FMEA

Design FMEA
1. To assess the risks of the elements of a product or POR
2. To quantify the interactions in terms of product functionality or POR specifications

Process FMEA
1. To assess the risks of the elements of a process
2. To quantify the interactions of production or business process in terms of process requirements

DFMEA
Element to be assessed
Elements of a product (function/ module) or process of record (POR)

PFMEA
Process steps of a production process or design flow

Potential failure modes Potential effects of the failures

Deviations caused by the design of a process or product Deviations from product specifications

Deviations in the process

Deviations from the process requirements

Team Selection
1. 2.

Put the Right Team together Define and sequence the process into digestible chunks Brainstorm Failure Modes, Causes, Effects and Controls Assign subjective rankings for Severity, Occurrence, and Detection Analysis: Calculate metrics and Pareto Chart the results Take Action on the Top 20% or top 3-5 issues
Define and Map Process Failure Modes Determine Severity (S) Causes

3.

4.

Effects

5.

Determine Occurrence (O) Controls Determine Protection (D) Analysis (RPN) Actions
4

6.

7.

Regular review the FMEA

Risk Priority Number (RPN) = Severity (Sev) x Occurrence (Occ) x Detection (Det)
PRODUCT/ PACKAGE/ PROCESS/ TECHNOLOGY: PREPARED BY: CORE TEAM: REVISION: DATE:

Product / Process Function

Potential Failure Mode

Effect

Sev

Cause

Occ

Control Prevention Detection

Det

RPN

Recommended Action

Owner

Completion Date Sev

Action Results Occ Det RPN 0

What are the Effects?

What are the Functions/ Features / Requirements?

How bad is it?

0 0 0 0 0 0

What can be done? -Design changes -Special Controls -Changes to Standards, Procedures or Guides

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

What can go wrong? -No function -Partial/ Over/ Degraded Function -Unintended Function

What are the Causes?

How often does it happen?

0 0 0 0 0 0

How can this be prevented and detected?

0 0

How good 0 is this 0 method at 0 detecting0 it? 0

0

Example

Mechanical Lid Thinner Wire Diameter Material Change to Pb free bump Longer Wire Length HHP offset Cu pillar
6

Design Intent Customer Needs - Can be specified and measured Customer Wants - Some cant be explained Product Requirements Manufacturing assembly requirements
Quality Function Deployment Customer Contacts Competitive Analysis Known Product Quality Reliability Requirements Manufacturing Requirements

Start with a list of: What the design is expected to do What the design is expected NOT to do

Think about what documents in your company are used to define these

If the product function is complex, break it down into smaller sub-systems. Identify Primary Vs Secondary functions

System

Body

Sub System Component

Doors

Exterior

Window

Interior

Door Inner Panel

Glass

Sealing With Strip

Latch / Lock

Consider

Customer Function Manufacturing Process

9

Consider

Customer Use or Inconvenience Safety or Regulatory Process Difficulty

10

How to rank and rate the effect on a standard scale

11

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Cause and effect diagrams are extremely helpful in analyzing and investigating these complex relationships Ask why, why, why, why, why

Methods Machinery Materials Man Mother Nature 5M

Potential Failure Mode

Potential Effects

Effect 1

Effect 2

Effect 3

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Design
Cause

Effect

Environment Exposure
Cause

A series of events will occur during the life of a disposable penlight

Effect

Moisture
Cause

Effect

Corrosion
Cause Effect

Poor Contact (High Resistance)

Cause
Effect

Insufficient Current
Cause

Effect

Dim Bulb

14

Likelihood or probability of happening

15

Measures to control error in design

16

How likely to be detected

17

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O 1 1 1 10 1 10 10

S 1 1 10 1 10 10 10

D 1 10 1 1 10 1 10

RPN 1 10 10 10 100 100 1000

Failure Impact Ideal ?? ?? ?? ?? ?? Trouble !

19

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Identify, quantify, and reduce design risk - especially for critical systems Provide a traceable document for making design decisions Prioritize which design activities to pursue next A DFMEA is not a one meeting activity - It needs to evolve with the product

Product Design Requirements

Design requirement document (if available from customer or supplier) Legal and technical regulations

Bill of Materials (BOM) and Specific Hardware Product Definition

List of components Components and/or samples as supplied by the customer
Drawings, sketches, animations, and simulations Description of systems and components

Previous Experience (Lessons Learned from Others)

Experience with similar concepts, designs, and DFMEA Customer and supplier inputs Design guides and design standards (for example ASME codes)

RPN: Risk Priority Number

RPN = (Severity) x (Occurrence) x (Detection)

Identification of both systems and components with high RPN values = high risk items.
Identification of Critical and Significant Characteristics

DFMEA integration into others

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Design FMEA
Occurrence Detection Occurrence
ItemFunction Potential Failure Mode Potential Effects of Failure Potential Causes/ Mechanism (s) of Failures Current DESIGN Controls Recommended Responsible Actions and Activity and Status Target completion Date

Detention

Severity

Severity

RPN

Process FMEA
Process Function Requirements

RPN

Design FMEA
System, Sub-system, component If > one function with different failure modes list all Basic function or purpose to meet

Process FMEA
Process or Operation Steps If numerous operations or process with difference Failure Modes list all

RPN

Potential Failure Mode

Potential Effects of Failure

Severity

Potential Causes/ Mechanism (s) of Failures

Current PROCESS Controls

Detection

Responsible Recommended Activity and Action Target Actions and completion Taken Status Date

Occurrence Severity Detention

Occurrence

RPN

Design Failures
Insufficient lubrication capability Incorrect material specified

Process Failures
Insufficient lubrication applied Incorrect material used

Failure Mode
System FMEA
The ramification of the problem

Effect

Cause
The Cause(s) of the Problem

The Problem

Design FMEA

The Cause(s) of the Problem from the System FMEA

The effect from the system FMEA with a Better Definition

New root causes for the design failure Modes

Process FMEA

The Cause(s) of the Problem from the Design FMEA

The Same effect as the Design FMEA

Specific root Causes for the Process Failure Modes

Design Requirement Customer Requirements

Part Characteristics Design Requirements

Product

Manufacturing Operations
Part Characteristics

Part

Production Requirement Manufacturing Operations

Process

Production

Identification and Prevention of Potential defects Design FMEA Process FMEA

Detection and Removal of Internal defects. SPC PPM Goods Inwards Inspection SPC Final Inspection

Detection and Elimination of External defects Inspection by customer

Design and Development

Manufacturing planning

Planning

Purchase

Manufacturing

Usage
Customer

Manufacturer

Process flow diagram Assembly instructions Design FMEA Current engineering drawings and specifications Data from similar processes
Scrap Rework Downtime Warranty

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Performing DFMEA on a pressure cooker

Pressure Cooker Block Diagram

1.

Safety valve relieves pressure before it reaches dangerous levels. Thermostat opens circuit through heating coil when the temperature rises above 250 C. Pressure gage is divided into green and red sections. "Danger" is indicated when the pointer is in the red section.

2.

3.

1.

Define Scope Resolution - The analysis will be restricted to the four major subsystems (electrical system, safety valve, thermostat, and pressure gage). Focus - Safety

2.

3.