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

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.

CustomerProcessInput Output

Supplier

SIPOC Focus: Start with the customer and work backwards

SIPOC Focus: Start with the customer and work backwards

Process Mapping

A means of systematically diagnosing activity and information flow

ProcessInputX1

X2

OutputCTQ1

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 - FMEAA 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

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

Updating an FMEA

Steps in the FMEA Process

• 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

Preparation FMEA Process Improvement

Definition of TermsFailure 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

Process

Step or

Part

Responsible:

Potential Failure

ModePotential Failure

Effects

SEV Potential Causes

OCC Current Controls

DET

RPN

Actions Recommended Resp.

Failure Modes and Effects Analysis (FMEA)

Process or

Product Name

Lists Failure Modes for

each Process Step

List of Process Steps or

Product Parts

Lists the Effects of each Failure

Mode Lists the Causes for each Failure

Mode: Each Cause is Associated with

a process input out-of-Spec

Rates the Severity of the Effect to the Customer on

a 1 to 10 Scale

Rates how often a particular

Cause or Failure Mode Occurs:

1 = Not Often

10 = Very Often

FMEA Form

Process

Step or

Part

Responsible:

Potential Failure

ModePotential Failure

Effects

SEV Potential Causes

OCC Current Controls

DET

RPN

Actions Recommended Resp.

Failure Modes and Effects Analysis (FMEA)

Process or

Product Name

An Improvement Plan is required when the RPN number exceeds 120

RPN number is recalculated when action is completed

FMEA Form (Cont.)

Designates who is responsible for

Action and projected completion data

Documents actions recommended based on RPN

Pareto

Documents how the Cause

is Currently being

controlled in the Process

Risk Priority Number (RPN) is:

Sev*Occ*Det

Rates how well the Cause or the Failure Mode can

be detected.

1 = Detect Every Time

10 = Cannot Detect