TOTAL QUALITY MANAGEMENT

ANJALI BISHT
1st Semester
M-PHARM QUALITY ASSURANCE
 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 .

 Total quality management increases the customer satisfaction by boosting
the quality.
 It does by motivating the work force and improving the way the company
operates.
 In an increasing competitive market firms with a continuous improvement
culture and external focus are more likely to survive and prosper .
 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.
 DEFINITION OF TQM
• A process designed to focus on customer expectations, preventing problems, building
commitment to quality in the workforce and promoting open decision- making.
• TQM is defined as a customer-oriented process and aims for effectiveness of business
operation.
• It make sure that all related works are toward the common goals of enhancing product
quality or service quality. Along with improving the production process or process of
contributing of services.
• TQM is a management approach which involves all employees and also customer for
continuous improved/ improvement in products and customer satisfaction.
PLAN

ACT TQM DO

CHECK
 PRINCIPLES OF TQM

• Management commitment.
• Employee empowerment.
• Fact based decision making.
• Continuous improvement.
 OBJECTIVES OF TQM
1.To provide high quality drug product to patient's.
2.Process improvement.
3.Defect prevention.
4.Helping teams to make better decision.
5.Continuous improvement to process system, people systems, people suppliers, patterns, products and services.
6.Companies can’t sustain on the philosophy of ‘take it or leave it’’.
7.Relationship with customer is the key.
8.Customer satisfaction- customer loyalty.
9.Motivate employees to do better every time.
10.
Develop relationship of openness and trust among the employee.
11.
Continuous process.
12.
Focus on customer satisfaction.
13.
Defect identification and quality improvement.
14.
Improvement of culture of organization.
 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, 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
o Be customer focused.
o Do it right the first time.
o Constantly improve.
o Quality is an attitude
o Telling staff what is going on.
o Educate and train people.
o Measure the work.
o Top management must be involved.
o Make it a good place work.
o Introduce the team work.
o Organize by process, not by function.
 TQM FRAMEWORK
Principles and
practices
People and relationship:-
Customer satisfaction
Employee involvement
Supplier partnership
Product or
Approach:-
service Customer
GURUS Continuous process improvement
realization
Measure:-
Shewart Performance measures
Deming
Juran Tools and technique
Figenbaum Benchmarking , experimental design
Ishikawa IT, quality function deployment , statistical process control
Crosby Quality management techniques , tool productive maintenance
Taguchi Environmental management system
Quality by design
Management tools
Taguchi’s quality engineering
 Components of TQM
Focus on
customer
expectation

Employee
involvement TQM Team work

Mastery of
process
 1. Focus on the customer

• The purpose of TQM is to satisfy customer requirement.

• These requirement keeps on changing with change in time, environment, needs, fashion,
situation etc.
• Thus company can’t stop they have to keep on working to satisfy the existing customer and
to gain the potential customers.
• Partnership with suppliers.
• Service relationship with internal customers.
• Customer-driven standards.
• Never compromise quality.
 2. Continuous improvement
o As customer requirement is changing companies need to adapt quickly.
o For this, they need new products, new process, new ways to marketing to stay ahead in
competition.
o Technology need to be improved as well.
o Excellence teams.
o Attain, maintain, improve standards.
 3. EMPLOYEE EMPOWERMENT

• Training.
• Excellence team.
• Measurement and recognition.
• Suggestion scheme.
• In order to keep a pace with costumer requirement, even employees need to trained and
develop regularly.
• This will improve quality, and reduce cost as well.
 4.PROCESS ORIENTED

• Thinking about the process.

• Handling of the process.
• Processes which are result oriented.
 OBSTACLES
• Lack of management commitment.
• Misunderstanding about the concept of TQM.
• Improper planning.
• Lack of employees commitment.
• Lack of effective communication.
• Lack of continuous training and education.
• Lack of interest or incompetence of leaders.
 BENEFITS OF TQM

1)Improvement of quality
2)Employee participation
3)Team work
4)Customer satisfaction
5)Employee satisfaction
6)Working relationship
7)Productivity
8)Communication
9)Profitability
10)
Market share
 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.
• Pure and API should be handle in an environmental giving the adequate protection against
contamination.
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.
• Temperature,
• Humidity,
• Light etc.
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.
• Marking and labeling should be legible and durable, provide sufficient information for
accurate identification and indication require storage conditions retest
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.
STERILE AREA AND LABELING:-
• Personnel suffering from an infectious disease or having open lesions on the exposed surface
of the body should avoid activities could compromise the quality of API.
• LABELLING.
• Each container should be identified by an appropriate label, showing at least the product
identification and assigned batch code.
• Containers for external distribution may require additional labels.
 ADVANTAGE OF TQM
o Improves reputation :faults and problems are spotted and sorted quicker.
o Higher employee morale: workers motivated by extra responsibility, team work and
involvement in decision of total quality management.
o Lower cost.
o Decrease waste as fewer defective products and no need for separate.
 DISADVANTAGE OF TQM
o Initial introduction cost.
o Benefits may not be seen for several years.
o Workers may be resistant to change.
o It can be lead to too much attention.
o Extremely demanding of management and staff.
o It is not a quick fix. TQM takes to implement.
THANKYOU