Deals in detail about total quality management (TQM) in all aspects of industries to be followed for optimum quality production and human resource management.
Deals in detail about total quality management (TQM) in all aspects of industries to be followed for optimum quality production and human resource management.
Total Quality Management in Pharma IndustryInthiyazBegum
INTRODUCTION:
Total quality management increases the customer satisfaction by boosting the quality.
In an increasing competitive market firms with a continuous improvement culture and external focus are more likely to survive and prosper.
What is TQM?
TQM is an approach to improving the effectiveness and flexibilities of business as a whole.
It is essentially a way of organizing and involving the whole organization every department, every activity and every single person at every level.
SIGNIFICANCE OF TQM:
The importance of TQM lies in the fact that in encourages innovation, make the organization adaptable to change , motivate people for better quality ,and integrates the business arising out of the common purpose and all those provide the organization with a valuable and distinctive competitive edge.
Elements of TQM :
Be customer focused
Do it right the first time
Constantly improve
Quality is an attitude
Reasons for TQM failure
TQM fails because :
Top management sees no reasons for change
Top management is not concerned for its staff
Top management is not committed to the TQM programmer
The company loses interest in the programmer after six months
The work force and the management do not agree on what needs to happen.
Benefits of TQM:
Improvement of quality
Employee participation
Team work
Working relationship
Customer satisfaction
Employee satisfaction
IMPORTANCE OF TQM IN PHARMA INDUSTRY :
Handling:
Containers should be opened carefully and subsequently resealed in an approved manner.
Highly sensitive materials such as penicillin's and cephalosporin's should be handle in separate production area.
Highly active should be manufacture in a dedicate area and using delectated reagent.
Storage:
Secure storage facilities should be designated for use to prevent damage of materials.
Should be kept clean and tidy and subject to the appropriate pest control measurement.
Environmental conditions should be recorded.
Storage conditions for API should be based upon stability studies taking into account time.
Packaging:
Labelling and packaging processes should be defined and controlled to ensure that correct packaging materials are used correctly and other specified requirements are met.
Printed labels should be securely to avoid mix ups arising store.
Facilities and equipment :
The location ,design, and construction of buildings should be suitable for the type and stage of manufacture involved protecting the product from contamination and protecting operators and the environment from the product.
Equipment surfaces in contact with materials used in API manufacturing should be non reactive.
Conclusion :
Total quality management encourages participation amongst ,employees ,managers ,and organizations whole.
The responsibilities either its professional, social , legal, one that the rest with the pharmaceutical manufacturing for the assurance of quality.
Control should be practiced rigorously.
Lack of management commitment, Inability to change organizational culture, Improper planning, Lack of continuous training and education, Incompatible organizational structure and isolated individuals and departments, Ineffective measurement techniques and lack of access to data and results,Paying inadequate attention to internal and external customers, Inadequate use of empowerment and team work,
Failure to continuously improve
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
Cost of Quality is a widely spread and widely misunderstood concept.Here is a presentation that will evaporate all your doubts regarding this topic.A very well explained case study of H&S motors.It is a very well structured presentation.
Total Quality Management in Pharma IndustryInthiyazBegum
INTRODUCTION:
Total quality management increases the customer satisfaction by boosting the quality.
In an increasing competitive market firms with a continuous improvement culture and external focus are more likely to survive and prosper.
What is TQM?
TQM is an approach to improving the effectiveness and flexibilities of business as a whole.
It is essentially a way of organizing and involving the whole organization every department, every activity and every single person at every level.
SIGNIFICANCE OF TQM:
The importance of TQM lies in the fact that in encourages innovation, make the organization adaptable to change , motivate people for better quality ,and integrates the business arising out of the common purpose and all those provide the organization with a valuable and distinctive competitive edge.
Elements of TQM :
Be customer focused
Do it right the first time
Constantly improve
Quality is an attitude
Reasons for TQM failure
TQM fails because :
Top management sees no reasons for change
Top management is not concerned for its staff
Top management is not committed to the TQM programmer
The company loses interest in the programmer after six months
The work force and the management do not agree on what needs to happen.
Benefits of TQM:
Improvement of quality
Employee participation
Team work
Working relationship
Customer satisfaction
Employee satisfaction
IMPORTANCE OF TQM IN PHARMA INDUSTRY :
Handling:
Containers should be opened carefully and subsequently resealed in an approved manner.
Highly sensitive materials such as penicillin's and cephalosporin's should be handle in separate production area.
Highly active should be manufacture in a dedicate area and using delectated reagent.
Storage:
Secure storage facilities should be designated for use to prevent damage of materials.
Should be kept clean and tidy and subject to the appropriate pest control measurement.
Environmental conditions should be recorded.
Storage conditions for API should be based upon stability studies taking into account time.
Packaging:
Labelling and packaging processes should be defined and controlled to ensure that correct packaging materials are used correctly and other specified requirements are met.
Printed labels should be securely to avoid mix ups arising store.
Facilities and equipment :
The location ,design, and construction of buildings should be suitable for the type and stage of manufacture involved protecting the product from contamination and protecting operators and the environment from the product.
Equipment surfaces in contact with materials used in API manufacturing should be non reactive.
Conclusion :
Total quality management encourages participation amongst ,employees ,managers ,and organizations whole.
The responsibilities either its professional, social , legal, one that the rest with the pharmaceutical manufacturing for the assurance of quality.
Control should be practiced rigorously.
Lack of management commitment, Inability to change organizational culture, Improper planning, Lack of continuous training and education, Incompatible organizational structure and isolated individuals and departments, Ineffective measurement techniques and lack of access to data and results,Paying inadequate attention to internal and external customers, Inadequate use of empowerment and team work,
Failure to continuously improve
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
Cost of Quality is a widely spread and widely misunderstood concept.Here is a presentation that will evaporate all your doubts regarding this topic.A very well explained case study of H&S motors.It is a very well structured presentation.
Total Quality Management (TQM) is a management approach that seeks to provide long-term success by providing unparalleled customer satisfaction through the constant delivery of quality IT services
TQM i.e. Total Quality Management plays an very important role in pharmaceutical industries in world-wide as it is very feasible and time saving and improves product quality at a great
extent.
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2. Contents
• Introduction.
• Concepts of tqm.
• Benefits of tqm.
• Characteristics of tqm.
• Key elements of tqm.
• Tqm in pharma industry.
• Advantages.
• Disadvantages.
• Conclusion.
• References.
2TOTAL QUALITY MANAGEMENT
3. Introduction
Total - made up of the whole
Quality - degree of excellence a product or service provides
Management - act, art or manner of planning, controlling,
directing,….
Therefore, TQM is the art of managing the whole to achieve
excellence.
3TOTAL QUALITY MANAGEMENT
4. The concept of TQM
• Produce quality work the first time.
• Focus on the customer.
• Have a strategic approach to improvement.
• Improve continuously.
• Encourage mutual respect and teamwork.
4TOTAL QUALITY MANAGEMENT
5. Various Definitions
Total quality management (TQM) has been defined as an
integrated organizational effort designed to improve quality at
every level.
The process to produce a perfect product by a series of measures
require an organized effort by the entire company to prevent or
eliminate errors at every stage in production is called total
quality management.
According to international organization for standards defined
tqm as, “TQM is a management approach for an organization,
centered on quality, based on the participation of all its
members and aiming at long-term success through customer
satisfaction and benefits to all members of the organization and
to the society. 5TOTAL QUALITY MANAGEMENT
6. Characteristics of TQM
Committed management.
Adopting and communicating about total quality
management.
Closer customer relations.
Closer provider relations.
Benchmarking.
Increased training.
Open organization
Employee empowerment.
Flexible production.
Process improvements.
Process measuring
6TOTAL QUALITY MANAGEMENT
7. Traditional approach and TQM
Quality element Previous state TQM
Definition Product-oriented Customer-oriented
Priorities Second to service and
cost
First among equals of
service and cost
Decisions Short-term Long-term
Emphasis Detection Prevention
Errors Operations System
Responsibility Quality Control Everyone
Problem solving Managers Teams
Manager’s role Plan, assign, control,
and enforce
Delegate, coach,
facilitate, and mentor
7TOTAL QUALITY MANAGEMENT
8. The three aspects of TQM
Counting
Customers
Culture
Tools, techniques, and training in
their use for analyzing,
understanding, and solving quality
problems
Quality for the customer as a
driving force and central concern.
Shared values and beliefs,
expressed by leaders, that define
and support quality.
8TOTAL QUALITY MANAGEMENT
9. Principles of tqm
1. Produce quality work the first time and every time.
2. Focus on the customer.
3. Have a strategic approach to improvement.
4. Improve continuously.
5. Encourage mutual respect and teamwork
9TOTAL QUALITY MANAGEMENT
10. The key elements of the TQM
Focus on the customer.
Employee involvement
Continuous improvement
10TOTAL QUALITY MANAGEMENT
11. Focus on the customer
• It is important to identify the organization’s customers.
• External customers consume the organization’s product
or service.
• Internal customers are employees who receive the output
of other employees.
11TOTAL QUALITY MANAGEMENT
12. • Since the quality is considered the job of all employees,
employees should be involved in quality initiatives.
• Front line employees are likely to have the closest contact with
external customers and thus can make the most valuable
contribution to quality.
• Therefore, employees must have the authority to innovate and
improve quality.
12TOTAL QUALITY MANAGEMENT
Employee Involvement
15. CONTINUOUS IMPROVEMENT
• The quest for quality is a never-ending process in which people
are continuously working to improve the performance, speed and
number of features of the product or service.
• Continuous improvement means that small, incremental
improvement that occurs on a regular basis will eventually add up
to vast improvement in quality.
• TQM is the management process used to make continuous
improvements to all functions.
• TQM represents an ongoing, continuous commitment to
improvement.
• The foundation of total quality is a management philosophy that
supports meeting customer requirements through continuous
improvement.
15TOTAL QUALITY MANAGEMENT
16. Continuous Process Improvement.
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, make process
more satisfying to the person doing
16TOTAL QUALITY MANAGEMENT
20. Importance of TQM in pharma industry
Handling:
• Containers should be opened carefully and subsequently
resealed in an approved manner.
• Highly sensitising material such as penicillins and
cephalosporins should be handled in separate production
areas.
• Highly active or toxic API (e.g. certain steroids, cytostatic
substances) should be manufactured in a dedicated area and
using dedicated equipment.
• Pure and final API should be handled in an environment
giving adequate protection against contamination.
20TOTAL QUALITY MANAGEMENT
21. Storage:
• Secure storage facilities should be designated for use to
prevent damage or deterioration of materials.
• These should be kept clean and tidy and subject to
appropriate pest control measures.
• Environmental conditions should be recorded.
• The condition of stored material should be assessed at
appropriate intervals.
• Storage conditions for api should be based upon stability
studies taking into account time, temperature, humidity,
light etc 21TOTAL QUALITY MANAGEMENT
22. Packaging:
• Labelling and packaging processes should be defined and
controlled to ensure that correct packaging materials are
used correctly and other specified requirements are met.
• Printed labels should be securely stored to avoid mix-ups
arising.
• Marking and labelling should be legible and durable, provide
sufficient information, for accurate identification and
indicate, if appropriate, required storage conditions, retest
and/or expiry date.
22TOTAL QUALITY MANAGEMENT
23. Facilities and equipment:
• The location, design, and construction of buildings should
be suitable for the type and stage of manufacture involved,
protecting the product from contamination (including
cross-contamination) and protecting operators and the
environment from the product.
• Equipment surfaces in contact with materials used in api
manufacture should be non-reactive.
23TOTAL QUALITY MANAGEMENT
24. Sterile area
• Personnel suffering from an infectious disease or having
open lesions on the exposed surface of the body should
avoid activities which could compromise the quality of
API.
• Smoking, eating, drinking, chewing and storage of food
should be restricted to designated areas separated from
production or control areas.
24TOTAL QUALITY MANAGEMENT
25. Labelling
• Each container should be identified by an appropriate
label, showing at least the product identification and the
assigned batch code, or any other easily understandable
combination of both.
• . Containers for external distribution may require
additional labels.
25TOTAL QUALITY MANAGEMENT
26. Computerised systems
• . Computer systems should be designed and operated to
prevent unauthorised entries or changes to the
programme.
• In the case of manual entry of quality critical data there
should be a second independent check to verify accuracy
of the initial entry.
• A back-up system should be provided of all quality critical
data.
26TOTAL QUALITY MANAGEMENT
27. Advantages of tqm
• Improves reputation- faults and problems are spotted and
sorted quicker.
• Higher employee morale- workers motivated by extra
responsibility ,team work and involvement indecisions of
tqm.
• Lower cost.
• Decrease waste as fewer defective products and no need
for separate.
27TOTAL QUALITY MANAGEMENT
28. Disadvantages of tqm
• Initial introduction cost.
• Benefits may not be seen for several years.
• Workers may be resistant to change.
28TOTAL QUALITY MANAGEMENT
29. A model for organization management.
29TOTAL QUALITY MANAGEMENT
31. BENEFITS OF TOTAL QUALITY
MANAGEMENT
• Financial benefits include lower costs, higher returns on sales and
investment, and the ability to charge higher rather than
competitive prices.
• Improved access to global markets, higher customer retention
levels, less
• Time required to develop new innovations, and a reputation as a
quality firm.
• Total quality management (tqm) is one such approach that seeks
to improve quality and
• Performance which will meet or exceed customer expectations.
31TOTAL QUALITY MANAGEMENT
32. CONCLUSION:
• TQM encourages participation amongst employees, managers and
organization as whole.
• Using Quality management reduces rework nearly to zero in an achievable
goal .The responsibilities either its professional, social, legal one that rest with
the pharmaceutical manufacturer for the assurance of quality of product are
tremendous and it can only be achieved by well organised.
• Work culture and complete engagement of the employees at the work place. It
should be realised that national & international regulations must be
implemented systematically and process.
• Control should be practiced rigorously.
• Thus quality is critically important ingredient to organisational success today
which can be achieved by TQM, an organisational approach that focusses on
quality as an over achieving goals, aimed at aimed at the prevention of defects
rather than detection of defects..
32TOTAL QUALITY MANAGEMENT
33. Reference:
33TOTAL QUALITY MANAGEMENT
• Text book of Total Quality Management by L.Suganthi and
Anand A.Samuel,2nd edition,2005,page no.49-61.
• Total Quality Management by R.S Nagarajan,
A.A.Arivalangar,new age international publishers,1st
edition,2009,page no.21.
• www.slideshare.com/tqm in pharma industry.