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THE ROLE OF QUALITY ASSURANCE IN FOOD PLANT SANITATION
CHAPTER 22
THE ROLE OF QUALITY ASSURANCE IN FOOD PLANT SANITATION Quality assurance personnel are generally assigned the responsibility of food plant inspection and overall control of food plant sanitation in a food plant. These are duties beyond the evaluation of incoming materials for compliance to specifications, for product control during the processing, and for the actual audit of all finished products for conformance to requirements. These responsibilities are of major significance in the total quality assurance program of a food company. Part 110.80 of the CGMP's covers quality control operations for food and food packaging operations. The rule requires food firms to adhere to adequate sanitation principles in all of the production procedures, including receiving, inspecting, transporting, preparing, manufacturing, packaging, and storage of foods. Someone must be assigned this responsibility and it usually falls to the Quality Assurance Manager or his Associates. The general rule is that "all reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source". To meet this rule, food firms must periodically evaluate their products for chemicals, microbial, or extraneous material contamination. If any food material is found contaminated, the manufacturer must determine whether the contamination renders the food "adulterated" within the meaning of the FDC Act. If the food is adulterated, it must either be rejected or reprocessed to eliminate any contamination. A contaminated batch may not be blended with uncontaminated batches, even if the final product would not be excessively contaminated.
274
CGMP'S/FOOD PLANT SANITATION
All raw materials must be inspected to ensure that they are clean and suitable for processing, and must be properly stored to avoid contamination and minimize deterioration. Part 110.80 (a) states that water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. The water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Part 110.80 (b) primarily details the means by which a manufacturer may prevent or minimize the growth of unwanted microorganisms in food. The rule recommends that manufacturers monitor such factors as time, temperature, humidity, a sub W, pressure, flow rate, and pH to ensure that mechanical breakdowns, delays, and temperature fluctuations do not contribute to the decomposition or contamination of food. Details relative process conditions are also spelled out in this section of the rule. Most importantly, the rule, part 110.80 (13) (i) states "use of quality control operation in which the critical control points are identified and controlled during manufacture". This is what modern Total Quality Assurance is all about. Total Quality Assurance is the modern term used by many food firms to assure management of the quality of incoming materials, materials in process, and the qualities of all finished products as well as products in the marketing channel. Total quality assurance is an umbrella term to cover the major aspects of quality assurance, that is, control, evaluation, audit, and activities such as R&D, food plant sanitation, and trouble shooting. The quality assurance department's primary function is to provide confidence for management and the ultimate consumer that the product and processes are what the firm has specified. A firm is in business to produce products--intended for sale to customers--from which the firm hopes to make a profit. The key word is the customer. The customer is the one a firm must satisfy and it is the customer who ultimately establishes the level of quality the firm manufactures. The customer is management's guide to quality and this is what the firm builds its specifications around and the label requirements. The firm must keep the customer satisfied if they expect to build repeat business.
THE ROLE OF QUALITY ASSURANCE
275
Quality assurance has the responsibilities to see that the customer is satisfied. Quality assurance does this by building a control program and regulating all processes to given standards of performance. These standards become very specific for each unit operation in the process.
-
FIGURE 22.1 Quality Assurance Personnel Establish The Paremeters Of Operation With The Line Operator
A second major responsibility of the quality assurance program is to evaluate the entire operation. That is, they must appraise the worth of all incoming materials, materials in process, and all finished products. Appraisal includes both subjective or sensory evaluation and objective evaluation or physical, chemical and microbiological testing for the various characteristics or attributes of the product, processes, personnel, equipment, facilities, etc.
276
CGMP'SlFOOD PLANT SANITATION
A third responsibilities of the quality assurance department is the actual audit of the firm's product in the warehouse, in the marketing channels, competing products, and the firm's product during its shelf life. Auditing includes compliance with label requirements, nutritional data in some cases, safety, and overall product quality. Techniques are similar to those used in product evaluation, that is, subjective and objective measurements. A fourth responsibility of the quality assurance department may include trouble shooting, research and development, waste disposal, and the many details of food plant inspection and food plant sanitation. Thus, the quality assurance personnel provide much valuable information and assistance to the success of any food firm. They have been aptly called the nerve center of the food operation as they do provide a constant flow of information to keep the firm and its personnel '*in the know" and "on the grow". Quality assurance personnel generally have training in chemistry, microbiology, engineering, as well as processing and technology pertaining to specific commodities. Graduate level quality assurance personnel may have extensions of the above basic areas and they should have a thorough understanding of research, that is, how to organize and conduct scientific studies to solve problems. Most graduate quality assurance personnel should be thoroughly knowledgeable about sanitation and the CGMP's. All quality assurance personnel must be able to communicate well, that is, they must be able to write, speak, and visualize solutions to problems and communicate this information to personnel so that they can comprehend the what, how and why of the situation. Quality assurance personnel should be part of the management team. They should be responsible for determining the process capabilities of the entire operation by each individual unit operation, they should be capable of planning the total quality assurance program, that is, the control, evaluation and audit of the process operations and all the products from receiving to warehousing. They should evaluate all raw ingredients and foods in process and be capable of handling complaint data and pinpoint it to time of production from their records and take corrective actions. They must be able to generate the cost of
THE ROLE OF QUALITY ASSURANCE
277
quality and the price of non-conformance. Further quality assurance personnel must provide feed back information to management and all production personnel. Quality assurance personnel must know how to solve problems through the use of cause and effect diagrams, process flow diagrams, statistical techniques, control charts, and Pareto principles. They must be able to identify problems, determine the cause, solutions for the causes, and how to control the process. Quality assurance personnel must know the latest in quick methods for determining product quality and how to conduct inspections to eliminate hazards in the plant. They must know the critical control points of the entire operation and they must be capable of controlling all critical control points to eliminate any potential problems in the process or of the products. Quality assurance personnel must be capable of carrying all of the above and the food plant inspections and they must be the spokes person on all sanitation and quality problems for the firm. They have mqjor responsibilities in the success of any food firm. REFERENCE Gould, Wilbur A. and Gould,Ronald W. 1988 Total Quality Assurance for the Food Industries. CTI Publications, Inc. Baltimore, Md.
THE ROLE OF QUALITY ASSURANCE IN FOOD PLANT SANITATION Quality assurance personnel are generally assigned the responsibility of food plant inspection and overall control of food plant sanitation in a food plant. These are duties beyond the evaluation of incoming materials for compliance to specifications, for product control during the processing, and for the actual audit of all finished products for conformance to requirements. These responsibilities are of major significance in the total quality assurance program of a food company. Part 110.80 of the CGMP's covers quality control operations for food and food packaging operations. The rule requires food firms to adhere to adequate sanitation principles in all of the production procedures, including receiving, inspecting, transporting, preparing, manufacturing, packaging, and storage of foods. Someone must be assigned this responsibility and it usually falls to the Quality Assurance Manager or his Associates. The general rule is that "all reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source". To meet this rule, food firms must periodically evaluate their products for chemicals, microbial, or extraneous material contamination. If any food material is found contaminated, the manufacturer must determine whether the contamination renders the food "adulterated" within the meaning of the FDC Act. If the food is adulterated, it must either be rejected or reprocessed to eliminate any contamination. A contaminated batch may not be blended with uncontaminated batches, even if the final product would not be excessively contaminated.
274
CGMP'S/FOOD PLANT SANITATION
All raw materials must be inspected to ensure that they are clean and suitable for processing, and must be properly stored to avoid contamination and minimize deterioration. Part 110.80 (a) states that water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. The water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Part 110.80 (b) primarily details the means by which a manufacturer may prevent or minimize the growth of unwanted microorganisms in food. The rule recommends that manufacturers monitor such factors as time, temperature, humidity, a sub W, pressure, flow rate, and pH to ensure that mechanical breakdowns, delays, and temperature fluctuations do not contribute to the decomposition or contamination of food. Details relative process conditions are also spelled out in this section of the rule. Most importantly, the rule, part 110.80 (13) (i) states "use of quality control operation in which the critical control points are identified and controlled during manufacture". This is what modern Total Quality Assurance is all about. Total Quality Assurance is the modern term used by many food firms to assure management of the quality of incoming materials, materials in process, and the qualities of all finished products as well as products in the marketing channel. Total quality assurance is an umbrella term to cover the major aspects of quality assurance, that is, control, evaluation, audit, and activities such as R&D, food plant sanitation, and trouble shooting. The quality assurance department's primary function is to provide confidence for management and the ultimate consumer that the product and processes are what the firm has specified. A firm is in business to produce products--intended for sale to customers--from which the firm hopes to make a profit. The key word is the customer. The customer is the one a firm must satisfy and it is the customer who ultimately establishes the level of quality the firm manufactures. The customer is management's guide to quality and this is what the firm builds its specifications around and the label requirements. The firm must keep the customer satisfied if they expect to build repeat business.
THE ROLE OF QUALITY ASSURANCE
275
Quality assurance has the responsibilities to see that the customer is satisfied. Quality assurance does this by building a control program and regulating all processes to given standards of performance. These standards become very specific for each unit operation in the process.
-
FIGURE 22.1 Quality Assurance Personnel Establish The Paremeters Of Operation With The Line Operator
A second major responsibility of the quality assurance program is to evaluate the entire operation. That is, they must appraise the worth of all incoming materials, materials in process, and all finished products. Appraisal includes both subjective or sensory evaluation and objective evaluation or physical, chemical and microbiological testing for the various characteristics or attributes of the product, processes, personnel, equipment, facilities, etc.
276
CGMP'SlFOOD PLANT SANITATION
A third responsibilities of the quality assurance department is the actual audit of the firm's product in the warehouse, in the marketing channels, competing products, and the firm's product during its shelf life. Auditing includes compliance with label requirements, nutritional data in some cases, safety, and overall product quality. Techniques are similar to those used in product evaluation, that is, subjective and objective measurements. A fourth responsibility of the quality assurance department may include trouble shooting, research and development, waste disposal, and the many details of food plant inspection and food plant sanitation. Thus, the quality assurance personnel provide much valuable information and assistance to the success of any food firm. They have been aptly called the nerve center of the food operation as they do provide a constant flow of information to keep the firm and its personnel '*in the know" and "on the grow". Quality assurance personnel generally have training in chemistry, microbiology, engineering, as well as processing and technology pertaining to specific commodities. Graduate level quality assurance personnel may have extensions of the above basic areas and they should have a thorough understanding of research, that is, how to organize and conduct scientific studies to solve problems. Most graduate quality assurance personnel should be thoroughly knowledgeable about sanitation and the CGMP's. All quality assurance personnel must be able to communicate well, that is, they must be able to write, speak, and visualize solutions to problems and communicate this information to personnel so that they can comprehend the what, how and why of the situation. Quality assurance personnel should be part of the management team. They should be responsible for determining the process capabilities of the entire operation by each individual unit operation, they should be capable of planning the total quality assurance program, that is, the control, evaluation and audit of the process operations and all the products from receiving to warehousing. They should evaluate all raw ingredients and foods in process and be capable of handling complaint data and pinpoint it to time of production from their records and take corrective actions. They must be able to generate the cost of
THE ROLE OF QUALITY ASSURANCE
277
quality and the price of non-conformance. Further quality assurance personnel must provide feed back information to management and all production personnel. Quality assurance personnel must know how to solve problems through the use of cause and effect diagrams, process flow diagrams, statistical techniques, control charts, and Pareto principles. They must be able to identify problems, determine the cause, solutions for the causes, and how to control the process. Quality assurance personnel must know the latest in quick methods for determining product quality and how to conduct inspections to eliminate hazards in the plant. They must know the critical control points of the entire operation and they must be capable of controlling all critical control points to eliminate any potential problems in the process or of the products. Quality assurance personnel must be capable of carrying all of the above and the food plant inspections and they must be the spokes person on all sanitation and quality problems for the firm. They have mqjor responsibilities in the success of any food firm. REFERENCE Gould, Wilbur A. and Gould,Ronald W. 1988 Total Quality Assurance for the Food Industries. CTI Publications, Inc. Baltimore, Md.