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
It 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?
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).4---56# HACCP Plan78Produces a defensible HACCP plan tailored to the client's facility, products, and applicable FDA or USDA regulatory regime.910## Prerequisites1112Gather before drafting:13141. Legal entity name, facility address(es), HACCP team roster152. Product list — ingredients, formulations, packaging, shelf life, intended consumers163. Process flow diagram(s) from receiving through distribution174. Facility layout and equipment list with calibration capability185. Supplier controls and incoming-material specifications196. Existing SOPs (sanitation, allergen, preventive controls)207. Regulatory scope: FDA 21 CFR 117 | FDA 21 CFR 123 (seafood) | USDA 9 CFR 417 (meat/poultry) | dual jurisdiction2122## Quick Start23241. Confirm jurisdiction and product category → select governing regulation252. Populate cover page and product descriptions from client intake263. Walk through process flow; flag each step for biological (B), chemical (C), and physical (P) hazards274. Run CCP decision tree on every hazard with a control measure285. Set critical limits with cited regulatory or scientific basis296. Define monitoring, corrective actions, verification, and recordkeeping for each CCP307. Compile references, add signature page, mark any unverified items `[VERIFY]`3132## Workflow3334### 1. Cover and Scope3536Include: legal entity, facility, products covered, regulatory regime, effective date, HACCP team (names + roles).3738### 2. Product Descriptions3940| Product | Ingredients | Processing | Packaging | Storage | Shelf Life | Intended Use/Consumers | Distribution |41|---|---|---|---|---|---|---|---|4243### 3. Process Flow4445- Insert or describe flow diagram(s)46- Narrative walk-through of each step47- Note: diagram must be verified on-site and updated when processes change4849### 4. Hazard Analysis5051| Step | Type (B/C/P) | Hazard | Likelihood | Severity | Preventive Measure | CCP? | Justification |52|---|---|---|---|---|---|---|---|5354Include allergen hazards where applicable.5556### 5. CCP Determination5758Apply decision tree per hazard. Record outcome:5960| Step | Hazard | Control Measure | Decision Tree Outcome | CCP? | Rationale |61|---|---|---|---|---|---|6263### 6. Critical Limits6465| CCP | Parameter | Critical Limit | Basis (Reg/Science) | Measurement Method | Frequency |66|---|---|---|---|---|---|6768### 7. Monitoring6970| CCP | What | How | Frequency | Who | Instrument/Calibration | Record |71|---|---|---|---|---|---|---|7273### 8. Corrective Actions7475| CCP | Deviation | Immediate Control | Product Disposition | Root Cause Fix | Authority | Record |76|---|---|---|---|---|---|---|7778### 9. Verification and Validation7980| Activity | Purpose | Frequency | Responsible Party | Record |81|---|---|---|---|---|8283Validation must cite scientific or technical evidence with explicit source.8485### 10. Recordkeeping8687| Record Type | Contents | Format | Retention Period | Storage Location | Access Controls |88|---|---|---|---|---|---|8990Retention period must match governing regime; cite the exact rule or mark `[VERIFY]`.9192### 11. References and Signatures9394- Cite all applicable regulations and guidance documents95- Use `[VERIFY]` for any uncertain citation or numeric limit96- Signature blocks for HACCP team approval and management approval9798## Pitfalls99100- **Wrong regime**: Confirm jurisdiction first — FDA Part 117 vs Part 123 vs USDA Part 417 changes plan requirements significantly101- **Invented limits**: Never fabricate critical limits; each must have a cited regulatory or peer-reviewed scientific basis102- **Generic plans**: Every value must be specific to the facility, process, and products — no boilerplate fill-in103- **Stale flow diagrams**: Plans are indefensible if the flow diagram does not reflect actual current operations104- **Missing allergen hazards**: Allergens must appear in the hazard analysis and link to monitoring and corrective actions105- **Unsupported validation**: Stating "validated" without citing the supporting evidence is a common audit failure106107---108109It 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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