The document discusses the importance of quality by design (QbD) in manufacturing to improve products for customers and society. It notes that QbD should start and end with the customer in mind, focusing on quality, intended purpose, and performance. QbD uses time-tested mathematical models and software to help understand process development, manufacturing efficiency, variability, capability, and variable interactions to extract a design space and balance quality, time, cost, and risk while improving quality of life. The overall message is that a conscious, team-based approach focusing on customers and society, rather than selfish interests, can help defeat issues like fear, anger, and corruption through quality by design.

1. …Is it Essential ?
On
Quality (of Life) by Design.

2. The Question Sounds like:
Is It Essential to Eat Good Fresh Balanced
Indigenous Diet?
Or
Can I keep the Option of Eating Fresh
Garbage?

4. (CURRICULUM DESIGN, Teaching &Training, and Duty/Job/Employment)

5. Material Path Spiritual Path
Synchronized Path
Confused State
Synchronized Path
will help Defeat:
Excessive Joy
Jealousy,
Fear,
Anger,
Sadness,
Sorrow
Greed,
Corruption

6. Is It About MINDSET ?
Excessive Joy...may be a sing of….Circulation & LV malfunction
Jealousy………..may be a sign of….Too many Toxins in Blood
Fear………….....may be a sign of…..Kidney malfunction
Anger……….....may be a sign of…..Liver malfunction
Sadness……….may be a sign of..…Lungs, Intestine malfunction
Sorrow………..may be a sign of….Spleen, Digestive malfunction
Greed…….......may be a sign of........Metabolic disturbance
Corruption…..may be a sign of………Total System Failure
LearningPeriodEarningPeriod …that depends on many factors

7. "Evil is Powerless, if the Good are Unafraid“
...Ronald Reagan.
I believe, from what I have understood so far, this is the essence of all the ancient world wisdom traditions.
'Goodness' is the healthy state of mind and that in turn will never
intentionally commits any wrong doing and that is why unafraid
(i.e., defeats fear and anger because there is no self interest (desire),
there is no 'I' or 'Mine' thing in the duty therefore absence of Ego).
The only thing that is there is 'We‘, which is the collective 'I' (i.e., team
work), and the only duty that is there is 'serving the society'.
God bless all with good health and longevity.
…Dr. K. V. Sarma
Author of Book: Quality of Life by Design
Dr. Karra, that was the nicest way I’ve ever heard to stop promoting
self interest and think of the team. I sincerely liked it…
…Harold Cope
Retired, Deputy Sheriff, State of Ohio, USA

8. It’s always a challenge
to assess someone’s mind
“There do seem to be links between some
of the health conditions and creativity, and
the notion that your brain can operate
differently”
... Claudia Kalb
Science journalist

11. Very Hard To Say

12. Balance / Moderation

13. 23,000 Human genes
> 150 times DNA content
comes from Bacteria
Quit the place that is not fit for living
Castor Oil ?
What are the
Input Variables?
1. Think Right
2. Speak Right
3. Do Right

14. WHY QbD IS ESSENTIAL?
To Improve Manufacturing ‘by my people’
……………………....What for?….…………………
To Develop Quality Products ‘for my people’
…….....………......Why?………….……………....
Because WE CARE
about the Quality-of-Life ‘of my people’
.......................Thank You……………………
DutyConscious

15. The Fist Step – Team Work
Ignore
“I”
“MINE”
“Desire”
(Selfishness)
(Greed)
Spiritual
P
E
A
C
E
Material
Q
U
A
L
I
T
Y
Think
“We”
“Us”
“Ours”
(Self-lessness)
(Oneness)
Success
Bliss
Result
Interactions
Design
Space

16. Second Step - Understand the Gap(s)
“QbD” should start and end with the CUSTOMER (in Mind) ONLY
- Quality, its intended purpose and Performance
- Eliminate the seemingly inevitable variation (with OFAT or modeling - QbD)
Product Pain killer Kill the pain, not the patient
Over promising and under serving

17. Courtsy: linda

18. Bench Mark Data from Benson & MaCab
S.No Measure Pharma
Industry
Winning
Pharma
Industry
World
class
factory
1 Stock turn 3-5 14 50
2 On-time delivery 60-80 % 97.4 % 99.6 %
3 Right First Time 85-95 % 96% 99.4 %
4 Overall Equipment
Effectiveness (OEE)
30 % 74 % 92 %
5. Cycle time 720 hrs 48 hrs 8 hrs
6 Safety / 10^5 hrs 0.100 0.050 0.001

20. Current Status of ‘Cost of Poor Quality’ (CPQ)
as % of sales – Indian Scenario.
S.No Industry Sigma Value Ppm defects Yield % CPQ as %
of Sales
1 Pharma 2 Sigma 3,08,537 69.2 25 – 30
2 Pharma 3 Sigma 66,807 93.3 20 – 25
3 Pharma 4 Sigma 6,210 99.4 12 – 18
4 Semiconductor 5 Sigma 233 99.98 4 – 8
5 Semiconductor 6 Sigma 3.4 99.99966 1 - 3

21. What is Fundamental ?

23. QbD Softwares built based on time-tested mathematical models will perhaps
help
• Process Development in any field
• Manufacturing Efficiency
• Product Variability
• Process Capability
• Interactions among the input variables
• Help understand the Quality Spectrum - Scope, Quality, Time, Cost, Risk
• Easy to understand contour diagrams to extract the desired Design Space
• ??? Clinical Performance

24. Improve
Quality
of Life
by Design
Dr. K. V. Sarma. Author
Quality of Life by Design

25. Conscious Design Multiplies the Quality of Life