TECHNOLOGY TRANSFER by SATYAM RAJ.pptx

1. TECHNOLOGY TRANSFER
PRESENTED BY
SATYAM RAJ
M.PHARMACY FIRST YEAR
DEPARTMENT :- QUALITY ASSURANCE
UNDER THE GUIDANCE OF
PROF. BHOOP
UNIVERSITY INSTITUE OF PHARMACEUTICAL SCIENCES
PANJAB UNIVERSITY, CHANDIGARH

2. The control process detects and takes action on sporadic
quality problems; the improvement process identifies and
takes action on chronic quality problems. In the control
process, statistical control charts detect the existence of
special causes of variation that result in sporadic problems.
The charts show sample data falling beyond statistical
control limits, i.e.. the process is "out of statistical control.“
Conversely, when a chart shows that a process is "in
statistical control," the process is in an of stability, and
variation is due to a set of common causes inherent in the
process.
MEASURING PROCESS CONTROL AND QUALITY IMPROVEMENT

3. Artistical control means stability, but stability does not always
mean customer satisfaction with the result. Unfortunately, a
process in statistical control can have serious quality problems.
Because the process is stable, the problems will continue
(become chronic) unless a basic change in the system of
common causes is made. Such a change, which typically
affects the average or variation, is the job of improvement.
"Removal of a special cause of variation, to move toward
statistical control, important though it may be, is not
improvement of the process“

4. • Adjust setting on the process
equipment.
• Change selected product design
parameters so that the design is more
robust to manufacturing conditions
• Identify the process variables that affect
the product determine the optimum
values for the variables, and set the
process to these values.
• Employ automated process controls to
continually. measure, analyze, and
adjust process variables that affect the
average.
• Investigate work methods and equipment
factors. This includes identifying the process
variables that affect the product result.
• Change selected product design parameters so
that the design is more robust to manufacturing
conditions.
• Identify and reduce the causes of variability due
to human inputs, The concept of system versus
worker-controllable input and the concept of self
control are useful guides.
• Reduce the variability of inputs to the process
through an improvement program with internal
and external suppliers.
Changing the average Reducing variability
TABLE NO -
Process improvement lead to problem as: - The process average is misdirected. The table no-1
shows possible corrective action.

5. • The inherent variability of the process is too large. Table no- 1
provides some of the approaches available to reduce variability.
• The instrumentation is inadequate.
• A process drift exists. Here the need is to quantify the amount of
drift in a given period of time and to provide a means of resetting
the process to compensate for this drift.
• Cyclical changes in the process exist. The need is to identify the
underlying cause and either remove it or reduce the effect on the
process.
• The process is unpredictable. Sudden changes can take place in
processes. As the capability studies quantify the size of these
changes and help to discover the reasons for them, appropriate
planning action can be taken.

6. • Temporary phenomena (e.g., a cold machine coming up to
temperature) can be result with by scheduling warming
periods plus checks at the predicted time of stability. due to
new materials) can be operating
• More enduring phenomena (e.g., changes with by specifying
setup re verification when such changes are introduced.

7. The statistical design of experiments is an essential analytical tool
for improvement that goes far beyond the investigation of out-of-
control points on a statistical control chart. This tool, when
combined with the knowledge of those who plan and run the
processes, replaces result intuitive decision making with a scientific
basis.
If a product does not meet specifications, then some type of action
is needed changing the average value, reducing the variability,
doing both, changing the specifications, sorting the product, etc. If a
product does meet the specifications, the alternatives are different
taking no action, using a less precise process, or reducing the
variability further. Table-2 shows the more usual permutations
encountered and provides suggestions on the type of action to be
taken.

8. Product meets specifications
Process variation small
relative to specifications
Process variation large
relative to specifications
Process is in control
Process is out of
control
Consider value in market place of tighter
specifications. Reduce inspection.
Continue tight controls on
process average.
Process is erratic and unpredictable and may be heading for trouble.
Investigate causes of lack of control.
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TABLE NO -
2

9. Product does not meet specifications
Process is in control
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Process is "misdirected to
wrong average. Generally
easy to correct permanently.
Process may be misdirected and also
too scattered. Correct misdirection.
Consider economics of more precise
process versus wider specifications
versus sorting the product.
Process is out of control Process is misdirected or erratic or both. Correct misdirection. Discover
cause of lack of control. Consider economics of more precise process versus
wider specifications versus sorting the product.
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