Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5428_Библиотеки_им_академика_М_И_Перельмана
.pdf
1.
2.
3.
4.
5.
6.
•
•
•
•
•
•
•
•
•
•
•
a close relationship with the customer to fully determine the needs of customer and to
receive feedback on the extent to which those needs are being met. The customer should be
closely involved in the product design and process development, with input at every stage,
so that the probability of quality problems is reduced before the full production begins.
There are six issues for Customer satisfaction
Who are the customers?
What do they require?
What are their measures and expectations?
Does my product/service exceed their expectations?
How do I satisfy their needs?
What corrective action is necessary?
The tools used for evaluation of customer satisfaction are:
Warranty cards/Questionnaire
Telephone/Mail Surveys
Focus Groups
Customer Complaints
Customer Satisfaction Index
Involvement of Employee
Employee participation can be defined as the degree to which employees in an organization
engage in various quality management activities. Through personal participation in quality
management activities employees acquire new knowledge, and obtain a sense of
accomplishment by solving quality problems. Participation is an important decision in
inspiring action on quality management. Participations of employee are teamwork, employee
suggestions, and commitment of the employee. Team work is a remarkable characteristic of
employee participation.
Following criteria are to be maintained for involvement of employee
People – most important resource/asset
Quality comes from people
Deming – 15% operator errors, 85% management system
Project teams – Quality Control Circles (QCC), QIT
Education and training – life long, continuous both knowledge and skills
https://t.me/med1917
•
•
•
•
•
•
•
•
•
Suggestion schemes; Kaizen, 5S teams
Motivational programmes, incentive schemes
Conducive work culture, right attitude, commitment
Continuous Process Improvement
Process refers to certain unique combination of machines, tools, methods, materials, and
people involved in production. Process Control and Improvement predicts a set of
methodological and behavioral practices, which are imposed to control and improve the
processes that produce products and services. In fact, the process control and improvement
can make the manufacturing process operate as desired, without breakdowns, missing
materials, fixtures, tools, etc. even in presence of variation in workforce.
Following points are to be maintained:
View all work as process – production and business
Process – purchasing, design, invoicing, etc.
Inputs – PROCESS – outputs
Process improvement – increased customer satisfaction
Improvement – 5 ways;
Reduce resources,
Reduce errors,
Meet expectations of downstream customers,
Make process safer, and
Make the process more satisfying to the person doing
https://t.me/med1917
Fig. 4.18 Construction of TQM
Problem solving methods are:
Identify the opportunity (for improvement)
Analyze the current process
Develop the optimal solution(s)
Implement changes
Study the results
Standardize the solution
Plan for the future
Supplier Partnership
https://t.me/med1917
1.
2.
3.
4.
5.
6.
7.
8.
9.
Supplier Quality Management is the set of supplier-related quality management practices for
improving quality of the supplies which may be products/ services. This can be shortly
expressed as supplier partnership. The practices include selection of suppliers,
communication with suppliers, understanding of performance of supplier, and supplier
quality audit. In current industrial production, interdependence of buyers and suppliers has
increased radically. To some extent the supplier has become an extension of the buyer’s
organization.
40% production Cost comes from the purchased materials; therefore, the supplier’s Quality
Management is equally important with respect to
Substantial portion quality problems from suppliers
Need partnership to achieve quality improvement – long-term purchase contract
Supplier Management activities as mentioned below:
Definition of the product/program requirements.
Evaluation potential and selection of the best suppliers
Conduction of joint quality planning and its execution
Required statistical evidence of quality
Certification of the suppliers, such as ISO 9000, GMP, etc1.
Development and application of Quality Ratings to the Suppliers
Defects/Percent non-conformity
Price and Quality costs
Delivery and Service
Performance Measures
Evaluation can be defined as systematic examination of the extent to which a unit can fulfill
the specified requirements. Juran and Gryna in1993 stated that a formal evaluation of quality
provides a starting point by an understanding of the size of the quality issue and the areas
demanding attention. Evaluation can recognize the difference between actual performance
and the goal. Evaluating the situation in an organization’s quality management practices
gives an important base for the organization to improve its quality management practices.
Product Design
Product design explains the expectations of the customer for functional requirements into
specific engineering and quality characteristics, which are known as specifications. Some
product design can improve the product quality better than that of competitors, and increases
https://t.me/med1917
the organization’s competitive advantage in the marketplace. There is a set of practices that
can be used to design the products.
Quality System Improvement
Quality system can be linked to the organizational structure, procedures, processes and
resources required to execute quality management. In the year 1987, the International
Standardization Organization published the ISO 9000 standards series on quality
management and quality assurance. The quality system improvement means to establish a
quality system as per the requirements of ISO 9000. The quality manual, quality system
procedures, and work instructions are established. The quality manual is a document that
states the quality policy and describes the quality system of an organization. It covers all the
applicable elements of the quality system standard required for the organization.
Recognition and Reward
Recognition can be defined as the public acknowledgement of superior performance of
specific activities. Reward can be defined as the benefits, such as increased salary, bonuses
and promotion, which are conferred for generally better performance with respect to goals.
Public recognition is another important source of human motivation. Improved performance
program means the performance by any individual, section, department or division within
the organization. To support the quality effort effectively, the organization must implement
an employee compensation system that strongly links the quality and customer satisfaction
with pay. One of the sources of human motivation at work is the social motivation.
Education and Training
Training means attainment of specific skills or knowledge. Training programs try to teach
the employees how to perform job or a specific job. On the other hand, education attempt to
provide the employees with general knowledge that can be applied in many different
settings. Cherrington suggested that training requires a systematic approach. A sound
education and training program requires systematic gathering of data about the employees’
or the organization’s requirement. A good assessment includes the analysis of.
How well the organization is achieving its goals,
The skills required by the workers to achieve these goals, and
The strengths and weaknesses of the existing workers.
To design effective training activities a careful analysis of these data is essential. Investment
in education and training is important to ensure the success of education and training
programs. Training is the second most used TQM implementation practice in the USA.
Organizations implementing TQM invest heavily in training of employees at different levels.
Without proper training it becomes difficult to improve the work of the employees.
https://t.me/med1917
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
References
Lund, W.; Good manufacturing practices. The pharmaceutical codex: Principle and
practice of pharmaceutics.; The pharmaceutical press, London,; Edition12, 1994, 362-
397.
Nally J, Kieffer R.G; GMP compliance, productivity and quality; Interpharm; 1998,
465-466.
Nally J.D: Good manufacturing practices for pharmaceuticals, Informa healthcare
USA, Inc, ISBN 10:0-8593-3972-3 & ISBN13:Edition 6, New York, 2007, 978-08493-3972- 1.
Schedule M. good manufacturing practices and requirement of premises, plant and
equipment for pharmaceutical product, 25.03.2012. Cdsco.nic.in/html/GMP/ Schedule
M(GMP).pdf.
Sharp, J.; Wider aspects of GMP. Good manufacturing practice: philosophy and
applications. Illinois, Interpharm Press, 1991, 71-79.
US FDA: Guidance for industry, Quality systems approach to pharmaceutical current
good manufacturing practice regulations, Food and drug administration, center for
drug evaluation and research (CDER), Center for biologics evaluation and research
(CBER), Center for veterinary medicine, office of regulatory affairs (ORA), Rockville,
MD, 2004, fda.gov/cvm/guidance/published.html.
Geneva: WHO Library Cataloguing in Publication Data; 2007. World Health
Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines
and Related Materials. Good Manufacturing Practices and Inspection; 2nd ed. Vol. 2.
Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for
Pharmaceutical Preparations. Annex 3- WHO Good Manufacturing Practices for
Pharmaceutical Products: Main Principles, Introduction. WHO Technical Report
Series, No 961, Forty-fifth Report.
U.S. Food and Drug Administration. Silver Spring: FDA; FDA's International Posts:
Improving the Safety of Imported Food and Medical Products. [Last updated on 2013
July 12; Last cited on 2014 Feb 19].
Chudley R. and Greeno R., (2001), Building Construction Handbook - Fourth edition,
Elsevier Butter – worth Heinemann, Oxford.
Graham Cole, (1998), Pharmaceutical Production Facilities -Design and Applications
(second edition), Taylor and Francis, London
ISPE, (1996 ), ISPE Baseline Pharmaceutical Engineering Guides for New Facilities Volume 2: Oral Solid Dosage Forms – First Edition, Tampa
https://t.me/med1917
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
World Health Organisation, (2004), Quality Assurance of Pharmaceuticals – A
compendium of guidelines and related materials - Volume 2 - Updated Edition - Good
Manufacturing Practices and Inspection, Geneva
Production management- Jaya Banerjee Shree Niwas Publications (2011)
Industrial Engineering and Production ManagementS.Chand S.Chand and Company
LTD (2008)
Tripathi, PC. and Reddy, PN.; Principles of Management; Tata McGraw-Hill.
Ahmed, T., Ali, S.M., Allama, M.M., Parvez,M.S. (2010). A Total Productive
Maintenance (TPM) Approach to Improve Production Efficiency and Development of
Loss Structure in a Pharmaceutical Industry. Global Journal of Management and
Business Research, 10(2), pp.186-190
Ahuja, I. and Khamba, J. (2007). An evaluation of TPM implementation initiatives in
an Indian manufacturing enterprise. Journal of Quality in Maintenance Engineering,
13(4), pp.338352.
Ahuja, I. and Khamba, J. (2008b). An assessment of maintenance management
initiatives in Indian manufacturing industry. International Journal of Technology,
Policy, Management.
Alardhi, M., Hannam, R. and Labib, A. (2007). Preventive maintenance scheduling for
multi‐cogeneration plants with production constraints. Journal of Quality in
Maintenance Engineering, 13(3), pp.276-292.
Al‐Najjar, B. (1996). Total quality maintenance. Journal of Quality in Maintenance
Engineering, 2(3), pp.4-20.
Anvari, F., Edwards, R. and Starr, A. (2010). Evaluation of overall equipment
effectiveness based on market. Journal of Quality in Maintenance Engineering.
Ben Daya, M. (2000). You may need RCM to enhance TPM implementation. Journal
of Quality in Maintenance Engineering.
Bhaudry, B. 2000. Management of Productivity through TPM. Productivity.
Halevi, G.; Handbook of Production Management Methods; Elsevier Ltd.; 2001
Industrial Engineering and Production Management S.Chand S.Chand and Company
LTD (2008)
Wang, X.; Inventory Management In A Pharmaceutical Company; National University
of Singapore, 2009
Whewell, R., 2010, Supply Chain in the Pharmaceutical Industry: Strategic Influences
and Supply Chain Responses, Gower Publishing Limited: England, pp. 201-228.
Shodhganga.inflibnet.ac.in/bitstrem/10603/3404/……/09-chapter/202pdf
https://t.me/med1917
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
Mohan, P., Glassey, J., and Montague, A., 2006, Pharmaceutical Operations
Management Manufacturing for Competitive Advantage, McGraw Hill
Bernold, LE. and Treseler, JF.; J. Construction Engineering and Management; 117, 4,
1991
Chase, R.B., Jacobs, F.R. and Aquilano, N.j., 2004, Operations Management for
Competitive Advantage, 10th ed., McGraw Hill: pp. 563-564
Aronson, JK.; Medication errors: what they are, how they happen, and how to avoid
them; Q.J.Med., 102, 513 – 521, 2009
Singh, RK., Kumar, P. and Kumar, R.; Strategic issues in pharmaceutical supply chain:
a review', International Journal of Pharmaceutical and Healthcare Marketing,; IJPHM;
10, 3, 234 – 257, 2016
Kapoor, D., Vyas, RB., Dadarwal, D.; Drug Development & Industrial Pharmacy Int.
J.; 1, 2, 1 – 6, 2018
Redaelli, EJ., Paiva, EL., Teixeira, R.; The Relationship between Manufacturer and
Distributors: Knowledge Transfer and Performance; 12, 4, 421 – 441, 2015
Retrieved from: http://www.unece.org/fileadmin/DAM/cefact/ recommendations
/rec19/ rec19_ ecetrd 138.
Retrieved from http://www.tw.gov.nl.ca/publications/best practicesmanual.pdf
Retrieved from
Kumar, N., Jha, A.; Pharmaceutical Good Distribution Practices – A Review of Global
Scenario; IJPSR; 6, 12, 1449 – 1452, 2015
WHO, Working Document QAS/04.068/Rev 2; 2005
WHO, Working Document QAS/08.252/Rev 1; 2009
WHO, Annex 5, WHO Technical Series No. 957, 2010
EC, Guidelines 2013/C343/01/2013
OPPI, Guidelines on Good Distribution Practices for Pharmaceutical Products, 2013
HAS, Guide-MQA-013-010, 2015
HPRA, IA-G0046-3, 2017
Donselaar, K.V., Woensel, T.V., Broekmeulen, R., and Fransoo, H., 2006, "Inventory
Control of Perishables in Supermarkets", International.J of Production Economics,
103(2), pp. 462-472
McComas, C., 1995, "Controlling Purchasing and Inventory to Reduce Waste",
Pollution Prevention Review, Spring, pp. 27-34
https://t.me/med1917
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
Rama Murthy, P., Production and Operations Management, New Age International
Publishers, 2005
Chase, R.B., Aquilano, N.J., and Jacobs, F.R., Production and Operations
Management: Manufacturing and Services, Richard D. Irwin, Inc., 1998.
Narshimha, S.L., Production Planning and Inventory Control, PHI, 2002
Garg, A.K., Production and Operations Management, Mc GrawHill, 2012
Chary, S.N., Operations Management, TMH, 1996
Baffa and Sarin, R., Modern Production/ Operations Management, John wiley and
Sons,2002
Fliedner G, “Hierarchial forecasting: Issues and use guidelines”, Industrial
management and data systems, 101(1), pp: 5-12.
Klassen, RD., and Flores, BE.; Forecasting Practices of Canadian Firms; International
Journal of Production Economics; 70,2,163-74, 2001
McCarthy, J., Minsky, ML., Rochester, N. and Shannon, CE.; A Proposal for the
Dartmouth Summer Research Project on Artificial Intelligence; AI Magazine;
27,4,2006
Davis, DF., McCarthy Byrne, TM., Golicic, S. and Mentzer, JT.; The Evolution of
Sales Forecasting Management; Journal of Forecasting; 25(5), 303-324, 2006
Makridakis, SG., Wheelwright, SC. and Hyndman, RJ.; Forecasting methods and
applications; Wiley, New York; 1998
Armstrong, 2006
Sanders and Manrodt, 2003
Obara, L.C (2003): Management Accounting for Managers (A strategic perspective)
Blue-Print Ltd: Port- Harcourt.
Anthony, Robert N, and Vijay Govindarajan; Management control systems. Chicago;
Irwin; 1997
Drury, J.C (1992): Management and Cost Accounting. Chapman and Hall: London
Hamilton, Martha M.; “Who’s Chainsaved Now? Dunlap out as Sunbeams’s losses
Mount” Washington Post, June 16, 1998
Obara, K., Sekito, T., Niimi, K., Ohsumi, Y.; J. Biol. Chem.; 29, 283(35); 23972 – 80,
2008
John, S. Oakland, Total Quality Management text with cases; Butterworth-Heinemann,
2003
https://t.me/med1917
1.
(a)
(b)
(c)
(d)
2.
(a)
(b)
(c)
(d)
3.
(a)
(b)
(c)
(d)
4.
(a)
(b)
(c)
(d)
5.
(a)
Exercises
Multiple Choice Questions Carrying 01 Mark
The types of risk associated with pharmaceutical products may be
Cross contamination with unexpected contaminants
False labeling
All of the above
None of the above
The objective of GMP in pharmaceutical industry is to
Reduce the cost of quality
Increase the cost of quality
Maintain the records starting from production to distribution of the products
All of the above
Which one of the following statements is correct?
Management personnel only must wash his/her hands with soap and water located
at each hand washing station.
Every personnel must wash his/her hands with soap and water located at each hand
washing station.
Personnel working only in production must wash his/her hands with soap and
water located at each hand washing station.
All of the above
Personnel working in the production area are expected to maintain a high degree of
personal cleanliness as mentioned below.
No person with mustaches or beards must not work in pharmaceutical company
No person with mustaches or beards must not work in pharmaceutical
manufacturing
No person with mustaches or beards must not work in pharmaceutical packaging
Men with mustaches or beards must cover them fully with a beard net
Which of the following statement is correct?
The protective clothing provided must be changed daily and when necessary
throughout the day.
https://t.me/med1917
Соседние файлы в папке Библиотека им академика М.И. Перельмана