U.S. Seafood HACCP Management System (21 CFR 123)
U.S. Seafood HACCP Management System (21 CFR 123)
An editable seafood HACCP documentation system for U.S. processors, repackers, importers and distributors, built around 21 CFR Part 123 and the FDA Fish and Fishery Products Hazards and Controls Guidance.
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By document type
| Category | Files |
|---|---|
| Manuals | 1 |
| Policies | 1 |
| Procedures & SOPs | 32 |
| Plans & Programmes | 31 |
| Forms & Records | 49 |
| Checklists & Audit Tools | 12 |
| Registers, Logs & Matrices | 9 |
| Training & Awareness | 26 |
| Guides & Work Instructions | 20 |
| Other Documents | 1 |
Key documents
| Reference | Document | Format |
|---|---|---|
| SH-MAN-001 | Seafood HACCP Manual | Word |
| SH-CCP-002 | Seafood HACCP Plan Procedure and Template | Word |
| SH-HAZ-002 | Histamine / Scombrotoxin Hazard Control Program | Word |
| SH-HAZ-003 | Seafood Parasite Control Program | Word |
| F-022 | Histamine Control Record | Word |
| SH-REG-011 | Seafood HACCP Master Workbook | Excel |
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Overview
Seafood hazards change with the species and the process. Histamine, parasites, Vibrio, natural toxins, chemicals and aquaculture drug residues each need their own control. Under 21 CFR Part 123 the processor has to show how each relevant hazard is handled, with sanitation monitoring and records to back it up. This system sets out that evidence.
It begins with a Part 123 requirements summary, a section-by-section compliance matrix in Word and Excel, and a gap assessment. A seafood hazard library carries a separate module for each hazard group. Guidance values are labelled as guidance, the histamine module reconciles the Hazards Guide values with those in CPG 540.525, and no critical control points are pre-assigned. Your HACCP team decides them.
The files reference 21 CFR Part 123 as amended, the FDA Fish and Fishery Products Hazards and Controls Guidance (June 2022 Edition) and CPG 540.525 on decomposition and histamine (November 2024). 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
- Regulatory core: a Part 123 requirements summary, a section-by-section compliance matrix and a gap assessment.
- Hazard programmes: histamine (scombrotoxin), parasites with freezing options labelled as guidance, molluscan shellfish, Vibrio, natural toxins, chemicals and aquaculture drug residues.
- Prerequisite programmes: supplier approval, receiving, storage, and time and temperature control, among others.
- Sanitation: an SSOP and monitoring records for the eight sanitation areas of Part 123.
- Traceability and recall: traceability including molluscan shellfish tag retention, and recall.
- Importers: importer verification support under 21 CFR 123.12, with notes on how it relates to FSVP.
- HACCP and assurance: HACCP principle procedures, validation and a scientific support register, reassessment, record control, training, internal audit, management review, illustrative HACCP and process models, forms, checklists, Excel workbooks, an implementation guide, a 30-day roadmap and an inspection readiness guide.
Who it's for
Seafood processors, repackers, importers and distributors covered by Part 123, including shellfish dealers. Retail and food service are out of scope. Each facility needs a Part 123 trained individual, and the training module notes that this person may be an external consultant.
For a Codex-style seafood HACCP system with histamine, parasite and metal CCPs, see the HACCP Seafood Management System. Retail seafood counters are covered by the U.S. Retail & Supermarket Food Safety Management System (FDA Food Code).
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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