FMEA PROCEDURE Ref. No.

: VEW-ENGG-P-10
VEW (FAILURE MODE EFFECTS Rev. No.: 00
ANALYSIS) Rev. Date: 01-04-2018

1.0PURPOSE
To establish a procedure to describe process FMEA technique.

2.0 SCOPE
This procedure applies to all types of “Pressed components & fabricated door assemblies for Bus
body application” for Automotive components undertaken for Development.

3.0 RESPONSIBILITY:
Dev. I/c / Quality Assurance I/C / MP Prepares, reviews & finalizes the Process FMEA in consultation
with Production I/C.

4.0 PROCEDURE:
4.1.1 FMEA is to be carried out for the following cases:

 New Product development

 New Process development
 Changed parts and processes

4.1.2 New failures and causes have been identified from the review of corrective action reports,
concession and process capability indices and the control charts.

4.1.3 Following records are to be available and referred during FMEA analysis:

 Historical quality data (failure wise and cause wise if available)

 Historical customer complaints
 Customer Returns reports, etc.

4.1.4 During the initial process Potential FMEA process, the responsible executive is expected to directly
and actively involve representatives from all affected areas. These areas should include but not
limited to Manufacturing, Materials, and Quality Assurance.

4.2 DEVELOPMENT OF PROCESS FMEA

4.2.1 Prepare a flow chart. This flow chart should identify the product/process characteristics associated
with each operation. Carry out risk assessment and conduct FMEA for all high risk process steps.
Copies of the flow charts/risk assessment should accompany the process FMEA.

4.2.2 Document the potential failures and their consequences & Application is described below. Points
are numbered according to the numbers circled on the form which is annexed.

Prepared By: MR Approved By: Managing Partner

 FMEA PROCEDURE Ref. No.: VEW-ENGG-P-10
VEW (FAILURE MODE EFFECTS Rev. No.: 00
ANALYSIS) Rev. Date: 01-04-2018

1. Product type – Indicate by marking “” for the product taken for FMEA

2. FMEA number – Enter the FMEA document number. The number shall be FMEA-CUSTOMER-001/2
etc. digits alpha-numeric in nature. First four digits shall be ‘FMEA’. Fifth & sixth digit shall be to
represent “Production” i.e., ‘F’ for Fabrication, etc. The last three digits shall be running Serial
Number starting from ‘001’ or shall be the Part number.

3. Key date – Enter the Key date from New Product Development Plan format No. FM.QA.____.

4. Product Group – Indicate the Product Group by marking “” for the appropriate type.

5. Process Responsibility – Enter the section/department responsible for maintaining the process.

6. Prepared by – Enter the name of the Team Leader and affix his signature.

7. Indicate by marking “” whether the FMEA is for existing product/new product

8. FMEA date – Enter the date when the original FMEA was completed and the revision number and revision
date as and when the FMEA undergoes revision.

9. Team – Enter name of Team Members, their department and designation. If space provided is not
sufficient, annex the detail.

10. Process – Enter a simple description of the process of operation taken up for analysis. Example: Extrusion,
Pouring etc.

11. Process Requirement – Enter simple end/output requirement of the process. A process may have more
than one process requirement, list them separately.

Example:

 Fabrication: while Fabricating see that the grade, thick & size is measured is OK.

12. Potential Failure Mode – Enter the potential failure mode for each process requirement separately by
asking how the process /component can fail to meet the process requirement. The assumption is that
the failure could occur but may not necessarily occur. ( These are negative of the Process
Requirement)

Prepared By: MR Approved By: Managing Partner

 FMEA PROCEDURE Ref. No.: VEW-ENGG-P-10
VEW (FAILURE MODE EFFECTS Rev. No.: 00
ANALYSIS) Rev. Date: 01-04-2018

Example:

 RM MS sheet/GI tubes – less thickness, more thickness, uneven sizes, foreign particles, moistures on
sheet surface.

13. Potential effects of failure – Enter the potential effects of failure i.e., the effect of failure mode on the
customer(s). The customer may be next operation, subsequent operation, and/or vehicle owner.
Each must be consider when assigning the potential effect of a failure.

Example:

 Thickness less – weight age in next process , rejection at customer end etc

 More Thickness– Improper mixing , rejection at customer end etc

Severity (S) – Severity is an assessment of the seriousness of the effect of the potential failure mode to
the internal or external customer. If the customer affected is internal, concerned section.

14. In-charge shall be consulted for severity estimation. The severity shall be estimated on a 1 to 10 scale
as per FMEA Manual.

15. Classification – Indicate the classification of special characteristics by the use of

Symbol < SC > / • for Product Characteristics and Process Characteristics. The same symbol should
be specified for the identified Special Characteristics in Control Plans, Drawings & related technical
documents. The above symbols are generic & during any customer specific requirement, we refer to
customer specifications (eg. For TMML we use symbols as given in the supplier development manual)

Potential Causes – List to the extent possible, each and every conceivable failure causes assignable to
each failure mode. Describe the cause in terms of something that can be corrected or can be
controlled. Assume all inputs are conforming to specification. Ambiguous phrases like operator error,
machine malfunction, fixture problem, etc., should be avoided. List out first level causes like Man,
Machine, Method, Material, Measurement & Mother nature etc., and write the root causes under
each first level causes. Typical examples are low curing time, Moisture present in the Gel coat
material, Air pressure less, high concentration of catalytic, etc.

For failure which have no direct relation to a cause, a cause and effect diagram should be drawn and
design of experiments to be considered to determine the effect of root causes.

While generating the causes, the potential failure only should be considered not the effects. Refer
the historical quality records, to verify that all causes occurred are listed.

Prepared By: MR Approved By: Managing Partner

 FMEA PROCEDURE Ref. No.: VEW-ENGG-P-10
VEW (FAILURE MODE EFFECTS Rev. No.: 00
ANALYSIS) Rev. Date: 01-04-2018

16. Occurrence (O) – Occurrence is how frequently the specific failure cause is projected to occur. The
occurrence ranking has a meaning rather than a value.
Estimate the likelihood of the occurrence of a cause on a 1 to 10 scale as per FMEA Manual.

Only occurrence resulting in the failure mode should be considered for ranking. Failure detecting
measures should not be considered here.

If available from a similar process, statistical data should be used to determine the occurrence
ranking. In all other cases, subjective assessment can be made.

If process capability included value such as Cp and Cpks are available for the similar processes those
can be considered.

17. Current Process Control – Enter the proposed or current control that detects the failure mode, should it
occur, or prevent the failure mode from occurring.

The types of Control are:

Type-1 Prevent the cause or failure from occurring (e.g., Mistake proofing,
atomization)

Type-2 Detect the cause mechanism and lead to corrective action (e.g., SPC
charts, set up approvals)

Type-3 Detect the failure mode (e.g., 100% inspection at stage or during the
subsequent operations).

18. Action taken – After an action has been taken, enters a brief description of the action taken and effective
date.

19. Action results – After the corrective action taken, the Team Leader is to verify the action for
implementation. Estimate and record the resulting ‘Severity’ (S), ‘Occurrence’ (O) and ‘Detection’ (D)
rankings. Calculate the “Resulting RPN”. If no actions are taken, leave the related ranking columns
blank.

All resulting RPNs should be reviewed and if further action is considered necessary, repeat Step-22
through Step-25.

The controls should be written against each causes listed in potential causes column. If no control on
the causes then write “No Control”.

Prepared By: MR Approved By: Managing Partner

 FMEA PROCEDURE Ref. No.: VEW-ENGG-P-10
VEW (FAILURE MODE EFFECTS Rev. No.: 00
ANALYSIS) Rev. Date: 01-04-2018

20. Detection (D) – Detection is an assessment of the probability that the proposed type of controls listed
under current control column will detect a cause or failure. The initial detection ranking is to be based
on Type-2 or 3 controls.
Estimate the detection ranking on a 1 to 10 scale as per FMEA manual.

The controls such as control charts, 100% inspection, sampling done on statistical basis is a valid
detection control and deserves low ranking. The low occurrence does not deserve low detection
ranking. Random quality checks are unlikely to detect the existence of an isolated defect. Sampling
done on a statistical basis is a valid detection.

For multiple controls where it is difficult to assess, the combined ranking is to be given.

21. Risk Priority Number (RPN) – The risk priority number is the product of Severity (S), Occurrence (O) and
Detection (D).

RPN = (S) X (O) X (D)

The RPN value will be between 1 to 1000. For higher RPNs, the team must undertake efforts to reduce
the risk through corrective action(s). In general, regardless of the resultant RPN, special attention
should be given when the severity of the potential failure effect is high.

22. Recommended Action – After completion of the steps described above, the RPNs are to be analyzed in
Pareto fashion to identify the priority areas for control.

Higher risk priority numbers generally requires immediate action, however, the severity ranking more
than 8 are to be considered with high priority irrespective of the RPN value.

The following actions should be considered:

 To reduce the probability of occurrence, revisions in process controls are required.

 The actions recommended should be to prevent/eliminate the causes to reduce the occurrence
ranking. The prevention techniques such as Mistake proofing methodology, SPC methods and
continuous improvement are to be considered.
 Only a process revision can bring about a reduction in the severity ranking.
 Generally improving detection control is costly and ineffective for quality improvement.
 Increasing quality control inspection frequency is not a positive corrective action and should only be
utilized as a temporary measure.
 Emphasis must be on preventing/reducing occurrence of a defect rather than detecting them.
 Recommend change to current control systems such as introduction of statistical process control and
process improvements rather than random quality checks or inspection.
If no action is recommended for a specific cause indicates by entering “NONE” in this column.

Prepared By: MR Approved By: Managing Partner

 FMEA PROCEDURE Ref. No.: VEW-ENGG-P-10
VEW (FAILURE MODE EFFECTS Rev. No.: 00
ANALYSIS) Rev. Date: 01-04-2018

23. Responsibility and target completion date – Enter the department/individual responsible for the
recommended action and the target completion date.

4.3 FMEA REVIEW AND UPDATING

4.3.1 This document is a living document and should always reflect the latest revision level. This is to be
reviewed whenever there is a change in process, modifications in controls, on identification of new
failures and causes, when the process becomes unstable and/or incapable.

4.3.2 Whenever FMEA is reviewed the concerned process related documents like Control Plans, Operating
Instructions, Setup Instructions, Maintenance Work Instructions, etc., are to be reviewed and updated
if required.

5.0 REFERENCE:

LIST OF DOCUMENTS & LIST OF RECORDS

1. Reference Manual for Process FMEA

2. Performa Format of Process FMEA

Prepared By: MR Approved By: Managing Partner