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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
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