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Failure Mode Effect Analysis

WMG, University of Warwick, profile picture
WMG, University of Warwick

This document provides an introduction and overview of Failure Mode Effect Analysis (FMEA). FMEA is used across several industries including automotive, aerospace, military, and others to analyze potential failures, their causes and effects. The document outlines the steps to conduct an FMEA, including defining the item or process being analyzed, identifying potential failure modes and their causes and effects, analyzing current prevention and detection controls, and determining a risk priority number. It then provides a sample FMEA analysis for purchasing milk for a lactose intolerant child, identifying potential failures from purchasing the wrong milk to packaging issues, and assessing prevention controls, occurrence, detection and severity to calculate risk.

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Failure Mode Effect Analysis Introduction and Example Dr. Kylash Makenji
• Introduction and Overview • What is Failure Mode Effect Analysis (FMEA)? • Who uses FMEA? • Pre-requisites • Working through a FMEA, Example • RPN’s, What to do next • Team exercise Contents
Introduction and Overview
What is FMEA?
Who uses FMEA? • Automotive – Jaguar Land rover, Ford, BMW, Honda, VW group – All of the others…… • Aerospace – Boeing, Airbus, NASA • Military – Armed forces, Air and Sea
• Prior to FMEA you need – A design, process or function – Bill of materials (BOM) – A specification, target or objective – Cross functional team, designer, engineer, manufacturing team……… • Additionally – Standard operating procedure – Ability to influence or change – Team skills and competencies, who does what Pre-requisites
Working through a FMEA
Document and steps overview
Use FMEA anywhere Buying some milk
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Log, dates, team members, design numbers and versions List a design, function or process items
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Record any and all potential failure modes
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 List the potential effects of the failure
• How severe is the failure mode to customers? – 10 = very severe, may kill – 1 = no effect Effect SEVERITY of Effect Ranking Hazardous without warning Very high severity ranking when a potential failure mode affects safe system operation without warning 10 Hazardous with warning Very high severity ranking when a potential failure mode affects safe system operation with warning 9 Very High System inoperable with destructive failure without compromising safety 8 High System inoperable with equipment damage 7 Moderate System inoperable with minor damage 6 Low System inoperable without damage 5 Very Low System operable with significant degradation of performance 4 Minor System operable with some degradation of performance 3 Very Minor System operable with minimal interference 2 None No effect 1 Severity
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 List the causes of failure
• How likely will the fault occur ? – Use data, explicit and tacit knowledge – If available, look at warranty and customer data OCCURRENCE of Failure Failure Prob Ranking Very High: Failure is almost inevitable >1 in 2 10 1 in 3 9 High: Repeated failures 1 in 8 8 1 in 20 7 Moderate: Occasional failures 1 in 80 6 1 in 400 5 1 in 2,000 4 Low: Relatively few failures 1 in 15,000 3 1 in 150,000 2 Remote: Failure is unlikely <1 in 1,500,000 1 Occurrence
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 If available use warrantee and customer data
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 What is in place to prevent the failure occurring
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 What is in place to detect the failure occurring
• How likely are you to detect the failure through controls, before your customer does? Detection Likelihood of DETECTION by Design Control Ranking Absolute Uncertainty Design control cannot detect potential cause/mechanism and subsequent failure mode 10 Very Remote Very remote chance the design control will detect potential cause/mechanism and subsequent failure mode 9 Remote Remote chance the design control will detect potential cause/mechanism and subsequent failure mode 8 Very Low Very low chance the design control will detect potential cause/mechanism and subsequent failure mode 7 Low Low chance the design control will detect potential cause/mechanism and subsequent failure mode 6 Moderate Moderate chance the design control will detect potential cause/mechanism and subsequent failure mode 5 Moderately High Moderately High chance the design control will detect potential cause/mechanism and subsequent failure mode 4 High High chance the design control will detect potential cause/mechanism and subsequent failure mode 3 Very High Very high chance the design control will detect potential cause/mechanism and subsequent failure mode 2 Almost Certain Design control will detect potential cause/mechanism and subsequent failure mode 1 Detection
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Risk Priority Number, (RPN) Severity x occurrence x detection = RPN
• Sort the FMEA in descending order – Create actions to reduce RPN value – Strive to continually improve – If you have further data, rework back into FMEA – Some actions may not reduce the RPN significantly • Beyond economical feasibility • Simulate and test to measure the impact to the RPN score RPN’s, What to do Next?
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Work with the highest RPN, and downwards, striving to continually improve Actions, targets etc
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Recalculate new RPN with action completed or to predict
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Some actions may not be feasible to put into place, technical or economic considerations
Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36Next time if you are doing a similar product or process use an existing FMEA, develop and improve
Team Activity Team 1 – Installing the sliding switch Team 2 – Connecting the sliding switch Team 3 – User behaviour, using the sliding switch
Volume Slide • Specification and details:- – Moving slide left to right will increase volume – Calibrated slide • 50% movement = 50% sound increase – Steel body construction – Plastic slide knob – Held in place by 2 screws, onto the PCB – 2 black wires to connect it to the PCB
Slide Volume PLAN VIEW UNDERSIDE / ELECTRICAL CONNECTION ELECTRICAL CONNECTIONS x2 FIXING LUGS x2 SLIDER
• Function is part of the design which is intentional as part of the overall specification • How is the specification being delivered – i.e. a volume slide – What can go wrong with it? • Function, assembly Function and potential failure mode
• What can go wrong with function and design of the volume slide? • Brainstorm – Ishikawa diagram Brainstorm
Ishikawa diagram (fishbone) EQUIPMENT PROCESS PEOPLE MATERIALS ENVIRONMENT MANAGEMENT PROBLEM POOR SOLDERING -INCORRECT EQUIPMENT -TOO HOT / COLD - NOT CALIBRATED
Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N
Scoring overview SEVERITY OCCURRENCE FAILURE PROBABILITY DETECTION RANKING Hazardous without warning Very High: Failure is inevitable >1 in 2 Absolute Uncertainty 10 Hazardous with warning 1 in 3 Very Remote 9 Very High High: Repeated failures 1 in 8 Remote 8 High 1 in 20 Very Low 7 Moderate Moderate: Occasional failures 1 in 80 Low 6 Low 1 in 400 Moderate 5 Very Low 1 in 2,000 Moderately High 4 Minor Low: Relatively few failures 1 in 15,000 High 3 Very Minor 1 in 150,000 Very High 2 None Remote: Failure is unlikely <1 in 1,500,000 Almost Certain 1
Any questions?

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Failure Mode Effect Analysis

  • 1. Failure Mode Effect Analysis Introduction and Example Dr. Kylash Makenji
  • 2. • Introduction and Overview • What is Failure Mode Effect Analysis (FMEA)? • Who uses FMEA? • Pre-requisites • Working through a FMEA, Example • RPN’s, What to do next • Team exercise Contents
  • 5. Who uses FMEA? • Automotive – Jaguar Land rover, Ford, BMW, Honda, VW group – All of the others…… • Aerospace – Boeing, Airbus, NASA • Military – Armed forces, Air and Sea
  • 6. • Prior to FMEA you need – A design, process or function – Bill of materials (BOM) – A specification, target or objective – Cross functional team, designer, engineer, manufacturing team……… • Additionally – Standard operating procedure – Ability to influence or change – Team skills and competencies, who does what Pre-requisites
  • 10. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Log, dates, team members, design numbers and versions List a design, function or process items
  • 11. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Record any and all potential failure modes
  • 12. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 List the potential effects of the failure
  • 13. • How severe is the failure mode to customers? – 10 = very severe, may kill – 1 = no effect Effect SEVERITY of Effect Ranking Hazardous without warning Very high severity ranking when a potential failure mode affects safe system operation without warning 10 Hazardous with warning Very high severity ranking when a potential failure mode affects safe system operation with warning 9 Very High System inoperable with destructive failure without compromising safety 8 High System inoperable with equipment damage 7 Moderate System inoperable with minor damage 6 Low System inoperable without damage 5 Very Low System operable with significant degradation of performance 4 Minor System operable with some degradation of performance 3 Very Minor System operable with minimal interference 2 None No effect 1 Severity
  • 14. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
  • 15. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 List the causes of failure
  • 16. • How likely will the fault occur ? – Use data, explicit and tacit knowledge – If available, look at warranty and customer data OCCURRENCE of Failure Failure Prob Ranking Very High: Failure is almost inevitable >1 in 2 10 1 in 3 9 High: Repeated failures 1 in 8 8 1 in 20 7 Moderate: Occasional failures 1 in 80 6 1 in 400 5 1 in 2,000 4 Low: Relatively few failures 1 in 15,000 3 1 in 150,000 2 Remote: Failure is unlikely <1 in 1,500,000 1 Occurrence
  • 17. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 If available use warrantee and customer data
  • 18. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 What is in place to prevent the failure occurring
  • 19. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 What is in place to detect the failure occurring
  • 20. • How likely are you to detect the failure through controls, before your customer does? Detection Likelihood of DETECTION by Design Control Ranking Absolute Uncertainty Design control cannot detect potential cause/mechanism and subsequent failure mode 10 Very Remote Very remote chance the design control will detect potential cause/mechanism and subsequent failure mode 9 Remote Remote chance the design control will detect potential cause/mechanism and subsequent failure mode 8 Very Low Very low chance the design control will detect potential cause/mechanism and subsequent failure mode 7 Low Low chance the design control will detect potential cause/mechanism and subsequent failure mode 6 Moderate Moderate chance the design control will detect potential cause/mechanism and subsequent failure mode 5 Moderately High Moderately High chance the design control will detect potential cause/mechanism and subsequent failure mode 4 High High chance the design control will detect potential cause/mechanism and subsequent failure mode 3 Very High Very high chance the design control will detect potential cause/mechanism and subsequent failure mode 2 Almost Certain Design control will detect potential cause/mechanism and subsequent failure mode 1 Detection
  • 21. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
  • 22. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Risk Priority Number, (RPN) Severity x occurrence x detection = RPN
  • 23. • Sort the FMEA in descending order – Create actions to reduce RPN value – Strive to continually improve – If you have further data, rework back into FMEA – Some actions may not reduce the RPN significantly • Beyond economical feasibility • Simulate and test to measure the impact to the RPN score RPN’s, What to do Next?
  • 24. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
  • 25. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
  • 26. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Work with the highest RPN, and downwards, striving to continually improve Actions, targets etc
  • 27. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Recalculate new RPN with action completed or to predict
  • 28. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Some actions may not be feasible to put into place, technical or economic considerations
  • 29. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36Next time if you are doing a similar product or process use an existing FMEA, develop and improve
  • 30. Team Activity Team 1 – Installing the sliding switch Team 2 – Connecting the sliding switch Team 3 – User behaviour, using the sliding switch
  • 31. Volume Slide • Specification and details:- – Moving slide left to right will increase volume – Calibrated slide • 50% movement = 50% sound increase – Steel body construction – Plastic slide knob – Held in place by 2 screws, onto the PCB – 2 black wires to connect it to the PCB
  • 32. Slide Volume PLAN VIEW UNDERSIDE / ELECTRICAL CONNECTION ELECTRICAL CONNECTIONS x2 FIXING LUGS x2 SLIDER
  • 33. • Function is part of the design which is intentional as part of the overall specification • How is the specification being delivered – i.e. a volume slide – What can go wrong with it? • Function, assembly Function and potential failure mode
  • 34. • What can go wrong with function and design of the volume slide? • Brainstorm – Ishikawa diagram Brainstorm
  • 35. Ishikawa diagram (fishbone) EQUIPMENT PROCESS PEOPLE MATERIALS ENVIRONMENT MANAGEMENT PROBLEM POOR SOLDERING -INCORRECT EQUIPMENT -TOO HOT / COLD - NOT CALIBRATED
  • 36. Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N
  • 37. Scoring overview SEVERITY OCCURRENCE FAILURE PROBABILITY DETECTION RANKING Hazardous without warning Very High: Failure is inevitable >1 in 2 Absolute Uncertainty 10 Hazardous with warning 1 in 3 Very Remote 9 Very High High: Repeated failures 1 in 8 Remote 8 High 1 in 20 Very Low 7 Moderate Moderate: Occasional failures 1 in 80 Low 6 Low 1 in 400 Moderate 5 Very Low 1 in 2,000 Moderately High 4 Minor Low: Relatively few failures 1 in 15,000 High 3 Very Minor 1 in 150,000 Very High 2 None Remote: Failure is unlikely <1 in 1,500,000 Almost Certain 1