Failure Mode & Effects Analysis

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Lack of integration and standardization of Risk Analysis

Risk Analysis of the same process is conducted for Quality, Environmental And Safety / Health, VDA 6.3, ISO 14001, By Different Teams

Integration of Risk Analysis

Integrated Risk Analysis benefits from the use of the same tool – i.e. FMEA for Risk Analysis

The FMEA prioritizes risks based on

Severity x Occurrence x Detection

FMEA (Failure Mode and Effects Analysis) is a tool to perform Risk Analysis.
While Risk Analysis is one key part of the overall Risk Management. FMEA may be the vehicle to perform a Risk Assessment of a particular Function, Process or System within the overall Risk Management.

As a FREE service in support of this Training we are offering to:
analyse, your current FMEA using our advanced FMEA Innovator Software.

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Failure Mode & Effects Analysis

  1. 1. FMEA Innovator The FMEA Innovator provides an intelligent solution for quick methodical assessment and quantification of risks associated with most business situations.
  2. 2. FAILURE MODE AND EFFECTS ANALYSIS <ul><li>Fully User customisable for </li></ul><ul><li>Design; Machine; System, Equipment and Process FMEA’s </li></ul><ul><li>and many other non-standard variants. </li></ul><ul><li>The FMEA Innovator provides an intelligent solution for quick methodical assessment and quantification of risks associated with most business situations. </li></ul><ul><li>With automatic (optional) interaction with Control Plan activities and </li></ul><ul><li>linked generation of graphs, charts and databases, </li></ul><ul><li>the FMEA Innovator provides accurate analysis of risk reduction opportunities. </li></ul><ul><li>Direct interaction with Risk Reduction activities promotes </li></ul><ul><li>constant improvement in a realistic manner. </li></ul><ul><li>Available as a Stand Alone or Integrated version </li></ul>
  3. 3. Knowing WHERE to start an FMEA <ul><li>Starting Point: </li></ul><ul><li>Define the System to be analyzed </li></ul><ul><li>Obtain or develop Process Flow Diagram </li></ul><ul><li>Establish Process Steps for Process Flow </li></ul><ul><li>Describe Functions from Process Steps. </li></ul>
  4. 4. <ul><li>Establish Process Steps for Process Flow </li></ul><ul><li>Step 1: _________________________ </li></ul><ul><li>Step 2: _________________________ </li></ul><ul><li>Step 3: _________________________ </li></ul>Starting Point STEP 3 PROCESS STEP STEP 1 STEP 2
  5. 5. <ul><li>Process Step </li></ul><ul><li>Reflects the sequence of the process (i.e. operation number) and is directly linked to the Function . </li></ul>Starting Point
  6. 6. <ul><li>Process Step and Function is automatically populated from Process Flow </li></ul><ul><li>The Product Requirements generally reflect the Specifications that must be achieved. </li></ul><ul><li>The Process Requirements generally reflect the Operating Conditions that is required for effective Process Control. </li></ul><ul><li>Potential Failure Mode: the way a Process or Product might fail </li></ul><ul><ul><ul><ul><ul><li>can be selected from the Database . </li></ul></ul></ul></ul></ul><ul><li>Potential Failure Effect : effects and consequences of the failure – to both the organization’s processes or to a downstream customer </li></ul><ul><li>Severity : can relate to the </li></ul><ul><ul><ul><ul><ul><li>End User ( S External ) </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Next Process ( S Internal ) </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Effect on Organisation ( S Current ) </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Note: The Severity of the Effect utilizes a numerical scale (usually 1-10) to quantify how “Severe the Effect” would be if the Failure Mode materialized. Severity Scales can be customized by the User and are available as Pop Up aids. </li></ul></ul></ul></ul></ul>Step 1
  7. 7. <ul><li>Process Step up to Potential Failure Mode already Populated ( in Previous Steps ) </li></ul><ul><li>Potential Failure Cause : how the failure could occur, described in terms of something that can be corrected or controlled. </li></ul><ul><li>Prevention Controls : Prevent the Cause of the Failure Mode from happening or reduce its Occurrence. </li></ul><ul><li>Occurrence : to quantify how often the Failure Cause would be expected to happen. It is the likelihood that a specific cause/ mechanism of failure will occur. </li></ul>Step 2
  8. 8. <ul><li>Process Step up to Potential Failure Mode already Populated ( in Previous Steps ) </li></ul><ul><li>Detection Controls : Detect the Failure Mode (and Prevent it from being processed further) with such detection having a pre-determined Reaction Plan </li></ul><ul><li>Responsibility : Identifying the Responsibility will assist in determining the correct allocation in the Detection Scale. </li></ul><ul><li>i.e. an Inspector may be more likely to Detect a Failure Mode than an Operator. </li></ul><ul><li>Detection : to quantify how reliable the Detection Controls are in finding the Failure Mode if it happened. Detection generally refers to the ability to detect the Failure Mode </li></ul><ul><li>Note: do not automatically presume that the detection ranking is low because the occur. </li></ul>Step 3
  9. 9. VIEW / ANALYZE Available as a Stand Alone or Integrated version. a quick and easy method for developing and documenting Control Plans. FAILURE MODE & EFFECTS ANALYSIS CONTROL PLANS RISK REDUCTION
  10. 10. INTEGRATED VERSION The Integrated Version combines FMEA Analysis & Control Plans with Risk Reduction activities and ensures accurate replication of appropriate Data from FMEA to Control Plan thereby saving up to 50% of the time utilised in traditional approaches .
  11. 11. CUSTOM VIEW Customize a condensed FMEA , Control Plan & Risk Reduction by simply hiding unwanted columns.
  12. 12. ACTION PLAN VIEW Enables improvement approval, target date setting, action recording, as well as accurate FMEA updating & review.
  13. 13. CLASSIFICATION Classification ( Y ) should be used to define potential Critical Characteristics and potential Significant Characteristics. Critical characteristics ( Y C ) (Characteristics with a Severity of 9 or 10 ) and are reliant on DETECTION should have associated Recommended Actions. Significant characteristics ( Y S ) ( Severity of 5 -8 & Occurrence of 4 – 10) should have associated recommended actions Top 20% of Failure Modes by RPN Failure Modes RPN
  14. 14. RPN SCALES Scales can be customized by the User and are available as Pop Up aids. T
  15. 15. Database Interaction Databases facilitate User Defined Auto Input and are available for all applicable Columns. These can be pre-set by the FMEA Facilitator , or can be entered “ on the fly ” by the FMEA Team .
  16. 16. Graphical Analysis Graphical Analysis verifies FMEA integrity and readily prioritizes areas for potential Risk Reduction. Analyze SOD Risk though the Process Sequence Analyze SOD Risk in Pareto Format Analyze Severity , Occurrence & Detection Risk though the Process Sequence
  17. 17. TEMPLATES Built-in Templates and a blank customizable template to use for information relating to the FMEA
  18. 18. PRINTING & HELP FUNCTIONS HELP is available both for Software Functions and for General FMEA Information. Auto Print Control pre-selects logical Print Layouts However, the User has full control from their Default or Custom Printer capabilities.
  19. 19. Failure Mode & Effects Analysis - FREE SERVICE Failure Mode & Effects Analysis Lack of integration and standardization of Risk Analysis Risk Analysis of the same process is conducted for Quality, Environmental And Safety / Health, VDA 6.3, ISO 14001, By Different Teams Integration of Risk Analysis Integrated Risk Analysis benefits from the use of the same tool – i.e. FMEA for Risk Analysis The FMEA prioritizes risks based on Severity x Occurrence x Detection FMEA (Failure Mode and Effects Analysis) is a tool to perform Risk Analysis. While Risk Analysis is one key part of the overall Risk Management. FMEA may be the vehicle to perform a Risk Assessment of a particular Function, Process or System within the overall Risk Management .
  20. 20. FREE SERVICE As a FREE service in support of this Training we are offering to: analyse, your current FMEA using our advanced FMEA Innovator Software. http://www.hoquality.com/FMEA/free-support-service.php
  21. 21. Questions? More Information? Quotation? <ul><li>THE HOUSE OF QUALITY </li></ul><ul><li>[email_address] </li></ul><ul><li>[email_address] </li></ul><ul><li>www.hoquality.com </li></ul>

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