U.S. Bakery HACCP & Preventive Controls Management System (21 CFR 117)
U.S. Bakery HACCP & Preventive Controls Management System (21 CFR 117)
An editable food safety documentation system for U.S. commercial, wholesale and industrial bakeries, combining HACCP with the preventive controls of 21 CFR Part 117.
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By document type
| Category | Files |
|---|---|
| Manuals | 9 |
| Policies | 4 |
| Procedures & SOPs | 18 |
| Plans & Programmes | 38 |
| Forms & Records | 97 |
| Checklists & Audit Tools | 29 |
| Registers, Logs & Matrices | 9 |
| Training & Awareness | 29 |
| Guides & Work Instructions | 36 |
| Tools & Workbooks | 2 |
| Other Documents | 59 |
Key documents
| Reference | Document | Format |
|---|---|---|
| BH-HACCP-001 | Bakery HACCP Manual | Word |
| BH-PC-001 | Bakery Preventive Controls Plan Template | Word |
| BH-VAL-001 | Bakery Thermal Kill-Step Validation Program | Word |
| BH-ALL-002 | Allergen Cross-Contact Control and Verification Procedure | Word |
| BH-FRM-030 | Thermal Kill Step Record | Word |
| BH-WB-001 | US Bakery HACCP Food Safety Master Workbook | Excel |
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Overview
Two bakery questions sit at the centre of this system. Is the bake a real kill step for this product in this oven? And what happens with raw flour, or flour added after baking, where the oven controls nothing? A kill-step validation programme answers the first. A flour programme answers the second, setting the control strategy for raw-flour pathogens by use.
The documents sit in numbered folders that follow the order in which a bakery builds its system, and each folder carries a short README text file. A bakery food safety manual, a HACCP manual on the NACMCF principles and a preventive controls manual for Part 117 Subparts C and G work together. Every critical limit and kill-step parameter is left as a bracketed placeholder for the bakery to establish.
The files reference 21 CFR Part 117 and ask you to check the eCFR text before use, the NACMCF HACCP Principles and Application Guidelines (1997), and U.S. allergen law with the FASTER Act 2021, which made sesame a major allergen from January 2023. Temperatures are in degrees Fahrenheit. AGS is independent and is not affiliated with the FDA. Regulations are referenced by citation. Standards are referenced by number and title only, and no standard text is included.
What this system covers
- Governance: the bakery food safety, HACCP and preventive controls manuals, a food safety policy, a HACCP team programme and a PCQI responsibilities module.
- Flour and materials: flour safety including flour added after the bake, grain, ingredient approval, mycotoxins, receiving and storage.
- Process controls: mixing, fermentation, baking, cooling, slicing, filling, topping, decorating and assembly, with kill-step validation and post-bake ready-to-eat controls.
- Allergens and organisms: allergen management and programmes for Salmonella, Listeria, Staphylococcus aureus, Bacillus cereus and mould.
- HACCP and food safety plan: product description templates, flow diagram models, a hazard analysis procedure with a hazard library, a CCP decision tree, critical limits, monitoring, corrective action, verification, validation and reassessment.
- Models: illustrative HACCP and process models by bakery product category.
- Tools and assurance: forms with an index, a master Excel workbook, checklists, training modules, an FDA inspection readiness guide, a Part 117 gap assessment, a regulatory compliance matrix, a reference library, an implementation guide and a 30-day roadmap.
Who it's for
Commercial, wholesale, industrial and manufacturing bakeries, small and medium as well as large, making bread, cakes, cookies, crackers, tortillas, pastries, donuts, pies, and filled and frozen bakery products. Food safety and QA managers, HACCP coordinators and PCQIs run it, and consultants who support bakeries can work from it.
For a Codex-based HACCP system for bakery and confectionery, see the HACCP Bakery & Confectionery Management System. For a sector-neutral food safety plan, see the U.S. Preventive Controls for Human Food 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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