Applied Root Cause Analysis:

Using Your Results to

Effectively Manage Risk

SPONSORED BY:
 Meet Our Speakers

Brendan Niemira, Ph.D. Deb Kane, M.S. John Butts, Ph.D.

U.S. Department of Agriculture J&J Snack Foods Corp. FoodSafetyByDesign LLC

Tim Jackson, Ph.D. Tim King, M.S.

U.S. Food and Drug Administration
Quality Matters LLC
Investing the time and effort to
clearly define the problem that
needs to be solved is a critical
step in getting to the true root
cause.
Overview
Why is Root Cause Analysis important?

Tools to use
Common pitfalls
Validation and Verification
The “fix” that doesn’t fix it
• Problems occasionally happen in every workflow
• Contaminations, compliance failures, equipment issues
• Superficial analysis of problems is common
• Mistakenly developing “solutions” that don’t solve the problem
• Lost time and effort
• Recurrence of the original problem
• Impacts on productivity, profitability, morale
• Root Cause Analysis (RCA)
• Workshop at the 2023 Food Safety Summit, extended in 2024
Why is RCA important?
Can you relate?
Reoccurring problems

Problem Solution

Repeat
Repeat issues? Problem solving biased?

Problem Solution Problem Solution

Repeat Repeat

Problem Solution

Repeat
Temporary Fixes
TREATING THE
SYMPTOMS
VISIBLE ISSUES
BANDAGES
INEFFECTIVE
Impact on Efficiencies
DEFINE PROCESS
CHANGE
TRAIN
UNTRAIN
RETRAIN
CREATES CHAOS &
CONFUSION
 SALES PRESS

FUTURE
TRUST OPPORTUNITIES

SOCIAL
MEDIA
FDA’s Expectations of Industry
Corrective actions must ensure (117.150 (a), (b)):

• Appropriate action is taken to identify and correct a problem

that has occurred with implementation of a preventive
control;
• Appropriate action is taken, when necessary, to reduce the
likelihood that the problem will recur;
• All affected food is evaluated for safety; and
• All affected food is prevented from entering into commerce
Photos: www.zentools.com; www.gitmind.com
 FDA’s Expectations of Industry
Use of Root Cause Analysis (RCA) methodology could
help:
• Correctly identify the root causes of food safety
problems
• Determine the origin and scope of a problem
• Determine appropriate corrective actions to
prevent recurrence
Methodology could be useful for certain trigger
events (outbreaks, recurrent issues)

Photos: www.zentools.com; www.gitmind.com

FDA’s Use of RCA
• Firm or FDA RCA following outbreak
• Analysis of recurring outbreaks
• Evaluation of information on adverse issues
• Recalls
• Information from surveillance or import analyses
• Information from firm inspections
• New and emerging issues
• Outcome will inform follow up actions
• Compliance actions
• Stakeholder communications
• Prevention activities

Photos: www.zentools.com; www.gitmind.com

Root Cause Analysis Tools to Use
RCA- The Gateway to Improvement

Root Improved Verification

Monitor & Describe Interim
Detect the Issue Actions
Cause Process & &
Analysis Controls Validation
Process Approach
Six Sources of Process Conditions That Can Cause Quality Issues (these are used
on the “fishbone” diagram)

1. Manpower (employee competency; aptitude)

2. Method (process steps; layout; sequencing)
3. Materials (chemicals, supplies, bins)
4. Machines (equipment, tools, devices)
5. Measurement (accuracy, lack of; type; use of)
6. Environment (ergonomics; distraction; complacency;
temperature, humidity, lighting…)
The 3 Levels of Root Cause
Identification
1. Why the process created the issue (process elements)

2. Why the issue went undetected- passed through the established

controls and inspections (ability to escape)

3. Where the organization’s food safety quality system is not

preventing this type of issue systemically
 example: systemic competency problems; inadequate process and/or
product change control
Human Factors- The Causes of
Human Error
• Skill aptitude
• Knowledge access
• Memory/recall lapse
• Cognitive decision making
• Personal discipline “stamina”
• Tools, equipment
• Ergonomics- stress/strain/fatigue
• Information, communications
• Environment issues: complacency creep, distractions, morale
• Sensory challenges: seeing, hearing, handling Resources will be provided at our
upcoming workshop!
RCA Analysis – it takes the right tools
Let’s Look at some:

• 5-Why*

• Cause-Effect Diagram (a.k.a. fishbone)*

• Hybrid: Cause-Effect Matrix

Training & examples will be provided at our
upcoming workshop!
 Using 5-Why Cause Analysis
The Problem
Statement

Drilling down to find

Why? root cause: getting
below the surface
Why?

Why?
An inadequacy in a process
element or control that caused
Tips & training at our upcoming workshop
Why? the issue to occur- it can be made
adequate with a corrective action
A 5-Why Example
Problem: Patient in Room 101 rolled out of bed and fell last night

1. Why did the patient fall out of bed?

Because the right side bed restraint opened during the night.

2. Why did the bed restraints open?

Because the restraint’s two fasteners weren’t closed correctly.

3. Why weren’t the fasteners closed correctly?

Because the technique used by the floor nurse was incorrect for that type of fastener.

4. Why did the nurse use an incorrect technique?

Root Cause: Because the necessary knowledge & skill was lacking in the nurse (new to the
hospital floor assigned for that night shift).
Cause-and-Effect Diagram (aka
“fishbone”)
PROCESS This tool brainstorms the
ELEMENTS suspect root causes in the
six process elements.

The EFFECT

Tips & training at our upcoming workshop

Cause-and-Effect Diagram (aka
“fishbone”)
Not using: Measurement or Equipment/Tools

People Materials
Training The WHY-WHY method is
used in conjunction with this
Suppliers New employees Forms tool (“branching”)
L
tr ack
ai o
ni f
ng No P.O. Numbers
on Raw Material
Confusion Communication
Audits
Invoices
ov e
m ffic

Su People not
e
O

bs
st titu following
Rush orders af t
f e

Environment Procedures
The Best of Both Worlds – Cause-
Effect Matrix
• Shape simplicity vs. fishbone

• Covers the 6 process elements

• Allows for some why-why analysis (3 levels)

• Converges to focus investigation on more likely causes

Cause Effect Matrix
Template Created by: Tim King Quality Matters LLC [email protected]
Write a problem statement below (state the item, the relevant requirement, and the NC condition) : Copyright 2023 Course of Workshop Attendees Given Right to Use
Listeria monocytogenes on a frozen appetizer
A) How could any aspect of this 80/20 Analysis: What in this row will we
B) Why would the aspects in C) Why would the aspects in "B"
7 Key Process Areas this process area possibly
"A" happen? happen?
investigated to determine if this process area
caused the problem was a part of the cause?
Product is par-cooked, sent to Point contamination of the
Method: how the process is done
a spiral freezer, then into spiral freezer, portioning &
per SOP or work instruction; or if
portioning and continuous roll packaging machines, or
deviations could have happened
packaging packaging material
Raw ingredients, par-cooked
Materials: any form of supplies,
finished product, packaging
parts, assemblies used in the
materials
process

Machinery: any type of tool, Materials handing during prep, Belts and conveyors post- Sanitation was inadequate or Test equipment for contamination, focusing
equipment, fixture, trays, bins, freezing, portioning, packaging freezer exposed to condensate, design of equipment made it on hard-to-reach areas
storage racks Listeria biofilm buildup difficult to clean
Personnel: Any aspect of Improper sanitation – high Excessive spray in confined Workers used high-pressure Review sanitation SOP, including execution
competency & aptitude pressure hoses, lack of color area near freezer outlet. hoses to get into difficult-to of sanitation process.
(knowledge; skills, experience,
coding reach areas
ability to perform consistent work)
Environment: temperature; Cross-contamination due to Legacy problems in workflow Constraints from several re- Review layout of equipment, traffic flow,
humidity, obstacles, lighting, poor workflow. Movement toolings. Ad hoc additions, ingredient storage and flow
layout from equipment
distractions, morale, oversight,
through raw ingredient area to retooling, repairs, change in changes. No coherent plan for
and presence of human error
freezer footprint. Made access difficult. traffic flow, controls.
factors
Measurement/Information: Monitoring not robust. Did not
accuracy; precision, access, lack of,
indicate facility-wide Listeria
vague, has errors, timeliness,
issue
communication breakdowns

Design: any aspect of the product Surface of cold product will re-
design that may be causing the freeze contaminating droplets
problem
RCA Tools Summary
• As is true with any tool: you must understand it and gain the skill to use it
effectively

• Having more than 1 tool can promote more robust RCA analysis

• There are many more tools out there- such as”

• Cause Logic Mapping
• Is Is-Not Analysis
• Correlation Studies

• Like most toolboxes- some get used more than others!

Join us May 8th for more!

Considerations for Success
Be strong
Common Pitfalls, Considerations for
SuccessCommon Pitfalls, Considerations for Success

Commitment

Tools /
Tone at the top – Team activity – all
Time – enough Implementation
management inputs
time allotted? Drag – which tool
commitment? considered?
to use?
 Problem Definition

• Defining the problem as the solution

• Problem statement is vague
• Solving the wrong problem

Event / Factor Analysis

Common • Bias, opinions, turf issues, blame game

• Focus on containment factors for symptoms, bandage

Watch Outs • Not considering organizational system deficiencies

Failure to follow-up on audit deviations

Design of training program insufficient

Line / equipment not designed for success

Human Performance Improvement

80% of critical Of those,30% are due to

individual competency gaps,
or serious events
are due to human and the rest are due to
performance organizational system
deficiencies.
Common Watch Outs
Corrections
• Perceived to be preventive controls

Corrective Actions
• Only focus on administrative controls
• Short-term, unsustainable fixes
• Lack of ownership for process changes

Preventive Controls
• Using corrective actions as PC
• Lack of validation
Root Cause:
Validation & Verification
Validation Process
The Validation Process includes
1. Testing to Validate the Root Cause
2. Preventive Controls to Manage
3. Validate Effectiveness of the Preventive Controls and,
4. Verification Monitoring to Hold Gains Long Term

Root Cause Validation of Source Preventive Control (s) Validation of Preventive Verification of Preventive
Controls1 Controls
Testing to validate the root cause
• Process must be data Investigate
driven
• Too often the true root
cause is missed, or
problem only partially Potential Root
solved Cause Identified

• Testing is designed to Root Cause

prove failure or Validation Testing
uncontrolled
variation leading to
failure if the root
cause remains in the Continue
No Validate Source
Partially Change Process to
Investigation Eliminated include a Correction
system without
effective preventive
controls
Yes
Preventive Controls to Manage
Root cause must be either
Eliminated or Managed
Validate Source

• Eliminate example is
removing a machine from
the process. Yes

• Managed means preventive Eliminate Action Manage

controls are deployed to
make the process capable
and in statistical control.

Requalify Process Establish Preventive

Controls
Validate Effectiveness of Preventive
Controls Establish Preventive
Controls

• This is the step Validate Preventive

most often missed Controls

or glossed over.
Define

• Tests must be Tests to Measure

Effectiveness of Preventive
Establish Upper and/or
Lower Specification Limits
Controls
designed to
challenge the
system. Out of Compliance

Test Results
Validation Process
Validate Effectiveness of the Preventive Controls
• Examples: Failure effects measured after controls challenged.
• Seek & Destroy Investigation (complete disassembly) on equipment
with root cause being managed.
• Entry way hurdle challenged with dirty footware.
• Greasy contaminated tool cleaned then pasteurized in COP tank.
• Dye test & Swabathon on corrected CIP system.
• Examine integrity of process shedding foreign material after running
dry or with inexpensive or pseudo product.
Verification monitoring to hold
gains long term
In Compliance
• In process Corrective and Preventive Action Taken
assessment or
testing to assure Reassess
Establish Routine Process
Control Monitoring
preventive Preventive Controls
Procedures
controls were
applied and
effective. Define Monitoring
Frequencies

• Post process or
finished product No
Failure Effect
Yes
Preventive Controls
testing. Eliminated Verified
Validation of Root Cause

• Provides data to educate and train future operators,

maintenance, process managers and management in
general.
• Simply put, “Why” is answered.
Closing. Lessons Learned!
Goal: fix it so it stays fixed
• RCA can’t be an ad hoc process and be fully successful
• Begin with the right team, the right tools, the right focus
• Think critically, ask the important questions
• Is this tool getting us to the root cause(s)?
• Are we using the tool properly?
• Can a different tool also help our investigation?
• Are we missing some aspect of the problem that could help shed light on the root
cause?
• Can we defend our logic- to management, regulators, auditors, or our customer?
• Develop effective, efficient solutions to prevent problems from recurring
RCA helps break the cycle
Join us on May 8, 2024 from 4:15 – 5:30 pm CST for
Root Cause Analysis – Putting it to Work for You!

The Food Safety Summit runs from May 6 – 9, 2024