QS 9000

Failure Mode and Effective Analysis

Quality
The quality of a product or service is the fitness of that product or service for meeting or exceeding its intended use as required by the customer Marketing and product planning, Product design and development Manufacturing Engineering Purchasing Manufacturing Inspection and test Packing and shipping Customer service

Responsible for Quality

Failure Mode and Effects Analysis

Customer driven approach

for preventing
High Risk Failures

An understanding on FMEA
Todays Customer What is FMEA? The origin of FMEA Underlying principles Scope of FMEA Benefits of FMEA Essential requirements Team formation

Todays Customer
Demanding Expecting

Quality in the Products and Services

Who is the Customer?

Not just the end user

What is FMEA?
FMEA is a systematized group of activities intended to

1) Recognize and evaluate the potential failure of a product/process and the effects thereof,
2) Identify actions which could eliminate or reduce chance of potential failure occurring, and 3) Document the entire process. All FMEAs focus on the design, whether it be of the product or the process. It is complementary to the process of defining what a design or process must do to satisfy the customer. the

What is FMEA?
Reduce Risk Priority Number (RPN)

Risk Priority Number

1 to 1000

Occurrence Ranking
1 to 10

Detection Ranking
1 to 10

Severity Ranking
1 to 10

The Origin of FMEA

(National Aeronautics and Space Administration) NASA in mid 1950-1960 MIL - STD - 16291

Purpose of FMEA?
To identity potential failure modes and evaluate the severity of their effects

To determine potential design/process deficiencies

To focus on eliminating product or process concerns To detect failure modes or their effects

To develop a ranked list of priorities to work on

To identify special characteristics for attention

Underlying Principles
If some thing can go wrong it will. The one that goes wrong will be the one that does the maximum damage. There is always somebody who knew that it will go wrong. Pareto law
70 % of failures/problems are caused by 30% of causes.

Scope of FMEA
When is an FMEA required? Concept design/new design,technology or process A modified design or process An existing part or process in their a new application or new environment

Benefits of FMEA
ISO9000/QS 9000 requirement Customer Satisfaction Reduced repair, re-test and down time Complement to design process
documentation - knowledge accumulation understanding system functions

error/mistake proofing techniques

Essential Requirements
The team
People committed to improve quality of product design to meet customer requirements

FMEA Quality objectives

1. Improve the design/process as the case may be

2. Address all high risk failure modes

3. Design Analysis / Verification / Verification Plans and control plans consider all identified failure modes

4. Consider all major lessons learned in past as inputs

5. Identify all key / special characteristics 6. Complete during Window of opportunity 7. Is the result of participation by the right people 8. Is done with efficient & effective use of time

Essential Requirements
Schematics Part specifications Function specs Process specs FMEA forms

How to develop and complete FMEA?

1. Assemble a CFT. Select the right personnel. Assign responsibilities 2. - Develop Block diagram for Design FMEA - Develop Process Flow Chart for Process FMEA

3. Exhaustively define Product/Process Design Indent

4. Collect historic data of rejections, field failures, etc., 5. Study TGR/TGW reports 6. Identify possible failure modes for each part/process 7. Assess their efforts on a 1 to 10 scale (Severity)

How to develop and complete FMEA?

8. Identify all potential causes for each failure mode

9. Estimate the chance of occurrence of each potential cause on 1 to 10 scale (Occurrence Ranking)
10. Identify Prevention controls

11. Assess whether occurrence ranking can be reduced

12. Identify Detection Controls 13. Assess the potential for detection for each failure mode and/or cause on a 1 to 10 scale (Detectability) 14. Arrive at Risk Priority Number for each potential cause of failure (S x O x D)

How to develop and complete FMEA?

15. Prioritize based on RPN and Severity

16. Recommend time bound actions directed at high RPNs and Severity rankings
17. Irrespective of RPN value, Severity Ranking of 9 or 10 requires special attention 18. Re-estimate S,O,D and RPN. Go back to step 15 19. Implement actions in a time bound manner

20. Verify whether FMEA Quality objectives met. If necessary go back to step 1

Process FMEA?
A Process FMEA is an analytical technique used by a manufacturing engineer or team as a means to assure that to the extent possible, the failure modes and and their associated causes / mechanism, caused by

process deficiencies, have been addressed.

The Process FMEA

Identifies the process functions an requirements

Identifies potential product and process related failure modes

Assesses the effects of the potential failures on the Customer Identifies the potential manufacturing and assembly process causes and identifies process variables on which to focus controls for occurrence reduction or detection of the failure conditions Identifies process variables on which to focus process controls

The Process FMEA

Develops a ranked list of potential failure modes thus establishing a priority system for preventive and / or corrective action considerations
Documents the results of the manufacturing or assembly process To address all manufacturing operations from individual components to assemblies

Process FMEA Who is the Customer ?

Normally the End user(s)

But may also include

- Downstream Manufacturing Operations - Servicing / Maintenance Activities

The Process FMEA When to Start / Complete ?

Should be initiated before or at Feasibility Stage, prior to tooling for production To be completed before finalisation of Pre-launch Control Plans. (Logical requirement, though not specifically mentioned in FMEA Reference Manual. All the recommended actions should preferably be completed prior to production trial run to ensure success of PPAP)

PFMEA and Design Indent

Assumes that product as designed will meet the Design indent

However, may include Potential Failure Modes on account of Design weaknesses Does not depend on product design changes to overcome process weaknesses However, takes into account the product design characteristics relative to planned manufacturing or assembly process to assure that, to the extent possible, the resultant product meets the customer needs and expectations

Team Formation

Main FMEA Terms

Potential Failure Mode Potential Effect(s) of Failure Severity Classification Potential Cause(s) of Failure Occurrence Current Process Controls Prevention Current Process Controls Detection Detection Risk Priority Number

PFMEA FORMAT

Potential Failure Mode

The manner in which a component, subsystem, or system could potentially fail to meet or deliver the intended function - described in physical / technical terms - not as symptoms necessarily by the customer Typical failure modes:
Cracked
Fractured Oxidized

Sticking
Loosened

Deformed
Leaking

Short circuited (Electrical)

Potential Effect(s) of Failure

It is defined as the effects of failure mode on the customer(s) Describe the effects of the failure in terms of what the customer might notice or experience. For end user, the effects should always be stated in terms of product or system performance such as:
Noise Inoperative Rough Unstable Erratic operation Poor appearance Unpleasant odor Leak

Operation impaired Intermittent operation

Potential Effect(s) of Failure

If the customer is the next operation or subsequent operation(s)/location(s) should be stated in terms of process/operation performance, such as:
Cannot fasten Cannot bore/tap Does not fit Does not connect

Cannot mount
Cannot face Damages equipment

Does not match

Causes excessive tool wear Endangers operator

Severity
Severity is the rank associated with the most serious effect for a given failure mode. A reduction in severity ranking index can be effected through a design change to system, subsystem or component, or a redesign of the process. Severity applies to the effect only

- Estimated on a 1 to 10 scale

Severity Ranking

Classification
This column is used to classify any special product or process characteristics (e.g. Critical, key, major, significant) for components, subsystems, or systems that may require additional process controls. This column may also be used to highlight high priority failure modes for engineering assessment. Special characteristics: The dimensions and features affecting the following qualify for special characteristic, 1. Marginal deviation beyond tolerance affects the performance significantly 2. Dimensions clearance) affecting fits (interference, transition or

Classification
Special Process Characteristics: is a process characteristic for which variation must be controlled to some target value to ensure that variation in a process or a special product characteristic is maintained to its target value during manufacturing and assembly.
Special Product Characteristics: Is a special product characteristics for which reasonably anticipated variation could significantly affect a products safety or compliance with governmental standards or regulations, or is likely to significantly affect customer satisfaction with a product.

Potential Cause(s) for Failure

Potential cause of failure is defined as how the failure could occur, described in terms of something that can be corrected or can be controlled. Typical failure causes may include, but are not limited to:
Improper torque over, under Inaccurate gauging Improper heat treat time, temperature Inadequate or no lubrication Part missing or mislocated Worn tool, Broken tool , Improper machine set up, Improper programming

Occurrence
Occurrence is the likelihood that a specific cause / mechanism will occur. Preventing or controlling the causes/mechanisms of failure through a design or process change is the only way a reduction in the occurrence ranking can be effected. Estimated on a 1 to 10 scale Occurrence Ranking

Current Process Controls

Current Process Controls are descriptions of the controls that either prevent to the extent possible the failure mode or cause/mechanism of failure occurring, or detect the failure mode or cause/mechanism of failure should it occur. These controls can be process controls such as error/mistake proofing, statistical process control, or can be post process evaluation.

Prevention: Prevent the cause/mechanism of failure or the failure mode from occurring, or reduce their rate of occurrence.
Detection: Detect the cause/mechanism of failure or the failure mode, and lead to corrective action(s).

Detection
Detection is the rank associated with the best detection control listed in the process control column.

- Estimated on a 1 to 10 scale

Detection Ranking

Risk Priority Number - R P N

The Risk Priority Number is the product of severity (S), occurrence (C), and detection (D) rankings.

RPN

(S) x (O) x (D)

Recommended Action(s)
To reduce the probability of occurrence, process and /or design revisions are required. An action oriented study of the process using statistical methods could be implemented with an ongoing feed back of information to the appropriate operations for continuous improvement an defect prevention Only a design and/or process revision can bring about a reduction in the severity ranking The preferred method to accomplish a reduction in the detection ranking is the use of error/mistake proofing methods.

Responsibility for the Recommended Action(s)

Enter the individual responsible for the recommended action and the target completion date.

Action(s) Taken
After the action has been implemented, enter a brief description of the actual action and effective date.

Action Results
After the preventive/corrective actions has been identified, estimate and record the resulting severity, occurrence, and detection rankings. Calculate and record the resulting RPN.

Engineering assessment for preventive/corrective actions 1. Severity ranking 8 2. Occurrence ranking > 2 and detection ranking > 4 3. Detection ranking > 6

PFMEA - Detection evaluation criteria

Detection ranking
1 2

Machining
Poka Yoke in station (Prevention type) Poka Yoke in station (Detection type)

Assembly
Poka Yoke in station (Prevention type) Poka Yoke in station (Detection type)

Remarks
Cannot produce discrepant part Cannot pass discrepant part; Automatic detection with automatic stop feature Cannot accept discrepant part Nil

3 4

5 6

7 8 9 10

Poka Yoke in subsequent Poka Yoke in operations subsequent stations Set up verification; Automatic testing with In-process sample automatic shut off gauging with Xbar-R chart 100% variable gauging !00% manual testing after processing with interlocks Go/No Go gauging with 100% manual testing attribute charting / with visual inspection Sampling on statistical basis Visual inspection by operator + 100% PDI check Visual inspection by operator only Indirect/random checks by QA/ Conformance Cannot detect or not checked

Interlocks for testing sequence Testing using soap suds/ Dipping in water

Nil Nil Audit checks / Checks indicated in QCPC Nil