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Systems Thinking
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Housekeeping
1
Systems Thinking
FSMA TRAINING:
SYSTEMS THINKING: WHAT IS IT?
2
Systems Thinking
Warm Welcome
Kathy Gombas
Senior Advisor, CFSAN Office of Food Safety
Co-Lead, FSMA Training Workgroup
3
Systems Thinking
2015 Sessions
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• Food Safety Culture 101 – March 19
• Systems Thinking – May 28
• Environmental Monitoring - June 25
• Food Safety Culture 201 - July 23
• Supply Chain Management - Aug 27
• Food Safety Culture 301 - Sept 24
• Minimizing Allergens Risk - Oct 22
Events for sharing industry best practices
& FDA perspectives
Spring 2015 Summer 2015 Fall 2015
FS C
ult
ure
10
1 –
Mar
ch 1
9
Develop & Deliver PC Rule Readiness Training
Envi
ron
men
tal M
on
ito
rin
g –
Ju
ne
25
Sup
ply
Ch
ain
Man
agem
ent
- A
ugu
st 2
7
PC Training Plan: FY15 PC Rule Readiness Plan & FY 15-18 PC Regulator Plan
Deliver PC Regulator Training FY2016-2018
Technical Knowledge
Behavior & Systems
Thinking
Inspectional Skills & Knowledge
Min
imiz
ing
Alle
rgen
s R
isk
– O
cto
ber
22
FSP
CA
Co
urs
e: P
rere
q f
or
PC
Reg
ula
tor
Co
urs
es
Jan. 2016 thru Sept 2018
Technical Knowledge Inspection Skills & Knowledge Behavior & Systems Thinking FSPCA Training
Develop PC Regulator Training
FS C
ult
ure
30
1 –
Sep
tem
ber
24
FS C
ult
ure
20
1 –
Ju
ly 2
3
Syst
ems
Thin
kin
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May
28
Systems Thinking
• What is systems thinking? Ernie Julian, RI Dept of Health
• Industry best practices on systems thinking Dave Cook, Kraft Foods Group
Ryan Brown, Cargill Animal Nutrition
Joe Levitt, Hogan Lovells US LLP
• FDA perspective on systems thinking Roberta Wagner
• Q & A Session
Agenda
6
Systems Thinking
7
Ernie Julian Chief, Office of Food Protection
Rhode Island Department of Health
WHAT IS SYSTEMS THINKING?
Systems Thinking
What’s the Problem?
• 2014 FoodNet data shows illness due to salmonella
hasn’t decreased since 2006-2008, and campylobacter
actually increased 13%
• Outbreaks reoccurring from same sources
• Inspectors finding same hazards over and over again at
same facility
• Reports of outbreaks happening and find facility had a history
of serious hazards
• How can we be more effective in eliminating serious
hazards to health on a long-term basis?
8
Systems Thinking
• Historically inspectors trained to find and document
violations
• Preventive Controls (PC) - mission is assuring industry has
systems in place to prevent and address hazards at all
times
What’s the problem?
9
Systems Thinking What is systems thinking?
• An approach to preventing and solving problems by
looking for
• Connections between people, structures and processes
• Recurring patterns
• Feedback loops that maintain a safe system
• If system not working, systems thinking looks for
• Ways to unfreeze, create change, and then refreeze the
system at a safe and predictable level
• Establish dominant feedback loops to maintain the new
safe level
10
Systems Thinking
HACCP & PC
• Hazard Analysis Critical Control Points (HACCP) and
Preventive Controls (PC) represent systems thinking on
the preventive side
• What are the likely hazards throughout the process from the
source to the consumer?
• What monitoring and controls can be put in place to keep
these hazards from causing illness?
• What are ways to document and verify that assures the
systems are working?
11
Systems Thinking
When to use systems thinking?
• During inspections/investigations, critical thinking needed to
determine why problems exists
• Systems thinking helps
• Determine the root causes
• Problem solve to eliminate the root cause not just the
symptom
• Provide monitoring and feedback by facility management to
maintain a safe system
12
Systems Thinking
During an outbreak
investigation
• It’s not enough to show that a facility is the cause of an
outbreak
• Why did the problem occur?
• The greatest predictor of future behavior is past behavior
• Unless cause is identified and system is put in place, it is
likely to happen again
13
Systems Thinking During investigations and
inspections: Facility
• Is the hazard limited to this facility or could this hazard
exist elsewhere?
• If the hazard is likely to be elsewhere, need to notify other
federal, state and local officials where the hazard may exist
• Coordinate elimination of the hazard
• Need for seamless integration
14
Systems Thinking
During an outbreak
investigation: Ingredient
• Need to determine if there is an ingredient that may
cause illness elsewhere
• Example: Salmonella montevideo outbreak
• Evaluation of the processing system showed
pepper was contamination source
• Recalled 1.2 million pounds of salami instead of
78,000 pounds of the Salmonella positive lot
15
Systems Thinking
Preventing ongoing illnesses
• Use environmental assessment with food and environmental sampling to determine root cause that led to subsequent pepper recalls
• Example: FDA Risk Assessment found • 12% of spice imports contaminated
• 7% contaminated with Salmonella
16
Systems Thinking
During an outbreak investigation
or inspection: Equipment
• Is their equipment at fault?
• Is this equipment likely to pose a hazard elsewhere?
17
Systems Thinking
RI Salmonella outbreak traced to
tomatoes and slicer
Blade side view of slicer
blade guard
Non-removable, non-cleanable white
plastic on inside of blade guard was
Salmonella+ PFGE match to outbreak
18
Systems Thinking
Finding root cause to
prevent ongoing illnesses • Root causes
• Example: Identified Florida tomatoes as Salmonella source – 42 illnesses nationally (RI, WA, VA, ME…)
• Same slicer model contributed to earlier Georgia outbreak
• Prevention • Worked with NSF on new slicer standard effective November
2012 • Worked with FDA to create educational materials about slicer safety
• FDA printed 100,000 posters
19
Systems Thinking
• Are corporate polices the problem?
• If so, unlikely to get change if corporate system is
pushing do it this way or employees are fired
• Evaluate all facilities if a corporate issue
• Notify other districts and states
20
During an outbreak investigation or
inspection: Corporate policy
Systems Thinking
• Determine if there is a lack of knowledge?
• If can’t answer basic questions and they were trained and
certified, who trained them?
• Example: Decertified 500 people and an instructor when we
found an instructor was taking the test for people
During an outbreak investigation or
inspection: Lack of knowledge
21
Systems Thinking
• Motivation root of problem?
• If there are positive pathogen results and owner’s memo
says: “Just ship it”
• Check if other facilities under same ownership
• Criminal prosecution possible
22
During an outbreak investigation or
inspection: Motivation
Systems Thinking
Summary
1. We need to identify why the problems exist and their root
causes
2. We then need to address those root causes and have
management put monitoring in place to assure safe
system at all times
3. Individuals and the current system resist change, follow-
up to make certain current system is changed and
monitoring / feedback system is put in place
4. If other unsafe facilities under the same ownership,
check to see if current system is likely to create same
hazards
23
Systems Thinking
24
Dave Cook Director of Global Auditing, Corrective & Preventive Action
Kraft Foods Group
INDUSTRY PERSPECTIVE:
Human Food
Systems Thinking Industry Perspective:
Human Food
1. What does systems thinking look like at Kraft?
2. What does training for corporate systems auditors look like
at Kraft?
3. Based on your experience working in Global Food Safety
Initiative (GFSI) on auditor competencies, how does Kraft’s
approach to training different than others in the industry?
25
Systems Thinking Kraft’s Food Safety
Management System
Fact and Scientific-
Basis
Written Food Safety Plans
Implemented System of Controls
Continuous Learning and Improvement
26
Systems Thinking
P R
O C
E S
S F
L O
W
Environmental
Contaminants Environmental
contaminants
SAFE
PRODUCT
Inherent food safety hazards
Distribution (refrigeration)
Packaging (modified atmosphere,
preservatives, single use)
Processing
(heat, pressure, curing, etc.)
Formulation (preservatives, pH, fat content)
Ingredients (preservatives, irradiation, pasteurization)
Consumer (cooking &
refrigeration instructions)
- hurdle to prevent microbial survival
- general controls
Managing Microbial Risk
27
Systems Thinking
Kraft Systems-based Audits
• Auditing approach has evolved over time - Away from observation or task (e.g., checklist) to systems focus
- Program, controls, data and implementation
• Similar shift occurred with USDA’s implementation of HACCP
• Kraft uses a systems-based approach to strengthen food
safety programs
• Advantages: - Effectively identifies risk and prioritizes food safety findings
- More effective measure of compliance (regulatory and internal)
- Promotes dialogue and good working relationships
- Builds a culture of prevention and drives continuous improvement
- Lines of communication to resolve questions, issues, and challenges
28
Systems Thinking
Examples of Programs Audited
HACCP
Allergen Control
Environmental Monitoring
Sanitation
Period Cleaning
Pest Control
Production Controls
Recall Plan
Supplier Verification
GMPs
Other Controls Hygiene Training
29
Programs Audited
Systems Thinking
Assigning Risks Zones
Boiler Rm
#2 Oil
Tk Rm
Intake/Receiving
Rm
Am
moni
a
Rm
Air
Comp.
Rm
Elect.
Rm
Semi-
Soft
Stagin
g
Dryer
#1
Grill
Rm.
Maint. Rm
Sched.
Rm
Bag
Rm
Tank Rm
Ferment Rm
Dry Blend
M
C
C
Old Cooler
M C C
Loading Dock #2
Dryer #2 Op rm #2
Warehouse Bag rm
Cooler Cheese Grinding Area
Cook Rm
MCC Rm
CIP Rm
#3 Bag Rm
Offices
Ramp Dry Blend Warehouse
#1 Warehouse
#1 Hallway
Pit Tanks
Water Soft. Heater
Oil Storage
Label Rm
Grill Office
pH Shed
Salt System
Main Entrance
Grn Rm
Shp Off
#3 Hallway
Baler
Lunch Rm
Women’s Restroom
Men’s Restroom Janitor’s Rm
Main Office
Conf. Rm
Lab
Conf. Rm
Storage SSE Off.
Lobby
QA Off. Inv. Clerk
Eng. Off.
ISO Aud. Off.
2nd Level
1st Level
#2 rest room
Plat
BAX
Mix Rm
Dryer #2
Spare rm
Semi- Soft
Back Entrance
Elevator
Spare
Motors
= Overhead roll up / sliding
High control zone: Product of high sensitivity can be exposed to the environment and/’or the operators
Controlled zone: Product that are not highly sensitive can be exposed to the environment and the operators
Non-manufacturing zone: There is no open product in this zone
Raw Zone: N / A Raw meat/ raw milk/ raw nuts received
Assigning risk zones to a manufacturing area is a control that helps minimize risk of cross-contamination. The implementation of zones may require other controls.
30
Systems Thinking Evaluating Zoning Start with conversation and overview of programs
1. Documented program including a map
- Zones clearly identified
2. Preventive Controls in place to support the program
- Distinctive uniforms, traffic patterns, Pathogen Environmental Monitoring
(PEM)
3. PEM data supports zoning effectiveness
- Findings monitored
- Corrections or Corrective actions taken when necessary
4. Implementation on Plant floor
Not all gaps present the same risk
• Footbath sanitizer strength not properly documented (Opportunity
for Improvement)
• An employee in wrong area – isolated incident (Minor)
• No zoning program or multiple or significant gaps in program (Major)
• Direct raw to ready to eat cross contamination (Critical) 31
Exa
mple
s f
or
dis
cu
ssio
n o
nly
Systems Thinking
Developing Auditor Competency
Technical Capability
Food Manufacturing Experience (3-5
years)
Quality Fundamentals
and Policy
Subject Matter Expertise
Pasteurizers, Meat Science,
Cheese Manufacturing,
Auditing Skills
American Society of
Quality Certified
3rd party certified
practitioners
Soft Skills
Behavioral Standards & Interviewing
Skills
Individual Development
Plans
Critical Thinking
Apprentice Program
Trainee
Observe Audits
0-6 months
Team Auditor
6 months– 2years
(Qualified)
Lead
Auditor
2 years
(Qualified)
Audit Management
Calibration and
Continuing Education
Monthly Auditor Calibrations
Annual Auditor Training
Policy Reviews
Performance Reviews
HACCP Certified
Technical Writing
32
Systems Thinking
Auditor Competence
GFSI Auditor Competence – Working Group
•Food Safety Inspector ≠ Food Safety Systems Auditor
•Define common core auditor competencies
•Train & test auditor technical capabilities
•Direct assess individual’s critical thinking ability to apply skills
during an audit
•Rigorous qualification and on-going calibration process for
auditors
33
Systems Thinking
Summary Considerations
A system based approach is suitable both for audits and regulatory inspections
• There is a well documented program
• Program is complete and adequate
• Plant can explain their programs
• Documentation and floor observation support compliance
• Observations are viewed through the lens of the relevant program(s) and food safety risk
Systems Based Audits - A tool for identifying and characterizing food safety issues and addressing root cause effectively
• Sets achievable target of sound programs that find and address issues
• Enables prioritization of resources and more targeted follow-up
• Emphasizes programs at every step, so drives continuous improvement
• Promotes strong working relationship between the auditor and the facility
• Builds a culture of prevention
34
Systems Thinking
35
Ryan Brown Global Supplier Quality Assurance Leader
Cargill Animal Nutrition
INDUSTRY PERSPECTIVE:
Animal Food
Systems Thinking
Industry Perspective:
Animal Food
36
1. What are some differences between animal and
human food?
2. How does culture play into food safety management?
3. How does the status quo fit into an effective
continuous improvement model?
4. Why is calibration a key component of system
thinking?
Systems Thinking
• The U.S. animal food industry consists of many different
segments (pet food, complete feed, animal health, premix, etc.)
each at a different level of food safety maturity.
• Risk (finished product, facility and raw material), industry
segment and company needs dictate the sophistication of a food
safety program.
• The following is one industry example of how a food safety
program can be implemented and how systems thinking plays a
role.
Food Safety Program &
Systems Thinking
37
Systems Thinking
Sanitation
Pest Control
Management of
Ingredients
etc.
HACCP Training Programs Internal Audit Management Review etc.
Additional requirements
for Pre-Requisite and
Food Safety
Management
Cargill Animal Nutrition FSQR Policy Manual
38
Food Safety, Quality and Regulatory
(FSQR) Policy Manual
38
Systems Thinking
Management Requirements
HACCP principles (Codex Alimentarius)
Good Practices / Prerequisite Programs
(PRPs)
• GAP, GMP
• Codex Alimentarius
Codex Alimentarius: HACCP
System and Guidelines for its
application
elements of
ISO 9001:2000 Food Safety
Management
System
Food
Safety
System
Basis
39
Food Safety Management Systems: a model e.g. ISO 22000
39
Systems Thinking
Pillars of a Food Safety Management
System (FSMS)
40
Systems Thinking
7.8 Verification
planning
8.4.2 Evaluation of
ind.verification
8.4.3. Analysis of
verification results
5.8 Mgmt. Review
8.5.2 Updating
the FSMS
Int. A
ud
its
Ext. A
ud
its
a) PRPs
b) “Inputs”
c) OPRPs & CCPs
d) Acceptable levels
e) Other procedures
• Confirm the FSMS is meeting
requirements
• Identify needs to improve the FSMS
• Identify Trends
• Plan the Internal Audit
• Ensure Corrections and Corrective
Action are effective
•Existing procedures and communication
•Hazard Analysis Decisions
•PRP’s
•Effectiveness of Training
Verification System
41
Systems Thinking
Audit Trails
42
Systems Thinking
• Document
• Record
• Train
• Spend against plan
• Internal/External communication
• Audit (internal/external)
• Verification
• HACCP
• Management Review
• Gap Assessment
• HACCP program planning
• Establish Measurable Objectives
• Budgeting
• Resource planning (human and financial)
• Communication Plan
• Management Review
• Corrective/Preventive action
• Update documents and adjust behavior
Act Plan
Do Check
43
Continuous Improvement Model
43
Systems Thinking
Auditor Training and Calibration
Identify Auditors Training (classroom
& on the job) On-going
Calibration
Technical Skills Auditor & Soft Skills
Auditor Code of Conduct
Listening Skills Observation
Skills Effective
Communication
Impact of Culture on
Communication
Conflict Avoidance
How to build trust
Positive Relationships – Building Rapport
How to interview and ask
questions
Following Audit Trails
Taking Notes Opening &
Closing Meeting
44
Systems Thinking
• Risk and intended use play important roles in systems
thinking. It is not a one size fits all approach.
• Observations are important to note, but root cause
analysis and effective corrective action enable
prevention.
• A facility’s food safety culture plays an important
component of how serious a facility is in continuously
improving versus being satisfied with the status quo.
• On-going calibration and a commitment of lifelong
learning of auditors is critical to ensure auditors have the
skills, experience and network to consistently audit. The
goal should be consistent audit findings.
• This industry-leading example, although it includes all of
the principles of FSMA, is more than FSMA requires.
Summary
45
Systems Thinking
46
Joe Levitt Partner, Hogan Lovells US LLP &
Former CFSAN Center Director
INDUSTRY & FDA PERSPECTIVE
Systems Thinking
1. How would systems thinking be applied to inspections
and other regulatory efforts?
2. What would inspections look like at FDA if a systems
based approach is used?
3. What we need to do to make that happen?
4. What if the FDA doesn’t take a systems based
approach?
Industry & FDA Perspective
47
Systems Thinking
• A big picture assessment, looking at
• Whether the facility’s relevant food safety systems are working
• The impact on food safety and public health
• It means taking a step back and looking at the forest
(total systems), not just the trees (non-conformities)
• Do the observations create a pattern or trend?
• What is the impact of that pattern or trend on public health?
• Approach is driven by questions and analysis
48
What is a systems-based
inspection?
Systems Thinking
• Review facility’s food safety programs (e.g., sanitation,
allergen control, environmental monitoring)
• Ask questions to understand those programs and what the
company is doing to implement them
• Assess non-conformities
• Are they systemic or isolated?
• What is the food safety risk and public health impact?
• Example: environmental monitoring results
49
What would inspections look
like if a systems-based
approach is used?
Systems Thinking
1. First, seek to understand the company’s food safety
programs
2. Second, look to see if the company is properly
implementing the programs
3. Finally, if there are non-conformances, ask yourself
what is their scope and significance?
50
Three Part Systems-Based
Inspection Approach
Systems Thinking
• Where is it?
• How frequent? Of the same type?
• Is product impacted?
• Was the facility aware of it?
• Were corrective actions taken?
• Were corrective actions effective?
Non-conformity Questions
51
Systems Thinking
• Teach investigators about food safety programs
• How to review programs vs. make visual observations about the
conditions in the facility
• Conduct targeted reviews of facility records
• Engage in a dialogue with the facility about conditions
and programs
• Evaluate corrective action records
• Example: Allergen control
52
How does FDA make this happen?
Systems Thinking
• Food safety could take a back seat to regulatory
compliance
• We all want public health to be the dominant goal, so inspections
need to be focused in that direction
• Companies will not be incentivized to develop a strong
food safety culture
• Industry will “work to the metrics” so make the metrics food safety
based and reward companies for “finding and fixing” problems
What if FDA doesn’t use
systems-based approach?
53
Systems Thinking
• FDA will only have a snapshot view of a facility
• Assessment based on what the investigator sees that day in the
facility, not what happens when the investigator is not there
• Inspections will be inefficient and ineffective
• Agency resources will be focused on technical deviations, rather
than protecting the public health
54
What if FDA doesn’t use
systems-based approach?
Systems Thinking
• Drives continuous improvement:
• Gives credit for work that’s being done
• Encourages compliance
• Focuses on opportunities
• Promotes cooperation and good working relationships.
• More effectively measures compliance by identifying
and prioritizing food safety issues so as to minimize risk
to consumers
55
Conclusion
Systems Thinking
56
Roberta Wagner Co-chair, FSMA Phase 2 Steering Committee
FDA PERSPECTIVE
Spring 2015 Summer 2015 Fall 2015
FS C
ult
ure
10
1 –
Mar
ch 1
9
Develop & Deliver PC Rule Readiness Training
Envi
ron
men
tal M
on
ito
rin
g –
Ju
ne
25
Sup
ply
Ch
ain
Man
agem
ent
- A
ugu
st 2
7
PC Training Plan: FY15 PC Rule Readiness Plan & FY 15-18 PC Regulator Plan
Deliver PC Regulator Training FY2016-2018
Technical Knowledge
Behavior & Systems
Thinking
Inspectional Skills & Knowledge
Min
imiz
ing
Alle
rgen
s R
isk
– O
cto
ber
22
FSP
CA
Co
urs
e: P
rere
q f
or
PC
Reg
ula
tor
Co
urs
es
Jan. 2016 thru Sept 2018
Technical Knowledge Inspection Skills & Knowledge Behavior & Systems Thinking FSPCA Training
Develop PC Regulator Training
FS C
ult
ure
30
1 –
Sep
tem
ber
24
FS C
ult
ure
20
1 –
Ju
ly 2
3
Syst
ems
Thin
kin
g -
May
28
Systems Thinking
FDA Perspective
6
Systems Thinking
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Systems Thinking
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