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Innovative Approach to FMEA facilitation

Govind Ramu, P.Eng,


ASQ CQMgr, CQE, CSSBB, CQA, CSQE, CRE, ASQ Fellow, QMS 2000 Principal Auditor IRCA (UK) Past Section Chair Ottawa Valley- ASQ Canada http://www.asq.org/sixsigma/about/govind.html

History of the FMEA

The TheFMEA FMEAdiscipline disciplinewas wasdeveloped developedin inthe theUnited UnitedStates States
Military Militaryin in1949 1949(Military (MilitaryProcedure ProcedureMIL-P-1629, MIL-P-1629,titled titled Procedures Proceduresfor forPerforming Performinga aFailure FailureMode, Mode,Effects Effectsand and Criticality CriticalityAnalysis. Analysis.

The Thefirst firstformal formalapplication applicationof ofFMEA FMEAdiscipline disciplinewas wasused usedin in

aerospace aerospacein inmid mid60s. 60s. It Itwas wasused usedas asa areliability reliabilityevaluation evaluationtechnique techniqueto todetermine determine the theeffect effectof ofsystem systemand andequipment equipmentfailures. failures.Failures Failureswere were classified classifiedaccording accordingto totheir theirimpact impacton onmission missionsuccess successand and personnel/equipment personnel/equipmentsafety. safety.

Reference: Reference:SAE SAEJJ1739 1739and andAIAG. AIAG.

What is FMEA?

A Astructured structuredapproach approachto to Identify Identify the the way way in in which which a a design design // process process can can fail fail to to meet meet critical critical customer customerrequirements. requirements. Estimating Estimatingthe therisk riskof ofspecific specificcauses causeswith withregard regardto tothe thefailures. failures. Evaluating Evaluatingthe theCurrent Currentcontrol controlplan planfor forpreventing preventingthe thefailures failuresfrom from occurring. occurring. Prioritizing Prioritizingthe theactions actionsthat thatshould shouldbe betaken takento toimprove improvethe thedesign/ design/ process. process.

When to use FMEA?

FMEA FMEAis isvery verybeneficial beneficialto toconduct conductwhile whiledesigning designinga aproduct productor or process. process. Design DesignFMEA FMEAshould shouldbe bedone doneduring duringinitial initialdesign designof ofthe theproduct. product. Process ProcessFMEA FMEAshould shouldbe bedone doneduring duringdesign designof ofmanufacturing manufacturing process. process. Process ProcessFMEA FMEAcan canbe beperformed performedfor forlegacy legacyproducts productsand andprocesses processes also alsoififthe theprocess processcarry carryhigh highrisks risksto toproduct productquality, quality,customer, customer,safety, safety, etc. etc.

Different Types of FMEA

Design FMEA An analytical technique used primarily by design responsible engineer/Team to assure potential failure modes; causes and effects have been addressed for design related characteristics.

Process FMEA An analytical technique used primarily by manufacturing responsible engineer/Team to assure potential failure modes; causes and effects have been addressed for process related characteristics.

System, Subsystem, Component level FMEA are possible scopes

Definitions
Criticality
Severity
Severity is an assessment of how serious the Effect of the potential Failure Mode is on the Customer. The Criticality rating is the mathematical product of the Severity and Occurrence ratings. Criticality = (S) X (O). This number is used to place priority on items that require additional quality planning.

Critical Characteristics
Critical Characteristics are Special Characteristics defined by organization that affect customer safety and/or could result in noncompliance with government regulations and thus require special controls to ensure 100% compliance.

Occurrence
Occurrence is an assessment of the likelihood that a particular Cause will happen and result in the Failure Mode during the intended life and use of the product.

Detection
Detection is an assessment of the likelihood that the Current Controls (design and process) will detect the Cause of the Failure Mode or the Failure Mode itself, thus preventing it from reaching the Customer.

Risk Priority Number


The Risk Priority Number is a mathematical product of the numerical Severity, Occurrence, and Detection ratings. RPN = (S) X (O) X (D). This number is used to place priority on items than require additional quality planning.

Definitions
Current Controls
FMEA Element Function
A Function could be any intended purpose of a product or process. FMEA functions are best described in verb-noun format with engineering specifications. FMEA elements are identified or analyzed in the FMEA process. Common examples are Functions, Failure Modes, Causes, Effects, Controls, and Actions. FMEA elements appear as column headings in the output form. Current Controls (design and process) are the mechanisms that prevent the Cause of the Failure Mode from occurring, or which detect the failure before it reaches the Customer.

Failure Mode
Failure Modes are sometimes described as categories of failure. A potential Failure Mode describes the way in which a product or process could fail to perform its desired function (design intent or performance requirements) as described by the needs, wants, and expectations of the internal and external Customers.

Cause
A Cause is the means by which a particular element of the design or process results in a Failure Mode.

Effect
An Effect is an adverse consequence that the Customer might experience. The Customer could be the next operation, subsequent operations, or the end user.

Customer
Customers are internal and external departments, people, and processes that will be adversely affected by product failure.

FMEA- A team based effort.

Input is required from shop


floor-supervision through to management. Engineering/ R & D Service. Reliability. Purchasing. Quality Engineering. Supplier Quality Engineering Manufacturing EH & S, ROHS

FMEA Traditional approach


Review design and process using a functional block diagram, system design, architecture and process flow chart. Use a brainstorming approach to gather potential failure modes. Use historical data from customer returns, complaints and internal issues from comparable products or processes. List potential effects, both internal and external, of failure. Assign severity, occurrence and detection (SOD) rankings based on the effect, probability of occurrence of the root cause and ability to detect the root cause before the failure mode happens. Calculate the risk priority number (RPN) by multiplying severity, occurrence and detection rankings. Also, calculate criticality by multiplying severity and occurrence. Prioritize the failure modes (risks) based on RPN score and/or criticality. Take actions to eliminate or reduce the risks.

TRADITIONAL APPROACH

FMEA FMEA DEVELOPMENT DEVELOPMENT PROCESS PROCESS

FMEA FMEA TEAM TEAM

Flow chart

FMEA FMEA Forms Forms

FMEA FMEA # #

Process Process I.D. I.D.

Owner Owner

Prepared Prepared By By

Part PartNo. No.

Due DueDate Date

FMEA FMEA DATE DATE

Core Core Team Team

Process Process Function Function

Pot PotFailure Failure Mode Mode

Failure Failure Effects Effects

Severity Severity

Class Class

Pot Pot Causes Causes

Occurrence Occurrence

Current Current Control Control

Detection Detection

Major issues

Quality of the FMEA Quantity of Completion Fundamental issues- Bundling


of causes! Fill it, Shut it, Forget it*!

* Courtesy: Famous 80s advertisement campaign from Hero Honda Motor cycle manufacturers India. (On fuel economy)

Pitfalls

During development: Not understanding the fundamentals of failure mode effects analysis (FMEA) development. Inadequate representation in the team from subject matter experts. Failing to identify the right inputs for the FMEA. Poor planning before assembling for brainstorming and failure ranking.

During implementation: Breaking the sessions into weekly meetings (thus losing continuity). Using severity, occurrence and detection (SOD) scales that are not representative of the industry, product family or process group. Failing to learn from the risks exposed at the component and modulelevel FMEA while drafting at the system level FMEA. Allowing the rigor of the tool to drive the intensity of initial interactions, causing fatigue for participants.

Pitfalls (Continued)
During implementation: (Continued) Wasting time on risk-rating debates. Failing to follow through on recommended actions. Failing to drive actions across the board in a systemic way. Failing to integrate the learning from design and process FMEAs or to link to control plans, critical to quality characteristics and critical to process parameters.

During sustainability: Not incorporating the identified, mitigated risks into manufacturing guidelines to be used for future product development. Failure to keep the FMEA alive by including feedback from subsequent stages of the product life cycle.

Sources of data
Customer Returns- DPPM data Product Design related E.g. Performance, reliability, etc. Process Design related E.g. Opportunity for error Process Control E.g. Out of Spec, Contamination Customer caused E.g. damage, S/W error, etc. BODY OF KNOWLEDGE Similar sources of data from comparable Products, processes of Organization % Defective, Defects per Unit Process Control E.g. Out of Spec, Contamination Supplier caused E.g. Out of Spec, non conformance, etc.

DFMEA / PFMEA (Potential)


Failure mode-Effects-Causes

Supplier caused E.g. Out of Spec, non conformance, etc. Customer Complaints Customer complaints on product or system performance With No product return or RMA Internal Ongoing Reliability issues Periodic Surveillance E.g. Out of Spec Product or Process Changes E.g. failure, etc.

External Knowledge Known Industry failure -Technical journals, publications, -Conferences, etc.

Supplier feedback Product/Process Design Related E.g. tight unrealistic tolerances, Capability. Process control issues E.g. traceability, yield, etc.

Scope Process (Process FMEA)


Formulate Cross functional Team Understand Customer/Process Requirements. Define the start and end of the Process All team members to walk and observe the process. Get the assemblers/ process operators to explain the process. Team makes notes and observations.

Brainstorm all potential causes for the failure modes

INNOVATIVE APPROACH

Inputs: Process Flow charts, Manufacturing WI, Historical process defect pareto, lessons learned, Etc

Brainstorming Software feature

Microsoft VISIO

Brainstorm all potential local & end effects for the failure modes

Brainstorm all potential failure modes

Utilize process flow chart-break down each step. Use knowledge of previous and existing parts/processes. Review all quality information E.g.: Scrap, rework, RMA,etc. Talk to internal and external customers.

Failure Mode
Failure Modes are sometimes described as categories of failure. A potential Failure Mode describes the way in which a product or process could fail to perform its desired function (design intent or performance requirements) as described by the needs, wants, and expectations of the internal and external Customers. Example: Fiber Damage, Contamination, hairline crack, Dimension oversize.

Effect
An Effect is an adverse consequence that the Customer might experience. The Customer could be the next operation, subsequent operations, or the end user. Example: Does not fit, Cannot load or fasten, poor performance, intermittent failure erratic operation.

Identify potential effects of failure

For each failure mode, identify the effect(s) on the current or next process or customer downstream in manufacturing/assembly process.

Describe the effects of failure in terms of what the customer might notice or experience.

Cause and Effect Cascade with an example


Cause = Corrosion Effect = High Resistance Cause = High Resistance Effect = Insufficient Current
Moisture Cause

Design

Cause Effect
Environmental Exposure

Cause Effect

Effect
Corrosion

Cause = Insufficient Current Effect = Dim Bulb

Cause = Design Effect = Env. Exposure Cause = Env. Exposure Effect = Moisture Cause = Moisture Effect = Corrosion

Cause Effect
Poor Contact (High Resistance)

Cause Effect
Insufficient Current

Cause Effect
Dim Bulb

Courtesy: Elsmar Cove

Determine severity rating

Severity is an assessment of the seriousness of the effect of Potential failure mode to the customer. Severity applies to effect only.

Note: Assigning severity rating should be performed as a team Including customer representative and or Design FMEA engineer. If the customer affected by a failure mode is a user outside the plant, team Should consult them and assign the rating.

Identify all potential causes of failure

How the failure could occur? Describe in terms of factors That can be corrected or controlled. There could be more than one cause for each failure!!

Example:Improper torque, Inaccurate gauging, inadequate lubrication, etc.

Note: Experiments may have to be conducted to determine causes using technical Problem solving.

Management should have control on the cause identified. The cause should be at the root level.

Determine occurrence rating

Occurrence is how frequently the specific failure cause Mechanism is projected to occur. Define Current Controls Systematic methods/devices in place to prevent or detect Failure modes or causes (before the effect happens).
Example: Poke-Yoke, automated control for setup verification

Note: If available from a similar process, statistical data should be used to determine Occurrence ranking.

Determine detection ranking

Detection is an assessment of the probability that the current process control will detect a Potential cause.

Also assess the ability of the process control to detect Low frequency failure modes or prevent from going Into the next process.

Note: Random quality checks are unlikely to detect the existence of an isolated Defect and should not influence the detection ranking. Sampling done on a Statistical basis is a valid detection control.

Current Controls
Design and Process controls are grouped according to their purpose. Type (1)

These controls prevent the Cause or Failure Mode from occurring, or reduce their rate of occurrence.
Type (2)

These controls detect the Cause of the Failure Mode and lead to corrective action.
Type (3)

These Controls detect the Failure Mode before the product reaches the customer. The customer could be the next operation, subsequent operations, or the end user.
The distinction between controls that prevent failure (Type 1) and controls that detect failure (Types 2 and 3) is important. Type 1 controls reduce the likelihood that a Cause or Failure Mode will occur, and therefore affect Occurrence ratings. Type 2 and Type 3 Controls detect Causes and Failure Modes respectively, and therefore affect Detection ratings.

Calculate the Risk Priority Numbers


The Risk Priority Number is the product of Severity (S) X Occurrence (O) X Detection (D) rankings. This value should be used to rank order the concerns In the process using Pareto. The RPN will be between 1and 1000.

Criticality is severity multiplied by occurrence. This is also an important metric. RPN can be reduced by improving the detection, but the process issue may remain intact. Criticality can be reduced only by improving the capability or redesign.

Prioritize Corrective actions

Concentrate on the Highest RPN Do not lose sight on effects with high severity. Think of how the occurrence can be reduced? How the detection can be improved? Where applicable use Mistake proofing techniques. Introduce changes in a controlled manner.

Reassess rankings when action completed

FMEA must be a Live document. Review Regularly. Reassess rankings whenever changes made to product/process. Add any new defects or potential problems when found.

References

Potential Failure Mode & Effects Analysis, fourth edition, Automotive Industry Action Group, 2008. Govindarajan Govind Ramu, Metrics That Trigger Actionable Discussions: Prioritize Process Improvements Using Gauge R&R and SPC Capability, ASQ Six Sigma Forum. Traditionally, NGT is used to collect ideas: www.asq.org/learn-about-quality/idea-creationtools/overview/nominal-group.html In FMEA development, it can be used to collect scores of SOD. Elsmar Cove archived file references.

Bibliography
Quality Training Portal, Resource Engineering Inc., What You Need to Know About Failure Mode and Effects Analysis (FMEA), www.qualitytrainingportal.com/resources/fmea/index.htm. May 2009 QP Standards Outlook Dan Reid- Major Upgrade.

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