Root Cause Analysis....................................

Root Cause Analysis

1. 1© 2004 Superfactory™. All Rights Reserved.
Root Cause Analysis
Superfactory Excellence Program™
www.superfactory.com

2. 2© 2004 Superfactory™. All Rights Reserved.
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.
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 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

3. 3© 2004 Superfactory™. All Rights Reserved.
Course Content
Course Objectives
What is Root Cause?
Benefits
The Problem Solving Process
Examples and Exercises

4. 4© 2004 Superfactory™. All Rights Reserved.
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

5. 5© 2004 Superfactory™. All Rights Reserved.
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

6. 6© 2004 Superfactory™. All Rights Reserved.
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

7. 7© 2004 Superfactory™. All Rights Reserved.
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!$$$$

8. 8© 2004 Superfactory™. All Rights Reserved.
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.

9. 9© 2004 Superfactory™. All Rights Reserved.
When should root cause analysis
be performed?
When PROBLEMS occur !!

10. 10© 2004 Superfactory™. All Rights Reserved.
How does it differ from what we do
now?
Firefighting!
Immediate Containment
Action Implemented
Problem
Identified
Immediate
Containment
Action
Implemented
Defined
Root Cause
Analysis
Process
Solutions
validated
with data
Solutions are
applied across
company and
never return!
USUAL APPROACH
PREFERRED APPROACH
Problem
Identified
Problem
reoccurs
elsewhere!
Find
someone to
blame!

11. 11© 2004 Superfactory™. All Rights Reserved.
How does it work?
PROCESS
D
PROCESS
C
PROCESS
B
PROCESS
A
CUSTOMER
“Customer”can be
InternalorExternal
Defectfound at “Customer”…

12. 12© 2004 Superfactory™. All Rights Reserved.
How does it work?
PROCESS
D
PROCESS
C
PROCESS
B
PROCESS
A
CUSTOMER
Nothing is allowed to further
escape to the customer
Containthe problem…

13. 13© 2004 Superfactory™. All Rights Reserved.
How does it work?
PROCESS
D
PROCESS
C
PROCESS
B
PROCESS
A
CUSTOMER
Nothing is allowed to further
escape to the next process
Containthe root process…

14. 14© 2004 Superfactory™. All Rights Reserved.
How does it work?
PROCESS
D
PROCESS
C
PROCESS
B
PROCESS
A
CUSTOMER
Corrective action implemented
so root cause of problem does
not occur again!
Preventthe problem…

15. 15© 2004 Superfactory™. All Rights Reserved.
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?

16. 16© 2004 Superfactory™. All Rights Reserved.
Corrective Actions
3 types of Corrective Action:
Immediateaction
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 anyprocess or product

17. 17© 2004 Superfactory™. All Rights Reserved.
Examples of Corrective Actions
Immediate (step #3)
Permanent (step #5)
Preventive (step #5)
All current batch of paperwork re-inspected by another
worker for same type of problem
Form changed to mandate completion of certain fields
Similar forms with same fields used all over in
company are changed to “mandatory”
If preventivenot addressed, problem will return!!

18. 18© 2004 Superfactory™. All Rights Reserved.
Examples of Corrective Actions
Immediate (step #3)
Permanent (step #5)
Preventive (step #5)
Part removed and replaced in product, retested
Product redesigned to account for part variability
Design process changed to require variation
analysis testing on similar supplier parts
If preventivenot addressed, problem will return!!

19. 19© 2004 Superfactory™. All Rights Reserved.
The Difference between
Permanent vs. Preventive Corrective Actions
Permanent
 Trained employee on proper machine use
 Changed product design to make parts easier to assemble
manually

 Specific customer document critical to project is identified with
red folder
 Update all customers with latest software revision to fix problem
 Fallen patient given full-time assistant to provide help moving
around hospital

 Employee fired for ethical violation
Preventive
 Made training a requirement to new employees working in that
area
 Changed design guidelines to not allow for use of part in full
scale production
 All documents that are critical to project are identified with red
folders
 Check for those software bugs added to checklist and
performed prior to release of software
 Process developed to identify “at risk” patients for falls who
require assistant
 Ethics training developed and provided to all employees

20. 20© 2004 Superfactory™. All Rights Reserved.
Problem Solving Process
Validate
Follow Up
Plan
Complete
Plan
Action
Plan
Root
Cause
Immediate
Action
Identify
Team
Identify
Problem
Problem
Solving
Process
1
2
3
4
5
6
7
8

21. 21© 2004 Superfactory™. All Rights Reserved.
Step #1
Identify the Problem
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?
Very important!

22. 22© 2004 Superfactory™. All Rights Reserved.
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

23. 23© 2004 Superfactory™. All Rights Reserved.
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!

24. 24© 2004 Superfactory™. All Rights Reserved.
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

25. 25© 2004 Superfactory™. All Rights Reserved.
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

26. 26© 2004 Superfactory™. All Rights Reserved.
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

27. 27© 2004 Superfactory™. All Rights Reserved.
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.

28. 28© 2004 Superfactory™. All Rights Reserved.
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 processthat caused the problem
if root cause is company-wide, elevate these process issues (outside of
team control) to upper management to address

29. 29© 2004 Superfactory™. All Rights Reserved.
Step #4
Tools
5 Why
failure mode, effect & criticality
analysis
fault tree analysis
brainstorming
flowcharting
cause & effect diagrams
pareto charts
barrier analysis
change analysis

30. 30© 2004 Superfactory™. All Rights Reserved.
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

31. 31© 2004 Superfactory™. All Rights Reserved.
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

32. 32© 2004 Superfactory™. All Rights Reserved.
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
Cause-Effect Diagram

33. 33© 2004 Superfactory™. All Rights Reserved.
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:
Cause-Effect Diagram
Environment Effect
PeopleEquipment
MethodsMaterials
NOTE: Causes are not limited to the 5 listed categories, but serve as a starting point

34. 34© 2004 Superfactory™. All Rights Reserved.
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:
Cause-Effect Diagram
Materials
Incorrect Quantity
Incorrect BOL
Wrong Destination
Methods
Late Dispatch
Shipping Delay
Spillage
Environment
Shipping
Problems
Traffic Delays
Weather
Equipment
Wrong Equipment
Dirty Equipment
Breakdown
People
Driver
Attitude
Dispatcher
Wrong Directions

35. 35© 2004 Superfactory™. All Rights Reserved.
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

36. 36© 2004 Superfactory™. All Rights Reserved.
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

37. 37© 2004 Superfactory™. All Rights Reserved.
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.

38. 38© 2004 Superfactory™. All Rights Reserved.
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

39. 39© 2004 Superfactory™. All Rights Reserved.
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

40. 40© 2004 Superfactory™. All Rights Reserved.
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?
Whowill look at what data?
How longafter the action plan will this be done?
What criteriain the data results will determine that the problem has not
recurred?

41. 41© 2004 Superfactory™. All Rights Reserved.
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

42. 42© 2004 Superfactory™. All Rights Reserved.
What does a good RCA look like?
The Root Cause is
Internally Consistent ,
Thorough, and
Credible

43. 43© 2004 Superfactory™. All Rights Reserved.
What does a good RCA look like?
The Complete Root Cause Analysisis
•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

44. 44© 2004 Superfactory™. All Rights Reserved.
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
whyquestions
•identification of risks & their potential contributions
determination of potential improvement in processes or systems

45. 45© 2004 Superfactory™. All Rights Reserved.
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

46. 46© 2004 Superfactory™. All Rights Reserved.
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!

47. 47© 2004 Superfactory™. All Rights Reserved.
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

48. 48© 2004 Superfactory™. All Rights Reserved.
Manufacturing
Root Cause Analysis
Example #1

49. 49© 2004 Superfactory™. All Rights Reserved.
Example #1
Identify Problem
Part polarity reversed on circuit board

50. 50© 2004 Superfactory™. All Rights Reserved.
Determine Team
Team members:
Team Leader –Terry
Inspector –Jane
Worker –Tammy
Worker -Joe
Quality Eng –Rob
Engineer –Sally

51. 51© 2004 Superfactory™. All Rights Reserved.
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

52. 52© 2004 Superfactory™. All Rights Reserved.
Root Cause
Part reversed
Why?

53. 53© 2004 Superfactory™. All Rights Reserved.
Root Cause
Part reversed
Worker not sure of correct part orientation
Why?

54. 54© 2004 Superfactory™. All Rights Reserved.
Part is not marked properly
Root Cause
Part reversed
Worker not sure of correct part orientation
Why?

55. 55© 2004 Superfactory™. All Rights Reserved.
Engineering ordered it that way from vendor
Part is not marked properly
Root Cause
Part reversed
Worker not sure of correct part orientation
Why?

56. 56© 2004 Superfactory™. All Rights Reserved.
Process didn’t account for possible
manufacturing issues
Engineering ordered it that way from vendor
Part is not marked properly
Root Cause
Part reversed
Worker not sure of correct part orientation

57. 57© 2004 Superfactory™. All Rights Reserved.
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.

58. 58© 2004 Superfactory™. All Rights Reserved.
Root Cause Analysis
Example #2

59. 59© 2004 Superfactory™. All Rights Reserved.
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.

60. 60© 2004 Superfactory™. All Rights Reserved.
Example #2
But What is the Root Cause?
The supervisor looks for a root cause by asking 'why?’

61. 61© 2004 Superfactory™. All Rights Reserved.
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.

62. 62© 2004 Superfactory™. All Rights Reserved.
Root Cause
Puddle of water on the floor
Why?

63. 63© 2004 Superfactory™. All Rights Reserved.
Root Cause
Puddle of water on the floor
Leak in overhead pipe
Why?

64. 64© 2004 Superfactory™. All Rights Reserved.
Water pressure is set too high
Root Cause
Puddle of water on the floor
Leak in overhead pipe
Why?

65. 65© 2004 Superfactory™. All Rights Reserved.
Water pressure valve is faulty
Water pressure is set too high
Root Cause
Puddle of water on the floor
Leak in overhead pipe
Why?

66. 66© 2004 Superfactory™. All Rights Reserved.
Valve not in preventative maintenance program
Water pressure valve is faulty
Water pressure is set too high
Root Cause
Puddle of water on the floor
Leak in overhead pipe

67. 67© 2004 Superfactory™. All Rights Reserved.
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.

68. 68© 2004 Superfactory™. All Rights Reserved.
Example #3
Root Cause Analysis
Example #3

69. 69© 2004 Superfactory™. All Rights Reserved.
Example #3
Identify Problem
Customers are unhappy because they are being shipped
products that don't meet their specifications.

70. 70© 2004 Superfactory™. All Rights Reserved.
Immediate Action
Inspect all finished and in-process product to ensure it meets
customer specifications.

71. 71© 2004 Superfactory™. All Rights Reserved.
Root Cause
Product doesn’t meet specifications
Why?

72. 72© 2004 Superfactory™. All Rights Reserved.
Root Cause
Product doesn’t meet specifications
Manufacturing specification is different from
what customer and sales person agreed to
Why?

73. 73© 2004 Superfactory™. All Rights Reserved.
Sales person tries to expedite work by calling
head of manufacturing directly
Root Cause
Product doesn’t meet specifications
Manufacturing specification is different from
what customer and sales person agreed to
Why?

74. 74© 2004 Superfactory™. All Rights Reserved.
Manufacturing schedule is not available for
sales person to provide realistic delivery date
Sales person tries to expedite work by calling
head of manufacturing directly
Root Cause
Product doesn’t meet specifications
Manufacturing specification is different from
what customer and sales person agreed to
Why?

75. 75© 2004 Superfactory™. All Rights Reserved.
Confidence in manufacturing schedule is not
high enough to release/link with order system
Manufacturing schedule is not available for
sales person to provide realistic delivery date
Sales person tries to expedite work by calling
head of manufacturing directly
Root Cause
Product doesn’t meet specifications
Manufacturing specification is different from
what customer and sales person agreed to

76. 76© 2004 Superfactory™. All Rights Reserved.
Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system
Why?

77. 77© 2004 Superfactory™. All Rights Reserved.
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?

78. 78© 2004 Superfactory™. All Rights Reserved.
Expediting and priority changes consume
parts not planned for
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?

79. 79© 2004 Superfactory™. All Rights Reserved.
Manufacturing schedule does not reflect
realistic assembly and test time
Expediting and priority changes consume
parts not planned for
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?

80. 80© 2004 Superfactory™. All Rights Reserved.
No ongoing review of manufacturing standards
Manufacturing schedule does not reflect
realistic assembly and test time
Expediting and priority changes consume
parts not planned for
Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system
Parts sometimes not available thereby
creating schedule changes

81. 81© 2004 Superfactory™. All Rights Reserved.
Corrective Action
Permanent –Manufacturing standards reviewed and
updated.
Preventive -Regular ongoing review of actuals vs
standards is implemented.

82. 82© 2004 Superfactory™. All Rights Reserved.
Root Cause Analysis
Example #4

83. 83© 2004 Superfactory™. All Rights Reserved.
Example #4
Identify Problem
Department didn’t complete their project on time

84. 84© 2004 Superfactory™. All Rights Reserved.
Determine Team
Team members:
Boss –Jim
Worker –Tom
Worker -Karen
Project Mgr –Bob
Admin –Sally

85. 85© 2004 Superfactory™. All Rights Reserved.
Immediate Action
Additional resources applied to help get the project team
back on schedule
No new projects started until Root Cause Analysis
completed

86. 86© 2004 Superfactory™. All Rights Reserved.
Root Cause
Didn’t complete project on time
Why?

87. 87© 2004 Superfactory™. All Rights Reserved.
Cause and Effect
Didn’t complete
project on time
EquipmentMaterials
PersonnelProcedures
Lack of worker
knowledge
Poor project
mgmt skills
Poor project plan
Inadequate
computer
programs
Inadequate
computer system
Poor
documentation
Lack of resources

88. 88© 2004 Superfactory™. All Rights Reserved.
Cause and Effect
Didn’t complete
project on time
EquipmentMaterials
PersonnelProcedures
Lack of worker
knowledge
Poor project
mgmt skills
Poor project plan
Inadequate
computer
programs
Inadequate
computer system
Poor
documentation
Lack of resources

89. 89© 2004 Superfactory™. All Rights Reserved.
Root Cause
Didn’t complete project on time
Resources unavailable when needed
Why?

90. 90© 2004 Superfactory™. All Rights Reserved.
Took too long to hire Project Manager
Root Cause
Didn’t complete project on time
Resources unavailable when needed
Why?

91. 91© 2004 Superfactory™. All Rights Reserved.
Lack of specifics given to
Human Resources Dept
Took too long to hire Project Manager
Root Cause
Didn’t complete project on time
Resources unavailable when needed
Why?

92. 92© 2004 Superfactory™. All Rights Reserved.
No formal process for submitting job opening
Lack of specifics given to
Human Resources Dept
Took too long to hire Project Manager
Root Cause
Didn’t complete project on time
Resources unavailable when needed

93. 93© 2004 Superfactory™. All Rights Reserved.
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

94. 94© 2004 Superfactory™. All Rights Reserved.
Example #5
Root Cause Analysis
Example #5

95. 95© 2004 Superfactory™. All Rights Reserved.
Example #5
Identify Problem
High pyrogen count on finished medical catheter product using
molded components.

96. 96© 2004 Superfactory™. All Rights Reserved.
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

97. 97© 2004 Superfactory™. All Rights Reserved.
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

98. 98© 2004 Superfactory™. All Rights Reserved.
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.


99. 99© 2004 Superfactory™. All Rights Reserved.
Logic Returns
There must be a better way! How about trying something called
“Root Cause Analysis”?

100. 100© 2004 Superfactory™. All Rights Reserved.
Root Cause
Pyrogens on molded components
Why?

101. 101© 2004 Superfactory™. All Rights Reserved.
Root Cause
Pyrogens on molded components
Parts released from molding even though they
had been sprayed with leaking cooling water
Why?

102. 102© 2004 Superfactory™. All Rights Reserved.
Disposition of contaminated parts procedure
does not discuss water
Root Cause
Pyrogens on molded components
Parts released from molding even though they
had been sprayed with leaking cooling water
Why?

103. 103© 2004 Superfactory™. All Rights Reserved.
Oil, grease, dust, human contact believed to
be primary sources of contamination
Disposition of contaminated parts procedure
does not discuss water
Root Cause
Pyrogens on molded components
Parts released from molding even though they
had been sprayed with leaking cooling water
Why?

104. 104© 2004 Superfactory™. All Rights Reserved.
No formal evaluation of contamination sources,
types, severity, and disposition action.
Oil, grease, dust, human contact believed to
be primary sources of contamination
Disposition of contaminated parts procedure
does not discuss water
Root Cause
Pyrogens on molded components
Parts released from molding even though they
had been sprayed with leaking cooling water

105. 105© 2004 Superfactory™. All Rights Reserved.
Corrective Action
Permanent –Disposition of contaminated parts procedure
re-written to include water.
Preventive -Formal study of contamination sources,
consequences, and disposition requirements.