OpEx Mistake-Proofing Training Module

OPERATIONAL EXCELLENCE
C O N S U L T I N G
1 February 26, 2014 – v 4.0
Operational Excellence - Mistake-Proofing
Workshop Instructor: Frank Adler, Ph.D.
Operational Excellence Consulting

C O N S U L T I N G
4 February 26, 2014 – v 4.0
Getting 99.9% “right” may not be “good enough”
Getting it right 99.9% of the time means …
268,500 defective tires shipped per year.
22,000 checks deducted from the wrong account
every hour.
19,000 babies dropped at birth per year.
12 babies given to wrong parents each day.
2 unsafe landings at O’Hare airport per day.This document is a partial preview. Full document download can be found on Flevy:
http://flevy.com/browse/document/opex-mistake-proofing-training-module-600

C O N S U L T I N G
7 February 26, 2014 – v 4.0
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)
• humidity, temperature, ...
Mistake-Proofing - Characterize Process Inputs
This document is a partial preview. Full document download can be found on Flevy:

C O N S U L T I N G
10 February 26, 2014 – v 4.0
The Process Flowchart
Mistake-Proofing a process should begin with a flow chart and a high-level risk
assessment (based on available data) of each process step.
A Process Flowchart is a graphical process description of the work flow or
activities using standard symbols for each of the activities.
Different types of activities are described with standard symbols. The problem
areas in the process are often relatively easy to discover when assessing the
flowchart.
An ellipse shows the start and the end point of the process.
A box describes an activity or process step.
A diamond shows a decision making step.
An arrow shows the direction from one activity to another.

C O N S U L T I N G
13 February 26, 2014 – v 4.0
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 sub-
processes 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
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
The Process Flow Chart

C O N S U L T I N G
16 February 26, 2014 – v 4.0
“Mistake Proofing” Course Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 35 min)
3. The Building
Block & Exercise
(≈ 35 min)
4. Process FMEA &
Exercise
(≈ 100 min)
5. Risk Analysis &
6. Human Errors
and Poka-Yoke &
7. Process Control
Plan & Exercise
(≈ 60 min)

C O N S U L T I N G
19 February 26, 2014 – v 4.0
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
20 Minutes

C O N S U L T I N G
22 February 26, 2014 – v 4.0
Failure Mode and Effects Analysis or FMEA is a
systematic methodology used to analyze the reliability of
processes or products, i.e. latent process or product
component failures and their effects on the overall
process/product performance and/or safety.
Failure Mode and Effects Analysis - Definition

C O N S U L T I N G
25 February 26, 2014 – v 4.0
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.
Process Failure Mode and Effect Analysis - Benefits

C O N S U L T I N G
28 February 26, 2014 – v 4.0
Process FMEA - The Template
PROCESS FMEA
Process Name: FMEA Team: Ranking Guidelines: [attached as copy] FMEA Worksheet Document No:
Process Responsible: Severity of failure effect: 1 = Minor/No effect 10 = Very high/Hazardous File Location:
FMEA Responsible: Occurrence of failure cause: 1 = Remote/Unlikely 10 = Very high/Almost inevitable Date (Orig.):
Other Areas Involved/Effected: Detection of failure cause: 1 = Very high/Almost certainly 10 = Very low/Unlikely Date (Rev.):
Risk Priority Number (RPN) = Severity * Occurrence * Detection Page of
Process Description and Potential Potential Severity Potential Occurrence Current Process Detection RPN Recommended Responsible Completion Status Action Results
Process Purpose Failure Mode Effect(s) of Failure of effect Cause(s) of Failure of cause Control(s) of cause (S*O*D) Action(s) Person Date Action Taken [S] [O] [D] RPN
The Process FMEA should be part of your Quality Management System.
Manage it like you manage every other document.
Every Process FMEA should have an owner. It is the owner’s responsibility
to understand and consider if process changes will impact the performance
of other processes
The Process FMEA should be a living document. Make sure it is updated
by the owner as needed and review it periodically as you review any other
QMS document
…This document is a partial preview. Full document download can be found on Flevy:

C O N S U L T I N G
31 February 26, 2014 – v 4.0
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
Filter misaligned – Filter not opened

C O N S U L T I N G
34 February 26, 2014 – v 4.0
Root Cause Analysis (RCA) Tools
Thorough probing to root causes will lead to broad,
fundamental issues, involving management policies, product
design, process capabilities or process control, technology
constraints, standard operating procedures, work instruc-
tions, training, … .
Root Cause Analysis Tool Box:
The 5 Why’s
Why – Why Diagram
Fishbone Diagram
Is – Is Not Matrix
Affinity Diagram
Interrelationship Diagram
Scatter Diagram
Box Plots
Histograms
Process Capability Studies
SPC or Pre-Control Charts
…

C O N S U L T I N G
37 February 26, 2014 – v 4.0
Root Cause Analysis Tools → Why – Why Diagram
Failure Mode:
Customer complaint
due to grinding marks
on the door frame
The door frame
had been “over-
ground”
Wrong Tool was
used
Operator was
untrained
Current grinding
method is not
capable
Cosmetic
requirements
not understood
Current grinding
method is too
complicated
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:
No written
cosmetic
standard exists
No formal
training exists
Training
Process was
not applied
Tools are not
marked
…
…

C O N S U L T I N G
40 February 26, 2014 – v 4.0
How to develop a Fishbone Diagram
Step 1: Define the failure mode to be analyzed
Step 2: Draw a horizontal trunk line (the backbone of the fish) and to
the right end of this write the failure mode (= fish’s head)
Step 3: Draw the main branches and write the selected categories
at the end of each main branch
Step 4: Brainstorm for all possible causes for each of the selected
categories
Step 5: Group the possible causes under each of the categories and
draw a minor branch for each cause
Step 6: Check that the diagram is complete and logical

C O N S U L T I N G
43 February 26, 2014 – v 4.0
1. Introduction to
Mistake-Proofing
(≈ 30 min)
3. The Building
Block & Exercise
(≈ 35 min)
4. Process FMEA &
Exercise
(≈ 100 min)
5. Risk Analysis &
6. Human Errors
and Poka-Yoke &
7. Process Control
Plan & Exercise
(≈ 60 min)

C O N S U L T I N G
46 February 26, 2014 – v 4.0
Process FMEA - Example for Occurrence Ranking
Rank Probability of Failure Mode Occurrence
Possible Failure Rates
PPM*) Failure rate ppk
1 Remote: Failure is unlikely. No failures ever
associated with almost identical processes.
≤ 1 1 out of
1 000 000
≥ 1.67
2 Very Low: Only isolated failures associated
with almost identical processes.
≤ 7 1 out of
150 000
≥ 1.50
3 Low: Isolated failures associated with similar
processes.
≤ 64 1 out of 15 000 ≥ 1.33
4-6 Moderate: Generally associated with
processes similar to previous processes which
have experienced occasional failures, but not in
major proportions.
≤ 500
≤ 2700
≤ 12 500
1 out of 2000
1 out of 400
1 out of 80
≥ 1.17
≥ 1.00
≥ 0.83
7-8 High: Generally associated with processes
similar to previous processes that have often
failed.
≤ 50 000
≤ 125 000
1 out of 20
1 out of 8
≥ 0.67
≥ 0.51
9-10 Very high: Failure is almost inevitable. ≤ 333 000
≥ 333 000
1 out of 3
≥ 1 out of 2
≥ 0.33
< 0.33
Please make sure that the Ranking Scheme reflects your organization’s needs. Otherwise, revise the
Ranking Scheme accordingly.

C O N S U L T I N G
49 February 26, 2014 – v 4.0
Risk Priority Number (RPN):
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.
0001)()()( ≤••= DetOccSevRPN
Process FMEA - Risk Priority Number

C O N S U L T I N G
52 February 26, 2014 – v 4.0
Actions that will influence the Process FMEA risk evaluation
are:
Corrective & Preventive Actions OS D
Redesign the process YM Y
Redesign the product MM M
Improve current control NN Y
Change material parts MN M
Change the field environment NM N
Improve reliability program YN Y
Improve employee training MN Y
Implement FMEA program YY Y
Implement SPC program YN Y
Improve quality plan YN Y
Y = Yes, M = Maybe, N = No
Process FMEA - Action Planning

C O N S U L T I N G
55 February 26, 2014 – v 4.0
Human Errors are inevitable !!!
Errors can´t be avoided. People will always make mistakes.
Human Errors - Dealing with Human Errors
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
mindset that promotes the belief that it is
unacceptable to allow for even a small number of
product or service defects caused by human
errors.

C O N S U L T I N G
58 February 26, 2014 – v 4.0
1. Work Progress
Understanding
Start
End
2. Work Object
Selection
3. Recognition of
Work Object’s State
4. Recognition of the
Motion to be done
on the Work Object
6. Motion Execution
Danger in the Motion
Human Errors - The Human Work Model

C O N S U L T I N G
61 February 26, 2014 – v 4.0
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?
5. Execution of Restricted Work
→ What tasks could be executed by unauthorized personnel?
The Human Work Model & The 16 Human Error Modes

C O N S U L T I N G
64 February 26, 2014 – v 4.0
4. Failure in “Recognizing Correct Motion to be Done on Work Object”
10. Incorrect Holding
→ What object of the process are prone to mishandling?
11. Incorrect Orientation
→ What orientation error is prone to occur?
12. Incorrect Positioning
→ What positioning setting error is prone to occur?
13. Incorrect Motion
→ What motion or movement error is prone to occur?
The Human Work Model & The 16 Human Error Modes

C O N S U L T I N G
67 February 26, 2014 – v 4.0
1. Work Progress
Understanding
Error Modes (1) - (5)
Start
End
2. Work Object
Selection
3. Recognition of
Work Object’s State
Error Modes (8)
Motion to be done
on the Work Object
6. Motion Execution
Danger in the Motion
Error Modes (9)
The Human Work Model & Error Modes

C O N S U L T I N G
70 February 26, 2014 – v 4.0
iii. Assembling the part onto the sub-assembly product
1. Forgetting to assemble the part
(mode 1: omission)
2. Assembling onto the wrong sub-assembly product
(mode 6: incorrect selection)
3. Holding a damageable part of the sub-assembly product
(mode 10: incorrect holding)
4. Assembling the part in the wrong position
(mode 11: incorrect positioning)
5. Assembling the part the wrong way around
(mode 12: incorrect orientation)
6. Inaccurately assembling the part
(mode 15: inaccurate motion)
Human Errors - Human Work Model Example

C O N S U L T I N G
73 February 26, 2014 – v 4.0
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
Ensures mistake and errors cannot become defects by automatically detecting error
conditions and immediately rejecting the part or shutting down the process. Poka-
Yoke devices work best when a specific step must be taken to re-start the process
once a mistake or error has been detected.
Five Key Mistake-Proofing Methods

C O N S U L T I N G
76 February 26, 2014 – v 4.0
Requirements:
• The outcome of the process or routine must be known in advance so as to have a
standard for comparison
• There must be an ability to create a break between cause and effect in the process
so as to provide an opportunity to insert a Poka-Yoke
Poka-Yoke devices work best in environments or processes:
• requiring substantial operator skill
• where training or turnover cost is high
• with frequent interruptions and distractions
• with a consistent set of mixed products
• with similarly positioned or configured parts, controls or tools
• requiring replacement or orientation of parts in order to prevent mispositioning
Where to use Poka-Yoke Devices?

C O N S U L T I N G
79 February 26, 2014 – v 4.0
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)
Human Error Prevention
• wrong order, incorrect selection, incorrect positioning, incorrect orientation, …
Seven Best Poka-Yoke Devices – Guide Pins

C O N S U L T I N G
82 February 26, 2014 – v 4.0
3. Limit Switches
Limit switches are electro-mechanical devices that are activated or deactivated when an
object comes in contact with them. They are used to detect the presence or absence of
an object.
Applications
• Proper positioning of safety devices
• Detection presence or absence of an object
• Positioning of a work piece
Features
• Requires physical contact
• Omission, excessive/insufficient repetition, incorrect selection, incorrect counting,
incorrect positioning, incorrect orientation
Seven Best Poka-Yoke Devices – Limit Switches

C O N S U L T I N G
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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
• Non-contact - Need to have sufficient light - Flexible (can be reprogrammed for a variety
of applications) - Compact systems are now available.
• Omission, incorrect selection, incorrect positioning, incorrect orientation, misrecognition,
…
Seven Best Poka-Yoke Devices – Vision Systems
Checking for Label Presence,
Color, Orientation, & Alignment.

C O N S U L T I N G
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Human Errors → Mistake-Proofing Examples
SIM cards only fit one way. The
right way.
Expose your team to (simple) everyday Mistake-Proofing devices
and examples and make them think about how they could use
these concepts in their own process and work area.

C O N S U L T I N G
91 February 26, 2014 – v 4.0
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.

C O N S U L T I N G
94 February 26, 2014 – v 4.0
Well Designed garage door openers have two
safety features: (1) a contact safety reverse
feature, which opens the door if it hits a person or
object, and (2) an infrared beam across the
doorway that causes the door to reverse
automatically if a person or pet who passes
through the beam.
A company called Metric Blue offers metric bolts
tinted blue. Why blue? So that when you have
mixed metric and inch-series parts and fasteners it
is easier to determine which standard you are
working with. Company literature says, “by
differentiating the metric fasteners (and tools)
through our "blue" coating, we've eliminated the
risk of failure or accidents due to mismatched
components.”

C O N S U L T I N G
97 February 26, 2014 – v 4.0
1. Introduction to
Mistake-Proofing
(≈ 30 min)
3. The Building
Block & Exercise
(≈ 35 min)
4. Process FMEA &
Exercise
(≈ 100 min)
5. Risk Analysis &
6. Human Errors
and Poka-Yoke &
7. Process Control
Plan & Exercise
(≈ 60 min)

C O N S U L T I N G
100 February 26, 2014 – v 4.0
Process: Name of the process to be controlled
Process Step: The process steps of the process to be controlled
Characteristic (Product/Process): Name of the characteristic of a process
step or a product, which will actually be controlled.
Specification: Actual specification, which has been set for the characteristic
to be controlled. This may be verified e.g. in standards, drawings,
requirements or product requirement documents.
Control Limits: Control limits are specified for characteristics that are
quantifiable and selected for trend analysis (x-bar/R, x/mR, p charts). When
the process exceeds these limits, corrective actions are required.
Measurement System: Method used to evaluate or measure the
characteristic. This may include e.g. gages, tools, jigs and test equipment or
work methods. An analysis of the repeatability and the reproducibility of the
measurement system must first be carried out (e.g. Gage R&R Study).
Process Control Plan - Template

C O N S U L T I N G
103 February 26, 2014 – v 4.0
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.
Some Benefits of Out-of-Control-Action-Plans

C O N S U L T I N G
106 February 26, 2014 – v 4.0
1. Introduction to
Mistake-Proofing
(≈ 30 min)
3. The Building
Block & Exercise
(≈ 35 min)
4. Process FMEA &
Exercise
(≈ 100 min)
5. Risk Analysis &
6. Human Errors
and Poka-Yoke &
7. Process Control
Plan & Exercise
(≈ 60 min)

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