Operational Excellence - Mistake-Proofing
Workshop Instructor: Frank Adler, Ph.D.
Operational Excellence Consulting
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February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
CONSULTING
“Mistake Proofing” Course Agenda
7. Process Control
Plan & Exercise
(≈ 60 min)
1. Introduction to
Mistake-Proofing
(≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
2. Process Mapping &
Exercise (≈ 35 min)
3. The Building
Block & Exercise
(≈ 35 min)
5. Risk Analysis &
Exercise (≈ 45 min)
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4. Process FMEA &
Exercise
(≈ 100 min)
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February 26, 2014 – v 4.0
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Mistake-Proofing - A Team Effort
The responsibility for Mistake-Proofing a process must be assigned
to an individual. However, the responsible individual is expected to
directly and actively involve representatives from all affected areas.
The team should reflect the needs and requirements that the
problem and culture of the organization requires. It consists of four
to six individuals with multidiscipline and multifunctional
backgrounds. In addition, all members should have ownership of
the problem/process.
Mistake-Proofing should be a catalyst
to stimulate the interchange of ideas
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thus promote a team approach.
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Mistake-Proofing - Characterize Process Inputs
Inputs can be classified as one of three types:
Controllable (C)
– can be adjusted or controlled during the process
• speeds, pressure, ...
Standard Operating Procedures (SOP)
– common sense items; activities that are always done just because it makes
sense
• set-up, cleaning, maintenance, ...
Noise (N)
– things one cannot control
– things one doesn't want to control (too difficult or expensive)
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• humidity, temperature, ...
7
February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
CONSULTING
“Mistake Proofing” Course Agenda
7. Process Control
Plan & Exercise
(≈ 60 min)
1. Introduction to
Mistake-Proofing
(≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
2. Process Mapping &
Exercise (≈ 35 min)
3. The Building
Block & Exercise
(≈ 35 min)
5. Risk Analysis &
Exercise (≈ 45 min)
This document is a partial preview. Full document download can be found on Flevy:
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4. Process FMEA &
Exercise
(≈ 100 min)
9
February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
CONSULTING
Traditional Process Flowchart
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The Process Flow Chart
A few more Tips:
Break the process into manageable process steps
But don’t worry too much, you can always continue doing that when starting to
analyze the process step if needed
Try to keep it to max. 10 - 15 process steps
You can always split process steps later or split the process into several subprocesses and form a project team around each sub-process
Verify that the process flow chart is accurate and complete
Perform a process walkthrough and/or onsite process observation to ensure the
you did not miss anything and all steps are in the correct sequence
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Make sure you have all the right people on board
The process flow chart helps you to understand who is involved in the process.
Pull subject matter experts in as and when needed
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February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
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Workshop Exercise: Coffee Brewing Process
Instructions to Exercise 1:
Develop a Process Flow Chart for the Coffee Brewing Process.
Define the first and last step of the process you want to mistake
proof
Brainstorm process steps in no particular order and write the
steps on Post-It notes
Order Post-It Notes on the Flip Chart according to the actual
process flow
Add any missing process steps. Try keeping it to 10 to 12 steps.
Connect process steps with arrows to visualize the process flow
Resources for Exercise 1:
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Flip Charts
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20 Minutes
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February 26, 2014 – v 4.0
Post-It Notes
Markers
OPERATIONAL EXCELLENCE
CONSULTING
The Building Blocks
Controls
Information In
•
•
•
•
• Procedures
• Policy
Information Out
•
•
•
•
Data
Instructions
Drawings
Programs
Data
Instructions
Drawings
Programs
Process
Product In
Product Out
Cycle Time
DPU or DPM
Resources In
Resources Out
• Tools
• Equipment
People
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• Test Sets
•
•
•
•
Tools
Equipment
People
Test Sets
Safety
• Facility
• Requirements
• Environmental
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February 26, 2014 – v 4.0
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Workshop Exercise: Coffee Brewing Process
Instructions to Exercise 2:
Develop a Building Blocks Diagram for the Coffee Making Process.
Draw a Building Block Diagram on a Flip Chart
Define the “Product In” and “Product Out” of the process
Brainstorm Building Block elements in no particular order, write
them on Post-It notes and stick them on the Flip Chart under the
appropriate category (Information In, Resources, Controls, …)
Resources for Exercise 2:
Flip Charts
Post-It Notes
Markers
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20 Minutes
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Failure Mode and Effects Analysis - History
First used in the 1960's in the Aerospace industry during Apollo
missions.
In 1974 the Navy developed MIL-STD-1629 regarding the use
of FMEA.
In the late 1970's, automotive applications driven by liability
costs, began to incorporate FMEA into the management of their
processes
Now used across many industries as a method to improve
quality and reliability and to manage risk.
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Failure Mode and Effects Analysis - The Four Types
The Four Types of FMEAs
System FMEA is used to analyze systems and sub-systems in early
concept and design stage. A System FMEA focuses on potential failure
modes between the functions of the system caused by system deficiencies.
It includes the interactions between systems and elements of the system.
Design FMEA analyses products before they are released to manufacturing.
A Design FMEA focuses on failure modes caused by design deficiencies.
Process FMEA analyses manufacturing and assembly processes. A
Process FMEA focuses on failure modes caused by process and assembly
deficiencies.
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Service FMEA analyses services before they reach the customer. A Service
FMEA focuses on failure modes caused by system or process deficiencies.
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Process Failure Mode and Effect Analysis - Benefits
Benefit of a Process FMEA
The benefits of the Process FMEA are:
assists in the analysis of the manufacturing or business process, and
identifies process deficiencies and offers a corrective action plan,
identifies the critical and/or significant characteristics and helps in
developing process control plans,
establishes a priority of corrective actions,
documents the rationale for changes.
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Process FMEA - The Template
PROCESS FMEA
Process Name:
Process Responsible:
FMEA Responsible:
Other Areas Involved/Effected:
Process Description and
Process Purpose
Potential
Failure Mode
FMEA Team:
Potential
Effect(s) of Failure
Severity
of effect
Ranking Guidelines:
Severity of failure effect:
Occurrence of failure cause:
Detection of failure cause:
Risk Priority Number (RPN) =
Potential
Cause(s) of Failure
Occurrence
of cause
Current Process
Control(s)
[attached as copy]
1 = Minor/No effect
1 = Remote/Unlikely
1 = Very high/Almost certainly
Severity * Occurrence * Detection
Detection
of cause
RPN
(S*O*D)
Process FMEA Body
FMEA Worksheet Document No:
File Location:
Date (Orig.):
Date (Rev.):
Page
of
10 = Very high/Hazardous
10 = Very high/Almost inevitable
10 = Very low/Unlikely
Recommended
Action(s)
Responsible
Person
Completion
Date
Status
Action Results
Action Taken
[S] [O] [D] RPN
Improvement Plan
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Process FMEA - The Template
Column: Process Step Description and Purpose
Enter a simple description of the process step or activity being
analyzed and indicate as concisely as possible its purpose.
– What is the purpose, objective, function, goal of the process step?
– What is the process step supposed to do ?
Where the process step involves numerous operations (e.g.
assembling) with different potential modes of failure, it may be
desirable to list the operations as separate process steps.
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Process FMEA - Potential Failure Modes
Process Step Description:
“Inserting the Coffee Filter”
Process Step Success Criteria:
Filter Present – Right Filter – Right Position – …
Potential Failure Modes:
No Filter – Too many Filters
Filter too small – Filter too large – Wrong Type
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Filter misaligned – Filter not opened
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Process FMEA - The Template
Column: Potential Cause(s) of a Failure Mode
Potential Cause of Failure is defined as why the failure could occur, described
in terms of something that can be corrected or can be controlled.
Only specific errors or malfunctions should be listed; ambiguous phrases (e.g.
operator error, machine malfunction) should not be used. List, to the extent
possible, every conceivable failure cause assignable to each potential failure
mode.
– Why would this failure mode occur?
– What circumstances could cause the failure mode?
Typical potential causes could be, but are not limited to:
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– improper heat treat (time, temperature), part missing
or misaligned, improper
torque (under, over), inadequate control procedure, human error like
omission or wrong selection, lack or improper operating instruction.
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February 26, 2014 – v 4.0
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How to apply the 5 Why’s
Description: The 5 Why’s Analysis helps to identify the root cause of a problem in a
graphical and systematic manner. It encourages the team to reach an answer that is
fundamental and actionable.
Procedure:
Step 1: Write the Failure Mode in the upper left corner of a flip chart or white board.
Step 2: Ask “Why?” this problem could occur. Write the potential cause underneath the
original Failure Mode.
Step 3: The potential cause identified in Step 2 now becomes a new Failure Mode. Repeat
Step 2 and ask “Why?”, e.g. “Why would this failure occur?", again.
Step 4: Continue Step 2 and Step 3 until you reach an answer that is fundamental and
actionable, e.g. standard operating procedure, work instruction, system issues, training
needs, … .
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Root Cause Analysis Tools → Why – Why Diagram
Description: The Why-Why Diagram helps to identify possible causes of a
problem or failure mode in a graphical and systematic manner. The tools helps the
team to recognize the broad network of possible causes and the relationship
among them.
Example:
Failure Mode:
Customer complaint
due to grinding marks
on the door frame
The door frame
had been “overground”
Wrong Tool was
used
Tools are not
marked
Operator was
untrained
No formal
training exists
Current grinding
method is not
capable
Training
Process was
not applied
Cosmetic
requirements
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No written
cosmetic
standard exists
…
…
Current grinding
method is too
complicated
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Root Cause Analysis Tools → Fishbone Diagram
The Fishbone Diagram (Cause-and-Effect or Ishikawa Diagram) is a systematic way
of looking at the causes of a problem and how they are related using pre-defined
categories, e.g. 4Ms & 1 E.
4M’s & 1E
Materials
Methods
= MEN
Effect or
Outcome
Main Branch
METHODS
MATERIALS
Potential
Failure Mode
Trunk
MACHINES
+ ENVIRONMENT
Minor Branch
Men
Machines
Environment
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Primary Causal Factor
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Process FMEA - The Template
Column: Current Controls
Current Process Controls are descriptions of the controls that either
prevent to the extent possible the failure mode from occurring or detect
the failure mode should it occur.
The focus is on the effectiveness of the control method/technique to
catch the problem before it reaches the customer.
Typical process controls could be, but are not limited to:
– Standard Operating Procedures (“SOPs”) & Work Instructions
– Checklists
– Error-proofing systems and devices (e.g. Poka-Yoke)
– Color coding or tags
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– Examining safety margins (e.g. Process Capability Studies)
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– Statistical Process Control (SPC) or Pre-Control
– Post-process evaluation (sample based inspection AQL).
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February 26, 2014 – v 4.0
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“Mistake Proofing” Course Agenda
7. Process Control
Plan & Exercise
(≈ 60 min)
1. Introduction to
Mistake-Proofing
(≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
2. Process Mapping &
Exercise (≈ 35 min)
3. The Building
Block & Exercise
(≈ 35 min)
5. Risk Analysis &
Exercise (≈ 45 min)
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4. Process FMEA &
Exercise
(≈ 100 min)
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Process FMEA - Example for Severity Ranking
Rank
Severity of the Effect of a Failure Mode
1
Minor: Unreasonable to expect that the minor nature of this failure would cause any real
effect on the product and/or service. Customer will probably not even notice the failure.
2-3
Low: Low severity ranking due to nature of failure causing only a slight customer
annoyance. Customer probably will notice a slight deterioration of the product and/or
service, a slight in convenience in the next process, or minor rework action.
4-6
Moderate: Moderate ranking because failure causes some dissatisfaction. Customer is
made uncomfortable or is annoyed by the failure. May cause the use of unscheduled
repairs and/or damage of equipment.
7-8
High: High degree of customer dissatisfaction due to the nature of the failure such as an
inoperable product or inoperative convenience. Does not involve safety issues or
government regulations. May cause disruptions to subsequent processes and/or
services.
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high:
Very
high severity
is when
failure
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affects safety and involves non-
compliance with government regulations.
Please make sure that the Ranking Scheme reflects your organization’s needs. Otherwise, revise the
Ranking Scheme accordingly.
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Process FMEA - Example for Detection Ranking
Rank
Probability of Failure Mode or Possible Cause Detection
Detection
1
Current control(s) almost certain to detect the failure mode.
Reliable detection controls are known with similar processes.
Almost certain
2
Very high likelihood current control(s) will detect failure mode.
Very high
3
High likelihood current control(s) will detect failure mode.
4
Moderately high likelihood current control(s) will detect failure
mode.
Moderately high
5
Moderate likelihood current control(s) will detect failure mode.
Moderate
6
Low likelihood current control(s) will detect failure mode.
7
Very low likelihood current control(s) will detect failure mode.
Very low
8
Remote likelihood current control(s) will detect failure mode.
Remote
9
Very remote likelihood current control(s) will detect failure mode.
10
No known control(s) available to detect failure mode .
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High
Low
Very remote
Almost impossible
Please make sure that the Ranking Scheme reflects your organization’s needs. Otherwise, revise the
Ranking Scheme accordingly.
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Process FMEA - Risk Priority Number
Risk Priority Number (RPN):
RPN = ( Sev) • (Occ ) • ( Det ) ≤ 1 000
For higher RPN’s the team must undertake efforts to reduce this
calculated risk through corrective action(s). In general practice,
regardless of the resultant RPN, special attention should be given
when severity is high.
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Process FMEA - Risk Assessment
Extreme cases where corrective & preventive actions must be
taken include the following process ratings.
Assessment Rating
S
O
Causes of Failure
Actions
D
1
Ideal situation (goal)
1
1
10
Assured mastery
1
1
1
Failure does not reach user
10
1
10
Failure reaches user
10
1
1
Frequent fails, detectable, costly
1
10
10 download
Frequent
fails, reach user
10 Full document
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1
Frequent fails with major impact
10
10
10
Trouble !
10
10
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February 26, 2014 – v 4.0
No action (N/A)
N/A
N/A
Yes
Yes
Yes
Yes
Yes, Yes, Yes
OPERATIONAL EXCELLENCE
CONSULTING
“Mistake Proofing” Course Agenda
7. Process Control
Plan & Exercise
(≈ 60 min)
1. Introduction to
Mistake-Proofing
(≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
2. Process Mapping &
Exercise (≈ 35 min)
3. The Building
Block & Exercise
(≈ 35 min)
5. Risk Analysis &
Exercise (≈ 45 min)
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4. Process FMEA &
Exercise
(≈ 100 min)
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Human Errors - Dealing with Human Errors
Human Errors are inevitable !!!
Errors can´t be avoided. People will always make mistakes.
Human Errors can be eliminated !!!
Any kind of mistake people make can be reduced or even eliminated.
People make fewer mistakes if they are supported by a production
system based on the principle that human errors can be prevented.
An organizations must establish a mistake-proofing
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promotes
the
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unacceptable to allow for even a small number of
product or service defects caused by human
errors.
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Quick Exercise
Identify 3 Human Errors
Please write down 3 Human Errors that have happened in your
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plant or organization over the last couple of weeks.
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Human Errors - The 16 Human Error Modes
1. Omission
2. Excessive / insufficient repetition
3. Wrong order
4. Early / late execution
5. Execution of restricted work
6. Incorrect selection
7. Incorrect counting
8. Misrecognition
9. Failing to sense danger
10. Incorrect holding
11. Incorrect positioning
12. Incorrect orientation
13. Incorrect motion
14. Improper holding
15. Inaccurate motion
16. Insufficient avoidance
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The Human Work Model & The 16 Human Error Modes
1. Failures in “Understanding the Work Progress”
1. Omission
→ What part of the process is prone to be omitted?
2. Excessive / Insufficient Repetition
→ What part of the process is prone to be excessively repeated?
3. Wrong Order or Sequence
→ In what wrong sequence can the process be executed?
4. Early / Late Execution
→ What execution can be early or late?
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5. Execution of Restricted Work
→ What tasks could be executed by unauthorized personnel?
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The Human Work Model & The 16 Human Error Modes
3. Failures in “Recognizing the State of the Work Object”
8. Misrecognition (or Misunderstanding or Misreading)
→ What misunderstanding or misreading is prone to occur?
→ What information, risk or failure/error is prone to be overlooked?
→ What miscommunication is prone to occur?
→ What incorrect decision is prone to occur?
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The Human Work Model & The 16 Human Error Modes
5. Failure in “Recognizing the Danger in the Motion”
9. Failure to Sense Danger
→ What information, risk or failure/error is prone to be overlooked?
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The Human Work Model & Error Modes
3. Recognition of
Work Object’s State
Start
1. Work Progress
Understanding
Error Modes (1) - (5)
Error Modes (8)
4. Recognition of the
Motion to be done
on the Work Object
5. Recognition of the
Danger in the Motion
Error Modes (9)
Error Modes (10) - (13)
2. Work Object
Selection
Error Modes (6) - (7)
6. Motion Execution
Error Modes (14) - (16)
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End
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Human Work Model & Error Modes - Example
A worker reads a work-order sheet, selects an appropriate part, and assembles it
onto a corresponding sub-assembly product.
Decomposition in Work Segments:
i.
reading the work-order sheet
ii.
getting a part to be assembled from parts boxes
iii.
assembling the part onto the sub-assembly product
Human Error Modes:
i.
Reading the work-order sheet
1. Forgetting to read the sheet
(mode 1: omission)
2. Reading the wrong sheet
(mode 6: incorrect selection)
3. Misreading the sheet
(mode 8: misrecognition)
ii. Getting
a part
to be
from
parts
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1. Forgetting to get the part
(mode 1: omission)
2. Selecting the wrong part
(mode 6: incorrect selection)
3. Dropping the part
(mode 14: improper holding)
February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
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Six Mistake Proofing Principles
1. Elimination seeks to eliminate an error-prone process step by redesigning the product
or process so that the task or part is no longer necessary.
Example: An example of elimination is the use of ambient-light sensors to turn outside
lighting on and off.
2. Prevention modifies the product or process so that it is impossible to make a mistake
or that a mistake becomes a defect.
Example: An example would be the implementation of an automatic dispenser to insure
the correct amount of adhesive is applied during an assembly process or the coin
dispenser in food stores preventing that customers are getting short changed.
3. Replacement substitutes a more reliable process to improve repeatability. This
includes use of robotics or automation that prevents a manual assembly error.
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is a partial
Fullwould
documentbe
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Example:
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not
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function when there is not enough
light to take a picture. Also some clothes dryers shut down when they detect an
overheating situation.
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February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
CONSULTING
Five Key Mistake-Proofing Methods
Variation Control
Use of special jigs, fixtures, or assembly tools that reduce the variation of how parts
are manufactured or assembled
Workplace Organization
Error prevention by proper organization of the workplace or work station; e.g.
implementation of a 5S Visual Workplace Program
Identification
Errors are prevented by use of clearly written, visual and easily available materials,
work instructions and tools
Process Checks
Performance of specific in-process checks to prevent errors
Poka - Yoke Devices
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Ensures mistake and errors cannot become defects
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by automatically detecting error
conditions and immediately rejecting the part or shutting down the process. PokaYoke devices work best when a specific step must be taken to re-start the process
once a mistake or error has been detected.
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February 26, 2014 – v 4.0
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CONSULTING
Human Errors - Poka-Yoke Mistake Proofing
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Why are most manholes round ?
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February 26, 2014 – v 4.0
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CONSULTING
Characteristics of a Good Poka-Yoke Device
Good Poka-Yoke devices, regardless of their implementation, share many
common characteristics:
they are simple and cheap. If they are too complicated or expensive,
their use will not be cost-effective.
they are part of the process, implementing what Shingo calls "100%"
inspection.
they are placed close to where the mistakes occur, providing quick
feedback to the workers so that the mistakes can be corrected.
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February 26, 2014 – v 4.0
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Seven Best Poka-Yoke Devices – Guide Pins
1. Guide Pins
Guide pins of different sizes and/or shapes and placed in the proper locations ensure
that parts are being assembled correctly by providing the operator feedback when a
mistake has been made. Guide pins can also be used in jigs to ensure proper
positioning of the part.
Applications
•
Proper alignment of a work piece
•
Proper orientation of a work piece
Features
•
Easy to develop & implement
•
May be the result of DFA and DFM activities
(Product Quality Planning)
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Human Error Prevention
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•
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wrong order, incorrect selection, incorrect positioning, incorrect orientation, …
February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
CONSULTING
Seven Best Poka-Yoke Devices – Error Detection/Alarms
Problem Statement: How to ensure that everything makes it in the box?
Solution: Use of a scale connected with a visual & audio alarms when the
weight of a package falls outside pre-defined specification limits.
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Cons: Variation in material may result in false fails and pass packages.
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February 26, 2014 – v 4.0
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CONSULTING
Seven Best Poka-Yoke Devices – Sensors
4.1 Proximity Sensors
Proximity sensors emit a high-frequency magnetic field and detect an upset in the field
when an object enters it. They can be used to detect the presence or absence of an
object.
Applications
•
Sensing of tank or bin level
•
Confirmation of part or object passes by
•
Detection presence or absence of object
•
Positioning of work piece
Features
•
Non-contact - Work in harsh environments - Small sensors are available for
installation in tight areas - Fast response speed
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Human Error Prevention
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•
83
Omission, excessive/insufficient repetition, incorrect selection, incorrect counting,
incorrect positioning, incorrect orientation, …
February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
CONSULTING
Seven Best Poka-Yoke Devices – Vision Systems
5. Vision Systems
Vision systems use cameras to look at a surface and then compare the surface viewed to a
“standard” or reference surface stored in the computer. They can be used to detect the
presence or absence of an object, the presence of defects, or to make distance
measurements.
Applications
•
Missing or incorrect parts in an automated assembly line
•
Poor quality surfaces or components
•
Correct orientation of parts or labels
•
Ensure correct relative position
•
Color detection
Features
•
Checking for Label Presence,
Color, Orientation, & Alignment.
Non-contact - Need to have sufficient light - Flexible (can be reprogrammed for a variety
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of applications) - Compact systems are now available.
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Human Error Prevention
•
85
Omission, incorrect selection, incorrect positioning, incorrect orientation, misrecognition,
…
February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
CONSULTING
Seven Best Poka-Yoke Devices – Checklists
7. Checklists
A checklist is a type of informational job aid used to reduce failure by compensating for
potential limits of human memory and attention. It helps to ensure consistency and
completeness in carrying out a task.
Applications
•
Shift Start-up
•
Product Changeover
•
Equipment Set-up
Features
•
Easy to develop - Easy to use - Easy for people to understand
Human Error Prevention
•
omission, early/late execution, wrong order, misrecognition, …
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February 26, 2014 – v 4.0
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CONSULTING
Human Errors → Mistake-Proofing Examples
Never forget your cell phone again.
«Pick to Light»: on an assembly line, if the above light
is green means that you must take the piece. If the
light above the rack is red means that you must not
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February 26, 2014 – v 4.0
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Human Errors → Mistake-Proofing Examples
It only fits one way by using guide pins and
asymmetric product design. Good Product
Quality Planning. → Guide “Pin”
Human Error prevention through a visual
workplace.
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91
February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
CONSULTING
Human Errors → Mistake-Proofing Examples
Getting the torque on bolts right is very tricky
business for many companies. Huck fasteners
mistake-proof this problem using a hybrid: half
“pop-rivet,” half bolt.
The tension on the bolt is created in a linear fashion
and the “nut” is clamped in place and the excess
bolt length is cut off.
Human Error detection through
automated defect detection devices
such as sensors, limit switches, scales,
….
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February 26, 2014 – v 4.0
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Human Errors → Mistake-Proofing Examples
Preventing missing weld nuts, with a
sensor linked to a visual & audio alarm.
Process will stop automatically and a
corrective action is required.
Consumer friendly Mistake-Proofing product
design improves usability and Customer
Satisfaction.
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… and many more.
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February 26, 2014 – v 4.0
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“Mistake Proofing” Course Agenda
7. Process Control
Plan & Exercise
(≈ 60 min)
1. Introduction to
Mistake-Proofing
(≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
2. Process Mapping &
Exercise (≈ 35 min)
3. The Building
Block & Exercise
(≈ 35 min)
5. Risk Analysis &
Exercise (≈ 45 min)
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4. Process FMEA &
Exercise
(≈ 100 min)
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February 26, 2014 – v 4.0
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CONSULTING
Process Control Plan - Template
Operational Excellence
Process Control Plan
Supplier:
Product:
Key Contact:
Process:
Date (Orig):
E-Mail / Phone:
Date (Rev):
Characteristic
Process Step
Product
Characteristic
Process
Characteristic
Specification
(LSL, USL &Target)
Control Limits
(LCL & UCL)
Measurement
System
Sample Size
Sample Frequency Control Method
Reaction Plan
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February 26, 2014 – v 4.0
OPERATIONAL EXCELLENCE
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Process Control Plan - Template
Sample Size: Sample size specifies how many parts are evaluated at any
given time. The sample size will be “100 %” and the frequency
“continuous” in case of 100% inspection.
Sample Frequency: Sample frequency specifies the how often a sample
will be taken, e.g. once per shift or every hour.
Control Method: Brief description of how the information/data will be
collected, analysed/controlled and reported. More detailed information
may be included in a named work instruction.
Reaction Plan: Necessary corrective actions to avoid producing nonconforming products or operating out-of-control. Corrective actions should
normally be in the responsibility of the person closest to the process, e.g.
theis machine
operator.
This
is tocansecure,
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will take place and the risk of non-conforming products will be minimized.
More detailed information may be included in a named work instruction.
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February 26, 2014 – v 4.0
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Some Benefits of Out-of-Control-Action-Plans
The OCAP is a systematic and ideal problem-solving tool for
process problems because it reacts to out-of-control situations in
real time.
OCAPs standardize the best problem-solving approaches from the
most skilled and successful problem solvers (experts/operators).
The OCAP also allows (and requires) off-line analysis of the
terminators to continually improve OCAP efficiency.
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February 26, 2014 – v 4.0
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Workshop Exercise: Coffee Brewing Process
Instructions to Exercise 6:
Develop a Process Control Plan for the Coffee Making
Process.
Create a Process Control Plan Template on a Flip
Chart
Develop a Process Control Plan for all 3 process
steps analyzed in the Process FMEA
Resources for Exercise 6:
Flip Charts
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Post-It Notes
45 Minutes
105
February 26, 2014 – v 4.0
Markers
OPERATIONAL EXCELLENCE
CONSULTING
The End …
“Perfection is not attainable, but if we chase perfection we can catch
excellence.”
- Vince Lombardi
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