Failure Mode and Effect Analysis

(FMEA)

Solution Overview

Knowledge Management
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OVERVIEW

FMEA is a systematic method of identifying and preventing problems in system, product and process before they occur.
Performing FMEA includes A procedure that examines each item in a system, considers how that item can fail and then
determines how that failure will affect (or disagregate through) the system.
The purpose of performing an FMEA is to evaluate the product's design characteristics relative to the planned manufacturing
process and experiment design to ensure that the resultant product meets customer needs andexpectations. When potential
failure modes are identified, corrective action can be taken to eliminate them or to
continually reduce a potential occurrence. The FMEA also documents the rationale for the chosen manufacturing process.
It provides for an organized citical analysis of potential failure modes and theassociated causes for the system being defined.
The technique uses occurrence and detection probabilities in conjunction with severity criteria to develop a risk priority
number (RPN) for ranking corrective action considerations.
The main purpose of FMEA is preventing problems, enhancing safety, and increasing customer satisfaction.
Generally
FMEA study are conducted in the product design or process development stages, but it is also useful conducting an FMEA
on existing products or processes may also yield benefits.
FMEA is a tool that allows us to:
· Prevent System, Product and Process problems before they occur.
· Reduce costs by identifying system, product and process improvements early in the development cycle.
· Create more reliable and robust processes.
· Prioritize actions that decrease risk of failure.

Approach to Solution
This document details how an FMEA to be implemented for any product with SAP QM functionality of FMEA.
Here we see the example of FMEA study of a product closet.
The individual components of an FMEA are arranged hierarchically as follows:
· One or more function lists is created for the FMEA for the system element in question.The function list contains all
system element functions. In the below example a function identified is
· More than one defect can exist for each function.
· A defect can have several effects. A defect can also have several causes.
· It is possible to specify more than one action (preventive and detection) for each cause.
characteristics can be assigned to a function. These characteristics can be used to test the function. These inspection
characteristics are often the result of a detection action.
You can copy the inspection characteristics to an inspection plan, if required.

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This hierarchy is shown in the following graphic:

Transaction code Activity

QM_FMEA FMEA cockpit used to initiate and perform FMEA study with various
sub options like creating of question list
QM_FMEA Creation of a FMEA, Question list and Preventive and detective actions
QPCP ( Optional) Maintenance of control plan integrated with FMEA

Collective name for business objects that are independent parts of the Failure Mode and Effects Analysis (FMEA). In the
context of the FMEA, the following objects are considered to be FMEA components:
Ø FMEA
Ø Question List
Ø Action (Detection action and preventive action)
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 Create an FMEA study (T CODE: QM_FMEA)
FMEA can of two types namely Product FMEA and Process FMEA.
For a product FMEA, an FMEA object can be defined, for example, by using the Material field.
For a process FMEA which we are not discusing here, it is possible to define the FMEA object, for example, by using
fields that describe the work center or operation.

The hierarchy levels for the higher-level element list are predefined by the hierarchy profile. The following hierarchy
profiles are supplied in the standard system:
Ø Hierarchy profile with direct links to an FMEA for a system element
Ø Higher-Level Element List
Ø System Element/Process Step (The system can refer to another FMEA.)
Ø Function (The function can refer to an FMEA function that is specified in the system
element.)
Ø Defect (The defect can refer to an FMEA defect that is specified in the system
element.)

Following screen print shows the initial screen for creation of a new FMEA as product FMEA for closet material
clode of KNSA-100.

Options for valuation specification for the FMEA study

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To be able to judge objectively the current state of a process or product and the effect of actions during the course of a
Failure Mode and Effects Analysis, it is possible to calculate the risk priority number (RPN) of an FMEA automatically.
This is possible as soon as you have determined the valuations for causes and effects of defects and entered them
in the system.
Calculation of risk priority number:

The system calculates the risk priority number for each potential defect of a function as follows:
It chooses the effect with the greatest significance B (highest number of points in valuation).
It chooses the cause with the greatest probability of occurrence A (highest number of points in valuation).
If one or more detection actions are assigned to the defect cause, the system chooses the highest probability of detection
E (lowest number if points in valuation) from all the assigned detection actions that have at least the status Confirmed .
The risk priority number results as follows: RPN = B * A * E.

List items
All lower-level elements that are created for a list using the hierarchy profile. This can be a function list , higher-level
element list , lower-level element list , or a question list .

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The display and functions for a list item are predefined by the list item type (such as characteristic, function, or defect) that
is stored in the hierarchy profile for the hierarchy level.

Question list:

You can assign the question list as a supporting element for an FMEA. For example, you can use it to evaluate conformity
to specified regulations or to provide a checklist for preparation. The assignment of question lists to an FMEA is optional.

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Lower-Level Element List
Contains all system elements that the FMEA object is composed of, or contains all process steps that precede the FMEA
object. The lower-level element list contains all elements on whose functions the FMEA object depend.
The references specified in the lower-level element list are used to form structure, defect and function networks that cover
the whole FMEA.
A lower-level element list is not an independent component; it is always created for an FMEA.

Actions

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Detection Action
Action to identify possible defects before the product is delivered to customers.
Detection actions refer to defect causes. The detection actions are assigned to causes that can trigger the defect.
You can assign as many detection actions as required to a cause.

Preventive Action
Action to prevent defects from occurring.
Preventive actions are assigned to causes.
You can assign as many preventive actions as required to a cause.

Calculation of RPN values

The calculated RPN value of each item of FMEA defect can be displayed at Cause level, Detection level and failure mode
level.
In the screen print below in the result tab the system displays the highest RPN value of all failure modes of the defects.
Based on valuation profile assigned.

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At the header level of the FMEA - in the result tab, the system displays the highest RPN value of all Failure modes. For
example, in the FMEA there are 3 defects with RPN values 130, 260 and 350, at the header level 350 will be displayed
once you click on valuate in the results tab, against this value system will do valuation of FMEA as per valuation profile
assigned and overall assessment.
The same logic applicable to defect also. The defect can have multiple causes and detection action, but will have only
one effect.
Since RPN is cause * detection * effect, it is calculated at individual cause level and the highest value is displayed at the
defect level.

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Executive Summary

This white paper is an overview document for FMEA detailing functionality of FMEA within ECC-QM

T Chandrashekhar
Business Process Sr. Consultant - Manufacturing

ALL FIELDS ARE COMPULSORY

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