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name: haccp-plan language: en description: Drafts U.S. HACCP plans for food production under FDA or USDA regimes. Triggers on requests involving HACCP plans, food safety plans, hazard analysis, critical control points, FSMA compliance, seafood HACCP (21 CFR 123), or meat/poultry HACCP (9 CFR 417). tags:

• analysis
• drafting
• regulatory
• research

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HACCP Plan

Produces a defensible HACCP plan tailored to the client's facility, products, and applicable FDA or USDA regulatory regime.

Prerequisites

Gather before drafting:

1. Legal entity name, facility address(es), HACCP team roster
2. Product list — ingredients, formulations, packaging, shelf life, intended consumers
3. Process flow diagram(s) from receiving through distribution
4. Facility layout and equipment list with calibration capability
5. Supplier controls and incoming-material specifications
6. Existing SOPs (sanitation, allergen, preventive controls)
7. Regulatory scope: FDA 21 CFR 117 | FDA 21 CFR 123 (seafood) | USDA 9 CFR 417 (meat/poultry) | dual jurisdiction

Quick Start

1. Confirm jurisdiction and product category → select governing regulation
2. Populate cover page and product descriptions from client intake
3. Walk through process flow; flag each step for biological (B), chemical (C), and physical (P) hazards
4. Run CCP decision tree on every hazard with a control measure
5. Set critical limits with cited regulatory or scientific basis
6. Define monitoring, corrective actions, verification, and recordkeeping for each CCP
7. Compile references, add signature page, mark any unverified items [VERIFY]

Workflow

1. Cover and Scope

Include: legal entity, facility, products covered, regulatory regime, effective date, HACCP team (names + roles).

2. Product Descriptions

Product	Ingredients	Processing	Packaging	Storage	Shelf Life	Intended Use/Consumers	Distribution

3. Process Flow

• Insert or describe flow diagram(s)
• Narrative walk-through of each step
• Note: diagram must be verified on-site and updated when processes change

4. Hazard Analysis

Step	Type (B/C/P)	Hazard	Likelihood	Severity	Preventive Measure	CCP?	Justification

Include allergen hazards where applicable.

5. CCP Determination

Apply decision tree per hazard. Record outcome:

Step	Hazard	Control Measure	Decision Tree Outcome	CCP?	Rationale

6. Critical Limits

CCP	Parameter	Critical Limit	Basis (Reg/Science)	Measurement Method	Frequency

7. Monitoring

CCP	What	How	Frequency	Who	Instrument/Calibration	Record

8. Corrective Actions

CCP	Deviation	Immediate Control	Product Disposition	Root Cause Fix	Authority	Record

9. Verification and Validation

Activity	Purpose	Frequency	Responsible Party	Record

Validation must cite scientific or technical evidence with explicit source.

10. Recordkeeping

Record Type	Contents	Format	Retention Period	Storage Location	Access Controls

Retention period must match governing regime; cite the exact rule or mark [VERIFY].

11. References and Signatures

• Cite all applicable regulations and guidance documents
• Use [VERIFY] for any uncertain citation or numeric limit
• Signature blocks for HACCP team approval and management approval

Pitfalls

• Wrong regime: Confirm jurisdiction first — FDA Part 117 vs Part 123 vs USDA Part 417 changes plan requirements significantly
• Invented limits: Never fabricate critical limits; each must have a cited regulatory or peer-reviewed scientific basis
• Generic plans: Every value must be specific to the facility, process, and products — no boilerplate fill-in
• Stale flow diagrams: Plans are indefensible if the flow diagram does not reflect actual current operations
• Missing allergen hazards: Allergens must appear in the hazard analysis and link to monitoring and corrective actions
• Unsupported validation: Stating "validated" without citing the supporting evidence is a common audit failure

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