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Figure
1 illustrates the role of FMEA in a typical quality system.
FMEA Potential Failure Mode and Effects RPN Risk Priority Number
Analysis
FTA Fault Tree Analysis SPC Statistical Process Control
• Begin with a Failure Mode (referred to as FM-1), and a list of all its potential
consequences.
•
Separate the consequences that can be assumed to result whenever the
Failure Mode FM-1 occurs. Identify these as Effects of FM-1.
•
Write additional Failure Modes for the remaining consequences
(consequences which could result when FM-1 occurs, depending on the
circumstances under which FM-1 occurred).
The new Failure Modes imply that unlikely consequences will result by
including the circumstances under which they occur.
• Separate the consequences that can be assumed to result whenever the
additional Failure Modes and their special circumstances occur. Identify these
consequences as Effects of the additional Failure Modes.
Fit & finish or squeak & rattle item does not conform. Most customers notice
Very Low
defect.
Fit & finish or squeak & rattle item does not conform. Average customers
Minor
notice defect.
Fit & finish or squeak & rattle item does not conform. Discriminating
Very Minor
customers notice defect.
None No effect
Table Suggested evaluation criteria and ranking system for the Severity of
1. Effects for a design FMEA
Table 2. Suggested evaluation criteria and ranking system for the Severity of Effects in
a process FMEA
Pakistan Institute of Quality Control
After Effects and Severity have been addressed, the next step is to
identify Causes of Failure Modes. This is another team activity.
Identification should start with Failure Modes that have the most severe
Effects. In a design FMEA, design deficiencies that result in a Failure
Mode are Causes of failure. Design deficiencies that induce a
manufacturing or assembly error are also included in design FMEAs as
Causes. The design FMEA assumes that manufacturing and assembly
specifications are met, and only seeks to identify failures resulting from
product design.
Unlike Effects, Causes are not evaluated as a group when assessing risk. Separate
values are assigned to each Cause of the Failure Mode. Current Controls sometimes
prevent the Cause of failure, the Failure Mode itself, or its Effects. Such Controls,
designated Type (1), are most desirable and can reduce initial Occurrence ratings.
Table Suggested evaluation criteria and ranking system for the Occurrence
3. of Failure in a design FMEA
Table Suggested evaluation criteria and ranking system for the Occurrence of
4. Failure in a Process FMEA
Type These controls detect the Cause of the Failure Mode and lead to
(2): corrective action.
These Controls detect the Failure Mode before the product reaches the
Type
customer. The customer could be the next operation, subsequent
(3):
operations, or the end user.
The distinction between controls that prevent failure (Type 1) and controls that detect
failure (Types 2 and 3) is important. Type 1 controls reduce the likelihood that a Cause or
Failure Mode will occur, and therefore affect Occurrence ratings. Type 2 and Type 3
Controls detect Causes and Failure Modes respectively, and therefore affect Detection
ratings.
Very Low Very low likelihood current Controls with detect Failure Mode or Cause 7
Low Low likelihood current Controls with detect Failure Mode or Cause 6
Moderate Moderate likelihood current Controls with detect Failure Mode or Cause 5
Moderately Moderately high likelihood current Controls with detect Failure Mode or
4
High Cause
High High likelihood current Controls with detect Failure Mode or Cause 3
Very High Very high likelihood current Controls with detect Failure Mode or Cause 2
Almost Current Controls almost certain to Failure Mode or Cause. Reliable
1
Certain detection controls are known with similar processes.
Table 6. Suggested evaluation criteria and ranking system for the Detection of a
Cause of failure or Failure Mode in a process FMEA
Pakistan Institute of Quality Control
A tabular FMEA documentation form has been
standardized by the AIAG. All input data must be
organized on the output form in the spaces and columns
provided. Some companies compile FMEA data on
worksheets, and then transfer the information to the form.
Other companies with electronic versions of the form can
fill in the table as FMEA elements are identified. FMEA
Facilitator collects the input data through an organized
and intuitive interface and places it on the form
automatically.
How important it is …?
What to check ?
Pakistan Institute of Quality Control
Control Plan - Example
Example : Polish Crankshaft
Evaluation /
measurement Sample
technique Size Freq. Control Method Reaction Plan
100 % inspection of
SPC (X bar-R
every previous 5
chart), operator
Surf tester 5 5th crankshaft,replace
verification of
(Tylor hobson) journals cranks belts/readjust
belt and
haft machine, notify line
machine setup
leader
CONTROL PLAN
Proc. docs.
Non conformance reports
?
Pakistan Institute of Quality Control
Control Plan –
Practice Session
Practice Session :