Under FSMA, each human or animal food processing facility will need a “Preventive Controls Qualified Individual” (PCQI) to oversee or conduct preparation of the food safety plan, validation of the preventive controls, review of records, and reanalysis of the food safety plan. During TraceGains' January FSMA Club webinar, TraceGains will host FDA attorney Marc Sanchez to explain the PCQI requirement and clarify what sort of training and experience FDA expects the author of your food safety plan to have. Specifically, the FSMA Club webinar will cover: Who is covered by the HARPC requirement for a PCQI; Who is responsible for developing a food safety plan; Validation of preventative controls; Reanalysis of the food safety plan; and, Employees vs. a third-party serving as the PCQI.

1. Qualify This!
The Preventative Controls Qualified Individual
Marc Sanchez, FDA Attorney & Founder
Contract In-House Counsel & Consultants, LLC
and
Gary Nowacki, CEO
TraceGains, Inc.

2. Mullins
Food
Products
The kind of company we keep….

3. Throughout
the webinar,
please enter
your questions
into the Chat
box, located on
the left side of
your screen.

4. Gary Nowacki
CEO
TraceGains
Marc Sanchez, Esq.
Founder
Contract In-House Counsel & Consultants LLC

5. 5
Unraveling the Qualified Individual Requirement
Marc C. Sanchez, Esq.
www.fdaatty.com
Qualify This!
™

6. “Qualified”
Ambiguous and Pervasive in FSMA
6
Qualified
Human and Animal HARPC
Qualified Individual requirement.
FSVP
Qualified individual recommendation.
Third Party Auditor
Qualified auditor requirement.

7. The Proposed Confusion
Qualified for One but Not for All
7
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

8. 8
Final Rule Made a Change
The 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
Qualified
Individual

9. Qualified Split
In the Final Rule Two “Qualifications” Emerge
9
Qualified Individual
This 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
PCQI

10. Implementing FSMA
Two Rules Require PCQI
10
Human and Animal
HARPC
Both require a PCQI maintain
compliance with the rule - e.g.
food safety plans
Qualified by FDA
Qualified can mean completion of
a FDA approved curriculum.
Otherwise Qualified
Training or job experience
qualifies an individual when equal
to the FDA curriculum.

11. FDA Curriculum
Under Development by the Food Safety Preventative Controls Alliance
11
15 Chapters Total
Food Safety
Plan Hazards
GMP
Developing a
Food Safety Plan
Food Safety Plan

12. 12
Auditor recommended installing “potato
washing” system that ultimately
contributed to the outbreak.
The Jensen Example
Recognize Risk
Would a PCQI identified the
risk of the washing system?
Mitigate the Risk
Would a PCQI recommended
chlorine spray or other kill
step?
PCQI
Ultimately is a proactive,
product/process specific, risk
focused, person.

13. Automating
Supplier and
Quality
Management

14. 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.

15. 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)

16. TraceGains Quality Management
To-do Lists, Alerts,
Corrective Actions
Trends & Graphs
Access Anywhere,
Anytime
CCPs
Pre-op Sanitize,
Calibrate, etc.
Verify CCPs Automate FSMA, GFSI
Audits & Records
GFSI
Documents
FSMA, GFSI, 365 Audit Ready™
Pre-Shipment
Checkoff
Staff Training

17. Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits

18. Gary Nowacki
gary.nowacki@tracegains.com
720-465-9400
www.tracegains.com
Marc Sanchez, Esq
msanchez@fdaatty.com
202.765.4491
www.fdaatty.com

19. www.surveymonkey.com/r/FSQA2016

20. Upcoming FSMA Club Webinars
with Guest Speaker Marc Sanchez
Feb. 25 – Preventative Controls for Animal Food
Mar. 18 – Allergens and Intentional Adulteration
Apr. 21 – Sanitary Food Transportation Final Rule