the U.S. Ready-to-Eat Foods Preventive Controls Management System (21 CFR 117).
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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