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Irungattukottai, Kanchipuram Dt-602 105
Irungattukottai, Kanchipuram Dt-602 105
1. PURPOSE:
To establish to describe process FMEA technique.
2. SCOPE:
Process of Special Product and Product Characteristics.
3. REFERENCES:
4. DEFINITIONS:
CFT Team
5. PROCEDURE:
5.1 Definitions:
5.1.1 Failure: - A “FAILURE” is that a component, assembly or system which does not meet the
requirements or function in accordance with design intent, i.e. not meeting the specifications.
5.1.2 Failure Mode: - A “FAILURE MODE” is the manner in which a component, assembly or system
failure occurs. e.g. how the component could not meet the specification.
Hazardous Very high severity ranking when a potential failure mode affects safe
without vehicle operation and / or involves noncompliance with government 10
warning regulation without warning
Very high severity ranking when a potential failure mode affects safe
Hazardous
vehicle operation and / or involves noncompliance with government 9
with Warning
regulation with warning
Fit & Finish / Squeak & Rattle item does not conform. Defect noticed
Very Low 4
by most customers (more than 75%)
Fit & Finish / Squeak & Rattle item does not conform. Defect noticed
Minor 3
by 50% customers
Fit & Finish / Squeak & Rattle item does not conform. Defect noticed
Very Minor 2
by discriminating customers (less than 25%)
Classification
Potential cause enters the potential cause as how the failure could occur and describe the cause in
terms of something that can be corrected / controlled.
Assume all inputs are conforming to specifications and design of the product is acceptable.
Ambiguous phrases like operator error, machine malfunction, fixture problem etc. should be avoidable.
List out first level causes like operator error, machine, method, material etc. and write the root causes
each first level causes.
Typical examples are misallocation, too low lubrication, die damage, inadequate pressure inaccurate
measurement etc.
For failures that have no direct relation of cause, cause and effect diagram is drawn and design of
experiments to be considered, not effect. Refer to the historical quality records, to verify that all causes
occurred are listed.
Potential cause enters the potential cause as how the failure could occur and describe the cause in
terms of something that can be corrected / controlled.
Assume all inputs are conforming to specifications and design of the product is acceptable.
Ambiguous phrases like operator error, machine malfunction, fixture problem etc. should be avoidable.
List out first level causes like operator error, machine, method, material etc. and write the root causes
each first level causes.
Typical examples are misallocation, too low lubrication, die damage, inadequate pressure inaccurate
measurement etc.
For failures that have no direct relation of cause, cause and effect diagram is drawn and design of
experiments to be considered, not effect. Refer to the historical quality records, to verify that all causes
occurred are listed.
Occurrence It is likelihood of ht occurrence on a 1 to 10 scale. In this failure detecting measures are not
to be considered (e.g. for 100% inspection at the process stage, the occurrence should not be rated 0 or
low).
While assessing, possible failure rates should be used if cause wise data is available, also the failure
rate of failure mode should be used. If process capability Indies such as Cp & Cpk are available for
similar process, those can be considered. Initial occurrence raking will be affected by prevention
controls such as mistake proofing techniques.
For all other causes, the criteria mentioned in the scale are to be used.
Current process control Enter the proposed or current controls that detect the failure mode which had
occurred or prevent the failure mode form occurring.
The categories of control are:
Prevent the cause or failure from occurring (e.g. mistake proofing).
Detect the cause mechanism and lead to corrective action (e.g. SPC charts, set up approvals
etc.)
Detect the failure mode (e.g. 100% inspection at stage or during the subsequently operations);
The controls should be written against each cause listed on potential cause column.
If no control exists on the cause, then write “No Control”.
Detection : Detection is an assessment of the probability that the proposed type of control listed under
current controls column will detect a cause or failure.
The controls such as Control Chart, 100% inspection, sampling done on statistical basis is a valid
detection control and desires low ranking. The low occurrence doesn’t deserve low detection ranking.
For multiple controls where it is difficult to assess the combined ranking can be given.
Insp Types
Detection Criteria: Suggested Range of Detection Methods Rank
A B C
Almost Absolute certainty
X Cannot detect or is not checked 10
Impossible of non detection
Controls will
Very Control is achieved with indirect or random
probably not X 9
Remote checks only
detect
Controls have
Control is achieved with visual inspection
Remote poor chance of X 8
only
detection
Controls have
Control is achieved with double visual
Very Low poor chance of X 7
inspection only
detection
Controls may Control is achieved with charting methods,
Low X X 6
detect such as SPC.
Control is based on variable gauging after
Controls may parts left the station, or Go / No Go gauging
Moderate X 5
detect performed on 100% of the parts after parts
left the station.
Controls have a Error detection in subsequent operations, or
Moderate
good chance to X X gauging performed on setup and first piece 4
High
detect check (for setup causes only)
Error detection in-station or error detection
Controls have a
in subsequent operations by multiple layers
High good chance to X X 3
of acceptance: supply, select, install, verify,
detect
cannot accept discrepant part.
Error detection in-station (automatic
Controls almost
Very High X X gauging with automatic stop feature) cannot 2
certain to detect
pass discrepant part.
Discrepant parts cannot be made because
Controls certain to
Very High X item has been error-proofed by 1
detect
process/product design..
Risk priority number (RPN): The risk priority number is the product of Severity (S),
Occurrence (O) and Detection (D). The highest severity of effect should be taken for calculating
Risk Priority Number (RPN) for each failure mode. If occurrence ranking is available, on each
cause listed, and detection is available for each of controls then multiply the S, O and D and write
RPN against each of row cause / controls.
Recommended action After completion of the steps described above, the RPNs are to be analyzed
using Pareto identify the priority area of control. As a policy, CFT has decided to take corrective action
only if the RPN value is more than 100 and / or severity is greater than or equal to 9 and occurrence is
more than 5 and detection is more than 5.
The recommended actions are to be taken to prevent / eliminate the causes to reduce the occurrence
ranking. The prevention methods techniques such as mistake proofing methodology and the SPC ate to
be considered. To reduce severity ranking, generally, the design revision is required.
The reductions in detection ranking are to be considered as last option, because improving the detection
controls is costly and ineffective. The areas or process where action is not required, at present are to be
recovered suitably in the format.
Enter the personnel responsible for those actions and the target date of completion.
Verification for implementation Team leader is to verify the action for implementation. After the
corrective actions have been implemented, estimate and record the resulting ‘Severity’, ‘Occurrence’,
‘Detection’ rankings. Calculate the “Resulting RPN”. If no actions are taken, leave the related ranking
column blank.
FMEA review and updating:- FMEA is a living document, this is to be reviewed whenever there is
change is design or process, on identification of new failures and causes.
All FMEA’s are reviewed once in six months for S, O & D ratings and corrective actions are initiated
accordingly, if required.
Whenever, FMEA is reviewed the concerned process related documents like control plans, operating
instructions, setting instructions, maintenance work instruction etc. are to be reviewed and updated if
required.
Document reference
Potential failure mode and effect analysis – Manual published by A.I.A.G (4th Edition)