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6 PFMEA & Control Plan 1 of 7
6 PFMEA & Control Plan 1 of 7
M-25P & M-26, IV Phase, Adityapur Industrial Area, Gamharia, Jamshedpur – 832108.
Procedure No. : IM / QP / 7.3.1.1
Rev No : 00
QUALITY PROCEDURE Rev Date :
Page : 01 of 07
TITLE : PROCESS FAILURE MODE & EFFECT ANALYSIS AND CONTROL PLAN
0.1 Purpose : To study the potential failure modes in the process and their associated causes / mechanism
for initiating corrective measures leading to development of control plan.
0.2 Scope : All the process followed for manufacturing item for supplying to customer.
0.3 Reference : Clause No 7.3.1.1 of IATF 16949:2016
0.4 Definition : FMEA – Failure Mode Effect Analysis, PFD – Process Flow Diagram, SOD – Severity,
Occurrence, Detection, RPN – Risk Priority Number, SQC – Statistical Quality Control
Sl. ACTIVITY Responsibility Ref. Doc /
No. Record
5.6 The following describes the information to be entered on the FMEA Core Team or
form / format (as per AIAG 4th Edition reference manual). FMEA Team
• FMEA Number (A) – Enter an number which is used to identify the
FMEA document. This is used for document control.
• Component Name or and Number (B) – Enter the name and number
of the system, subsystem, or component which is being analyzed.
• Responsibility (C) – Enter the OEM, organization, and department or
group who is responsible for design or process. Also enter the supply
organization name, if applicable.
• Model Year / Program (D) – Enter the intended model year and
program that will use or be affected by the design / process being
analyzed (if known).
• Key date (E) – Enter the initial FMEA due date, which should not
exceed the scheduled production design / process release date.
• FMEA date (F) – Enter the date the original FMEA was completed and
the latest revision date.
• Core Team (G) – Enter the team members responsible for developing
the FMEA. Contact information (i.e. name, organization, contact no
and e-mail id etc) may be included in a referenced supplemental
document.
• Prepared by (H) – Enter the name and contact information including
the organization (company) of the engineer responsible for preparing
the FMEA.
Body of the FMEA form / format (fields a to n ) – The body of the
FMEA contains the analysis of risks related to the potential failures and
improvement action being taken.
• Item / Function / Requirements (a) – Item / Function can be separated
into two (or more) columns or combined into a single, bridged
column which encompasses these elements. Interfaces (as items of
analysis) can be either combined or separate.
Prepared By : Approved By : Review & Release Controlled By:
• Item (a1) – Enter the items, interfaces, or parts which have been Core Team or
identified through block diagram, P-diagrams, schematics and other FMEA Team
drawings and other analysis conducted by the team.
• Function (a1) - Enter the function of the item or interface being
Analyzed which are necessary to meet the design / process intent
based on customer requirements and the team’s discussion.
• Requirements (a2) – An additional column requirement, may be
added to further refine the analysis of the failure mode. Enter the
requirement for each of the functions being analyzed (based on
customer requirements and the team’s discussion.
• Potential Failure Mode (b) – Potential failure mode is defined as the
manner in which a component, subsystem or system could potentially
fail to meet or deliver the intended function described in the item
column.
• Potential Effect of Failure (c) – Potential effect of failure are defined
as the effects of the failure mode on the function, as perceived by the
customer.
• Severity (S) (d) – Severity is the value associated with the most
serious effect for a given failure mode. Severity is a relative ranking
within the scope of the individual FMEA.
Severity Rank – Suggested Criteria Guidelines in AIAG 4 th Edition
reference manual.
• Classification (e) – This column may be used to highlight high-
priority failure modes and their associated causes.
As a result of this analysis, the team may use this information to
Identify special characteristics.
• Potential Cause / Mechanism of Failure Mode (f) – This information
can be separated into multiple columns or combined into a single
column.
• Occurrence (g) – Occurrence is the likelihood that a specific cause / Core Team or
mechanism will occur resulting in the failure mode within the design FMEA Team
or process life.
A consistent occurrence ranking system should be used to ensure
continuity. The occurrence number is a relative ranking within the
scope of the FMEA and may not reflect the actual likelihood of
occurrence.
Occurrence Rank – Suggested Criteria Guidelines in AIAG 4th Edition
reference manual.
• Current Process / Design Controls (h) – Current process or design
controls are those activities conducted as part of the design / mfg
process that have been completed or committed to and that will
assure the design / manufacturing process adequacy for the design or
process functional and reliability requirement under consideration.
There are two types of controls to consider : -
Prevention : Eliminate (prevent) the cause of the mechanism of
failure or the failure mode from occurring, or reduce its rate of
occurrence.
Detection : Identify (defect) the existence of a cause, the resulting
mechanism of failure or the failure mode, either by analytical or
physical methods, before the item is released for production.
Detection control should include identification of those activities
which detect the failure mode as well as those that detect the cause.
• Detection (D) (i) – Detection is the rank associated with the best
detection control listed in the current design or manufacturing process
control detection column. When more than one control is identified, it
is recommended that the detection ranking of each control be included
as part of the description of the control. Record the lowest ranking
value in the detection column.
Detection is a relative ranking within the scope of the individual
FMEA. In order to achieve a lower ranking, generally the design or
Process control (analysis or verification activities) has to be improved.
Detection Rank – Suggested Criteria Guidelines in AIAG 4th Edition
reference manual.
Prepared By: Approved By: Review & Release
Controlled By:
6.0 Based on the PFMEA, a Control Plan is developed pursuing the Core Team or
following steps : FMEA Team
• The Control Plan must follow the process from receipt of raw material
Through shipping steps.
• There must be a one-to-one match of the operation number and
descriptions between PFD, FMEA and Control Plan to allow for
Cross-referencing of the documents.
• Part / Process Number – Enter the part / process number as per
Identified in FMEA.
• Process Name / Operation Description – Enter the process name /
Operation description as per identified in FMEA.
• Machine, Devices, Jig, Tools for Manufacturing – Enter the machine,
devices, jig, tools description as per using during manufacturing
Process.
• Characteristics – Enter the product and process characteristics in
serial number wise as per identified in FMEA and process / operation
wise.
• Special Characteristic Classification – Enter the product / process
Specification’s special characteristic classification as per mentioned
in drawing / specifications or identified in FMEA.
• Product / Process Specification – Enter the product / process
Specification as per mentioned in drawing / specifications or and
Identified in FMEA.
• Methods –
Measurement Technique – Enter the inspection equipments name at
the time of using in particular product / process specification
Inspection time (for controlling).