Chill Out About FSMA - It's Complex, but it's Not Rocket Science
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Chill Out About FSMA It’s Complex, but it’s Not Rocket Science Marc Sanchez, FDA Attorney & Founder Contract In-House Counsel & Consultants, LLC and Gary Nowacki, CEO TraceGains, Inc.
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Transcript of Chill Out About FSMA - It's Complex, but it's Not Rocket Science
Chill Out About FSMAIt’s Complex, but it’s Not Rocket Science
Marc Sanchez, FDA Attorney & FounderContract In-House Counsel & Consultants, LLC
andGary Nowacki, CEO
TraceGains, Inc.
Gary NowackiCEOTraceGains
Marc Sanchez, Esq.FounderContract In-House Counsel & Consultants LLC
Worried About FSMA?Marc C. Sanchez, Esq.
FDA Atty (CIHCC, LLC)fdaatty.com
Welcome
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First substantive change to the FD&C in 75+ yearsWhat is FSMA?Provided FDA with new authority:
• Mandatory Recall • Facility Registration Suspension
Provided Industry with new rules to comply withFocused on Self-EnforcementEnhanced ability to enforce through private litigation
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Rules form the core of FSMASeven Rules of FSMA
1. Preventative Controls Rule – Human: Effective 2016*
2. Preventative Controls Rule – Animal: Effective 2016*
3. Foreign Supplier Verification: Effective 2017*
4. Produce Safety: Effective 2017*
5. Intentional Adulteration (Food Defense): Effective 2017*
6. Sanitary Transportation: Effective 2017*
7. Accreditation of Third Party Auditors: t/b/d (finalized October 2015)
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FSMA is familiar but differentFear Not
Similar to HACCP primary goal of FSMA is to
proactively identify risks
Risk Identification Similar to HACCP FSMA
also seeks documented plans on how the risks
identified will be controlled
Risk Control
Rather than rely on FDA to verify risks are identified and controlled, FSMA is
largely self-enforced
Supplier Verification FSMA is a modernization a
decade behind consumer and industry changes
Pace of Change
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Similar to HACCP but Different ApproachPreventative Controls
GMP UpdateFirst since 1986 – focus on training and formalizing cross-allergen contact.
Definition of “Farm”Primary Production vs Secondary Activities
Risk IdentificationLike HACCP conduct a hazard analysis
Risk Control/MonitorLike HACCP develop risk control procedures.
Similar goals, but different approaches. HARPC requires
identification of risks specific to products or manufacturing
methods and control of those risks to prevent
contamination.
Bulk of the rule is HACCP-esque
HACCP vs. HARPC
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The foreign counterpart to HARPCForeign Supplier Verification Program
Risk Analysis Risk Control Monitoring Verification Adaptive
Similar to HARPC (and
HACCP) identify
product/operations specific
hazards
Likewise develop procedures
to control hazards – testing,
audits, etc.
Hazard control is on-going
between importer and
foreign supplier, including
compliance history
Supplier verification can take
many forms, including on-
site inspections.
Like HARPC the hazard
control plan adapts
significant changes/new
hazards
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cGMPs required for first timeAnimal HARPC
Simply the Animal version of HARPC – same hazard analysis, control, monitoring and verification. What is new? Requires GMPs for animal
food facilities forming a baseline of safe production standards.
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01
Strategically Build on Existing
Practices
FSMA Success
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Determine the types of hazards
associated with
product/operations
Hazard Analysis
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Determine how to monitor
and control hazards
Risk Control
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Ensure proper documentation
of risk analysis and control
Records
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Ensure suppliers are compliant
and controlling hazards
Proactive Monitoring
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Hazard analysis and monitoring is
specific to your products and therefore
requires the right training and
certification (“qualified individual”).
Ensure Training and Cert.
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Inspections, WLs, Recalls are
opportunities to adapt hazard
analysis
Adapt
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The details are new but the concepts the same
FSMA Is Not Rocket Science
Questions?
FSMA is Nothing NewInstead it builds on familiar industry
practices by adding new methods
and documentation to HACCP and GMPs.
************
Automating Supplier and
Quality Management
TraceGains Products
Specification Publishing
Create, maintain, and publish your company’s unique specifications to ensure compliance on incoming ingredients.
Supplier Compliance
Automate lot-by-lot compliance across purchasing, COAs,
receiving, testing, and plant floor.
Finished Goods COAs
Generate finished goods COAs, manage
customer-specific formats, and send to
customers on demand.
Supplier Management
Automatically manage supplier qualification,
documents, and relationships.
Quality Management
Automate HACCP / HARPC and comply with GFSI, FSMA, safety, and quality.
Supplier Analysis& Scorecarding
TraceGains Supplier Management
To-do Lists,Corrective Actions
Access Anywhere,Anytime
Allergens OrganicAudits KosherNutritionSupplier Qualification
FSMA, GFSI, 365 Audit Ready™
C.O.O.L. Specifications
24/7 Monitoring
eNotifications
Labeling(e.g., Genesis)
TraceGains Quality Management
To-do Lists, Alerts,Corrective Actions
Trends & Graphs
Access Anywhere,Anytime
CCPsPre-op Sanitize, Calibrate, etc.
Verify CCPs Automate FSMA, GFSI Audits & Records
GFSI Documents
FSMA, GFSI, 365 Audit Ready™
Pre-ShipmentCheckoff
Staff Training
Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
Gary [email protected]
720-465-9400www.tracegains.com
Marc Sanchez, [email protected]
202.765.4491www.fdaatty.com
