Solving and Preventing Problems

Root Cause AnalysisFailure Mode and Effect Analysis

Professor James A. HewettNew 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)

A structured investigation that aims to identify the true cause of a problem and the actions

necessary to eliminate it

RCA is a problem solving process

A tool that enables the identification and prevention of process or product errors

before they occur

FMEA is a problem prevention process

March 23rd, 2005Texas City, TX

• BP refinery Isomerization unit startup

• Liquid hydrocarbons released from blowdown drum

• Subsequent vapor cloud explodes

• 15 killed, 180 injured

BP Isom Unit VideoRefinery 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 CausesSenior executives:• inadequately addressed controlling major hazard risk. • did not provide effective safety culture leadership • did not provide resources to prevent major accidentsBP 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

Industry1. Analysis is a process and involves teams2. Focus is on SOLUTIONS3. Cause and Effect in NON-LINEAR

4. Contain Action and Conditional Causes5. Facilitated by Process Thinking Tools

Problem Solving ISProcess ThinkingIn industry, assigned to teams of

stakeholders

RCA TOOLBOX

Define Problem

Brainstorm Causes

Data Collection

Data Analysis

Root Cause Identification

Solution Implementation

Problem Elimination

RCA for CAPA

Solutions are the focus, NOT BLAME

Let’s Start SimpleWhat happened? What caused it? What is the solution?

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

Poor Placement of sign Lettering on

sign damagedLack of

employee training

Cost cutting program

Replacement schedule

not followed

Solutions are also non-linear

Always at least TWO causes Action Causes = Triggers

Conditional Causes = Pre-existing conditions

Match OxygenOily RagsFI

RE

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

AVOID THE BLAME GAME

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?

75% Financial resources an obstacle

Survey of 40 Community Colleges that do NOT have undergraduate research

programs

Perez, J. 2003. Undergraduate Research at Two-Year Colleges. New Directions For Teaching And Learning; no. 93, Spring 2003

80% Research would be an intellectual challenge to students

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 Tools1.The Five Whys2.Fish Bone Diagrams3.Matrix Diagrams4.Fault Tree Analysis

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.

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 effect2. 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 ToolsUse “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, 1908Cubs 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

Fault Tree AnalysisAND

                     

The output event occurs if all input events occur.

Simple Parallel Configuration [See Example]

OR

             

Invasive BP monitoring case