SMP Consept Guidebook

2014.01.14. ver.4

International Manufacturing
Manufacturing
Nippon Paint Co., Ltd.
Contents

1. Outline & background of SMP concept

2. Key words of SMP concept

3. Diagram of SMP concept

4. Observance of basic rules (edited 2014.01.14.)

5. Basic concept of SMP activity items

6. Concept of HE prevention activity

7. Concept of First Lot Control

8. Monitoring parameters (item added 2014.01.15)

9. Evaluation criteria of SMP diagnosis

10. Understanding test of SMP concept

oncept

ed 2014.01.14.)

ded 2014.01.15)
Outline of SMP concept
SMP:Strong Manufacturing Program=Program to establish strong man

1.Background of starting SMP activity

-Production did something wrong,
　because we could obtain good sample at the technical lab.
When production was told by technical like the above,
production was always vulnerable position,
because there were no system nor structure at production
to rebut or to substantiate the rightness .
Necessity of SMP concept
-System & structure to obtain consistent quality
(built-in quality)
-System & structure of less chance to make mistakes
-Records of production history for traceability of problem.

2.Concept of SM (Strong Manufacturing)

Enhancement of manufacturing system/structure
= Establish manufacturing system/structure that can be trusted intern
-Anytime, anybody and at anywhere can obtain good quality.
-Obtain good quality from the first batch.

Traditional concepts SM concepts

Escape/outflow prevention Generation prevention
Not to supply defectives Not to supply defectives
to the customer: detect to the customer: activity
defectives by inspection, for not to generate
stop delivery of detected defectives, stop delivery
defectives. of generated defectives.
Downstream management Upstream management
Take measures for the
React according to the
expected
situation
situation
Result oriented Condition oriented
Change the conditions Control the conditions to
from the obtained result obtain expected result
Recurrence prevention Occurrence prevention
Take measures after Take measures before
having problems having problems

3.Concrete items of SMP activity

-5S
-Visual control, Signage
-QA4 Basic principles
-QA Process Control Table (QAPCT)
-First Lot Control (FLC)
-Raw Material QA
-DR List (DR=Design Review)
-Abnormality Reporting System
-HE Prevention activity
-Suggestion System
-QC Circle activity

Assumption to implement the above activities

-Strong QC Engineering function
-Culture creation for observance of basic rules

Increase productivity (indirect)

Production cost reduction
Decrease failure cost (direct)

Main target of SMP activity

ng manufacturing system

ed internally and externally.

SMP Key Words

production did something wrong (because tech could make good sample at their lab)
no system nor structure were established to rebut even production is wrongly accused.
production is not trusted

[System/structure trusted by internal and external]

1.consistency
2.less chance to make mistakes
3.good records for traceability

[Kew words for trusted production system/structure]

Anytime, anybody and at anywhere can obtain the same (good) quality
target system/structure of SMP
Obtain a good quality from the first batch (even less experience)
concept of FLC
Change from "downstream management" to "upstream management"
concistency=builtin quality, reliable production
Change from "escape/outflow prevention" to "occurrence prevention"
only by escape prevention activities cannot stop delvering defectives to the customer,
and no improvement of quality
Change from "recurrence prevention" to "occurrence prevention"
everybody will take countermeasures after having actual problems.
 take measures before having actual probles is the essence of SMP.
Make section border intentionally fuzzy/unclear
wisdom for taking care of matter which responsible section is unclear
5-Genism (actual place, actual thing、fact, fundamental, principle)
fundamental concept of SMP, and for on-site management,
especially essencial for investigation of HE.
5-Whys
it cannot prevent recurrence by countermeasures based on superficial investigation.
effective method for root cause investigation.
Change from result oriented to condition/process oriented
other properties are not always the same even conditions are adjusted
to obtain certain result the same as usual.
a method to expect other properties or invisible properties the same
is to control the conditions.
[eg]at the grinding process, not to adjust grinding conditions to get the required result,
but control the grinding condition as usual to expect the same result as usual.
if it cannot get the same result as usual even control the conditions,
then something is wrong. treat as abnormal.
Don’t mix up ends and means
the ends of QAPCT is not preparation, but utilization for consistency.
the ends of DR List is not prepartion nor accumuration of DR information,
but utilize it for problem prevention (Q-KY) at FLC.
Do not proceed any operation without S.O.P.
Do not let them do any operation without S.O.P.
even for nonsteady operation, prepare S.O.P. prior to the nonsteady operation.
handwritten S.O.P. is acceptable for a nonsteady operation.
 Concept of Strong Manufacturing through daily QA Activities

First Lot Control Customer Complaint

Q-KY R.M. DR Abnormality Negative

QA List (lose money)
Human Error
QA Process Control Table
Visual Control, Signage(Instruction Board) Suggestion
5S Positive
Standardization QC Circle (gain money)
Training & Education
On a daily Basis Check by Mng/Spv

Regular Batch First Batch

Foundation of SMP Activity

Basic Activity
Q-KY Activity
Kaizen Activity
Observance of basic rules

1.It is social fundamental to observe restrictive rules

Not only in society, but also in the company, observance of
"ABC" to maintain good order.
Especially production on-site, thorough observance of basic
foundation of every activity.
Without the foundation of observance of basic rules, it is im
achieve "built in quality" at the production on-site.

2.Role of site management

(1)Establish the rules
Any which way will be OK if there is no rule.
Rules are necessary to maintain good order.
Make clearly-stated rules by SOP, PWS, QAPCT, Signages,
*Without clearly-stated, it is not a rule. (implicit rule is no

(2)Establish the rules easy to observe

Only saying "Observe established rules" won't work.
There are certain reasons why established rules are not o
Do not establish the rules at the office, but observe actua
see the reality, and establish practical rules easy to obse
You should keep in your mind that not only establish the
but establish the rules easy to observe.

(3)Site check
Even you think that you established the rules easy to obs
it doesn't mean rules are observed 100% at actual site.
Management of the site should confirm the condition of o
by on a daily basis site check, whether the rules are obse
and if not, observe why rules are not observed at his/her
If the case rules are not observed, observe closely why th
the rules, and if necessary, instruct immediately to obser
the rule easier to observe.
(It depends on the situation why rule is not observed.)
At the time of on a daily basis site check, try to extraxt p
causing HEs, accidents, etc simultaneously, and take mea
 which are extracted risks before having actual problems
(proactive prevention)

3.Responsibility of site management

The site check mentioned above is the most important resp
site management.
We hear so often a kind of excuse saying that "I'm so busy a
to check the site."
Site management whoever saying such an excuse is abando
important responsibility as a site management.
Without doing this, site management won't get pay!!
Observe the rules=operators
Let observe the rules=management
Not good situation of observance to the rules is managem

Create a vision of the resiponsible territory as a manager/su

share that vision with the subordinates, always grasp a gap
the actual situation/condition and the vision, and take meas
gap toward the achievement of the vision.
 observance of rules is

rvance of basic rules is

ic rules, it is impossible to

PCT, Signages, etc.

mplicit rule is not acceptable)

on't work.
rules are not observed.
t observe actual place well,
s easy to observed.
y establish the rules,

les easy to observe,

t actual site.
e condition of obsevance of rules
rules are observed or not,
rved at his/her site.
closely why they cannot observed
iately to observe the rule, or revise

t observed.)
ry to extraxt potential risks of
, and take measures for those
tual problems or accidents.

important responsibilty for

t "I'm so busy and I don't have time

cuse is abandoning their most

get pay!!

les is management's fault.

as a manager/supervisor,
ays grasp a gap between
and take measures for the
Establishment of Strong Manufacturing System
*Basic concept of each item of SMP activity

Ⅰ.Basic Activity
1. 5S
［1］Definition of 5S（NPC）
Item Meaning Definition
Seiri Disposition Differentiate between the necessary and unnecessary, and discard
the unnecessary.
Seiton Order Things must be kept in order so that they are readily and safely
taken out in the required quantity when needed.
Seiso Cleaning Keep the workplace clean, free from dust, debris, contamination
or rust.
SeiketsuCleanlinessKeep yourself clean and neat and maintain a pleasant, sanitary,
easy-to-work environment.
ShitsukeDiscipline Make it habit to follow specified procedures in the workshop so as to
develop a constitution where improvement can be carried out as part
daily duties.

［2］Effectiveness of 5S
Safety, Equipment Maintenance, Efficiency, Quality, Morale

［3］Customer's viewpoint of 4S
The condition of first 4S is the mirror which reflects final "S" (Discipline) of the
operation. Customer can easily judge whether the company has a good culture to
observe a rule or not when they check the 4S condition of the operation, even
for a short time to check at the time of audit, for example.
Even outstanding SOPs are prepared, it is very doubtful that those outstanding
SOPs are actually observed at the operation which 4S condition is bad.
On the other hand, an operation which 4S condition is satisfactory, they will expe
that the operation is observing SOPs when that operation make batches, so that
the operation is able to give customer a sense of assurance.

［4］Utilization of 4S concept as a Manager/Supervisor

It's a kind of dangerous signal of possibility to have serious accident or quality tr
at your area in the near future, when 4S condition of your area get out of order.
When 4S condition become worse, then it's a time to tighten the reins.
But a manager/supervisor who are not checking workplace by his/her own will no
able to realize that signal.

2. Visual Control
The purpose of "Visual Control"
Create the situation of that not only a person in charge, but anybody can easily
normal or abnormal by visually, and detect abnormal situation in the early stage
abnormality, so that to minimize the damage from the abnormality.

3. Signage (Instruction board, Indication, Marking)

The purpose of Signage
-To prevent mistake such as misunderstanding, false feeling, etc.
-Reminder of important process, opearation, etc.
-Reminder of safety operation.
-Reminder of others.
Ⅱ.4 Major QA Principles
1. QA Process Control Table (QAPCT)
Summary of manufacturing knowhow at each manufacuring process, from the
viewpoint of Quality Assurance in the manufacturing process.
What need to be assured at each process, and what need to be done from that
purpose are summarized not by product, but through whole manufacturing proce
From the different viewpoint, QAPCT is the material which let employees unders
why those operations are required at each process from the viewpoint of quality
Each concrete method or instruction are not spacified in QAPCT, but specify in
SOPs, PWS(BT), etc.

2. First Lot/Batch Control (FLC)

Generally, a first batch product tend to have problems compare with regular batc
products, because of less experience, less knowledge about new product, etc.
FLC is the concept that aim to get good quality even from the first batch, utilizin
past knowhow, experience, etc.
The aim of FLC is not to take measures after having problems, but predict potent
risks from past experience and take measures for those to prevent problems whi
may occur at the first batch.
Nevertheless, nobody knows what may happen at the first batch, so it is also ver
important FLC activity to minimize the damage, even though unfortunately havin
troubles at the first batch, by determining precise batch size for first batch and
second batch and those manufacturing timing/schedule.

3. Design Review (DR) List

Summary of problems experienced in the past as knowhow into a list for one of
Q-KY tool for FLC activity.
Search material (or similar material) consist in the new formula from DR list, and
confirm whether those materials caused problems in the past or not.
If the similar problems from a material consist in the new formula are expected,
then take measures for those before having actual problems.
From this point of view, it is very important to accmulate DR information through
daily activities.
Information in DR List is also very useful information for design/technical division
so it is effective to use DR List in that division.
But for SMP, it is vital to accumulate and utilize DR information from the viewpoi
Strong Manufacturing.

4. Raw Material (RM) QA

New raw materials are also tend to cause problems because of less knowledge
and experience compare with regular raw materials..
Even regular raw materials, actual situation is getting information from RM supp
about instruction of utilization or storage condition of the RM after having proble
If getting information about RM after having problem, then why not try to get th
information before having problems caused by the RM.
Even for a new RM, before having actual problems, get information about that RM
such as storage condition, how to use it, etc. from the RM supplier, using knowle
of similar RM, considering production process which apply for the product contai
that new RM.
Then prevent predicted troubles, or prevent troubles of wrong storage condition
wrong way of utilization of new RM because of ignorance of the RM.
This is the concept of RMQA activity.
 From obtained information, necessary instructions should be added to PWS, SOP
etc. accordingly, to prevent troubles.

Ⅲ.Other activities
1. QC Circle Activity
Small group activity, especially QC Circle activity, is very useful to let employees
quality-consciousness.
Organize small group (at most 10 members), who work at the same operation, an
a subject for improvement of their own working area, such as productivity impro
quality improvement, cost reduction, etc., and conduct the activity for certain pe
(6months, at longest 1 year), to achieve the target for the selected subject using
QC methods, etc, through their own daily job.
It is very difficult for employees to maintain and improve their motivation only do
given jobs or what was told to do.
But, the small group activities are also useful from this perspective.

2. Suggestion System
Suggestion activity is another activity to maintain and improve employees' motiv
There are many improvement items at job site, such as small efficiency improvem
safety improvement, potential risks to cause HE, etc. which only employees can s
through their daily job
There are also many improvement items in existing PWSs, SOPs from the same
perspective above.
Suggestion activity is that to improve or level up current system or situation by
these suggestions from employees through their daily job.
It is one of the way to give them awards according to the expected effectiveness
of the suggestion to maintain this activity attractive.

3. Abnormality Reporting System

It depends on individual sensitivity to judge what is abnormal and what is not ab
When abnormality occurred, just taking temporary/immediate action and not tak
countermeasures for the cause, it will occur again in the near future.
On the other hand, once abnormality occur, managements tend to punish or blam
employee who caused the abnormality.
But such a situation, they try to hide when abnormality occurred and it is hard to
establish the climate to report positively when abnormality occurred.
Utilize abnormality reporting system as a tool to improve current system or situa
by reporting even small abnormal situations and take countermeasures for those
to prevent recurrence.
By utilizing abnormality system as a tool for improvement mentioned above, enc
employees to submit abnormality reports, and also try to improve their sensitivit
against abnormal situation on a daily basis, to activate the system.

4. HE(Human Error) Prevention Activity

HE is the same as abnormality, managements tend to blame whoever caused HE,
but on the assumption that a human is normally making mistakes, how you can
minimize number of HE is never ending subject for the management.
HE as well as abnormality, it is essential to investigate immediately after HE occu
to find out root cause of the HE to prevent similar HE recurrence.
It seems like a HE, but most of the cases, actual causes are lack or defects of
current system, so improve lack or defects of current system through taking
countermeasures to prevent recurrence for each HE.
It is important to take measures to prevent recurrence after having actual HE,
but much more important thing is that to take measures for potential risks to
prevent HE before actual occurrence.
For this purpose, utilize abnormality reporting system and/or suggestion system,
and it is very important preventive activities to extract potential risks of HE and
take measures for those, through on a daily basis KY patrol by manages/supervis
 ry, and discard

y and safely

ontamination

nt, sanitary,

workshop so as to
arried out as part of

iscipline) of the
s a good culture to
operation, even

ose outstanding
n is bad.
ory, they will expect
e batches, so that

ident or quality trouble

get out of order.
e reins.
his/her own will not

nybody can easily judge

in the early stage of
ality.
ocess, from the

e done from that

anufacturing process.
employees understand
ewpoint of quality assurance.
T, but specify in

e with regular batch

w product, etc.
first batch, utilizing

but predict potential

vent problems which

h, so it is also very
nfortunately having
r first batch and

o a list for one of

a from DR list, and

r not.
ula are expected,

formation through

n/technical division,

from the viewpoint of

less knowledge

ion from RM supplier

fter having problem.
y not try to get that

tion about that RM,

lier, using knowledge
he product contain

storage condition or
e RM.
dded to PWS, SOPs,

to let employees have

ame operation, and set

roductivity improvement,
vity for certain period
cted subject using

motivation only doing

ctive.

employees' motivation.
fficiency improvement,
y employees can sense

s from the same

m or situation by

cted effectiveness

and what is not abnormal.

action and not taking
uture.
to punish or blame

ed and it is hard to
urred.
nt system or situation
measures for those

tioned above, encourage

ove their sensitivity
tem.

hoever caused HE,

es, how you can
ment.
ately after HE occurred

k or defects of
hrough taking

ving actual HE,

tential risks to

uggestion system,
al risks of HE and
manages/supervisors.
Human Error Prevention activity

1.Heinrich's Law
Safety (Accident) Quality

major (serious) injury 1 major (serious) problem

minor injury ' minor problem

29
1

unsafe act tiny problem

(near miss) (near miss)
300
*problem: mistake, customer's complaint, etc.

2.Concept of HE prevention activity

Everybody will react after having serious accident/problem.
And mostly ignores not serious accidents/problems.
It is important to take measures for serious accidents/problems actually occurred.
And it is also important to take measures for not serious accident/problem actually occurred.
But much more important or higher lever of activity is to take measures for the situations
which may cause accidents/problems in the near future, which means prevention activity.
Measures to prevent recurrence (after having actual problem) : normal
Measures to prevent occurrence (before having actual problem): superior

3.Prevention activity
You cannot reduce or eliminate major/serious injuries/problems only taking measures for it,
 and not taking any measures for minor and tiny injuries/problems.
In other words, you have to take measures for minor and tiny injuries/problems, if you want to
prevent occurrence or recurrence of major injury/problem.

4.Tools for prevention activities

Abnormality reporting system is one of good tool for preventing HE.
Use all the employees' eyes to detect the possibility of occurrence of problems by applying
abnormality reporting system and take measures for each report.
*NPC is also having Near-miss reporting system
Abnormality report: use for trouble actually occurred
Near-miss report : use for trouble not actually occurred but almost occurred or
detect the situation which may occur problems.

5.Training
For these activities, sensitivity and sensibility of employees are essential.
To increase/improve sensitivity/sensibility of employees, KYT is one of good training system.

What is "KYT"?
Kiken Yochi Training in Japanese. Meaning is "Training for Risk Prediction".
How to proceed "KYT"?
*Prepare a sheet of picture/photo as a KYT material.
Organize small group (5 to 10 members) for the training.
Step 1: Point out any risks may happen from the situation of the material
by brain-storming method among the group members.
*Point out in this manner "*** may happen because of *****"
Step 2: Pick/Determine the most serious risk as a group from the risks pointed out
at "Step 1".
Step 3: List the measures for the most serious risk picked at "Step 2"
by brain-storming method.
Step 4: Choose the most effective measure as a group from the measures listed at "Step 3".
**Whole process of KYT should be completed within 15 minutes.
First Lot/Batch Control

Concept

Obtain good quality from the first batch

Minimize company's damage even failure of first batch

Background

[in the past]

-Spent busy time for trouble shooting

-"Less experience" was good excuse when fail to make good quality at the fi

-"It's technical's responsibility because we made a batch as we were told", w

-No/Less information sharing for a new product

-"If everything goes OK, then customer will buy Xgal/month, so make X gal f
It's much more efficient than making several small batches.

[perceptional change]

-Why don't you utilize limited manpower more efficiently?

Utilize limited manpower for preventive activities rather than trouble shoot

-Why don't you utilize past experience for KY to prevent problem occurrence

-"Whose responsibility for fail" doesn't mean anything to the company

Is your role only messenger boy/girl?

Why don't you review first batch making from production view point?

-Is the guy, who made a decision, superman/woman?

Is that decision the best for the company?

Why don't we share information, and come up with the best decision for th

-What happens if everything doesn't go OK?

Does customer need Xgal at one time?

 What is the ideal minimum batch size as a first batch?

Then even we failed, unfortunately, company's damage is only xgal, not Xg

Major FLC activities

-DR (Design Review) especially from production view point
Check DR List, review data and sample from technical, run pre lab test, etc
-RM-QA
Try to get useful information about new RM from RM supplier and technical
Useful information of the RM is not always the same for technical and prod
-Production Preparation Meeting
Information sharing
Determine first lot batch size,
Production schedule for first and second batch
Etc.
-Batch ticket preparation for the first batch
-Monitor first batch making (whoever prepared the batch ticket)
-First batch productivity evaluation
-First batch quality evaluation
-First batch customer's line trial evaluation
-Take countermeasures for the future batch, if any

[definition of "First Batch"]

-New product, new color,
-Formula change (change ingredient, change ratio, add new ingredient, etc.)
-Process change
-others
*not necessary to run whole process of the FLC all the time
Just run necessary portion of FLC according to the situation of the first batc
 the first batch

old", when failed

X gal for the first batch"

e shooting

rrence?

for the company?

not Xgal.

st, etc.

chnical.
d production.

t, etc.)

st batch.
Monitoring Parameters for SMP activities

1.Necessity of monitoring parameters

Normally, there are needs prior to actual Kaizen activities.
But, we started to implement the SMP activities without actual Kaizen
Because of this (=without actual Kaizen target), it became very unclea
managements and operators who are implementing SMP activities,
why they are implementing SMP activities on a daily basis.
We need to judge whether SMP activities are working functionally for t
company/plant or not, by monitoring parameters which are set by acco
to the needs of the company/plant.
It is essential to set monitoring parameters to judge whether SMP acti
are working functionally or not for the company/plant.

2.Viewpoints of monitoring parameters

There are two viewpoints for monitoring parameters for SMP activity.
(1)Monitoring parameter directly related to SMP activities themselves
This parameter is to set each SMP activity target as monitoring
parameter.
ex.:added/revised items of QAPCT, preparation/revision items of sign
implementation ration of FLC, success ratio of FLC,
number of extracted potential risks of HE, number of improvemen
of extracted potential risks, number of suggestion, number of AB
Number of QCC, SMP diagnosis result, etc.

(2)Monitoring parameter directly related to company performance

This parameter is to set how SMP activities contributed to the compa
performance as monitoring parameter.
ex.:number of customer complaints, compensation cost, amount/cos
return goods, amount/price of defect products generated,
amount/price of defect products inventory, amount/price of dispos
materials, etc.
These are so-called "failure cost", which affect negatively to
company performance.
Decide what should be the monitoring parameters according to
the needs of company/plant

3.Application of monitoring parameters

By checking parameter item 2.(1) above, judge whether SMP activiti
are implemented actively or slow down, for on a daily basis managem
But only checking these parameters, it is not able to judge whether
SMP activities are working functionally for the company/plant or not
 It is necessary to check parameter item 2.(2) above, which is directly
related to company performance, for judging whether SMP activities
working functionally or not.

Even though, it may judge SMP activities are implemented aggressiv

parameters item 2.(1) above, it is not too strong a word there is alm
no meaning of implementing SMP activities, if the activities are not
contributing to the parameters item 2.(2) above.

Because of this, not only checking parameters item 2.(1), but finally
parameters item 2.(2), it is necessary to judge activities are working
not, set the target and point to be strengthen for SMP activities.

4.Stratified management of monitoring parameter

It depends on how monitoring parameters are set, but especially par
item 2.(2) above, result are shown as total company/plant which refl
also activities by technical/sales, etc.
Because of this, these parameters are including the result of departm
which are not implementing SMP activities, sometimes it is not able
precisely whether SMP activities are working functionally or not only
company-wide parameters.
Therefore, stratify the result by department which is cause of proble
and focus to the result of the department which implementing SMP
activities, and from there, judge the performance of SMP activities.

*When stratify the result of parameters by caused department,

if the contribution ratio of SMP activity implementing department i
not so high for the company, then take measures to the departmen
,which are not implementing SMP activities, as company to improve
company performance.
l Kaizen target.
y unclear to
ities,

ally for the

t by according

SMP activities

activity.
mselves
ing

s of signage,

rovement
er of AB report,

ance
he company

ount/cost of

of disposal

to

ing to

P activities
management.
whether
nt or not.
s directly
activities are

ggressively by
re is almost
are not

ut finally by
working OK or
ities.

cially parameter
hich reflects

f departments
not able to judge
not only by

of problem,
ng SMP
tivities.

ent,
rtment is
partments
improve
SMP Diagnosis Evaluation Criteria 100

Item Evaluation Criteria Full Your Result 5 4 3 1 0

mark score
s
5S -everything is in place 5 0.00 Most of items have Some items don't have Most of items don't
(no violation of reserved place) reserved place and no reserved place, or have reserved place, or
violation of reserved some violation of violation of reserved
place reserved place place

-no small items are left around Small items are not left Some small items are Many small items are
around left around left around

-no obstructions on the passages No obstructions on the Some obstructions are Almost always
passages even during left on the passages obstructions are left on
operation during operation the passages

-clean facility, equipment, Kept clean even at the Kept clean at the time Very dirty even the
instruments, etc time of breaking points of no operation time of no operation
of each operation

Signage, -appropriate contents 5 0.00 Appropriate contents, Too many items in one Inappropriate contents,
Visual Control and effective to board, written by too and effectiveness is
prevent small letters doubtful to prevent HE,
HE, etc. etc.
 -appropriate location Indicating close to the Indicating close to the Indicating location is
actual operation, and actual operation, but not
the most effective whether the most related to the actual
location effective location is operation
doubtful

-timely updating Timely updating of Some are not updated Many old, not updated
contents accordingly accordingly signages
*Clear indication of the
date of preparation

-apply the concept to whole site Apply the contents of Some places are not Almost no concept is
signages, VC to whole enough application of applied
site the concept

QAPCT -appropriate contents 5 0.00 Appropriate contents Some contents are not Most of the contents
as appropriate as QAPCT are not appropriate as
QAPCT QAPCT

-timely reviewing/updating Timely updating of Some are not updated Most of the items are
contents accordingly accordingly not updated, not match
with actual operation

-application of QAPCT Utilize QAPCT when Not enough utilization Only preparing QAPCT
HE of QAPCT and no utilization
occurred, preparation
of SOP, education, etc.
 -observance to QAPCT Each operator observes Some items of QAPCT Most of the contents
the contents of are not observed of QAPCT are not
QAPCT observed

Observance -intention to prepare rules 15 0.00 Establish rules easy to Some rules are not so Most of the rules are
to the rules (SOP/PWS etc) easy to observe observe easy to observe not so easy to observe

-level of observance to the rules Each operator observes Some rules are not Most of the rules are
(thorough observance) rules very well observed not observed

-feed back accordingly when the rule Feedbacks are done by Sometimes, feedbacks Almost no feedbacks
is not appropriate (difficult to AB report, etc. are not done
observe) accordingly

-frequency of monitoring observance Monitored by Mg/Spv Not on a daily basis, Almost no monitoring
to the rules by Mg/Spv on a daily basis. but by Mg/Spv
monitored periodically

PWS(=Batch -validity of instructions 10 0.00 Instructions are Some instructions are Actual equipment,
Ticket) considered equipment, not match with actual process, operation, etc.
Preparation process, operation, etc. operation are almost not
very well considered

-timeliness of revision Timely revision is done Some regular Many items/PWSs are
accordingly revisions/amendments revised by hand
are done by hand
FLC Activities -timeliness of activities 12 0.00 Necessary items are FLC is implemented, Most of the cases are
(FLC, RM-QA, DR) implemented before 1st but implemented after
and 2nd batch making sometimes timing is not making 1st batch
without fail appropriate

-thoroughness of activities Every product in Some products are not Person in charge is
(FLC, RM-QA, DR) *1 determined category implemented FLC, even determining which
for in determined category product to run FLC
FLC is implemented

-effectiveness of activities Many effective FLC Some effective FLC Just implementing FLC
(QKY to prevent problems) activities to prevent activities to prevent activities, effectiveness
occurrence of problems occurrence of problems of activities are
doubtful

AB Card -frequency/timeliness of 3 0.00 AB Cards are prepared AB Cards are prepared Almost no AB Cards
Preparation preparing AB Card accordingly thru tech only for limited are
related activities activities prepared

-participation to prepare Every member of QC Some members are not Almost no members are
AB Card engineering group preparing AB Card preparing AB Card
prepares AB Card
-contents of AB Card Appropriate contents Some contents are not Contents are doubtful
as appropriate as
tech info accumulation tech info accumulation
HE Prevention -plan for HE prevention activity 15 0.00 Established plan for HE Plan is established, but Plan is not established
prevention activity not enough for prevent
(as prevent occurrence, occurrence
not recurrence)

-frequency of KY on-site patrol Monitored by Mg/Spv Not on a daily basis, Almost no monitoring
by Mg/Spv on a daily basis. but by Mg/Spv
monitored periodically

-effectiveness of countermeasures Well applied 5-GENism, Well application of No application of 5-

for prevent recurrence 5-Whys concepts for 5-GENism and 5-Whys GEN
*practice of 5-GENism, 5-Whys countermeasures to concepts are not ism, 5-Whys concepts,
prevent recurrence enough and effectiveness of
countermeasures are
doubtful

AB Report -participation in AB Reporting system 10 0.00 Everybody participates Some are not Almost no activity
in activity participating

-effectiveness of countermeasures Well applied 5-Whys Well application of No application of

for prevent recurrence (5-Whys) concepts for 5-Whys concept is not 5-Whys concept,
countermeasures to enough and effectiveness of
prevent recurrence countermeasures are
doubtful

QCC -suitability of subject 5 0.00 Theme, subject and Some theme, etc. are Relevance of theme,
members are not appropriate as etc. are doubtful as
appropriate QCC activity QCC activity
as QCC activity
 -participation Activity is not only in Activity is mainly in Activity is very limited,
production, but in production area or no activity
entire (Some are not
company participating)
(Every employee
belongs to one of QCC
team)

-briskness of the activity Each team is holding QCC meeting is held Very few meeting is
QCC meeting moderately held
frequently

Suggestion -participation 5 0.00 Activity is as a Activity is not as a Limited activity, or

company, company, or target is performance is a long
and each division has not good enough, or way from the target
its target of the not
activity, so good performance
performance meets the
target

Monitoring -suitability of parameters 10 0.00 Selected parameters, Selected parameters Selected parameters
Parameters such as failure cost reflect performance not are
ratio, reflect the so well almost not reflecting
performance of SMP the
activities very well performance

-interest/analysis of parameters Analyze together the Result analysis of No result analysis of

result of parameters parameters are not so parameters, or analysis
and SMP activities strongly related to is not link to SMP
SMP activities
activities
 -taking measures from the analysis SMP activity
plan/target for next
year is established
from the result of
performance analysis of
this year
Relation between plan/ Result of the analysis
target of next year and is
the result of　perform- almost not reflected to
ance analysis of this SMP activity
year is not so strong plan/target for next
year.

Total 100 0.00

*1: not every (new) product, but every (new) product in the category to run FLC
determined by management
Point for each item and its criterion Rank Points
　Point　Criterion A >=85 (A+>=95 A>=90 A->=85)
　　　5: satisfactory level B 70<= to <85 (B+>=80 B>=75 B->=70)
(both substanceand thoroughness)

　　　4: almost satisfactory level 　C　　　　　　 55<= to <70 (C+>=65 C>=60 C->=55)
　　　3: so-so level D 40<= to <55 (D+>=50 D>=45 D->=40)
　　　1: not enough level E <40 (E+>=30 E>=20 E-<20)
　　　0: far away from the
expectation/wrong direction
/ not implemented
Understanding Test SECTION NAME SCORE

of SMP Concept

answer
Q 1　:　What is ＳＭＰ stand for? Select the most suitable one from below "A" - "D".(１P) column
A:　Abbreviation of Seisan Management Plan *Seisan=Production in Japanese
B:　Abbreviation of Strong Manufacturing Program
C: Abbreviation of　Super Machinery Production
D: Abbreviation of　Special Maintenance Production

Q 2 :　Select 3 items from "A" - "F" below which are necessity of SMP concept.
　　　 (2P each: 6P)
　Necessity of SMP concept. answer column
A: System & structure to obtain consistent quality. (built-in quality)
B: System & structure not to cause equipment troubles.
C: System & structure to record production history for traceability of problem.
Ｄ：System & structure of less chanced to make mistakes.
E: System & structure to know whether products are normal or abnormal, even difficult to trace causes of abnormality
F: System & structure to stop outflow of defective products by inspection, even mistake occurred at production.

Q 3 :　Select the suitable terms for "(A)" - "(K) from the key words shown below.(1P each: 10P)
　Concepts of SM
Enhancement of manufacturing system/structure.
=Establish manufacturing system/structure that can be trusted internally and externally.
-Anytime, anybody, and at anywhere can obtain good quality.
-Obtain good quality from the first batch.
Traditional concepts SM concepts
(　A　) prevention (　B　) prevention
Not to supply defectives to the Not to supply defectives to the customer
customer : activity for not to generate defectives, stop
: detect defectives by inspection, stop delivery of generated defectives.
delivery of detected defectives.
(　C　) management (　D　) management
React according to the situation Take measures for the expected situation
(　E　) oriented (　F　) oriented
Change the conditions from the Control the conditions to obtain expected
obtained result
result
(　G　) prevention (　H　) prevention
Take measures ( I ) having problems Take measures ( J ) having problems

( Key Words) answer column

generation / outflow / result / A B
occurrence　/ condition / upstream /
downstream / equipment / logbook / C D
recurrence / after / before / system /
first batch / suggestion / quality /
occurrence　/ condition / upstream /
downstream / equipment / logbook /
recurrence / after / before / system / E F
first batch / suggestion / quality / G H
production
I J
Q 4 :Following is mentioning about abnormality reporting system. Fill out "(A)" - "(F)" with suitable
term shown in the key word box. (2P each: 12P)

It depends on individual ( A ) to judge what is abnormal and what is not abnormal.

When abnormality occurred, just taking temporary/immediate action and not taking ( B ), it will occur ( C )
in the near future. On the other hand, once abnormality occurred, managements tend to punish or blame
employee who caused the abnormality. But such a situation, they try to hide when abnormality occurred
and it is hard to establish the climate to report positively when abnormality occurred.
Utilize abnormality reporting system as a ( D ) to improve current system or ( E ) by reporting even small
abnormal situations and take countermeasures for those to prevent recurrence. By utilizing abnormality
system as a tool for improvement mentioned above, ( F ) employees to submit abnormality reports,
and also try to improve their ( A ) against abnormal situation on a daily basis, to activate the system.
Key Words answer column
level / evaluation /sensitivity / A
incidence B
/ again / ratio / recovery method /
countermeasures for the cause / C
ability / equipment / situation / D
formula / raw material / submission /
tool /encourage/ similar / system / E
HE / KY F

Q5: Fill out "( A )" with suitable term. (5P)　

answer column
One of the purpose of SMP activity is to reduce
A
production cost. What is the main target of SMP
activity for this purpose?
Increase productivity [indirect]
Production cost reduction
Decrease ( A ) [direct]

Main target of SMP activity

Q 6 : Following is mentioning about a part of SMP concept.　
Fill out "(A)" - "(E)" with suitable term. (2P each: 10P) answer column
　　　　It cannot prevent ( A ) by countermeasures based on A
( B ) investigation, when abnormality or HE occurred. B
The concepts of ( C ) and ( D ) are effective method for C
( E ) investigation. Especially, ( C ) is fundamental D
concept of SMP, and for on-site management. E
Q 7 : Mark "O" if the following action is correct, or mark "X" if incorrect,
answer
in the right-hand side answer column of each item. (1P each : 5P) column
Procedure change was necessary for this batch, because of having a problem at the previous lot. This
batch was already started, so new procedure was instructed orally, and an operator followed that
instruction.
There was ground leakage at a machinery room on a rainy day, so put the signage of
"Caution!! Ground leakage" in the room.
There was a request from QC to take sample only for this batch, so a team leader and an operator in
charge held a meeting for the procedure of sample taking, prepared a handwritten instruction, then the
operator followed that instruction when taking a sam

There was a report from an operator that he felt mixing condition looked weaker than usual. So, told to
the operator to extend mixing time for 10 minutes.
Grinding process was proceeded with standard grinding time, but the fineness didn't meet the spec, so
extend grinding time for this batch, and apply this grinding from following batches.
Q 8 : The following is mentioning about observance of basic rules.
Fill out the ( ) with suitable term, and complete the sentence. (2P)
It is social fundamental to observe restrictive rules. Not only in society, but also answer column
in the company, observance of rules is "ABC" to maintain good order.
Especially production on-site, thorough observance of ( ) is foundation
of every activity. Without the foundation of observance of basic rules, it is impossible
to achieve "built in quality" at the production on-site.

Q 9 : Mark each item "O" if correct, or "X" if incorrect , for the role/responsibility of on-site
management, mentioned below. (1P each : 6P)
answer column
Set an operating rule, and required to section in charge to instruct the rule on PWS/batch ticket.
There was a wrong instruction on a PWS, so amended PWS to correct instruction by hand.
A rule looked hard to follow, but led an operator to follow the rule, during on-site patrolling.
Set a rule and trained the rule by OJT to operators. Then checked the condition of observance of
the rule, and they were following well. So at the later on-site patrol, not checking the condition of
observance of that rule.

Found a violation of a rule during on-site patrol, but an operator was under operation, so gave a
correct
instruction at a following day's morning meeting.
It was so busy to prepare materials for following day's meeting, so skipped on-site patrol.

Q10 : Quote 5 items of the effectiveness of 5S activity. (5P)

answer column score

Q11 : Select the suitable term for "(A)" and "(B)" from key words shown below. (2P each : 4p)
Customer's viewpoint of 4S
The condition of first 4S is the mirror which reflects final "S" ( A ) of the operation. answer column A
Customer can easily judge whether the company has a good culture to observe a rule or not
when they check the 4S condition of the operation, even for a short time to check at the time
of audit, for example. Even outstanding ( B ) are prepared, it is very doubtful that those
outstanding SOPs are actually observed at the operation which 4S condition is bad. answer column B
On the other hand, an operation which 4S condition is satisfactory, they will expect that the
operation is observing ( B ) when that operation make batches, so that the operation is able
to give customer a sense of assurance.
　Key words
true / system / discipline / PWS (batch ticket) / SOPs / plant manager /
company's policy / management / operating condition / abnormality report

Q12 : What need to take action as a manger, when 4S condition of own area become worse? (3P)
　　　　　 answer column

Q13: What is the purpose of "Visual Control"? (3P)

answer column
Q14 : Each explanation on left-hand side is about "4 Major QA Principles". (2P each : 8P)
　　　Fill out right-hand side box with suitable "Major QA Principle" explained on the left.

q-1 answer column q-1

Even for a new RM, before having actual problems, get information
about that RM, such as storage condition, how to use it, etc. from the
RM supplier, using knowledge of similar RM, considering production
process which apply for the product contain that ne

q-2 answer column q-2

Summary of manufacturing knowhow at each manufacturing process,
from the viewpoint of Quality Assurance in the manufacturing
process.
The material which let employees understand why those operations
are required at each process from the viewpoint of quali
q-3 answer column q-3
Aim to get good quality even from the first batch, utilizing past
knowhow, experience, etc. Not to take measures after having
problems, but predict potential risks from past experience and take
measures for those to prevent problems which may occur at th

q-4 answer column q-4

Search material (or similar material) consist in the new formula from
the summary, and confirm whether those materials caused problems
in the past or not. If the similar problems from a material consist in
the new formula are expected, then take measures

Q15 : Questions about HE prevention activity. Fill out (?) with suitable term. (P3, P2 : P5)
　 q-1　It is important to take measures to prevent recurrence after having actual HE,
　　 but much more important thing is that to take measures for potential risks to 　　　　
( ? ) of actual HE. (3P)
answer column q-1

　q-2 What are the tools for ( ? ) mentioned above? Quote several tools for those. (2P)
answer column q-2

Q16 : Questions about First Lot Control. (1P each : 5P)

Which situation mentioned below should treat as First Lot. Mark "O" which are need to treat
as first lot, or mark "X" which are no need to treat as first lot. answer column
Batch size is increased from this batch, and cannot use usual tank, so changed to bigger tank.
Almost no change in batch making procedure, but one ingredient is added from this batch.
Using the same tank available for 800 to 1000Kg , and this batch is changed from 850Kg to 900Kg.
Charging material as a semi finished goods in the past, but this batch is charging as individual RM .
Total formula is the same as usual, but charging order of RM is changed from this batch.

Q17 : The following is mentioned about purpose/importance of FLC activity.

Fill out "(A)" - "(E)" with suitable term. (2P each : 10P)
answer column
Purp Aim to ( A ) even from the first batch, utilizing past knowhow, A
ose 1 experience, etc. which is so-called ( B ) concept.
Purp Aim to ( A ) even from the first batch, utilizing past knowhow,
ose 1 experience, etc. which is so-called ( B ) concept.
B
C
To minimize ( C ), even though unfortunately having troubles at D
Purp
ose 2 the first batch, by determining precise ( D ) for first batch and
second batch and those ( E ). E
8P)