Analyze Opportunity Part 1 Failure Modes Effect Analysis (FMEA)

Analyze Opportunity Part 1 Failure Modes Effect Analysis (FMEA)

Learning Objectives To understand the use of Failure Modes Effect Analysis (FMEA) To learn the steps to developing FMEAs To summarize the different types of FMEAs To learn how to link the FMEA to other Process tools 2

Benefits Allows us to identify areas of our process that most impact our customers Helps us identify how our process is most likely to fail Points to process failures that are most difficult to detect 3

Application Examples Manufacturing: A manager is responsible for moving a manufacturing operation to a new facility. He/she wants to be sure the move goes as smoothly as possible and that there are no surprises. Design: A design engineer wants to think of all the possible ways a product being designed could fail so that robustness can be built into the product. Software: A software engineer wants to think of possible problems a software product could fail when scaled up to large databases. This is a core issue for the Internet. 4

What Can Go Wrong? What Is A Failure Mode? A Failure Mode is: The way in which the component, subassembly, product, input, or process could fail to perform its intended function Failure modes may be the result of upstream operations or may cause downstream operations to fail Things that could go wrong 5

FMEA Why Methodology that facilitates process improvement Identifies and eliminates concerns early in the development of a process or design Improve internal and external customer satisfaction Focuses on prevention FMEA may be a customer requirement (likely contractual) FMEA may be required by an applicable Quality Management System Standard (possibly ISO) 6

FMEA A structured approach to: Identifying the ways in which a product or process can fail Estimating risk associated with specific causes Prioritizing the actions that should be taken to reduce risk Evaluating design validation plan (design FMEA) or current control plan (process FMEA) 7

When to Conduct an FMEA Early in the process improvement investigation When new systems, products, and processes are being designed When existing designs or processes are being changed When carry-over designs are used in new applications After system, product, or process functions are defined, but before specific hardware is selected or released to manufacturing 8

Examples History of FMEA First used in the 1960’s in the Aerospace industry during the Apollo missions In 1974, the Navy developed MIL-STD1629 regarding the use of FMEA In the late 1970’s, the automotive industry was driven by liability costs to use FMEA Later, the automotive industry saw the advantages of using this tool to reduce risks related to poor quality 9

A Closer Look The FMEA Form Identify failure modes and their effects 10 Identify causes of the failure modes and controls Prioritize Determine and assess actions

Specialized Uses Types of FMEAs Design Analyzes product design before release to production, with a focus on product function Analyzes systems and subsystems in early concept and design stages Process Used to analyze manufacturing and assembly processes after they are implemented 11

Team Input Required FMEA: A Team Tool A team approach is necessary. Team should be led by the Process Owner who is the responsible manufacturing engineer or technical person, or other similar individual familiar with FMEA. The following should be considered for team members: – – – – 12 Design Engineers Process Engineers Materials Suppliers Customers – Operators – Reliability – Suppliers

Process Steps FMEA Procedure 1. For each process input (start with high value inputs), determine the ways in which the input can go wrong (failure mode) 2. For each failure mode, determine effects Select a severity level for each effect 3. Identify potential causes of each failure mode Select an occurrence level for each cause 4. List current controls for each cause Select a detection level for each cause 13

Process Steps FMEA Procedure (Cont.) 5. Calculate the Risk Priority Number (RPN) 6. Develop recommended actions, assign responsible persons, and take actions Give priority to high RPNs MUST look at severities rated a 10 7. Assign the predicted severity, occurrence, and detection levels and compare RPNs 14

Information Flow FMEA Inputs and Outputs 15 Inputs Outputs C&E Matrix Process Map Process History Procedures Knowledge Experience List of actions to prevent causes or detect failure modes FMEA History of actions taken

Severity, Occurrence, and Detection Analyzing Failure & Effects Severity Importance of the effect on customer requirements Occurrence Frequency with which a given cause occurs and creates failure modes (obtain from past data if possible) Detection The ability of the current control scheme to detect (then prevent) a given cause (may be difficult to estimate early in process operations). 16

Rating Scales Assigning Rating Weights There are a wide variety of scoring “anchors”, both quantitative or qualitative Two types of scales are 1-5 or 1-10 The 1-5 scale makes it easier for the teams to decide on scores The 1-10 scale may allow for better precision in estimates and a wide variation in scores (most common) 17

Rating Scales Assigning Rating Weights Severity 1 Not Severe, 10 Very Severe Occurrence 1 Not Likely, 10 Very Likely Detection 1 Easy to Detect, 10 Not easy to Detect 18

Calculating a Composite Score Risk Priority Number (RPN) RPN is the product of the severity, occurrence, and detection scores. Severity 19 X Occurrence X Detection RPN

Key Points Summary An FMEA: Identifies the ways in which a product or process can fail Estimates the risk associated with specific causes Prioritizes the actions that should be taken to reduce risk FMEA is a team tool There are two different types of FMEAs: Design Process Inputs to the FMEA include several other Process tools such as C&E Matrix and Process Map. 20