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:
- Legal entity name, facility address(es), HACCP team roster
- Product list — ingredients, formulations, packaging, shelf life, intended consumers
- Process flow diagram(s) from receiving through distribution
- Facility layout and equipment list with calibration capability
- Supplier controls and incoming-material specifications
- Existing SOPs (sanitation, allergen, preventive controls)
- Regulatory scope: FDA 21 CFR 117 | FDA 21 CFR 123 (seafood) | USDA 9 CFR 417 (meat/poultry) | dual jurisdiction
Quick Start
- Confirm jurisdiction and product category → select governing regulation
- Populate cover page and product descriptions from client intake
- Walk through process flow; flag each step for biological (B), chemical (C), and physical (P) hazards
- Run CCP decision tree on every hazard with a control measure
- Set critical limits with cited regulatory or scientific basis
- Define monitoring, corrective actions, verification, and recordkeeping for each CCP
- 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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1---2name: haccp-plan3description: 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).4license: Apache-2.05---67# HACCP Plan89Produces a defensible HACCP plan tailored to the client's facility, products, and applicable FDA or USDA regulatory regime.1011## Prerequisites1213Gather before drafting:14151. Legal entity name, facility address(es), HACCP team roster162. Product list — ingredients, formulations, packaging, shelf life, intended consumers173. Process flow diagram(s) from receiving through distribution184. Facility layout and equipment list with calibration capability195. Supplier controls and incoming-material specifications206. Existing SOPs (sanitation, allergen, preventive controls)217. Regulatory scope: FDA 21 CFR 117 | FDA 21 CFR 123 (seafood) | USDA 9 CFR 417 (meat/poultry) | dual jurisdiction2223## Quick Start24251. Confirm jurisdiction and product category → select governing regulation262. Populate cover page and product descriptions from client intake273. Walk through process flow; flag each step for biological (B), chemical (C), and physical (P) hazards284. Run CCP decision tree on every hazard with a control measure295. Set critical limits with cited regulatory or scientific basis306. Define monitoring, corrective actions, verification, and recordkeeping for each CCP317. Compile references, add signature page, mark any unverified items `[VERIFY]`3233## Workflow3435### 1. Cover and Scope3637Include: legal entity, facility, products covered, regulatory regime, effective date, HACCP team (names + roles).3839### 2. Product Descriptions4041| Product | Ingredients | Processing | Packaging | Storage | Shelf Life | Intended Use/Consumers | Distribution |42|---|---|---|---|---|---|---|---|4344### 3. Process Flow4546- Insert or describe flow diagram(s)47- Narrative walk-through of each step48- Note: diagram must be verified on-site and updated when processes change4950### 4. Hazard Analysis5152| Step | Type (B/C/P) | Hazard | Likelihood | Severity | Preventive Measure | CCP? | Justification |53|---|---|---|---|---|---|---|---|5455Include allergen hazards where applicable.5657### 5. CCP Determination5859Apply decision tree per hazard. Record outcome:6061| Step | Hazard | Control Measure | Decision Tree Outcome | CCP? | Rationale |62|---|---|---|---|---|---|6364### 6. Critical Limits6566| CCP | Parameter | Critical Limit | Basis (Reg/Science) | Measurement Method | Frequency |67|---|---|---|---|---|---|6869### 7. Monitoring7071| CCP | What | How | Frequency | Who | Instrument/Calibration | Record |72|---|---|---|---|---|---|---|7374### 8. Corrective Actions7576| CCP | Deviation | Immediate Control | Product Disposition | Root Cause Fix | Authority | Record |77|---|---|---|---|---|---|---|7879### 9. Verification and Validation8081| Activity | Purpose | Frequency | Responsible Party | Record |82|---|---|---|---|---|8384Validation must cite scientific or technical evidence with explicit source.8586### 10. Recordkeeping8788| Record Type | Contents | Format | Retention Period | Storage Location | Access Controls |89|---|---|---|---|---|---|9091Retention period must match governing regime; cite the exact rule or mark `[VERIFY]`.9293### 11. References and Signatures9495- Cite all applicable regulations and guidance documents96- Use `[VERIFY]` for any uncertain citation or numeric limit97- Signature blocks for HACCP team approval and management approval9899## Pitfalls100101- **Wrong regime**: Confirm jurisdiction first — FDA Part 117 vs Part 123 vs USDA Part 417 changes plan requirements significantly102- **Invented limits**: Never fabricate critical limits; each must have a cited regulatory or peer-reviewed scientific basis103- **Generic plans**: Every value must be specific to the facility, process, and products — no boilerplate fill-in104- **Stale flow diagrams**: Plans are indefensible if the flow diagram does not reflect actual current operations105- **Missing allergen hazards**: Allergens must appear in the hazard analysis and link to monitoring and corrective actions106- **Unsupported validation**: Stating "validated" without citing the supporting evidence is a common audit failure107108---109110It looks like I don't have write permission to the file. Want me to try writing it again so you can approve, or would you prefer to copy the content above?
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