FMEA Basic Program Introduction

What is : F M E A ?

F M E A

Failure Mode Effects Analysis

FMEA is a method basically to prevent, and, if not possible, to reduce the failures. Hence, FMEA reduces the product development cycle time and the product development costs.
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FMEA - Integrated Quality Assurance

Customer Preventive QA

Development

Production Analytical QA

Customer

QA1 Quality Specification

QA2

QA3
Supplier Q.A
Production
SPC Insp. QR Results

Design Process FMEA FMEA

0-Km Field

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FMEA - History of FMEA

How was the FMEA Technique developed? ??? First questioning during problem analyses: What happens if ..?

1955 Spread of "Analysis of potential problems (APP)" by Kepner-Tregoe 1963 Development and use of the FMEA by NASA for the Apollo project 1965 Use of the FMEA for aircraft and aerospace technology 1975 Use of the FMEA in nuclear technology 1977 Start of FMEA use in the automotive industry 1980 Widespread use of the FMEA in USA, Japan and Europe 1990 Additional use of the FMEA in Medical technology Communications technology Household appliance technology ...
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FMEA - Why FMEA ?

Very important Characteristics of the FMEA technique :

+ Preventive effect - Preventive Quality Assurance + Earliest contact with all responsible persons and departments + Use of a systematic and logical method + Most complete document for your work - Design or Process + Good basis for the product assessment and product decision + Prevention of risks of failures in future - save Cost and Image

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FMEA - Why FMEA ?

concept

design

sample

testing

production

sale

Failure rate in %

Current Status
Origin of Failures Solving of Failures

Time

FMEA helps to solve the Failures at the Origin Phase itself !!

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FMEA - Why FMEA ?

Detection and avoidance of potential defects

QFD/ Concept Development System Design Process FMEA

Discovery and elimination of int./ext. defects

SPC part mfg. SPC assy.

Discovery and elimination of int./ext. defects

FMEA helps to solve the Failures

1000.00
Costs - Rs./Defect

with low cost !!

Costs - Rs./Defect

100.00 10.00 1.00

Product planning Product develop/ process planning Purchasing/ Production in-house of final production product

Use of product

Manufacturer

Customer
Slide 10 FMEAandQA10.ppt MICO/Kailasam 18.8.2000

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SRD-Q/07.10.2003

FMEA - Why FMEA ?

Legal requirements (Product liability, environmental protection Increased customer expectations More intense competition

legal aspects)

Quality management system requirement TS 16949 Shorter Development time Low Overall Cost

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FMEA - When FMEA ? FMEA has to be done afresh when : A New product is under development, The Product and/or Process changes significantly, The Product has to meet technical safety requirements, The Customer demands.

FMEA has to be updated when : New application of the existing product, Introduction of new Process in Manufacturing, Negative experience of Products in the works or with Customers - 0-Km or Field.

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FMEA - Application of FMEA

The FMEA Technique and Methodology helps us to : Analyse the strengths and weaknesses of any Subject Decide on measures to solve possible problems/failures.

Hence, FMEA Technique and methodology can be used : In all Technical Areas, In all non-technical Business Areas and also In personal Areas like buying of an important and expensive things.

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FMEA - Types of FMEA FMEA Type System FMEA Short Name SFMEA Purpose To meet Target Spec.

Design FMEA Interface FMEA Process FMEA Supplier FMEA Transport/Logisitic FMEA * = Special Types of FMEA

DFMEA IFMEA* PFMEA SFMEA* TFMEA*

To meet Target Spec. To function well with Customers Product To meet Design Spec. To meet Design and Ordering Spec. To ensure Quality in Transport & Storage.
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FMEA - Design and Process FMEA's

Design FMEA Purpose : Responsibility : Objective : To meet target specifications Development To avoid Quality failures in design Compliance with target specifications After design selection Prior to the production release

Process FMEA To meet the specifications in the drawings Process Planning To avoid Quality failures in Process Compliance with drawings With product release Prior to series production start up

Check for : FMEA Start : FMEA End :

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FMEA - FMEA Schedule

System development Product development Concept Design Validation Production engineering Planning Purchasing Trial prod. Mass prod. System FMEA Initial version Performance of corrective actions Design FMEA Initial version Performance of corrective actions Additional updating Additional updating

Process FMEA Initial version Performance of corrective actions Additional updating

Proposal for special characteristics (int.), QA1 System Component development development order order

Definition of special Manufacturing of special characteristics, QA2 characteristics e.g.. Cpk, QA3 Product release Start of production (Product delivery release)

Start Production planning B(C)-sample order/product production/ pre-release testing

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FMEA - FMEA Team Members

System FMEA Core team System development (responsible) Application Moderator Occasional Product particidevelopment pation Sales Central departments Purchasing

Design FMEA Design (responsible) Testing laboratory Plant (Process planning or Quality assurance) Moderator Application/System development Endurance testing Central departments Sales Plant Purchasing

Process FMEA Process planning (responsible) Quality assurance Production department Moderator Development (Design and/or testing) Central departments Purchasing

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FMEA - Planning & Preparation

The following points have to be taken into consideration for the successful completion of FMEA : Right moment to do FMEA The team members Composition, Knowledge of FMEA Technique and capability to work in a Team Logical and transparent method of selecting the Components/Processes to be considered in FMEA Clear and complete preparations by structuring the functions, failure modes and effects in the FMEA format Collection of all necessary Documents and Papers.

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FMEA - Format

FMEA
PRODUCT QUALITY : PART NO. ASSURANCE : NO COMPONENT FUNCTION . OR PROCESS FAILURE MODES FAILURE EFFECTS C FAILURE CAUSES FAILURE PREVENTION FAILURE DETECTION S

10 * (*

PAGE : DEPT. : FMEA - NO. : DATE O : D RP ACTIONS R:/I N :14 11 12 13

* *

* *

* *)

> Limit
Action for failure prevention Action for failure detection How is the risk avoided?

Current condition
(* * * *)

Which function should be fulfilled ?

What can go wrong ?

What is already being done against the failure ?

How high is the risk ?

[* [* * * * * *] *]

Improved condition after both actions are completed

S = Severity of failure effects R = Responsible Department O = Failure occurrence probability I = Date of Implementation

D = Failure detection probability Risk Priority Number RPN = S x O x D C = Risk Class/Spl. Characteristics Classification * System, Design, Process

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FMEA - Planning & Preparation

To ensure proper and effective FMEA team work, the following documents should be available for discussion and use in the FMEA : Design FMEA
System FMEA or System Description Specifications - Target and Product Development Drawings, Parts lists Risk/Spl. Characteristics list Product Try-out & Validation plan Functional Analysis/Simulation results Structure Analysis/Strength Calculations Test Results of Samples/Comparable Products Technical Customer Documentation (TKU) Offer Drawing

Process FMEA
Design FMEA or Functional Description Process Layout, Product Quality Plan - PQP Machine/Process Specifications Work Instruction Charts Manufacturing Drawings, Parts Lists Test results of samples - Plant & Customer Machine and Process Capability Indices Machine and Process Try-out Results Failure Rates of Comparable Products Training Plan for Operators Tool and Fixture Drawings

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FMEA - System Structuring - Col. 1

Definition : No. = Numbering of the component or process Comments : - System FMEA: the number of the system component as per the component list or system block diagram - Design FMEA: the number of the component being ranked, according to the parts list (or structure list) - Process FMEA: the number of the work or process step according to the process plan The identification of functions and failure causes are done with supplemental digits separated by dots - e.g. xx.xx.xx. What is the number of the component or process being Question : analysed?

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FMEA - System Structuring - Col. 2

Definition : Component or process = the object being analysed

Comments :

- System FMEA: a list of the system components to be analysed (e.g. according to the component list) - Design FMEA: a list of the components to be analysed, according to the parts list - Process FMEA: a list of the processes/process steps to be analysed, according to the process plan The depth of detail for the FMEA and selection of the objects to be analysed must be done by the Core Team during the preparatory phase and will be reviewed and ratified by the FMEA team.

Question:

Which components or processes are to be analysed?

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FMEA - System Structuring - Col. 2

2. Component or process Examples System FMEA Motronic Component Design FMEA Starter Assembly Parts Process FMEA Final grinding of armature shaft Process Process steps final grinding feed clamp grind remove

Starter ECU Sensor Ignition switch

complete armature armature shaft winding lamination Commu -tator

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FMEA - Functional Analysis - Function - Col. 3

Definition :

Function = functions and characteristics that are fulfilled by the component or process - The System FMEA covers all important functions, operating condition and conditions of system components on the basis of the system design specification, starting from a black-box point of view.

Comments :

- The Design FMEA covers all important end functions and operating conditions of components, on the basis of the component design specification, starting from the initial prototypes.

- The Process FMEA covers all important process functions (process plan) and part characteristics (drawing). Also refer to: Part/Function matrix or structuring using IQ-FMEA Question : Which functions do the components or processes have to fulfill?

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FMEA - Functional Analysis - Function - Col. 3

3. Functions Examples
System FMEA Motronic
Object : Starter Functions Enable cold start Supply torque Operating conditions Temp. range Voltage range Operating states Starting Driving Parked Operating conditions

Design FMEA Starter

Object : Armature Shaft. Component Receive lateral force Functions Position stator core Temp. range Voltage range

Process FMEA Grinding armature shaft Object : Grg. Process step Characteristics maintain dim. tolerances maintain toler. for cylindricity Process functions Ease of maintenance Process capability Clamping forces rpm range

Slide 34

FMEAandQA34.ppt

MICO/Kailasam 18.8.2000

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SRD-Q/07.10.2003

FMEA - Failure Analysis - Mode - Col. 4

Definition : Failure mode is the improper function or the type and way required function or a characteristic could not be fulfilled.
Comments : - The System FMEA examines all potential malfunctions and

functional limitations that result from the function of the system components and are functionally described.

- The Design FMEA examines all potential malfunctions and failure modes that result from component functions and are described as a physical quantity. Design for manufacturing must also be considered. - The Process FMEA examines all potential process failures that result from the required process functions and part characteristics and are described as a deviation. Question : Which imaginable failure modes impair the function or the characteristic?

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FMEA - Failure Analysis - Mode - Col. 4

4. Failure mode Examples

System FMEA Motronic Component: Starter poor cold starting no torque supplied too noisy creates too much heat Design FMEA Starter Component : Armature shaft armature shaft broken armature shaft frozen tight armature shaft axial play too large stator core loose
Process FMEA Final grinding armature shaft

Process step: Grinding dimensional tolerance exceeded form tolerance exceeded cylindricity tolerance exceeded surface scratched

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FMEA - Failure Analysis - Effects - Col. 5

Definition :

Failure effect = effect/consequence of the failure mode on the system, from the customers point of view end customer

Comments : - As exactly as possible, describe all different failure effects on the

- Describe the functional effects on the highest level object being ranked (system, vehicle, environment) - Describe the failure effects as they are noticed/felt by the customer/user (dissatisfaction/annoyance) - Understandable depiction of the chain of effects direct effect -> next effect -> final effect (e.g. part -> sub-assembly -> system) - The final effect is the basis for later ranking of the failure effect. Question : Which effects/consequences can be imagined for the failure mode?

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FMEA - Failure Analysis - Effects - Col. 5

5. Failure effects - Examples

System, Design and Process FMEA

vehicle doesnt start sudden increase of engine speed sudden loss of engine power unstable idle speed loss of fuel vehicle cant be steered brakes dont work car radio doesnt work loss of assist for brakes, steering

unstable vehicle performance legal requirements not fulfilled emissions limit value exceeded problems with cold starts increased fuel consumption 0-mileage complaint (OEM) noise problem odor problem optical defects

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FMEA - Failure Assessment - Col. 10

Definition : The goal of the FMEA is to discover all potential weaknesses or risks and to rank them with a critical assessment.

General Rules for critical assessment

- Go through the ranking tables from 10 (worst ranking) to 1. - Do not lower the ranking unless there are reasons for this. - If there is no consensus on the ranking, then the higher of the possible rankings is used.

Attention:

Critical ranking is a prerequisite for an effective FMEA!

Question : With what assessment criteria, can the risk be ranked ?

Note : These Rules are applicable to ranking of S, O, & D (Col. 10,11 & 12)
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FMEA - Failure Assessment - Severity - Col. 10

Definition :

The ranking for S - Severity, reflects the significance of the effects of the failure mode on the end customer.

Comments : - To ensure correct ranking, it is to be assumed that the failure mode has occurred and has not been detected in the plant. - Rankings 10 and 9 are used if the safety and/or compliance with legal requirements may be impaired or if the failure leads to a stranded vehicle. - Rankings 8 to 1 assess the impairment of the system and/or the customers reaction. - Already implemented actions that limit the failure effects are considered when S is ranked. - The ranking table for severity applies to the System, Design and Process FMEA, since in all FMEAs the effect on end customer is ranked.

Question :

How severe is the effects of the failure mode on the end customer?

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FMEA - Failure Assessment - Severity - Col. 10

Severity Ranking Table for System, Design and Process FMEAs.

General assessment criteria

Extremely serious failure, which affects safety and/or violates legal requirements, without warning. Extremely serious failure, which probably affects safety and/or violates legal requirements, with warning, or leads to a conked-out vehicle. Serious failure, loss of primary functions, e.g. vehicle is conked-out. Serious failure, function of the vehicle is strongly impaired, immediate servicing is required. Limited function of important sub-systems. Moderately serious failure, failure of important operational and comfort systems, immediate servicing is not required. Moderately serious failure, limited function of important operational and comfort systems. Moderately serious failure, little loss of function of operational and comfort systems, detectable by any driver. The failure is insignificant. The customer is only slightly bothered, and will probably only notice slight interference, can be noticed by the average driver. It is unlikely, that the failure could have a noticeable effect on the behavior of the vehicle or system. Only noticeable by experts/ experienced drivers. No effect.

Ranking points
10 9

Application-specific assessment criteria

8 7

6 5 4 3

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FMEA - Failure Assessment - Col. 6

Definition : - Special characteristics (also called significant or critical characteristics), ensure proper performance of the finished product during storage, handling, installation and operation; some automobile manufacturers identify them with proprietary symbols. - Customer related characteristics are (customer-required or internally defined) dimensions and characteristics that are especially important and must be strictly met to ensure proper installation and operation of products. They are also used for internal quality assurance.

Comments : - Product characteristics and process parameters can be special

characteristics. - Selection based on the FMEA is currently under development.

Question :

Which customer-specific and/or internally defined characteristics are identified in drawings or meet the assessment criteria?

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FMEA Failure Assessment - Col. 6

FMEA
QUALITY ASSURANCE NO COMPONENT . OR PROCESS PRODUCT : PART NO. : FUNCTION FAILURE MODES FAILURE EFFECTS C FAILURE CAUSES FAILURE PREVENTION FAILURE DETECTION S

6 R0

10 11 12 13

PAGE : DEPT. : FMEA - NO. : DATE O : D RP ACTIONS R:/I N :

14

Enter here the Special Characteristics Symbol

S = Severity of failure effects R = Responsible Department

O = Failure occurrence probability I = Date of Implementation

D = Failure detection probability Risk Priority Number RPN = S x O x D C = Risk Class/Spl. Characteristics Classification * System, Design, Process

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FMEA - Failure Assessment - Cause - Col. 7

Definition : Failure causes = causes and conditions that can lead to the failure mode being considered.
Comments :

- The System FMEA examines failure of functional groups or components and their connections, including both layout and field performance. - The Design FMEA examines design, selection and layout mistakes as well as manufacturing and assembly defects which are influenced by the design. - The Process FMEA examines all process-related failure causes. Only an exact description of the actual failure cause will enable correct ranking and definition of specific and effective improvement actions.

Question : Which failure causes can produce the failure mode being ranked?

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FMEA - Failure Assessment - Cause - Col. 7

7. Failure causes - Examples

System FMEA Interfaces interruption short-circuit reverse polarity loose contact Sub-assembly component failure loss of function limited function malfunction Layout unsuitable layout of the components components not suited for the application Design FMEA Dimensions diameter too small length insufficient Processes assembly sequence defined wrong unsuitable fastening method Material insufficient strength no protective surface finish Form; Position; Tolerance roundness inadequate coaxiality tolerance too large Process FMEA Man not meticulous enough missing information Machine input material too large grinding wheel too small Method process plan incomplete shipping damages Material Non-homogeneous material Environment

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FMEA - Risk Analysis - Prevention - Col. 8

Definition : Failure prevention = already implemented actions that - decrease the failure occurrence (O = ) - limit the failure severity (S = )
Comments :

The System FMEA (Field and layout) considers implemented actions that minimize the risk of system layout mistakes or avoid or limit the effects of these mistakes. The Design FMEA considers implemented actions that minimize or avoid the risk of design mistakes.

The Process FMEA considers implemented actions that minimize or avoid the risk of process defects. Question : Which actions to avoid mistakes and defects are already introduced or prescribed?

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FMEA Risk Analysis - Prevention - Col. 8

8. Failure prevention - Examples

System FMEA
Ways to reduce effects (S = ) Redundance Substitute functions Ways to limit occurrence (O = ) Power reserves Robust layout Experience with similar systems Simulation Calculations Exact functional definition

Design FMEA
Design Low chance of improper use Optimal, robust layout Utilizing experience Proven designs Expert advice Optimization methods Calculation methods Optimization tests Information to production Drawings (comments) Order, test and process specifications Use of internal & external standards and guidelines

Process FMEA
Machine Machine, process capability Maintenance/Service Method Work instructions Measurement system analysis Material Order specification Lot documentation Environment Ergonom. work station design Clean room conditions Man Mistake-proof design of work stations Experience

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FMEA - Risk Assessment - Occurrence - Col. 11

Definition : The O ranking reflects the probability that the failure mode, as a result of
the failure cause being considered, will occur at the customer/user, without being discovered beforehand.

Comments : - To avoid double ranking, it is assumed that the failure mode and cause have not been detected before the customer accepts the product. - Implemented actions that prevent the failure cause are assumed effective and are considered when O is ranked. - The failure rates (e.g. - rates, ppm) are based on the number of failures that are expected within the required lifetime of the product. - Dependence on operating time (h), driving distance (km), number of cycles, process capability (cpk), etc. must be considered.

Question : How high is the probability that the failure mode, as a result of the failure
cause being considered - without means of detection -will occur at the customer/user?

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FMEA - Risk Assessment - Occurrence - Col. 11

System and Design FMEA

General assessment criteria
Very high. It is almost certain that the failure mode and cause will occur very frequently. High. The failure mode/cause occur repeatedly. Problematic, not a mature system/design. Medium. The failure mode/cause occurs occasionally. Advanced maturity of the system/design. Low. Occurrence of the failure mode/cause is low, proven system/design layout. Unlikely. Occurrence of the failure mode/cause is unlikely. possible failure rate* 1/10 1/20 1/50 1/100 1/200 1/1.000 1/2.000 1/15.000 1/150.000 <1/1.500.000 ppm* 100.000 50.000 20.000 10.000 5.000 1.000 500 67 6,7 <0,67 Ranking points 10 9 8 7 6 5 4 3 2 1 Application-specific assessment criteria

*per LT (LT = Lifetime of the product)

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FMEA - Risk Assessment - Occurrence - Col. 11

Process FMEA
General assessment criteria
possible failure rate ppm 100.000 50.000 20.000 10.000 5.000 1.000 500 67 6,7 <0,67 Cpk -* -* -* -* 0,94 1,10 1,17 1,33 1,50 >1,67 Ranking points 10 9 8 7 6 5 4 3 2 1 Application-specific assessment criteria

Very high. It is almost certain that the failure 1/10 mode and cause will occur very frequently. 1/20 High. The failure mode/cause occur repeatedly. Process is not precise. 1/50 1/100

1/200 Medium. The failure mode/cause occurs occasionally. Can be compared with 1/1.000 processes that occasionally produce defects, 1/2.000 but not to a significant extent. Low. Occurrence of the failure mode/cause 1/15.000 is low, proven process. 1/150.000 Unlikely. Occurrence of the failure mode/cause is unlikely. <1/1.500.000

* Cpk calculation meaningless

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SRD-Q/07.10.2003

FMEA - Risk Analysis - Detection - Col. 9

Definition : Failure detection = Test activities or symptoms that are suitable for timely detection of a failure mode or cause.
Comments :

- In the System FMEA (Layout), these are test activities and validation done until the system release. - In the System FMEA (Field), these are signs and sypmtoms that are suitable for timely detection of the failure mode or cause. - In the Design FMEA, these are tests and validation, as well as other methods of detecting failures, until the product release. - In the Process FMEA, these are all tests and possibilities of detecting failures, until delivery to the customer. Most accurate description of the effectiveness of the test activities or of the symptoms regarding the probability of detecting the failure.

Question : Which test activities or symptoms are defined for timely detection of failures?

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SRD-Q/07.10.2003

FMEA - Risk Analysis - Detection - Col. 9

9. Failure detection - Examples

System FMEA Field
Signs Warning lamp display Acoustic signal Fault memory readout during service Symptoms Loud noises unsteady engine running increased fuel consumption Layout Vehicle testing Simulation Summer and winter testing

Design FMEA
Endurance testing Climatic testing Initial sample testing (customer) Vibration testing Testing of individual characteristics

Process FMEA
Measurements and tests at the work station Process and visual tests In-process and final testing Quality/Reliability testing Technology analysis 100 %-testing Random sample testing Product audit System audit

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FMEA - Risk Assessment - Detection - Col. 12

Definition : The D ranking reflects the probability that the failure mode or cause is

detected before the product arrives at the customer or that the failure is detected in the field by an implemented detection action and displayed to the operator (e.g. driver).

Comments : - System FMEA: (Field) assessment of the possibilities of detection by the system and display to the operator (e.g. driver). (Layout) assessment of the detection possibilities until system release. Design FMEA: assessment of the detection possibilities until product release. Process FMEA: assessment of the detection possibilities until transfer to the customer. The main ranking criterion is the effectiveness of testing as related to detecting the failure characteristic.

Question : How high is the probability that the failure mode or cause being considered will

be detected before the product arrives at the customer or the failure is detected and displayed by the system?

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SRD-Q/07.10.2003

FMEA - Risk Assessment - Detection - Col. 12

Design FMEA
General assessment criteria
Unlikely. It is impossible or improbable that the failure mode/cause will be discovered during the development phase by testing or analysis activities. Very low. The probability is very low that the failure mode/cause will be discovered during the development phase by testing or analysis activities. Low. The probability is low that the failure mode/cause will be discovered during the development phase by testing or analysis activities. Medium. The probability is moderate that the failure mode/cause will be discovered during the development phase by testing or analysis activities. High. The probability is high that the failure mode/cause will be discovered during the development phase by testing or analysis activities. Very high. It is certain that the failure mode/cause will be discovered during the development phase by testing or analysis activities. Ranking points 10 Application-specific assessment criteria

9 8 7 6 5 4 3 2 1

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FMEA - Risk Assessment - Detection - Col. 12

Process FMEA
General assessment criteria
Improbable. The failure will not or cannot be detected. Very low. The probability of detecting the failure is very low. Low. The probability of detecting the failure is low. Medium. The probability of detecting the failure is moderate. High. The probability of detecting the failure is high. Very high. The probability of detecting the failure is certain. Certainty of Ranking test method points 10 Application-specific assessment criteria

90%

9 8 7 6 5 4 3 2

98%

99,70%

99,90%

99,99%

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FMEA - Risk Assessment - Detection - Col. 12

General assessment Certainty of Ranking test method points criteria
Improbable. The failure will not or cannot be detected. Very low. The probability of detecting the failure is very low. Low. The probability of detecting the failure is low. 90% 10

Random failures dependent on the failure cause

No testing or random sample testing.

Systematic failures dependent on the failure cause

No testing, applicable SPC rules per QA-Information not complied with. Visual/manual inspection *
Random sample testing * of a measureable characteristic 100% visual/manual inspection Random sample testing SPC * (applicable SPC rules as per QA-Information complied with)

100% visual inspection (e.g. surface finish or bubble method for leak testing) 100% manual testing (e.g. strength test of plugged connectors)

Depending on: capability, stability and monitoring of the test equipment ** small/large sample size manual/automati c sample removal manual/automati c registration of measurement data different test method for rework

98%

8 7

100% automatic testing of a measureable characteristic (e.g. length, current, leaks, flow rate) 100% automatic testing with yes/no result

Depending on: capability, stability and monitoring of the test equipment **

Medium. The probability of detecting the failure is moderate. High. The probability of detecting the failure is high.

99,70%

6 5 4 3 2

99,90%

Manual selection with/without confirmation, no/manual/autom-atic identification autom. selection with/w/o automatic identification different test method for rework

100% automatic testing

Very high. The probability of detecting the failure is certain.

99,99%

** see booklet Quality assurance in the Bosch Group, Volume 10

* with traceability and 100% testing of lots with bad parts

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SRD-Q/07.10.2003

FMEA - Risk Assessment - RPN - Col. 13

Definition : The Risk Priority Number - RPN - is the product of the individual rankings RPN = S x O x D Comments : Actions Mandatory for - RPN > 125 -O>3

Question : Which failure causes have RPN > 125 limit and/or individual rankings O > 3 agreed limit?

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SRD-Q/07.10.2003

FMEA - Quality Improvement Actions - Col. 14

General Guidelines :
System FMEA Some departments have defined: Depending on the detail level of the FMEA (system, sub-system, component), the limit for implementation of quality improvements should be an RPN between 60 and 300.( 300 only for SW-or electrical FMEA ) Design FMEA For high O-rankings, actions have to be implemented to ensure achievement of the defined quality target for the product at SOP. This means that generally O = 2 to 3 should be achieved. The target in future is O = 1 ! Means of detection have to be performed to ensure achieving quality targets. Process FMEA For safety parts, the target is O = 1. If this cannot be achieved, then suitable means of detection must be installed to ensure that no defective parts are delivered to the customer. If the probability of failure occurrence is high, then actions have to be implemented to achieve the quality target. Generally, this requires controlled processes, i.e. Cpk > 1,33 1,67 or O = 1 or 2

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SRD-Q/07.10.2003

FMEA - Quality Improvement Actions - Col. 14

Brain-storm and generate actions :

Definition : Actions decided and to be implemented serve to reduce risk of failure by : 1. 2. 3. 4. 5. Totally avoiding the failure cause Totally avoiding the failure mode Reducing the probability of the failure cause Limiting the effects of the failure mode Increasing the probability of detecting the failure mode or cause

Comments : - During this phase, the team should look for any imaginable improvement

ideas. - FMEA is a creative technique and a helpful tool for this . - Failure prevention actions always have priority.

- Failure detection is usually expensive and does not improve quality. Question : Which quality improvement actions are possible?

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SRD-Q/07.10.2003

FMEA - Quality Improvement Actions - Col. 14

Prioritise and select actions :

Definition : The proposed actions are selected according to: - sufficient reduction of the risk priority numbers and - lowest possible costs and - shortest date of introduction

Comments : - Actions to prevent the failure mode or cause have to be checked for

effectiveness. Actions to reduce S, O and D have to be assessed according to the FMEA ranking tables. Actions to reduce S, O and D might be possible to be combined. Costs and deadlines have to be determined for the lowest risk numbers. Select the best-suited actions and, after agreeing to implement them, enter the expected ranking in column 14 (in parenthesis). Responsibility (R:) and implementation date (I:) must be entered.

Question : Which of the proposed actions are the most suitable?

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SRD-Q/07.10.2003

FMEA - Quality Improvement Actions - Col. 14

Implement actions decided by FMEA Team and Update FMEA document :

Definition : Actions that have been selected and agreed upon must be implemented according to schedule.
Comments : - After implementation of the action, the new rating for O and D is

compared with the old estimated rating and the accepted ratings and RPN are entered in the respective columns (Col. 11,12,13).

- The current, applicable rating is always written without parenthesis. - The original rating remains for comparison and is written in rectangular brackets [ ].

Question : - Is there a schedule for implementation of all improvement actions? - Were all improvement actions implemented on time? - Were the improvement actions effective = ( ) - ranking?

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SRD-Q/07.10.2003

FMEA - Quality Improvement Actions - Col. 14

FMEA
PRODUCT QUALITY : PART NO. ASSURANCE : NO COMPONENT FUNCTION . OR PROCESS FAILURE MODES FAILURE EFFECTS C FAILURE CAUSES FAILURE PREVENTION FAILURE DETECTION S

10 8

PAGE : DEPT. : FMEA - NO. : DATE O : D RP R:/I N ACTIONS :14 11 12 13

Condition after FMEA

6 336

> Limit

(8 3

6 144) Failure Prevention Action R : Dept I : CW/Yr. Failure 48) Detection Action R : Dept I : CW/Yr

(8 3 2

FMEA Goal : No open actions at SOP !

[8 7 [8 3

6 336] Old ranking 6 144] Failure Prevention Action completed 48 Failure Detection Action completed

Improved condition after both actions are completed

S = Severity of failure effects R = Responsible Department O = Failure occurrence probability I = Date of Implementation

3 2

D = Failure detection probability Risk Priority Number RPN = S x O x D C = Risk Class/Spl. Characteristics Classification * System, Design, Process

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SRD-Q/07.10.2003

FMEA - Management Reporting

FMEA-Monitoring and Reporting Method

350

295
300

SOP
250

Planned Actions 244

200

Number of Actions

150

Implemented Actions
100

50

Time Scale (Recommended reporting frequency - Monthly)

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SRD-Q/07.10.2003

FMEA - Efficiency of FMEA

Correct Analysis is guaranteed by precise definition and knowledge of the concepts of the design / process, Systematic procedure for complete coverage of the product and production sequences, Clear and un-ambiguous method of Analysis and Evaluation, Exchange of information and opinion forming in the working group, Preventive avoidance of Failures in Development and in Production Cost saving due to reduction in subsequent product or process changes, Clear documentation of causes and measures for avoiding Failures and its repetition
SRD-Q/07.10.2003

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FMEA - Mistakes in FMEA

Incomplete and/or Pseudo FMEA, Inadequate FMEA - not all Failure modes considered & too few Failure causes listed, Actions for Failure prevention not considered, Description of Failure Modes, effects, causes, prevention & detection actions are inadequate and/or ambiguous, Failure mode, effect, cause mixed-up, Product function (Target requirements) and Process function (Drawing requirements) mixed-up, Too long time taken for brain-storming for Causes and actions, Casual involvement of Team members in discussions.

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SRD-Q/07.10.2003

FMEA Additional Information

FMEA must be supported : - Organisational structure - Co-ordinators in Corporate and Dept. levels - Encouraging and releasing engineers for FMEA training - Inclusion of FMEA in deadline schedules FMEA must be demanded : - Corporate objective : Preventive Quality Assurance - As a safeguard in respect of producer liability - More stringent customer requirements FMEA must be understood : - Training in FMEA basic seminar and refresher course - Advanced seminar for Co-ordinators - Exchange of experience between FMEA users.

Slide 72

FMEAandQA72.ppt

MICO/Kailasam 18.8.2000

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SRD-Q/07.10.2003

FMEA - Computer support for FMEA

IQ FMEA software is currently used at RB:

Fmea.exe

Both tools can be downloaded from the ZQ server to your PC via Intranet.

IQ-FMEA
Structure the system Link to failure effects with the failure network Analysis and statistic functions Several languages Create summaries, cover sheets and schedules Choice of form sheets (VDA, QS9000, RB) Data administration

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SRD-Q/07.10.2003

FMEA - Summary

FMEA is
- A systematic method for early, analysis of functional failure, - Applicable to SYSTEMS, PRODUCTS and PROCESSES, - A structured method for farsighted, all-embracing investigation of all potential failure modes, failure causes and their effects, - A method of qualitative failure evaluation and revealing risks of failure, - A method for avoiding or reducing risks of failure by introducing suitable improvement measures.

Conclusion :
- FMEA is an up-to-date & effective technique for failure prevention and reducing development cost and time, which leads to customer satisfaction.
Slide 74 FMEAandQA74.ppt MICO/Kailasam 18.8.2000

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SRD-Q/07.10.2003