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---5
6# HACCP Plan
7
8Produces a defensible HACCP plan tailored to the client's facility, products, and applicable FDA or USDA regulatory regime.
9
10## Prerequisites
11
12Gather before drafting:
13
141. Legal entity name, facility address(es), HACCP team roster
152. Product list — ingredients, formulations, packaging, shelf life, intended consumers
163. Process flow diagram(s) from receiving through distribution
174. Facility layout and equipment list with calibration capability
185. Supplier controls and incoming-material specifications
196. 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 jurisdiction
21
22## Quick Start
23
241. Confirm jurisdiction and product category → select governing regulation
252. Populate cover page and product descriptions from client intake
263. Walk through process flow; flag each step for biological (B), chemical (C), and physical (P) hazards
274. Run CCP decision tree on every hazard with a control measure
285. Set critical limits with cited regulatory or scientific basis
296. Define monitoring, corrective actions, verification, and recordkeeping for each CCP
307. Compile references, add signature page, mark any unverified items `[VERIFY]`
31
32## Workflow
33
34### 1. Cover and Scope
35
36Include: legal entity, facility, products covered, regulatory regime, effective date, HACCP team (names + roles).
37
38### 2. Product Descriptions
39
40| Product | Ingredients | Processing | Packaging | Storage | Shelf Life | Intended Use/Consumers | Distribution |
41|---|---|---|---|---|---|---|---|
42
43### 3. Process Flow
44
45- Insert or describe flow diagram(s)
46- Narrative walk-through of each step
47- Note: diagram must be verified on-site and updated when processes change
48
49### 4. Hazard Analysis
50
51| Step | Type (B/C/P) | Hazard | Likelihood | Severity | Preventive Measure | CCP? | Justification |
52|---|---|---|---|---|---|---|---|
53
54Include allergen hazards where applicable.
55
56### 5. CCP Determination
57
58Apply decision tree per hazard. Record outcome:
59
60| Step | Hazard | Control Measure | Decision Tree Outcome | CCP? | Rationale |
61|---|---|---|---|---|---|
62
63### 6. Critical Limits
64
65| CCP | Parameter | Critical Limit | Basis (Reg/Science) | Measurement Method | Frequency |
66|---|---|---|---|---|---|
67
68### 7. Monitoring
69
70| CCP | What | How | Frequency | Who | Instrument/Calibration | Record |
71|---|---|---|---|---|---|---|
72
73### 8. Corrective Actions
74
75| CCP | Deviation | Immediate Control | Product Disposition | Root Cause Fix | Authority | Record |
76|---|---|---|---|---|---|---|
77
78### 9. Verification and Validation
79
80| Activity | Purpose | Frequency | Responsible Party | Record |
81|---|---|---|---|---|
82
83Validation must cite scientific or technical evidence with explicit source.
84
85### 10. Recordkeeping
86
87| Record Type | Contents | Format | Retention Period | Storage Location | Access Controls |
88|---|---|---|---|---|---|
89
90Retention period must match governing regime; cite the exact rule or mark `[VERIFY]`.
91
92### 11. References and Signatures
93
94- Cite all applicable regulations and guidance documents
95- Use `[VERIFY]` for any uncertain citation or numeric limit
96- Signature blocks for HACCP team approval and management approval
97
98## Pitfalls
99
100- **Wrong regime**: Confirm jurisdiction first — FDA Part 117 vs Part 123 vs USDA Part 417 changes plan requirements significantly
101- **Invented limits**: Never fabricate critical limits; each must have a cited regulatory or peer-reviewed scientific basis
102- **Generic plans**: Every value must be specific to the facility, process, and products — no boilerplate fill-in
103- **Stale flow diagrams**: Plans are indefensible if the flow diagram does not reflect actual current operations
104- **Missing allergen hazards**: Allergens must appear in the hazard analysis and link to monitoring and corrective actions
105- **Unsupported validation**: Stating "validated" without citing the supporting evidence is a common audit failure
106
107---
108
109It 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?
majiayu000