fsma club: qualify this! - preventative controls qualified individual
TRANSCRIPT
Qualify This!The Preventative Controls Qualified Individual
Marc Sanchez, FDA Attorney & FounderContract In-House Counsel & Consultants, LLC
andGary Nowacki, CEO
TraceGains, Inc.
Mullins Food
Products
The kind of company we keep….
Throughout the webinar, please enter
your questions into the Chat
box, located on the left side of your screen.
Gary NowackiCEOTraceGains
Marc Sanchez, Esq.FounderContract In-House Counsel & Consultants LLC
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Unraveling the Qualified Individual Requirement Marc C. Sanchez, Esq.www.fdaatty.com
Qualify This!
™
“Qualified”Ambiguous and Pervasive in FSMA
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Qualified
Human and Animal HARPCQualified Individual requirement.
FSVPQualified individual recommendation.
Third Party AuditorQualified auditor requirement.
The Proposed ConfusionQualified for One but Not for All
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Defined as a person who has the necessary education, training, and experience to perform the activities needed to meet the FSVP requirements
“Qualified individual” for FSVP
Qualified by FDA curriculum or equal training/job experience. The focus is on writing, implementing, and managing food safety plans.
“QUALIFIED INDIVIDUAL” FOR HARPC
Under the proposed HARPC rule, a FSVP qualified individual would not be a HARPC qualified individual, but a HARPC qualified individual may be a FSVP qualified individual.
CROSS QUALIFIED?Qualified individual under HARPC now means
“education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as
appropriate to the individual's assigned duties.”Now on par with FSVP.
Final rule creates parity
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Final Rule Made a ChangeThe final rule shifted the term from “qualified individual” to “preventative controls qualified individual” in an attempt to add clarity. It also added consistency between FSVP and HARPC.
Preventative Controls QualifiedIndividual
Qualified SplitIn the Final Rule Two “Qualifications” Emerge
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Qualified IndividualThis is the term used in the Proposed
Human and Animal HARPC
Preventative Controls Qualified Individual
This is the new term, but the old one is still in use too.
QI
PC
QI
Implementing FSMATwo Rules Require PCQI
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Human and Animal HARPC
Both require a PCQI maintain compliance with the rule - e.g.
food safety plans
Qualified by FDAQualified can mean completion of a FDA approved curriculum.
Otherwise QualifiedTraining or job experience
qualifies an individual when equal to the FDA curriculum.
FDA Curriculum Under Development by the Food Safety Preventative Controls Alliance
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15 Chapters Total
Food Safety Plan Hazards
GMP
Developing a Food Safety Plan
Food Safety Plan
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Auditor recommended installing “potato washing” system that ultimately
contributed to the outbreak.
The Jensen Example
Recognize RiskWould a PCQI identified the risk of the washing system?
Mitigate the RiskWould a PCQI recommended chlorine spray or other kill step?
PCQI Ultimately is a proactive, product/process specific, risk focused, person.
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
www.surveymonkey.com/r/FSQA2016
Upcoming FSMA Club Webinarswith Guest Speaker Marc Sanchez
Feb. 25 – Preventative Controls for Animal Food
Mar. 18 – Allergens and Intentional Adulteration
Apr. 21 – Sanitary Food Transportation Final Rule