Failure Mode Effects Analysis (FMEA)

Failure Mode Effects Analysis(FMEA) Abbr. Version DTQS-NPQ July 2000

FAILURE • What’s the failure • Failure class • Failure occurrence • What’s the reason for failure Proprietary Material of Duracell Global Business Management Group

FAILURE Questions? Proprietary Material of Duracell Global Business Management Group

Failure Mode Effects Analysis • FMEA • A systematic group of activities intended to: • Recognize the potential failure(s) of a product or process and the severity of effect of that failure(s). • Identify critical characteristics. • Rank order potential design and process deficiencies. • Identify actions that can eliminate or reduce the chance of the potential failure from occurring and reaching the customer. • Document the process. Proprietary Material of Duracell Global Business Management Group

FMEA Purpose • To eliminate the cause of failure …if this is not possible • reduce how often the failure occurs • improve the ability to detect the failure before itreaches the customer Proprietary Material of Duracell Global Business Management Group

FMEA History and Types • History • 50’ Fighter Plane Design • 60’ Apollo Plan • 70’ Automobile/Medical Instrument • 80’ Micro-electronic • 90’ QS9000, ISO9000 • Types • DFMEA • PFMEA Proprietary Material of Duracell Global Business Management Group

Process FMEA Form Proprietary Material of Duracell Global Business Management Group

Team Selection Define Process Detail Failure Mode Causes Effects Calculate Risk Numbers Build Pareto Chart Develop Recommended Actions Process FMEA Flow Proprietary Material of Duracell Global Business Management Group

Process FMEA Flow Team Selection Define Process Detail Failure Mode Causes Effects Calculate Risk Numbers Build Pareto Chart Develop Recommended Actions Proprietary Material of Duracell Global Business Management Group

Process FMEA • Cross Functional and Multilevel • Operators, Mechanics, Engineers, Leaders • Team Leader Designated • Recommended to be Process Owner • Must be Empowered to implement actions • Functional experts can be pulled in as needed • Smaller “Core” group may be useful initially to provide framework. Team Selection Proprietary Material of Duracell Global Business Management Group

Process FMEA • Develop a Process Flow diagram that is representative of the process as it truly is. • Decide the Rating Scales • Outline Operator, Machine, Product Interactions Define Process Operator involvement is imperative at this step! Proprietary Material of Duracell Global Business Management Group

Severity Rating Proprietary Material of Duracell Global Business Management Group

Occurrence Rating Proprietary Material of Duracell Global Business Management Group

Detection Rating *Could be time based e.g. Takes x minutes or days to detect a failure. Proprietary Material of Duracell Global Business Management Group

Process FMEA • Brainstorm failure modes. • Select and define failure modes that impact critical characteristics. • Identify root causes. • Define effects of failure mode. • Determine how often failure modes occur. • Determine current controls ability to detect. Detail Failure Mode Causes Effects Proprietary Material of Duracell Global Business Management Group

Process FMEA • Calculate Risk Priority Number (RPN) for each failure mode. • RPN = severity x occurrence x detection. Calculate Risk Numbers Proprietary Material of Duracell Global Business Management Group

Process FMEA • Build Pareto’s • One for Severity • One for Severity x Occurrence • One for RPN (Severity x Occurrence x Detection) • Identify “Vital Few” Failure Modes • Can also use $ Build Pareto Chart Proprietary Material of Duracell Global Business Management Group

Process FMEA • Develop and implement actions on “Vital Few” Failure Modes Develop Recommended Actions Proprietary Material of Duracell Global Business Management Group

Detail Failure Mode Causes Effects Calculate Risk Numbers Build Pareto Chart Develop Recommended Actions Process FMEA • Evaluate effect of actions taken on process in terms of severity, occurrence and detection. • Recalculate RPN and reassess risk number. • Reprioritize and repeat. Proprietary Material of Duracell Global Business Management Group

1 List Process Steps 6 What makes it go wrong? 10 Calculate Severity x Occurrence 14 Actions Completed 2 What can go wrong? 12 Determine Corrective Actions 7 Rank Occurrence How often does it go wrong? 4 Rank Severity How bad is it? 13 Assign Responsibilities 11 Calculate RPN Severity x Occurrence x Detection 3 What happens if it goes wrong? 8 How do we currently control this? 15 Recalculate risk numbers and reprioritize RPN’s 5 Safety? 9 Rank Detection What is our confidence to find it? Process FMEA Format Proprietary Material of Duracell Global Business Management Group

List all process controls for each cause. What is our confidence in each control to prevent each cause, or detect the effect/failure mode? From the failure mode, what are the effects? What is the worst severity of all effects? List all causes of the failure mode, not the causes of the effect. How often do each cause of the failure mode occur? Process FMEA Relationships Proprietary Material of Duracell Global Business Management Group

Form edited for clarity Process FMEA Relationships Proprietary Material of Duracell Global Business Management Group

Effect Cause Determine Severity Determine Occurrence Identify Current Controls Calculate Risk Priority Number Actions leading to Continuous Improvement Determine Detectability FMEA Summary Identify Potential Failure Mode Proprietary Material of Duracell Global Business Management Group

Potential Failure Mode • The problem, the concern, the opportunity to improve, the failure, the reject. • Think of the specific loss of the process function. • Example Questions: • How could this process fail to complete its intended function? • Why could this part be rejected at this operation? • What does the customer (internal or external) find unacceptable? • How would the part not conform to specifications at this operation? Proprietary Material of Duracell Global Business Management Group

Potential Effect(s) of Failure • The consequence of the failure mode on the next process, operation, product, customer (internal or external) and/or government regulations. • Example Questions: • What does the customer (internal or external) experience as a result of the failure mode described? • What happens or what are the ramifications of this failure? • Consequences may be to the design itself, the product, the customer, and/or government regulations. • Severity ranking applies to the effect only. Proprietary Material of Duracell Global Business Management Group

Potential Cause of Failure(s) • The process deficiency that results in the failure mode. • The root cause. • Example Questions: • In what way can this system fail to perform its intended function? • Why? Why? Why? Why? Why? • What circumstances could cause the failure? • How or why can the part fail to meet its engineering specifications? • Occurrence ranking is how often the specific cause occurs. Proprietary Material of Duracell Global Business Management Group

Current Controls • A method, procedure, test or engineering analysis designed to catch the problem before it reaches the next operation or customer. • Can be simple, ex. Audits, sampling, sensors, SPC, operator checks, in process tests, fixturing. • Can be complex, ex. FEI, Mil Standards, Computer Simulation, Laboratory Tests. • Focus for the detection rating is in the effectiveness of the control to catch the problem before it reaches the customer. Proprietary Material of Duracell Global Business Management Group

Recommended Actions • May be a specific action to correct a deficiency or mitigate a risk. • May be a recommendation for further study. • Idea should be to reduce the severity, occurrence, detection or a combination. Effort should be placed on reducing severity and occurrence first with improving detection second. It should be noted that a reduction in severity normally requires a design or process change. • Identify a specific individual to accept responsibility for the action with a target completion date. • Verify actions taken and reprioritize. Proprietary Material of Duracell Global Business Management Group

FMEA Benefits • A systematized methodology • Prioritizes risks and focuses limited resources • Identifies shortcomings in control plans • Fact based - avoids emotion • Provides a living document to manage risks and resources in the future • Helps serve as “Corporate Memory” for Intellectual Property • Increases throughput • Decreases waste • Cost reduction Proprietary Material of Duracell Global Business Management Group

Questions? Proprietary Material of Duracell Global Business Management Group

Failure Mode Effects Analysis (FMEA)