Failure Mode & Effect Analysis (FMEA) Training Presentation

Presentation Objectives Understand FMEA concepts and learn when to use them Learn how to identify failure modes in processes and design Know how to organize, plan and run an FMEA project

What is FMEA? A tool used to identify and evaluate failure modes in a process or design, and help determine the causes of those failures Designed to prioritize potential failures based on risk Designed to reduce the chances of failure by driving actions for improvement Presents only the failure modes and does not solve problems on its own

Types of FMEA Design FMEA – Primary focus is product Process FMEA – Primary focus is the process Equipment/Machine FMEA – Primary focus is equipment

FMEA Process Map

When to use FMEA New process development New product development Changes in man, machine, method, materials or environment

FMEA Success Factors A team approach is imperative Accurate data Background knowledge of the process Experienced personnel

FMEA Toolbox Large, open meeting room Large table and wall space with marker boards Paper and post-it notes, note pads Tape for paper and sketches on walls Marker pens Snacks/drinks

Process Analysis Find and review existing process maps, SIPOC analysis, Value Stream Maps, etc. Team must fully understand the how, when and why of each process involved (What is the point of the process?) Walk through the entire process, step-by-step Encourage questions Uncover data and hidden process steps

What is the point? example

What is the point? example What is the point (purpose/objective) of a key? How can it be clearly defined – ask for suggestions (Suggestion) “It is a tool to open doors”: It is designed to do this when doors are locked for the safety and security of the contents This is only one suggestion and may be different than someone else’s – how close is it to other suggestions?

What is a Failure? The condition or fact of not achieving the desired result or outcome; insufficient or non-performing Note: Evaluate processes and understand the point for each process step

What is a Failure Mode? The manner in which a process, equipment or machine can potentially fail. A description of the potential opportunity for non-conformance at a specific point in time Such as – premature operation; failure to operate at a prescribed time; operational failure; or resultant failure (as from a bad set-up)

Failure Mode Considerations How could process steps or pieces of equipment fail their intended functions? Why could a component, document or service be rejected at this particular operation? Voice of the Customer (VOC): What would the customer consider acceptable/unacceptable?

Examples of failure modes (think 8 wastes) Incorrect information Out of round Deformation Undersized Cracks Late/early Dirty Incomplete Under-performing Missing Scratched Ripped Dented Unreadable

What is Effect? To determine effect, consider impact on customer Customer could be: end user, subsequent operation or downstream process or document There can be more than one effect for each failure mode Think about difference in perspective between each type of customer: Internal –vs- external

Severity in FMEA Severity is the level of significance of the effect of the potential failure mode Severity applies to the effect only

Severity Ranking

Potential cause of failure Be specific in describing failure – no ambiguity Ex. The key does not work –vs- The key is worn down and chipped on two teeth List all potential causes in terms of how something could be corrected Find the root cause using analysis tools: C&E, Brainstorming, 5Y’s, etc.

Causes of Process Failure examples Wrong components Missing components Processing the wrong part or document Fatigue Poor control procedures Wrong tools or fixtures; not set-up properly

Occurrence in FMEA Is the frequency a specific failure Cause is likely to arise Review similar processes or products and the failure modes associated with them If similar items not available, use the FMEA Team to assess the items subjectively and then develop guidelines

Occurrence Ranking

Current Controls Existing Process Controls in place which would: (Type 1) Prevent the cause or failure mode from occurring, or reduce the rate of occurrence (Type 2) Detect the cause & lead to corrective action (Type 3) Detect the failure mode Poke Yoke, SPC or post process evaluation

Examples of Process Controls Jigs and fixtures Light curtains and sensors Bar coding with integrated software Training matrix Work Instructions and procedures Order/Job sheets Databases

Detection in FMEA Is the assessment of the likelihood of finding the Failure Mode before The failure occurs The next downstream process Leaving the factory/facility

Detection Ranking

Risk Priority Number (RPN) RPN = Severity x Occurrence x Detection The output of an FMEA is the RPN The RPN is calculated based on information from The potential failure modes; Their effects & causes; & The current ability of the process to detect the failures before they reach the customer Is calculated as the product of three quantitative ratings, each one related to the effects, causes and controls The RPN’s are then sorted & actions are recommended for the top issues

Take Action! When An effect of Failure has a Severity of 8 or higher The product of Severity & Occurrence is high When the RPN is high > 75 or whatever your business decides The RPN is calculated for the entire process or design first Failure Modes with the highest RPN = Highest Priority!

Suggested Actions Minimize Severity through Design modifications or Process modifications Reduce the likelihood of Occurrence by Design or process improvement Improve Detection Poor action but may be necessary

Actions for Improvement Identify the high RPN’s Determine what to do to achieve an improvement Implement the improvement action Recalculate the RPN

Improvement Actions are Visible Should be ‘SMART’ Specific Measurable Achievable Relevant Time bound

Use the FMEA template Follow this link for the template: http://REALKaizen.com