You are on page 1of 105

Root Cause Analysis

Superfactory Excellence Program™


www.superfactory.com

© 2004 Superfactory™. All Rights Reserved. 1


Disclaimer and Approved use

 Disclaimer
 The files in the Superfactory Excellence Program by Superfactory Ventures LLC
(“Superfactory”) are intended for use in training individuals within an organization. The
handouts, tools, and presentations may be customized for each application.
 THE FILES AND PRESENTATIONS ARE DISTRIBUTED ON AN "AS IS" BASIS WITHOUT
WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED.

 Copyright
 All files in the Superfactory Excellence Program have been created by Superfactory and there
are no known copyright issues. Please contact Superfactory immediately if copyright issues
become apparent.

 Approved Use
 Each copy of the Superfactory Excellence Program can be used throughout a single Customer
location, such as a manufacturing plant. Multiple copies may reside on computers within that
location, or on the intranet for that location. Contact Superfactory for authorization to use
the Superfactory Excellence Program at multiple locations.
 The presentations and files may be customized to satisfy the customer’s application.
 The presentations and files, or portions or modifications thereof, may not be re-sold or re-
distributed without express written permission from Superfactory.

 Current contact information can be found at: www.superfactory.com

© 2004 Superfactory™. All Rights Reserved. 2


Course Content

 Course Objectives
 What is Root Cause?
 Benefits
 The Problem Solving Process

 Examples and Exercises

© 2004 Superfactory™. All Rights Reserved. 3


Course Objectives

Upon completion of this course, participants should be able


to:

 Understand the importance of performing root cause analysis


 Identify the root cause of a problem using the problem solving process
 Understand the application of basic quality tools in the problem solving
process

© 2004 Superfactory™. All Rights Reserved. 4


What is a root cause?

ROOT CAUSE =
 The causal or contributing factors that, if corrected, would prevent
recurrence of the identified problem

 The “factor” that caused a a problem or defect and should be permanently


eliminated through process improvement

 The factor that sets in motion the cause and effect chain that creates a
problem

 The “true” reason that contributed to the creation of a problem, defect or


nonconformance

© 2004 Superfactory™. All Rights Reserved. 5


What is root cause analysis?

 A standard process of:

 identifying a problem
 containing and analyzing the problem
 defining the root cause
 defining and implementing the actions required to
eliminate the root cause
 validating that the corrective action prevented
recurrence of problem

© 2004 Superfactory™. All Rights Reserved. 6


Benefits

By eliminating the root cause…


You save time and money!
 Problems are not repeated
 Reduce rework, retest, re-inspect, poor quality costs, etc…
 Problems are prevented in other areas
 Communication improves between groups and
 Process cycle times improve (no rework loops)
 Secure long term company performance and profits

$$ Less rework = Increased profits! $$


© 2004 Superfactory™. All Rights Reserved. 7
Importance of the root cause

Not knowing the root cause can lead to costly band aids.

 The Washington Monument was degrading


Why? Use of harsh chemicals
Why? To clean up after pigeons
Why so many pigeons? They eat spiders and there are a lot of spiders at the
monument
Why so many spiders? They eat gnats and lots of gnats at the monument
Why so many gnats? They are attracted to the light at dusk.
Solution: Turn on the lights at a later time.

© 2004 Superfactory™. All Rights Reserved. 8


When should root cause analysis
be performed?
When PROBLEMS occur !!

© 2004 Superfactory™. All Rights Reserved. 9


How does it differ from what we do
now?

USUAL APPROACH
Firefighting! Problem
Problem
Immediate Containment reoccurs
Identified
Action Implemented elsewhere!

Find
someone to
blame!

PREFERRED APPROACH
Immediate Defined Solutions are
Solutions
Problem Containment Root Cause applied across
validated
Identified Action Analysis company and
with data
Implemented Process never return!

© 2004 Superfactory™. All Rights Reserved. 10


How does it work?

Defect found at “Customer”…


PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

“Customer” can be
Internal or External

© 2004 Superfactory™. All Rights Reserved. 11


How does it work?

Contain the problem…


PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Nothing is allowed to further


escape to the customer

© 2004 Superfactory™. All Rights Reserved. 12


How does it work?

Contain the root process…


PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Nothing is allowed to further


escape to the next process

© 2004 Superfactory™. All Rights Reserved. 13


How does it work?

Prevent the problem…


PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Corrective action implemented


so root cause of problem does
not occur again!

© 2004 Superfactory™. All Rights Reserved. 14


But who’s to blame?

 The “no blame” environment is critical


 Most human errors are due to a process error
 A sufficiently robust process can eliminate human errors
 Placing blame does not correct a root cause situation
 Is training appropriate and adequate?

 Is documentation available, correct, and clear?

 Are the right skillsets present?

© 2004 Superfactory™. All Rights Reserved. 15


Corrective Actions

3 types of Corrective Action:

 Immediate action

 The action taken to quickly fix the impact of the problem so the “customer” is
not further impacted

 Permanent root cause corrective action

 The action taken to eliminate the error on the affected process or product

 Preventive (Systemic) root cause corrective action

 The action taken to Prevent the error from recurring on any process or product

© 2004 Superfactory™. All Rights Reserved. 16


Examples of Corrective Actions

Immediate (step #3)


All current batch of paperwork re-inspected by another
worker for same type of problem
Permanent (step #5)
Form changed to mandate completion of certain fields

Preventive (step #5)


Similar forms with same fields used all over in
company are changed to “mandatory”

If preventive not addressed, problem will return!!

© 2004 Superfactory™. All Rights Reserved. 17


Examples of Corrective Actions

Immediate (step #3)


Part removed and replaced in product, retested

Permanent (step #5)


Product redesigned to account for part variability

Preventive (step #5)


Design process changed to require variation
analysis testing on similar supplier parts

If preventive not addressed, problem will return!!

© 2004 Superfactory™. All Rights Reserved. 18


The Difference between
Permanent vs. Preventive Corrective Actions
Permanent Preventive
 Trained employee on proper machine use  Made training a requirement to new employees working in that
area

 Changed product design to make parts easier to assemble  Changed design guidelines to not allow for use of part in full
manually scale production

 All documents that are critical to project are identified with red
 Specific customer document critical to project is identified with folders
red folder
 Check for those software bugs added to checklist and
 Update all customers with latest software revision to fix problem
performed prior to release of software

 Fallen patient given full-time assistant to provide help moving


 Process developed to identify “at risk” patients for falls who
around hospital require assistant

 Ethics training developed and provided to all employees
 Employee fired for ethical violation

© 2004 Superfactory™. All Rights Reserved. 19


Problem Solving Process

Identify
8 Problem 2

Validate Identify
Team
7 3
Problem
Follow Up
Plan Solving Immediate
Action

Process
Complete Root
Plan Cause

Action
6 Plan 4

5
© 2004 Superfactory™. All Rights Reserved. 20
Step #1

Identify the Problem


Very important!
 Clearly state the problem the team is to solve
 Teams should refer back to problem statement to avoid getting
off track
 Use 5W2H approach
 Who? What? Why? When? Where? How? How Many?

© 2004 Superfactory™. All Rights Reserved. 21


Step #1

5W2H
 Who? Individuals/customers associated with problem
 What? The problem statement or definition
 When? Date and time problem was identified
 Where? Location of complaints (area, facilities, customers)
 Why? Any previously known explanations
 How? How did the problem happen (root cause) and how will the problem
be corrected (corrective action)?
 How Many? Size and frequency of problem

© 2004 Superfactory™. All Rights Reserved. 22


Step #2

Identify Team
When a problem cannot be solved quickly by an individual, use a
team!

 Should consist of domain knowledge experts


 Small group of people (4-10) with process and product knowledge,
available time and authority to correct the problem
 Must be empowered to “change the rules”
 Should have a designated Champion
 Membership in team is always changing!

© 2004 Superfactory™. All Rights Reserved. 23


Step #2

Key Ideas for Team Success

 Define roles and responsibilities


 Identify external customer needs
 Identify internal customer needs
 Appropriate levels of organization present
 Clearly defined objectives and outputs
 Solicit input from everyone!
 Good meeting location
 near work area for easy access to info
 quiet for concentration and avoiding distractions

© 2004 Superfactory™. All Rights Reserved. 24


Step #2

Roles and Responsibilities

 Champion: Mentor, guide and direct teams, advocate to upper


management
 Leader: day-to-day authority, calls meetings, facilitation of team, reports
to Champion
 Record Keeper: Writes and publishes minutes
 Participants: Respect all ideas, keep an open mind, know their role
within team

© 2004 Superfactory™. All Rights Reserved. 25


Step #3

Immediate Action

 Must isolate effects of problem from customer


 Usually “Band-aid” fixes
 100% sorting of parts

 Re-inspection before shipping

 Rework

 Recall parts/documents from customer or from storage

 Only temporary until corrective action is implemented (very costly, but


necessary)
 Must also verify that immediate action is effective

© 2004 Superfactory™. All Rights Reserved. 26


Step #3

Verify Immediate Action

 Immediate action = activity implemented to screen, detect and/or


contain the problem

 Must verify that immediate action was effective
 Run Pilot Tests
 Make sure another problem does not arise from the temporary
solutions

 Ensure effective screens and detections are in place to prevent further


impact to customer until permanent solution is implemented.

© 2004 Superfactory™. All Rights Reserved. 27


Step #4

Root Cause

 Brainstorm possible causes of problem with team


 Organize causes with Cause and Effect Diagram
 “Pareto” the causes to identify those most likely or occurring most often
 Use 5 Why? method to further define the root cause of symptoms
 May involve additional research/analysis/investigation to get to each
“Why?”
 Must identify the process that caused the problem
 if root cause is company-wide, elevate these process issues (outside of
team control) to upper management to address

© 2004 Superfactory™. All Rights Reserved. 28


Step #4

Tools
 brainstorming  5 Why
 flowcharting  failure mode, effect & criticality
 cause & effect diagrams analysis
 pareto charts  fault tree analysis
 barrier analysis
 change analysis

© 2004 Superfactory™. All Rights Reserved. 29


Step #4

5 Why’s

 Ask “Why?” five times


 Stop when the corrective actions do not change
 Stop when the answers become less important
 Stop when the root cause condition is isolated

© 2004 Superfactory™. All Rights Reserved. 30


What is a Cause-Effect Diagram?

 A Cause-Effect (also called “Ishikawa” or “Fishbone”) Diagram is a


Data Analysis/Process Management Tool used to:

 Organize and sort ideas about causes contributing to a


particular problem or issue
 Gather and group ideas
 Encourage creativity
 Breakdown communication barriers
 Encourage “ownership” of ideas
 Overcome infighting

© 2004 Superfactory™. All Rights Reserved. 31


Cause-Effect Diagram

 A Cause-Effect Diagram is typically generated in a group


meeting
 It is a graphical method for presenting and sorting ideas
about the causes of issues or problems

© 2004 Superfactory™. All Rights Reserved. 32


Cause-Effect Diagram

 Steps used to create a Cause-Effect Diagram:


 Define the issue or problem clearly
 Decide on the root causes of the observed issue or problem
 Brainstorm each of the cause categories
 Write ideas on the cause-effect diagram. A generic example is shown
below:

Materials Methods

Environment Effect
Equipment People

NOTE: Causes are not limited to the 5 listed categories, but serve as a starting point

© 2004 Superfactory™. All Rights Reserved. 33


Cause-Effect Diagram

 Allow team members to specify where ideas fit into the diagram
 Clarify the meaning of each idea using the group to refine the ideas. For
example:

Materials Methods

Incorrect Quantity Late Dispatch


Spillage
Incorrect BOL Shipping Delay
Wrong Destination

Traffic Delays

Shipping
Environment
Wrong Equipment
Problems
Weather Driver
Dispatcher Attitude
Breakdown Dirty Equipment Wrong Directions

Equipment People

© 2004 Superfactory™. All Rights Reserved. 34


Cause-Effect Diagram

 After completing the Cause-Effect Diagram, take the following


actions:
 Rank the ideas from the most likely to the least likely cause cause
of the problem or issue
 Develop action plans for identifying the essential data, resources
and tools

© 2004 Superfactory™. All Rights Reserved. 35


Expected Outcome

• Individuals have become part of a problem solving team


 The sources of problems and other issues have been identified using
a systematic process
 Team members see issues from a similar perspective
 Ideas and solutions are documented
 Communication is improved
 Team members assume ownership

© 2004 Superfactory™. All Rights Reserved. 36


Step #5

Corrective Action Plan

 Must verify the solution will eliminate the problem


 Verification before implementation whenever possible

 Define exactly…
 What actions will be taken to eliminate the problem?

 Who is responsible?

 When will it be completed?

 Make certain customer is happy with actions


 Define how the effectiveness of the corrective action will be measured.

© 2004 Superfactory™. All Rights Reserved. 37


Step #5

Verification vs. Validation


(Before) (After)

 Verification
 Assures that at a point in time, the action taken will actually do what is
intended without causing another problem

 Validation
 Provides measurable evidence over time that the action taken worked
properly, and problem has not recurred

© 2004 Superfactory™. All Rights Reserved. 38


Step #6

Complete Action Plan

 Make certain all actions that are defined are completed as planned

 If one task is still open, verification and validation is pushed back

 If the plan is compromised, most likely the solution will not be as effective

© 2004 Superfactory™. All Rights Reserved. 39


Step #7

Follow Up Plan

 What actions will be completed in the future to ensure that the root cause
has been eliminated by this corrective action?
 Who will look at what data?
 How long after the action plan will this be done?
 What criteria in the data results will determine that the problem has not
recurred?

© 2004 Superfactory™. All Rights Reserved. 40


Step #8

Validate and Celebrate

 What were the results of the follow up?

 If problem did reoccur, go back to Step #4 and re-evaluate root cause,


then re-evaluate corrective action in Step #5
 If problem did not reoccur, celebrate team success!

 Document savings to publicize team effort, obtain customer satisfaction


and continued management support of teams

© 2004 Superfactory™. All Rights Reserved. 41


What does a good RCA look like?

 The Root Cause is


 Internally Consistent ,
 Thorough, and
 Credible

© 2004 Superfactory™. All Rights Reserved. 42


What does a good RCA look like?

The Complete Root Cause Analysis is


• inter-disciplinary, involving experts from the frontline services
• involving of those who are the most familiar with the situation
• continually digging deeper by asking why, why, why at each level of
cause and effect.
• a process that identifies changes that need to be made to systems
• a process that is as impartial as possible

© 2004 Superfactory™. All Rights Reserved. 43


What does a good RCA look like?

To be thorough a Root Cause Analysis must include:


• determination of human & other factors
• determination of related processes and systems
• analysis of underlying cause and effect systems through a series of
why questions
• identification of risks & their potential contributions
 determination of potential improvement in processes or systems

© 2004 Superfactory™. All Rights Reserved. 44


What does a good RCA look like?

To be Credible a Root Cause Analysis must:


• include participation by the leadership of the organization &
those most closely involved in the processes & systems
• be internally consistent

© 2004 Superfactory™. All Rights Reserved. 45


Hints about root causes

 One problem may have more than one root cause


 One root cause may be contributing to many problems
 When the root cause is not addressed, expect the problem
to reoccur
 Prevention is the key!

© 2004 Superfactory™. All Rights Reserved. 46


Review

 You learned:
 How to identify the root cause
 Why it is important
 The process for proper root cause analysis
 How basic quality tools can be applied to examples

© 2004 Superfactory™. All Rights Reserved. 47


Manufacturing

Root Cause Analysis


Example #1

© 2004 Superfactory™. All Rights Reserved. 48


Example #1

Identify Problem

Part polarity reversed on circuit board

© 2004 Superfactory™. All Rights Reserved. 49


Determine Team

 Team members:
 Team Leader – Terry
 Inspector – Jane
 Worker – Tammy
 Worker - Joe
 Quality Eng – Rob
 Engineer – Sally

© 2004 Superfactory™. All Rights Reserved. 50


Immediate Action

 Additional inspection added after this assembly process


step to check for reversed part defects

 Last 10 lots of printed circuit boards were re-inspected to


check for similar errors

© 2004 Superfactory™. All Rights Reserved. 51


Root Cause

Part reversed

Why?

© 2004 Superfactory™. All Rights Reserved. 52


Root Cause

Part reversed

Worker not sure of correct part orientation

Why?

© 2004 Superfactory™. All Rights Reserved. 53


Root Cause

Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Why?

© 2004 Superfactory™. All Rights Reserved. 54


Root Cause

Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Engineering ordered it that way from vendor

Why?

© 2004 Superfactory™. All Rights Reserved. 55


Root Cause

Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Engineering ordered it that way from vendor

Process didn’t account for possible


manufacturing issues

© 2004 Superfactory™. All Rights Reserved. 56


Corrective Action

 Permanent – Changed part to one that can only be placed in correct


direction (Mistake proofed). Found other products with similar problem and
made same changes.

 Preventive - Required that any new parts selected must have


orientation marks on them.

© 2004 Superfactory™. All Rights Reserved. 57


Root Cause Analysis
Example #2

© 2004 Superfactory™. All Rights Reserved. 58


Example #2

Identify Problem

A manager walks past the assembly line and notices a puddle of


water on the floor. Knowing that the water is a safety hazard, she
asks the supervisor to have someone get a mop and clean up the
puddle. The manager is proud of herself for “fixing” a potential
safety problem.

© 2004 Superfactory™. All Rights Reserved. 59


Example #2

But What is the Root Cause?

The supervisor looks for a root cause by asking 'why?’

© 2004 Superfactory™. All Rights Reserved. 60


Immediate Action

Knowing that the water is a safety hazard, the manager asks the
supervisor to have someone get a mop and clean up the puddle.

© 2004 Superfactory™. All Rights Reserved. 61


Root Cause

Puddle of water on the floor

Why?

© 2004 Superfactory™. All Rights Reserved. 62


Root Cause

Puddle of water on the floor

Leak in overhead pipe

Why?

© 2004 Superfactory™. All Rights Reserved. 63


Root Cause

Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Why?

© 2004 Superfactory™. All Rights Reserved. 64


Root Cause

Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Water pressure valve is faulty

Why?

© 2004 Superfactory™. All Rights Reserved. 65


Root Cause

Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Water pressure valve is faulty

Valve not in preventative maintenance program

© 2004 Superfactory™. All Rights Reserved. 66


Corrective Action

 Permanent – Water pressure valves placed in preventative


maintenance program.

 Preventive - Developed checklist form to ensure new


equipment is reviewed for possible inclusion in preventative
maintenance program.

© 2004 Superfactory™. All Rights Reserved. 67


Example #3

Root Cause Analysis


Example #3

© 2004 Superfactory™. All Rights Reserved. 68


Example #3

Identify Problem

Customers are unhappy because they are being shipped


products that don't meet their specifications.

© 2004 Superfactory™. All Rights Reserved. 69


Immediate Action

Inspect all finished and in-process product to ensure it meets


customer specifications.

© 2004 Superfactory™. All Rights Reserved. 70


Root Cause

Product doesn’t meet specifications

Why?

© 2004 Superfactory™. All Rights Reserved. 71


Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from


what customer and sales person agreed to
Why?

© 2004 Superfactory™. All Rights Reserved. 72


Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from


what customer and sales person agreed to

Sales person tries to expedite work by calling


head of manufacturing directly
Why?

© 2004 Superfactory™. All Rights Reserved. 73


Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from


what customer and sales person agreed to

Sales person tries to expedite work by calling


head of manufacturing directly

Manufacturing schedule is not available for


sales person to provide realistic delivery date
Why?

© 2004 Superfactory™. All Rights Reserved. 74


Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from


what customer and sales person agreed to

Sales person tries to expedite work by calling


head of manufacturing directly

Manufacturing schedule is not available for


sales person to provide realistic delivery date

Confidence in manufacturing schedule is not


high enough to release/link with order system

© 2004 Superfactory™. All Rights Reserved. 75


Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Why?

© 2004 Superfactory™. All Rights Reserved. 76


Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Parts sometimes not available thereby


creating schedule changes
Why?

© 2004 Superfactory™. All Rights Reserved. 77


Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Parts sometimes not available thereby


creating schedule changes

Expediting and priority changes consume


parts not planned for
Why?

© 2004 Superfactory™. All Rights Reserved. 78


Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Parts sometimes not available thereby


creating schedule changes

Expediting and priority changes consume


parts not planned for

Manufacturing schedule does not reflect


realistic assembly and test time
Why?

© 2004 Superfactory™. All Rights Reserved. 79


Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Parts sometimes not available thereby


creating schedule changes

Expediting and priority changes consume


parts not planned for

Manufacturing schedule does not reflect


realistic assembly and test time

No ongoing review of manufacturing standards

© 2004 Superfactory™. All Rights Reserved. 80


Corrective Action

 Permanent – Manufacturing standards reviewed and


updated.

 Preventive - Regular ongoing review of actuals vs


standards is implemented.

© 2004 Superfactory™. All Rights Reserved. 81


Root Cause Analysis
Example #4

© 2004 Superfactory™. All Rights Reserved. 82


Example #4

Identify Problem

Department didn’t complete their project on time

© 2004 Superfactory™. All Rights Reserved. 83


Determine Team

 Team members:
 Boss – Jim
 Worker – Tom
 Worker - Karen
 Project Mgr – Bob
 Admin – Sally

© 2004 Superfactory™. All Rights Reserved. 84


Immediate Action

 Additional resources applied to help get the project team


back on schedule

 No new projects started until Root Cause Analysis


completed

© 2004 Superfactory™. All Rights Reserved. 85


Root Cause

Didn’t complete project on time

Why?

© 2004 Superfactory™. All Rights Reserved. 86


Cause and Effect

Procedures Personnel
Lack of worker
knowledge
Poor project plan
Poor project
mgmt skills Lack of resources

Didn’t complete
project on time

Inadequate Poor Inadequate


computer documentation computer system
programs

Materials Equipment

© 2004 Superfactory™. All Rights Reserved. 87


Cause and Effect

Procedures Personnel
Lack of worker
knowledge
Poor project plan
Poor project
mgmt skills Lack of resources

Didn’t complete
project on time

Inadequate Poor Inadequate


computer documentation computer system
programs

Materials Equipment

© 2004 Superfactory™. All Rights Reserved. 88


Root Cause

Didn’t complete project on time

Resources unavailable when needed

Why?

© 2004 Superfactory™. All Rights Reserved. 89


Root Cause

Didn’t complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Why?

© 2004 Superfactory™. All Rights Reserved. 90


Root Cause

Didn’t complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Lack of specifics given to


Human Resources Dept
Why?

© 2004 Superfactory™. All Rights Reserved. 91


Root Cause

Didn’t complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Lack of specifics given to


Human Resources Dept

No formal process for submitting job opening

© 2004 Superfactory™. All Rights Reserved. 92


Corrective Action

 Permanent – Hired another worker to meet needs of next


project team

 Preventive - Developed checklist form with HR for


submitting job openings in the future

© 2004 Superfactory™. All Rights Reserved. 93


Example #5

Root Cause Analysis


Example #5

© 2004 Superfactory™. All Rights Reserved. 94


Example #5

Identify Problem

High pyrogen count on finished medical catheter product


using molded components.

© 2004 Superfactory™. All Rights Reserved. 95


Immediate Action

Immediate Action (and panic!)

 Quarantine all finished and in-process product


(over $2 million worth!)
 Analyze location of pyrogen to find common denominator

© 2004 Superfactory™. All Rights Reserved. 96


Panic-Driven Action

Panic-driven Immediate Reaction


(without root cause analysis)

 Pyrogen traced to molding cooling water leak


 Holy cow!… cooling water system hasn’t been cleaned in 15 years!
 Shut down 24/7 molding operation for 2 days to clean cooling water system
 Implement system for weekly analysis of cooling water for pyrogens
 Threaten to fire anyone who doesn’t report a cooling water leak

© 2004 Superfactory™. All Rights Reserved. 97


Panic-Driven Action - Results

Results of Panic-driven Immediate Reaction


(without root cause analysis)

 Day 1 after cooling water system cleaning: water tests clean of pyrogens
 Day 2: cooling water is saturated with pyrogens. Uh oh.
 All operators and technicians reporting “possible water leaks” on all presses, all molds, all shifts…
“just in case”.
 Molding operation shuts down. Operations manager nearly fired.
 “Help” flying in from corporate offices and other molding plants.
 Hourly conference calls to give status updates to executives.

© 2004 Superfactory™. All Rights Reserved. 98


Logic Returns

There must be a better way! How about trying something called


“Root Cause Analysis”?

© 2004 Superfactory™. All Rights Reserved. 99


Root Cause

Pyrogens on molded components

Why?

© 2004 Superfactory™. All Rights Reserved. 100


Root Cause

Pyrogens on molded components

Parts released from molding even though they


had been sprayed with leaking cooling water
Why?

© 2004 Superfactory™. All Rights Reserved. 101


Root Cause

Pyrogens on molded components

Parts released from molding even though they


had been sprayed with leaking cooling water

Disposition of contaminated parts procedure


does not discuss water
Why?

© 2004 Superfactory™. All Rights Reserved. 102


Root Cause

Pyrogens on molded components

Parts released from molding even though they


had been sprayed with leaking cooling water

Disposition of contaminated parts procedure


does not discuss water

Oil, grease, dust, human contact believed to


be primary sources of contamination
Why?

© 2004 Superfactory™. All Rights Reserved. 103


Root Cause

Pyrogens on molded components

Parts released from molding even though they


had been sprayed with leaking cooling water

Disposition of contaminated parts procedure


does not discuss water

Oil, grease, dust, human contact believed to


be primary sources of contamination

No formal evaluation of contamination sources,


types, severity, and disposition action.

© 2004 Superfactory™. All Rights Reserved. 104


Corrective Action

 Permanent – Disposition of contaminated parts procedure


re-written to include water.

 Preventive - Formal study of contamination sources,


consequences, and disposition requirements.

© 2004 Superfactory™. All Rights Reserved. 105