This action might not be possible to undo. Are you sure you want to continue?
Failure Mode and Effective Analysis
• 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
High Risk Failures
An understanding on FMEA
Today’s Customer What is FMEA? The origin of FMEA Underlying principles Scope of FMEA Benefits of FMEA Essential requirements Team formation
Today’s Customer Demanding Expecting Quality in the Products and Services .
Who is the Customer? Not just the end user .
All FMEAs focus on the design. and 3) Document the entire process. the . 2) Identify actions which could eliminate or reduce chance of potential failure occurring. It is complementary to the process of defining what a design or process must do to satisfy the customer. whether it be of the product or the process.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.
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 .
16291 .STD .The Origin of FMEA (National Aeronautics and Space Administration) NASA in mid 1950-1960 MIL .
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 .
. Pareto law 70 % of failures/problems are caused by 30% of causes.Underlying Principles If some thing can go wrong it will. There is always somebody who knew that it will go wrong. The one that goes wrong will be the one that does the maximum damage.
technology or process A modified design or process An existing part or process in their a new application or new environment .Scope of FMEA When is an FMEA required? Concept design/new design.
Benefits of FMEA ISO9000/QS 9000 requirement Customer Satisfaction Reduced repair.knowledge accumulation understanding system functions error/mistake proofing techniques . re-test and down time Complement to design process documentation .
Essential Requirements The team People committed to improve quality of product design to meet customer requirements .
FMEA Quality objectives 1. Consider all major lessons learned in past as inputs 5. Is the result of participation by the right people 8. Is done with efficient & effective use of time . Identify all key / special characteristics 6. Improve the design/process as the case may be 2. Address all high risk failure modes 3. Complete during Window of opportunity 7. Design Analysis / Verification / Verification Plans and control plans consider all identified failure modes 4.
Essential Requirements Schematics Part specifications Function specs Process specs FMEA forms .
5. Collect historic data of rejections. Select the right personnel.Develop Process Flow Chart for Process FMEA 3. Study TGR/TGW reports 6.How to develop and complete FMEA? 1. . Assemble a CFT. Assign responsibilities 2.Develop Block diagram for Design FMEA . Identify possible failure modes for each part/process 7. etc. Exhaustively define Product/Process Design Indent 4. Assess their efforts on a 1 to 10 scale (Severity) .. field failures.
Arrive at Risk Priority Number for each potential cause of failure (S x O x D) . Assess the potential for detection for each failure mode and/or cause on a 1 to 10 scale (Detectability) 14.How to develop and complete FMEA? 8. Identify Detection Controls 13. Estimate the chance of occurrence of each potential cause on 1 to 10 scale (Occurrence Ranking) 10. Assess whether occurrence ranking can be reduced 12. Identify all potential causes for each failure mode 9. Identify Prevention controls 11.
Recommend time bound actions directed at high RPNs and Severity rankings 17. If necessary go back to step 1 . Re-estimate S. Severity Ranking of 9 or 10 requires special attention 18.How to develop and complete FMEA? 15. Verify whether FMEA Quality objectives met. Go back to step 15 19.O. Implement actions in a time bound manner 20. Prioritize based on RPN and Severity 16. Irrespective of RPN value.D and RPN.
have been addressed. caused by process deficiencies. the failure modes and and their associated causes / mechanism. .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 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 • • .
Servicing / Maintenance Activities .Process FMEA – Who is the Customer ? • Normally the End user(s) • But may also include .Downstream Manufacturing Operations .
(Logical requirement. though not specifically mentioned in FMEA Reference Manual.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. All the recommended actions should preferably be completed prior to production trial run to ensure success of PPAP) .
may include Potential Failure Modes on account of Design weaknesses Does not depend on product design changes to overcome process weaknesses However. the resultant product meets the customer needs and expectations . to the extent possible.PFMEA and Design Indent • • • • Assumes that product as designed will meet the Design indent However. takes into account the product design characteristics relative to planned manufacturing or assembly process to assure that.
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 .
or system could potentially fail to meet or deliver the intended function .Potential Failure Mode The manner in which a component. subsystem.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 applies to the effect only . or a redesign of the process. subsystem or component.Estimated on a 1 to 10 scale Severity Ranking .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.
Marginal deviation beyond tolerance affects the performance significantly 2. major. 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. Critical. transition or . Dimensions clearance) affecting fits (interference. or systems that may require additional process controls. 1. significant) for components.g. key.Classification This column is used to classify any special product or process characteristics (e. subsystems.
or is likely to significantly affect customer satisfaction with a product. . Special Product Characteristics: Is a special product characteristics for which reasonably anticipated variation could significantly affect a product’s safety or compliance with governmental standards or regulations.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.
under Inaccurate gauging Improper heat treat – time. Improper programming . Typical failure causes may include. but are not limited to: Improper torque – over. Improper machine set up. described in terms of something that can be corrected or can be controlled. Broken tool .Potential Cause(s) for Failure Potential cause of failure is defined as how the failure could occur. temperature Inadequate or no lubrication Part missing or mislocated Worn tool.
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 .
and lead to corrective action(s). or detect the failure mode or cause/mechanism of failure should it occur. • Detection: Detect the cause/mechanism of failure or the failure mode. or can be post – process evaluation. .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. statistical process control. • Prevention: Prevent the cause/mechanism of failure or the failure mode from occurring. • These controls can be process controls such as error/mistake proofing. or reduce their rate of occurrence.
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 . .
RPN = (S) x (O) x (D) . and detection (D) rankings.Risk Priority Number .R P N The Risk Priority Number is the product of severity (S). occurrence (C).
Recommended Action(s) To reduce the probability of occurrence. . 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. process and /or design revisions are required.
Calculate and record the resulting RPN. . Action Results After the preventive/corrective actions has been identified. Action(s) Taken After the action has been implemented. estimate and record the resulting severity. and detection rankings.Responsibility for the Recommended Action(s) Enter the individual responsible for the recommended action and the target completion date. enter a brief description of the actual action and effective date. occurrence.
Detection ranking > 6 . Severity ranking 8 2.Engineering assessment for preventive/corrective actions 1. Occurrence ranking > 2 and detection ranking > 4 3.
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 . 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.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.
This action might not be possible to undo. Are you sure you want to continue?
We've moved you to where you read on your other device.
Get the full title to continue listening from where you left off, or restart the preview.