Sawgrass Nutra Labs

Facility HACCP Plan

This HACCP Plan defines the hazard identification, evaluation, and control framework used by Sawgrass Nutra Labs (SNL) to manage food safety and quality risks associated with the manufacture of dietary supplements in capsule and powder dosage forms.

Controlled Document Statement:
This HACCP Plan summarizes hazard analysis and control mechanisms implemented by Sawgrass Nutra Labs. Detailed operational execution is governed by approved QMS governance documents, Family Packs, Standard Operating Procedures (SOPs), QC requirements, and Master Manufacturing Records (MMRs) maintained within the Sawgrass Nutra Labs Quality Management System (QMS).

Document Control
Regulatory Alignment
HACCP Team
Prerequisite Programs
Hazard Classification
Hazard Evaluation Criteria
Process Flow
Hazard Analysis
CCP Decision Logic
CCP Control Plan
Monitoring
Corrective Actions
Verification
Recordkeeping
Plan Validation

Document Control

Field	Value
Document ID	SNL-HACCP
Version	1.0
Status	Approved
Prepared By	Quality Assurance
Approved By	Quality Unit
Effective Date	TBD
Review Cycle	Annual
Retention	Per SNL Record Retention Policy

QMS Control System References

The hazard controls identified within this HACCP Plan are implemented through approved governance documents, program families, and operational procedures maintained within the Sawgrass Nutra Labs Quality Management System (QMS).

The HACCP Plan does not establish new operational controls. It maps hazard management to existing QMS control systems.

Control Domain	Primary QMS Reference	Description
Enterprise Quality Governance	QMS Policy & Unified Governance Manual	Defines enterprise quality framework, authority, and governance
Risk Management Program	QMS Manual – Risk Management Program	Defines enterprise risk identification, evaluation, and control methodology
Sanitation, Environmental Monitoring & Pest Control	QMS-FP-SAN – Sanitation QMS Family Pack	Defines sanitation program governance including cleaning, EMP, and pest control
Production Controls	QMS-FP-PROD – Production Family Pack	Defines manufacturing process controls
Quality Assurance Operations	QMS-FP-QA – Quality Assurance Family Pack	Defines QA oversight, verification, and quality system execution
Quality Control Laboratory	QMS-FP-QC – Quality Control Family Pack	Defines QC testing, identity verification, and laboratory controls
Packaging Operations	QMS-FP-PKG – Packaging Family Pack	Defines packaging and labeling control processes
Material Handling & Warehouse	QMS-FP-MH – Material Handling Family Pack	Defines receiving, storage, and material control processes
Supplier Qualification	QC Supplier Qualification Program	Defines supplier approval, monitoring, and material acceptance controls
Traceability & Recall	SOP-REC – Traceability & Recall Program	Defines product traceability and recall readiness

Regulatory Alignment

This HACCP Plan aligns with Codex Alimentarius HACCP principles and supports compliance with FDA 21 CFR Part 111 dietary supplement cGMP requirements.

HACCP Team

Role	Responsibility
QA Manager	HACCP program administration
Quality Unit Director	Final authority for quality and hazard escalation decisions
Production Manager	Manufacturing process expertise
Packaging Supervisor	Packaging hazard control oversight
Procurement Manager	Supplier risk management

Prerequisite Programs

Sanitation, Environmental Monitoring & Pest Control Program (QMS-FP-SAN)
Supplier Qualification Program (QC-SUP)
Material Acceptance & Identity Testing Program (QC-MAT)
Preventive Maintenance Program (Maintenance Controls)
Personnel Training & Competency Program (QMS Training Program)
Calibration Program (QC Calibration Controls)
Allergen Control Program (Production & Packaging Controls)
Traceability & Recall Program (SOP-REC)

These prerequisite programs are implemented through approved QMS family packs, QC requirements, SOPs, and controlled operational records maintained within the Sawgrass Nutra Labs Quality Management System (QMS). The HACCP Plan references these control systems and does not establish new operational procedures.

Hazard Classification

Biological hazards – microbial contamination
Chemical hazards – pesticides, heavy metals, adulterants
Physical hazards – foreign materials
Allergen cross-contact hazards

Hazard Evaluation Criteria

Hazards are evaluated using a risk-based assessment considering both the severity of potential impact and the likelihood of occurrence. This evaluation determines whether a hazard is adequately controlled through prerequisite programs (PRPs) or requires designation as a Critical Control Point (CCP).

Risk Level	Severity	Likelihood
Low	Minimal impact on consumer safety	Rare occurrence
Moderate	Potential safety or quality impact	Occasional occurrence
High	Serious consumer health impact	Likely or recurring occurrence

Process Flow Diagram

Receiving
↓
Quarantine
↓
Sampling / Identity Testing
↓
Material Release
↓
Weighing / Dispensing
↓
Blending
↓
Encapsulation OR Powder Filling
↓
Packaging
↓
Finished Product Release
↓
Distribution

The process flow diagram was reviewed and verified onsite by the HACCP team to confirm that it accurately represents actual manufacturing operations performed at Sawgrass Nutra Labs.

Hazard Analysis

Process Step	Hazard	Hazard Type	Severity	Likelihood	Control Measure	Justification	CCP
Receiving	Heavy metal contamination or contaminated raw material	Chemical	High	Low	Supplier Qualification Program (QC-SUP), incoming material COA verification, and QC material release controls	Controlled through supplier qualification and QC release procedures	No
Sampling / Identity Testing	Incorrect ingredient identity or substitution	Chemical / Quality	High	Moderate	Incoming material identity testing per QC Material Acceptance Program (QC-MAT)	Only correctly identified ingredients may be released for use	Yes
Weighing / Dispensing	Ingredient mix-up or incorrect dispense quantity	Physical / Quality	Moderate	Low	Controlled weighing and batch verification procedures defined within the Production Family Pack (QMS-FP-PROD)	Procedural verification and reconciliation reduce the likelihood of substitution or error	No
Blending	Cross contamination or microbial growth	Biological / Chemical	Moderate	Low	Sanitation and environmental hygiene controls defined within the Sanitation Family Pack (QMS-FP-SAN)	Controlled through prerequisite sanitation and environmental control programs	No
Encapsulation / Powder Filling	Foreign material contamination	Physical	Moderate	Low	Equipment inspection, line clearance, and preventive maintenance controls defined within the Production (QMS-FP-PROD) and Maintenance programs (QMS-FP-MAINT)	Routine equipment checks and area clearance prevent introduction of foreign material	No
Packaging	Incorrect label, undeclared allergen, or product mix-up	Allergen / Quality	High	Moderate	Packaging verification, label control, and component reconciliation defined within the Packaging Family Pack (QMS-FP-PKG)	Packaging controls ensure correct product identity and approved label application	Yes
Distribution	Product damage or loss of traceability	Physical / Quality	Moderate	Low	Finished product release controls and product traceability defined within the Traceability & Recall Program (SOP-REC)	Controlled through release authorization, storage, and distribution traceability procedures	No

CCP Decision Logic

Is a hazard present at the process step?
Is control necessary to prevent or reduce the hazard to an acceptable level?
Is the process step specifically designed to control the hazard?
Could contamination or error occur at unacceptable levels without control?
If the hazard cannot be adequately controlled later in the process, the step is designated as a CCP.

Critical Control Point Control Plan

CCP	Hazard	Critical Limit	Monitoring	Verification	Responsible Role	Records	Corrective Action
Ingredient Identity Verification	Incorrect or substituted ingredient	Ingredient must pass approved identity testing and match specification prior to release	Identity testing performed for each incoming lot before use	QC review of identity test results and batch record verification	Quality Control	Incoming material identity testing records	Reject lot, place on hold, and initiate supplier investigation
Label Verification	Incorrect labeling, undeclared allergen, or product mix-up	Label artwork, product code, and packaging components must match the approved packaging specification and batch record	Packaging line verification at startup and at defined periodic intervals	QA review of packaging records and reconciliation documentation	Packaging Supervisor / QA	Packaging line verification log and reconciliation records	Stop line, quarantine affected product, investigate deviation, and correct before restart

Monitoring

Control	Monitoring Activity	Frequency	Responsible
Ingredient Identity	Identity test verification	Each incoming lot	Quality Control
Label Verification	Packaging line checks	Startup + periodic checks	Packaging Supervisor
Environmental Monitoring	Environmental sample review	Per environmental monitoring schedule	Quality Control

Corrective Actions

Stop the affected operation
Segregate and identify impacted material or product
Notify Quality Assurance and/or Quality Unit
Document the deviation or nonconformance
Investigate root cause
Implement corrective and preventive action (CAPA)
Verify effectiveness of corrective action prior to resuming normal operation

Verification

Activity	Frequency
Internal QA Audit	Annual
HACCP Plan Review	Annual
Environmental Monitoring Review	Quarterly
Supplier Program Review	Annual
CCP Record Review	Per batch / routine review

Recordkeeping

Hazard analysis documentation
CCP monitoring logs
Incoming material identity and release records
Packaging line verification and reconciliation logs
Environmental monitoring records
Deviation and CAPA records
Training records
Supplier qualification records

Plan Validation

The HACCP Plan has been reviewed and validated by the HACCP team to confirm that identified hazards are adequately controlled through defined process controls, critical control points, and prerequisite programs. Validation includes review of supplier controls, identity testing requirements, packaging verification activities, sanitation controls, and supporting QMS procedures.

Sawgrass Nutra Labs

Facility HACCP Plan

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