2. TQM
Total:
• Make up of the
whole
Quality:
• Degree of
excellence
Management:
• Process of
planning,
organising
- PRATIK TERSE 2
TQM consist of 3 words:
Background: 1990
1911, 1930
1940, 1969
1980-1990
3. TQM
Definition:
• Total Quality Management (TQM) is a management approach
towards quality for long term success through customer
satisfaction.
• In TQM effort, all members of an organization participates in
improving processes, products, services & the culture they work.
• It is long term planning.
• It is never ending process.
- PRATIK TERSE 3
5. TQM
TQM Approach:
• Customer Focused- The customer ultimately determines the level of quality so it
is always beneficial to recognize customer requirements towards product
quality.
• Total Employee involvement- Building quality in product is not single persons
job, all employees should participate in working toward common goals.
• Continual improvement- This is very important and large concept of TQM.
Continual improvement drives an organization to become more competitive and
more effective at meeting customer expectations.
- PRATIK TERSE 5
6. TQM
Philosophies of TQM:
- PRATIK TERSE 6
Philosopher Philosophy
Walter A. Shewhart Understanding variability, Concept of
statistical control chart
W. Edward Deming 14 Points of quality improvement
Joseph M Juran Concept of quality cost, Quality trilogy
(planning, control, improvement)
Armand E Feigenbaum Total quality control
Philip B Crosby Concept of Zero defect, do it right at first
time
Kaoru Ishikawa Concept of internal customer, quality circles
Genichi Taguchi Concept of product design quality, developed
Taguchi loss function
7. TQM
Advantages of TQM:
• Innovation in process
• Greater productivity
• Reduced defects in products
• Increase customer satisfaction
• Higher profitability and reduced costs
• Higher employee morale
• Better adaptability to changing marketing conditions
• Increase competitiveness
- PRATIK TERSE 7
8. ICH
ICH denotes for "International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human consumption".
The International Conference on Harmonization (ICH) is a project that makes
together the regulatory bodies of Europe, Japan and the United States and
professionals from the pharmaceutical domain in the three areas to discuss
scientific and technical views of medicinal product registration. (QSEM)
- PRATIK TERSE 8
9. ICH
History of ICH:
• Since ICH's origin in 1990, the ICH process has step by step evolved.
• ICH's first 10 years saw substantial progress in the growth of Tripartite ICH Guidelines on
Safety, Quality and Efficacy topics (QSEM).
• Work was also undertaken on a number of important multidisciplinary subjects, which
admitted MedDRA (Medical Dictionary for Regulatory Activities) and the CTD (Common
Technical Document).
As the second tenner the exploitation of ICH Guidelines continued, but with more care given to
the following need to:
• Maintain already present Guidelines as science and technology continued to develop;
• Expand communication and spreading of information on ICH Guidelines with non-ICH
regions became a key focus;
• Provide the implementation of ICH Guidelines in ICH's own regions;
- PRATIK TERSE 9
10. ICH
Entering into its third tenner of activity,
• ICH's attention is directed towards continuing the benefits of
harmonization outside the ICH regions.
• Training, active participation of non ICH regions in Guideline exploitation is
seen as key in this effort.
- PRATIK TERSE 10
11. ICH
- PRATIK TERSE 11
ICH mission:
• ICH’s mission is to make suggestions
towards accomplishing greater
harmonisation in the interpretation and
application of technical Guidelines and
requirements for medicinal product
registration.
