Solving and Preventing Problems

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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
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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)

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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
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March 23rd, 2005Texas City, TX

• BP refinery Isomerization unit startup
• Liquid hydrocarbons released from blowdown drum
• Subsequent vapor cloud explodes
• 15 killed, 180 injured

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BP Isom Unit VideoRefinery investigation
animation
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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

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BPs RCA of the Texas City Event
Fault or Logic Tree Analysis
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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.

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The Anatomy of a Problem and the Problem Solving
Process in Industry

• Analysis is a process and involves teams
• Focus is on SOLUTIONS
• Cause and Effect in NON-LINEAR
• Contain Action and Conditional Causes
• Facilitated by Process Thinking Tools

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Problem Solving ISProcess Thinking

• In industry, assigned to teams of stakeholders

Define Problem
Brainstorm Causes
RCA TOOLBOX
Data Collection
Data Analysis
Root Cause Identification
Problem Elimination
Solution Implementation
RCA for CAPA
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Solutions are the focus, NOT BLAME
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Lets Start SimpleWhat happened? What caused it?
What is the solution?
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Language and story-telling are linear, Cause and
Effect is Non-linear

• 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
Lettering on sign damaged
Poor Placement of sign
Lack of employee training
Replacement schedule not followed
Cost cutting program
Solutions are also non-linear
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Always at least TWO causes

• Action Causes Triggers
• Conditional Causes Pre-existing conditions

Oxygen Oily Rags
FIRE
Match
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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 ?

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Lack of Focus on Solutions
AVOID THE BLAME GAME
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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 implementedie. HOW?

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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?

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Survey of 40 Community Colleges that do NOT have
undergraduate research programs

• An Incompatible faculty model (ex. Teaching load)
• Lack of faculty preparation (research and PBL)
• Lack of access to a community of CC researchers
• Lack of four-year school research collaborations
• Insufficient Administrator Education

Perez, J. 2003. Undergraduate Research at
Two-Year Colleges. New Directions For Teaching
And Learning no. 93, Spring 2003
Results of RCA conducted at Finger Lakes
Community College in Fall 2006
Integrated solution becomes a model for reform
and an NSF CCLI proposal
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Root Cause Analysis Tools

• The Five Whys
• Fish Bone Diagrams
• Matrix Diagrams
• Fault Tree Analysis

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Five Whys or Why-Why

• 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.

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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 ?
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Fishbone Diagram Assembling the Fish

• At the head of the Fishbone is the defect or
  effect
• The major bones are the capstones, or main
  groupings of causes.
• The minor bones are detailed items under each
  capstone.
• Common capstones
• People
• Equipment
• Material
• Information
• Methods/Procedures
• Measurement
• Environment
• Test logic of bones top-down OR bottom-up like
• this happens because of g g happens because of
  f f happens because of e e happens because of d
  .. Etc.

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Combining ToolsUse 5 Whys to analyze bones
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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

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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

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October 14th, 1908Cubs over Tigers 4 games to 1
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Fault Tree Analysis
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Invasive BP monitoring case