The term “FMEA” is an abbreviation for the failure analysis tool referred to as “Failure Modes & Effects Analysis”. The purpose of this tool and methodology is to analyze failure modes and the effects of each failure mode. For example, a failure mode of loading a blank envelope into the printer would be “loading envelope upside down”. The effect would be “printing Ship To address on wrong side of envelope”. All things considered, printing a single envelope upside down is no big deal. The overall cost and time to re-print is relatively low. But what if your company is a printing company? What if you load the envelopes incorrectly and print 15,000 envelopes on the WRONG SIDE? The potential effects of this extreme scenario would likely cost you hundreds of dollars and several hours of lost production time. The effect on your customer may be a delayed shipment on critical marketing material related to an upcoming major trade show. Congratulations! By not adequately addressing this failure mode, you have added stress, cost and time to a profit margin that was already very slim. Formal use of the failure modes and effects analysis (FMEA) tool began in the 1940s, where it was first used to study failures, defects or malfunctions by reliability engineers in the US Military. The tool was used to anticipate each possible failure and the consequence of each failure as a means of mitigating risk. Since then, this risk prevention tool has been used by various industrial and government entities from NASA to the EPA, and later Ford, GM and Chrysler. Today, the FMEA is used in various functions as a means of error-proofing or designing defect detection mechanisms into machines (MFMEA), processes (PFMEA), material movement or logistics (LFMEA) and product designs (DFMEA).

Severity (1 to 10) x Occurrence (1 to 10) x Detection (1 to 10) = Total RPN (1 to 1000) How bad would it be? x What’s the likelihood? x How hard would it be to detect and contain? = RPN

The following list provides further guidance on the use and misuse of the failure modes and effects analysis tool:

Use

• inventory of known OR potential failure modes

• part of contract agreement used to assess & report risk

• connects with Control Plan to illustrate mitigation or reaction to each known or potential failure mode

• helps prioritize order of importance based on risk priority number (RPN)

• captures "lessons learned" about failures or potential failures from similar situations, products or processes as a means of minimizing risk

• ensures that all failures are considered from prototype to pre-production and through launch of full production

• helps to define actions and responsibility for cross-functional teams

• increases profitability by reducing overhead expense such as rework, repair, sorting and scrap

Misuse

• typically used at the time of process signoff or approval from the customer, then archived ("tossed aside") therefor failing to be properly update and communicate to team (dormant vs. evergreen)

• not connected as an OUTPUT to CAPA process (CAR or PAR should nearly always reduce S, O and/or D); with every corrective or preventive action taken, the S, O and/or D SHOULD be lowered or the action taken was ineffective

• opportunity lost in risk reduction by stopping at customer sign-off

• increases waste through reliance on redundant systems (i.e. detection mechanisms no longer needed)

• higher level management reliance on a poorly conceived or misleading FMEA rankings

• intentionally ranking failure modes lower than true risk in order to avoid required improvement activities

• misrepresentation of the true risk of a process that is then benchmarked for future product and process design

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