Conducting A Process FMEA

What is an FMEA
• FMEA Stands for
– Failure Mode & Effects Analysis
• Simply put this means
– Looking at the system analytically
– Determining what can go wrong
– What will the effects of that failure be
– How can we stop the failure happening
– How can we tell if it has happened
– Which failures will cause the biggest issues
– Which failures will have the worst impacts
 Basic Assumptions
• Assume the following when conducting an FMEA
– All materials entering the process stage are to specification
• If not, improve the process that allowed the defect.
– The essential design of the product meets the customer’s requirement
• Good production is no solution to bad design
– Gauges are calibrated and capable
• FMEA should require calibration/capability but not be used to manage it
– Operator Error is not a cause
• If operators can make errors then the process is not robust
 Before You Begin
• The following documents/information will be needed
– The Design FMEA
(or at least the ‘pass-through’ control characteristics it produced)
– A Process Flow Diagram
The FMEA follows the process step by step so it stands to reason that some
idea of what the process is will be needed before you begin
– Drawings, Models or Samples of the design components
Determining failure modes and controls is far easier if you have something to
work with
– Any pre-existing jigs, fixtures or production data
As with components, knowledge of the exact methods proposed for production
make for a more robust FMEA
 The FMEA Form
• Item/Process Step
– Short description for the process stage (i.e. Moulding)
• Process Function/Specification
– Detailed description of what the process stage is expected to
accomplish.
– Should be very detailed & analytical
– Must include any characteristics passed down from the DFMEA
– Anything not in the specification will not influence the FMEA and will
remain uncontrolled within the process
 Example 1
For a process stage titled ‘Fill Kettle’
The process specification might be,
‘Fill the kettle with water’
But a better specification would be,
‘Add clean water to the boiling chamber of calibrated & PAT tested electric kettle (K1) until the
water level meets the “maximum fill level” mark when the kettle base is placed on a
horizontal surface. Ensure that water is not spilled onto the floor and does not contact the
external electrical connections of the kettle. Ensure that no foreign contamination enters the
kettle during the fill operation’.
This more detailed specification suggests potential failure modes that the first does not,
• Dirty water might be used
• Kettle might be overfilled
• The wrong kettle might be used
• Water might be spilled
• Kettle might be contaminated by debris
 Next Steps
• List all the ways in which the process might fail to meet the
specification (The Failure Modes)
• Determine the potential effects of those failures, determine how
severe those effects are and assign a number from 1 to 10 to each
(SEV)
• Determine what might cause the process to fail in the described
way, the ‘Mechanisms for Failure’
 Next Steps
• List all existing (planned) controls intended to prevent the expected
cause.
• Determine how likely it is that this failure mechanism will occur given
the prevention controls listed. Assign a number based on that likely
hood (OCC)
• Calculate the Potential Impact Index by multiplying SEV & OCC
 Next Steps
• List all existing (planned) controls intended to detect that the
expected failure has occurred.
• Determine how likely it is that the occurrence of the failure will be
detected through the controls listed. Assign a number based on that
likely hood (DET)
• Calculate the Risk Priority Number by multiplying the Potential
Impact Index & DET values to give an overall indication
 What do the numbers tell us?
• SEV – Indicates how big a problem each individual product affected
by the failure will cause
• OCC – Indicates how likely it is that the process failure will result in
a non-conforming product
• PII – Indicates how big an issue the failure mode is likely to be to the
customer (the customer may be the OEM, end user or a down
stream process)
• DET – Indicates how likely we are to detect that the failure mode
has occurred
• RPN – Indicates how big a problem the failure is for us
 What Next
• Determine any SIGNIFICANT or CRITICAL characteristics
– May be passed down from the DFMEA
– May have severe, or very severe potential effects
• Failure of primary function of item
• Risk to health & safety as a result of failure
• Item may cause a breach of law through failure
– Any failure that would negate the primary function(s) of the item and
might potentially occur without detection are significant
– Any failure that place health or safety at risk and might potentially occur
without detection are critical
– Any failure that would cause a breach of law and might potentially occur
without detection are critical
 What Next
• Ensure adequate controls are in place for significant and critical
characteristics
• Look at high (Over 40) PII numbers and improve controls
• Look at High RPN’s (Over 100) and improve controls
• Review and rescore FMEA based on new controls
• For continuous improvement, review and improve top 4 RPN’s on a
rolling basis

NOTE: Nothing on a PFMEA can alter the severity score, this can only
be changed through a change of design, or a change of use.