danger! pitfalls of converting haccp plans to fsma food ... · the food safety modernization act...
TRANSCRIPT
Slide 1 of 15
Danger! Pitfalls of converting HACCP Plans to
FSMA Food Safety Plans?
Food Safety Summit 2018
Deb Kane, Director Food Safety & QA
J&J Snack Foods Corp. 1
Slide 2 of 15
2
Slide 3 of 15
3
Slide 4 of 15
4
Slide 5 of 15
5
Slide 6 of 15
Program PRP – prerequisite PC – preventive control
Supply
Allergen
Sanitation
Examples of PCs outside of CCPs
Slide 7 of 15
Program PRP – prerequisite PC – preventive control
Supply • Supplier Approval Program• Review audit reports • Review food safety programs
Allergen
Sanitation
Examples of PCs outside of CCPs
Slide 8 of 15
Program PRP – prerequisite PC – preventive control
Supply • Supplier Approval Program• Review audit reports • Review food safety programs
• Supply-chain applied control (kill-step)• COA (allergen free)• LOG for potential chemical hazards
Allergen
Sanitation
Examples of PCs outside of CCPs
Slide 9 of 15
Program PRP – prerequisite PC – preventive control
Supply • Supplier Approval Program• Review audit reports • Review food safety programs
• Supply-chain applied control (kill-step)• COA (allergen free)• LOG for potential chemical hazards
Allergen • Raw material receiving• Proper storage & cleaning spills• Color-coding for tools/utensils• Personnel practices
Sanitation
Examples of PCs outside of CCPs
Slide 10 of 15
Program PRP – prerequisite PC – preventive control
Supply • Supplier Approval Program• Review audit reports • Review food safety programs
• Supply-chain applied control (kill-step)• COA (allergen free)• LOG for potential chemical hazards
Allergen • Raw material receiving• Proper storage & cleaning spills• Color-coding for tools/utensils• Personnel practices
• Ensure labels are correct – receiving • Ensure correct label or package used• Allergen changeover/rework procedures
Sanitation
Examples of PCs outside of CCPs
Slide 11 of 15
Program PRP – prerequisite PC – preventive control
Supply • Supplier Approval Program• Review audit reports • Review food safety programs
• Supply-chain applied control (kill-step)• COA (allergen free)• LOG for potential chemical hazards
Allergen • Raw material receiving• Proper storage & cleaning spills• Color-coding for tools/utensils• Personnel practices
• Ensure labels are correct – receiving • Ensure correct label or package used• Allergen changeover/rework procedures
Sanitation • Facility hygiene as necessary• Cleaning operations not a source
of contamination• Waste management• SSOPs
Examples of PCs outside of CCPs
Slide 12 of 15
Program PRP – prerequisite PC – preventive control
Supply • Supplier Approval Program• Review audit reports • Review food safety programs
• Supply-chain applied control (kill-step)• COA (allergen free)• LOG for potential chemical hazards
Allergen • Raw material receiving• Proper storage & cleaning spills• Color-coding for tools/utensils• Personnel practices
• Ensure labels are correct – receiving • Ensure correct label or package used• Allergen changeover/rework procedures
Sanitation • Facility hygiene as necessary• Cleaning operations not a source
of contamination• Waste management• SSOPs
• Verification of allergen removal• Verifications post-thermal (RTE products)• Corrections can be made prior to running*
Examples of PCs outside of CCPs
Slide 13 of 15
Food Safety Plans
Systematic process based on science
Specific to a facility (products may be grouped if hazards/controls are generally the same)
Preventive Controls specific to a product/process based on the HAZARD ANALYSIS conducted by the FS Team at the plant
• Allergens: where is the risk for cross-contact in the facility? Equipment, process, people?
• Supply-chain: if PC is review of the COA, needs to be managed at the plant level
• Sanitation: how easy is equipment to clean (e.g., age, condition, materials – fabric belts)?
Slide 14 of 15
QUESTIONS??
Slide 15 of 15
Deb Kane, J&J Snack Foods Corp.
New Jersey’s Regulatory Approach:
Preventative Controls and Limited Scope PC
Inspections
Danielle Clemons, MPH
MFRPS Coordinator
Public Health & Food Protection Program (PHFPP)
Agenda•Food Firm Inventory
•Tools of Enforcement
•Frequently Cited Violations
New Jersey’s Response to FSMA
• What did these legislative changes mean and who is required to comply?
• How do we prepare staff ?
• Do we have the RESOURCES?!?
• Where do we START!?!?!
New Jersey Food Firm InventoryRisk Typing
High Risk • Activities
- Canning, vacuum packaging, smoking
AND/OR
- Handing of foods frequently implicated in foodborne illness
AND/OR
- POOR COMPLIANCE HISTORY
• Inspection Frequency
- Every Year
OR
- Complaints
Risk Categorizing Continued
MEDIUM RISK• Activities
- cooking, cooling, holding under controlled temperatures, pasteurization
AND/OR
- potentially hazardous foods not typically implicated in foodborne illness
• Inspection Frequency
- Every 3 years
OR
- Complaint
Low Risk
• Activities
- Storing and handling of foods where temperature
control is not required AND/OR
- Non-potentially hazardous foods AND/OR
- ROUTINE COMPLIANCE
• Inspection Frequency
- Every 4 years OR Complaints
Total Manufactured Food Firms
• ~3000 total firms
• 64% Classified Low Risk Firms
• 75% firms
– small (<500 employees) or
very small (< 1 mil)
Capacity Assessment• Regulatory Authority
- New Jersey has not adopted 21 CFR 117 PC Rule
- FDA Pocket Credentials- Confers upon the recipient the authority to perform activities in designated program areas as a federal official within their own state (or local) jurisdiction.
• Staff
- 21 Full time inspectors
- 11 inspectors issued pocket credentials
- 0 State PC Inspectors/ 2 Federal PC
• Training Plan
- Required and prerequisite coursework
- Timelines
Inspections Scope & ApproachLimited Scope 110/117
• Educate before and while you Regulate!!
• Broad Based Assessment
• Ask Questions
• Document Review
Current Inspectional Data
• Issuance of 483’s
• Nationally
• New Jersey
• Data Trends
• Top Categories of Frequently Cited Violations
- Production and Processes 24%
- Sanitary Operations 24%
- Facility Procedures 18%
- Sanitary Facilities and Controls 14%
QUESTIONS
C. DANIELLE CLEMONSMFRPS COORDINATORPO BOX 369TRENTON, NJ PHONE: (609) 826-4935
Contact Information
Donna F Schaffner, 2018
Utilizing your HACCP Plan
as one component of the
“FSMA Puzzle”
Speaker: Donna F. SchaffnerAssoc Director: Food Safety, QA & Training Programs
Rutgers Food Innovation Center, Bridgeton, NJ 08302
Presentation for the
2018 Food Safety Summit
“Pitfalls” symposium – May 10, 2018.
Slide 1 of 13
Donna F Schaffner, 2018
The FSMA Puzzle…
The Food Safety Modernization Act (FSMA) is an
extensive, complex set of regulations for how food
processing businesses must conduct innumerable
activities that might have an influence on “Food
Safety” with requirements for documentation of all
those activities.
Slide 2 of 13Donna F Schaffner, 2018
Donna F Schaffner, 2018
The FSMA Supply Chain…
Implementation of the
“Preventive Controls” rules will
have far-reaching
consequences supply chain
back to the “original grower”…
Donna F Schaffner, 2018 Slide 3 of 13
of all goods/ ingredients used
in food production; affecting all
entities involved with the
production, transportation,
holding or storage of food.
Donna F Schaffner, 2018
Food Safety Modernization Act
Preventive Controls for Human Food: compliance dates: Sept. of 2016, 2017, 2018
Preventive Controls for Animal Feed:
compliance dates: Sept. of 2017, 2018, 2019
Produce Regulations:
compliance dates: Jan. of 2018, 2019, 2020
Foreign Supplier Verification Program:
compliance dates: Jan. of 2017, 2018, 2019
Sanitary Transportation of Food:
compliance dates: June of 2017 & 2018
Intentional Adulteration of Food:
compliance dates: July of 2019, 2020, 2021
Slide 4 of 13
Donna F Schaffner, 2018
Traditional HACCP Plans…
Only concentrated on the
PROCESS while things
were inside the
processing facility.
Everything else is just a
“pre-requisite” and often
NOT subjected to nearly
the same amount of
scrutiny as the CCPs.
receiving
storage
packaging
storage
shipping
cooking
cooling
CCP
CCP
Slide 5 of 13
Donna F Schaffner, 2018
Preventive Control
Food Safety Plans…
Place importance on a
much wider area… going
far beyond just the
PROCESS.
Preventive Controls Food
Safety Plans must include
the traditional CCPs as
Process PCs, Allergen
and Sanitation PCs as
well as Supply Chain PCs
and ‘others’ if needed.
receiving
storage
packaging
storage
shipping
cooking
cooling
CCP
CCP
Supply
Chain
PCs
Allergen &
Sanitation
PCs
Allergen &
Sanitation
PCs
Allergen &
Sanitation
PCs
labeling
Foreign material
control devices Process PCs
Allergen PCs
Slide 6 of 13
Allergen &
Sanitation
PCs
Allergen &
Sanitation
PCs
Donna F Schaffner, 2018
Supply chain Preventive Controls
– Aflatoxins, Unapproved pesticides, etc.
Allergen Preventive Controls
– Prevention of cross-contact
– Proper allergen declaration on labels
Sanitation Preventive Controls
– Environmental exposure of RTE foods
– Areas of likely cross-contamination
– Areas of likely allergen cross-contact/
shared equipment
Slide 7 of 13
Required in Preventive Control Food Safety
Plans but NOT required in HACCP Plans…
Donna F Schaffner, 2018
Training Requirements…
The PCHF rule contains strict training
requirements: every food manufacturer
must have at least one PCQI (Preventive
Controls Qualified Individual) to write,
maintain and implement a risk-based Food
Safety Plan for each type of food made.
Slide 8 of 13Donna F Schaffner, 2018
This has caused a huge increase in demand for people
having a HACCP background and additional
knowledge of increasingly complex government
regulations required for holding the PCQI qualification.
After the PCHF rule, other Rules have been released
making an ever-increasing number of pieces required
for completion of the FSMA puzzle.
EXAMPLE Hot Sauce Production Flow
(21.) Pre-shipment Review
(20.) Storage
(22.) Shipping to Customers
(19.) Case Pack, Label & Palletize Finished Product
Employee
name
Department/
PositionGMPs
Food
SecurityHACCP
Elo Filler
Operation
Sanitation -
basic
Sanitation -
Chemicals
Robert A. Prod. Machine Op. 1-15-08 1-22-08 2/10/2008 2-15-08
David B. Prod. Manager 1-15-08 1-22-08 1-30-08 2/10/2008 2-22-08
Carlos M. Receiving clerk 1-15-08 1-22-08 1-30-08
Larry M. Sanitation Manager 1-15-08 1-22-08 2-01-08 2-15-08 2-22-08
Elva N. Sanitation worker 1-15-08 1-22-08 1-30-08 2-15-08 2-22-08
Nelly O. QA technician 1-15-08 1-22-08 1-30-08 2/10/2008 2-15-08 2-22-08
Donna S. QA - HACCP Coord. 1-15-08 1-22-08 1-30-08 2/10/2008 2-15-08 2-22-08
Employee Training Log
Training & Date
Donna F Schaffner, 2018
Additional FSMA Rules…
The Foreign Supplier Verification Program
(FSVP) and Intentional Adulteration Rules (AI),
released subsequent to the PC rule, have added
addition required pieces to the FSMA puzzle
beyond traditional HACCP.
*The IA rule is primarily addressing the “bioterrorism”
component of the Food Defense program
requirements, while the “Economically Motivated
Adulteration” (EMA) and “disgruntled employee”
components are required to be covered in your
Preventive Controls Food Safety Plan.
(*not previously required in HACCP Plans)
Slide 9 of 13Donna F Schaffner, 2018
Food Fraud?
Donna F Schaffner, 2018
Ensure that all individuals who perform
activities related to food safety are
qualified to perform their duties.
Personnel AND Supervisors of personnel
assigned to Food Safety activities must
receive appropriate training for their
respective responsibilities in implementation.
Must keep written training records /
documentation of the appropriate trainingfor all employees (beyond HACCP!)
Donna F Schaffner, 2018
Training Requirement for FSMA Rules…
Slide 10 of 13
Donna F Schaffner, 2018
Auditors Training required…
“Internal Auditors” as required by GFSI-level 3rd party
audits for verifying compliance with all of the new FDA
requirements, now have new requirements for
credentials showing that they are Qualified Individuals
in regards to auditing.
Donna F Schaffner, 2018 Slide 11 of 13
PCHF “Supply Chain” requirements include
conducting annual audits of suppliers who
must control significant Supply Chain
Preventive Controls. Persons conducting
audits must have credentials showing they
are Qualified Individuals for auditing.
Donna F Schaffner, 2018
And in conclusion…
• Food manufacturing companies will need to have their Food
Safety – Preventive Controls Plan, compliant with Foreign
Supplier Verification Programs, and possibly also needing to
comply with the Produce Safety Rule, the Sanitary
Transportation Act, and others, depending on the business.
• The FSMA-puzzle consists of many pieces…
HACCP was just a start to the puzzle. Our job
now is to get ALL the pieces to fit together!
Donna F Schaffner, 2018Slide 12 of 13
Donna F. Schaffner: Assoc. Director Food Safety & Training
Rutgers Food Innovation Center
450 East Broad Street , Bridgeton, NJ 08302
[email protected] (856) 459-1900 x4528
Any Questions?
Utilizing your HACCP Plan as one
component of the FSMA Puzzle
Slide 13 of 13Donna F Schaffner, 2018