this ppt consist of project by project approach which is part of quality improvement and cost reduction and detail about design a remedy, prove effectiveness of the remedy, deal with resistance to change.

1. QUALITY IMPROVEMENT
AND
COST REDUCTION
(PROJECT BY PROJECT APPROACH)
PRESENTED BY:
JINAL N. PRAJAPATI
M.PHARM SEM-II
DEPARTMENT OF QUALITY ASSURANCE
ROLL NO: 17SSRMPH11
SSR COLLEGE OF PHARMACY
1

2. PROJECT BY PROJECT APPROACH:
The most effective approach to improvement is project by project.
The approach was originally proposed by Juran in 1964 as “break
through sequence”
Here project is the chronic problem chosen for the solution.
A quality improvement project addresses-
 The deficiencies dimension of quality
 A quality planning project focuses on planning product and process
features
 A quality control project analyzes a collection of sporadic problems.
2

3. Three main step in quality improvement,
quality planning or quality control projects:
 Identifying projects
 Proving the need
 Organizing project teams
Quality improvement project involves these
tasks:
 Verifying the project need and mission
 Diagnosing the causes
 Providing a remedy and proving its effectiveness
 Dealing with resistance to change
 Instituting controls to hold the gains
3

4. Other approaches to improvements include:
 Plan, do, study, act
 Six sigma
 Lean six sigma
 Reengineering
4

5. Example of a project:
The project concerns the soldering process used in the
manufacture of printed circuit boards.
Any solder connection can cause testing problems or
performance and reliability problems for the customer.
Identify steps of breakthrough sequence for improvement.
5

6. 1.Verify the project need and mission:
The project was statistically out of control and numerous solder
connections required touch-up.
Mission: reduce the number of defective solder connections
Fig.no.1 soldering
6

7. 2.Diagnose the causes:
A team of people, not from one department but from several cross-
functional departments, was setup to guide the project and do the
diagnosis.
Depicts the distribution of symptoms by type of solder defects.
(fig.no.2 pareto diagram)
7

8. Fig.no.2. solder defect types, pareto analysis
8

9. Data on the defects were analyzed and theories were offered on the
causes of the defects.
Fig.no. 3 cause and effect diagram summarizing the theories.
These theories were grouped into categories, thereby allowing a
checklist to be developed that supervisors and the control inspector
used to evaluate the theories. After additional data collection and
analysis, low solder temperature was found to be main cause of
defects.
Fig.no.4 shows part of analysis
9

10. Fig.no.3 ishikawa cause and effect diagram
10

11. Fig.no.4.temperature/time relationship when flow or dip soldering is applied
11

12. 3. Provide remedy and prove its effectiveness :
Data and further analysis revealed that, for ideal soldering
conditions, either the temperature of the solder should be raised or
the conveyer speed of the wave soldering machine should be
reduced.
A trial was conducted using a higher temperature. This resulted in
improvement in solder defects without any adverse effects.
4.Deal with resistance to change:
From the start of the project, a manufacturing engineer on the team
argued that the cause was outside the control of the machine. The
diagnosis convinced him . But he felt that raising the temperature
would result in “reflow of tin under the solder mask, thereby
causing solder shorts and peeling of the soldermask”. 12

13. This belief, based on a trial conducted 10 years earlier on other
equipments, had been expressed so often that it was no longer
questioned. The trial of the remedy over-came this resistance.
5.Institute controls to hold the gains:
The defects levels was reduced by 62% and the out-of-control
points on ststistical control charts were eliminated. To ensure the
improved level was maintained, the process was monitored.
Not only was the improved level maintained but the elimination of
the dominant cause (low temperature)
Performance has been improved to the point that the hand solder
touch-up operation may be eliminated.
13

14. Improving the performance of tablet
production:
From xyz pharmaceutical company samples was collected from
tablet department, ampoule department, and syrup department.
As per table no.1 and fig no.5 Xyz pharmaceutical company noticed
84.5% defects were attributed to tablet department, while 14.1%
and 1.4% for ampoule and syrup department
So, it is valuable to solve the tablet department problems.
And it was found that 1.4% defects due to physical and 85.9% due to
microbiological
Data was collected of 3 months for 2 types of tablets:
1. Analgesic tablets
2. Digestive enzyme tablet
14

15. department No. of item/
batch
Sample/
batch
No. of batch No. of item
non
conform
No. of
batches non
conform
Problem
sorting
ampoule 600,000 60,000 15 1000 --- Physical
tablet 30,000 3000 30 6000 5 microbiologi
cal
syrup 15000 1500 15 100 1 Microbiologi
cal
Table no.1 problem batch analysis for one month production
15

16. Fig.no.5.pareto chart department defects analysis
16

17. Data was collected of 3 months for 2 types of tablets:
1. Analgesic tablets
2. Digestive enzyme tablet
and it was found that microbiological defect and nonconformity
is greater for D.E.T
And D.E.T taken for further study and analysis done to recognize
the reason of microbiological testing and it was detected that
main reason for high bacterial count is coating solution due to
that 80% of total bacterial count.
So, we have have to solve the coating process to improve the
tablet process.
17

18. 1.Verify the project need and mission:
Reduce the bacterial count of digestive enzyme tablet (D.E.T) that
lead to causes customer satisfaction of internal customer to give
safe drug to patient.
2.Diagnose the causes:
The team was selected to represent the main branches affecting the
D.E.T production.
The following individuals were responsible for the production
process of (D.E.T) with high quality and were chosen according to
their awareness and responsibility of work in each of the four
processes of the (D.E.T) production process.
Quality Controls Team Leader
Production Shift Leader
Planning & Scheduling Team Leader
Supply Manager 18

19. Fig.no.6 SIPOC ANALYSIS
19

20. As shown at Fig. 7 the data was collected from the team
revealed that the source of variation was the process
environment. By using cause effect study on the mentioned
variable as in it was noticed that Raw materials for
pharmaceutical products was a source for some forms of
microbial growth, depending on the nutritive properties and
moisture contents.
Fig no.7 cause that affect the bacterial count of coating solution
20

21. Bacterial count
of control of
D.E.T
Machine and
equipments
method
Raw
material
environment
personnel
Fig.no.8 cause and effect diagram of environment process that
affect coating solution 21

22. 3. Provide remedy and prove its effectiveness :
Table.no.2 factorial design result
22

23. The cleaning & disinfection method was the most affecting factor that
caused the total variation in the overall process.
Table.no.3 Remedies of cleaning process
23

24. 4.Institute controls to hold the gains:
Manual cleaning lowered the bacterial count of the coating
solution to 285 cfu/ml and affected on sigma level to be 4.2 σ
which exceeded the target (not more than 500 cfu /ml).
24

25. Design a remedy:
The remedy must fulfill the original project mission, particularly
with respect to meeting customer needs.
This step identifies the customers, define their needs, and
proves the effectiveness of the remedy.
In some cases, designing a remedy requires major replanning of
the project or process and may involve a structured approach to
the replanning.
25

26. Prove effectiveness of the remedy:
Before remedy is adopted, it must be proven effective. Two steps are
involved:
1.Preliminary elimination of the remedy under conditions that
stimulate the real world:
Such evaluation can use a “paper” reliability prediction, a dry run in a
pilot plant, or testing of a prototype. But these preliminary
evaluations have assumptions that are never fully met, eg. the
prototype is assumed to be made under typical manufacturing
conditions, when actually it is made in the engineering model shop.
26

27. 2. Final evaluation under real-world conditions:
There is no substitute for testing remedies in the real world.
eg. Remedy is change in a mfg. procedure-> new procedure must be
tried under typical factory conditions
Remedy is change in a maintenance procedure->effectiveness must
be demonstrated in the field environment by personnel with
representative skills level.
Finally, after a remedy is proven effective, an issue of communication
remains.
Similar problems elsewhere in an organization , therefore , useful to
communicate the remedy
1. To others who may face similar
2. To those responsible for planning future products and processes27

28. Deal with resistance to change:
Various objections to the remedy may be voiced by different parties,
e.g. out right rejection of the remedy by a manager. “Resistance to
change” is the usual name.
Change consists of two parts:
1. A technological change
2. A social consequence of the technological change
People often voice objections to technological change, although the
true reason for their objection is the social effect.
To achieve change we must:
1. Be aware that we are dealing with a pattern of human habits, beliefs
and traditions.
2. Discover the exact social effect of the proposed technological
changes. 28

29. REFERENCES:
1. FRANK M. GRYAN, RICHARD C. H. CHUA, JOSEPH A. DEFEO,
Juran’s QualityPlanning and Analysis for enterprise
Quality, Fifth edition, published by Tata McGraw Hill
Education Private Limited page.no.60-64,103-104.
2. El-Menhawy A., Mohamed N. M., Arafa H. A., and Abd
Elmonem A. R, Improving the performance of
pharmaceutical tablet production using six sigma
methodology (modulation on digestive enzyme tablet),
IJPSR accepted, 11 May, 2015; published 01 August, 2015.
29

30. THANK YOU
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