On May 15, 2015, the USDA Food Safety Inspection Service (FSIS) released the final requirements for Hazard Analysis & Critical Control Points (HACCP) Systems Validations. Learn how to be ready, and avoid non-compliance and enforcement actions?
2. Webinar Logistics
2
• 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
6. 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.”
7. 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
8. New Regulatory Requirements Timetable
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FSIS Compliance
Guideline HACCP
Systems
Validation
Published
Federal Register
Notice
&
FSIS Notice 27-15
Published
FSIS Verification
Deadline for
Organizations with
500+ Employees
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
9. 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 Validation
1) Scientific or Technical Support (Design)
2) In-Plant Validation Data (Execution)
10. 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
11. 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
12. 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
13. 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
15. Two Elements of Validation
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• Scientific - Challenge Study
• In-Plant Validation
16. 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
17. 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
18. 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
19. 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
20. 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
21. 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
22. 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
23. 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)
24. 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.
26. 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
27. 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.
29. Upcoming Events
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• Network with industry leaders
• Master best practices
• Discover new technologies
http://www.alchemysystems.com/alchemy-conference/
Diana - 5 MINUTES BEFORE START
Hello and welcome to today’s webinar New HACCP Regulations – Plan Now!
The webinar will begin in approximately 5 minutes. All lines will be in listen only mode for this discussion
If you need assistance for this online event, please call us at 888-259-8414 or use the chat function in your GoToWebinar window. The meeting will begin shortly. Thank you.
2 MINUTES BEFORE START
Hello and welcome to today’s webinar, New HACCP Regulations – Plan Now!
The webinar will begin in approximately 2 minutes. All lines will be in listen only mode for this conference.
If you need assistance for this online event, please call us at 888-259-8414 or use the chat function in your GoToWebinar window. The meeting will begin in 2 minutes. Thank you.
START
Welcome everyone, and thank you for joining us for today’s webinar, New HACCP Regulations – Plan Now! Before we get started, let’s cover a few quick logistical details [CLICK]
All lines will be in listen-only mode for the duration of the show. However, we do want to hear from you – please post questions early and often in the GoToWebinar Question Box on your right, and we’ll get to as many as possible during the formal Q&A at the end.
Last but not least: We will be sending you a link to the recorded webinar shortly after the event for your review.
With that, let’s introduce our speakers for today’s discussion [CLICK]
Dr. Amit Morey, Ph.D.: Dr. Morey is an Applied Scientist and subject matter expert on food safety and shelf life. He works with food processing plants and their management to resolve issues raised by the USDA/FDA and their clients. Formerly the Principal Scientist, Special Projects at Food Safety Net Services, Dr. Morey is currently the Founder and President of I.D.E.A. Food Industry Consultants Inc.
Jeff Chilton: Jeff has over 30 years of experience in the food industry, specializing in food safety, quality assurance, and plant management. He was President of Chilton Consulting Group for 16 years assisting clients achieve GFSI certification under the SQF, BRC, or FSSC 22000 standards.
My name is Diana Peña, and I will be your moderator today.
Here is what we plan to cover in our discussion [CLICK]
Jeff will set the stage by providing an overview of the new USDA regulatory requirements then walk through the HACCP plan reassessment process.
Dr. Morey will outline the two types of validation methodologies.
Finally, we’ll round it out with Q&A.
Identify the product, its packaging, and target pathogen
Ensure that the inoculation method can yield desired level of pathogen on product
Ensure that the sampling method is sufficient to recover pathogens from the product
Use a cocktail of pathogens
Conduct a small trial of test procedures if the product hasn’t been worked on before
Mimic in-plant conditions as closely as possible
Test the critical factors at that processing step affecting growth/survival of the target pathogen