— Eliminate Minor defects (Potential abnormality)

— Restore machining conditions

— Change Adjustment into Setup operation

Quality Assurance & Maintenance

Improvement Maintain

Sporadic defects

Chronic defects
 Quality Pillar Roadmap
Reactive Proactive Level-1 Level-2
Step 1, 2, 3 & 4
Autonomous Maintenance
Step (4) 5 & 6

Focused Improvement CAP-Do

AM Support & Corrective Maintenance
Planned Maintenance Time Based Maintenance, Predictive
Maintenance

Quality
Maintenance

ISO / FDA
In-House Periodical Audit
Quality Audit
Layer-By Layer Training
Training
(OJT, Cascade Training)
5S’s @ QA Lab. Safety / Operation efficiency
Product Design Design Review
Supplier Assure quality of product
 QA Design Deployment

Required Man Method

Machine Material
Quality Characteristic （Skill) （Standardize)

Cap; Identify in
2
Seal up “Liquid” - (Torque – X kg/mm )
drawings
Quality Characteristic

Cap ; Dement ion – Tolerance (±Y mm)

Process

If need a special
inspection skills, Controlled Items
Need a training by Suppliers

Phase-1 Phase-2
Quality Deployment Process Design
(Man-Machine System)

Phase-3 Machine Deployment Step-4

(QA Matrix – QM Matrix) Standardization

Page 8-2
 Quality Maintenance (Hinshitsu-Hozen)

Quality Maintenance (Hinshitsu-Hozen) is

activities “to set equipment conditions that preclude quality defects, based on
the basic concept of maintaining perfect equipment to maintain perfect quality
of processed goods and products. The conditions are checked and measured in
time-series to verify that measured values are within standard values to prevent
defects. The transition of measured values is watched to predict possibilities of
defects occurring and to take countermeasures beforehand.”
 Quality Maintenance Step Deployment
Phase Key Activities Tools Steps

1. Present Status Analysis Stratified Trend Data Step-1 Confirming Present Status
1. Monthly
2. Daily Data Collection
Improvement 2. Select machines (Process) Q-A Matrix Step-2 Survey process which generated
defects.
3. Organize Defect Pattern Sporadic VS Chronic Step-3 Survey and analyze 3M conditions.
Defects
4. Restore Step-4 Study “FUGUAI” countermeasures
and restore malfunctions.
5. Analyze & Improve for CAP-Do & Step-5 Analyze conditions for Non-
repeated quality defects. 5-why Analysis defective products that are not
P-M Analysis confirmed.
6. Review Step-6 3M conditions defects KAIZEN
Maintenance 7. Identify the relationship Q-M Matrix Step-7 Set 3M conditions.
between Quality
Characteristic & Machine
Conditions
8. Develop & Implement Trend Control Step-8 Improve Checking methods
Trend Control intensification.
9. Standardize Operation Standards Step-9 Decide Check standard values.
M-P Information
10. Review Step-10 Revise standard
 Step-1
Step-2
Step-3
Sporadic VS Chronic

Present Status Analysis

Select Machine
Chronic defects
Sporadic defects

Step-4
Restore (equipment)
Improvement

Step-5
CAP-Do for Chronics

Step-6
Review

Step-7
Q-M Matrix

Step-8
Trend Control
Quality Maintenance Approach
Maintain

Step-9
Standardize

Step-10
Review
 Step-1 Present Status Analysis
1. Collect Quality Defects Data
1-1 Outside Defects (ex. Consumer complains) By QA
1-2 In-process Defects By Manufacturing

2. Data Collection & Summary

1-1 Monthly Trend (Stratified by Type of Defects)
1-2 Daily Trend (Stratified by Type of Defects)
3-1 Improving constantly, but Not “Zero”

Good Timing to start Quality Maintenance

Analyze
Trend Pattern 3-2 Defects (Rate) Fluctuates

Focused Improvement (CAP-Do)

3-3 Getting worse

Reestablish fundamentals
(AM,PM,FI,T&E)
 Step-2 Select machine
2-1 Develop Q-A Matrix to evaluate “focused machine”

Quality Assurance Matrix

Quality Characteristic

Responsibility
Frequency
Proactive

Standard
Reactive

Record
Process Material Appearance Wrapping Action
Out of
Hardness Hardness Scratch Black spot Open
position

Extruder C/O Sampling OP QCS S-01

C/O Temp ( C )Time ( )min OP OPS Checklist

Wrapping 3/H Quality Index < 1.0 OP QCS Sampling

D Routine checking OP A/M S Checklist

Note
Frequency; C/O = Change Over, 3/H = 3 per hours, D = Daily
Standard;
QCS = Quality Control Standard, OPS = Operation Standard

(C) Shinichi Shinotsuka All rights reserved 2000

2-2 Analyze the relationship between Defects and Machine conditions.

Select “Focused Machine” for QM

 Quality Assurance Matrix

Quality Characteristic

Responsibility
Frequency
Proactive

Standard
Reactive

Record
Process Material Appearance Wrapping Action
Out of
Hardness Hardness Scratch Black spot Open
position

Extruder C/O Sampling OP QCS S-01

C/O Temp ( C )Time ( )min OP OPS Checklist

Wrapping 3/H Quality Index < 1.0 OP QCS Sampling

D Routine checking OP A/M S Checklist

Note
Frequency; C/O = Change Over, 3/H = 3 per hours, D = Daily
Standard;
QCS = Quality Control Standard, OPS = Operation Standard
 Step-3 Sporadic vs. Chronic Defects

The way of organizing Quality Defects Data

Cause
(A) Known (B)Unknown
(1)Already Taken

A-1 B-1
Cause was known, Cause was not known,
Action was already taken. Action was already taken.

Quality defects take place. Quality defects take place.

Action

A-2 B-2
(2) Not taken

Cause was known, Cause was not known,

Action was not taken. Action was not taken.

Quality defects take place. Quality defects take place.

(C) Shinichi Shinotsuka All rights reserved 2000

 Sporadic vs. Chronic Defects
Quality Defects Key Approach

A-1
Cause was known, Training &
Dent
Action was already taken.. Standardization

A-2
Cause was known, Develop Action plan

Review
Action was not taken.

B-1 CAP-Do cycle

Cause was not known, Analyze causes &
Action was already taken. Take permanent action

B-2 Misalignment seal CAP-Do cycle

Cause was not known, (Collect numeric data)
Action was not taken. Open Seal P-M Analysis
 Step-4 Restoration
— Eliminate Minor defects (Potential abnormality)
— Restore machining conditions
— Change Adjustment into Setup operation

“Dent” comes from Unstable transfer

 Step-5 CAP-Do for Chronic losses

Use CAP-Do Improvement Cycle toward Zero Defects.

Develop “Zero Defects Machine”

Step-6 Review

Yes Step-7 Setting up

“Zero Defect”
Operating Conditions

No Quality Maintenance
Matrix
Return to Step-3
 Machine (ID; )
Team
Profile 5W’s1H Plan
5-Why Immediate Action
Data Analysis 1 Month Action
Quality
(Trend Graph) Cascade (Single-Path) Over 1 Month Action Maintenance
Defects (%)
(By Line) (By Type) Or Matrix
P-M Analysis
Summarize
Phenomenon OPL
(Trend Graph) OPL
(Action Taken)
Defects (%) OPL
(Action Taken) Trend
(By Machine) (By Type) (Action Taken) Control
Chart
(OPL-4)
OPL-1 Simple Sketch
Defects (%) or (Piece) Principle of Why happen? (Trend Graph)
(By Type) Movement Defects (%) or (Piece)
Daily Tracking (By Type)
Daily

(Trend Graph)
Q-A Matrix OPL-2 OPL-3 Defects (%)
Running Mechanism (By machine)(By Type)

conditions of Benefit
Actual Defects study Defects Summary
Sample
 Step-7 Quality Maintenance Matrix
Identify the relationship between Quality Characteristic
and Machines Conditions

Individual Setup right conditions

P-M analysis
Improvement
(Technical aspect)
“Decide rightly”

Autonomous Basic concept of

Maintenance Continuous Improvement

Optimal condition
Planned Minor defect Control conditions
Maintenance Restoration (Management aspect)
Adjustment & Control “Strictly follow”

7 STEPS
M-P Design
Initial Flow Control
Machine Diagnosis Accomplish
Education & Training Technology ZERO DEFECTS
 Example ; Quality-Maintenance Matrix
Station
Wrapping Machne
Maintenance Process
Items Unit / Comp. Position recognition
Cuttin Arm
to be inspected Sensor
Recognition Swing
Develop
Parameter Photo eye Worn
Mark Movement Q-M Matrix
Means Visual Check gauge Check gauge
Check
No. of PCS.
by machine
Within
Criteria No dust < XXmm < YY C
OK range

Frequency Shift Shift Week Week

Quality
Characteristic
Responsible person Operator Operator T/L Operator

Misalighn seal < 5 mm X X X X

Open seal Not Open X

Identify the relationship

between Quality characteristic
and Machine conditions
 Step-8 Trend Control
— Trend control sheet
z Machine Diagnosis Technology
— X-R control chart
— Cp, CpK Value
— Autonomous Maintenance
z Daily Check sheet
 Step-9 Standardization
— Skill training program
— M-P design sheet Design Review Steps

• Products Design Planning

– Easy to product MP Information

• Equipment Design Design

– Reliability & Maintainability

Manufacturing

Initial Flow Cotrol

Instllation

Trial
Standardization

Mass Production
Information
MP Design Indivial Improvement
Autonomous Maint.
Operating Planned Maint.
 Step-10 Review

Yes Continue Zero Defects

“Zero Defect”
Challenge Next Machine
Not Continue

Return to Step-7