022

BS EN ISO 9001 : 2000

CERTIFICATE NO: A2I6901

PFMEA
TRAINING
STRIVE FOR EXCELLENCE
BERUSAHA KE ARAH KECEMERLANGAN
 FMEA INTRODUCTION

Potential Failure Mode and Effect

Analysis

As systematic approach to:
i. Recognize and evaluate potential failure
mode of product and process and the effect
of the failure
ii. Identify action that could eliminate or
reduce the chance of potential failure
occurring
iii. Document the entire process
WHERE DOES FMEA COME FROM ?
DIFFERENT TYPE OF FMEA
OUR FOCUS IS PROCESS FMEA
WHY WE USE FMEA ?
WHEN ARE FMEA REQUIRED
KEY FOR SUCCESSFUL IMPLEMENTATION

 Timeliness – before the event

action
 Not after fact exercise
WHERE IS IDEAL SITUATION

New design, new technologies or new

process

Modification of existing design or process

Use of existing design or process in a new
environment, location or application
FMEA’S – TEAM APPROACH

Should be cross functional team :

i. Process
ii. RND
iii. Production
iv. Quality
v. Service, etc
THE INPUTS

Warranty data

Customer return of defective part

Dealer information

Customer surveys

Competitor analysis

Customer complaint
IMPORTANT THINGS

Process FMEA assume the product as

design will meet the design intent

Potential failures which can occur because
of the a design weakness need not, but
may be included in a process FMEA

Process flow diagram must be ready
before do the FMEA
FMEA HEADER

Key date – initial FMEA due date which should

not exceed the scheduled start of production
date
THE 10 STEPS

Establish process functions

1. ESTABLISH PROCESS FUNCTION

Enter a simple description of the process

(e.g – cutting, crimping, jointing, sub assembly,
layout, taping )

Indicate concisely purpose of the process

Where the process involve numerous operation
with different failure mode, list the operation as a
separate process

Must understand customer / process requirement
2. BRAINSTORM ALL POTENTIAL FAILURE MODE
DEFINATION OF A FAILURE MODE

The manner in which process could potentially fail to meet

the process requirement

Should be described in physical or technical term not a
symptom (e.g - bent, hole off location, hole missing,
deformed, mis-labeled, missing, etc)

Can be a cause associated with a potential failure in a
subsequent process or an effect associated with a
potential failure mode in previous process. However,
assume incoming part are correct except the historical
data shown the deficiency of incoming part quality
DEFINATION OF A FAILURE MODE - CONT

The team should be able to answer the

following questions:
1. How can the process can fail to meet
the process requirement ?
2. Regardless of engineering specification,
what would a customer (end user,
subsequent operations) consider
objectionable ?
3. IDENTIFY POTENTIAL EFFECT OF FAILURES
DEFINATION – EFFECTS OF FAILURE
4. DETERMINE THE SEVERITY RANKING

An assessment of the seriousness of the

effect of potential failure mode to
customer

Team should agree on evaluation criteria
and ranking system

Ranking from 1 to 10
SAFETY

FUNCTION

FORM /
FIT
5. IDENTIFY ALL POTENTIAL CAUSES OF FAILURE
DEFINATION OF CAUSES

• Improper torque –over , under

• Improper weld – current, time, temperature
• Part missing
6. DETERMINE OCCORRENCE RANKING

Occurrence is how frequently the specific

failure cause/mechanisms is projected to
occur

Should be base on current process control

Team should agree on evaluation criteria
and ranking system

Ranking from 1 to 10
7. DEFINE CURRENT CONTROL METHOD

Descriptions of the controls that either:

i. Prevention - Prevent the failure mode
from occurring (error proofing device,
SPC)
ii. Detection - Detect the failure mode
should it occurring (inspection,
subsequence operation)

Priority – use i. prevention if posible
8. DETERMINE DETECTION RANKING

An assessment of the current process

control to detect failure mode

Team should agree on evaluation criteria
and ranking system

Ranking from 1 to 10

Do not automatically presume the
detection number is low because the
occurrence is low but assess the ability of
the process control to detect / prevent
low frequency failure mode
9. CALCULATE RISK PRIORITY NUMBER

RPN =
SEVERITY X OCCORRENCE X DETECTION
10. PRIORITIZE CORRECTIVE ACTIONS

Recommended action for highest RPN’s first

( NAZA – RPN 100 above need to do recommended
action)

How can we reduce the occurrence?

How can we improve the detection?

Use process improvement skills

Where possible apply mistake proofing
techniques.

Recalculate new RPN

Standardization across all products or processes

Note :- Mistake proofing process will result in

either lower occurrence or detection
rankings
REASSESS RANKINGS WHEN ACTION COMPLETED

FMEA must be a living document

Review regularly

Reassess rankings whenever changes
made to product and/or process

Add any new defects or potential
problems when found
 022

BS EN ISO 9001 : 2000

CERTIFICATE NO: A2I6901

RISK
REDUCTION
STRIVE FOR EXCELLENCE
BERUSAHA KE ARAH KECEMERLANGAN