casemark/haccp-plan

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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