TOTAL QUALITY MANAGEMENT

Prawan Dahal
MPharm, MBA
 TQM (INTRODUCTION)
• Total quality management (TQM) is an ongoing process of detecting
and reducing or eliminating errors.
• It is used to streamline supply chain management, improve
customer service, and ensure that employees are trained.
• The focus is to improve the quality of an organization's outputs,
including goods and services, through the continual improvement
of internal practices.
• Total quality management aims to hold all parties involved in the
production process accountable for the overall quality of the final
product or service.
• There are often eight guiding principles to TQM that range from
focusing on customers, continually improving, and adhering to
processes.
• Total quality management is a structured approach to
overall organizational management.
• The focus of the process is to improve the quality of an
organization's outputs, including goods and services,
through the continual improvement of internal practices.
• The standards set as part of the TQM approach can
reflect both internal priorities and any industry standards
currently in place.
• Industry standards can be defined at multiple levels and
may include adherence to various laws and regulations
governing the operation of a particular business.
• Industry standards can also include the production of
items to an understood norm, even if the norm is not
backed by official regulations.
 Total Quality Management (TQM) – 3 Major
Process Components of TQM
• Process # 1. Policy Management:
• It can also be referred to as policy deployment,
management by policy, etc.
• Policy management is a systematic process used to direct
corporate resources towards solving problems and making
improvements in selecting high priority areas.
• Policy management is essential for executing corporate
strategy.
• There should be a total commitment from top
management and other employees for policy management.
• Process # 2. Daily Management:
• Daily management process is to ensure that overall
operations are improved and the things done as per
planning.
• Daily management is a means both to control and to
improve day to day operations. Day to day management
problems are solved by daily management process.
• Top management ensures that processes for satisfying
customer needs are in place. The managers and
supervisors are responsible for actual execution and
checking of TQM system.
• Process # 3. Team Activity:
• Team activity is essential to achieve organisational
goals and helping in quality improvement.
• The team characteristics may differ depending on the
type and nature of problem to be solved. A work
atmosphere must be developed where managers and
workers listen to and respect each other’s ideas.
• This type of atmosphere can be developed only when
there is a commitment to achieve objectives. The team
approach is a better way of building trust and respect.
• Some common functions of TQM are:
• i. Quality policy & its communication
• ii. Team work & participation
• iii. Problem solving tools & technique.
• iv. Standardization
• v. Quality system
• vi. Quality costs & management
• vii. Process control
• viii. Customer-supplier integration
• ix. Education & training
• x. Quality audit & review.
 Customer Focus
• This puts the focus back on the people buying the product or service.
Customers determine the quality of your product.
• If a product fulfills a need and lasts as long or longer than expected,
customers know that they have spent their money on a quality
product.
• When customer wants or needs are identified, there is a better
chance of figuring out how to get the right materials, people, and
processes in place to meet and exceed their expectations.
• To implement this TQM principle:
– Research and understand your customers’ needs and expectations.
– Align your organization’s objectives with customer needs.
– Communicate with customers, measure satisfaction, and use the results to
find ways to improve process.
– Manage customer relationships.
– Find a balance for satisfying customers and other interested parties (such as
owners, employees, suppliers, and investors).
 Total employee commitment. ...
• Productivity, processes, or sales can’t be increased without the total
commitment of all employees.
• To implement this:
– Clearly communicate and acknowledge the importance of each individual
contribution to the completed product.
– Stress that each team / individual accepts ownership and give them the
responsibility and opportunity to solve problems when they arise.
– Encourage employees to self-evaluate performance against goals and
objectives, and make modifications as necessary to improve workflow.
– Acknowledge successes and optimized performance to build confidence in
employees and stakeholders.
– Make responsibilities clear, provide adequate training, and make sure
resources are used as efficiently as possible.
– Encourage people to continually seek opportunities to learn & move into
other roles to increase their knowledge, competence, & experience.
– Create an environment where employees can openly discuss problems and
 Process Centered/ Approach
• Adhering to processes is critical in quality management.
Processes ensure that the proper steps are taken at the right
time to ensure consistency and speed up production.
• To implement this TQM principle:
– Use Total Quality Management tools such as process flowcharts to
define and delineate clear roles and responsibilities so everybody
knows who does what at certain times.
– Create a visual action plan so everybody can easily see the specific
activities that need to be completed to achieve the desired result.
– Analyze and measure current activities to see where improvements
can be made or where steps in the process are creating
bottlenecks.
– Evaluate the impact your processes and activities may have on your
 Integrated System
• Different departments of an organization should be interconnected
with horizontal processes that should be the focus of Total Quality
Management.
• In an integrated system, everybody in every department should
have a thorough understanding of policies, standards, objectives,
and processes.
• Integrated systems help the company to look for continual
improvement in order to achieve an edge over the competition.
• To implement this TQM principle:
– Promote a work culture focused on quality.
– Use flowcharts and other visual aids to help employees understand how
their functions fit in with the rest of the company.
– Use as-is process analysis to see where improvements can be made.
– Make training available for employees who need to learn new processes
and who want to explore opportunities for advancement.
 Strategic and Systematic Approach
• ISO says this as “Identifying, understanding and managing
interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its objectives.”
• Multiple processes within a development or production cycle are
managed as a system of processes in an effort to increase efficiency.
• To implement this TQM principle:
– Provide your people with the proper training and resources that will help
them complete their individual steps in the process.
– Continually improve processes and products, and upgrade equipment as
necessary to reach goals.
– Make continual improvement a measurable objective for all employees.
– Recognize, acknowledge, and reward innovations and process
improvements.
 Continual Improvement
• Optimal efficiency and complete customer satisfaction doesn’t
happen in a day—organization should continually find ways to
improve processes and adapt products and services as customer
needs shift.
• As previously stated, the other Total Quality Management
principles should help the organization keep an eye toward
continual improvement.
• To implement this TQM principle:
– Implement policies to establish product, process, and system
improvements as measurable goals for individuals, teams, and
departments.
– Recognize, acknowledge, and encourage innovation to improve
processes and development.
– Encourage employees to participate in available training sessions to
learn and take on new and additional roles.
 Fact-based decision-making
• Analysis and data gathering lead to better
decisions based on the available information. Making
informed decisions leads to a better understanding of
customers and market.
• To implement this TQM principle:
– Analyze and check data to ensure that it is reliable and
accurate.
– Make relevant data available to stakeholders.
– Use valid methods to gather and analyze data.
– Make decisions based on the facts learned from the data in
addition to your experience and intuition.
 Communications
• Everybody in an organization needs to be aware of plans,
strategies, and methods that will be used to achieve goals.
• There is a greater risk of failure if there is not a good
communication plan.
• To implement this TQM principle:
– Establish an official line of communication so that all employees
know about updates, policy changes, and new processes.
– Where possible, involve employees in decision-making.
– Make sure everybody in every department understands their
roles and how they fit in with the rest of the company.
 Quality Manual
• A quality manual is a document that states the
company’s intentions for operating and executing the
processes within its quality management system.
• The Quality Manual’s purpose is to serve as the how-to
document company’s operational processes.
• Any policy within the organization that affects the ability
to deliver high-quality products, meet customer’s
demands, and satisfy other requirements like GMP/ISO
requirements can be detailed in the manual.
• These policies define how a department managers will
implement procedures within the boundaries specified in
the quality manual, and then used by managers and
implement procedures.
• It typically includes:
– Quality Policy Statement
– Quality Policies
– Standard Operating Procedures
– Work Instructions
• Quality policy statement: This document details the level
of commitment an organization exhibits in maintaining
quality.
• Quality policies: The quality policy outlines a company’s
plans in great detail and includes extensive documentation.
• Standard operating procedures: These procedures identify
the parties responsible for carrying out each activity and
their allotted time frames.
• Work instructions: Work instructions highlight the activities
and procedures set to occur
 Benefits of Quality Manual
• Quality manual is an excellent business decision, as these
resources:
– Aid in designing quality management processes.
– Enable companies to build effective quality management systems.
– Facilitate continuous improvement within an organization.
– Present a clear, concise system overview.
– Don’t require the assistance of a consultant.
– Provide a more efficient means of running a business.
– Facilitate easy registration..
– Save companies time and money when implementing GMP/ISO
requirements
 Quality Circle
• Quality circles are small groups of employee of
different levels in the firm who come together to
discuss and solve problems in production.
• Managers, assembly line workers and engineers mix
together and everyone’s opinion is valued and
respected. Membership of quality circles is voluntary.
• Employees involved in quality circles may become
more motivated as they feel valued within the
company. Employees who are doing the job often
have a better idea on how to improve processes.
 Steps of Quality Circle
• There are 12 steps of Quality Circle
– Identification of work related problems
• A Category Problem (involvement of other department is not
required)
• B category Problem (involvement of other department is
necessary)
• C category Problem (involvement of management is necessary)
– Selection of problem ( A then B then C)
– Define the problem (by brainstorming, flow chart
preparation)
– Analyze the problem (analyze all aspects of problem like
number of times problem occurred, defect quantity and
effect of problem in detail))
– Identification of cause (Cause and Effect Diagram)
• Finding out the root cause
• Data analysis (Histogram, Scatter diagram)
• Developing solution
• Foreseeing probable resistance (identify potential problem & solution)
• Trial Implementation
• Regular Implementation
• Follow up and Review (Incorporate the changes in relevant documents
for standardization and in working system as SOP, flow sheet etc)
 Quality Review
• Quality Review is the process of reviewing the quality of
services delivered against the Quality Standards.
• It is an inspection with a specific structure, defined roles, and
procedure designed to ensure a product's completeness and
adherence to quality standards.
• The Quality Review is used to check if all Objectives of a Quality
Goal have been achieved.
• The process includes an onsite quality audit, a quality audit
report and a performance report, trend report etc.
• The aim of the review is to assess the quality management
system for:
– adequacy or sufficiency,
– suitability to purpose, and
– effectiveness.
• In addition, a quality management review allows organizations
to decide what next steps are required to develop and improve
the current approach to quality.
• The key inputs necessary for an effective quality management
review include:
– QMS documentation (for assessment of system performance)
– Any significant changes to the QMS
– Audit reports (internal and external audits)
– Customer feedback
– Corrective action and Preventive Action (CAPA) reports
– Results of the previous QMR (i.e., any follow-up actions)
– Any new or revised regulations that impact QMS requirements
– Training needs
– Personnel issues (staffing changes that affect the QMS)
– Other company events or developments that impact quality
management
THANK YOU