Potential Failure Mode & Effects Analysis

Process$/$Product: FMEA Date: $($original$)$

FMEA Team: $($Revised$)$

Responsibility: Page: of

Prepared By:

Process Actions Results

Process Steps or Product Functions Potential Failure Mode Potential Effects of Failure Severity $(1-10)$ Potential Cause$($s$)$ of Failure Occurrence $(1-10)$ Current Controls Detection $(1-10)$ Risk Priority Number $($RPN$)$ Recommended Action Responsibility and Target Completion Date Action Taken Revised Severity $(1-10)$ Revised Occurrence $(1-10)$ Revised Detection $(1-10)$ Revised Risk Priority Number

Score Severity Guidelines

AIAG Six Sigma

$10$ Hazardous without warning Injure a customer or employee Bad

$9$ Hazardous with warning Be illegal

$8$ Very High Render product or service unfit for use

$7$ High Cause extreme customer dissatisfaction

$6$ Moderate Result in partial malfunction

$5$ Low Cause a loss of performance which is likely to result in a complaint

$4$ Very Low Cause minor performance loss

$3$ Minor Cause a minor nuisance but can be overcome with no performance loss

$2$ Very Minor Be unnoticed and have only minor effect on performance

$1$ None Be unnoticed and not affect the performance Good

Score Occurrence Guidelines

AIAG Six Sigma

$10$ Very High: Persistent Failures, Ppk $<0\mathrm{.}55$ More than once per day $>30\%$ Bad

$9$ Very High: Persistent Failures, Ppk $>=0\mathrm{.}55$ Once every $3-4$ days $<30\%$

$8$ High: Frequent Failures, Ppk $>=0\mathrm{.}78$ Once every week $<5\%$

$7$ High: Frequent Failures, Ppk $>=0\mathrm{.}86$ Once per month $<1\%$

$6$ Moderate: Occasional Failures, Ppk $>=0\mathrm{.}94$ Once every $3$ months $<0\mathrm{.}03\%$

$5$ Moderate: Occasional Failures, Ppk $>=1\mathrm{.}00$ Once every $6$ months $<1$ per $10,000$

$4$ Moderate: Occasional Failures, Ppk $>=1\mathrm{.}10$ Once per year $<6$ per $100,000$

$3$ Low: Relatively Few Failures, Ppk $>=1\mathrm{.}20$ Once every $1-3$ years $<6$ per million

$2$ Low: Relatively Few Failures, Ppk $>=1\mathrm{.}30$ Once every $3-6$ years $<3$ per $10$ million

$1$ Remote: Failure is Unlikely, Ppk $>=1\mathrm{.}67$ Once every $6-9$ years $<2$ per billion Good

Score Detection Guidelines

AIAG Six Sigma

$10$ Almost Impossible: Absolute certainty of non$-$detection Defect caused by failure is not detectable Bad

$9$ Very Remote: Controls will probably not detect Occasional units are checked for defects

$8$ Remote: Controls have poor chance of detection Units are systematically sampled and inspected

$7$ Very Low: Controls have poor chance of detection All units are manually inspected

$6$ Low: Controls may detect Manual inspection with mistake$-$proofing modifications

$5$ Moderate: Controls may detect Process is monitored $($SPC$)$ and manually inspected

$4$ Moderately High: Controls have a good chance to detect SPC is used with an immediate reaction to out of control conditions

$3$ High: Controls have a good chance to detect SPC as above, $100\%$ inspection surrounding out of control conditions

$2$ Very High: Controls almost certain to detect All units are automatically inspected

$1$ Very High: Controls certain to detect Defect is obvious and can be kept from affecting the customer Good