FMEA

is a systematic method of identifying and preventing system, product and process problems before they occur
is focused on preventing problems, enhancing safety, and increasing customer satisfaction

FMEA

 Ideally,

FMEAs are conducted in the product design or process development stages, although conducting an FMEA on existing products or processes may also yield benefits
is used to identify ways in which components or system can fail to perform their design intentions.

FMEA

 FMEA

also identify the effects of those functional failures on the system of which those components or subsystems are a part. It is qualitative technique. FMEAs is systematically evaluating and documenting the potential impact of each functional failure on equipment reliability, personnel safety, system performance and maintainability requirements.

Ideally,

Early

in the process improvement investigation

When

new systems, products, and processes are being designed

existing designs or processes are being changed

When

When

carry-over designs are used in new applications

After

system, product, or process functions are defined, but before specific hardware is selected or released to manufacturing

The history of FMEA/FMECA goes back to the early 1950s and 1960s. U.S. Navy Bureau of Aeronautics, followed by the Bureau of Naval Weapons: National Aeronautics and Space Administration (NASA): Department of Defense developed and revised the MIL-STD-1629A guidelines during the 1970s.

 FMEA

is a tool that allows you to:

Provides

an auditable method for the identification of equipment failure modes and resulting consequences or hazards.
the need for costly equipment modifications in service by identifying problems early in the design process.

Avoid

 Identify

single point failures and requirements for redundancy or safety systems

Identify

non-compliance with regulatory requirements

input to the development test programme to highlight key features to be tested

Provide

 Identify

the need for built in test or suitable testing provisions in service. communication between various engineering disciplines involved in the project

Aid

Ensure

that the reliability engineer has thorough understanding of the operation of the system under analysis

FMEA

often misses key failures, identify single failures not combinations of failures

Time The Not

consuming and costly

FMEA Process is tedious

suitable for quantification of system reliability

 One

of the most important factors for the successful implementation of an FMEA program is timeliness. is meant to be a before-the-event action, not an after-the-fact exercise.

It

Actions

resulting from an FMEA can reduce or eliminate the chance of implementing a change that would create an even larger concern.

There are number of steps to be followed:

1.

Obtain all necessary information on the system to be analyzed

Establish ground rules and assumptions for the analysis Construct a hierarchical block diagram for the system Conduct FMEA based upon the information derived in steps 1 to 3

2.

3.

4.

Drawings

of the item

Drawing

showing the relationship of the item under analysis with the overall system
material of construction

Expected Process

parameters, pressure, flow, temperature, etc

System

inputs & outputs

Expected
Expected Operator

operating environment
equipment utilization interfaces

It is important that this information is made available at an early stage.

It is necessary to establish the ground rules & assumptions to proceed analysis in a consistent approach. Assumptions are based upon consideration of how client will operate the equipment or what materials or equipment types will be used by the designer.

It is useful to generate assumptions record sheets which are agreed as acceptable by the client or designer.

What

constitutes failure ? an FMEA is to be conducted ?

Whether What

format/standard is to be used for the analysis ? level of the system will the analysis start from ?

Which

to Is

be considered in the analysis ?

the analysis to consider environmental impacts ?

What

are the system boundaries ?

Block

diagram should be constructed which illustrate the operation, redundancy, interactions, functional inputs and outputs of the system. produce a series of diagrams to show both functional relationship and operating configuration. produce separate diagrams for each mode of operation.

To

To

Extremely

useful to develop a hierarchical numbering system for each element of the system.

Clearly

be seen which parts belong to which modules and which modules belong to which sub-system.

It

is recommended

to

list all functions of the equipment before examining the potential failure modes of each of those functions.
include operating conditions (such as; temperature, loads, and pressure), and environmental conditions in the components list.

to

STEP 1 Define the scope of FMEA along with a clear definition of the process to be studies STEP 2 Assemble the team multidisciplinary team with subject matter expert(s) plus advisor

STEP 3 Develop and verify the flow diagram (this is a process vs. chronological diagram)

Consecutively number each process step identified in the process flow diagram

STEP 3 Identify all sub processes under each block of this flow diagram. Consecutively letter these sub-steps

Create a flow diagram composed of the sub processes

STEP 4 Conduct a hazard analysis

List failure modes List all failure mode causes

Determine severity

STEP 5 Recommendation and outcome measures

Decide to eliminate, control or accept the failure cause Describe an action for each failure mode cause that will eliminate or control it

Identify

outcome measures that will be used to analyze and test the re-designed process
a single, responsible individual by title to complete the recommended action

Identify

Indicate whether top management has concurred with the recommended actions

Inputs Brainstorming C&E Matrix Process Map Process History Procedures Knowledge Experience

Information Flow

Outputs List of actions to prevent causes or detect failure modes History of actions taken

FMEA

Failure Effects Relationship

The

relationship between failure modes and effects is not always 1 to 1.

Failure Mode 1 Failure Mode 2 Failure Mode 1

Effect 1 Effect 2 Effect 1 Effect 1

Failure Mode 2
Failure Mode 1

Effect 2

The

FMEA can be implemented using a hardware (bottom-up) or functional (top-down) approach

to system complexity, it is performed as a combination of the two methods.

Due

Hardware

Approach :

The

bottom-up approach is used when a system design has been decided already. component in the system on the lowest level is studied one-by one (detailed arrangement).

Each

Hardware

Approach :

Sufficient

information is available to uniquely identify the component parts of a system.

 Functional

Approach :

It

dictates a top down approach.

Often

used in hazard identification as method of identifying effects of functional failures on plant safety.

 Functional

Approach :

It

takes less time to complete than the hardware approach.

functional method is used when hardware items cannot uniquely identified

The

 FMEA

worksheet should contain :

a.

System/indenture level : describes the level that the analysis being conducted Reference drawing : drawing number & issue

b.

c.

Mission phase/type : record functional mode

 FMEA

worksheet should contain :

d. Identification/reference number : uniquely identification of component/ part no/ tag no e. Item functional identification : component name

 FMEA

worksheet should contain :

f. g.

Failure entry code : sub reference no Failure mode : potential failure mode

h. Failure causes : mechanism that could cause the failure

 FMEA

worksheet should contain :

i.

Symptom detected by : How failure being detected

j. Local effect : diagnostic on immediate effect

 FMEA

worksheet should contain :

k.

Effect on unit output : failure affected other equipment

l. Compensating provisions : safeguards

 FMEA

worksheet should contain :

m. Severity class : essential guide in focusing on the safety related effects n. Recommendations & action taken : Followup on findings

Driving to work
Decided to perform FMEA on driving to work Want to include the processes associated with this activity Meant as an illustrative example by walking through the steps

Step 1 Define the scope Step 2 Assemble the team Step 3a gather information about how process works describe it graphically.

Step 3b consecutively number each process

Step 3c if process is complex, choose area to focus on

Step 3d if necessary, list sub-process steps and consecutively number

Step

3e wake up (sub-process flow diagram)

Step

4 List all failure modes

Step

We will conduct an FMEA on the truck stop example we used to create a C&E Matrix A Black Belt wants to improve customer satisfaction with the coffee served at the truck stop The process map and completed C&E matrix follow

Process Map

Inputs
Hot Water Soap Scrubber Clean Carafe Cold Water Measuring Mark Full Carafe

Outputs
Clean Carafe
Cleaned Carafe Dirty Water Wet Scrubber Full Carafe

Inputs
Customer Order Size Specification Complete Order Hot Coffee Cup Filled Cup Customer Cream Sugar Amount Desired Complete Order Money Receive Coffee Order Pour Coffee into Cup

Outputs
Complete Order

Fill Carafe w/Water

Filled Cup

Pour Water into Maker Place Filter in Maker Put Coffee in Filter

Filled Maker Empty Carafe Maker w/Filter Maker w/Filter & Coffee Operating Maker Heat Brewed Coffee Hot Coffee

Filter

Offer Cream & Sugar

Customer Reply Amount Specified Complete Order

Maker w/Filter Fresh Coffee Dosing Scoop

Maker w/Filter & Coffee

Complete Transaction

Turn Maker On

Make Change Temperature Taste Strength Smile Happy Customer

Coffee Delivery

Say Thank You

Brewing Coffee

Select Temperature Setting

54

C&E Matrix

Temp of Coffee 8 Process Step ----- Process input -----

Taste 10

Strength 6

Process Outputs Importance --------- Total --------0 36 144 16 36 144 34 120 6 52 132 24 0 0 0 0 0 0 0 0 0 0 0 0

--------- Correlation of Input to Output --------0 0 0 0 0 3 9 0 3 3 1 0 3 9 1 3 9 1 3 0 1 9 1 0 1 9 1 1 9 0 3 1 3 3 1 0

Clean Carafe Fill Carafe with Water Pour Water into Maker Place Filter in Maker Put Coffee in Filter Turn Maker On Select Temperature Setting Receive Coffee Order Pour Coffee into Cup Offer Cream & Sugar Complete Transaction Say Thank You

We will focus on one of the two steps with the highest scores

55

Determine Failure Modes

56

Identify Effects and Severity

57

Identify Failure Causes and Score

58

Identify Controls and Score

59

RPNs

60

Identify Actions and Responsibilities

61

Compare RPNs

62

Choose a workplace (activity) Do a FMEA analysis, identify at least :

5 items/category 4 or more question per items/category.

Please use given log sheet and determine recommendations