POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)

PRODUCT PROCESS RESPONSIBILITY

KEY DATE

CORE TEAM

PROCESS FUNCTION POTENTIAL POTENTIAL POTENTIAL CAUSES / REQUIREMENTS CURRENT CONTROL

CURRENT RESPONSIBILITY
FAILURE MODE EFFECTS OF MECHANISMS OF FAILURE PREVENT DETECTION RECOMMENDED
SEV CLASS OCCR PROCESS RPN & TARGET COMP.
FAILURE ION ACTIONS
CONTROL DT

0
 FMEA NO REV.NO

PREPARED BY

FMEA DATE (ORG) FMEA DATE (REV)

ACTION RESULTS
RESPONSIBILITY
ACTION
& TARGET COMP. SEV OCCR DETECT RPN
TAKEN
DT

0
 Process FMEA Score Card

Severity Rating (How Serious is the effect)

Effect Customer Effect Manufacturing Effect Severity
Hazardous without Affects safety and/or non-compliance with regulation without May endanger operator (machine or equipment) without
10
warning warning. warning
Hazardous with Affects safety and/or non-compliance with government
May endanger operator (machine or equipment) with warning 9
warning regulation with warning.

Very High Loss of primary function 100% production scrapped and/or manufacturing stopped 8

Product functions but at reduced performance. Customer very

High Some production scrapped, and/or some line disruption 7
dissatisfied.
Product functions but comfort/convienience item inoperable.
Moderate Some production scrapped, and/or line disruption 6
Some Customer dissatisfaction
Product functions but comfort/convienience item operable at
Low 100% Production requires rework 5
reduced level of performance.
Customer inconvenience issue e.g. rattle, apperance. Noticed
Very Low Some production requires rework 4
by most customers
Customer inconvenience issue e.g. rattle, apperance. Noticed
Minor Some production requires rework 3
by 50% of customers
Customer inconvenience issue. Noticed only by discriminating
Very Minor Some production requires rework, can be carried out on-line 2
customers (less than 25% )

None No discernable effect Slight inconvenience to operation or operator, or no effect 1

Occurrance Rating (How Likely is the cause)

Proability Criteria: Occurance rating (Likely Failure Rates) Capability index (PPK) Occurance
10
Very High: Persistant > 100 per thousand pieces (10% Per 1000) less than 0.55
Failures
50 per thousand pieces (5% Per 1000) Greater than or equal to 0.55 9

8
High: Frequent 20 per thousand pieces (2% Per 1000) Greater than or equal to 0.78
Failures
10 per thousand pieces (1% Per 1000) Greater than or equal to 0.86 7
6
5 per thousand pieces (0.5% Per 1000) Greater than or equal to 0.94
Moderate:
Occasional Failures 2 per thousand pieces (0.2% Per 1000) Greater than or equal to1.0 5
4
1 per thousand pieces (0.1% Per 1000) Greater than or equal to1.1

Low: Relatively Few 0.5 per thousand pieces (0.05% Per 1000) Greater than or equal to1.2 3
Failures
2
0.1 per thousand pieces (0.01% Per 1000) Greater than or equal to1.3
Remote: Failures is
Unlikely < 0.1 per thousand pieces Greater than or equal to1.67 1

Detection Rating (How effective are the current controls)

Detection Criteria Suggested Detection Method Detection
Almost Impossible Adsolute cretanity of non-detection Cannot detect or is not checked 10

Very Remote Controls will probably not detect Control is achieved with indirect or random checks only
9

Remote Controls have poor chance of detection Control is achieved with visual inspection only 8

Very Low Controls have poor chance of detection Control is achieved with double visual inspection only
7
Low Control may detect Control is achieved with charting methods, such as SPC 6

Control is based on variable gauges or 100% Go/No Go

Moderate Control may detect
gauging 5
Moderately High Controls have a good chance to detect Error detection in subsequent operation 4

Error detection in subsequent operation or multipal detection in

High Controls have a good chance to detect
subsequent operation 3

Very High Controls almost certain to detect Error detection in operation. Cannot pass defect on 2

Very High Controls certain to detect Defect cannot be made because of error proofing
1