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The FMEA Form
The FMEA Form
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Analyze Opportunity Part 1

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1Analyze Opportunity Part 1. Failure 11in early concept and design stages Process
Modes Effect Analysis (FMEA). Used to analyze manufacturing and assembly
2Learning Objectives. To understand the processes after they are implemented.
use of Failure Modes Effect Analysis Specialized Uses. 11.
(FMEA) To learn the steps to developing 12FMEA: A Team Tool. A team approach is
FMEAs To summarize the different types of necessary. Team should be led by the
FMEAs To learn how to link the FMEA to Process Owner who is the responsible
other Process tools. 2. manufacturing engineer or technical
3Benefits. Allows us to identify areas person, or other similar individual
of our process that most impact our familiar with FMEA. The following should
customers Helps us identify how our be considered for team members: – Design
process is most likely to fail Points to Engineers – Operators – Process Engineers
process failures that are most difficult – Reliability – Materials Suppliers –
to detect. 3. Suppliers – Customers. Team Input
4Application Examples. Manufacturing: A Required. 12.
manager is responsible for moving a 13FMEA Procedure. 1. For each process
manufacturing operation to a new facility. input (start with high value inputs),
He/she wants to be sure the move goes as determine the ways in which the input can
smoothly as possible and that there are no go wrong (failure mode) 2. For each
surprises. Design: A design engineer wants failure mode, determine effects Select a
to think of all the possible ways a severity level for each effect 3. Identify
product being designed could fail so that potential causes of each failure mode
robustness can be built into the product. Select an occurrence level for each cause
Software: A software engineer wants to 4. List current controls for each cause
think of possible problems a software Select a detection level for each cause.
product could fail when scaled up to large Process Steps. 13.
databases. This is a core issue for the 14FMEA Procedure (Cont.). 5. Calculate
Internet. 4. the Risk Priority Number (RPN) 6. Develop
5What Is A Failure Mode? A Failure Mode recommended actions, assign responsible
is: The way in which the component, persons, and take actions Give priority to
subassembly, product, input, or process high RPNs MUST look at severities rated a
could fail to perform its intended 10 7. Assign the predicted severity,
function Failure modes may be the result occurrence, and detection levels and
of upstream operations or may cause compare RPNs. Process Steps. 14.
downstream operations to fail Things that 15FMEA Inputs and Outputs. Inputs.
could go wrong. What Can Go Wrong? 5. Outputs. C&E Matrix Process Map
6FMEA. Why Methodology that facilitates Process History Procedures Knowledge
process improvement Identifies and Experience. List of actions to prevent
eliminates concerns early in the causes or detect failure modes History of
development of a process or design Improve actions taken. FMEA. Information Flow. 15.
internal and external customer 16Severity, Occurrence, and Detection.
satisfaction Focuses on prevention FMEA Severity Importance of the effect on
may be a customer requirement (likely customer requirements Occurrence Frequency
contractual) FMEA may be required by an with which a given cause occurs and
applicable Quality Management System creates failure modes (obtain from past
Standard (possibly ISO). 6. data if possible) Detection The ability of
7FMEA. A structured approach to: the current control scheme to detect (then
Identifying the ways in which a product or prevent) a given cause (may be difficult
process can fail Estimating risk to estimate early in process operations).
associated with specific causes Analyzing Failure & Effects. 16.
Prioritizing the actions that should be 17Rating Scales. There are a wide
taken to reduce risk Evaluating design variety of scoring “anchors”, both
validation plan (design FMEA) or current quantitative or qualitative Two types of
control plan (process FMEA). 7. scales are 1-5 or 1-10 The 1-5 scale makes
8When to Conduct an FMEA. Early in the it easier for the teams to decide on
process improvement investigation When new scores The 1-10 scale may allow for better
systems, products, and processes are being precision in estimates and a wide
designed When existing designs or variation in scores (most common).
processes are being changed When Assigning Rating Weights. 17.
carry-over designs are used in new 18Rating Scales. Severity 1 = Not
applications After system, product, or Severe, 10 = Very Severe Occurrence 1 =
process functions are defined, but before Not Likely, 10 = Very Likely Detection 1 =
specific hardware is selected or released Easy to Detect, 10 = Not easy to Detect.
to manufacturing. 8. Assigning Rating Weights. 18.
9History of FMEA. First used in the 19Risk Priority Number (RPN). RPN is the
1960’s in the Aerospace industry during product of the severity, occurrence, and
the Apollo missions In 1974, the Navy detection scores. Severity. X. Occurrence.
developed MIL-STD-1629 regarding the use X. Detection. =. RPN. Calculating a
of FMEA In the late 1970’s, the automotive Composite Score. 19.
industry was driven by liability costs to 20Summary. An FMEA: Identifies the ways
use FMEA Later, the automotive industry in which a product or process can fail
saw the advantages of using this tool to Estimates the risk associated with
reduce risks related to poor quality. specific causes Prioritizes the actions
Examples. 9. that should be taken to reduce risk FMEA
10The FMEA Form. A Closer Look. 10. is a team tool There are two different
11Types of FMEAs. Design Analyzes types of FMEAs: Design Process Inputs to
product design before release to the FMEA include several other Process
production, with a focus on product tools such as C&E Matrix and Process
function Analyzes systems and subsystems Map. Key Points. 20.
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