The document outlines a comprehensive approach to process risk analysis and mistake-proofing, emphasizing the importance of preventing defects in manufacturing or business processes. It describes a structured 10-step process that includes elements like process mapping, root cause analysis, and the use of poka-yoke principles to minimize errors. Additionally, it highlights the necessity of teamwork, involving individuals from various affected areas to ensure successful implementation and ownership of the processes.

1. 1 April 9, 2016 – v 5.0
Lean Six Sigma Mistake-Proofing Process
by Operational Excellence Consulting LLC

2. 2 April 9, 2016 – v 5.0
Process Risk Analysis & Mistake-Proofing - Overview
 Things can go wrong. People will make mistakes.
 However, letting mistakes become defects that cause Customer dissatisfaction or
waste and rework is avoidable.
 Process Risk Analysis & Mistake-Proofing, is the systematic process of identifying
and preventing defects from occurring in an organization’s manufacturing or
business process.
 It’s essence is to design both product and processes so that mistakes are
impossible to make or, at the least, they are easy and early to detect and correct.

3. 3 April 9, 2016 – v 5.0
Process Risk Analysis & Mistake-Proofing - Overview
Our Process Risk Analysis & Mistake-Proofing Solution follows a proven 10 Step
Process, combining Process Failure Mode and Effects Analysis, Root Cause Analysis,
Poka-Yoke Principles and Process Control Plans with an effective team driven approach.
Perform Risk Analysis
Develop Mistake-Proofing Solutions
Implement Mistake-Proofing Solutions
Establish Process Control Plan
List Current Process ControlsDevelop a Process Variables Map
Develop a Cause & Effects Matrix
Determine Potential Root Causes
Determine Potential Failure Modes
Determine Potential Effects

4. 4 April 9, 2016 – v 5.0
“Process Risk Analysis & Mistake Proofing” Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 90 min)
3. Cause & Effect
Matrix & Exercise
(≈ 60 min)
4. Process FMEA &
Exercise
(≈ 60 min)
5. Risk Analysis &
Exercise (≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
7. Process Control
Plan & Exercise
(≈ 60 min)

5. 5 April 9, 2016 – v 5.0
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.

6. 6 April 9, 2016 – v 5.0
 The responsibility for performing a Process Risk Analysis &
Mistake-Proofing of 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 normally consists of four to six individuals with multidiscipline and
multifunctional backgrounds. In addition, all members should have
ownership of the problem/process.
Process Risk Analysis & Mistake-Proofing - A Team Effort
 Mistake-Proofing should be a catalyst
to stimulate the interchange of ideas
between the functions effected and
thus promote a team approach.

7. 7 April 9, 2016 – v 5.0
 Y's are the attributes or characteristics of the results (Critical-to-Quality or
CTQ) of completing the process step
 X's are the are the attributes or characteristics of the inputs that impact the
ability to achieve the outputs and their Y's of that process or process step
 The output or Y of a process or process step is a function of the process
inputs or Xs
 To eliminate or reduce variation in the output or Y of a process or process
step one needs to eliminate or reduce the variation in the process inputs or Xs
 Note: An output or Y from one process step can be an input or X from a later
process step
Process or
Process Step
Input's & X’s
Output's & Y’s
Foundation of Process Thinking and Improvement

8. 8 April 9, 2016 – v 5.0
Process inputs can be categorized using the 6Ms
 Manpower
 Machine
 Materials
 Methods
 Measurement
 Mother Nature
Process Inputs & The 6Ms

9. 9 April 9, 2016 – v 5.0
Process 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, ...
Characterize Process Inputs

10. 10 April 9, 2016 – v 5.0
The Human Being – Often the Biggest “Noise” Input …
The order really
has to go out
today !!!
Lost a lot of
money in Poker
last night.
Hopefully
Molly is doing
well in her test
today.
It is Friday !!!
Wonder what
I should wear
tonight.
… in your Process.

11. 11 April 9, 2016 – v 5.0
“Process Risk Analysis & Mistake Proofing” Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 90 min)
3. Cause & Effect
Matrix & Exercise
(≈ 60 min)
4. Process FMEA &
Exercise
(≈ 60 min)
5. Risk Analysis &
Exercise (≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
7. Process Control
Plan & Exercise
(≈ 60 min)

12. 12 April 9, 2016 – v 5.0
Process Variables Mapping → Basics
• Process Variables Maps should include:
– All value-added and non-value-added process steps
– Major activities and/or tasks in each process step
– Process Inputs and Xs for each process step
– Process Outputs and Ys for each process step
– Data Collection Points if applicable
• The Process Variables Map documents the process as it is actually
performed, not necessarily as it is supposed to be performed
• Key deliverable from the Process Variables Map is a complete list of
all the Process Inputs and Xs within the project scope, from which
all future work will be performed

13. 13 April 9, 2016 – v 5.0
Process Variables Mapping → Preparation
• Team Effort
– Process Owners / Leaders, Workers, Supervisors, Technicians /
Engineers / Developers, Upstream and Downstream Representatives
(Suppliers and Customers)
• Inputs to Mapping
– Brainstorming and operator knowledge / experience
– Operator manuals / standard work instructions
– Customer specifications
– 6Ms - Machine (Equipment), Methods (Procedures), Measurement,
Materials (Information), Manpower (Personnel), Mother Nature
(Environment)
• Excel Template
– Process Variables Map – Template.xls

14. 14 April 9, 2016 – v 5.0
Process Variables Mapping → Step-by-Step Approach
1. Identify the process or sub-process, with its external inputs and
customer outputs (High Level Process Map)
2. Identify all process steps in the process or sub-process graphically
3. List outputs and their Ys for each process step (before listing the
inputs)
4. List all inputs and their Xs for each process step and classify them
as controlled or uncontrolled
5. Optional: Add process specifications for the identified Xs and Ys

15. 15 April 9, 2016 – v 5.0
Process Variables Map → Step 1: High Level Process Map
High Level Process Map
 Define the process or sub-process in simple terms (one box!)
 List the 5 – 10 key process steps or activities performed as part of this process
 Identify the Outputs, their Ys (measurable attributes of the outputs), and the
Customer Requirements
 Briefly list the general types of external inputs → Use the 6 Ms as input categories
BIG Project Ys
Xs or INPUTS Ys or OUTPUTS
INPUTS Coffee Machine Quantity of Coffee (in ml)
Think 6 M's Coffee Maker (Operator) Taste of Coffee (Scale 1 - 10)
Man Coffee Powder
Machine Water
Material Coffee Filter
Method Power Outlet
Measure Coffee Cup
Mother Earth
1. Prepare Coffee Machine
2. Add Coffee Filter & Coffee
Powder
3. Add Water
4. Turn on Coffee Machine
5. Pour Coffee into Coffee Cup
Coffee Making Process

16. 16 April 9, 2016 – v 5.0
Process Variables Map → Step 2: Identify Process Steps
Identify Process Steps
 Include all value-added and non value-added process steps and
key activities or tasks
 Hint: Process Step Names are verbs or gerunds
Answering Phone
1. Greeting customer
2. Getting customer
Information
3. Getting order
information
4. Time needed
Completing
Order Form
1. Completing and
entering order
information into
production system
Making & Packaging
Pizza
1. Preparing &
making pizza
2. Packaging
pizza
Delivering Pizza
1. Transporting
pizza to customer’s
location
Pizza Delivery Process

17. 17 April 9, 2016 – v 5.0
Process Variables Map → Step 3: List the Outputs & Ys
List the outputs and Ys for each process step. Include both process
and product outputs.
Ys
1. Time to answer
2. Accuracy of
customer info
3. Order / quantity
4. Delivery time
1. Accuracy of order
information
2. Accuracy of pricing
info
3. Speed to complete
form
Answering Phone
1. Greeting customer
2. Getting customer
information
3. Getting order
information
Time needed
Completing Order
Form
1. Completing and
entering order
information into
production system
Ys
1. Temperature of
the pizza
2. Time to complete
1. Time to deliver
2. Correct quantity
3. Correct order
4. Pizza Temperature
5. Pizza Condition
Making &
Packaging Pizza
1. Preparing &
making pizza
2. Packaging pizza
Delivering Pizza
1. Transport pizza
to customer’s
location

18. 18 April 9, 2016 – v 5.0
Process Variables Map → Step 4: List and Classify Xs
 List all Xs for each Inputs (usually specific attributes of the input
which could be a source of variation)
 Classify Xs
– Controlled (C): These are inputs that you adjust or control while
the process is running (Examples: Speed, feed rate, pressure,
temperature, experience level of worker, data system size)
– Uncontrolled (U): Noise variables. These are things you cannot,
or do not currently, control (Examples: Ambient temperature,
humidity, order quantity, training hours of worker)
• Could be due to the expense or difficulty controlling them
This step is where the team should spend most of its time

19. 19 April 9, 2016 – v 5.0
Ys
1. Time to answer
2. Accuracy of
customer info
3. Order / quantity
4. Delivery time
1. Accuracy of order
information
2. Accuracy of pricing
info
3. Speed to complete
form
Process Variables Map → Step 4: List and Classify Xs
Information from customer C
Greeting script C
Answering procedure C
Telephone system U
Number of calls U
Order information clarity C
Order form layout C
Number of phones U
Computer program U
Pricing options C
Xs Type
Answering Phone
1. Greeting customer
2. Getting customer
information
3. Getting order
information
Time needed
Completing Order
Form
1. Completing and
entering order
information into
production system
…

20. 20 April 9, 2016 – v 5.0
Process Variables Map → Step 5: Add Specifications
 Document any known operating specification or requirements for
each X and Y if applicable

21. 21 April 9, 2016 – v 5.0
Process Variables Mapping → Next Steps
 Identify “Easy Opportunities” and “Quick Fixes”
 Review current process controls
 Assess effectiveness of current process controls
 Generate action plan with clear responsibilities and time lines
 Identify opportunities to improve or develop process controls
 Identify critical process inputs or Xs for the Process FMEA
 …

22. 22 April 9, 2016 – v 5.0
The Coffee Making Process

23. 23 April 9, 2016 – v 5.0
Workshop Exercise: Coffee Brewing Process
Instructions to Exercise 1:
Develop a Process Variables Map for the Coffee Making Process.
1. Review the High Level Process Map
2. Review (& modify) the identified process steps in the process
3. List outputs and their Ys for each process step
4. List all inputs and their Xs for each process step and classify
them as controlled or uncontrolled
5. Optional: Add process specifications for the identified Xs and Ys
Resources for Exercise 2:
 Flip Charts
 Post-It Notes
 Markers
30 Minutes

24. 24 April 9, 2016 – v 5.0
“Process Risk Analysis & Mistake Proofing” Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 90 min)
3. Cause & Effect
Matrix & Exercise
(≈ 60 min)
4. Process FMEA &
Exercise
(≈ 60 min)
5. Risk Analysis &
Exercise (≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
7. Process Control
Plan & Exercise
(≈ 60 min)

25. 25 April 9, 2016 – v 5.0
Cause & Effect Matrix → Basics
 This is a simple matrix to quantify and emphasize the importance of
customer requirements
 Relates the Xs to the Ys (Customer Requirements) using the
process map as the primary source of information
 Process Ys are weighted as to their importance to the customer
 Process Xs are scored as to their relationship to Process Ys

26. 26 April 9, 2016 – v 5.0
Cause & Effect Matrix → Results
 Pareto of Process Xs to be evaluated further using the Process FMEA
 Funnels the complete list of inputs and Xs generated in the Process
Variables Map
 Identify Ys that would be prioritized for Measurement Systems
Analysis and initial Process Capability Studies (Six Sigma tools)
 Continues the review and assessment of the Process Control Plan

27. 27 April 9, 2016 – v 5.0
Cause & Effect Matrix → Steps- by-Step Approach
1. Identify key customer requirements (Ys) from Process Variables Map
2. Rank order and assign priority factor to each Y (usually using a 1 to
10 scale)
3. Identify all process steps and Xs from the Process Variables Map
4. Evaluate correlation of each X to each Y
• Low score: changes in the X have small effect on the Y
• Moderate score: changes in the X can have some affect the Y
• High score: changes in the X can greatly affect the Y
5. Cross multiply correlation values with priority factors for Ys and sum
for each X

28. 28 April 9, 2016 – v 5.0
Importance to Customer >>
(weighting value)
Process Step X
ProjectY1
ProjectY2
ProjectY3
ProjectY4
Total
1 Process Step 1 X 1 0
2 Process Step 1 X 2 0
3 Process Step 1 X 3 0
4 Process Step 1 X 4 0
5 Process Step 1 X 5 0
6 Process Step 1 X 6 0
7 Process Step 1 X 7 0
8 Process Step 1 X 8 0
Cause & Effect Matrix → Step 1: List the Ys
1. List the
Process Ys
These Ys are
your high level
Ys from your
High Level
Process Map.
Most
processes will
have fewer
than 3 or 4.

29. 29 April 9, 2016 – v 5.0
Importance to Customer >>
(weighting value)
Process Step X
ProjectY1
ProjectY2
ProjectY3
ProjectY4
Total
1 Process Step 1 X 1 0
2 Process Step 1 X 2 0
3 Process Step 1 X 3 0
4 Process Step 1 X 4 0
5 Process Step 1 X 5 0
6 Process Step 1 X 6 0
7 Process Step 1 X 7 0
8 Process Step 1 X 8 0
Cause & Effect Matrix → Step 2: Weight the Ys
2. Weight Ys as to
Customer
importance. The
weighting is
normally from 1 to
10 with 10 being
the most important
or a distribution of
100 points across
the identified Ys.

30. 30 April 9, 2016 – v 5.0
Importance to Customer >>
(weighting value)
Process Step X
ProjectY1
ProjectY2
ProjectY3
ProjectY4
Total
1 Process Step 1 X 1 0
2 Process Step 1 X 2 0
3 Process Step 1 X 3 0
4 Process Step 1 X 4 0
5 Process Step 1 X 5 0
6 Process Step 1 X 6 0
7 Process Step 1 X 7 0
8 Process Step 1 X 8 0
Cause & Effect Matrix → Step 3: List Steps and Xs
3. List
Process Xs by
Process Step
3. Be sure to include
each process and all
process Xs for each
step

31. 31 April 9, 2016 – v 5.0
Importance to Customer >>
(weighting value)
Process Step X
ProjectY1
ProjectY2
ProjectY3
ProjectY4
Total
1 Process Step 1 X 1 0
2 Process Step 1 X 2 0
3 Process Step 1 X 3 0
4 Process Step 1 X 4 0
5 Process Step 1 X 5 0
6 Process Step 1 X 6 0
7 Process Step 1 X 7 0
8 Process Step 1 X 8 0
Cause & Effect Matrix → Step 4: Relate Xs to Ys
4. Relate or correlate
Xs to Ys based upon
team members
experience

32. 32 April 9, 2016 – v 5.0
Relating Xs to Customer Requirements (Ys)
 The team is ready to relate the Ys to the Xs
 Correlational scores: No more than 4 levels
 0, 1, 3 and 9 are typical values
 Assignment of the scoring takes the most time
 Independent scoring can help speed up process by having each team
member first fill out the matrix silently
 The most common scoring values are:
0 = No relationship / impact
1 = The X only remotely affects the Y
3 = The X has a moderate effect on the Y
9 = The X has a direct and strong effect on the Y
 Some practitioners combine the 0 and 1 scores

33. 33 April 9, 2016 – v 5.0
Importance to Customer
(weighting)
10 9 7
1 2 3
Numberof
cracks
Numberof
pinholes
Surface
Defects
Total
Process Step X
1 Slip Prep Raw material vendor 3 0 0
2 Slip Prep Solid returns % 3 0 0
3 Slip Prep Liquid returns % 3 0 0
4 Slip Prep Operator experience 1 1 0
5 Slip Prep Slip rheological properties 9 0 0
6 Slip Prep Slip stirring speed 9 9 0
7 Slip Prep Deflocculant concentration 9 0 0
8 Slip Prep Composition formula 3 0 0
9 Slip Prep Operator 9 9 9
10 Mold Casting Type of plaster 9 0 0
11 Mold Casting Cast parameters 9 0 3
12 Mold Casting # of thickness pieces 9 3 3
13 Mold Casting # of finishing pieces 9 1 3
14 Mold Casting Tool type 9 1 9
15 Mold Casting Temperature 9 9 9
16 Mold Casting Humidity 9 1 1
17 Mold Casting Operator training 3 3 3
18 Mold Casting Work procedure detail 3 1 1
19 Mold Casting Installation 3 1 3
20 Mold Casting Drying time 9 3 1
4. Relate Xs to
Ys
Cause & Effect Matrix → Step 4: Relate Xs to Ys
This is a subjective estimate of how influential the Xs are on the Ys

34. 34 April 9, 2016 – v 5.0
Importance to Customer >>
(weighting value)
Process Step X
ProjectY1
ProjectY2
ProjectY3
ProjectY4
Total
1 Process Step 1 X 1 0
2 Process Step 1 X 2 0
3 Process Step 1 X 3 0
4 Process Step 1 X 4 0
5 Process Step 1 X 5 0
6 Process Step 1 X 6 0
7 Process Step 1 X 7 0
8 Process Step 1 X 8 0
Cause & Effect Matrix → Step 5: Prioritize the Xs
Sum of Weighting values x Correlation scores across all Ys
5. Cross-
multiply, sort &
prioritize

35. 35 April 9, 2016 – v 5.0
10 4 8
Process Step Key Process Input Xs
Paperwork
errors
Visitduration
Unbilled
expenses
Total
Verify patient / payer info Patient forms Amount of needed info 9 9 9 198
Update chart Care giver Time on job 9 9 9 198
Update chart Environment Time during shift 9 3 9 174
Update chart Environment Number of forms to update 9 3 9 174
Verify patient / payer info Reviewer Knowledge of requirements 9 1 9 166
Verify patient / payer info Environment Federal requirements 9 0 9 162
Verify patient / payer info Environment State requirements 9 0 9 162
Verify patient / payer info Environment Hospital requirements 9 0 9 162
Update chart Diagnosis information Quantity of items 9 0 9 162
Update chart Diagnosis information Code clarity 9 0 9 162
Complete billing info Billing clerk Knowledge of requirements 9 0 9 162
Complete billing info Billing clerk Knowledge of codes 9 0 9 162
Complete billing info Chart Code accuracy 9 0 9 162
Complete billing info
Chart Completeness of patient
info
9 0 9 162
Complete billing info Payer Requirement clarity 9 0 9 162
Rating of Importance to Customer >>
Cause & Effect Matrix → Example

36. 36 April 9, 2016 – v 5.0
Too many Inputs & Xs? Narrow the Focus!
 Phase 1
• Place the Ys across the top of the matrix and weight
• Place ONLY the process steps down the side of the matrix
• Score the relationship of the process steps to the Ys
• Prioritize the process steps
 Phase 2
• Start a new C&E Matrix with the Xs from only the top process steps from
Phase 1 above
• Score the relationship of the Xs to the Ys
→ Focuses the efforts and gives the team a feeling that they’re working
on the important process steps first
→ Gives you a running start at the FMEA and preliminary Control Plan
Analysis

37. 37 April 9, 2016 – v 5.0
Cause & Effect Matrix → Next Steps
 Process FMEA
• Transfer the highest ranked Xs to Process FMEA
• Consider what it means if many of your highly ranked Xs are classified
as Uncontrolled
 Capability Review
• Check Capability Summary for those Xs ranked high in the C&E matrix
• If key process capabilities are not known, create a plan to study
measurement systems and collect baseline data
 Process Control Plan Review
• Consider existing process controls for all highly ranked Xs and Ys from
the C&E Matrix
• Document short- and long-term Process Control Plan opportunities
• Identify and implement “Low hanging fruit” and “Quick wins”

38. 38 April 9, 2016 – v 5.0
Cause & Effect Matrix → Initial Control Plan Evaluation
 Key Question: Have you identified any obvious gaps in your existing
process controls that will have to be addressed for this process to be
successful?
 Standard Operating Procedures
• Do they exist?
• Are they up-to-date and comprehended?
• Do “operators” know where to find them?
• Is “operator” certification necessary and done?
• Is there a process audit timetable?
 Controlled Inputs and Xs
• How is monitoring done?
• When are Xs verified?
• Are specifications and optimum target values known?
• Are target values consistent?

39. 39 April 9, 2016 – v 5.0
Workshop Exercise: Coffee Brewing Process
Instructions to Exercise 2:
Develop a Cause & Effect Matrix for the Coffee Making Process.
1. Rank order and assign priority factor to each Y
2. List all process steps and Xs from the Process Variables Map
3. Evaluate correlation of each X to each Y (low – moderate – high)
4. Cross multiply correlation values with priority factors for Ys and
sum for each X
5. Identify and review TOP 10 – 15 Xs and inputs
Resources for Exercise 2:
 Flip Charts
 Post-It Notes
 Markers
30 Minutes

40. 40 April 9, 2016 – v 5.0
“Process Risk Analysis & Mistake Proofing” Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 90 min)
3. Cause & Effect
Matrix & Exercise
(≈ 60 min)
4. Process FMEA &
Exercise
(≈ 60 min)
5. Risk Analysis &
Exercise (≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
7. Process Control
Plan & Exercise
(≈ 60 min)

41. 41 April 9, 2016 – v 5.0
 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.
Failure Mode and Effects Analysis → History

42. 42 April 9, 2016 – v 5.0
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

43. 43 April 9, 2016 – v 5.0
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 manufacturing, service
or transactional process deficiencies.
 Service FMEA analyses services before they reach the customer. A Service
FMEA focuses on failure modes caused by system or process deficiencies.
Failure Mode and Effects Analysis → The Four Types

44. 44 April 9, 2016 – v 5.0
Outputs of a Process FMEA
A Process FMEA can be described as a systematic group of
activities intended to:
 recognize and evaluate the potential failure of a (new) product/
process and its effects,
 develop a ranked list of potential failure modes, thus establishing a
priority system for corrective action and improvement consideration,
 identify actions which could eliminate or reduce the chance of the
potential failure occurring, and
 document the result of the process.
Process Failure Mode and Effects Analysis → Outputs

45. 45 April 9, 2016 – v 5.0
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

46. 46 April 9, 2016 – v 5.0
Important Note before we get started:
 When conducting a Process FMEA, it is assumed that the design is the
best it can be. If this assumption is not made, the FMEA team will
perform the Design and Process FMEA simultaneously and will move in
a circular pattern not accomplishing its task.
 The only way to address the Design FMEA in the Process FMEA of
conducting the Process FMEA is when the root cause of the failure
modes in the process are caused by design specifications.
Process Failure Mode and Effects Analysis

47. 47 April 9, 2016 – v 5.0
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
Process FMEA Body Improvement Plan

48. 48 April 9, 2016 – v 5.0
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
 …

49. 49 April 9, 2016 – v 5.0
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.
Process FMEA → The Template

50. 50 April 9, 2016 – v 5.0
Column: Potential Failure Mode
Potential Failure Mode is defined as the manner in which the process
step could potentially fail to meet the process step requirements and/or
design intent. It is a description of the non-conformance at that specific
operation.
– How could this process step fail to complete its intended function?
– Why could this part be rejected after this process step?
– What does the customer find unacceptable?
– How would the part not conform to specifications after this process step?
Typical failure modes could be, but are not limited to:
– bent, burred, cracked, deformed, short circuited, dirty, handling damage,
improper set-up, tool worn, misprinted, or missing.
Process FMEA → The Template

51. 51 April 9, 2016 – v 5.0
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

52. 52 April 9, 2016 – v 5.0
Column: Potential Effect(s) of a Failure Mode
Potential Effects of Failure are defined as the effects of the failure
mode on the customer(s). It describes the effects of the failure in
terms of what the customer might notice or experience.
– What does the customer experience as a result of the failure mode
described?
– What happens or what is (are) the ramification(s) of this problem or
failure?
Typical potential effects could be, but are not limited to:
– noise, inoperative, poor signal strength, or rough.
If the “customer” is one of the next process steps:
– cannot mount, cannot face, or does not fit.
Process FMEA → The Template

53. 53 April 9, 2016 – v 5.0
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:
– 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.
Process FMEA → The Template

54. 54 April 9, 2016 – v 5.0
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
 …

55. 55 April 9, 2016 – v 5.0
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, … .

56. 56 April 9, 2016 – v 5.0
Potential
Root Cause
Root Cause Analysis Tools → The 5 Why’s
Potential Failure Mode (Object & Defect)?
WHY? → The door frame had been “over-ground”
WHY? → Team member did not use the grinder properly
There could be grinding marks on the door frame
WHY? → Team member was not properly trained

57. 57 April 9, 2016 – v 5.0
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
…
…

58. 58 April 9, 2016 – v 5.0
How to develop a Why–Why Diagram
Procedure:
Step 1: Write the failure mode on a Post-It note and
place it at the far left of a flip chart or white board.
Step 2: Ask “Why?” this failure mode does or could occur. Write all these
possible causes on Post-It notes (one for each) and place them in a column right
to the initial failure mode. Connect the failure mode with the possible causes.
Step 3: Each of the possible causes now becomes a new failure mode. Repeat
Step 2 and ask “Why?”, e.g. “Why does this situation could cause the problem?”,
again. Connect the new failure mode with the associated possible causes.
Step 4: Continue Step 2 and Step 3 with each new failure mode until you reach
answers that are fundamental and actionable, e.g. standard operating
procedure, work instruction, system issues, training needs, … .
1
2 3

59. 59 April 9, 2016 – v 5.0
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
= MEN
METHODS
MATERIALS
MACHINES
+ ENVIRONMENT
Effect or
Outcome
Machines
Materials Methods
Environment
Trunk
Primary Causal Factor
Main Branch
Minor Branch
Men
Potential
Failure Mode

60. 60 April 9, 2016 – v 5.0
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

61. 61 April 9, 2016 – v 5.0
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
– Examining safety margins (e.g. Process Capability Studies)
– Statistical Process Control (SPC) or Pre-Control
– Post-process evaluation (sample based inspection AQL).
Process FMEA → The Template

62. 62 April 9, 2016 – v 5.0
Workshop Exercise: Coffee Brewing Process
Instructions to Exercise 3:
Define Potential Failure Modes, Effects and Possible Causes for 2-3
Process Steps of the Coffee Making Process.
 Create a Process FMEA Template on a Flip Chart
 Select a process step to be analyzed
 Identify all potential Failure Mode for the selected process step.
 For each of the identified Failure Modes, determine the potential
Effects and possible Causes.
 Identify the current Controls for each identified Cause or Failure
Modes.
 Repeat the last 4 activities above for 1 or 2 additional process
steps.
Resources for Exercise 3:
 Flip Charts & Markers45 Minutes

63. 63 April 9, 2016 – v 5.0
“Process Risk Analysis & Mistake Proofing” Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 90 min)
3. Cause & Effect
Matrix & Exercise
(≈ 60 min)
4. Process FMEA &
Exercise
(≈ 60 min)
5. Risk Analysis &
Exercise (≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
7. Process Control
Plan & Exercise
(≈ 60 min)

64. 64 April 9, 2016 – v 5.0
Risk Analysis
1. Severity (Sev): Severity is an assessment of the seriousness of
the effect of the potential failure mode to the customer.
2. Occurrence (Occ): Occurrence is how frequently the specific
failure cause/mechanism is projected to occur.
3. Detection (Det): Detection is an assessment of the likelihood
that a failure mode will stay undetected by the proposed process
controls and thus will leave the manufacturing or assembly process.
Process FMEA → Risk Analysis

65. 65 April 9, 2016 – v 5.0
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.
9-10 Very high: Very high severity is when the failure 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.

66. 66 April 9, 2016 – v 5.0
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.

67. 67 April 9, 2016 – v 5.0
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. High
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. Low
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. Very remote
10 No known control(s) available to detect failure mode . Almost impossible
Please make sure that the Ranking Scheme reflects your organization’s needs. Otherwise, revise the
Ranking Scheme accordingly.

68. 68 April 9, 2016 – v 5.0
Process FMEA → General Comments to Risk Analysis
Achieving agreement across the FMEA Team about the “correct” risk
ranking is not always easy or possible. Below some team decision rules
an organization may consider to not waste valuable time on non-value
add discussions.
 If the disagreement is an adjacent category, average out the
difference. For example, if one member says 4 and someone else
says 6, the ranking in this case should be 5.
 If the disagreement jumps one category, then consensus must be
reached. Even with one person holding out, total consensus must be
reached. No average, no majority. Everyone in that team must have
ownership of the ranking. They may not agree 100 %, but they need
to be able to “live with it”.

69. 69 April 9, 2016 – v 5.0
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 - RPN

70. 70 April 9, 2016 – v 5.0
Workshop Exercise: Coffee Brewing Process
Instructions to Exercise 4:
Perform a Risk Assessment (Sev, Occ, Det & RPN) for 3
Process Steps of the Coffee Making Process.
 Perform a Severity Assessment on all potential Failure
Effects identified in the last exercise
 Perform an Occurrence Assessment on all potential Root
Causes identified in the last exercise
 Perform a Detection Assessment on all current Process
Controls identified in the last exercise
 Calculate the RPN for every Failure Effect – Root Cause –
Process Controls combination
Resources for Exercise 4:
 Flip Charts
 Markers45 Minutes

71. 71 April 9, 2016 – v 5.0
Extreme cases where corrective & preventive actions must be
taken include the following process ratings.
Assessment Rating Causes of Failure Actions
OS D
11 1 Ideal situation (goal) No action (N/A)
11 10 Assured mastery N/A
110 1 Failure does not reach user N/A
110 10 Failure reaches user Yes
101 1 Frequent fails, detectable, costly Yes
101 10 Frequent fails, reach user Yes
1010 1 Frequent fails with major impact Yes
1010 10 Trouble ! Yes, Yes, Yes
Process FMEA → Risk Assessment

72. 72 April 9, 2016 – v 5.0
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

73. 73 April 9, 2016 – v 5.0
“Process Risk Analysis & Mistake Proofing” Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 90 min)
3. Cause & Effects
Matrix & Exercise
(≈ 60 min)
4. Process FMEA &
Exercise
(≈ 60 min)
5. Risk Analysis &
Exercise (≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
7. Process Control
Plan & Exercise
(≈ 60 min)

74. 74 April 9, 2016 – v 5.0
The Human “Noise” Factor
The order really
has to go out
today !!!
Lost a lot of
money in Poker
last night.
Hopefully
Molly is doing
well in her test
today.
It is Friday !!!
Wonder what
I should wear
tonight.
Stop trying to fix your people. Fix your Process.

75. 75 April 9, 2016 – v 5.0
 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.

76. 76 April 9, 2016 – v 5.0
Difference between Mistake and Defect
“There must have
been an error
detected; the machine
shut down by itself!”
“I have an extra part. I must
have omitted a step!”
"The causes of defects lie in worker mistakes, and defects are
the results of neglecting those mistakes. It follows that mistakes
will not turn into defects if they are discovered and eliminated
beforehand.” Dr. Shigeo Shingo

77. 77 April 9, 2016 – v 5.0
Please write down 3 Human Errors that have happened in your
plant or organization over the last couple of weeks.
Quick Exercise
Identify 3 Human Errors

78. 78 April 9, 2016 – v 5.0
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
5. Recognition of the
Danger in the Motion
Human Errors → The Human Work Model

79. 79 April 9, 2016 – v 5.0
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
Human Errors → The 16 Human Error Modes

80. 80 April 9, 2016 – v 5.0
Please try to assign each of the 3 Human Errors you wrote down earlier
to one of the 16 Human Error Modes we will now discuss in more detail.
Quick Exercise
Categorize the 3 Human Errors

81. 81 April 9, 2016 – v 5.0
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

82. 82 April 9, 2016 – v 5.0
2. Failures in “Selecting the Work Object”
6. Incorrect Selection (or Identification)
→ What object of the process is prone to be incorrectly selected or
identified?
7. Incorrect Counting (or Calculating)
→ What objects of the process can be counted, measured or
calculated incorrectly?
The Human Work Model & The 16 Human Error Modes

83. 83 April 9, 2016 – v 5.0
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?
The Human Work Model & The 16 Human Error Modes

84. 84 April 9, 2016 – v 5.0
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

85. 85 April 9, 2016 – v 5.0
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?
The Human Work Model & The 16 Human Error Modes

86. 86 April 9, 2016 – v 5.0
6. Failure to “Execute Correct Motion on Work Object”
14. Improper Holding
→ What object of the process are prone to mishandling?
15. Inaccurate Motion
→ What motion or movement error is prone to occur?
16. Insufficient Avoidance
→ What can be unintentionally touched, stuck or splashed?
→ What movement can cause harm?
The Human Work Model & The 16 Human Error Modes

87. 87 April 9, 2016 – v 5.0
1. Work Progress
Understanding
Error Modes (1) - (5)
Start
End
2. Work Object
Selection
Error Modes (6) - (7)
3. Recognition of
Work Object’s State
Error Modes (8)
4. Recognition of the
Motion to be done
on the Work Object
Error Modes (10) - (13)
6. Motion Execution
Error Modes (14) - (16)
5. Recognition of the
Danger in the Motion
Error Modes (9)
The Human Work Model & Error Modes

88. 88 April 9, 2016 – v 5.0
Were you able to assign each of your 3 Human Errors
to one of the 16 Human Error Modes?
Quick Exercise
Categorize the 3 Human Errors

89. 89 April 9, 2016 – v 5.0
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)
Human Work Model & Error Modes → Example
ii. Getting a part to be assembled from parts boxes
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)

90. 90 April 9, 2016 – v 5.0
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

91. 91 April 9, 2016 – v 5.0
Human Errors → 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 change from a rectangular to a
round manhole.

92. 92 April 9, 2016 – v 5.0
Human Errors → Six Mistake Proofing Principles
3. Replacement substitutes a more reliable process to improve
repeatability. This includes use of robotics or automation that prevents
a manual assembly error.
Example: An example would be the coin dispenser in food
stores preventing that customers are getting short changed.
4. Facilitation is the most used principle and employs techniques and
combining steps to make a process step easier to perform or less error-
prone. This includes visual controls including color coding, marking or
labeling parts; checklists that list all tasks that need to be performed;
exaggerated asymmetry to facilitate correct orientation of parts.
Example: An example would be to color code parts that are similar in
shape or the use of a slipping-type torque wrench to prevent over
tightening.

93. 93 April 9, 2016 – v 5.0
Human Errors → Six Mistake Proofing Principles
5. Detection involves identifying a mistake before further processing
occurs so that the operator can quickly correct the defect.
Example: Examples would include a weld counter to ensure the correct
number of welds or a software modification that will not allow incorrect
entries.
6. Mitigation seeks to minimize the effects of the mistake. This includes
mechanisms that reduce the impact of a error and defect; products
designed with low-cost, simple rework procedures when an error is
discovered; extra design margin or redundancy in products to
compensate for the effects of errors.
Example: An example would be a smoke or heat detector
detecting a hazardous situation.

94. 94 April 9, 2016 – v 5.0
 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

95. 95 April 9, 2016 – v 5.0
Poka (= inadvertent error) - Yoke (= avoid)
devices help us avoid defects, even when inadvertent errors are
made.
Poka - Yoke helps build Quality
into Processes and Products
Human Errors → Poka-Yoke Mistake Proofing
Poka-yoke (poh-kah yoh-keh) was coined in Japan during
the 1960s by Shigeo Shingo who was one of the
industrial engineers at Toyota.

96. 96 April 9, 2016 – v 5.0
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?

97. 97 April 9, 2016 – v 5.0
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.
Characteristics of a Good Poka-Yoke Device

98. 98 April 9, 2016 – v 5.0
1. Guide “Pins” of Different Size & Shape
2. Error Detection and Alarms
3. Limit Switches
4. Sensors
5. Vision Systems
6. Counters and Timers
7. Checklists
Human Errors → Seven Best Poka-Yoke Devices

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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

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2. Error Detection & Alarms
In general, an error detection device can provide a visual alarm such as a flashing light
or an audible alarm such as a horn or siren.
These devices signal that a problem is either about to occur or has just happened. With
a warning effect, the response is not automatic; someone has to take action.
Application
• The signal must be triggered by something in the process, usually a sensor.
Features
• For audible warnings, there are sirens, horns, bells, and even voice synthesizers.
• For visual alarms, there are lights that flash, rotate, strobe, or just light up.
Warning: If you do use warnings, the audible or visual signal must stand out from
background noise and lights. If audible alarms are used, be careful not to exceed noise
standards.
Be careful of “alarm silence buttons.” It is easy to silence the alarm and then forget to
take action. Operators need thorough training on how to react to warnings.
Seven Best Poka-Yoke Devices → Error Detection/Alarms

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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.
Seven Best Poka-Yoke Devices → Error Detection/Alarms
Cons: Variation in material may result in false fails and pass packages.

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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
Human Error Prevention
• Omission, excessive/insufficient repetition, incorrect selection, incorrect counting,
incorrect positioning, incorrect orientation
Seven Best Poka-Yoke Devices → Limit Switches

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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
Human Error Prevention
• Omission, excessive/insufficient repetition, incorrect selection, incorrect counting,
incorrect positioning, incorrect orientation, …
Seven Best Poka-Yoke Devices → Sensors

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4.2 Laser Displacement Sensors
Laser displacement sensors focus a semiconductor laser beam on a target and use the
reflectance of the beam off the target to determine the presence of a target and distance
to it.
Applications
• Measuring distance
• Detection of presence or absence of a feature
• Confirmation of part or object passes by
• Positioning of work piece
Features
• Non-contact - Works in harsh environments - Some devices can achieve
measurement precision down to .004 mils (0.1µm).
Human Error Prevention
• Omission, incorrect selection, incorrect counting, failing to sense danger, …
Seven Best Poka-Yoke Devices → Sensors

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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.
Human Error Prevention
• Omission, incorrect selection, incorrect positioning, incorrect orientation, misrecognition,
…
Seven Best Poka-Yoke Devices → Vision Systems
Checking for Label Presence,
Color, Orientation, & Alignment.

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6. Counters & Timers
Counters (optical or electro-mechanical) look at the occurrence of events. They are usually
triggered by some type of sensor. Counters can be programmed to shut down the process
if a set number of events do not occur or if too many events do occur. Timers can shut
down the process if processing time or activity time does not meet or exceeds a preset
level.
Applications
• Ensuring the proper number of events occurred
• Preventing failure of equipment or a component
by timing usage
Features
• Flexible - Easy to use - Easy for people to understand
Human Error Prevention
• excessive/insufficient repetition, incorrect counting, incorrect positioning, incorrect
orientation, …
Seven Best Poka-Yoke Devices → Counters & Timers
Correct Number of Holes

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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, …
Seven Best Poka-Yoke Devices → Checklists

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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.

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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
take that piece.

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Human Errors → Mistake-Proofing Examples
Some of you may not remember. I still do and have
lost (and found) a few of them.
Does it fit. Error detection and defect
prevention. → Limit Switches

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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.

112. 112 April 9, 2016 – v 5.0
Human Errors → Mistake-Proofing Examples
An oil change facility puts the dip stick on the
fender protector.
Removing the fender protector will cause the
dip stick to clatter on the floor unless it has been
reinserted. → Workplace Organization
After a patient died from receiving a medication that
was not properly diluted, all of that medication was
diluted before being stored. → Pre-Kitting

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Human Errors → Mistake-Proofing Examples
Human Error detection through
automated defect detection devices
such as sensors, limit switches, scales,
… .
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.

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Human Errors → Mistake-Proofing Examples
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.”

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Human Errors → Mistake-Proofing Examples
Consumer friendly Mistake-Proofing product
design improves usability and Customer
Satisfaction.
… and many more.
Preventing missing weld nuts, with a
sensor linked to a visual & audio alarm.
Process will stop automatically and a
corrective action is required.

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Workshop Exercise: Coffee Brewing Process
Instructions to Exercise 5:
Develop improved Process Controls using Mistake-Proofing
Principles and Poke-Yoke Devices where possible.
 Brainstorm and develop as many mistake-proofing
methods and Poke-Yoke devices to the process steps
with the highest RPN and highest Detection ranking as
time allows
Resources for Exercise 5:
 Flip Charts
 Post-It Notes
 Markers
30 Minutes

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“Process Risk Analysis & Mistake Proofing” Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 90 min)
3. Cause & Effect
Matrix & Exercise
(≈ 60 min)
4. Process FMEA &
Exercise
(≈ 60 min)
5. Risk Analysis &
Exercise (≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
7. Process Control
Plan & Exercise
(≈ 60 min)

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Process Control Plan → Objective
A Control Plan is a written statement of an organization’s quality planning
actions for a specific process, product, or service.
The Objective of an effective Process Control Plan is to
 operate processes consistently on target with minimum variation,
which results in minimum waste and rework
 assure that product and process improvements that have been
identified and implemented become institutionalized
 provide for adequate training in all standard operating procedures,
work instructions and tools
Customer
Requirements
Product & Part
Characteristics
Process
Input & Output
Characteristics
Process
Controls
Process
Control
Plan

119. 119 April 9, 2016 – v 5.0
Process Control Plan → Template
Supplier: Product:
Key Contact: Process:
E-Mail / Phone:
Product
Characteristic
Process
Characteristic
Characteristic
Process Step
Specification
(LSL, USL &Target)
Date (Orig):
Date (Rev):
Control Method Reaction Plan
Control Limits
(LCL & UCL)
Measurement
System
Sample Size Sample Frequency
Operational Excellence
Process Control Plan

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 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

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 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 non-
conforming products or operating out-of-control. Corrective actions should
normally be in the responsibility of the person closest to the process, e.g.
the machine operator. This is to secure, that immediate corrective actions
will take place and the risk of non-conforming products will be minimized.
More detailed information may be included in a named work instruction.
Process Control Plan → Template

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Start
Checkpoints
Activators
Corrective ActionsNo
No
No
Yes
Yes
Yes
Yes
Yes
Yes
End
No
No
Out-of-Control-Action-Plans (OCAP)

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 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

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 Process maps detail manufacturing
steps, material flow and important
variables
 Key product variables identified with
importance to customer, desired target
value and specification range defined
 Key and critical process input variables
identified with targets, statistically
determined control limits & control
strategies defined
 Measurement systems are capable
with calibration requirements specified
 Sampling, inspection and testing plans
include how often, where and to whom
results are reported
 Reaction plan in place for out-of-spec
conditions and material
 Operating procedures identify actions,
responsibilities, maintenance schedule
and product segregation requirements
 Training materials describe all aspects
of process operation and responsibili-
ties
 Process improvement efforts fully
documented and available for refe-
rence
 Control plan is reviewed and updated
quarterly and resides in the operating
area
Process Control Plan → Check List

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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
 Post-It Notes
 Markers
45 Minutes

126. 126 April 9, 2016 – v 5.0
“Process Risk Analysis & Mistake Proofing” Agenda
1. Introduction to
Mistake-Proofing
(≈ 30 min)
2. Process Mapping &
Exercise (≈ 90 min)
3. Cause & Effect
Matrix & Exercise
(≈ 60 min)
4. Process FMEA &
Exercise
(≈ 60 min)
5. Risk Analysis &
Exercise (≈ 30 min)
6. Human Errors
and Poka-Yoke &
Exercise (≈ 60 min)
7. Process Control
Plan & Exercise
(≈ 60 min)

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The End …
“Perfection is not attainable, but if we chase perfection we can catch
excellence.” - Vince Lombardi

128. 128 April 9, 2016 – v 5.0
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