SlideShare ist ein Scribd-Unternehmen logo
1 von 30
Downloaden Sie, um offline zu lesen
New HACCP Regulations – Plan Now
Jeff Chilton | Dr. Amit Morey
June 12, 2015
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
Today’s Speakers
3
Jeff Chilton
Alchemy
Diana Peña
Moderator
Dr. Amit Morey
I.D.E.A. Food
Industry
Consultants
Agenda
4
• New USDA Regulatory Requirements Overview
• HACCP Plan Reassessment Processes
• Validation Methodology
• Q&A
5
New USDA Regulatory Requirements
Jeff Chilton
Alchemy
HACCP Primer
6
• 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
7
• 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
8
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
HACCP Systems Validation Compliance Guideline
9
• 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)
Scientific or Technical Support (Design)
10
• 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
11
• 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)
12
• 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!
13
• 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 Morey
I.D.E.A. Food
Industry
Consultants 14
Two Elements of Validation
15
• Scientific - Challenge Study
• In-Plant Validation
Important Considerations
16
• 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
17
• 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
18
• 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
19
• 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
20
• 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
21
• Fat content
• Size and shape of the food
• Number and type of processing steps
• Product species
• Public health risk
Critical Operational Parameters
22
• 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
23
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
24
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.
25
The Alchemy Approach
Global Food Safety Initiative Certification
26
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
27
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.
28
Q & A
Upcoming Events
29
• Network with industry leaders
• Master best practices
• Discover new technologies
http://www.alchemysystems.com/alchemy-conference/
THANK YOU
Telephone: 888.988.8832
contactus@alchemysystems.com
www.alchemysystems.com
http://blog.alchemysystems.com/

Weitere ähnliche Inhalte

Was ist angesagt?

Food Safety And HACCP
Food Safety And HACCPFood Safety And HACCP
Food Safety And HACCPApril Alovera
 
FSMA Impacts Packaging
FSMA Impacts PackagingFSMA Impacts Packaging
FSMA Impacts PackagingKerry Beach
 
Inside the Mind of a Food Safety Auditor
Inside the Mind of a Food Safety AuditorInside the Mind of a Food Safety Auditor
Inside the Mind of a Food Safety AuditorTraceGains
 
Risk analysis and HACCP System
Risk analysis and HACCP SystemRisk analysis and HACCP System
Risk analysis and HACCP SystemParminder Mitter
 
Guidance on BRC food issue 8 documentation requirements
Guidance on BRC food issue 8 documentation requirementsGuidance on BRC food issue 8 documentation requirements
Guidance on BRC food issue 8 documentation requirementsGlobal Manager Group
 
Principles of HACCP Practical Training
Principles of HACCP Practical TrainingPrinciples of HACCP Practical Training
Principles of HACCP Practical TrainingPrimority Ltd
 
SAI Global Traceability in Supply Chains
SAI Global Traceability in Supply ChainsSAI Global Traceability in Supply Chains
SAI Global Traceability in Supply ChainsSwitzerland09
 
SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8
SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8
SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8Switzerland09
 
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...TGA Australia
 
Food safety Enhancement program
Food safety  Enhancement  programFood safety  Enhancement  program
Food safety Enhancement programAmandeep Singh
 
Food Safety & Food Quality Auditing.
Food Safety & Food Quality Auditing.Food Safety & Food Quality Auditing.
Food Safety & Food Quality Auditing.Sourabh Bhartia
 
SAI Global Webinar: Tips for Effective Internal Auditing
SAI Global Webinar: Tips for Effective Internal AuditingSAI Global Webinar: Tips for Effective Internal Auditing
SAI Global Webinar: Tips for Effective Internal AuditingSwitzerland09
 
Difference between HACCP and ISO 22000
Difference between HACCP and ISO 22000Difference between HACCP and ISO 22000
Difference between HACCP and ISO 22000PECB
 
HACCP Principles for Operators in Food Services and Retail Establishment.
HACCP Principles for Operators in Food Services and Retail Establishment. HACCP Principles for Operators in Food Services and Retail Establishment.
HACCP Principles for Operators in Food Services and Retail Establishment. Eng. A.karam Al Malkawi
 
BRC Global Standards Self-Assessment Tool for Food Safety Issue 6.
BRC Global Standards Self-Assessment Tool for Food Safety Issue 6.BRC Global Standards Self-Assessment Tool for Food Safety Issue 6.
BRC Global Standards Self-Assessment Tool for Food Safety Issue 6.Faten Dyab
 

Was ist angesagt? (20)

Food Safety And HACCP
Food Safety And HACCPFood Safety And HACCP
Food Safety And HACCP
 
FSMA Impacts Packaging
FSMA Impacts PackagingFSMA Impacts Packaging
FSMA Impacts Packaging
 
Inside the Mind of a Food Safety Auditor
Inside the Mind of a Food Safety AuditorInside the Mind of a Food Safety Auditor
Inside the Mind of a Food Safety Auditor
 
Risk analysis and HACCP System
Risk analysis and HACCP SystemRisk analysis and HACCP System
Risk analysis and HACCP System
 
Guidance on BRC food issue 8 documentation requirements
Guidance on BRC food issue 8 documentation requirementsGuidance on BRC food issue 8 documentation requirements
Guidance on BRC food issue 8 documentation requirements
 
What's New in BRC Food Safety Issue 8
What's New in BRC Food Safety Issue 8What's New in BRC Food Safety Issue 8
What's New in BRC Food Safety Issue 8
 
Principles of HACCP Practical Training
Principles of HACCP Practical TrainingPrinciples of HACCP Practical Training
Principles of HACCP Practical Training
 
SAI Global Traceability in Supply Chains
SAI Global Traceability in Supply ChainsSAI Global Traceability in Supply Chains
SAI Global Traceability in Supply Chains
 
SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8
SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8
SAI Global Webinar: Deep Dive - BRC Food Safety Issue 8
 
Haccp catering
Haccp cateringHaccp catering
Haccp catering
 
Who Guidance on Process Validation for Non Serile Pharmaceuticals
Who Guidance on Process Validation for Non Serile PharmaceuticalsWho Guidance on Process Validation for Non Serile Pharmaceuticals
Who Guidance on Process Validation for Non Serile Pharmaceuticals
 
140623 haccp-06
140623 haccp-06140623 haccp-06
140623 haccp-06
 
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...
 
Food safety Enhancement program
Food safety  Enhancement  programFood safety  Enhancement  program
Food safety Enhancement program
 
Food Safety & Food Quality Auditing.
Food Safety & Food Quality Auditing.Food Safety & Food Quality Auditing.
Food Safety & Food Quality Auditing.
 
SAI Global Webinar: Tips for Effective Internal Auditing
SAI Global Webinar: Tips for Effective Internal AuditingSAI Global Webinar: Tips for Effective Internal Auditing
SAI Global Webinar: Tips for Effective Internal Auditing
 
ISO 22000 & HACCP
ISO 22000 & HACCPISO 22000 & HACCP
ISO 22000 & HACCP
 
Difference between HACCP and ISO 22000
Difference between HACCP and ISO 22000Difference between HACCP and ISO 22000
Difference between HACCP and ISO 22000
 
HACCP Principles for Operators in Food Services and Retail Establishment.
HACCP Principles for Operators in Food Services and Retail Establishment. HACCP Principles for Operators in Food Services and Retail Establishment.
HACCP Principles for Operators in Food Services and Retail Establishment.
 
BRC Global Standards Self-Assessment Tool for Food Safety Issue 6.
BRC Global Standards Self-Assessment Tool for Food Safety Issue 6.BRC Global Standards Self-Assessment Tool for Food Safety Issue 6.
BRC Global Standards Self-Assessment Tool for Food Safety Issue 6.
 

Andere mochten auch

How fsma changes_will_impact_ the_seafood_ business
How fsma changes_will_impact_ the_seafood_ businessHow fsma changes_will_impact_ the_seafood_ business
How fsma changes_will_impact_ the_seafood_ businessRon Calonica
 
Manual Haccp
Manual HaccpManual Haccp
Manual HaccpMartin
 
Food safety 2020 - Are you ready?
Food safety 2020 - Are you ready? Food safety 2020 - Are you ready?
Food safety 2020 - Are you ready? Alchemy Systems
 
Meat Institute Outlook: The Power of an Engaged Employee
Meat Institute Outlook: The Power of an Engaged EmployeeMeat Institute Outlook: The Power of an Engaged Employee
Meat Institute Outlook: The Power of an Engaged EmployeeAlchemy Systems
 
FSM Food Transportation Regulations
FSM Food Transportation RegulationsFSM Food Transportation Regulations
FSM Food Transportation RegulationsAlchemy Systems
 
Combine Your HACCP & HARPC Plan
Combine Your HACCP & HARPC PlanCombine Your HACCP & HARPC Plan
Combine Your HACCP & HARPC PlanKassy Marsh
 
The Mind of the Food Worker Webinar Slides
The Mind of the Food Worker Webinar SlidesThe Mind of the Food Worker Webinar Slides
The Mind of the Food Worker Webinar SlidesAlchemy Systems
 
Build an Effective Serious Injury Prevention Strategy (in Food Manufacturing)...
Build an Effective Serious Injury Prevention Strategy (in Food Manufacturing)...Build an Effective Serious Injury Prevention Strategy (in Food Manufacturing)...
Build an Effective Serious Injury Prevention Strategy (in Food Manufacturing)...Alchemy Systems
 
Attract & Retain Millennial Talent in the Food Industry
Attract & Retain Millennial Talent in the Food Industry Attract & Retain Millennial Talent in the Food Industry
Attract & Retain Millennial Talent in the Food Industry Alchemy Systems
 
Haccp risk assessment
Haccp risk assessmentHaccp risk assessment
Haccp risk assessmentashok kumar
 
HACCP-cod fish
HACCP-cod fishHACCP-cod fish
HACCP-cod fishTara Tousi
 
Food Safety Program – BD Food Safety
Food Safety Program – BD Food SafetyFood Safety Program – BD Food Safety
Food Safety Program – BD Food SafetyCharles Beckham
 
HACCP IN PRACTICE
HACCP IN PRACTICEHACCP IN PRACTICE
HACCP IN PRACTICERahul Gupta
 

Andere mochten auch (20)

HACCP a practical approach
HACCP a practical approachHACCP a practical approach
HACCP a practical approach
 
H.A.C.C.P.
H.A.C.C.P.H.A.C.C.P.
H.A.C.C.P.
 
How fsma changes_will_impact_ the_seafood_ business
How fsma changes_will_impact_ the_seafood_ businessHow fsma changes_will_impact_ the_seafood_ business
How fsma changes_will_impact_ the_seafood_ business
 
Haccp training
Haccp trainingHaccp training
Haccp training
 
HACCP Presentation
HACCP PresentationHACCP Presentation
HACCP Presentation
 
Manual Haccp
Manual HaccpManual Haccp
Manual Haccp
 
Food safety 2020 - Are you ready?
Food safety 2020 - Are you ready? Food safety 2020 - Are you ready?
Food safety 2020 - Are you ready?
 
Meat Institute Outlook: The Power of an Engaged Employee
Meat Institute Outlook: The Power of an Engaged EmployeeMeat Institute Outlook: The Power of an Engaged Employee
Meat Institute Outlook: The Power of an Engaged Employee
 
Haccpplan (2)
Haccpplan (2)Haccpplan (2)
Haccpplan (2)
 
FSM Food Transportation Regulations
FSM Food Transportation RegulationsFSM Food Transportation Regulations
FSM Food Transportation Regulations
 
Combine Your HACCP & HARPC Plan
Combine Your HACCP & HARPC PlanCombine Your HACCP & HARPC Plan
Combine Your HACCP & HARPC Plan
 
HACCP PlanPreserves
HACCP PlanPreservesHACCP PlanPreserves
HACCP PlanPreserves
 
The Mind of the Food Worker Webinar Slides
The Mind of the Food Worker Webinar SlidesThe Mind of the Food Worker Webinar Slides
The Mind of the Food Worker Webinar Slides
 
Build an Effective Serious Injury Prevention Strategy (in Food Manufacturing)...
Build an Effective Serious Injury Prevention Strategy (in Food Manufacturing)...Build an Effective Serious Injury Prevention Strategy (in Food Manufacturing)...
Build an Effective Serious Injury Prevention Strategy (in Food Manufacturing)...
 
Attract & Retain Millennial Talent in the Food Industry
Attract & Retain Millennial Talent in the Food Industry Attract & Retain Millennial Talent in the Food Industry
Attract & Retain Millennial Talent in the Food Industry
 
Haccp risk assessment
Haccp risk assessmentHaccp risk assessment
Haccp risk assessment
 
Haccp worksheet
Haccp worksheetHaccp worksheet
Haccp worksheet
 
HACCP-cod fish
HACCP-cod fishHACCP-cod fish
HACCP-cod fish
 
Food Safety Program – BD Food Safety
Food Safety Program – BD Food SafetyFood Safety Program – BD Food Safety
Food Safety Program – BD Food Safety
 
HACCP IN PRACTICE
HACCP IN PRACTICEHACCP IN PRACTICE
HACCP IN PRACTICE
 

Ähnlich wie New HACCP Regulations - Plan Now!

Balancing Compliance, Risk & Performance: Optimize Your Food Safety & Quality...
Balancing Compliance, Risk & Performance: Optimize Your Food Safety & Quality...Balancing Compliance, Risk & Performance: Optimize Your Food Safety & Quality...
Balancing Compliance, Risk & Performance: Optimize Your Food Safety & Quality...SafetyChain Software
 
HACCP verification and documentation
HACCP verification and documentation HACCP verification and documentation
HACCP verification and documentation SannoBano
 
Understanding and Controlling Bioprocess Variation | Parker domnick hunter
Understanding and Controlling Bioprocess Variation | Parker domnick hunterUnderstanding and Controlling Bioprocess Variation | Parker domnick hunter
Understanding and Controlling Bioprocess Variation | Parker domnick hunterParker Hannifin Corporation
 
good laboratory practices.pptx
good laboratory practices.pptxgood laboratory practices.pptx
good laboratory practices.pptxssuserd2507a
 
Confusing Validation with Verification: The Risks and Best Practices
Confusing Validation with Verification: The Risks and Best PracticesConfusing Validation with Verification: The Risks and Best Practices
Confusing Validation with Verification: The Risks and Best PracticesSafetyChain Software
 
BMT GxP Training 10-22-2021 1.pptx
BMT GxP Training 10-22-2021 1.pptxBMT GxP Training 10-22-2021 1.pptx
BMT GxP Training 10-22-2021 1.pptxhaploidentical
 
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTSPHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTSMd. Saddam Nawaz
 
Preparation of haccp plan
Preparation of haccp planPreparation of haccp plan
Preparation of haccp planAnuj Jha
 
Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)RushikeshPalkar1
 
Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validationJahnabi Sarmah
 
PET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET RadiopharmaceutialsPET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET Radiopharmaceutials@Saudi_nmc
 
cgmp presentation upld.pptx
cgmp presentation upld.pptxcgmp presentation upld.pptx
cgmp presentation upld.pptxDimple Marathe
 
QA Audit by Signorina Y. Bueno (WMSU-ZC)
QA Audit by Signorina Y. Bueno (WMSU-ZC)QA Audit by Signorina Y. Bueno (WMSU-ZC)
QA Audit by Signorina Y. Bueno (WMSU-ZC)signorina bueno
 

Ähnlich wie New HACCP Regulations - Plan Now! (20)

Balancing Compliance, Risk & Performance: Optimize Your Food Safety & Quality...
Balancing Compliance, Risk & Performance: Optimize Your Food Safety & Quality...Balancing Compliance, Risk & Performance: Optimize Your Food Safety & Quality...
Balancing Compliance, Risk & Performance: Optimize Your Food Safety & Quality...
 
HACCP verification and documentation
HACCP verification and documentation HACCP verification and documentation
HACCP verification and documentation
 
Understanding and Controlling Bioprocess Variation | Parker domnick hunter
Understanding and Controlling Bioprocess Variation | Parker domnick hunterUnderstanding and Controlling Bioprocess Variation | Parker domnick hunter
Understanding and Controlling Bioprocess Variation | Parker domnick hunter
 
good laboratory practices.pptx
good laboratory practices.pptxgood laboratory practices.pptx
good laboratory practices.pptx
 
Haccp
HaccpHaccp
Haccp
 
HACCP guidence Docs
HACCP guidence DocsHACCP guidence Docs
HACCP guidence Docs
 
HACCP Basics.ppt
HACCP Basics.pptHACCP Basics.ppt
HACCP Basics.ppt
 
Confusing Validation with Verification: The Risks and Best Practices
Confusing Validation with Verification: The Risks and Best PracticesConfusing Validation with Verification: The Risks and Best Practices
Confusing Validation with Verification: The Risks and Best Practices
 
BMT GxP Training 10-22-2021 1.pptx
BMT GxP Training 10-22-2021 1.pptxBMT GxP Training 10-22-2021 1.pptx
BMT GxP Training 10-22-2021 1.pptx
 
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTSPHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
 
RAC review Chapter 10.pptx
RAC review Chapter 10.pptxRAC review Chapter 10.pptx
RAC review Chapter 10.pptx
 
Quality control and quality assurance
Quality control and quality assuranceQuality control and quality assurance
Quality control and quality assurance
 
Preparation of haccp plan
Preparation of haccp planPreparation of haccp plan
Preparation of haccp plan
 
Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)
 
Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validation
 
PET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET RadiopharmaceutialsPET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET Radiopharmaceutials
 
cgmp presentation upld.pptx
cgmp presentation upld.pptxcgmp presentation upld.pptx
cgmp presentation upld.pptx
 
QA Audit by Signorina Y. Bueno (WMSU-ZC)
QA Audit by Signorina Y. Bueno (WMSU-ZC)QA Audit by Signorina Y. Bueno (WMSU-ZC)
QA Audit by Signorina Y. Bueno (WMSU-ZC)
 
PHARMACEUTICAL VALIADATION
PHARMACEUTICAL VALIADATIONPHARMACEUTICAL VALIADATION
PHARMACEUTICAL VALIADATION
 
Face.ppt
Face.pptFace.ppt
Face.ppt
 

Mehr von Alchemy Systems

Build an Effective Serious-injury Prevention Strategy (in Food Manufacturing)
Build an Effective Serious-injury  Prevention Strategy (in Food Manufacturing)Build an Effective Serious-injury  Prevention Strategy (in Food Manufacturing)
Build an Effective Serious-injury Prevention Strategy (in Food Manufacturing)Alchemy Systems
 
Strategies to Reduce Food Waste for Increased Profitability
Strategies to Reduce Food Waste for Increased ProfitabilityStrategies to Reduce Food Waste for Increased Profitability
Strategies to Reduce Food Waste for Increased ProfitabilityAlchemy Systems
 
Food Waste Webinar Preview
Food Waste Webinar PreviewFood Waste Webinar Preview
Food Waste Webinar PreviewAlchemy Systems
 
Exceeding BRC Expectations: Addressing the Human Element of Food Safety
Exceeding BRC Expectations: Addressing the Human Element of Food SafetyExceeding BRC Expectations: Addressing the Human Element of Food Safety
Exceeding BRC Expectations: Addressing the Human Element of Food SafetyAlchemy Systems
 
Global Food Safety Training Survey 2016
Global Food Safety Training Survey 2016Global Food Safety Training Survey 2016
Global Food Safety Training Survey 2016Alchemy Systems
 
SQF Conference 2015: THE MIND OF THE FOOD WORKER -- RESULTS OF A BREAKTHROUGH...
SQF Conference 2015: THE MIND OF THE FOOD WORKER -- RESULTS OF A BREAKTHROUGH...SQF Conference 2015: THE MIND OF THE FOOD WORKER -- RESULTS OF A BREAKTHROUGH...
SQF Conference 2015: THE MIND OF THE FOOD WORKER -- RESULTS OF A BREAKTHROUGH...Alchemy Systems
 
Staying Ahead of the Audit Curve with Food Industry Process Audits
Staying Ahead of the Audit Curve with Food Industry Process AuditsStaying Ahead of the Audit Curve with Food Industry Process Audits
Staying Ahead of the Audit Curve with Food Industry Process AuditsAlchemy Systems
 
Customized Alchemy Training
Customized Alchemy TrainingCustomized Alchemy Training
Customized Alchemy TrainingAlchemy Systems
 
Technologies that Drive Operational Performance & Retail Associate Behavior
Technologies that Drive Operational Performance & Retail Associate BehaviorTechnologies that Drive Operational Performance & Retail Associate Behavior
Technologies that Drive Operational Performance & Retail Associate BehaviorAlchemy Systems
 
Training: You Can't Afford Not To
Training: You Can't Afford Not ToTraining: You Can't Afford Not To
Training: You Can't Afford Not ToAlchemy Systems
 
Building an Asset Protection Brand
Building an Asset Protection BrandBuilding an Asset Protection Brand
Building an Asset Protection BrandAlchemy Systems
 
CLFP Food Processing Expo Session: Protecting Your People Profits & Brand
CLFP Food Processing Expo Session: Protecting Your People Profits & BrandCLFP Food Processing Expo Session: Protecting Your People Profits & Brand
CLFP Food Processing Expo Session: Protecting Your People Profits & BrandAlchemy Systems
 

Mehr von Alchemy Systems (12)

Build an Effective Serious-injury Prevention Strategy (in Food Manufacturing)
Build an Effective Serious-injury  Prevention Strategy (in Food Manufacturing)Build an Effective Serious-injury  Prevention Strategy (in Food Manufacturing)
Build an Effective Serious-injury Prevention Strategy (in Food Manufacturing)
 
Strategies to Reduce Food Waste for Increased Profitability
Strategies to Reduce Food Waste for Increased ProfitabilityStrategies to Reduce Food Waste for Increased Profitability
Strategies to Reduce Food Waste for Increased Profitability
 
Food Waste Webinar Preview
Food Waste Webinar PreviewFood Waste Webinar Preview
Food Waste Webinar Preview
 
Exceeding BRC Expectations: Addressing the Human Element of Food Safety
Exceeding BRC Expectations: Addressing the Human Element of Food SafetyExceeding BRC Expectations: Addressing the Human Element of Food Safety
Exceeding BRC Expectations: Addressing the Human Element of Food Safety
 
Global Food Safety Training Survey 2016
Global Food Safety Training Survey 2016Global Food Safety Training Survey 2016
Global Food Safety Training Survey 2016
 
SQF Conference 2015: THE MIND OF THE FOOD WORKER -- RESULTS OF A BREAKTHROUGH...
SQF Conference 2015: THE MIND OF THE FOOD WORKER -- RESULTS OF A BREAKTHROUGH...SQF Conference 2015: THE MIND OF THE FOOD WORKER -- RESULTS OF A BREAKTHROUGH...
SQF Conference 2015: THE MIND OF THE FOOD WORKER -- RESULTS OF A BREAKTHROUGH...
 
Staying Ahead of the Audit Curve with Food Industry Process Audits
Staying Ahead of the Audit Curve with Food Industry Process AuditsStaying Ahead of the Audit Curve with Food Industry Process Audits
Staying Ahead of the Audit Curve with Food Industry Process Audits
 
Customized Alchemy Training
Customized Alchemy TrainingCustomized Alchemy Training
Customized Alchemy Training
 
Technologies that Drive Operational Performance & Retail Associate Behavior
Technologies that Drive Operational Performance & Retail Associate BehaviorTechnologies that Drive Operational Performance & Retail Associate Behavior
Technologies that Drive Operational Performance & Retail Associate Behavior
 
Training: You Can't Afford Not To
Training: You Can't Afford Not ToTraining: You Can't Afford Not To
Training: You Can't Afford Not To
 
Building an Asset Protection Brand
Building an Asset Protection BrandBuilding an Asset Protection Brand
Building an Asset Protection Brand
 
CLFP Food Processing Expo Session: Protecting Your People Profits & Brand
CLFP Food Processing Expo Session: Protecting Your People Profits & BrandCLFP Food Processing Expo Session: Protecting Your People Profits & Brand
CLFP Food Processing Expo Session: Protecting Your People Profits & Brand
 

Kürzlich hochgeladen

Piping techniques in decorating cakes and cupcakes.
Piping techniques in decorating cakes and cupcakes.Piping techniques in decorating cakes and cupcakes.
Piping techniques in decorating cakes and cupcakes.Jolyn Sambrano
 
HOTMEN TAJUR BOGOR JAWA BARAT INDONESIAA
HOTMEN TAJUR BOGOR JAWA BARAT INDONESIAAHOTMEN TAJUR BOGOR JAWA BARAT INDONESIAA
HOTMEN TAJUR BOGOR JAWA BARAT INDONESIAAPermataAnnisa3
 
Empowering Communities: Food Donation NGO Making a Difference
Empowering Communities: Food Donation NGO Making a DifferenceEmpowering Communities: Food Donation NGO Making a Difference
Empowering Communities: Food Donation NGO Making a DifferenceLovely Foundation
 
Explore The flavors Of Indian cuisine In Budapest : Indian Palate
Explore The flavors Of Indian cuisine In Budapest : Indian PalateExplore The flavors Of Indian cuisine In Budapest : Indian Palate
Explore The flavors Of Indian cuisine In Budapest : Indian PalateIndian Palate
 
Food Supplement Directive No. 333-2020.pdf
Food Supplement Directive No. 333-2020.pdfFood Supplement Directive No. 333-2020.pdf
Food Supplement Directive No. 333-2020.pdfMohamed Miyir
 
Beet Kvass The Probiotic-Rich, Fermented Tonic from Eastern Europe
Beet Kvass The Probiotic-Rich, Fermented Tonic from Eastern EuropeBeet Kvass The Probiotic-Rich, Fermented Tonic from Eastern Europe
Beet Kvass The Probiotic-Rich, Fermented Tonic from Eastern EuropeGarden Goddess, LLC
 
Reclaiming Pure Traditions Plants Enrichen Our Farms and Food.pdf
Reclaiming Pure Traditions Plants Enrichen Our Farms and Food.pdfReclaiming Pure Traditions Plants Enrichen Our Farms and Food.pdf
Reclaiming Pure Traditions Plants Enrichen Our Farms and Food.pdfStephen Gleave
 

Kürzlich hochgeladen (7)

Piping techniques in decorating cakes and cupcakes.
Piping techniques in decorating cakes and cupcakes.Piping techniques in decorating cakes and cupcakes.
Piping techniques in decorating cakes and cupcakes.
 
HOTMEN TAJUR BOGOR JAWA BARAT INDONESIAA
HOTMEN TAJUR BOGOR JAWA BARAT INDONESIAAHOTMEN TAJUR BOGOR JAWA BARAT INDONESIAA
HOTMEN TAJUR BOGOR JAWA BARAT INDONESIAA
 
Empowering Communities: Food Donation NGO Making a Difference
Empowering Communities: Food Donation NGO Making a DifferenceEmpowering Communities: Food Donation NGO Making a Difference
Empowering Communities: Food Donation NGO Making a Difference
 
Explore The flavors Of Indian cuisine In Budapest : Indian Palate
Explore The flavors Of Indian cuisine In Budapest : Indian PalateExplore The flavors Of Indian cuisine In Budapest : Indian Palate
Explore The flavors Of Indian cuisine In Budapest : Indian Palate
 
Food Supplement Directive No. 333-2020.pdf
Food Supplement Directive No. 333-2020.pdfFood Supplement Directive No. 333-2020.pdf
Food Supplement Directive No. 333-2020.pdf
 
Beet Kvass The Probiotic-Rich, Fermented Tonic from Eastern Europe
Beet Kvass The Probiotic-Rich, Fermented Tonic from Eastern EuropeBeet Kvass The Probiotic-Rich, Fermented Tonic from Eastern Europe
Beet Kvass The Probiotic-Rich, Fermented Tonic from Eastern Europe
 
Reclaiming Pure Traditions Plants Enrichen Our Farms and Food.pdf
Reclaiming Pure Traditions Plants Enrichen Our Farms and Food.pdfReclaiming Pure Traditions Plants Enrichen Our Farms and Food.pdf
Reclaiming Pure Traditions Plants Enrichen Our Farms and Food.pdf
 

New HACCP Regulations - Plan Now!

  • 1. New HACCP Regulations – Plan Now Jeff Chilton | Dr. Amit Morey June 12, 2015
  • 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
  • 3. Today’s Speakers 3 Jeff Chilton Alchemy Diana Peña Moderator Dr. Amit Morey I.D.E.A. Food Industry Consultants
  • 4. Agenda 4 • New USDA Regulatory Requirements Overview • HACCP Plan Reassessment Processes • Validation Methodology • Q&A
  • 5. 5 New USDA Regulatory Requirements Jeff Chilton Alchemy
  • 6. HACCP Primer 6 • 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 7 • 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 8 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 9 • 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) 10 • 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 11 • 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) 12 • 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! 13 • 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
  • 14. Validation Methodology Dr. Amit Morey I.D.E.A. Food Industry Consultants 14
  • 15. Two Elements of Validation 15 • Scientific - Challenge Study • In-Plant Validation
  • 16. Important Considerations 16 • 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 17 • 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 18 • 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 19 • 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 20 • 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 21 • Fat content • Size and shape of the food • Number and type of processing steps • Product species • Public health risk
  • 22. Critical Operational Parameters 22 • 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 23 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 24 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 26 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 27 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 29 • Network with industry leaders • Master best practices • Discover new technologies http://www.alchemysystems.com/alchemy-conference/

Hinweis der Redaktion

  1. 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]
  2. 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]
  3. 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]
  4. 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.
  5. 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
  6. Diana
  7. Diana