Failure Modes Effects Analysis (FMEA) Six Sigma Continuous Improvement Training Six Sigma Simplicity Continuous Improvement - FMEA

Objectives Discuss what FMEA is for Review how to use FMEA Address steps involved in constructing an FMEA Using FMEA for risk assessment Continuous Improvement - FMEA

What is FMEA? FMEA: Failure Modes Effects Analysis. A proactive, preventative evaluation. What does it do? Helps to evaluate how a process or design can fail Helps to quantify risk factors assisting in prioritizing current or future potential projects Can act as a forum for process or design improvements and preventative actions Assists in identifying weaknesses in current control plan May lead to reduction in manufacturing costs to improved design or set-up processes Continuous Improvement - FMEA

Some Sources of Risk? Total Risk Potential Safety Hazards Poor control plans & SOP’s Unclear Customer Expectations Vague Workmanship Standards Raw Material Variation Total Risk Machine Reliability/Poor Process Capability Poorly developed Specification Limits Measurement Variation (On- Floor and QC) The FMEA seeks to attack and identify RISKS through an RPN number. D. H. Stamatis, FMEA:FMEA from Theory to Practice, Quality Press, 1995 Continuous Improvement - FMEA

Types of FMEA? PFMEA --- Process or Potential Failure Modes Effects Analysis. May be used where a process needs to be evaluated for potential failures. May be a manufacturing or transactional process DFMEA --- Design Failure Modes Effects Analysis. Generally used in Research/Development where designs are analyzed for potential weaknesses SFMEA --- System Failure Modes Effects Analysis. Used to evaluate system issues that cross corporate functions Continuous Improvement - FMEA

Process Mapping / Brown Paper Initial Capability Study Where Can FMEA Fit In? Process Mapping / Brown Paper X-Y Matrix Initial Capability Study FMEA Continuous Improvement - FMEA

When Do I Do an FMEA? They can begin as soon as a project is selected for a certain process, system or design First one usually started no later than Measure Phase, or beginning of the Analysis Phase FMEA document is a dynamic document Should be revised as improvements or changes made to a process Also done in the Control Phase of the project for use as a Control Plan. Continuous Improvement - FMEA

Who Does an FMEA? This is a team process. Team sizes may vary, but recommended size is approximately 5-7 members. Depending upon the type of FMEA being done, members may come from: Research and Design Engineers Manufacturing Supervisors, Manufacturing Engineers, Manufacturing Operators (very important members) Quality Department Members Sales Marketing Testing or Validation Department Human Resources Maintenance Supplier Continuous Improvement - FMEA

How to Do an FMEA 1. For each Process Input, determine the ways in which the input can fail (these are failure modes) 2. For each failure mode associated with the inputs, determine effects 3. Identify potential causes of each failure mode 4. List the current controls for each cause 5. Define or adapt definitions of Severity, Occurrence and Detection appropriate to what is being evaluated 6. Assign Severity, Occurrence and Detection ratings to each cause 7. Calculate RPN (spreadsheet does it automatically) 8. Determine recommended actions to reduce high RPN’s 9. Take appropriate actions and document 10. Update FMEA documents as appropriate 11. Recalculate RPN’s Continuous Improvement - FMEA

FMEA Document Continuous Improvement - FMEA

Sales creates quote/orders FMEA: Step 1 Process Function (or step) --- Refers to the function of a process or step within a process. A manufacturing example might be “Drilling Holes,” and a transactional example, “Create Sales Orders.” Sales creates quote/orders Continuous Improvement - FMEA

Sales creates quote/order FMEA: Step 1 (cont’d) Failure Mode --- the way a process input may fail. Can be associated with a defect (in manufacturing) or a process input within a transactional process. A manufacturing example would be: “Wrong Hole Size” or a transactional example being, “Incorrect Information.” Sales creates quote/order Incorrect info Continuous Improvement - FMEA

FMEA: Step 2 Effect --- The impact on process or customer requirements. This impact or result may be on a downstream process, the system, design or end-user customer. A manufacturing example may be, “Parts scrapped” and a transactional example could be, “Wrong person gets benefits”: Sales creates quote/order Incorrect info Customer does not receive product Customer receives incorrect product Order cancelled Continuous Improvement - FMEA

FMEA: Step 3 Cause --- Source of the failure mode. Sales creates quote/order Incorrect info Customer does not receive product Customer gave wrong info Customer gave wrong info Type/operator Customer receives incorrect product Customer changes mind Part deviation Continuous Improvement - FMEA

FMEA: Step 4 Current Process Controls --- Methods/devices in place to prevent or detect failure modes or causes. Prevention consists of mistake-proofing, automated controls and set-up verifications. Controls consists of audits, checklists, Inspection, laboratory testing, training, SOP’s, preventive maintenance, etc. Customer gave wrong info Repeat/verify info with customer (shipping vs billing address) Quality review by random sampling Continuous Improvement - FMEA

FMEA Step 5: Severity Addresses how severe the failure mode and effect is to the customer. Also may address safety concerns. See below: Effect Criteria: Severity of Effect Defined Ranking Hazardous: Without Warning GRAVE SAFETY concern/ violation, Possible Injury/ Death to customer or employee 10 With Warning Major Safety/ / Health/ Environmental concern and/ or may be illegal 9 Very High Render the product or service unfit for use 8 High Cause extreme Customer dissatisfaction . 7 Moderate Result in partial malfunction, major customer dissatisfaction i 6 Low Cause a loss of performance likely to result in a complaint 5 Very Low Cause minor performance loss 4 Minor Cause a minor nuisance, can be overcome with no loss 3 Very Minor Be unnoticed, minor effect on performance 2 None Be unnoticed and not effect performance. 1 Also refer to the AIAG guidebook: Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, 1995. Page 35. Chrysler Corporation, Ford Motor Company, General Motors Corporation. Continuous Improvement - FMEA

Guidelines for Failure Possible Failure Rates FMEA Step 5: Occurrence Addresses the frequency the failure mode occurs. See below: Guidelines for Failure Possible Failure Rates Probability Ranking Very High: Failure is almost inevitable More than one per day > 30% 10 Once every 3 to 4 days £ 30% 9 High: Generally associated with processes similar to previous processes that have often failed. Once per week £ 5% 8 £ 1% Once per Month 7 £ .03% Moderate: Generally associated with processes similar to previous processes that have experienced occasional failures but not in major proportions : Once every 3 months 6 Once every 6 months £ 1 per 10,000 5 , Once a year 4 . £ 6 per 10,000 Low: Isolated failures associated with similar processes. Once every 1 – 3 years £ 6 per million 3 Very Low: Only isolated failures associated with almost identical processes Once every 3 – 6 years £ 3 per 10 million 2 Remote: Failure is highly unlikely. No failures ever associated with almost identical processes. Once every 6 – 50 years £ 2 per billion 1 * Also refer to the AIAG guidebook Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, 1995. Page 39. Chrysler Corporation, Ford Motor Company, General Motors Corporation. Continuous Improvement - FMEA

FMEA Step 5: Detection Addresses the ability of methods or systems in place to detect the failure if it occurs. See guidelines below: Criteria: Detection Ranking Almost Impossible Defect caused by failure is not detectable. 10 Very Remote Occasional units are checked for defects. 9 Remote Units are systematically sampled and inspected. 8 Very Low All units are manually inspected. 7 Low Manual inspections with mistake-proofing. 6 Moderate Process is monitored (SPC) and manually inspected. 5 Moderately High SPC utilized with immediate reaction to out-of-control (OOC) condition. 4 High SPC (above) with 100% inspection (for OOC condition). 3 Very High All units are automatically inspected/ tested/ verified. 2 Almost Certain Defect is obvious and kept from affecting Customer. 1 * Also refer to AIAG guidebook Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, 1995. Page 39. Chrysler Corporation, Ford Motor Company, General Motors Corporation. Continuous Improvement - FMEA

FMEA Step 5: Additional Information One thing that will save a lot of time is if the Black Belt defines the scales and definitions previous to the FMEA meeting Scales do not have to be 1-10. They may also be 1, 3, 7, 10 or similar scale Additional characteristics may be factored into the RPN. For example, one Black Belt added an “Impact” characteristic. The intent was to quantify the impact to the process Continuous Improvement - FMEA

FMEA: Step 6 We could put the following scores for the information we had below: Customer does not receive product Repeat/verify info with customer (shipping vs billing address) 4 Customer gave wrong info 2 2 4 Quality review by random sampling Customer gave wrong info 2 4 4 Repeat/verify info with customer (shipping vs billing address) Type/operator 3 2 Severity will continue all the way down for the issue on the left… Continuous Improvement - FMEA

Let’s Look at Each Characteristic FMEA: Step 7 Risk Priority Number (RPN) --- The risk priority number allows the team to quantify various failure modes to assist in prioritizing the team’s improvement efforts. The RPN is the product of: Severity x Occurrence x Detection The value of each of these characteristics is determined by the team. The higher the RPN, the higher priority the potential failure mode becomes. Prevention becomes the focus of the team Let’s Look at Each Characteristic Continuous Improvement - FMEA

FMEA: Step 7 We could put the following scores for the information we had below: We Get An RPN =4X2X2= 16 Customer does not receive product 4 Customer gave wrong info 2 Repeat/verify info with customer (shipping vs billing address) 2 16 4 Quality review by random sampling Customer gave wrong info 2 4 32 4 3 Repeat/verify info with customer (shipping vs billing address) Type/operator 2 24 Continuous Improvement - FMEA

Causes of Failure (X’s) FMEA: Before Actions 12 2 Repeat/verify info with customer (shipping vs billing address) 3 Operator error 8 Customer gave wrong info (credit card) Order delayed 16 Wrong address 4 Order not deliverable 60 5 Pre-production report Part has EOL/leadtime increased Order cancelled 1 Call customer Part deviation Verify order with customer Customer changes mind Customer receives incorrect product 48 Quality review by random sampling Type/operator 24 32 Customer gave wrong info Customer does not receive product Incorrect info Sales creates quote/order RPN D E T Current Controls O C Causes of Failure (X’s) S E V Failure Effects Failure Mode Process Function Continuous Improvement - FMEA

FMEA: Step 8 Recommended Actions --- Actions that are decided on by the team that will eliminate, reduce the impact or prevent the failure mode from occurring. Customer gave wrong info 2 Quality review by random sampling 4 32 Confirm Customer Requirement before issue order Continuous Improvement - FMEA

FMEA: Step 9 Responsible Person & Target Date --- Actions have a much better rate of completion when they are assigned a person with an expected date of completion. Once completed, update the FMEA form and fill out the “Taken Action” field. R. Day 12-Dec-02 Customer gave wrong info 2 Quality review by random sampling 4 Confirm Customer Requirement before issue order 32 Continuous Improvement - FMEA

FMEA: Step 10 and 11 10. Update FMEA documents as appropriate 11. Re-assign the re-assign Severity, Occurrence and Detection ratings. Then Recalculate RPN’s Quality review by random sampling 32 Confirm Customer Requirement before issue order R. Day 12-Dec-02 4 As recommend Actions 4 1 2 8 Re-score each line and then recalculate. Continuous Improvement - FMEA

In Class Exercise Break into your designated groups. Use the XY matrix created during the last module. Using the methodology you have learned today, create a preliminary FMEA for two steps from the in-class project. You have 30 minutes for this exercise. Be prepared to report your results to the class. Continuous Improvement - FMEA

Failure Modes Effects Analysis (FMEA) Six Sigma Continuous Improvement Training Continuous Improvement - FMEA