Process Mapping Defined

A graphic representation of steps,

events, operations, and relationships
of resources within a process
Process mapping provides a common
definition of the Suppliers, Inputs,
Process Steps, Outputs, and
Customers for your project
Elements Of A Process

Input Output
Supplier Process Customer

Customer–Whoever receives the output of your process.

Output–The material or data that results from the operation of a
process.
Process–The activities you must perform to satisfy your customer’s
requirements.
Input–The material or data that a process does something to or with.
Supplier–Whoever provides the input to your process.
SIPOC Focus:
Start with the customer and work backwards
Process Mapping
A means of systematically diagnosing activity and information
flow
Input Output
Process
X1 CTQ1
X2 CTQ2

To prepare:
 Establish the process boundaries
 Observe the process in operation
 List the outputs, customers, and their key requirements
 List the inputs, suppliers, and your key requirements
Benefits Of Process Mapping

Can reveal unnecessary, complex, and redundant

steps in a process. This makes it possible to simplify
and troubleshoot.
Can compare actual processes against the ideal. You
can see what went wrong where.
Can identify steps where additional data can be
collected.
Failure Modes and Effects
Analysis (FMEA)
Definition - FMEA
A structured approach to:
> Identifying the ways in which a process can fail to meet
critical customer requirements
> Estimating the risk of specific causes with regard to these
failures
> Evaluating the current control plan for preventing these
failures from occurring
> Prioritizing the actions that should be taken to improve the
process

Identify ways the product or process can fail.

Then plan to prevent those failures
What & How of FMEA
What is failure modes and effects analysis?
> Identify ways the product or process can fail
> Plan how to prevent those failures

How does FMEA work?

> Identify potential failure modes and rate the severity of their
effect
> Evaluate objectively the probability of occurrence of causes
and the ability to detect the cause when it occurs
> Rank order potential product and process deficiencies
> Focus on eliminating product and process concerns and
help prevent problems from occurring
Purposes & Benefits of FMEA
• Improves the quality, reliability, and safety of
products/processes
• Helps to increase customer satisfaction
• Official part of the Transition documentation and
Contract
• Documents and tracks actions taken to reduce risk
When Is an FMEA Started?
• When new systems, products, and processes are
being designed
• When existing designs or processes are being
changed (i.e. Six Sigma project)
• When carryover designs/processes will be used in
new applications, or new environments
• After completing a problem solving study (to prevent
recurrence of problem)
Who Prepares an FMEA?
• The team approach to preparing FMEAs is recommended

• The responsible system or product leads the FMEA team

• The responsible design is expected to involve

representatives from all affected activities. Team members
should include design, manufacturing, assembly, quality,
reliability, service, purchasing, testing, supplier, and other
subject matter experts as appropriate
Updating an FMEA
How often is an FMEA updated?
> Whenever a change is being considered to a product’s
design, application, environment, material, or process

Who updates an FMEA?

 The individual responsible for the system or product is

responsible for keeping the FMEA up to date

 Suppliers keep their own FMEAs up to date

 Steps in the FMEA Process
Preparation FMEA Process Improvement

• Develop process map & identify process steps

• List ways process inputs can vary (causes) and identify associated failure
modes and effects
• List other causes (sources of variability) and associated FM&E’s
• Assign severity, occurrence and detection rating to each cause
• Calculate risk priority number (RPN) for each potential failure mode
scenario
• Determine recommended actions to reduce RPN’s
• Establish timeframes for corrective actions
• Take appropriate actions
• Re-calculate all RPN’s
• Put controls into place
Definition of Terms
Failure mode
> The manner in which a part or process can fail to meet specification
> Usually associated with a defect or non-conformance
Cause
> A deficiency that results in a failure mode
> Causes are sources of variability associated with key process input
variables
Effect
> Impact on customer if failure mode is not prevented or corrected
> Customer can be downstream or the ultimate customer

The Failure Mode can be thought of as the “in-process” defect,

whereas an Effect is the impact on the customer requirements.
FMEA Calculations
Risk ratings: Scale: 1 (best) to 10 (worst)
Severity (SEV): How significant is the impact of the effect to the
customer (internal or external)?
Occurrence (OCC): How likely is the cause of the failure mode to
occur?
Detection (DET): How likely will the current system detect the cause
or failure mode if it occurs?

Risk priority number:

A numerical calculation of the relative risk of a particular failure mode
RPN = SEV x OCC x DET
This number is used to place priority on which items need additional quality
planning
 FMEA Form
Failure Modes and Effects Analysis (FMEA)
Lists Failure
Process
List of or
Process Rates the Severity of the
Modes for
Steps or Name each Process
Product Effect to the Customer on
a 1 to 10 Scale
Responsible:
Product Parts Step

Process
Potential Failure
Potential Failure S O D R
Step or
Mode E C E P Actions
Effects
Part V Potential Causes C Current Controls T N Recommended Resp.

Lists the Effects

of each Failure
Mode Lists the Causes
for each Failure
Mode: Each Cause Rates how often
is Associated with a particular
a process input Cause or Failure
out-of-Spec Mode Occurs:
1 = Not Often
10 = Very Often
FMEA Form (Cont.)
Failure Modes andRisk PriorityAnalysis (FMEA)
Effects
Number
Process or (RPN) is:
Product Name Sev*Occ*De
Responsible: t Documents actions
Documents recommended
how the Cause based on RPN
is Currently Pareto
Process being
Potential Failure
Potential Failure S in O D R
Step or controlled
Mode E C E P Actions
Part
Effects the Process
V Potential Causes C Current Controls T N Recommended Resp.

Rates how well

the Cause or the
Failure Mode can Designates who is
be detected. responsible for
1 = Detect Every Action and projected
Time completion data

10 = Cannot
Detect

An Improvement Plan is required when the RPN number exceeds 120

RPN number is recalculated when action is completed