Chemical Quality Assurance

Module 1. Introduction to chemical quality assurance

Lesson 1
CONCEPT AND IMPORTANCE OF CHEMICAL QUALITY CONTROL IN DAIRY INDUSTRY

1.1 Introduction

The Indian Dairy Industry has acquired substantial growth in the recent years. Milk group contributes highest to the total output of the agricultural sector. Despite all these facts, we are not able to make a dent in the international market. Our export is still far- far below than the countries, whose milk production is less. The obvious reason for this is the quality of our raw milk and thereby the quality of the finished products. Most of the dairy plants are still sticking to the old system maintaining their quality, without considering the developments made in the tools to attain a consistent quality of any food product. Rising liberalization of agro-industrial markets and the world-wide integration of food supply chains require new approaches and systems for assuring food safety. At present, concern over food safety is at an all-time high. In response, the public and the private sector have developed new process standards and require suppliers of food products to follow them. Both, the market and legislations in importing countries demand for comprehensive and transparent schemes reaching from “farm to fork” and “boat to throat” Organizations in the food sector will need to manage risk, demonstrate good corporate responsibility and meet legal requirements if they are to remain competitive, protect their reputation and enhance their brand. Hence, quality management tools like Hazard analysis and critical control points (HACCP), ISO 22000:2005 - Food Safety Management Systems, Six Sigma etc are very much relevant in the present era of Globalization and aware consumers.

1.2 Importance of Chemical Quality Control In Dairy Industry

Milk is a highly perishable commodity. This perishable character of milk makes the life tough for the milk handlers, especially in the absence of proper infrastructure of cooling and erratic power supply. Since, dairy animals are fed on agricultural byproducts and crop residues, therefore the contaminant present in the animal get secreted along with milk in the form of pesticide and veterinary drug residues. These contaminants not only affect the health of the consumers, but also the quality of the products especially fermented products. Moreover, some of the unscrupulous persons involved in this trade are further tarnishing the image of Indian dairy industry by adulterating milk with various chemicals, which are injurious to health. In the wake of all these facts, quality control of milk assumes very high importance and priority. The chemical quality control in dairy industry will enable the industry in the following ways:

• The strict quality control both chemical and microbiological will deter the adulteration of milk and will improve the quality of raw milk.
• The improvement of the raw milk quality through regular checks can improve the quality of the milk products prepared from such milk.
• It will install the confidence in national consumers, who are drifting away from the indigenous milk products.
• It will also increase the export potential of Indian milk products, and finally the National image with reference to Indian milk quality.
• The strict quality control will also increase the revenue of a dairy producer.

1.3 Quality Control and Quality Assurance

As per ISO: 8402 (1994): Quality is the totality of features and characteristics of a product or service that bear (determine) on its ability to satisfy stated or implied needs (requirements)”

Quality α 1/variability

“Quality control (QC) involves the set of activities used to ensure that the products and services meet / fulfill requirements for quality”

Traditionally Q.C is a laboratory function only and is related to analysis of samples i.e testing and judging of raw materials/ and finished products for acceptance or rejection.

1.3.1 Purpose & aim

To ensure that products are within the well defined and accepted standards thereby protecting the legal and health rights of consumers and financial interests of producers / manufacturers.

1.3.2 Limitations

Recall of products is more because products are tested in the last stage or as finished products. This ultimately wears the impact on reputation of the company.

“Quality assurance (QA) is the set of activities which ensures that the quality levels of products and services are properly maintained and that the supplier and customer quality issues are properly resolved”

Quality assurance gives adequate confidence that product or service will satisfy given requirements for quality.

1.3.3 Purpose/Aim

1.3.3.1 Internal purpose

Within an organization QA provides confidence to the management.

1.3.3.2 External purpose

Outside the organization provides confidence to consumers or others. Compared to QC, QA is much wider in the sense, it demands full control over the quality of raw materials, control over the process at different levels and control over distribution set up etc.

Notion is that “Prevention rather than Detection”. It is a proactive approach rather than a reactive approach.

OBJECTIVES AND IMPORTANCE OF QUALITY ASSURANCE

—To maintain legal standards and legal requirements
—To fulfill customer’s requirement in terms of various attributes

• Physical (body, texture, colour, etc)
• Chemical composition
• Microbiological
• Safety
• Consumers should get what they pay for
• This leads to increased consumer satisfaction and less complaints

—To check adulteration in incoming material in order to prevent substandard product, hazards or problems in the process
—To check efficiency of processes: heating, cooling, removing hardness from water, effluent treatment etc
—To safeguard nutritive value of milk and milk products
—To check wastage of material
—To help in research and developments
—To ensure general cleanliness and sanitation in factory premises

BENEFITS

• Reduction in unit cost of production
• Reduction in wastage and scrape
• Less complaints from customer
• Avoids repeated inspection
• Increases production since rejection reduces
• Efficiency of unit goes up
• Management gets proud place in society
• Boost employee’s morale
• Reduction in production bottlenecks

ROLE OF QUALITY ASSURANCE DEPARTMENT

• Sanitation- defines requirements for cleaning and sanitary activity and their monitoring
• Sanitation standard operating procedure (SSOP)
• Standard operating procedure (SOP)
• Good manufacturing practices (GMP)
• Foreign material control
• Quality control- Chemical and Microbiological testing
• Documentation control
• Pest control
• Hazardous material control
• Allergen Protocol for controlling allergenic material
• Record control- identification and maintenance
• Calibration
• Water quality and water treatment programmes
• Sensory training and sensory evaluation
• Supplier certification and ongoing supplier evaluations
• Receiving, storage and control of raw ingredients and packaging material
• Control of non-conforming product and process
• Product identification traceability and Product recall
• Handling customer’s complaints
• Labeling- application and control of labels
• Preventive maintenance
• Formalized management review process
• Waste water (effluent treatment programme)
• Training
• Corrective/preventive action- root cause analysis and follow up evaluation to confirm effectiveness of action taken
• Internal auditing

Why focus on quality?

1. Globalization/ liberalization

Globalization has changed the way businesses are done. Availability of the number and variety of products has increased in the market. After the liberalization (after 1991) in India several players including multinationals have entered into food business. This has increased the level of competition. If one has to sustain the competition he can’t do so with the substandard products.

2. Technological advances in food processing (e.g. Nanotechnology, Genetic engineering)

The applications of modern science and biotechnology for food production and genetically modified foods and crops have presented novel opportunities and made enormous contributions in agriculture and food production. Certain technological development has also posed risks to food safety due to insufficient knowledge. Like Genetically modified organisms (GMO)/ Genetically modified foods and use of Nano technology for food production. These technologies are controversial and a cause of concern since we still have limited knowledge of their impact on human health for current and future generations and on natural ecosystems.

Advancement of technology has also affected food safety in positive manner. Development latest instruments like biosensors, Nano Sensors in Pathogen detection and various chromatographic techniques which helps in identifying food safety hazards.

Several advances made in the areas like maintaining nutritional quality, increasing the shelf life of foods, better transportation and storage facilities, better packaging materials etc. has potential to enhance the safety and quality of food.

Emergence of functional food is also an area which can affect the food safety. Due to their diversity all functional foods require a case by case evaluation for their safety.

3. New hazards and concerns

Furthermore, higher levels of environmental pollution in our soil, water, and air are increasing the presence of contaminants such as toxic metals, dioxins, and polychlorinated biphenyls (PCBs) in food. Also, several substances designed to increase overall food production, such as insecticides, veterinary therapeutics, and hormones, are affecting the quality and content of food being produced, often with poorly understood long-term consequences.

In addition certain hazards like Bisphenol A in certain packaging materials (e.g. polycarbonate), E.coli 0157:H7, trans fat in formulated foods, acrylamide in fried products, fungal toxins like aflatoxin can affect food safety adversely and hence endanger quality of food.

4. Increased consumer awareness

Due to increased level of literacy and better communication facilities consumer has become aware and conscious about the quality and safety of food he consumes. Healthy, nutritious, safe and better quality products are therefore the need of the hour.

5. Stricter regulatory frame works

Regulatory bodies of the worlds including India are becoming stricter and science based. This has led to adoption of better processing technologies and measures which ensures good quality food to the consumers by food processor. New laws are passed considering new threats to the food safety and changed nature of food business worldwide.

Evolution of Quality Concept

Historically control of quality in food parallels the history of food production. From the earliest beginnings every food manufacturer, handler and consumer attempted to evaluate and control the quality of the food he used. Initially various attributes of quality were measured and decisions made on the basis of sensory evaluation. With development of chemical and instrumental methods for evaluating food quality and statistical methods for interpretation of results, work in the area of quality control expanded. Now quality control has grown as a distinct discipline. All concepts of quality, emerged over a period of time are presented below in a chronological order.

Craftman (<1900)

• Inspection of a product was not distinguished from the task of producing it.
• Each craftman was inspecting his own work to avoid customer’s complain.

Operator (1900 – 1910)

• Due to industrial revolution machines were employed for the production and craftman became operator of the machine.
• Since the machines were not able to inspect its own output, the operator became the inspector of the quality.

Foreman (1910 – 1920)

• When there were several machines & operator foreman (supervisor) was appointed for supervision of the production work.
• It became the responsibility of a foreman to inspect and decide the quality.

Inspection (1920 – 1940)

• During this era, responsibility for judging the quality was given to inspector.
• There was little or no planning for determining whether the product was right or not.
• Term often used hundred percent (100%) which meant differently to different people.

Statistical Quality Control (SQC)

• During the World War II, there was a tremendous requirement for mass production of weapons and other materials, which necessitated the concept of Quality control by making use of statistical tools. This use of statistical tools in controlling the processes was termed as Statistical Quality Control.
  
• This was an extension of the inspection phase where inspectors provided with a few statistical tools, such as sampling plans & control charts.
• The most significant contribution was sampling inspection, rather than total inspection.
• It is the collection, analysis and interpretation of data to solve a particular problem.
• SQC concept provides a basis for determining a good or acceptable process behavior model
• Any deviation from the model can be traced, identified & eliminated from a process, so that it continues to produce product of acceptable quality.

Deming’s Philosophy: Adward Deming proposed his concept of quality assurance. According to which, it involves both process monitoring and eliminating the causes of unsatisfactory performance at all stages.

• It is the name given to entire cycle of activities through which the fitness for use of process, product or service is achieved, with a view to carry out a company’s quality function in accordance with the laid down quality objective and policies.
• has divided quality control into four activities i.e.

1) Plan 2) Do 3) Check and 4) Act. Which is known as Deming’s PDCA cycle/wheel.

Plan

• Establish goals
• Standardize working procedures
• Train employees

Do

• Carry out the work according to plan

Check

• Verify for compliance with the plan

Act

• In case of non-compliance, find out and remove its root cause(s)
• The Deming’s PDCA cycle applies to all situations and area where “quality control’ is needed (wanted).
• It is the universal model and covers all activities relating to “Quality Control” , “Quality Assurance” as well as “Quality Improvement”.

Quality Control (QC)

During the passage of time a separate ‘Quality control department’ came into existence in each factory

• The QC department devoted itself primarily to quality functions.
• Role of QC department was to examine the finished product with a view to verify whether it fulfilled requirements for quality or not.

Total Quality Control (TQC)

• Quality functions cannot be truly achieved by QC department alone
• The department depends on the help rendered by almost all other departments of the company to achieve the goals

—Field force determines the quality needs of the consumers (users)
— The research and development department creates a product concept which can meet these needs
—Chemist or design engineer than prepare product and material specifications suitable for the required quality and specify procedures and instruments to measure the quality
—Purchase department procured material of the right quality
—Plant operators use the processes and equipments to manufacture product
—Inspectors measure the quality attributes and determine fitness of the product for use.
—Sales department market the product and take care at pre-sale stage, on-sale stage and after sale stage.
—Field force gives consumers’ reaction, i.e. it creates opportunities for the product improvement which in turn restarts the whole cycle of activities.

• TQC is an integrated organizational approach to delight customers by meeting their expectations on a continuous basis through involvement of everyone in the organization.
• It is an effective system of integrating quality development, quality maintenance and quality improvement efforts of various groups in an organization so as to provide product or service at the most economical levels and which meet full customers’ satisfaction.
• It helps in minimizing rejection and rework.

Quality Assurance (QA)

• ISO:8402 (1994)- it comprises the planned and systematic activities implemented within the quality system to provide adequate confidence that a given entity (process/product/service) will fulfill requirements for quality
• All QA activities serve to build confidence internally among the management of organization and externally among its customers and authorities.
• To build confidence quality assurance has to be built into the process; which includes creating records, documenting plans, documenting specifications and reporting reviews.

Such activities and documentation serves to control quality as well as assure it.

Total Quality Management (TQM)

• TQM may be defined as an integrated organizational approach in delighting customers by meeting their expectations on a continuous basis through everyone involved with the organization working on continuous improvement in all spheres namely-process, products and service along with proper problem solving methodology.
• Tools = SQC, QC, TQC, QA : often solve problem in one area of business such as quality of supply or excellence in manufacturing
  So what is required is ?

—a process designed to focus on customer expectation
— preventing problems
—building commitment to quality in workforce
—promoting open decision making

• TQM is a journey- it is the path as well as the goal.

Basic principles of TQM

—Be customer focused – place the customer at the centre of everything you do
—Do it right first time and every time- quality first and always
— Continuous improvement – by using the tool of PDCA in every aspect of work
—Communicate and educate

• Improve communication means tell the people what is going on
• Educate- train the people and retain them

—Measure and recorded

• While finalizing the goals, the Quality indicators (measurements) should be finalized.
• Record the measures as per prescribed documentation
• It allows the company to make decisions based on facts, not opinion.

—Do it together- introduce team working

• Reduces conflict and in-fighting and increases trust and respect
• Bitting problems with wider range of skill – therefore better and more balance solution

Elements of TQM and Integrated TQM Model

The TQM model has three major area

Total Employee Involvement (TEI)

• Include- transformation, Kiazen (small improvement), Hoshin Kanri (Policy development), small group activity, etc.

Total Waste Elimination (TWE)

• Include the concept of segregation, arrangement, cleanliness, maintenance or standard and discipline for everything (men and material) i.e. house Keeping.
• Follow the principle of JIT (Just-In-Time), so minimum inventories are maintained.

Total Quality Control (TQC)

• Include – SQC, PDCA cycle, HACCP, QSM (ISO-9000)

Benefits of TQM

• TQM can bring several benefits for consumers, company and employee, if implemented properly.

For customers

• Greater care
• Value for money
• Greater satisfaction
• Better availability
• Result in better customer loyalty.

For company (organization)

• Continuous improvement in quality
  
• Better motivated work force
• Defects are reduces
• Reduction in cost
• Increase in productivity
• Faster solution of problems

Result in increased cash flow and net profit

For employees

• Empowerment
• More respect
• More training and better skill
• Appreciation and recognition
• Work satisfaction