Transcript Root Cause Analysis Program - Northeast Biomanufacturing

Solving and Preventing Problems
Root Cause Analysis
Failure Mode and Effect Analysis
Professor James A. Hewett
New York Hub Director, Northeast Biomanufacturing Center
Professor of Biology, Finger Lakes Community College
Goals for Workshop
• Introduce you to the concepts of RCA and
FMEA
• Review examples of where RCA tools are
applied
• Immerse you in some problem solving
activities
• Direct you to resources for further study
(Note: We do not expect to make you RCA
and FMEA experts)
RCA is a problem solving process
A structured investigation that aims to identify
the true cause of a problem and the actions
necessary to eliminate it
FMEA is a problem prevention process
A tool that enables the identification and
prevention of process or product errors
before they occur
March 23rd, 2005
Texas City, TX
• BP refinery
Isomerization unit
startup
• Liquid hydrocarbons
released from
blowdown drum
• Subsequent vapor
cloud explodes
• 15 killed, 180 injured
BP Isom Unit Video
Refinery investigation animation
Putting you to work
(without “tools”)
• Define the Problem
• Identify Cause(s)
• Which causes are at the
ROOT (ultimate causes)
• Suggest Potential Solutions
for BP
BP’s RCA of the Texas City Event
Fault or Logic Tree Analysis
Root Causes
Senior executives:
• inadequately addressed controlling major hazard risk.
• did not provide effective safety culture leadership
• did not provide resources to prevent major accidents
BP Texas City Managers did not:
• create an effective reporting and learning culture
• ensure supervisors enforced plant policies and procedures.
• incorporate good practice design in the operation of the ISOM
unit.
• ensure that operators were supervised and supported by
experienced, technically trained personnel during unit startup
• effectively incorporate human factor considerations in its
training, staffing, and work schedule for operations
personnel.
The Anatomy of a Problem and
the Problem Solving Process in
Industry
1. Analysis is a process and involves teams
2. Focus is on SOLUTIONS
3. Cause and Effect in NON-LINEAR
4. Contain Action and Conditional Causes
5. Facilitated by Process Thinking Tools
Problem Solving IS
Process Thinking
In industry, assigned to teams of
stakeholders
Define Problem
Brainstorm Causes
Data Collection
RCA TOOLBOX
Data Analysis
Root Cause Identification
Problem Elimination
Solution Implementation
RCA for CAPA
Solutions are the focus, NOT BLAME
Let’s Start Simple
What happened? What caused it? What is the
solution?
Language and story-telling are linear,
Cause and Effect is Non-linear
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Pain CB
Injury CB
Fall CB
Slipped CB
Wet surface CB
Leaky Valve
Solution = fix
valve and clean
up floor
Did not see warning sign
Poor Placement of sign
Lettering on
sign damaged
Lack of
employee training
Replacement schedule
not followed
Cost cutting program
Solutions are also non-linear
Always at least TWO causes
Match
FIRE
Action Causes = Triggers
Conditional Causes = Pre-existing conditions
Oxygen
Oily Rags
It is too easy to focus on action
causes
• CONDITIONAL
– Oxygen in the atmosphere
– Oily rags not confined and properly disposed
– Lack of no smoking signs in area
– Lack of mandatory employee safety training
– Lack of mandatory safety inspections
• ACTION
– Match strike: employee sneaks a smoke and burns
down warehouse
• WHAT IS THE SOLUTION ?
Lack of Focus on Solutions
Root Cause
Analysis (RCA)
Example
Why are CCs not implementing
recommended biology curriculum reform
recommendations?
• Solutions require an analysis of root causes.
• Many reports are solution driven and not focused on
root causes.
• RCA: Identify conditions (causes) and then keep asking
WHY?
• Every recommended reform effort should connect to a
root cause, and presented with a solution that can be
implemented…ie. HOW?
Simple Example
• Conditional Cause: My administration is not
supportive of implementing the reform
recommendations at my institution.
• Action Cause: I asked for release time to develop a
project and my administration said: “No”
• Published Solution: Community Colleges must get
institutional “buy in” and administrative support
for reform of science curricula.
• Great . . . . . . . . . HOW?
• Focus: WHY is the administration not supportive?
Survey of 40 Community Colleges
that do NOT have undergraduate research
programs
75% Financial resources an
obstacle
80% Research would be an
intellectual challenge to
students
Perez, J. 2003. Undergraduate
Research at Two-Year Colleges.
New Directions For Teaching And
Learning; no. 93, Spring 2003
1. An Incompatible faculty model (ex.
Teaching load)
2. Lack of faculty preparation
(research and PBL)
3. Lack of access to a community of
CC researchers
4. Lack of four-year school research
collaborations
5. Insufficient Administrator Education
Results of RCA conducted at
Finger Lakes Community College
in Fall 2006
Integrated solution becomes a model for
reform and an NSF CCLI proposal
Root Cause Analysis Tools
1.The Five Whys
2.Fish Bone Diagrams
3.Matrix Diagrams
4.Fault Tree Analysis
Five Whys or Why-Why
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As always, define the problem
Identify a starting point (a causal level)
Ask Why (generates a new causal level)
Continue rounds of WHY
Look for “points of ignorance”
– these are launching points for
collecting more information or…….
– ROOT CAUSES for developing
solutions.
WHY- WHY
• Contamination in Bioreactor – WHY?
Filter Failed – WHY?
Accidentally shipped as part of a bad lot – WHY?
Employee mixed numbers on released lots – WHY?
Inadequate lot tracking system – WHY?
We have reached a Point of ignorance
SOLUTION ?
Fishbone Diagram
Assembling the Fish
1. At the head of the Fishbone is the defect or effect
2. The major bones are the capstones, or main groupings of
causes.
3. The minor bones are detailed items under each capstone.
4. Common capstones:
• People
• Equipment
• Material
• Information
• Methods/Procedures
• Measurement
• Environment
5. Test logic of bones: top-down OR bottom-up like:
6. this happens because of g; g happens because of f; f happens
because of e; e happens because of d ….. Etc.
Combining Tools
Use “5 Whys” to analyze bones
Matrix Diagrams
• A graphical display of
connections
• A multivariate analysis
tool
• Uses weight measures to
identify root causes
• Variety of shapes
• L-shaped most widely
used and described here
Constructing the matrix
• Identify problem
characteristics and
possible causes
• Problem characteristics
on one axis and
possible causes on the
other
• Symbols used at
intersections to weight
impact
• Sums presented to
evaluate root causes
Relation
Symbol
Weight
Weak
1
Medium
3
Strong

9
October 14th, 1908
Cubs over Tigers 4 games to 1
Fan
Feedback
Poor Farm
system
Poor
Manager
Poor
Coaches
Poor
Facilities
Cursed
Can’t Hit

Can’t Pitch

Can’t
Catch

Can’t win
the big
game
SUM

3
18

4
1
36
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Fault Tree Analysis
A
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Invasive BP monitoring case