OP-7.3.1.1 Process Failure Mode and Effect Analysis

Operational Procedure MIYOSHI PRECISION (MALAYSIA) SDN BHD
Process Failure Mode And Effect Analysis

Operational Procedure : OP- 7.3.1.1 Revision: 4 Page 1/7
Revision History
Rev No Details of Revision Date

00 Initial Release 28.02.07
01 To update the procedure and to add-in Revision History as a front 30.08.07
page for procedure.
02 Upgrade to ISO 9001:2008 requirement 14.10.10
03 Changes at approval Authorities and other minor amendments 13.12.10
04 Changes at approval Authorities 03.05.11
Approval Authorities
Prepared Reviewed Reviewed Reviewed Approved

By By By By By
Name Kala Allan Teen Nicole Lee S.H.Yu C.A.Tan
Date 03.05.11 03.05.11 03.05.11 03.05.11 03.05.11
Designatio Doc. Cont. EMR OSHMR QMR MD

n
Signature
Responsible Outline of Procedure Interfaces

QA  PFMEA initiation - Drawing / Specifications

from Customer
PFMEA Team  Preliminary Analysis - Process Flow & Control

Plan
PFMEA Team  PFMEA review & - PFMEA Form

Evaluation
- Risk Assessment Table
- Relevant historical data
PFMEA Team  PFMEA follow-up & - PFMEA reports

action
I PURPOSE
To achieve defect prevention rather than defect detection: -
 Recognizing and evaluating potential failure of a process and it's effect
 Identifying action to eliminate and or reducing the probability of a potential

failure mode to occur
 Continuously improving on the product and process
II APPLICATION
To define and describe the Process Failure Mode & Effect Analysis procedure as
required by the automotive customer. In addition, the procedure shall only be
implemented for process or product that is ISO/TS 16949:2002 prerequisite.
III RESPONSIBLE
This procedure is concerns Engineering and Quality Assurance.
IV DEFINITION
PFMEA - Process Failure Mode & Effects Analysis
PFMEA Team - Designated person of various department Sales & Marketing,

Engineering, Production, SCM, QA, etc.)
RPN - Risk Priority Number
APQP - Advanced Product Quality Planning

V PROCEDURE
1.0 PFMEA Initiation
1.1 QA authorized personnel shall organize a cross-functional team to perform

PFMEA task to review & analyze of a new or revised parts/process when required
from APQP team leader or Customer.
1.2 PFMEA team member shall consist of QA, production, engineering, tool room,
store, purchasing, and planning for brainstorming purpose.
1.3 PFMEA should be completed before trial production. Therefore, the key date should
be defined clearly in the PFMEA report.
2.0 Preliminary Analysis
2.1 The team should conduct preliminary analysis by referring to the relevant process
flow chart and control plan, which cover right from in-coming inspection until
delivery of final product.
2.2 PFMEA team members should study the details of all the processes in the flow
chart and control plan in-order to understand the process requirements before
PFMEA to be carried out.
2.3 Relevant reports such as inspection report, reject report, rework report, scrap
report, customer complaint records, drawing, spec, etc. may be referred before
PFMEA being performed.
3.0 PFMEA Review & Evaluation
3.1 Together, the team shall deduce, evaluate, review and assign the following
item/parameter into each designated column in the PFMEA report.
 Process function & requirements
 Potential process failure mode

 Potential effects of failure ( local, subsequent process or end user / customer)
 Severity ranking of each potential effects of failure.
 An optional step in classifying any special process characteristic as critical,

key, major, significant etc.
 Identify the potential cause(s) mechanism of failure. Follow by assigning

appropriate ranking for occurrence (O).
 Relevant data / reports may be used for reference purposes before the ranking
for occurrence being decided. Appropriate QC tools such as fishbone diagram
may be used for brainstorming purposes.
3.2 To fill in the current process control according to present Control plan. Current
process control for consideration are those that :
 Prevent the cause of failure mode from occurring such as daily preventive
maintenance
 Detect failure of process such as in-process inspection
 Subsequently the team members will then assign appropriate ranking for
detection & fill in detection column.
3.3 The team shall compute the risk priority number (RPN).
RPN = Severity (S) x Occurrence (O) x Detection (D)
The value calculated should fall "between 1 to 1000".
3.4 If RPN >=100, recommended actions are required or specified by customer
3.5 However, when RPN <100, if Severity X Occurrence >=36, then recommended
action should be identified.
3.6 The intent of any recommended action is to reduce any one or all of the
occurrence, severity and / or detection rankings.
3.7 Recommended action in terms of corrective action or preventive action which

may include the following : -
 Reducing occurrence of potential process failure mode
 Changing the present current process control aiming at preventing defects.

Where appropriate, the concept of Poka-Yoke / mistake proofing shall be
introduced.
 Increase the effectiveness of current detection method.
 The team shall determine and select responsible person / selection to take up
the responsibility to improve the designated process characteristic and decide
the completion date for the task.
4.0 PFMEA follow-up
4.1 The PFMEA team leader shall follow up on the task given to selected section or
person and get the required feedback / response for reassigning the severity,
occurrence and detection (into each designated column) and compute the new
risk priority number for each characteristic. The resulting RPN shall be reviewed
in order to justify any additional action required.
4.2 The team shall be responsible in assuring that all recommended action is
effectively implemented so that process improvement is achieved.
4.3 The PFMEA report is a living document & should always reflect the latest
design level & practices in the production floor. Therefore, it should be revised if
necessary.
VI REFERENCE
QS-9000 Potential Failure Mode & Effects Analysis Reference Manual
Control Plan
VII RELEVENT RECORDS
Process FMEA Cover Page
Process FMEA Form
VIII APPENDIX
Nil

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Operational Procedure MIYOSHI PRECISION (MALAYSIA) SDN BHD

Process Failure Mode And Effect Analysis

Rev No Details of Revision Date

04 Changes at approval Authorities 03.05.11

Prepared Reviewed Reviewed Reviewed Approved

Name Kala Allan Teen Nicole Lee S.H.Yu C.A.Tan

Date 03.05.11 03.05.11 03.05.11 03.05.11 03.05.11

Designatio Doc. Cont. EMR OSHMR QMR MD

Responsible Outline of Procedure Interfaces

QA  PFMEA initiation - Drawing / Specifications

PFMEA Team  Preliminary Analysis - Process Flow & Control

PFMEA Team  PFMEA review & - PFMEA Form

PFMEA Team  PFMEA follow-up & - PFMEA reports

To achieve defect prevention rather than defect detection: -

 Recognizing and evaluating potential failure of a process and it's effect

 Identifying action to eliminate and or reducing the probability of a potential

 Continuously improving on the product and process

This procedure is concerns Engineering and Quality Assurance.

PFMEA - Process Failure Mode & Effects Analysis

PFMEA Team - Designated person of various department Sales & Marketing,

RPN - Risk Priority Number

APQP - Advanced Product Quality Planning

1.0 PFMEA Initiation

1.1 QA authorized personnel shall organize a cross-functional team to perform

2.0 Preliminary Analysis

3.0 PFMEA Review & Evaluation

 Process function & requirements

 Potential process failure mode

 Potential effects of failure ( local, subsequent process or end user / customer)

 Severity ranking of each potential effects of failure.

 An optional step in classifying any special process characteristic as critical,

 Identify the potential cause(s) mechanism of failure. Follow by assigning

 Detect failure of process such as in-process inspection

RPN = Severity (S) x Occurrence (O) x Detection (D)

The value calculated should fall "between 1 to 1000".

3.4 If RPN >=100, recommended actions are required or specified by customer

3.7 Recommended action in terms of corrective action or preventive action which

 Reducing occurrence of potential process failure mode

 Changing the present current process control aiming at preventing defects.

 Increase the effectiveness of current detection method.

4.0 PFMEA follow-up

QS-9000 Potential Failure Mode & Effects Analysis Reference Manual

VII RELEVENT RECORDS

Process FMEA Cover Page

Process FMEA Form

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