TOTAL QUALITY

MANAGEMENT
 INTRODUCTION
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.
 TQM is consider an important catalyst in this context.
 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.
 TQM ensures that the management adopts a strategic
overview of the quality and focuses on prevention rather than
inspection.
•Total Quality Management is “a process designed to
focus on customer expectations, preventing problems,
building commitment to quality in the workforce and
promote open decision making”

•M.Edwards Deming and Joseph M.Juran developed the

concept of TQM.

•It has 4 components:

•1-Quality Planning
•2.Quality Assurance
•3.Quality Control
•4.Quality Improvement
 OBJECTIVES
• -Continous process
• -Focus on Customer Satisfaction
• -Defect Identification and Quality Improvement
• PRINCIPLES/ELEMENTS OF TQM
1.Involvement and utilization of assets in each
employee including management.
• 2.Involvement of management and provide
organizational support.
• 3.Focus on Customers.
• 4.Linkage in between quality and productivity.
• 5.Strategic and Systemic approach for higher
improvement and profitability.
• 6.Gradual and Centered Process.
 PHILOSOPHIES OF TQM
• I) Dr.W.Edwards Deming:
• Deming introduced Statistical Quality Control into industrial
operations.
• He defined Quality as being the direct result of quality of
design, quality of conformance and the quality of the sales and
service functions.
• He developed a set of 14 points for management. His beliefs
were that quality management and improvement were the
responsibility of all employees in a company.
• Managers should develop partnerships with operating level
business people.
• Deming advocacy PDCA:Plan,Do,Check,Act.
 PHILOSOPHIES OF TQM
• II) Dr Joseph M Juran:
• Juran defined quality as being “Fitness for Use”. He developed his
10 points plan that is the backbone of TQM.
• The Juran Method
• 1.Build awareness of the need and opportunity for improvement.
• 2.Set goals for improvement
• 3.Organise to reach the goals
• 4.Provide training
• 5.Carry out projects to solve problems
• 6.Report Progress
• 7.Give recognition
• 8.Communicate results
• 9.Keep the score
• 10.Maintain momentum by making annual improvement part of
the regular system and processes of the company.
 PHILOSOPHIES OF TQM
• III) Armand Feigenbaum:
• Was the originator for the term “Total Quality Control”. He believed that
significant quality improvement could only be achieved by the participation
of everyone in the organisation.
• Fire-fighting quality management should be replaced with clear, customer-
oriented quality management which the employees understand and can
commit themselves to.
• He believed that the goal of Quality improvement was to reduce the total cost
of quality to as low a percentage as possible.
• IV) Philip Crosby:
• He defined quality as being “Conformance to Requirements”
• He developed a programme with 14 steps that focus on changing an
organisation using action plans for their implementation.
• His beliefs were:
• 1.Quality means conformance and not elegance
• 2.It is always cheaper to do a job right first time round
• 3.The only performance indicator is the cost of quality
• 4.The only performance standard is Zero defects.
INTERNATIONAL CONFERENCE FOR HARMONISATION (ICH)
GUIDELINES
• ICH started in 1990 is unique harmonization project involving
the regulatory authorities and pharmaceutical industries of
US,EU and Japan.
• The new ICH Association was officially established on October
23,2015.It is a non profit legal entity under Swiss Law.

• OBJECTIVES:
• To improve efficiency of new drug development and
registration process.
• To improve public health, prevent duplication of clinical trials
in humans and minimize the use of animal testing without
compromising safety and effectiveness.
 ICH MEMBERS
• Regulatory Members/Participants
• -European Commission
• -US Food Drug Administration-FDA
• -Ministry of Health , Labour and Welfare of Japan-MHLW also represented
by Pharmaceuticals and Medical Devices Agency (PMDA)
• -Health Canada
• -Swiss medic
• -Agencia Nacional de Vigillancia Sanitaria -ANVISA, Brazil
• -Ministry of Food and Drug Safety –MFDS, Republic of Korea.
• Industry Members Standing Observers
• EFPIA IFPMA

• JPMA WHO
• PhMRA CIDSCO from India
• IGBA
• WSMI
• BIO
 ICH HARMONIZATION PROCESS
• 1.Formal ICH procedure-New topic for harmonization of ICH
• 2.Q and A procedure-Clarification of existing guidelines.
• 3.Revision Procedure
• 4.Maintenance Procedure
• 5.Implementation

• QSEM:QUALITY/SAFETY/EFFICACY/
MULTIDISCIPLINARY
• 1.Quality (Q1-Q11)-includes stability studies, thresholds for
impurities, testing, GMP and risk management.

• 2.Safety (S1-S10)-ICH has produced a comprehensive set of safety

guidelines related to carcinogenecity,genotoxicity and reprotoxicity.
Nonclinical testing strategy for assessing QT interval prolongation
liability-single cause of drug withdrawals in recent years.
QSEM:QUALITY/SAFETY/EFFICACY/MULTIDISCIPLINARY
• 3)Efficacy (E1-E16)-work carried out by ICH under efficacy is
design, conduct , safety and reporting of clinical trials. Also Novel
medicines and biotechnological processes and use of genomics
techniques for better targeted medicines.
• 4) Multidisciplinary (M1-M8) –includes ICH medical
terminology , electronic standards for transfer of regulatory
documents, common documents.
• Q-SERIES GUIDELINES
• Q1-STABILITY Q2-ANALYTICAL VALIDATION
• Q3A-Q3D-IMPURITIES Q4-PHARMCOPOEIAS
• Q5-QUALITY OF BIOTECHNOLOGICAL PRODUCTS
• Q6A-Q6B-SPECIFICATIONS
• Q7-GMP Q8-PCEUTICAL DEVELOPMENT
• Q9-QUALITY RISK MANAGEMENT Q10-PCEUTICAL QUALITY
SYSTEM
• Q11-DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES
 ICH STABILITY TESTING GUIDELINES

• Q1A-Stability Testing of New Drug Substances and Products-

• Q1B-Stability Testing: Photostability Testing of New Drug
Substances and Products
• QIC-Stability Testing for New Dosage Forms
• Q1D-Bracketing and Matrixing Designs for Stability Testing of
New Drug Substances
• Q1E- Evaluation for Stability Data-this for evaluation of data
found after analysis of drug products for stability testing.
• Q1F-Stability Data Package for Registration Applications in
Climatic Zones
 QBD-QUALITY BY DESIGN
• Is defined as systematic approach to development that begins
with predefined objectives and emphasizes product and process
understanding and process control, based on sound science and
quality risk management.
• It covers designing, developing formulations and manufacturing
processes to ensure predefined product quality.

• ADVANTAGES:-
• 1.Better understanding of the process
• 2.Eliminate batch failures
• 3.More efficient and effective control of change
• 4.Avoid regulatory compliance problems
• 5.Empowerment of technical staff.
• 6.Increase manufacturing efficiency , reduce costs and project
rejections and waste.
 QBD-QUALITY BY DESIGN

• ADVANTAGES:-
• 7.Build scientific knowledge base for all products.
• 8.Better interact with industry on science issues.
• 9.Ensure consistent information
• 10.Incorporate risk management
• 11.Reduce end product testing.
OVERVIEW OF QBD
 ELEMENTS OF QBD
• --QTTP-Quality Target Product profile-identifies the
critical quality attributes(CQAs) of the drug product. It
includes dosage form, delivery systems, dosage
strengths.
• It is summary of quality characteristics of drug product
to be achieved taking into consideration dosage
strengths and also pharmacokinetic characteristics.
• --Product Design and Understanding –includes
identification of Critical Material Attributes (CMAs)
• --Process Design and Understanding—includes
identification of Critical Process Parameters (CPPs)
• --Control Strategy
• --Process Capability and continual improvement.
 QBD TOOLS

• 1.Risk Assessment:
-Is a systematic process of organizing information to support
a risk decision to be made within a risk management process.
There are three components of risk asessment:1.risk
identification,2.risk analysis,3.risk evaluation.
1.Risk identification-to identify sources of hazards that refers
to risk problems, can include historical data, theoretical
analysis, stakeholders concerns.
2.Risk Analysis-estimation of risk associated with the
identified hazards.
3.Risk Evaluation- quantitative or qualitative scale can be
used to determine the significance of the risk.
 QBD TOOLS
• 2.Design of Experiment: (DoE)
- structered,organised method for determing the relationship
between factors affecting a process and the output of that
process is known as “Design of Experiment”
- -is an excellent tool that helps scientists to manipulate
factors according to a prespecified design.
- -is a method to determine the relation ship between inputs
and outputs of a process.
- -it also helps to identify optimal conditions, CMAs,CPPs
and design space.
 QBD TOOLS
• 3.Process Analytical Technique: (PAT)
• -is defined as tools and systems that utilize real time
measurements, or rapid measurements during processing,
of evolving quality and performance attributes of in process
materials to provide information to ensure optimal
processing to produce final product that conforms to the
standards.
• -PAT ensures the process remains within an established
Design Space.
• -is 3 step process-design, analyze and control
 ISO 9000
• ISO 9000 is set of international standards established by
International Organization for Standardization as the basis
for quality management system and quality assurance.
• First published in 1997,revised in 1994.

• Objective:-
• To facilitate international trade by providing a single-
accepted set of standards for references.
• 3 Quality Standards:-
• ISO-9000:2000
• ISO-9001:2000
• ISO-9004:2000
STANDARDS AND GUIDELINES
ADVANTAGES
 ELEMENTS OF ISO 9000
• 1.Management Responsibility
• 2.Quality System
• 3.Contract Review
• 4.Design Control
• 5.Document Control
• 6.Purchasing
• 7.Handling of Purchaser Supplied Product
• 8.Product Identification and Traceability
• 9.Process Control
• 10.Inspection and Testing
• 11.Inspection,Measuring and Test Equipment
• 12.Inspection and Test Status
• 13.Control of Nonconforming Product
• 14.Corrective Action
• 15.Handling,Storage,Packaging and Delivery
• 16.Quality Records
• 17.Internal Quality Audits
• 18.Training
• 19.Servcing
• 20. Statistical Techniques.
 STEPS FOR ISO CERTIFICATION
• ISO refers to International Organization for
Standardization.
• It is an independent organisation that provides
standards in terms of quality, safety, and efficiency of
products and services provided by businesses.
• With the increasing competition among the business, it
is important to deliver high quality of goods & services
in order to sustain in the market.
• ISO certification helps to improve your business
credibility as well as overall efficiency of the business.
 PREREQUISITE TO ISO CERTIFICATION
PROCESS
• I. Choosing the type of ISO Certification
• First of all, you need to choose the type of ISO
certification required for your business. There are
various types of ISO certification available such
as :
• ISO 9001 2008 – Quality Management
• ISO 14001 – Environmental Management
• ISO 27001 – Information security Management
• ISO 22008 – Food Safety Management and so
on.
• II. Choosing an ISO Certification Body
• It must be noted that ISO itself does not provide
certification to the companies. Certification is done
by the external bodies.
 While choosing the ISO registrar, the following to
keep in mind:
• Evaluate several ISO Certification service
providers.
• Check if they are following the CASCO standards.
CASCO is the ISO committee that works on issues
relating to conformity assessment.
• Check whether it is accredited or not. Accreditation
is not compulsory but they must meet the
requirements of ISO Accreditation bodies.
PROCES FOR ISO CERTIFICATION IN INDIA
• Create an application /contract
• The applicant and the registrar should agree on a contract.
• This contract usually defines rights and obligations of
both parties and includes liability issues, confidentiality,
and access rights.
• Quality Documents Review
• The ISO auditor will view all quality manuals and
documents related to various policies and procedures
being followed in the organization.
• Review of existing work will help the ISO auditor to
identify the possible gaps against the requirements
stipulated in the ISO standards.
• Make an Action Plan
• After the ISO auditor communicates the existing gaps an
action plan to eliminate these gaps is required.
• Prepare the list of the required tasks to be performed to bring
the desired changes .
• Impart training to employees to work efficiently while
adapting to new procedures.
• Make all the employees aware of the ISO standards in terms
of work efficiency and quality standards.
• Initial Certification Audit
• Stage 1:
• The ISO auditor audit the changes made by the
organization.
• Then try to identify the possible non-conformities in
systems and procedures to the desired quality
management system.
• Divide these non-conformities into minor and major
non-conformities.
• The applicant must carefully assess all non-
conformities and get it aligned as per the desired
quality standards through modification in the
techniques and processes used by the organisation.
• Stage 2:
• After all the required changes are done in the organisation,
the ISO auditor does the final auditing.
• The auditor checks whether all the non-conformities have
been eliminated as per ISO quality standards.
• If the ISO auditor is satisfied, the final ISO audit report is
prepared and forwarded to the registrar.
• Completing the ISO Certification
• After all non-conformities are addressed and all the findings
are put in the ISO audit report, the registrar will grant you the
ISO certification.
• Surveillance Audits
• Surveillance audit is basically conducted to ensure that ISO
quality standards are being maintained by the organization
from time to time.
• Cost involved in the ISO Certification Process
• Cost for getting ISO certification is not fixed and
varies from organization to organization. The ISO
certification agency calculates the cost of ISO
certification separately for each organization after
considering them on different parameters such as-
• Number of employees
• Number of Processes
• Level of risk associated with the scope of services
of the organisation
• Complexity of the management system
• The number of working shifts etc.
• Time involved in the ISO Certification Process
• Time taken in completing the whole process of
ISO certification also varies from organization to
organization.
-Generally, the time required to complete the process
of ISO certification is approximate :
• Small organizations: 6-8 months
• Medium organizations: 8-12 months
• Large organisation: 12-15 months
 ISO 14000
• ISO 14000 is a series of international
standards designed to help organizations
operate with sustainability, adhere to
environmental regulations, and continuously
improve processes.
• The ISO 14000 standard contains ISO
14001:2015 which specifies the requirements
for an effective Environmental Management
System (EMS).
 SIGNIFICANCE

• ISO 14000 is important because it enables

organizations to move beyond regulatory
compliance and take a proactive approach
toward environmental management..
• When companies systematize and standardize
their operations with an internationally-
accredited framework, not only can it help them
implement sustainable business practices that
protect the environment, but they can also
inevitably achieve conformance to
environmental regulations with ease.
 ADVANTAGES
• Certification of an EMS is entirely voluntary, but it can
demonstrate credibility and reinforce an organization’s
commitment to its environmental responsibilities .

1.Enhanced Company Image and Brand Reputation

• The initial benefit of being an ISO 14000-certified
company means demonstrating excellent environmental
performance and corporate citizenship.
• Inevitably, having a reputation for minimizing negative
effects on the environment can boost corporate image,
increase brand equity, and multiply customer loyalty.
2.Greater Conservation of Resources and Reduction of Wastes
• Controlling and managing waste, effluent, and emissions
are good indicators that a business is promoting
environmental protection by preventing any source of
pollution and contamination.
• With effective systems in place, natural resources,
including air and water, land and precious minerals can
be conserved.
3.Better Conformance to Legal and Other Requirements
• Taking a strategic approach toward environmental
management can proactively show adherence with
current and future regulatory and statutory requirements.
• Moreover, ISO 14000 certification can result in improved
health and safety outcomes, reducing the risk of costly
• Increased Profitability, Marketability, and
Sustainability
• Finally, being ISO 14001:2015-certified can also
provide financial gains, establish better
relationships with stakeholders, and expand to
different markets.
• Instead
of companies with a high risk of environmental
impact
, many businesses with good environmental
performance may only engage with
organizations that have certified EMS
frameworks.
 ISO 14000 STANDARDS

• Standards is developed by ISO Technical Committee ISO/TC

207 and its various subcommittees.
 ELEMEN TS
• Environmental Policy
• Environmental aspects
• Legal and Other Requirements
• Objectives and Targets
• Environmental management program
• Structure and responsibility
• Training awareness and competence
• Communication
• EMS Documentation
• Document Control
 NABL
• NATIONAL ACCREDITATION BOARD FOR
TESTING AND CALIBRATION LABORATORIES
• -Sole Laboratory autonomous Accreditation body
• -has agreement with ILAC-International
Laboratory Accreditation Cooperation.
• -Valuable for International Recognition and
mutual acceptance of test results.
• -Reduces cost for both the exporters and
importers.
• -
• Responsibilities:-
• -Promote development and maintenance of good
practice in testing and measuring.
• -To establish and maintain international recognition for
its National Accreditation Programme.
• Advantages:-
• -Recognition: National and International
• -Acceptance-Public and Industry
• -Assurance-to Clients of GLP
• -Comparability-Measurements
• -Decision- makers rely on test results
• -Staff Motivation
• -Better Support
 PTOCEDURE FOR ACCREDITATION

• Applicant Laboratory will submit 5 copies of

application and Quality Manual to NABL.
• Lead Assessor conducts preassessment of the
laboratory.
• Corrective action to be taken if any.
• -Participation in various assessment programme
expected.
• -Final Assessment of the laboratory within a
period of 3 months.
• -6 to 8 months –period for process of
accreditation.
 QUESTIONS
• 1.What is Total Quality Management? Give its
objectives and components.
• 2.Write the different philosophies put forth
related to Total Quality Management.
• 3.Explain the process of ISO Certification.
• 4.Give the difference between ISO and NABL.
• 5.What is NABL? Give its advantages and
explain the process of accreditation.
 References
• 1.Pharmaceutical Quality Assurance-by
Chakraborty and Manekar.
• 2.Article on Total Quality Management-
Research Gate-
• https://
www.researchgate.net/publication/315671329
_Total_quality_management
• 3. Pharmaceutical Quality Assurance-by Potdar.