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Root_Cause_Analysis.ppt
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© 2004 Superfactory™. All Rights Reserved.
Root Cause Analysis
Superfactory Excellence Program™
www.superfactory.com
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© 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.
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
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© 2004 Superfactory™. All Rights Reserved.
Course Content
Course Objectives
What is Root Cause?
Benefits
The Problem Solving Process
Examples and Exercises
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© 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
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© 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
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© 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
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© 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! $$
$$
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© 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.
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© 2004 Superfactory™. All Rights Reserved.
When should root cause analysis
be performed?
When PROBLEMS occur !!
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© 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!
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© 2004 Superfactory™. All Rights Reserved.
How does it work?
PROCESS
D
PROCESS
C
PROCESS
B
PROCESS
A
CUSTOMER
“Customer” can be
Internal or External
Defect found at “Customer”…
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© 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
Contain the problem…
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© 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
Contain the root process…
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© 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!
Prevent the problem…
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© 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?
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© 2004 Superfactory™. All Rights Reserved.
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
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© 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 preventive not addressed, problem will return!!
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© 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 preventive not addressed, problem will return!!
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© 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
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© 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
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© 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!
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© 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
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© 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!
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© 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
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© 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
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© 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
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© 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.
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© 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 process that caused the problem
if root cause is company-wide, elevate these process issues (outside of
team control) to upper management to address
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© 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
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© 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
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© 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
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© 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
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© 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
People
Equipment
Methods
Materials
NOTE: Causes are not limited to the 5 listed categories, but serve as a starting point
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© 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
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© 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
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© 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
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© 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.
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© 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
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© 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
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© 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?
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?
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© 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
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© 2004 Superfactory™. All Rights Reserved.
What does a good RCA look like?
The Root Cause is
Internally Consistent ,
Thorough, and
Credible
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© 2004 Superfactory™. All Rights Reserved.
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
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© 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
why questions
• identification of risks & their potential contributions
determination of potential improvement in processes or systems
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© 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
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© 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!
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© 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
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Determine Team
Team members:
Team Leader – Terry
Inspector – Jane
Worker – Tammy
Worker - Joe
Quality Eng – Rob
Engineer – Sally
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© 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
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© 2004 Superfactory™. All Rights Reserved.
Root Cause
Part reversed
Worker not sure of correct part orientation
Why?
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Part is not marked properly
Root Cause
Part reversed
Worker not sure of correct part orientation
Why?
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© 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?
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© 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
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© 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.
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© 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.
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© 2004 Superfactory™. All Rights Reserved.
Example #2
But What is the Root Cause?
The supervisor looks for a root cause by asking 'why?’
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© 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.
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© 2004 Superfactory™. All Rights Reserved.
Water pressure is set too high
Root Cause
Puddle of water on the floor
Leak in overhead pipe
Why?
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© 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?
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© 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
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© 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.
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© 2004 Superfactory™. All Rights Reserved.
Example #3
Identify Problem
Customers are unhappy because they are being shipped
products that don't meet their specifications.
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© 2004 Superfactory™. All Rights Reserved.
Immediate Action
Inspect all finished and in-process product to ensure it meets
customer specifications.
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© 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?
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© 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?
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© 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?
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© 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?
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© 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?
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© 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?
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© 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
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© 2004 Superfactory™. All Rights Reserved.
Corrective Action
Permanent – Manufacturing standards reviewed and
updated.
Preventive - Regular ongoing review of actuals vs
standards is implemented.
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© 2004 Superfactory™. All Rights Reserved.
Example #4
Identify Problem
Department didn’t complete their project on time
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Determine Team
Team members:
Boss – Jim
Worker – Tom
Worker - Karen
Project Mgr – Bob
Admin – Sally
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© 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
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© 2004 Superfactory™. All Rights Reserved.
Cause and Effect
Didn’t complete
project on time
Equipment
Materials
Personnel
Procedures
Lack of worker
knowledge
Poor project
mgmt skills
Poor project plan
Inadequate
computer
programs
Inadequate
computer system
Poor
documentation
Lack of resources
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© 2004 Superfactory™. All Rights Reserved.
Cause and Effect
Didn’t complete
project on time
Equipment
Materials
Personnel
Procedures
Lack of worker
knowledge
Poor project
mgmt skills
Poor project plan
Inadequate
computer
programs
Inadequate
computer system
Poor
documentation
Lack of resources
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© 2004 Superfactory™. All Rights Reserved.
Root Cause
Didn’t complete project on time
Resources unavailable when needed
Why?
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Took too long to hire Project Manager
Root Cause
Didn’t complete project on time
Resources unavailable when needed
Why?
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© 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
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© 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
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© 2004 Superfactory™. All Rights Reserved.
Example #5
Identify Problem
High pyrogen count on finished medical catheter product using
molded components.
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© 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
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© 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
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© 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.
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© 2004 Superfactory™. All Rights Reserved.
Logic Returns
There must be a better way! How about trying something called
“Root Cause Analysis”?
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© 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?
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© 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
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© 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.