Systems Thinking

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Housekeeping

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Systems Thinking

FSMA TRAINING:

SYSTEMS THINKING: WHAT IS IT?

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Systems Thinking

Warm Welcome

Kathy Gombas

Senior Advisor, CFSAN Office of Food Safety

Co-Lead, FSMA Training Workgroup

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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

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Develop & Deliver PC Rule Readiness Training

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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

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Jan. 2016 thru Sept 2018

Technical Knowledge Inspection Skills & Knowledge Behavior & Systems Thinking FSPCA Training

Develop PC Regulator Training

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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

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Systems Thinking

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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?

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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?

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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

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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?

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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

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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

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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

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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

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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

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Systems Thinking

During an outbreak investigation

or inspection: Equipment

• Is their equipment at fault?

• Is this equipment likely to pose a hazard elsewhere?

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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

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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

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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

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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

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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

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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

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Systems Thinking

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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?

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Systems Thinking Kraft’s Food Safety

Management System

Fact and Scientific-

Basis

Written Food Safety Plans

Implemented System of Controls

Continuous Learning and Improvement

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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

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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

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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

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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.

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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

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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

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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

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Systems Thinking

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Ryan Brown Global Supplier Quality Assurance Leader

Cargill Animal Nutrition

INDUSTRY PERSPECTIVE:

Animal Food

Systems Thinking

Industry Perspective:

Animal Food

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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

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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

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Food Safety, Quality and Regulatory

(FSQR) Policy Manual

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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

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Food Safety Management Systems: a model e.g. ISO 22000

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Systems Thinking

Pillars of a Food Safety Management

System (FSMS)

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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

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Systems Thinking

Audit Trails

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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

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Continuous Improvement Model

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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

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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

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Systems Thinking

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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

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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

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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

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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?

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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

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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

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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?

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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

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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

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Conclusion

Systems Thinking

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Roberta Wagner Co-chair, FSMA Phase 2 Steering Committee

FDA PERSPECTIVE

Spring 2015 Summer 2015 Fall 2015

FS C

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10

1 –

Mar

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9

Develop & Deliver PC Rule Readiness Training

Envi

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Ju

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Sup

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Man

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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

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ure

20

1 –

Ju

ly 2

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Syst

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May

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Systems Thinking

FDA Perspective

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Systems Thinking

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Systems Thinking

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