QUALITY ASSURANCE

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

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)

Sample Organizational Chart

A Vice President for QA is chargedwith specific responsibilities that include:

Serving as a focal point for quality matters, including corrective action and continual improvement activities

Formulating and recommending 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

Coordinating the efforts of standards committees,

quality improvementteams, and other groups whose activities touch on

the qualityarea

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.

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.

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

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.

• 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

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.

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

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

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

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

QA program is built around threefundamental 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.

QA program is built around threefundamental 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

QA program is built around threefundamental 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

• 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.

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.

Specific Major Functions of the QA Departmentinclude 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.

Specific Major Functions of the QA Departmentinclude 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.

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.

Other functions of the QA department

• Education and Training• Process Improvement• Standards• Special Projects• Consulting• Auditing the Quality Program

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,

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

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.

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.

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.

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.

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 theplant 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

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.

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

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 productsb. Operating proceduresc. Finished products

Physical evaluation and qualification of raw and processed products, and ingredients

Chemical evaluation of raw and processed products, and ingredients

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

The basic responsibilities of a QA department are recording and reporting the results from

Waste disposal control

Compliance with Federal, State, and Municipal requirements andstandards

Specification compliance during marketing and distribution for consumer confidence and assurance of the integrity of the product and company

Additional responsibilities include.

Training, problem solving, developmentof test and operational procedures, occupational safety and healthregulations, 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

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.

QA PERSONNEL

products being packed the amount of

control desired by management

the size of the operation

Some qualifications of QA personnel are:

1. Honesty. Truthfulness in reports, in decisions, and above all, in analysis2. Salesmanship3. Ability to speak the industry’s language and write intelligently4. Cooperative spirit (a team player)5. Alertness and responsiveness to necessary changes6. Courteous and neat in appearance7. Reliable8. Adequately trained9. Ability to instruct production employees as to:

a. What is to be doneb. How it is to be donec. Why it must be done

The Vice President of QAThe 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

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

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

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

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