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New HACCP Regulations – Plan Now Jeff Chilton | Dr. Amit Morey
June 12, 2015
Webinar Logistics
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• All lines are in listen-only mode
• Post your questions early and often!
• A link to the webinar recording will be emailed shortly after the event
Today’s Speakers
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Jeff ChiltonAlchemy
Diana PeñaModerator
Dr. Amit MoreyI.D.E.A. Food
Industry Consultants
Agenda
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• New USDA Regulatory Requirements Overview
• HACCP Plan Reassessment Processes
• Validation Methodology
• Q&A
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New USDA Regulatory Requirements
Jeff ChiltonAlchemy
HACCP Primer
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• HACCP – Hazard Analysis Critical Control Point System
• Seven Principles of HACCP
• HACCP Validation is part of HACCP Principle #6
NACMCF Definition of Validation - “That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP Plan, when implemented properly, will effectively control the hazards.”
Impact For Your Organization
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• HACCP systems reassessments required annually
• Must complete prior to USDA verification dates
• Initial validations – 90 days
• Minimum record review periods– Large organizations: 90 calendar days– Small and very small organizations: 13 Production Days
• Microbiological testing requirements – Not required if the process is consistent with the Critical
Operational Parameters (COP) identified in the support– Will be required if different COP are used or if the scientific
support does not contain microbiological data
New Regulatory Requirements Timetable
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FSIS Compliance Guideline HACCP Systems Validation Published
FSIS Verification Deadline for Organizations with 500+ Employees
April 2015 May 2015 Jan. 4, 2016 Apr. 4, 2016
Validation: Demonstrate the HACCP System adequately controls identified hazards to produce safe, unadulterated product
FSIS: Food Safety & Inspection Service
HACCP Systems Validation Compliance Guideline
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• HACCP System Validation – Validation is focused on the HACCP System, not just the HACCP
Plan– Prerequisite Programs are part of the HACCP System
• What has to be validated?– HACCP CCP Critical Limits– Prerequisite Programs– Critical Operational Parameters
• Two Elements of Validation1) Scientific or Technical Support (Design)2) In-Plant Validation Data (Execution)
Scientific or Technical Support (Design)
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• Published support that closely matches the actual process and shows the establishment processes controls hazards
• Identify the Critical Operational Parameters (COPs) relevant to the establishment’s processes
8 Major Types of Scientific or Technical Support
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• Published regulatory processing guidelines
• Regulatory performance standards
• Best practice guidelines
• Peer reviewed scientific or technical data or information
• Expert advice from processing authorities
• Challenge studies
• Pathogen modeling programs
• Data gathered by the establishment in-plant
In-Plant Validation Data (Execution)
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• In-plant observations
• Measurements
• Microbiological test results
• Other control measure information
• Establishment actions required to meet requirements– Implement COP consistent with the parameters cited in the
support– Identify at least one product from each HACCP category to gather
in-plant validation data– Collect in-plant data demonstrating effectiveness of the
implementation of the COPs– Analyze the data to determine COP’s effective implementation
HACCP Plan Reassessment – Start Planning Now!
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• Identify critical operational parameters
• Gather and analyze required records
• Collect documentation
• Develop written HACCP Plan, SSOP and PRP verification
• Assess compliance with plant audit
• Review records
Validation Methodology
Dr. Amit MoreyI.D.E.A. Food
Industry Consultants 14
Two Elements of Validation
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• Scientific - Challenge Study• In-Plant Validation
Important Considerations
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• Identify a reputed lab/food microbiologist/person with significant experience in conducting validations
• Scientific design of validation study
• Use appropriate target pathogens or indicator organisms
• In-lab validation should mimic in-plant conditions
• DON’T CUT CORNERS
Challenge Study
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• Identify the product, its packaging, and target pathogen
• Ensure the inoculation method can yield desired level of pathogen on product
• Confirm sampling method is sufficient
• Use a cocktail of pathogens
• Conduct a small trial of test procedures
• Mimic in-plant conditions as closely as possible
• Test critical factors at processing step affecting growth/survival of the target pathogen
Challenge Study Report
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• Specify the level of pathogen reduction, elimination, or growth control (e.g., for stabilization)
• Describe the process, including all critical parameters affecting the reduction or elimination
• Provide source of documentation
• Include same level of detail as is provided for peer-reviewed studies
Example - Validation of Antimicrobial Against L. Monocytogenes in Hot Dogs
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• Manufactured at the processing plant with same ingredients and manufacturing conditions
• Transport and hold under refrigeration
• Select 3-5 L. monocytogenes isolates related to RTE meats from a standard culture collection such as ATCC
• Use low and high level of inoculum
• Package and store in same way as commercial samples
• Follow a standard or published microbiological method
In-Plant Validation
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• Collected for a wide variety of different products and worst case scenarios
• Gather in-plant data for at least one product from each HACCP process category utilized
• Use food science principles in deciding the product types used to gather data
• Use documentation outlining why product or product types were chosen for initial validation
• Consider similarities and differences in species, process, intrinsic factors, product public health risk, and food safety hazards
In-Plant Validation - Product Selection Considerations
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• Fat content
• Size and shape of the food
• Number and type of processing steps
• Product species
• Public health risk
Critical Operational Parameters
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• Time
• pH
• Temperature
• Contact Time
• Concentration
• Product Coverage
• Humidity
• Humidity
• Spatial Configuration
• Dwell Time
• Pressure
• Water Activity
• Equipment Settings or calibration
In-Plant Validation – Scenario 1
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Process implemented is consistent with the scientific support, and contains microbiological data
• Identify the critical operating parameters in the scientific support, AND
• Implement those critical operational parameters in the establishment's production process consistent with the scientific support, AND
• Collect in-plant data that demonstrates that the critical operating parameters are being met (e.g., data on quantifiable characteristics of the critical operational parameters)
In-Plant Validation – Scenario 2
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Process NOT implemented is consistent with the scientific support, and DOES NOT contain microbiological data
• Identify the critical operating parameters in the actual process AND
• Collect in-plant microbiological data demonstrating the intervention’s effectiveness under actual in-plant conditions or identify scientific support with microbiological data demonstrating the effectiveness of those critical operational parameters, AND
• Collect in-plant data that demonstrates that the modified critical operating parameters are being met.
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The Alchemy Approach
Global Food Safety Initiative Certification
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Gap Analysis
Detailed inspection of your programs, facility, and employees against the standard requirements
Program Development
Customized programs for your facility to meet the standard requirements
Implementation Review
Detailed internal audit and coaching with employees to prepare for certification audit
Audit Support
On-site audit support during certification to serve as a liaison between certification body
HACCP / HARPC Consulting
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Our consultants work with your HACCP team to ensure your food safety plan meet regulatory requirements and exceeds customer expectations.
• Create a new HACCP / HARPC plan
• Third party reassessment of an existing plan to meet USDA or FDA requirements
• Third party verification and validation to ensure accuracy and scientific support
An accurate HACCP / HARPC plan is essential to protecting people, profits, and brands.
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Q & A
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