Doc. No.

: PDC-GL-01
GUIDELINE
Rev. No. : 0
Rev. Date: 02.02.2018
Title: FMEA
Page No: 1 of 9

GUIDELINE -
FMEA

Approval:

Prepared Reviewed Approved

 Doc. No.: PDC-GL-01
GUIDELINE
Rev. No. : 0
Rev. Date: 02.02.2018
Title: FMEA
Page No: 2 of 9

01. Purpose:

To establish a work instructions for potential failure mode and effects analysis to recognize and
evaluate the potential failures and its effects, identify actions which could eliminate or reduce
the chance of the potential failure occurring and document the process.

02. Scope:

This work instructions is applicable to Process FMEA

03. Process owner:

Production team leader and CFT members

04. Instruction:

1. FMEA is to be carried our for the following cases:

 New product development

 New process development
 Changed parts and processes
 Existing processes become unstable and incapable.

2. New failures and causes have been identified from the review of corrective action
reports, concession and process capability.

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.
 Field / service reports, etc.
 Process capability reports of all processes as appropriate.
4. During the initial design / 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 technical,
manufacturing, materials, quality assurance and technical services.

5. Development of process FMEA

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

 Document the potential failures and their consequences in format.

Application is described below. Points are numbered according to the
numbers circled on the form.

1. Product type - Indicate by making “” for the Product taken for
FMEA.

2. FMEA number - Enter the FMEA document number. The number

shall be either digit or alphanumeric in nature.

3. Key date - Enter the key date from APQP timing chart.

4. Product Group - Indicate the product group.

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

maintaining the process.

6. Generic Size - Enter the size, brand name for which the FMEA is
applicable.

7. Prepared by - Enter the name of the Team Leader and affix his
signature.

8. Indicate by marking “” whether the FMEA is for existing product / new
product.
9. 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.

10. Process - Enter a simple description of the process of operation

taken up for analysis.
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Rev. Date: 02.02.2018
Title: FMEA
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11. Team - Enter name of Team members, their department

and designation. If space provided is not
sufficient, annex the detail.

12. Process requirement - Enter simple end / output requirement of the

process. A process may have more than one
process requirement. List them separately.

13. Potential Failure Mode – Enter the potential failure mode for each
process requirement separately by asking how
can the process / component fail to meet the
process requirement and or design intent. The
assumption is that the failure could occur but
may not necessarily occur.

14. Potential effects of failure – Enter the potential effects of failure i.e.,
the effect of failure mode on the customers. The
customer may be considering when assigning
the potential effect of a failure.

15. 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 in-charge shall be
consulted for severity estimation. The severity
shall be estimated on a 1 to 10 scale as per
FMEA stage, notify the design responsible
person for incorporating in the concerned
documents.

16. Classification – Indicate the classification of special characteristics by

the use of Symbol as identified. If a classification
is identified during the process FMEA stage,
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Rev. No. : 0
Rev. Date: 02.02.2018
Title: FMEA
Page No: 5 of 9

notify the design responsible person for

incorporating in the concerned documents.

17. Potential Causes – List to the extent possible, each and every
conceivable failure causes assignable to each
mode. Describe the cause in terms of
something that can be corrected or can be
controlled.

Assume all inputs are conforming to specification of

the product is acceptable during first iteration. List out
first level causes like man, machine, method, material,
etc., and write the root causes under each first level
causes.

For failures, which have no direct relation to a

cause, a cause and effect diagram should be
drawn 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.

18. 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
used to determine the occurrence raking. In all
other causes, subjective assessment can be made.
If process capability included value such as Cp and
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Cpks are available for the similar processes those

can be considered.

19. Current process control – Enter the proposed or current controls that
detects the failure mode, should it occur, or
prevent the failure mode for occurring.

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.

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 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) &
detection (D).
RPN=(S) x (O) x (D).
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The RPN value will be between 1 to

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

22 Recommended action – After completion of the steps described

above, the RPNs are to be analysed in
Pareto fashion to identify the priority areas
for control.
Higher risk priority numbers generally requires immediate actions.
However, the severities ranking more than 8 are to be considered with
high priority irrespective of the RPN values. The following action
should be considered.

 To the probability of occurrence, process revisions are required.

 The action recommended should be to prevent / eliminate the causes
to reduce.
 The Occurrences ranking. The prevention techniques such as
mistake proofing methodology, SPC methods & continues
improvement are to be considered.
 Only a design / process revision can bring about a reduction is the
severity ranking.
 Generally improving detection control is costly & ineffective for quality
improvement.
 Increasing quality control inspection frequency is not appositive
corrective action & should be utilized as a temporary measure.
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 Emphasis must be on preventing / reducing occurrence of a defect

rather than detecting them.
Recommended change to current control systems such as introduction of statistical
process control and process improvements rather the random quality checks or
inspection, if no action is recommended for a specific cause indicate by entering
“NONE” in this column.

23 Responsibility and target completion date-Enter the

department/individual responsible for recommended action and the
target Completion date.

24 Action taken – After an action has been taken, enter a brief

description of the Action taken and effective date.

25 Action results – After the corrective action taken, the resulting

‘Severity’ (S), ‘Occurrence’ (O) and ‘Detection’ (D) rankings. Calculate
The “Resulting RPN”.

Note: Take mitigate action for RPN values >125

FMEA review and updation:

1. This document is a living document and should always reflect the latest
design or process, on identification of new failures and causes, when the
process becomes unstable and / or incapable.

2. Whenever FMEA is reviewed the concerned process related documents

Maintenance work Instructions, etc., are to be reviewed and updated if
required.

3. Receive the customer complaints by customer support representative and

register the complaint in complaint register.

4. Action details for customer complaints will be updated in customer complaint

master list .

5. Based on customer complaint master list – check FMEA revision applicable or

not by Development team.

6. If applicable update the FMEA to address customer complaint with revision

number, Revision date and amendment of change by Development team.
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Rev. No. : 0
Rev. Date: 02.02.2018
Title: FMEA
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05. Document reference:

S no Document name Version
1 AIAG manual 4th Edition

06. Record reference:

S no Record name Format No Retention period

Customer complaints – FMEA / control plan Calendar year + 3

1
updation report (Month _____) years
Customer complaints master - FMEA / control Calendar year + 3
2
plan updation summary years

07. Revision history :

S no Date Amendment details Changed by Remarks

01 02.02.2018 Initial release - -

08. IATF Clause ref: 6.1.2.1