4. 古有明訓:預防勝於治療
扁鵲 vs. 蔡桓公
扁鵲 vs. 魏文王
魏文王問扁鵲 :“ 們家兄弟三人,都精於醫術,說 你
到底 一位哪 醫術最好?”
扁鵲回答 :“說 長兄最好,中兄次之,我最差。”
文王又問:“那麼為什麼你名聲最好?”
救災 vs. 防災 vs. 避災
4
5. ISO Guideline
7.3 Design and Development
− 7.3.2.2 Manufacturing Process Design Input
The manufacturing process design includes the use of error-proofing
methods to a degree appropriate to the magnitude of the problems and
commensurate with the risks encountered
− 7.3.3.1 Product Design
design FMEA, …, product error-proofing, …
− 7.3.3.2 Manufacturing Process Design Output
The manufacturing process design output shall include results of error-
proofing activities
…, process FMEA, …, results of error-proofing activities, …
8.5.2 Corrective Action
− 8.5.2.2 Error-proofing
The organization shall use error-proofing methods in the corrective
action process
5
8. VOC: Customer Expectations
TIME~40’s ~70’s ~90’s ~00’s
DEFECT
ppm Defectppm Defect
(Control Mode – Detection of Errors)(Control Mode – Detection of Errors)
RiskRisk EliminationElimination
% Defect% Defect
(Reactive Mode of Operation – Detection of Defect)(Reactive Mode of Operation – Detection of Defect)
Error PreventionError Prevention
(Proactive Prevention of Errors)(Proactive Prevention of Errors)
0
(Proactive Elimination of Errors)(Proactive Elimination of Errors)
飛航
醫藥
8
9. The Challenger disaster occurred on
January 28, 1986, when the NASA
Space Shuttle Challenger (mission
STS-51-L) broke apart 73 seconds into
its flight, leading to the deaths of its
seven crew members, which included
five NASA astronauts and two
payload specialists.
復興航空 235 號班機 (ATR 72 機型 )
空難,發生於 2015 年 2 月 4 日上午
10 時 55 分,該班機原定從臺北
松山機場飛往金門尚義機場,在起飛後
不久即墜毀於基隆河,造成 43 人死亡
、 17 人受傷 ( 含地面 2 人 ) 。但是,
ATR 72 空難事故已非第一遭…
ONE MISTAKE IS TOO MANY
10. Was Challenger an accident?
Contributory cause was a
“serious flaw in the decision
making process leading up to
the launch”.
ONE MISTAKE IS TOO MANY
重返危機現場
Seconds From Disaster
類型 紀錄片
原創
Darlow Smithson
Productions
季數 6
集數 67
每集長度 45-50 分鐘
播映頻道 國家地理頻道
http://zh.wikipedia.org/wiki/ 重返危機現場
11. $ 1.2 Billion - Cost of building the Challenger
$ 100 Million - Cost of a shuttle mission
$ 46 Million - Cost of launching a spacecraft
$ 7.7 Million - Litigation costs for the lives of four astronauts
$ 41.7 Million - Estimate cost of one life of an astronaut
7 months - Time spent to recover the debris of the
spacecraft using 31 ships, 52 aircrafts and
6000 workers
ONE MISTAKE IS TOO MANY
12. $ 350 Million - Cost of redesigning in fixing the O-ring
$ 292 Million - Cost of a compartment escape
1 year - Estimated delay in the program
ONE MISTAKE IS TOO MANY
19. Cause vs. Effect
5M1E Operation
Q: Quality
C: Cost
D: Delivery
S: Safety
M: Morale
(Input) (Process) (Output)
Cause Effect
X Y
(Error) (Defect)
19
Effect
Cause i
Cause i1
Root
Cause
Defect = y = f (xi) ( xi )
( y )
26. Guideline to Effective Error-Proofing (CQI-18)
1. Focus on proactive error-proofing through both product and process design,
and continual improvement activities.
2. Elimination or significant reduction of process sensitivity due to variation
(e.g., operator performance, tool wear, multiple machines, etc.).
3. Effective detection for errors that cannot be eliminated.
4. Subsequent error-proofing for problem elimination.
5. Control of detected errors/non-conforming product.
6. Deployment of error-proofing on similar operations (read across).
7. Communication of best practices and prior experience to
eliminate repeat issues.
8. Fully integrating error-proofing approaches with existing quality tools
and procedures (APQP, FMEAs, Control Plans, etc.)
9. An assessment system for error-proofing.
10. Appropriate monitoring and controls for installed error proofing.
11. Guidance for layered process audits of error-proofing.
26
https://www.aiag.org/staticcontent/files/Quality_Error-Proofing.pdf
27. Be PROACTIVE, not just REACTIVE
REACTIVE
Solution of Problems
Monitoring of Wastes
PROACTIVE
Prevention of Problems
Elimination of Wastes
優先採取應急措施!
但是別忘了再發防止!
防範未然!
27
29. Required
target
Expected
target
Problem
occur
Policy
deploy
Product *
problem solving
Gap
analysis
Task
definition
Need
new
product
or not
New product
development
Need new
process or
not
New process
Innovation
Effect
is OK
or not
Product
Kaizen
completed
Need
NPD or
not
A
Process
Kaizen
Need new
system
or not
New system
Innovation
Effect
is OK
or not
Process
Kaizen
completed
Need
new
process
or not
A
System
Kaizen
A
B
Effect
is OK
or not
System
completed
A
B
B
B
Y
N
N
Y
Y
N
N
Y N
Y
Y
N
Y
N
Y
N
Quality
information
Business plan
- SPC → OCAP
- Nonconformity
→ OCAP, NCN
- SCAR → 8D
- Vision
- Mission
- Objective
- Strategy
Improvement
Innovation
* Product
or
service
29
(Kaizen)
system thinking
30. Levels of Error Proofing
30
Level Prevention Detection
1. Force Control
(No human intervention)
Physical contact or electronic
control prevents the mistake
from being made
Physical contact or electronic
control prevents the mistake
from getting to the customer
2. Shutdown
The process is shutdown
before the mistake can be
made
The process is shutdown
immediately after a mistake
is detected
3. Warning
(by Sensory Alert)
A warning light or audible
alarm signals that a mistake
is about to be made
A warning light or audible
alarm signals that a mistake
has just been made
Ref: Lean Teams USA Lean Consulting
32. EPL Case: Railroad Crossing System
Defect is detected at
post process
Defect is detected at
working process
Error is detected
Before
Defect occurrence
Error is prevented
from occurrence
Error is eliminated
completely
Flyover DesignFlyover Design
LEVEL 1
Error Elimination
With LightWith Light
With FenceWith Fence
LEVEL 2
Error Prevention
With LightWith Light
W/O FenceW/O Fence
LEVEL 3
Error Detection
Defect Prevention
W/O SignalW/O Signal
W/O LightW/O Light
LEVEL 5
Defect detection
@ Post Process
With SignalWith Signal
W/O LightW/O Light
LEVEL 4
Defect detection
@ Source
BetterBetter WorseWorseRailroad Crossing System
System
re-design
32
33. Hint: Try to avoid human error by design
33
EPL = ?
45. Error Proofing by way of FMEA
LEVEL 1
Error Elimination
LEVEL 2
Error Prevention
LEVEL 3
Error Detection
Defect Prevention
LEVEL 5
Defect Detection
@ Post Process
LEVEL 4
Defect Detection
@ Source
Problem
Description
Failure ModeFailure Mode
Root Cause Analysis Root Cause Analysis
Why happen?
(Occurrence)
Why escape?
(Detection)
Corrective Action Corrective Action
Effect Validation Preventive Action
Preventive Action EPL (3, 4, 5)
EPL (1, 2, 3)
capability of detection (↑)probability of occurrence (↓)
E
P
L
OD
D
E
T
(
D
)
檢
出
度
RPN SO
Current Process Contor (Detection)
現行流程管制 (偵測)
DET
(X)
SD SOD
Cause(Xn)
原因
Failure Mode
失效模式
DET
(Y)
Current
Process
Control
(Prevention)
現行流程管制
(預防)
O
C
C
(
O
)
發
生
率
E
P
L
SOD ODSD
SEV
Actions Taken
已實施對策
Completion
Date
實際完成日期
OCC DET
RPN
Action Results
改正後的結果
SO
Recommend
ed Action
建議對策
Responsibility & Target
Completion Date
對策之負責人及完成日期
Who
負責人
Date
預計完成日期
45
70. Level 5 of Error-Proofing
ZD
LEVEL 5
Defect detection
@ Post Process
70
71. Level 5 of Quality Control Method
Defect A Defect B
LEVEL 5
LEVEL 5
LEVEL 5
LEVEL 5
Defect Detection @ Post Process
It doesn’t matter how near or far the control is from the process.
It doesn’t matter if the control is automated or manual.
As long as it is after the process, it is Level 5.
PROCESS A PROCESS B
PROCESS
GATE B
QA GATE A
71
72. Level 5 Examples
100% Inspection after Final Test
Outgoing Quality Gate
Final Test
ASSEMBLY
ASSEMBLY
QA GATE
FINAL TEST
72
73. Level 4 of Error-Proofing
ZD
LEVEL 4
Defect detection @ Source
Defect is detected
before it leaves the
current process
73
74. Level 4 of Quality Control Method
Defect A
Defect Detection @ Source
It doesn’t matter if the control is automated or manual.
Defect is detected before it leaves the current process
PROCESS A PROCESS B
PROCESS
GATE B
QA GATE A
LEVEL 4
LEVEL 5
LEVEL 5
Defect B
74
75. Level 4 Examples
Sampling inspection while the lot is in
process
100% Visual Mechanical Inspection after
Leadscan
A conveyor carries the product under a
pivoting flag. A correctly assembled
product passes under the flag. An
incorrectly assembled product tips the
flag, and a sensor detects the flag
movement.
ASSEMBLY
ASSEMBLY
QA GATE
FINAL TEST
LEADSCAN 100% VMI
Same operator is
doing these two
activities
75
76. Level 3 of Error-Proofing
ZD
LEVEL 3
Error Detection
and/or
Defect Prevention
Error is detected before
the defect occurs
76
77. Level 3 of Quality Control Method
PROCESS A OUTPUTINPUT
End Result Attribute
Output Variable
Defect
Process Inputs
Resources Parameters
Input Variable Error
When it is the defect that
is being controlled, it is
either Level 4 or Level 5.
Error is detected before the defect occurs
When it is the error being controlled,
it is Level 3.
77
78. Level 3 Examples
This safety harness buckle has a
red mark indicating that it has not
been locked (incorrect). When
the buckling is complete the red
mark is covered.
Hungry Jack syrup has a small
window near the bottom of the
container that changes from black
to clear when heated revealing the
word HOT. This signals that the
syrup is warm and ready to serve.
When the forces of commercial self-
interest and of dental hygiene
combine, how can it not lead to error
proofing? This toothbrush has
colored bristles that become clear at
the tips of the bristles through use.
Planned obsolescence at its best.
Process Parameter Monitoring
Temperature, pressure monitoring
Tool life monitoring
Chemical analysis
78
79. Level 2 of Error-Proofing
ZD
LEVEL 2
Error Prevention
Error is prevented from occurring
79
80. Level 2 of Quality Control Method
PROCESS OUTPUTINPUT
When it is the defect that
is being controlled, it is
either Level 4 or Level 5
Error is prevented from occurring
When it is the error being
controlled, it is Level 2 or Level 3.
Control System
80
81. Level 2 Examples
This Stove burner turns off
automatically when pot or pan is
removed.
Hotel Rooms are equipped with
a room key holder which turns
off the power when the key is
removed. This ensures no
electricity flows to the room
while it is vacant.
Electric Airpot – Automatically
turns off when the desired
temperature is reached.
Process Parameter Controllers
Temperature sensor & controllers
Liquid sensors & controllers
81
82. Level 1 of Error-Proofing
ZD
LEVEL 1
Error Elimination
Error is completely eliminated
82
83. Level 1 Examples
Diskette cannot be inserted in
other ways.
Ports & connectors are designed
so that they cannot be
interchanged. Male, female,
different sizes, shapes, etc.
You cannot forget to return the
cap of the fuel tank.
Error is completely eliminated
Process & Products Design Intervention.
Leaded packages to leadless
Plating process to pre-plated leadframes
To think about
system redesign
solutions
83
84. 附 三:錄 ABC’s to ZD
A
B
C
D
E
ATTITUDE
BELIEF
COMMITMENT
DISCIPLINE
ENTHUSIASM
84
85. It starts with the right ATTITUDE,
BEILEF and leadership
COMMITMENT,
then continues with
DISCIPLINE and ENTHUSIASM.
85
ABC’s to ZD
86. A ATTITUDE
All is well that begins
well!
Our attitude at the
beginning of this
task will affect its
outcome more than
anything else.
86
87. B BELIEF
What matters is not
the idea a man
holds but the depth
at which he holds it.
It is easier to believe
than to doubt.
87
88. C COMMITMENT
It separates doers
from dreamers.
Commitment starts
from the heart. It is
tested by actions
and opens doors to
achievements.
88
89. D DISCIPLINE
Discipline is what
keeps you going
well in the race!
A man that has it,
has within him the
principle of action
and the motivation
to act.
89
90. E ENTHUSIASM
Nothing great was
ever achieved
without enthusiasm.
It spells the
difference between
mediocrity and
accomplishment.
90
這幅作品是由曾經在钮芬兰岛 st. johns担任美商“全球海域石油钻探公司”的钻油平台专案任务经理所提供的。为了确保钻油平台的作业安全,每当有“冰山警报” 时,钻油平台就必须派遣潜水人员以及任务专家,在所有冰山可能经过的路径海域尽快完成海况调查,并且依据调查报告调派越洋型拖船(ocean tug),待命将冰山拖离任何可能危及钻油平台作业安全的区域。 由于当天的海况出奇的风平浪静,海水清澈无比,阳光又正好是直接照射的角度,所以钻油平台上的潜水人员才得以拍摄下这幅冰山全貌的完美杰作! 根据钻油平台上的专家们估计,这座冰山的总重至少超过“三亿公吨”。
冰山理論(Iceberg Theory)
冰山水上部分和水下部分的比例到底是多少?根據阿基米德(浮力)原理:浸入液體的物體受到向上的浮力,而浮力大小等於它排開液體的質量。
- 淡水約1/10 : 9/10 (淡水密度為1kg/m3, 冰的密度為0.9kg/m3)
海水約1/8 : 7/8 (海水密度是海水鹽度、溫度以及壓力三者的函數,約為1.01~1.03kg/m3)
很多领域都提出过冰山理論(iceberg theory),如:心理學、文學、醫學、管理學等。那麼何謂冰山理論呢?它的形成機制又為何呢? 文學界的海明威在英美文學裡樹立了一個很具原創性的寫作風格,叫「冰山理論(iceberg theory)」,意思是他講故事的方式就像只講冰山露在海面上那八分之一,其他的那八分之七就靠這八分之一的功力來讓人想像,這種「留白」式的寫作法對後世創作者產生很大的影響。海明威说:“冰山運動之雄偉壯觀,是因為他只有八分之一在水面上。文学作品中,文字和形象是所谓的“八分之一”,而情感和思想是所谓的“八分之七”。前兩者是具體可見的,後兩者是寓於前者之中的。The Iceberg Theory (also known as the "theory of omission") is a term used to describe the writing style of American writer Ernest Hemingway (July 21, 1899 – July 2, 1961). Hemingway is best known for works such as The Sun Also Rises, A Farewell to Arms, and The Old Man and the Sea.
冰山絕大部分的體積是在海平面以下的,所以光從露在外面的體積是無法估計整座冰山到底有多大。而露在最外面的確實是引人矚目的。冰山理論告訴我們:冰山所能被我們看見的部分只是它整體的八分之一,而八分之七的部分都埋在海面下。要想撼動整座冰山,必須要撼動其埋藏於水下的不可見的那八分之七。One eighth of an iceberg is above the water. All of the rest is underneath the water.
我們就来認識一下文化的冰山结構,冰山上層包括:1、物質文化;2、語言溝通能力;3、宗教信仰;4、教育程度和審美觀,這些都是可見的。冰山下層主要包括人們對待不同問題的各種態度,包括工作、成就、發展、權威等,也就是態度價值觀。影響個人發展的往往取决於冰山下面看不見的那部分。
佛洛依德強調我們 人所知道的意識部分只不過是如冰山上面所見到的十分之一罷了。但,真正未知的潛意識部分卻是在冰山下面的十分之九。所以所謂以佛洛依得為主要哲學觀的心理分析的治療觀點喜歡放在那些潛意識、未知的部分,讓它可以浮現出水面、意識之上,得以修通過往早年經驗所帶給我們的影響。
事故的發生,可分為根本、間接和直接等三種原因:
根本原因(三次原因):管理、教育訓練、社會、歷史、傳統
間接原因(二次原因):人(不安全行為)、物(不安全環境)
直接原因(一次原因):與危害的能源、有害的物質接觸
(很多夫妻一吵架,就歸因於“一定是上輩子欠你的”,根本沒有試著找出失和的根因去改善。)
1. 找原因:失效樹、特性要因圖(石川馨, 魚骨圖)、5 why分析表 (what-what analysis before why-why analysis)、…
2. 潛在的原因(risk) + 真因(error) → 缺點(defect)
3. 針對不同階層的原因下對策,得到的改善效果大大不同。
(1)短期對策:治標(消除現象) 、短效、表面、被動、reactive
(2)長期對策:治本(消除原因) 、長效、系統、主動、proactive
說明:
tip of the iceberg 通常用來形容事情只是「剛開始;冰山一角」,類似的用法還有 the thin end of the wedge、 just the beginning。
示範句:
With all these other corporate scandals now happening, it seems that Enron was just the tip of the iceberg.
現在有這麼多的企業醜聞發生,看來安隆案只是冰山一角而已。
會話這樣說:
Margaret: Can you believe these new procedures at work?! 瑪格莉特:工作的新程序真是令人難以置信!
David: These changes are only the tip of the iceberg. There are a lot more coming.
大衛:這些改變只是冰山一角。還會有更多新規定呢。