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Fmea Procedure

The document outlines the procedure for conducting Failure Mode and Effect Analysis (FMEA) to identify and mitigate potential failures in critical processes used for product manufacturing. It details the responsibilities of the development head and FMEA teams, the factors considered during analysis, and the criteria for assessing severity, occurrence, and detection of failures. Additionally, it specifies the review criteria for FMEA and the importance of documenting and prioritizing risks based on the Risk Priority Number (RPN).

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devendra shukla
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3 views

Fmea Procedure

The document outlines the procedure for conducting Failure Mode and Effect Analysis (FMEA) to identify and mitigate potential failures in critical processes used for product manufacturing. It details the responsibilities of the development head and FMEA teams, the factors considered during analysis, and the criteria for assessing severity, occurrence, and detection of failures. Additionally, it specifies the review criteria for FMEA and the importance of documenting and prioritizing risks based on the Risk Priority Number (RPN).

Uploaded by

devendra shukla
Copyright
© © All Rights Reserved
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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QUALITY SYSTEM PROCEDURE Doc. No.

: P/QMS/02

Rev. No. : 01
FALIURE MODE EFFECT ANALYSIS
Date : 24/02/2017

1 . PURPOSE:
To establish and maintain a procedure for process failure.
2. SCOPE:

This procedure applies to all major / critical processes which are being used to make various products.
3. DEFINITIONS:
FMEA (Failure Mode and Effect Analysis)
An FMEA can be described as a synchronized group of activities which are intended to:
a) Recognize and evaluate the potential failure of a product / process and its effects.
b) Identify action, which could determine or reduce the chance of the potential failure occurring.
c) To document the process.
4. RESPONSIBILITY:
1.1 HEAD (Development.) is responsible for conducting various FMEA with the help of various Section
Heads, who are in charge of processes.

2. PROCEDURE :

2.1 HEAD (development) makes the process flow chart and identifies critical / special processes. FMEA
Teams are formed department-wise which includes HEAD (QA), A rep. From Dev., Engg., Prod., Material,

are assigned the responsibility for conducting FMEA’s.

2.2 FMEA team looks at the following factors :

a) Identifies potential product related process failure modes.

b) Assesses the potential customer effects of the failure.

c) Identifies the potential manufacturing or assembly process causes reduction or and identifies the
process variables on which to focus controls for occurrence detection of the failure conditions.

d) Develops a ranked list of potential failure modes, thus establishing a priority system for corrective action
considerations.

2.3 IN-PUT FOR FMEA:-


Note:Following points to be considered while making PFMEA
a) Past Defect History, (Customer + Development Stage + In-house Problem included) F/DEV/09

b)- Defects items expected,- defects items unable to capture at customer end, F/DEV/10

- Defects items difficult to repair at customer end.


c)- Process Flow Diagram (F/PFD/01)

Prepared By Approved By
QUALITY SYSTEM PROCEDURE Doc. No. : P/QMS/02

Rev. No. : 01
FALIURE MODE EFFECT ANALYSIS
Date : 24/02/2017

d)- Part Drawing


e )Occurrence Rating Chart F/DEV/12
f) Detection Rating Chart F/DEV/13
g )Severity Ranking Criteria F/DEV/14

FMEA REVISION RULE:-

PFMEA to be reviewed at the time of market failure or in case of customer complaint received and when
any critical issue/ Rejection occur in-house.

PFMEA also Revise Once in Year to consider product requirement & their potential failures & its effects.

2.3 The various FMEA’s are filled in the same manner as referred in the marking manual for FMEA.
2.4 FMEA Assesses through their experience and available data by the following factors :
A) SEVERITY (S) :

Severity is an assessment of the seriousness of the effect of the potential failure mode to the customer
Severity applies to effect only. The severity should be estimated on a ‘1’ to ‘10’ scale. The rating is done
strictly as per chart given in FMEA Manual under heading of severity evaluation criteria.
B) OCCURANCE (O) :
Occurrence is how frequently the specific failure cause / mechanism is projected to occur. The occurrence
ranking number has a meaning rather than a value. Occurrence ranking number also be given as per the
FMEA manual using the evaluation criteria chart. Estimate the likelihood of occurrence on a '1‘ to '10’ scale
only occurrences resulting in the failure mode should be considered for this ranking.

C) DETECTION (D) :
Detection is assessed by the team based on the probability than the current process control will detect or not. The
potential cause / mechanism or the probability that the proposed process control will detect the subsequent failure
mode before the part / component used in manufacturing / process locations.

Detection ranking is given based on suggested evaluation criteria given in FMEA chart on ‘1’ to ‘10’ scale.

Random quality checks are unlikely to detect the existence of an isolated defect and should not influence the
detection ranking. Sampling done on statistical basis is a valid detection control. Do not automatically presume that
the detection ranking is low because the occurrence is low (e.g. when control charts are used), but do assess the
ability of the process controls to detect low frequency failure modes or prevent them from going further in the
process.

D) RISK PRIORITY NUMBER (RPN) :


The Risk Priority Number is the product of Severity (S), Occurrence (O) and Detection (D) ranking.
i.e. RPN = S x O x D

Prepared By Approved By
QUALITY SYSTEM PROCEDURE Doc. No. : P/QMS/02

Rev. No. : 01
FALIURE MODE EFFECT ANALYSIS
Date : 24/02/2017

This value should be used to rank order the concerns in the process. The RPN will be between ‘1’ and ‘1000’. For
higher RPN’s the team must undertake efforts to reduce this calculated risk through corrective actions. Regardless of
the resultant RPN, special attention should be given when severity is high.

CUT OF CRITERIA: - Check rating of severity, occurrence and detection . if it is more than eight any than
action first on that if all these are less than eight than focus on RPN more than 150.

2.5 Review Criteria:


Review PMEA in the following conditions
•Customer complaint
• Top In-house defect
F/DEV/10
• Market failure
• Once in a year
• Horizontal Application
2.6 Reference:-
AIAG 4th edition

1 2/24/2017 Cut of criteria added


Revision No. Revision Date Revision History Revised By

Prepared By Approved By

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