Process Failure Mode and Effects Analysis

COURSE MATERIAL ON

Failure Mode and Effect Analysis (FMEA)

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Process Failure Mode and Effects Analysis Failure Modes and Effects Analysis (FMEA) is a methodology for analyzing potential reliability problems early in the manufacturing cycle where it is easier to take actions to overcome these issues BEFORE HAND, thereby enhancing reliability through a strong manufacturing process. It is an analytical technique to assure that potential failure modes and their associated causes have been considered and addressed FMEA is used to 1) Identify potential failure modes, 2) Determine their potential effect on the operation of the product, and 3) Identify actions to mitigate these potential failures. 4) A crucial step is anticipating what might go wrong with a product/process. While anticipating every failure mode may not be possible, the development team should formulate as extensive a list of potential failure modes as possible. The early and consistent use of FMEAs in the design process allows the engineer to design out failures and produce reliable, safe, and customer pleasing products. FMEAs also capture historical information for use in future product improvement. Often the engineer uses safety factors, as a way of making sure that the design will work and protected the user against product or process failure. As described in a recent article: "A large safety factor does not necessarily translate into a reliable product. Instead, it often leads to an over designed product with reliability problems." Hence FMEA is crucial. FMEA is a systemized group of activities to: 1. Recognize and evaluate the potential failure of a product / process and its effects 2. Identify actions which could eliminate or reduce the chance of potential failure occurring 3. Document the process
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Process Failure Mode and Effects Analysis

Benefits of FMEA FMEA is designed to assist the engineer improve the quality and reliability of design / process.

Improve product/process reliability and quality Increase customer satisfaction Early identification and elimination of potential product/process failure modes Prioritize product/process deficiencies Capture & document engineering/organization knowledge Emphasizes problem prevention Documents risk and actions taken to reduce risk Provide focus for improved testing and development Minimizes late changes and associated cost Catalyst for teamwork and idea exchange between functions

Common Definitions: Failure: A Failure of a component, assembly or system is defined as a state when it fails to meet the requirements or function in accordance with the design intent. (Ex. Not meeting the specification of tolerance, hardness.) Failure Mode: A Failure Mode is the manner / way in which a component, assembly or system failure occurred.

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Process Failure Mode and Effects Analysis Who should do FMEA? 1. Cross Functional Team Effort with a leader 2. Team of knowledgeable individuals Ex. Expertise in Manufacturing, Assembly, Quality etc. 3. Team should include representatives of sub-contractors and/or customers FMEA Timing The FMEA is a living document. Throughout the product development cycle change and updates are made to the product and process. These changes introduces new failure modes. It is therefore important to review and/or update the FMEA when:

A new product or process is being initiated (at the beginning of the cycle). Changes are made to the operating conditions the product or process is expected to function in. A change is made to either the product or process design. The product and process are inter-related. When the product design is changed the process is impacted and vice-versa. New regulations are instituted. Customer feedback indicates problems in the product or process Pro-Active rather than reactive

Benefits / Advantages of FMEA 1. Avoids late change crisis 2. Reduces or eliminates chance of implementing corrective change 3. Excellent technique for preventive action 4. Interactive process which is never ending

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Process Failure Mode and Effects Analysis Types of FMEA

System - focuses on global / whole system functions - Power transmission system / car functioning. Design - focuses on components and subsystems - Axle shaft Process - focuses on manufacturing and assembly processes - Heat treatment

Requirements Process FMEA shall consider all processes Aiming at defect prevention rather than defect detection Use PFMEA manual & CFT / MDT approach Process Function/ Requirements: Specify the description and Function of the process List out the expected Outputs of the Process Examples: Process function / description Turning Drilling Radius machining Threading Plating

We need a detailed process flow chart for the job / item for which we are planning to carry out FMEA. Requirements for Turning process - Outer diameter as specified - Run-out requirement - Good surface finish (as specified) Potential Failure Mode: Defined as the potential ways in which the above requirements cannot be met?

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Process Failure Mode and Effects Analysis Two critical Assumptions are 1. Consider all inputs are acceptable 2. Consider the Design is acceptable Methodology: List the failure modes those are possible to occur against the requirements specified in the previous column. Apart from Engg. Specification, what would a customer consider objectionable Each failure should be listed in technical terms Looking at similar products or processes and the failures that have been documented for them is an excellent starting point. CUSTOMER is -Next operation. -Subsequent Operation. -End user EXAMPLE: OD requirement can fail in 2 ways UNDERSIZE OR OVERSIZE Run out can fail through.. Good surface finish can fail through..

Potential Effect(s) of Failure: The potential effects, the failure is likely to have on the, 1) Next operation 2) Subsequent operation 3) Customer /End user/ Environment Talk in terms of the effects using the terminology specified in Severity rating table. For each failure mode, more than one effect can be listed. Examples: - Cannot get located - Does not fit /Does not match - Scrap, re-work - Vehicle / item inoperable - Loss of primary function - Customer dissatisfaction
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Process Failure Mode and Effects Analysis Severity: The seriousness of the effect that it can cause. The amount of damage that it can cause which is tried to be quantified. What is the need to quantify? WE CANNOT IMPROVE WHAT WE CANNOT MEASURE. Methodology: Assess the seriousness of the effect in a 1-10 scale This rating applies to EFFECT only (i.e. previous column) Consult subsequent Manufacturing / Assembly plant Consider the Design FMEA which could have listed out the effects of potential failures 5) Safety related effects should be rated in Nos.9 or 10 6) While giving ranking consider only the required criteria (i.e. next operation / vehicle)
1) 2) 3) 4)

Classification: Classify special process characteristics (e.g. critical, key, major) Potential Cause(s) / Mechanism (s) of Failure: The causes should be listed in technical terms and not in terms of symptoms. Examples of potential causes include: 1. List the first level potential causes such as Man Machine Tool Process parameter Fixture etc.

2. List the root causes under the first level causes using WHY, WHY, analysis. 3. Describe the causes in such a way that they can be eliminated or controlled 4. Dont use ambiguous statements such as operator mal- functioning fixture problem etc.
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Process Failure Mode and Effects Analysis 4) Use the cause and effect diagram, if required 5) Consider input materials last. Examples: Under Man - Fails to clean / Fails to assemble - Fails to tighten - Mis-locate Under machine - Inadequate lubrication - Excessive vibration - Excessive spindle run-out Under process / method - Improper time / temperature - Inadequate gating / venting Under design - Symmetric design - Difficult to assemble Under Raw Material - Mixed material - New source / Alternate material - Excessive hardness Occurrence: Is the likely hood that the failure mode can occur. Estimate the probability of occurrence on a 1-10 scale Rate against each causes Possible Failure Rates are based on the number of failures that are anticipated during the process execution Use statistical data available from a similar process as a basis for ranking For a new process, if there is no previous experience, use team judgment Dont consider failure detecting measures while giving ranking (100% inspection) Assume that the failures have occurred.

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Process Failure Mode and Effects Analysis

Current Process Controls: Current Controls are mechanisms that prevent the cause of the failure mode from occurring only or which detect the failure before it reaches the Customer. Each of these controls should be assessed to determine how well it is expected to identify, prevent or detect failure modes. After a new product or process has been in use, previously undetected or unidentified failure modes may appear. The FMEA should then be updated and plans made to address those failures to eliminate them from the product/process. Type of Controls: Prevention: Prevent the cause/mechanism of failure or the failure mode from occurring, or reduce their rate of occurrence. EXAMPLES: ERROR PROOFING.. Machine automatically stops when coolant stops preventing bad surface finish Detection: Detect the cause/mechanism of failure of failure mode, and lead to corrective action(s). Examples - Visual Check, - S.P.C - On-line monitoring - Post-process evaluation through inspection ADITYA CONSULTANTS

Process Failure Mode and Effects Analysis List the existing controls, which can prevent/detect the causes or failure mode While listing, specify the frequency of detection measures. Detection: Detection is an assessment of the likelihood that the Current Controls will detect the Cause of the Failure Mode or the Failure Mode itself, thus preventing it from reaching the Customer. Based on the Current Controls, consider the likelihood of Detection using the following table for guidance Assess the probability of controls listed in the previous column, which will prevent/detect the cause or failure mode While giving ranking, assume the failure is occurred Dont assume ranking is low because the occurrence is low Random controls should not influence detection ranking Sampling done on a statistical basis is a valid detection control Risk Priority Number (RPN): Risk Priority Number is the multiplication of severity x occurrence x detection. While calculating RPN, consider only highest severity rating of each failure mode Policy for RPN to take action. - Define a target RPN and anything above that can be considered for action. - Consider only high priority number to take action and review periodically Recommended actions: As a first priority, take action on causes to reduce occurrence ranking The next priority is to consider action on controls to reduce detection ranking. Severity ranking can be reduced by elimination of failure mode by change in processes or design.

Specify the responsibility and target completion date for every action identified
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Process Failure Mode and Effects Analysis

During APQP, the FMEA completion dates should be prior to production run

Action Results: These actions include specific inspection, testing or quality procedures; selection of different components or materials, redesign of the item to avoid the failure mode; monitoring mechanisms; performing preventive maintenance; and inclusion of back-up systems. Describe the verification results Where effectiveness measure is required, specify the targets achieved. Actions Taken After the assessment of the actions taken, re-assess the values of severity, occurrence, detection and RPN

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