CHAPTER 10
Total Quality Management (TQM)
Quality
The standard of something as measured against other things of similar
kind, the degree of excellence of something. “An improvement in product
quality”
A distinctive attribute or characteristic possessed by someone or
something. “ He shows strong leadership qualities”
Quality is defined by the customers, rather than the designer or the
inspector. A number of parameters associated with quality has been
redefined as the concept of quality is gradually changing
Quality Circle
Quality Circle provides an effective channel of communication between the employees and
the top management for discussion on problems related to quality
“ A group who meet voluntarily and regularly to identify and solve their own work-related
problems and implement their solutions with management approval” ( Industrial Society )
Consists of 6-12 members
Membership can be rotated or sub-group can be formed, if too many volunteers
Senior or experienced members of the circle becomes leader
Unions are supportive and involved due to close workforce involvement and job satisfaction
“Structured way of making management listen”
Quality Circle Presentation to manages
Identification of Problem
Action if
Authorized
Prioritization
Solution
Discussion
and
Investigation
Quality Control
Quality Control is (QC) is a procedure or set of procedures intended to ensur that a
manufactured product or performed service adheres to a defined set of quality criteria
or meets the requirements of the client or customer
QC is similar to, but not identical with, quality assurance (QA). Both are needed to
get a picture of how the two processes work together to boost your organization”s
quality improvement and help reduce corrective actions
QC is the inspection phase of QA
It is a series of test procedures used to verify that a product is safe and effective after
mass production
You canot “test quality into” a product by relying on QC alone
There are different methodologies for both QA and QC, like Agile, Six Sigma and
other project management or process
Quality Control
• Quality Control can be defined as being concerned with checking for errors
during and after processof manufacture
• Modern control techniques are based on idea of (1) error-free or (2) zero-
defect approach or (30 doing it right first time
• Reason- costs involved in correcting errors
• At the strategic management level, decisions are made about total quality
management and systems of quality control
• The strategic approach includes:
- Analysis of current position
- Choice of an appropriate starting point
- Implement of policy, deciding what will be done, how, by whom and by
when
Quality Assurance
Quality assurance is the establishment of standards for processes,
materials and finished products that meet applicable regulatory
requirements
Quality assurance covers all aspects of product development and
manufacturing from raw material control to process validation and final
product release
QA is an acronym that stands for quality assurance
QA also involves corrective action when deviations or errors occur, so
that the product is still safe and effective
QA requires a combination of planning, testing and monitoring
Companies must develop strategies for meeting quality standards before
any product is manufactured
QA helps companies avoid costly recalls and maintain a good reputation
Quality Assurance (QA )
Quality Assurance provides a framework for quality control and quality improvement
QA supports teams of employees with :
Systems, resources,and discretion appropriate to their unique contribution to the
organization
To keep them in tune with progress of quality management and improvement
How Management can help teams?
Understand quality characeristics
Be realistic about the standards to be attained
Undertake quality control through a measurement process, interpret the results and
make propose changes
Difference between QA and QC
Quality assurance and quality control are often used interchangeably, but
they are two different processes taking place at different times
Each play distinct roles in life sciences companies that are vital for effective
management
They are essential for regulated companies because it ensures the safety and
efficacy of their products
QA involves the design of process, such as documenting standard operating
procedures (SOPs) according to ISO 9000 standards. A safe, effective
product should be the result every time process are followed
QC involves the testing of products to ensure they meet standards for safety
and efficacy
Difference between QA and QC
Effective QA is proactive. It aims to prevent defects before they
occurethrough process design. QC is reactive and exists to
identify defects in the quality of products after they have
happened
QA involves the design of process, such as documenting
standard operating procedures ( SOPs) according to ISO 9000
standards. QC involves the testing of products to ensure they
meet standards for safety and efficacy
QA is process-oriented and it focuses on preventing quality
issues. QC is product-oriented and focused on identifying
quality issues in manufactured products that could affect
customer satisfaction
QA Process:
• Documentation
• Audits
• Supplier management
• Personnel training
• Change control
• Investigation procedures
QC Procedures :
• Batch inspection
• Product sampling
• Validation testing
• Laboratory testing
• Software testing
QA control systems are the methods and procedures which are used to
safeguard quality standards. QC systemsmeasure parts, including the outputs
of the systems
The result of QA activities is a roadmap for creating high-quality products. It
involves defining standards for product design, manufacture, packing,
distribution, marketing and sales. QC involves verification of products post
manufacture and before distribution, or confirmingsafty and efficacy
QA activities involve the entire team. Every member of life sciences
organization is responsible for QA activities by following SOPs. QC is
generally responsible for certain personnel within the organization whose
duties include following SOPs for producttesting
Quality
Quality is defined by the customers, rather than the designer or the inspector. A
number of parameters associated with quality has been redefined as the concept of
quality is gradually changing.
Total Quality Management ( TQM)
It is essential to understand the term of “Total” and “Quality” in TQM . It describes
a management approach to long-term success through customer satisfaction. In a
TQM effort, all members of an organization participate in improving process,
products, services and culture in which they work
Steps of TQM
• Continuous improvement
• Employee involvement
• A process-oriented approach
• Empowering employees to contribute to organizational success
Meaning of” Total” in TQM
Total in TQM means development of all aspects of an organization in
satisfying the customer. This can be accomplished if partnership environment
at each stage of the business process is recognized within and outside the
organization. It involves:
Customer-Supplier relationship based on mutual trust and respect
Win-win strategy for both
- Organizations in-house requirements by the customers
- Customer’s needs are well understood by the supplier
- Suppliers are partners in achieving zero-defect situation
- Regular monitoring of supplier’s process and products by the customer
Total Quality Management
TQM is a continuous and endless process of wanting to improve
It’s aim to bring a change in culture in a company, where each employee
can directly participate in areas and decisions concerning his/her work
It builds positive attitudes of emploees towards quality and organization
It enhances respect for each other leading a meaningful workplace
Total Quality Management
TQM Integration:
- Management techniques
- Improvement efforts
- Technical tools under a single discipline
Objectives :
Giving quality products to the customers
Main Features of TQM :
- Top management’s direct involvement
- Strong customer satisfaction
- Company – wide participation
- Systematic and documented methods for solving quality problems
Quality
Quality is defined by customer needs and expectations. Thereby Quality is
what customer wants
“Quality is the totality of futures and characteristics of a product/service that
bear on its ability to satisfy a given need” – American Society of Quality
Control
“Quality refers to an level of functionality possessed by a product/service
based on the producers capability and customer”s need” – Badiru and Ayeni
(1993)
Dimensions of Quality
Performance
Features
Durability
Reliability
Serviceability
Appearance
Safety
Time
Compatibility
Jurans’s Quality Trilogy
Quality
Provided the basic foundation of
Planning
TQM’s practical application.
He suggestd the following 3 phases
of activities for continuous quality Juran’s
improvement: Quality
Trilogy
Quality
Improvement Quality Control
Juran’s Trilogy – Quality Planning
“ Quality is required to be planned for which special training is required” –
Juran
Steps for Planning of Quality:
Identify the customers and their needs ( both external and internal
customers)
Translate the customer’s needs into technical specifications
Optimize the product design and process parameters capable of
producing the required product
Place the process into operation
Juran’s Trilogy – Quality Control
Quality Control is the process of detecting adverse changes in the
process and taking corrective action when the process shows signs of
drifting from its optimal setting.
Statistical techniques and SPC should be used to control the quality. The
activities include:
Evaluate the actual performance of the product
Compare the actual performance with the product goals
Act the performance
Juran’s Trilogy – Quality Improvement
Quality problems may be classified into two broad catagories:
- Sporadic
- Chronic
Sporadic Problems
- Problems are sudden changed for the worse
- Are best handled by statistical techniques
Chronic Problems
- Problems Persists for a long time
- Problems are solved by behavioral models which involve teamwork and
employee participation
- It is estimated that 80% losses are due to chronic problems
- A quality breakthrough is needed to reduce the chronic waste
ISO ( International Organization for Standardization)
Published the first five stadards on international Quality Assurance
(QA), known as ISO 9000 Standards
- These standards were described as “ the refinement of all the most
practical and generally applicable principles of quality systems” and “
the culmination of agreement between the world’s most advanced
authorities of these standards as the basis of a new era of quality
management
ISO ( International Organisation for Standards )
The actual standards are:
1. ISO 9000 – a road map for use of other standards in this series. It defines five key
quality items in the ISO terminology
2. ISO 9001 – It specifies a model when two parties require the demonstration of a
supplier’s capability to design, produce, install and service a product
3. ISO 9002 – It specifies a model for quality assurance in production and installation
4. ISO 9003 – It is a model for quality assurance in the final inspection
5. ISO 9004 – It provides quality management guidelines for developing and
implementing a quality system and in determining the extent to which every
element is applicable
ISO 9000 vs TQM
ISO 9000 TQM
A set of standards and focuses on documents -TQM focuses on developing human elements
Product confirms to specification -Customer delight and satisfaction
Certification -Total organization- all resources
Audits and checks -Internal and external trust
Key processes -Leadership
Quality system -Internal customer
External trust -Flexibility and change management
Visibility of capability prior to delivery -Top management commitment
An assurance to external customers that
a quality system is being pursued - Continuous improvement
Integrated Model :
Quality
Managing for Quality • Q
Strategy
Products and Services Develop the Quality into an Operation:
• Product ( Service ) Design Factors
• Conformation to Design Factors
Factors Affecting Quality: Relationships among Factors Affecting Analysis:
• Management Quality and Performance : Diagnosis by Management
• Employees Customer Perceptions Statistical Analysis
• Product ( Services ) Expected Quality Outcomes Inspection
• Facilities, Process and Equipment Factors Affecting Quality Sampling
• Materials Control Charts
• Vendors
• Top Management Commitment Conformance to Objectives
Management Approaches • Design Product for Quality
Customer Involvement Behaviour and Quality • Design and Control of production
Supplier Partnership Processes
Benchmark and Continuous Improvement • Customer Service
• Build Team of Empowered
Employees
Results
Quality Circle
Quality Circle provides an effective channel of communication between the employees and
the top management for discussion on problems related to quality
“ A group who meet voluntarily and regularly to identify and solve their own work-related
problems and implement their solutions with management approval” ( Industrial Society )
Consists of 6-12 members
Membership can be rotated or sub-group can be formed, if too many volunteers
Senior or experienced members of the circle becomes leader
Unions are supportive and involved due to close workforce involvement and job satisfaction
“Structured way of making management listen”
Quality Circle Presentation to manages
Identification of Problem
Action if
Authorized
Prioritization
Solution
Discussion
and
Investigation
