This document discusses quality assurance theories and applications. It describes the roles and responsibilities of a quality assurance department. Key points include: - QA's role is to evaluate and advise on a company's quality program, not be responsible for quality control operations. - QA should report directly to top management to maintain independence. - A QA program consists of quality control, evaluation, and auditing functions. - QA personnel monitor compliance, procedures, records, issues, and ensure quality at all stages of production. - The vice president of QA is responsible for quality policies, programs, and leadership and acts as an advisor to top management on quality matters.

1. QUALITY ASSURANCE

2. THEORIES AND APPLICATIONS OF
Quality Assurance
Yes
• describes and manages the
activities of control,
evaluation, audits, and
regulatory aspects of a food
processing system
• QA program consists of an in-
house consulting organization;
it evaluates the quality
program and gives advice,
suggestions, and instructions
for its improvement
• is an advisory function
No
• not a police function
• not responsible for the
quality program, it does not
operate the system, and it
does not do quality control
• not responsible for the
quality of the products the
organization provides to its
customers

3. THEORIES AND APPLICATIONS OF
Quality Assurance
Other functions:
• QA department should report directly to top management in order
to have independence in serving the organization
• the head of quality assurance should have the title of vice
president and report directly to the president of the enterprise
• QA may audit the system and provide assistance in making
improvements, but the planning, organizing, staffing, directing, and
controlling of the quality program are in the hands of upper and
production management (divisional quality control (QC) staff
promotes quality in the division and assists and consults with
production as required; the responsibility for the quality of
divisional products rests directly with production)

4. Sample Organizational Chart

5. A Vice President for QA is charged
with specific responsibilities that include:
Serving as a focal point for quality matters, including corrective action and
continual improvement activities
Formulating
and
recommendin
g company
policies,
strategies,
tactics, and
goals and
objectives
relating to
quality
Reviewing and
helping to
coordinate quality
aspects of design of
line plans
Assisting and
counseling top
managers on quality
matters
Exercising authority
over QA groups in
different plants
Concurring with the
appointment of QA
directors for
different plants
Serving as a
resource for
information in the
quality area,
includingregulatory
and competitive
information

6. Coordinating the efforts
of standards committees,
quality improvement
teams, and other groups
whose activities touch on
the quality
area
Monitoring quality and
reporting to top
managers on the status of
quality in the enterprise
Providing leadership for
the quality function as
necessary
Fostering awareness of
quality and helping to
gain credibility for the
quality improvement
effort
Interacting on quality
matters with external
organizations, e.g.,
government agencies,
professional associations,
etc.

7. A distinction needs to be drawn
between QA and QC
QA
• all those planned and
systematic actions necessary
to provide adequate
confidence that a product or
service will satisfy given
requirements for quality.
• QA is a strategic management
function that establishes
policies, adapts programs to
meet established goals, and
provides confidence that these
measures are being effectively
applied
QC
• the operational techniques
and activities that are used
to fulfill requirements for
quality
• a tactical function that
carries out the programs
established by the QA.

8. FUNCTIONS OF A QUALITY ASSURANCE
PROGRAM
• QA functions involve establishing and
managing the company’s quality
organizations, designing operating
procedures, discussing the quality direction
with top management, introducing them to
the fundamentals of quality, and making
certain there is consistency in management
pronouncements

9. How?
• The minimum requirement is for food processors to apply
good sanitation practices, which include the design and
layout of the premises, provision of adequate facilities, and
programs for cleaning and sanitation (pest control)
• Additional QA programs, such as Hazard Analysis and
Critical Control Point (HACCP), audits of several areas of
manufacturing, of sanitation, and of the product in the
market are also the responsibilities of a QA department.
• QA programs enable the application and verification of
control measures intended to assure the quality and safety
of food. They are required at each step in the food
production chain to ensure safe food and to show
compliance with regulatory and customer requirements.

10. • The programs are a set of controls
implemented and verified by the responsible
person(s) at each step in the chain (e.g.,
producers, farmers, fishermen, food
processors, retailers, distributors, storage and
transport personnel, etc.).
• Governments have an important role in
providing policy guidance on the most
appropriate QA programs and verifying and
auditing their implementation as a means of
regulatory compliance

11. Selection and application of
QA programs depends on:
• the step in the food production chain, size of
the food business, type of product produced,
etc., and may include Good Manufacturing
Practices (GMPs), Good Agricultural Practices
(GAPs), Good Laboratory Practices (GLPs),
HACCP systems, and HACCP-based systems.

12. A good QA System
• meet the demands for safe, high-quality foods
• enable food processors to address global
marketplace opportunities while maintaining
high quality and safety
• to provide confidence for management and
the consumer — the person a company must
satisfy and who actually establishes the level
of quality of the products a company
manufactures

13. A good QA System
• to guarantee that the consumer receives what he
desires and that the company makes the profit it
deserves
• maintain monitoring activities on the available
growing literature on concepts, techniques, and
programs related to quality issues, to select the
best ideas and bring them to management’s
attention
• additional functions in product development,
plant sanitation, waste disposal, and research on
processes, equipment, ingredients

14. Significant Aspect of QA is;
• through its functions, upper management is able
to monitor, at all times and through all stages of
manufacturing, the level of quality of its product,
as well as keeping in line with industry trends.
• QA professional is provided with the necessary
independence to be effective in his or her
functions. In turn, the QA professional needs to
be competent and knowledgeable in the various
aspects of the food industry, including regulatory,
processing, sanitation, safety, and human
relations

15. Significant Aspect of QA is;
• the selection, training, and respect given to
QA professionals are very important factors of
the company’s quality program
• The QA department’s personnel should be
considered as in-house consultants, advisors,
and trainers for the company, to help the
production of quality products through audits,
to make recommendations for improvements,
and to provide assistance in making such
improvements

16. QA program is built around three
fundamental functions:
• Quality Control
– A program established around a processing
operation to regulate a resulting product by some
standard, the function of QC is associated with the
production line, i.e., with specific processes and
unit operations. QC activities are the operator’s
tools that help him to maintain a production line
in accordance with predetermined parameters for
a given quality level.

17. QA program is built around three
fundamental functions:
• Quality Evaluation
– Describing or appraising the worth of a product,
quality evaluation generally means taking a
measurement of the product to the QC laboratory
to evaluate the performance of incoming
materials, products in process, or finished
products. The finished product can be evaluated
as offered in the market, ready for the consumer.
This is carried out by product quality audits

18. QA program is built around three
fundamental functions:
• Quality Audits
– Quality audits are programs designed to verify or
examine a product or manufacturing process over
time. These can be classified as manufacturing quality
audits, sanitation/GMPs audits, HACCP audits, product
quality audits, and other special types of audits. A
quality audit is a fundamental part of a QA program. It
allows for quality verification of a product during
manufacture, in the warehouse, in the distribution
system, and in the market to assess performance over
time or for comparison to competitor brands

19. • Each person with responsibility for a portion of
the program should conduct regular assessments
or reviews of the effectiveness of the quality
program and its operation. Such assessments are
a normal part of good process management. In
addition, there should be a systematic review of
the quality program by an authority that is not
directly responsible for the process or its
operations; such a review is a quality audit.
• A quality audit is a planned, systematic
examination of a manufacturing program and its
implementation to determine its adequacy and
the degree of conformance to it. It concentrates
on quality-related aspects of production.

20. Two types of Audit
• An internal
quality audit is
a review
conducted by
employees of
the
organization.
• A third-
party audit is
conducted
by an
outside
organization.

21. Specific Major Functions of the QA Department
include monitoring of:
• Compliance with specifications. Legal
requirements, industry standards, internal
company standards, shelf-life tests, customers’
specifications.
• Test procedures. Testing of raw materials,
finished products, in process tests.
• Sampling procedures and schedules. Suitable
sampling schedules should be used to maximize
the probability of detection while minimizing
workload.

22. Specific Major Functions of the QA Department
include monitoring of:
• Record-keeping and reporting procedures.
Maintenance of all QA records so that customer
complaints and legal problems can be dealt with.
• Troubleshooting. Solution of problems caused by
poor quality raw materials, erratic supplies,
malfunctioning process equipment; investigation
of reasons for poor quality product to avoid
repetition.
• Special problems. Customer complaints
production problems, personnel training, short
courses, etc.

23. A typical QA department may include a
chemistry lab, a raw materials inspection lab, a
sensory lab, and a microbiology lab. All these
disciplines serve to assure that the food
produced is of the highest quality, and will bring
customers back.

24. Other functions of the QA department
• Education and Training
• Process Improvement
• Standards
• Special Projects
• Consulting
• Auditing the Quality Program

25. CAREERS IN QUALITY ASSURANCE
• A Bachelor of Science degree in food science with an
option in QA will give graduates an advantage
• Other college degrees that lead to careers in QA
include those in chemistry, microbiology, and
nutritional sciences
• Master of Science degree program in food
safety/quality assurance. The program, which includes
participation by the departments of biomedical
sciences, consumer studies, environmental biology,
food science, pathobiology, and population medicine,
and the School of Engineering,

26. Careers
• Usually, graduates of university food science
programs hold these positions. In a typical
hierarchy, technicians report to a laboratory
supervisor who in turn reports to the QA
manager.
• In some food companies, the technicians do
not necessarily have college degrees

27. QA careers at the technician level
• Microbiology lab technician. Responsible for the
day-to-day activities in the microbiology lab.
Must be knowledgeable of sterile techniques,
mathematics, and accurate reporting of data.
• Chemistry lab technician. Responsible for the
day-to-day chemical analysis of food in the
chemistry lab. Must have knowledge in basic
chemistry, physics, mathematics, and accurate
reporting of data.

28. QA careers at the technician level
• Inspection lab technician. Knowledge of the
sanitary handling of food samples,
mathematics, and record-keeping.
• Customer service. Responsible for handling
customer complaints and tracking down test
results and product. Must be knowledgeable
of specifications and broad legal
responsibilities. Helps to be people oriented.

29. QA careers at the technician level
• Specifications. Responsible for accurate,
organized record-keeping so that, if needed,
product can be traced and verified.
• Laboratory supervisor. In charge of the lab
personnel and their daily activities.
Responsible for scheduling both personnel
and testing.

30. QA RESPONSIBILITIES AND
OPERATIONAL INTERACTIONS
The delegation of responsibilities within the
food Industry describing the level of
responsibilities and interaction between
operations personnel. The figure shows the
primary functions of marketing, manufacturing,
and QA.

31. senior person
for QA
• Reports directly to upper management, with the same status as the heads
of marketing and manufacturing
plant QC managers
• Report to the director of QA, with close functional ties with plant
managers
• QA experts recommend that plant laboratories report directly to QA
rather than to production. Why?
food scientists in the
plant QC laboratories
• Bear the responsibility of maintaining a steady output of quality products
• much responsibility as possible should be delegated to the laboratories.
Not only are these groups closer to the quality problems

32. The director
of QA
• incharged with exercising tight control
over all aspects of quality. His or her
accepted duties include the approval of
all product labels, packaging, product
specifications, special releases of
products, and data sheet
Important
Points
• If no decisive measures are taken to
enforce specific objectives of
manufacturing and their control, a QA
program will remain a well-meaning but
ineffective body of rhetoric.

33. Important
points
• If no decisive measures are taken to enforce
specific objectives of manufacturing and their
control, a QA program will remain a well-meaning
but ineffective body of rhetoric.
• Procedures should be stated in a concise form,
pinpointing job assignments and with the means
for communication within the organization
• A realistic appraisal should be made of
business needs and the resources and
manpower available for meeting these
demands. A valuable tool would be a
QA manual, comprising these
procedures, to be distributed to all
supervisory personnel

34. The basic responsibilities of a QA department are recording and
reporting the results from
Line inspection and control of:
a. Supplies, ingredient materials, and raw products
b. Operating procedures
c. Finished products
Physical evaluation and qualification of raw and processed
products, and ingredients
Chemical evaluation of raw and processed products, and
ingredients

35. The basic responsibilities of a QA department are recording and
reporting the results from
Microbiological evaluation of raw and
processed products, and ingredients
Warehousing conditions for shelf-life
time, temperature control,
and handling procedures
Sanitation control of products,
processes, and storage

36. The basic responsibilities of a QA department are recording and
reporting the results from
Waste disposal control
Compliance with Federal, State, and
Municipal requirements and
standards
Specification compliance during marketing
and distribution for consumer confidence
and assurance of the integrity of the product
and company

37. Additional responsibilities include.
Training, problem solving, development
of test and operational procedures, occupational safety
and health
regulations, and special research development projects
The most important responsibility of the QA
professional is that of a team player as well as being a
leader in the efficient production of a quality product

38. ORGANIZATION OF A QA PROGRAM
• The organization of a QA program is the first step that must be
carefully considered. Upper management must support the
program and the QA department should be directly responsible to
upper management.,
• It is necessary for the QA professional to provide each of the other
departments with specific information regarding quality at the
receiving platform, or on the line, or even in the warehouse; but he
should not be responsible to these groups as such.
• Management — rather than any of the departments within the
company — must make the decision between quality and quantity.
The QA professional should, however, have the authority from
management to work closely with production to maintain
operations so that the product being packed at all times meets the
desired standards.

39. QA PERSONNEL
products being
packed
the amount of
control desired
by management
the size of the
operation

40. Some qualifications of QA personnel are:
1. Honesty. Truthfulness in reports, in decisions, and above all, in
analysis
2. Salesmanship
3. Ability to speak the industry’s language and write intelligently
4. Cooperative spirit (a team player)
5. Alertness and responsiveness to necessary changes
6. Courteous and neat in appearance
7. Reliable
8. Adequately trained
9. Ability to instruct production employees as to:
a. What is to be done
b. How it is to be done
c. Why it must be done

41. The Vice President of QA
The vice president of QA should report to the president and
should have a strong voice in selecting the QC staffs. This will
prevent the problem of plant managers making QC
appointments
• To serve as a key guidance for quality matters, corrective
actions, and continual improvement activities
• To formulate and recommend the company’s policies,
strategies, tactics, and goals relating to quality
• To review and help coordinate quality aspects of
production plans
• To assist and counsel division managers on quality matters

42. The Vice President of QA
• To exercise authority over QC groups in the
divisions
• To concur with the appointment of the division
QA directors
• To serve as a resource for information on quality
issues, including competitive information
• To foster awareness of quality and help to gain
credibility for quality improvement efforts
• To monitor quality and report to top
management

43. The Vice President of QA
• To coordinate efforts of standards
committees, quality improvement teams, and
other groups whose activities touch on quality
matters
• To interface on quality matters with external
organizations, including government agencies
and professional organizations
• To provide leadership for the company’s
quality effort as necessary

44. The Vice President of QA
• Maintain high professional standards for
managing quality organizations or groups
• Provide education and training relating to
quality
• Implement quality programs, projects,
procedures, and information systems
• Recommend employee recognition programs
• Foster development and use of standards

45. The Vice President of QA
• Promote and conduct special studies of tools,
techniques, and procedures that might
improve quality
• Promote appropriate and effective quality
audits
• Assess the enterprise’s quality relative to
competitors
• Recommend appropriate corrective actions