Quality, Quality Assurance and TQM

1. QUALITY ASSURANCE
& TQM
PREPARED BY –
PRATHAMESH
PAWALE

2. QUALITY
Quality :-
"The totality of features and characteristics of a product or service that bear on
its ability to satisfy stated or implied needs“
Or
“Quality of food may be defined as the composite of those characteristics that
differentiate individual units of a product, and have significance in determining
degree of acceptability of that unit by the user”
Quality Control (QC):-
A system of maintaining standards in manufactured products by testing a sample
of the output against the specification.

3. QUALITY MANAGEMENT
Quality Management is the
act of overseeing all activities
and tasks that must be
accomplished to maintain a
desired level of excellence.
This includes the determination
of a quality policy, creating and
implementing quality planning
and assurance, and quality
control and quality
improvement.

4. QUALITYASSURANCE
• Assurance is nothing but a positive declaration on a product or
service, which gives confidence. It is certainty of a product or a
service, which it will work well. It provides a guarantee that the
product will work without any problems as per the expectations
or requirements.
• Quality assurance can be defined as "part of quality
management focused on providing confidence that quality
requirements will be fulfilled.“

5. RELATED KEY TERMS
• Quality Control
• Quality Management
• Quality Circles
• Quality Improvement
• Total Quality Management

6. QUALITY CONTROL
• Quality control (QC) is a process through which a business seeks to ensure that
product quality is maintained or improved.
• Quality control involves testing of units and determining if they are within the
specifications for the final product.
• The purpose of the testing is to determine any needs for corrective actions in the
manufacturing process.
• Good quality control helps companies meet consumer demands for better
products.
• In food and drug manufacturing, quality control includes ensuring the product
does not make a consumer sick, so the company performs chemical and
microbiological testing of samples from the production line.

7. QUALITY CIRCLES
A quality circle or quality control
circle is a group of workers who do
the same or similar work, who meet
regularly to identify, analyse and
solve work-related problems. It
consists of minimum three and
maximum twelve members in
number.

8. PRINCIPLES OF QUALITY ASSURANCE
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System approach to Management
6. Continual Improvement
7. Decision Making
8. Mutually beneficial Supplier Relationship

9. ROLE OF QA
• The main role of a Quality Assurance (QA) department is to
ensure all these quality aspects meet with the necessary
requirements
• along with continuous maintenance and improvement of
quality, record keeping, reporting, problem hunting and
solving, and, ultimately, making sure a safe, high quality
product is delivered to the customer.

10. ROLE OF QA
• QA is the backbone of food manufacturing; food has a direct effect
on health and can be lethal if proper protocol is not followed.
• Some of the main steps a QA food manufacturing site must take
include regular GMP audits to monitor site standards,
microbiology testing of materials and inspection of finished
products via sampling.
• Also, a thorough sanitation process, with swabs taken to indicate
cleanliness and hygiene, and daily taste panels based on sensory
analysis.

11. COMPONENTS OF QUALITY
ASSURANCE
Strategic
Level
Tactic Level
Operational Level
Long Term
Decision
Ex. Quality policy
Medium Term Decision
Ex. Training, QA
operation
Day to day
Operation
Ex. SOP
worksheet

12. QA VS. QC
Quality Assurance Quality Control
It is a process which deliberates on
providing assurance that quality request
will be achieved.
QC is a process which deliberates on
fulfilling the quality request
A QA aim is to prevent the defect.
(detect weakness)
A QC aim is to identify and improve
the defects.(detect defect)
QA is the technique of managing quality. QC is a method to verify quality.
QA is process oriented. QC is Product oriented.
QA Defines standards and methodologies
to followed in order to meet the customer
requirements.
QC ensures that the standards are
followed while working on the
product.
All team members are responsible for QA. Testing team is responsible for QC.
EX. Verification Ex. Validation

13. OBJECTIVE OF QA
• Managing GMP
• Managing GLP
• Managing a Safety Programme
• Assuring Quality of raw material
• Assuring Quality and traceability of FG
• Evaluating Plant Environment
• Developing HACCP plan

14. QUALITY MANAGEMENT
• Quality management is the act of overseeing all activities
and tasks that must be accomplished to maintain a
desired level of excellence.
• This includes the determination of a quality policy,
creating and implementing quality planning and
assurance, and quality control and quality improvement.
• In general, quality management focuses on long-term
goals through the implementation of short-term
initiatives.

15. WHAT IS TQM?
TOTAL
QUALITY
MANAGEMENT
Made up of whole
Degree of Excellence
of Product
Act of handling

16. TQM DEFINITION
• TQM a Supervision concept coined by W. Edward Deming
• A core definition of total quality management (TQM) describes a
management approach to long-term success through customer satisfaction.
• "A management approach of an organisation centred 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 organisation and
society.“
• Goal
“Do the Right things Right, the First time, Every time”

17. TQM PROGRAM
Co-
Operation
Commitment
Continuous
Improvement
Culture
Control
Customer
Focus

18. DEMING'S WHEEL FOR CONTINUOUS
IMPROVEMENT

19. TQM
• Total means 100%, so TQM is about managing all
aspects of quality and ultimate goal should be the ‘Total
Customer Satisfaction’.
• Every functional area should stick to the quality plan of
the organization and strive to attain the planned quality
target. Each offering from the organization should be of
optimum quality. Because, “one rotten apple can spoil the
whole basket.”

20. TQM OBJECTIVES
Total customer satisfaction
Addressing all aspects of dimensions of quality
Addressing the quality aspect in everything – products, services,
processes, people etc.
Satisfying all customers – internal as well as external
Involving everyone in the organization in the attainment of the
said objective
Addressing the total organizational issue of retaining customers
Improving profits, as well as generating new business for the
future.
Demanding total commitment from all in the organization
towards the achievement of the common goal.

21. BARRIERS TO TQM IMPLEMENTATION
• Lack of Management Commitment
• Inability to Change Culture
• Improper planning
• Lack of Continuous Training
• Incompatible organizational structure
• Isolated Individuals and departments
• Ineffective measurement techniques
• Lack of Access to Data
• Inadequate Attention to External & Internal Customers
• Inadequate Empowerment and Teamwork
• Failure to Continually Improve

22. PRINCIPLES OF TQM
TQM
Customer
Focus
Involveme
nt of
People
Factual
Approach
to Decision
Making
System
Approach
Continual
Improvem
ent
Process
Approach
Mutually
beneficial
Supplier
Relationship
Leadership

23. ELEMENTS OF TQM
1. Foundation
• Ethics: Ethics is an individual’s understanding of what is good and
bad at the workplace. Ethics teach an individual to follow code of
conduct of organization and adhere to rules and regulations.
• Integrity: Integrity refers to honesty, values and an individual’s
sincerity at workplace. You need to respect your organization’s
policies.
• Trust: Employees need to trust each other to ensure participation
of each and every individual.

24. ELEMENTS OF TQM
2. Bricks
• Training: Employees need to be trained on Total Quality
Management. Managers need to make their fellow workers
aware of the benefits of total quality management and how
would it make a difference in their product quality and eventually
yield profits for their organization.
• Teamwork: Team work is a crucial element of total quality
management. Rather than working individually, employees need
to work in teams. Team members ought to help each other to
find a solution and put into place.
• Leadership: Leadership provides a direction to the entire process
of Total Quality Management.

25. ELEMENTS OF TQM
3. Binding Motor
Communication - Communication binds employees and extracts
the best out of them. Information needs to be passed on from the
sender to the recipient in its desired form.
4. Roof
Recognition: Recognition is the final element of Total Quality
Management. Recognition is the most important factor which acts
as a catalyst and drives employees to work hard as a team and
deliver their lever best. Every individual is hungry for appreciation
and recognition

26. GOOD MANUFACTURING PRACTICES
• Good Manufacturing Practices are the part of
quality assurance which ensures that products
are consistently produced and controlled to the
quality standards appropriate to their intended
use and as required by the marketing
authorization or product specification.
• GMPs are the basic operational and
environmental conditions required to produce
safe foods.

27. WHAT ARE CGMP?
• Good Manufacturing Practice (GMP) is a system for
ensuring that products are consistently produced and
controlled according to quality standards.
• CGMP refers to the Current Good Manufacturing
Practice regulations enforced by the FDA.
• CGMPs provide for systems that assure proper design,
monitoring, and control of manufacturing processes and
facilities.

28. GMP CHECKLIST
Buildings and Facilities
Materials Management
Quality Control System
Manufacturing
Packaging and labeling
Quality Management
System
Personnel and
Training
Purchasing and
Customer Service
Completion

30. GOOD HYGIENE PRACTICES
• It refers to the set of practices
associated with the preservation
of health and healthy living.
• It Include all practices regarding
the conditions and measures
necessary to ensure quality.

31. AREAS EXAMINED UNDER GHP
1) Primary Production
2) Construction, Buildings and Facilities
3) Control of Operation
4) Maintenance and Sanitation
5) Establishment: Personal hygiene
6) Transportation
7) Product information and Consumer Awareness
8) Training

32. GOOD LABORATORY PRACTICES
• Good laboratory practice(GLP) are accepted methods to carry
out activities or operations in a laboratory. The authorities and
laboratory organizations say that these practices help ensure
safety.
• “Good Laboratory Practice (GLP) deals with the organization,
process and conditions under which laboratory studies are
planned, performed, monitored, recorded and reported. GLP
practices are intended to promote the quality and validity of test
data.”
• In 1972, New Zealand was the first country to introduce good
laboratory practice. The United States subsequently followed in
1978 after the Industrial Bio Test Laboratories (IBT Labs)
scandal.

33. GLP

34. PRACTICES FOLLOWED IN LAB
• All Personnel working in lab must wear uniform/aprons
to perform in the lab practices.
• Wearing of Mask, head cap, covers, gloves, shoes, etc.
should be hygienically recommended under GLP.
• Safety glasses, protective eye glasses are essential to carry
hazardous operations.
• Ill person should not allow to work.
• Avoid poor illumination, obnoxious flavours and noise in
lab.
• Provision of exhaust fans in lab.

35. GOOD AGRICULTURAL PRACTICES
• Good Agricultural Practices (GAPs) are
the basic environmental and operational
conditions necessary for the production
of safe, wholesome fruits and vegetables.
• The Food and Agricultural Organization
of the United Nations (FAO) uses good
agricultural practice as a collection of
principles to apply for on-farm
production and post-production
processes, resulting in safe and
healthy food and non-food agricultural
products, while taking into account
economical, social and
environmental sustainability.

36. GAP
• The purpose of GAPs is to give logical guidance in
implementing best management practices that will help to
reduce the risks of microbial contamination of farm produce.
• Examples of GAPs include worker hygiene and health,
manure use and water quality throughout the production and
harvesting process.
• GAP are set of practices that address to environment , eco
and social sustainability for all farm processes for safety and
quality produce.

37. OBJECTIVES OF GAP
• To ensure safety & Quality produce
• To capture new Market advantage
• To improve use of Natural Resources
• To improve Workers health and Working Condition
• To create new market opportunities to farmers and
exporters
• To export Trade of Agricultural produce