FMEA 101: How to Effectively Avoid Unintended Project Consequences

© 2018 Value-Train
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Who is Bill Bentley?
• Data Scientist/Data Analyst < New me
• Process Improvement Expert < Old me
• Electrical Engineer< Older me
• Businessman
• Educator
• Entrepreneur – Owner of Value-Train
• Like to sail, motorcycle, fix problems and garden.
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© 2018 Value-Train
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What is Value-Train?
• Data Analytics Consulting
• Data Analytics Training
• Process Improvement Consulting
• Corporate and individual Training
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© 2018 Value-Train
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What training?
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© 2018 Value-Train 5
What is FMEA?
FMEA is an acronym that stands for
Failure Modes and Effects Analysis
•
5

FMEA Definition
A Risk Assessment Tool
A procedure by which each:
potential failure mode in a system is analyzed
to determine the effects of each failure
We then classify each failure mode effect according to:
its severity
the likelihood of it occurring
its detection ease
6

What is an FMEA?
A ‘Quasi’ – Quantitative
advanced planning tool
Identify Risks
Prioritize Risks
Document Risks
Mitigation Plan
7

History of FMEA
• Aerospace in the 1960s.
• Ford in 1972.
• “Big Three” in 1988.
• Quality standard in 1993.
8

FMEA Deployment
• A layered approach is highly recommended
• FMEAs are like ONION LAYERS. Each Layer:
• Closer to the root cause
• More detailed
• Closer to root cause
• Do too many and you will cry.
9

Types of FMEA
Type Applies to:
Product Manufacturing
Process Services (Projects)
Human Error Any
Assembly Manufacturing
Design Product Development
10

FMEA Benefits
• Encourages Simultaneous
Planning
• Helps Prevent Process
Problems Early
• Identifies Road Blocks
 Provides Record for
Future Development
 Identifies where Controls
can be Effective
11

Steps of FMEA
1. Compile Information
about the System to be
Analyzed
2. Break Complex Systems
into Pieces
3. Construct Flow Charts
4. Determine Functions
5. Determine Potential
Failure Modes
Effects of Each Failure
Mode
Causes of Each Failure
Mode
12

Steps in FMEA (continued)
8. Assign a Severity Rating
for each effect
9. Assign an Likelihood
Rating for each failure
10. Determine the ability to
detect the failure mode
11. Calculate and prioritize a
Risk Priority Number
(RPN) for each failure
13

Steps in FMEA (continued)
12. Review the process
13. Take action to eliminate or reduce the Risk Priority
Number.
14. Recalculate the resulting RPN as the failure modes are
reduced or eliminated.
14

PMI and Risk
PMI’s PMBOK addresses Project Risk Management
processes. The six processes included in PMBOK's Project
Risk Management chapter are:
11.1 Risk Management Planning
11.2 Risk Identification
11.3 Qualitative Risk Analysis
11.4 Quantitative Risk Analysis
11.5 Risk Response Planning
11.6 Risk Monitoring and Control
15

Risk Management in Projects
• Project Managers deal with risk in the following ways:
• 1) Avoid or Eliminate Risk –Identifying an alternate solution
which eliminates the risk.
• 2) Transfer Risk –Transferring the impact of risk–e.g.,
insurance.
• 3) Assume Risk – The manager can assume the risk and decide
to deal with it, when the need arises.
• 4) Prevent or Mitigate Risk – Plan a preventive action in order
to mitigate the impact of risk.
FMEAs can help with all of these.
16

FMEA Information Gathering
• Process Flow Diagrams
• Engineering Drawings
• Project Specifications
• Completed Problem Solving Analyses
• Process Operation Descriptions
• Data Collection Plan Descriptions
• ISO 9000 Information
• Other Relevant Information That Describes Project
• Change Requests
• Completed Problem Solving Documents
17

Flow Chart The Process
• Draft an initial, “high-level” flowchart of the process
being examined.
• This initial flowchart will assist the team in determining if
they need to narrow the scope of the process.
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Preliminary Analysis – Flow Chart
• Identify the sequence and steps.
• Construct the chart.
• Draw a flowchart
• Look for areas for improvement
• Is the process standardized?
• Are steps repeated or out of sequence?
• Are there steps that do not add value?
• Are there steps where errors occur frequently?
• Are there rework loops?
• Analyze the results.
19

Choose (Limit) the FMEA Scope
• This part of the FMEA process is truly a make or break
point for your FMEA. FMEAs are not a tool that will fix all
the failure points at one time.
• Choose a manageable and focused process or specific
part of the process that allows the team to conduct an
effective FMEA that will find and fix all the critical failure
modes within those process boundaries.
• FMEAs are already challenging. When a
• process scope is too large it becomes
• difficult to conduct a thorough analysis.
20

Determine Functions
Determine what each system or process
step is supposed to do before analyzing for
potential failures.
21

Defining Purpose of Each Function
A product element usually has only one primary function.
This is the function which the product was specifically
designed to perform. An overhead projector's positive
function is to project images.
Its secondary function are those which could have
adverse effects. Some of these could be generate heat or
consume power. In this case, the secondary functions
could be viewed as negative.
22

Defining A Purpose
All purposes should be defined using two
words, a verb and a noun. Stating purposes
this way helps simplify the analysis
process.
23

Defining A Purpose - Examples
Product
Electric Motor
Light Bulb
Fuel Tank
Purchase Order
Purpose
Produces Torque
Generates Light
Contains Fuel
Authorizes Purchase
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Determine Failure Modes (5)
How might a process fail or produce an output that is
unacceptable? = failure mode
What is the likelihood of each failure mode
occurring?
Assume that the each failure will occur for the
following steps.
25

Failure Cause Examples
• Out of date documents
• Incorrect calculations
• Wrong assumptions
• Wrong material ordered
• Lower grade component
• Lack of standards
• Untrained people
• SMEs not available when needed
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‘Potential’ Failure Modes
Potential failure modes that would only
occur under certain operating conditions
should also be considered.
Example: Our proposed drainage system
will overflow if we have a 100 year rainfall
event.
27

Potential Effects of Failure (6)
• State the effects of the failure mode on the
customer.
• What will the customer experience?
• Always state in terms of system performance.
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Typical Failure Effects
• Noise
• Unstable
• Impaired
• Draft
• Over Budget
• Poor Quality
• Explosion
• Project Phase Late
• Wrong Items Delivered
• Explosion
• Intermittent Operation
• Erratic Operation
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Potential Causes Of Failure
• A potential cause of failure is defined as an
indication of a design or process weakness,
the consequence of which is the failure
mode.
• The causes should be listed as concisely
and completely as possible so that
remedial efforts can be aimed at pertinent
causes.
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Potential Causes of Failure
• Incorrect specifications
• Incorrect instructions
• Insufficient Staff
• Poor mold form
• Handling damage
• Inadequate security
• Improper permitting
• Improper tool setup
• Incorrect material thickness
specified
• Inappropriate material
specified
• Improper heat treatment
• Inaccurate gauging
• Incorrect feeds, speeds
• Worn tooling
Typical Failure Causes could be:
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Severity
• An assessment of the seriousness of the effect of the
potential failure mode to the next assembly or to the
customer.
• Severity applies to the effect and the effect only.
• A reduction in severity ranking index can be affected only
through a design change for the part or the process.
32

Severity
The FMEA process ranks the severity.
A typical scale will rank the severity from 1
(least severe) to 10 (most severe.)
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FMEA - Severity
Effect SEVERITY of Effect Ranking
Hazardous without
warning
Very high severity ranking when a potential failure mode affects safe
system operation without warning
10
Hazardous with warning Very high severity ranking when a potential failure mode affects safe
system operation with warning
9
Very High System inoperable with destructive failure without compromising safety 8
High System inoperable with equipment damage 7
Moderate System inoperable with minor damage 6
Low System inoperable without damage 5
Very Low System operable with significant degradation of performance 4
Minor System operable with some degradation of performance 3
Very Minor System operable with minimal interference 2
None No effect 1
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Failure Occurrence Likelihood
• How frequently the failure mode is
projected to occur as a result of a specific
cause.
• The occurrence ranking number has a
meaning which has a value
• We need to estimate the likelihood of the
occurrence of potential failure modes on a
1 to 10 scale.
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FMEA - Probability
PROBABILITY of Failure Failure Prob Ranking
Very High: Failure is almost inevitable >1 in 2 10
1 in 3 9
High: Repeated failures 1 in 8 8
1 in 20 7
Moderate: Occasional failures 1 in 80 6
1 in 400 5
1 in 2,000 4
Low: Relatively few failures 1 in 15,000 3
1 in 150,000 2
Remote: Failure is unlikely <1 in 1,500,000 1
36

Detection
Detection is an assessment of the ability of
the proposed process verification to
identify a potential process weakness or
failure mode before the part or assembly is
released for production.
37

Detection
This system assigns a ranking showing the
likelihood that the existence of a defect will
be detected by controls before the next or
subsequent process, or before the part or
component leaves the manufacturing or
assembly location, or before the next step
in the service process or project.
38

Detection
• Assume the failure has occurred and then
assess the capabilities of all current controls
to prevent shipment of the part having this
failure mode or defect.
• Do not automatically presume that the
detection ranking is low because the
occurrence is low, but do assess the ability of
the process controls to detect low frequency
failure modes or prevent them from going
further in the process.
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FMEA - Detection
Detection Likelihood of DETECTION by Design Control Ranking
Absolute Uncertainty Design control cannot detect potential cause/mechanism and subsequent
failure mode
10
Very Remote Very remote chance the design control will detect potential
cause/mechanism and subsequent failure mode
9
Remote Remote chance the design control will detect potential cause/mechanism
and subsequent failure mode
8
Very Low Very low chance the design control will detect potential cause/mechanism
7
Low Low chance the design control will detect potential cause/mechanism and
subsequent failure mode
6
Moderate Moderate chance the design control will detect potential cause/mechanism
5
Moderately High Moderately High chance the design control will detect potential
cause/mechanism and subsequent failure mode
4
High High chance the design control will detect potential cause/mechanism and
subsequent failure mode
3
Very High Very high chance the design control will detect potential cause/mechanism
2
Almost Certain Design control will detect potential cause/mechanism and subsequent
failure mode
1
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Risk Priority Number
The risk priority number, RPN, is the product
of the Occurrence, Severity, and Detection
rankings. This value should be used to rank
order the concerns in the design.
RPN = (occurrence) x (severity) x (detection)
41

Corrective Action
• The intent of any recommended action is
to reduce any one or all of the Occurrence,
Severity, and/or Detection rankings.
• Corrective action should be first directed at
the HIGHEST ranked concerns and at
CRITICAL items.
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Failure Modes for FMEA’s
• The team developing the FMEA turns out to be one
individual.
• Is created to satisfy a customer or third party
requirement– NOT to improve the process.
• Is developed too late in the process and does not improve
the product/process development cycle.
• Is not reviewed and revised during the life of the
product/system.
• Is perceived either as too complicated or as taking too
much time.
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Typical FMEA Form
Process FMEA
Part/Process Suppliers Affected: Prepared by:
Name:
Manufacturing Model Year: FMEA Date:
Reponsibility:
Other Areas: Release Date: Key ProductionDate:
Process Purpose Potential Potential Severity Class Potential Occur Current Detect RPN Recom Respon Actions
Failure Effects Cause Controls Actions
Mode
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Partial Example – Pizza Store
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Partial Example – Training Center
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PECB
Training Courses
• Information Security
• Quality Management Systems
• Continuity, Resilience And Recovery
• IT Security
• Governance, Risk And Compliance
Exam and certification fees are included in the training price.
https://pecb.com/en/education-and-certification-for-individuals
www.pecb.com/events

THANK YOU
?
valuetrain@gmail.com
www.value-train.com
linkedin.com/in/billbentley/
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FMEA 101: How to Effectively Avoid Unintended Project Consequences

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