FMEA (Failure Mode and Effects Analysis)

Failure Mode and Effects Analysis (FMEA) is a systematic team driven approach that identifies potential failure modes in a system, product, or manufacturing / assembly operation caused by either design or manufacturing / assembly process deficiencies.

It also identifies critical or significant design or process characteristics that require special controls to prevent or detect failure modes. FMEA is a tool used to prevent problems from occurring. Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. Failure modes means the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that affect the customer, and can be potential or actual. Effects analysis refers to studying the consequences of those failures. Failures are prioritized according to how serious their consequences are, how frequently they occur and how easily they can be detected. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones.

 Failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service. When to Use FMEA

When a process, product or service is being designed or redesigned, after quality function deployment. When an existing process, product or service is being applied in a new way. Before developing control plans for a new or modified process. When improvement goals are planned for an existing process, product or service. When analyzing failures of an existing process, product or service. Periodically throughout the life of the process, product or service

FMEA Development FMEAs are developed in three distinct phases where actions can be determined. It is also imperative to do pre-work ahead of the FMEA to assure that the Robustness and past history are included in your analysis.

Step 1 is to determine all failure modes based on the functional requirements and their effects. If the severity of the effect is a 9 or 10 (meaning safety or regulatory in nature) actions are considered to

change the design or process by eliminating the Failure Mode if possible or protecting the customer from the effect.

Step 2 adds causes and Occurrences to each Failure Mode. This is the detailed development section of the FMEA process. Reviewing the probability or occurrence number in order of the highest severity and working downwards, actions are determined if the occurrence is high (> 4 for non safety and regardless of occurrence >1 when the severity is 9 or 10) Step 3 considers testing, design verification and inspection methods. Each combination from steps 1 and 2 which are considered at risk requires the detection number to be selected. The detection number represents the ability of planned tests and inspections at removing defects or excite failure modes to fail.

FMEA cycle:

FMEA Working Model

e.g. How can FMEA be used to reduce the risk of medication errors? To cite one example, a multidisciplinary committee could use FMEA to assess new drugs being considered for the formulary. Heres how the process would work . Step 1: The committee would explore how the intended product would be procured and used, from acquisition through administration. Who would

prescribe the drug and for what type of patient? Where would the drug be stored? Who would prepare and dispense it? How would it be administered? Step 2: Potential failure modes (how and where systems and processes may fail) would be identified while considering how the product would be used. Could the drug be mistaken for another similarly packaged product? Does the label clearly express the strength or concentration? Does the name sound or look like another drug on the formulary? Are dosing parameters complex? Is the administration process error prone? Step 3: Once failure modes have been identified, staff would determine the likelihood of a mistake occurring and the potential consequences of an error. What would happen to the patient if the drug were given in the wrong dose, at the wrong time, to the wrong patient, by the wrong route, at the wrong rate or at the wrong time? Step 4: Staff would identify any preexisting processes in place that could help detect the error before it reaches the patient, and evaluate their effectiveness based upon knowledge of human factors. Step 5 : If failure modes could cause errors with significant consequences, actions would be taken to prevent the error, detect it before it reaches the patient, or minimize its consequences. A few examples include using an alternative product; preparing the drug in the pharmacy; standardizing drug concentrations, order communication and dosing methods; using auxiliary warning labels or computer alerts; and requiring entry of specific data into computer systems before processing orders. Benefits of FMEA

Improve the quality, reliability and safety of a product/process Improve company image and competitiveness Increase user satisfaction Reduce system development timing and cost Collect information to reduce future failures, capture engineering knowledge Reduce the potential for warranty concerns Early identification and elimination of potential failure modes Emphasize problem prevention Minimize late changes and associated cost Catalyst for teamwork and idea exchange between functions Reduce the possibility of same kind of failure in future Documents and tracks action taken to reduce risk Integrates with Design for Manufacturing & Assembly techniques

Applications for FMEA

Process - analyze manufacturing and assembly processes. Design - analyze products before they are released for production. Concept - analyze systems or subsystems in the early design concept stages. Equipment - analyze machinery and equipment design before they are purchased. Service - analyze service industry processes before they are released to impact the customer.

Types of FMEA

Process: analysis of manufacturing and assembly processes

Design: analysis of products prior to production Concept: analysis of systems or subsystems in the early design concept stages Equipment: analysis of machinery and equipment design before purchase Service: analysis of service industry processes before they are released to impact the customer System: analysis of the global system functions Software: analysis of the software functions

Uses of FMEA

Development of system requirements that minimize the likelihood of failures. Development of methods to design and test systems to ensure that the failures have been eliminated. Evaluation of the requirements of the customer to ensure that those do not give rise to potential failures. Identification of certain design characteristics that contribute to failures, and minimize or eliminate those effects. Tracking and managing potential risks in the design. This helps avoid the same failures in future projects. Ensuring that any failure that could occur will not injure the customer or seriously impact a system. To produce world class quality products