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SAI K . RAMASWAMYDR. GRETCHEN A. MOSHER
NC-213 ,KANSAS CITY
HARPC: Preventive Controls & Food Safety
Implications
NC-213The U.S. Quality Grains Research Consortium
2Food Safety Modernization Act (FSMA)
Most sweeping food safety reform: signed 2011
34 sections already enforced , 7 sections in rulemaking
Wide impact- Farmers to Grain handlers to Processors to Importers
Prevention rather than reaction
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Good Manufacturing Practices (GMP’s) (Pre-FSMA)
Systematic program to ensure food products meet safety, quality & legal requirements
HACCP (Hazard Analysis and Critical Control Point) one such popular program
Focus on managing critical controls to prevent, eliminate or reduce hazards
Mostly a voluntary program
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GMP’s - post FSMA
Same goal different approach to handle safety, quality & legal requirements
Identify hazards and controls measures + Risks associated with the hazards
Required to implement Hazard Analysis and Risk-Based Preventive Controls (“Harp sea”)
Mandatory for many of food & grain handling facilities registered with FDA
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HARPC (“Harp sea”)
Preventive Controls- Section 103 of FSMA For Human Food For Animal food Intentional adulteration ( not addressed by HARPC)
Different from HACCP despite common concepts (HACCP subset of HARPC)
Applies to all facilities that process, pack or hold food and feed E.g.: Grain Elevators
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HARPC- Key Elements
Identify & evaluate hazards
Create programs/procedures to mitigate or prevent hazards
Develop methods to effectively monitor preventive controls
Maintain records of monitoring
Specify corrective measures in case of issues with preventive controls
Re-analyze
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HACCP Vs. HARPC
HACCPWorldwide standard
Applies to a wide variety of food products
Focus on control steps
Requires qualifies team
HARPCUS standard
Applies to FDA regulated products
Preventive programs
Needs qualified individual
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HACCP Vs. HARPC Compliance
HACCPVoluntary across most
food industry
Mandatory for certain foods like seafood, juice, meat and poultry
HARPCMandatory for all
facilities requiring FDA registration
Exemptions for FDA mandatory HACCP programs
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GMP’s at Grain Elevators
Currently voluntary
Mandatory to maintain proper records & register with FDA for traceability
Implementing quality management to handle globalization and legislation risks
Also using quality management as a tool to handle food safety as well as worker safety risks
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Business FSMA
Quality Meeting customer requirements Prevent grain spoilage Product safety
Financial Revenue loss Recovering preservation &
storage costs
Safety Personnel safety
BiologicalChemicalPhysicalAllergensRadiological
Potential Risks at Grain Elevators
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Preventive Controls for Quality Risks
Standardize operation
Improve inventory management
Minimizing variance by monitoring and measuring
Empower employees
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Quality Management & Preventive Control
QMS processes facilitate:
Documentation of work tasks for control and consistency
Clear statement of decision making responsibilities
Provides statistical targets for quality traits
Improvement of management processes for inventory
Established methods for problem solving and appropriate corrective actions
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HARPC & Quality Management
Plan• Identify & evaluate hazards
Do• Create programs to mitigate/prevent
hazards and develop preventive controls
Check
• Monitor and maintain records
Act• Apply corrective measures when needed
and re-analyze
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Recommendations
Grain elevators can manage grain quality and product safety with QMS
QMS can help manage inventory and help decision making related to :
Preservation methods Storage options Blending Shipping details
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Recommendations cont..
Grain elevators implementing QMS are better suited to handle changes due to new legislation
QMS focus on control, consistency, and reproducibility helpful in hazard management part of HARPC program
QMS could assist in managing risk of intentional adulteration and keeping the facility secure
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Questions
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Potential Risks at Grain Elevators
Quality Meeting customer requirements Prevent grain spoilage Product safety
Financial Revenue loss Recovering preservation & storage costs
Safety Personnel safety
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