Failure Mode & Effect Analysis

Objectives
Understand the Failure Mode and Effects Analysis

(FMEA) as a proactive analytical tool for reliability improvement Understand the process of developing desugn FMEA and process FMEA Brief overview of FMEA formats and rating system for design and process FMEA Understanding the application example of design FMEA

Introduction
Failure Mode and effect analysis is an analytical

technique that combines the technology and experience of people in identifying foreseeable failure modes of a product or process and planning for its elimination.

Types of FMEA
Design FMEA

Process FMEA
Equipment FMEA Maintenance FMEA

Concept FMEA
Service FMEA System FMEA

Environmental FMEA

Reliability
Reliability is defined as the probability of the product

to perform as expected for a certain period of time, under the given operating conditions and at a given set of product performance characteristics

Failure Rate
Failure rate is the frequency with which

an engineered system or component fails, expressed for example in failures per hour

Benefits of FMEA
Assists in determining the best possible design and development

options to provide high reliability and manufacturability potential. Assists in considering the possible failure modes and their effect on the reliability and manufacturability of the product. Provides a well-documented record of improvements from corrective actions implemented. Provides information useful in developing test programs and inline monitoring criteria. Provides historical information useful in analyzing potential product failures during the manufacturing process. Provide new ideas for improvements in similar designs or processes.

How is FMEA formed?

Block Diagram

Boundary Diagram It breaks the FMEA into

manageable levels Parameter Diagram Graphical representation of input and output responses Interface Matrix Relationship among the subsystems, assemblies, subassemblies and components within the object as well as the interface with the neighboring systems.

Four Stages of FMEA

Specifying Possibilities Quantifying Risk

Correcting High Risk Causes

Re-evaluation of risk

Design FMEA Document

FMEA number

System, subsystem, component, model no.

Design Responsibility Prepared By

Key Date
FMEA Date Core Team

Item/Function
Potential Failure Mode

Design FMEA Document

Potential Effects of Failure

Severity
Classification Potential Causes of Failure

Ranking Severity of Effect for Design FEMA

Effect Criteria: Severity of Effect on Product (Customer Effect) Ran k 10

Failure to Meet Safely &/or Potential failure mode affects safe vehicle Regulatory Requirements operation &/or involves noncompliance with government regulation without warning Potential failure mode affects safe vehicle operation &/or involves noncompliance with government regulation with warning Loss or Degradation of Primary Function Loss of primary function (vehicle inoperable, does not affect safe vehicle operation) Degradation of primary function (vehicle operable, but at reduced level of performance) Loss or Degradation of Secondary Function

8 7

Loss of secondary function (vehicle operable, 6 but comfort/convenience functions inoperable). Degradation of secondary function (vehicle operable, but comfort/convenience functions at reduced level of performance). 5

Current Design Control Prevention

There are two approaches to Design Control Prevention of the cause of failure Detection of the cause of failure. Prevention control should always be preferred over detection controls where possible.

Occurrence (O)
Chance that one of the specific causes/mechanisms will occur. Reduction or removal in occurrence ranking must not come from

any reasoning except for a direct change in the design. Design change is the only way a reduction in the occurrence ranking can be effected. Likelihood of occurrence is based on a 1-to-10 scale, with 1 being the least chance of occurrence & 10 being the highest chance of occurrence.

Criteria for Occurrence Ranking in DFMEA

Likelih ood of Failure Criteria: Occurrence of Cause-DFMEA (DESIGN LIFE/ RELIABILITY OF ITEM/VEHICLE) New Technology/new design with no history Criteria: Occurrence of Cause-DFMEA (INCIDENTS OF ITEM/VEHICLE) >=100 per thousand pieces>=1 in 10 PPK RAN K

Very High High

<0.55 >=0.55

10 9

Failure is inevitable with new 50 per thousand design, new application or pieces 1 in 20 change in duty cycle/operating conditions Failure is likely with new 10 per thousand design, new application or pieces 1 in 100 change in duty cycle/operating conditions Failure is uncertain with new 10 per thousand design, new application or pieces 1 in 100 change in duty cycle/operating

>=0.78

>=0.86

Current Design Control Detection

These are the design controls which are expected to detect failure mode before the release of the design. These include reliability tests such as fatigue tests, salt spray tests, prototype tests, functional tests, etc.

Detection (D)
A relative measure of the assessment of the ability of the design

control to detect either a potential cause/mechanism or the subsequent failure mode before the component, sub-system, or system is completed for production. In order to achieve a lower detection ranking in subsequent versions of the document, the planned designs must be improved. The team should agree on an evaluation criteria & ranking system that remains consistent throughout the life of the design FMEA.

Risk Priority Number (RPN)

Product of severity (S), Occurrence (O), & Detection (D)

rankings, as shown below: RPN=(S)*(O)*(D) Value of the RPN can range from 1 to 1000, with 1 being the smallest design risk possible. The engineering team must make efforts to reduce a relatively high RPN Team should also look at relatively low RPN if there is severity of concern regarding the risk.

Likelihood of Detection by design Control

Opportunity of Detection Criteria: Likelihood of Detection RA Likelihood NK of Detection by Design Control 10 9 Almost Impossible Very Remote

No Detection Opportunity Not likely to detect at any stage

No current design control; Cannot detect or is not analyzed Design & analysis/detection controls have a weak detection capability; Virtual analysis (e.g., CAE, FEA, etc) is not correlated to expected actual operating conditions Product verification/validation after design freeze & prior to launch with pass/fail testing (Subsystem or system testing with acceptance criteria such as ride & handling, shipping, evaluation, etc)

Remote

Post Design Freeze & Prior

Product verification/validation after design freeze & prior to launch with test to failure

Very Low

Recommended Actions
The team should begin to examine the corrective action that may

be employed. According to the 4th edition of AIAG FEMA manual, the actions must be prioritized for high severity first (9 & 10), followed by high occurrence & high detection number. Purpose is to reduce one or more of the criteria that constitute the RPN. Increase in design validation actions will result in only the detection rankings. Only a design reduction can bring about a reduction in the severity rankings.

Responsibility & Target Completion Dates

Here the individual or group responsible for the recommended

actions & the target completion date should be entered as reference for future document users.

Action Taken & Resulting PRM

After an action is taken, a brief description of the actual action &

its effective date should be entered. After the corrective actions have been identified, the resulting severity, occurrence, & its detection rankings should be reestimated. The resulting PRN should be re-calculated & recorded

The Process FEMA Document

An analytical technique utilized by Manufacturing Responsible

Response Team Mean to assure that potential failure modes & their associated causes/mechanisms have been considered & addressed. Process FEMA is only documentation of the opinions of the responsible engineering team as a whole. Similarities between process & design FEMA includes

Actively involving representatives from all affected areas Including all the concerns from all the involved departments Treating the document as a living document that is being revised constantly & updated over time.

The Process FEMA Document

A process FEMA is required for all new parts/processes,

changed parts/processes, & carryover parts/ processes in the new applications or environments. When creating &/or revising the process FEMA document, it may be assumed that product will meet the design intent as designed. Just as the philosophies of design FEMA & process FEMA are similar, so are the corresponding documents. The top section of the document has the same form & purpose as the design FEMA document, except Design Responsibility become Process Responsibility.

Process Function/ Requirements

Instead of entering the item being analyzed & its function, as its

design FEMA, a description of process being analyzed is given here The purpose of the process should be given as completely & concisely as possible. If the process being analyzed involves more than one operation, each operation should be listed separately listed along with its description.

Potential Failure Mode

In the process FEMA, one of the three types of failure should be

listed here. The first & most prevalent is the manner in which the process could potentially fail to meet the process requirements. The two remaining modes include potential failure modes in a subsequent (downstream) operation & an effect associated with a potential failure in a previous (upstream) operation. Each potential failure mode for the particular operation must be listed in terms of a component, sub-system, system, or process characteristics.

Potential Effects of Failure

The potential effects of failure are the effects perceived by the

customer, whether intentional or external (the end-user). The effect of the failure must be described in terms of what the customer will notice or experience. It must also be stated whether the failure will impact personal safety or break any product regulations.

Severity (S)
Same role as it does in design FEMA. Severity applies only to effect. If a customer affected by a failure mode is the assembly plant or

product user, assessing the severity may lie outside the immediate process engineers field of experience. Scale of 1 to 10 is used as in design FEMA.

Classification (CLASS)
This column is used to classify any special product characteristics

for components, sub-systems, or systems that may require additional process controls.

Occurrence (O)
Occurrence section of FEMA is the same as in design

FEMA. Occurrence is how frequent the specific failure cause/mechanism is projected to occur.

Guidelines for Severity Ranking for Process FEMA

Effect Criteria: Severity of Effect on Product (Customer Effect) Potential failure mode affects safe vehicle operation &/or involves noncompliance with government regulation without warning Criteria: Severity of Effect on Process (Manufacturing/ Assembly Effect) May endanger operator (machine or assembly) without warning. Ra nk

Failure to meet safety &/or

10

Regulatory Potential failure mode affects Requirement safe vehicle operation &/or s involves noncompliance with government regulation with warning Loss or degradation of Primary

OR may endanger operator 9 (machine or assembly) with warning.

Loss of primary function (vehicle 100% of product may have inoperable, does not affect safe to be scrapped. Line vehicle operation) shutdown or stop ship.

Criteria for Occurrence Ranking for Process FMEA

Likelihood of Failure Very High High Criteria: Occurrence of Cause (Incidents Per Items/Vehicles) >=100 per thousand pieces>=1 in 10 50 per thousand pieces 1 in 20 10 per thousand pieces 1 in 100 10 per thousand pieces 1 in 100 Moderate 2 per thousand pieces 1 in 500 PPK <0.55 >=0.55 >=0.78 >=0.86 >=0.94 RA NK 10 9 8 7 6

.5 per thousand pieces 1 in 2000

.1 per thousand pieces 1 in 10000 Low 0.01 per thousand pieces 1 in 100000 0.001 per thousand pieces 1 in 1000000 Very Low Failure is eliminated through preventive

>=1.00
>=1.10 >=1.20 >=1.230 >=1.67

5
4 3 2 1

Current Process Controls Detection

List the controls that are effective but will detect the failure

mode, after the component is produced. This will typically include inspection & test controls. Examples could be statistical process control, 100% inspection with gauge, final inspection with inspection fixture & patrol inspection.

Detection (D)
Assessment of the probability that the proposed current process

control will detect a potential weakness or subsequent failure before the part or component leaves the manufacturing operation The remaining sections of the process FEMA do not differ from the sections of design FEMA The design engineer is responsible for assuring that all actions recommended have been implemented.