What You Need to Know About Failure Mode and Effects Analysis (FMEA)

Every product or process has modes of failure. The effects represent the impact of the failures. An FMEA is a tool to: Identify the relative risks designed into a product or process. Initiate action to reduce those risks with the highest potential impact. Track the results of the action plan in terms of risk reduction.

FMEAs help us focus on and understand the impact of potential process or product risks. A systematic methodology is used to rate the risks relative to each other. An R ! or Risk riority !um"er is calculated for each failure mode and its resulting effect#s$. The R ! is a function of three factors: The %everity of the effect& the fre'uency of (ccurrence of the cause of the failure& and the a"ility to detect #or prevent$ the failure or effect. R ! ) %everity rating * (ccurrence rating * +etection rating The R ! can range from a low of , to a high of ,&---

(nce the R !s are determined& you need to develop an Action lan to reduce the risks of failure modes of unaccepta"ly high R !s. !e.t& use the FMEA as the "asis for developing a /ontrol lan. /ontrol lans are a summary of defect prevention and reactive detection techni'ues.

FMEA Resources
The urpose of an FMEA +FMEA or FMEA0 The FMEA rocess Assem"ling an FMEA Team +esign FMEA %cope ,- %teps to /onduct a +FMEA 1inking +FMEAs and /ontrol lans 2etting More (ut of +FMEAs rocess FMEA %cope ,- %teps to /onduct a FMEA 1inking FMEAs and /ontrol lans 2etting More (ut of FMEAs FMEA 1imitations and itfalls

FMEA Checklists and For s

Many of these forms can "e downloaded as E.cel %preadsheets or 3ord +ocs

FMEA For s
FMEA Team %tart45p 3orksheet +esign FMEA %cope 3orksheet rocess FMEA %cope 3orksheet 2eneric %everity Rating %cale 2eneric (ccurrence Rating %cale 2eneric +etection Ranking %cale FMEA Analysis 3orksheet 4 art , FMEA Analysis 3orksheet 4 art 6

Click here to read our Newsletter that focuses on FMEAs!

"i#s to Make FMEAs More Effecti$e

Custo i%e the ratin& scales
3hile industry guidelines suggest customi7ing generic ranking scales& they do not re'uire it. 8owever& "y taking the time to add organi7ation4specific e.amples of applications of the ranking definitions& FMEA teams will have an easier time applying the scales. The use of meaningful& relevant e.amples saves teams time and improves consistency of rankings from team to team.

'se the sa e (custo ) rankin& scales throu&hout the or&ani%ation

(nce a custom set of ranking %cales are developed& use them for every FMEA study conducted in the organi7ation. 9y using the same scales& the R ! for every failure mode and effect can "e compared on a relative level and the highest potential risks for the organi7ation can identified.

Add a Control (lan ri&ht to the FMEA Worksheet

/ontrol lans ensure a system is in place to control the risks of the same failure modes identified in the FMEA. 3hile /ontrol lans can "e developed independently of FMEAs& it is time4 and cost4effective to link /ontrol lans directly to FMEAs. The /ontrol lan descri"es how each potential failure mode will "e controlled and how it should "e reacted to if it #the

failure mode$ does occur. To add a control plan component to an FMEA& add :columns; to the FMEA 3orksheet for the control factors& the specifications and tolerances& the measurement system& sample si7e& sample fre'uency& the control method& and the reaction plan.

'se a tea

a##roach

A team will "e a"le to generate a more comprehensive list of potential failures than any one individual could do. A team approach will lead to a richer and more accurate analysis of the risks associated with a process or design.

)ooks and "rainin& on FMEA

The FMEA Reference 2uide A "asic guide that covers the FMEA rocess 4 %tep4"y4step. (nly <=.=> each or <?.=> each when purchased in > packs. FMEA Investigator /omprehensive online training on design and process FMEAs following AIA2@A%4=--- standards. Availa"le online or in /+4R(M or !etwork versions. /lick here for more information. /lick here to try a sample lesson. FMEA Investigator for the %ervices@(ffice The same great training as you get with FMEA Investigator& "ut the e.amples are related to office and service types of transactions rather than manufacturing of product. Availa"le online or in /+4R(M or !etwork versions. /lick here for more information. /lick here to try a sample lesson. The 9asics of FMEA For years consistently in the top ,-&--- at Ama7on.com this "ook provides a simple and straightforward overview of FMEAs. /lick here for more information.

(rocess FMEA *co#e

Control (lans assure a syste is in #lace to control the risks of the sa e failure odes as identified in the (FMEA! While Control (lans can be de$elo#ed inde#endently of (FMEAs+ it is ti e and cost,effecti$e to link Control (lans directly to (FMEAs! "he #ri ary intent of Control (lans is to create a structured a##roach for control of #rocess and #roduct characteristics while focusin& the or&ani%ation on characteristics i #ortant to the custo er!
A /ontrol lan does assure well thought4out reaction plans are in place in case an out4of4control condition occurs and provides a central vehicle for documentation and communication of control methods. %pecial attention is typically given to potential failures with high R !s and those characteristics that are critical to the customer.

A Control (lan deals with the sa e infor ation e-#lored in a FMEA #lus ore! "he a.or additions to the FMEA needed to de$elo# a Control (lan are/
Identification of the control factors. The specifications and tolerances. The measurement system. %ample si7e. %ample fre'uency. The control method. The reaction plan.

0on1t let Control (lans beco e static!

Bust like work instructions& make /ontrol lans a living document. As changes in product or process characteristics& specifications& measurements systems& sampling& control methods& or the reaction plan are identified& update the control plan. 5se the revision as a communication tool to spread the word of the changes to the supply chain. 9y making the FMEA a living document& you can "e sure that potentials for failure are continually "eing eliminated or reduced.