CAE 308 Food Quality Management
UNIT-1: QUALITY AND QUALITY MANAGEMENT: Quality- Definition, Historical Perspective, Quality in different areas of society, Terminology of Quality, Basic tools of Quality, Quality Management- Importance, Principle, Processes, Requirements, Implementation & Certification of a QMS.
1.1 Quality
The Oxford American Dictionary defines quality as “a degree or level of excellence.” According to Garvin – Quality is an unusually slippery concept, easy to visualize and yet exasperatingly difficult to define. The word ‘quality’ normally conveys notions of nebulous factors that are not readily measured or tied down. Quality conveys a positive connotation to whatever it is applied The standard of something as measured against other things of a similar kind; the degree of excellence of something.
Concept of quality – historical background
The concept of a quality as we think of it now first emerged from the Industrial Revolution. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet ‘quality criteria’.
Quality, as a profession and the managerial process associated with the quality function, was introduced during the second half of the 20th century and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession.
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1.2 Terminology of Quality Management
• The field of quality management has its own set of terminology that includes many acronyms. Here’s a list of some common terms, along with definitions, to help you navigate the world of operational excellence.
• Advanced Product Quality Planning (APQP): Processes and Procedures, as part of the AIAG (Automotive Industry Action Group) industry best practices, put in place to ensure product design integrity throughout the manufacturing process. Find out more by watching our APQP webinar.
• Corrective and Preventive Action (CAPA): A process of identifying the root cause of problems identified in the nonconformance process, as well as the definition of the initial issue correction, and finding a way to prevent future occurrences. Learn more.
• Change Management: Robust process to guarantee controls in place to maintain change process integrity, authorization, and traceability with process and documentation changes.
• Complaint Management: The process of logging, analysing, reporting, and responding to customer criticisms, as well as determining whether a regulatory filing is required. Read more on our Evaluation Page.
• Corrective Action Management: The method of taking steps to address nonconformances in the production process.
• Document Control and Management: The process of tracking, maintaining version control of, and storing documents to ensure document integrity through approvals and change management. Document Control is also a key component of Training Compliance Management. Explore the offering on our Support Page.
• Enterprise Quality Management Software (EQMS): End-to-end enterprise-wide quality management software, including full integration of applications that standardize and optimize production processes to help manufacturers optimize quality, minimize manufacturing interruption, and improve manufacturing margins as well as comply to industry requirements and regulations. Explore the QAD CEBOS suite of EQMS products.
• Gauge Management: Tracking and reporting the accuracy of a company’s gauge calibrations to guarantee inspection accuracy and reduce escaped defects. Read about QAD CEBOS Gauge Calibration and Management products on our Operations Page.
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• Hazard Analysis and Critical Control Points (HACCP) Software: A solution that takes a preventative approach to food safety during the production process.
• International Automotive Task Force (IATF) 16949: An automotive original equipment manufacturer (OEM) industry requirement that establishes global quality standards. Take a deeper dive into the need for IATF standards in our blog.
• International Organization for Standardization (ISO) Standards: Worldwide process best practices for industrial and commercial production that are set by ISO, a global quality organization.
• ISO 9000/9001: International standards for quality management and assurance that specify the elements needed to enforce quality standards in any industry. Read our blog on ISO 9000 Standards.
• ISO 13485: Specifies the quality management system requirements for companies in the medical device manufacturing industry.
• ISO 17025: Outlines the requirements a laboratory needs to meet to demonstrate competence in calibration and testing.
• Layered Process Audit (LPA): A frequency and outcome-based proactive process-based method of conducting internal audits so companies can ensure that they are meeting quality management standards. Learn more about how QAD CEBOS supports LPAs.
• Materials Management Operations Guidelines (MMOG): MMOG/LE defines a global set of industry best practices for supply chain management and allows an organization to assess their internal processes and implement, verify, and track the resulting improvement.
• MQ1: QAD CEBOS’ suite of enterprise-wide quality management software that automates business processes and integrates data.
• New Product Introduction (NPI) or New Product Launch (NPL): Software that allows for the updating and revision of the product design, accelerating the design, development, and launch of a new or improved product while reducing costs and improving quality. Get the details on the QAD CEBOS approach to NPI. Watch our APQP webinar.
• Nonconformance Report (NCR): A document that records a problem with quality and the resulting corrective action that was taken, as well as steps taken to prevent the problem from happening again.
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• Production Part Approval Process (PPAP): A system put in place to ensure that suppliers produce quality products, particularly in the automotive manufacturing industry, and demonstrate good manufacturing practices (GMP). Check out the features of QAD CEBOS PPAP.
• Process Adherence: A group demonstrates with evidence that they understand and follow standards for business processes that ensure quality and consistency.
• Process Compliance: People in an organization follow governance and regulatory requirements.
• Process Audit: Evaluating outcomes to determine if production processes are being managed effectively enough to ensure quality.
• Quality Management System (QMS): A set of policies and procedures required for design, development, and production that ensure operational excellence and customer satisfaction. Explore the full range of QAD CEBOS QMS products.
• Quality Management Standards: Guidelines and requirements that ensure products consistently meet an expected level of quality based in ISO, AIAG, VDA MMOG/LE guidelines.
• Quality Process Compliance: Meeting the standards that external regulatory organizations set for product quality. Learn the steps to take to meet quality compliance in our blog.
• Risk Management: Identifying, evaluating, and prioritizing potential problems and mitigating actions so processes can be put in place to prevent product nonconformity. Find out more about how QAD CEBOS helps clients with Risk Management.
• Six Sigma: A method for improving processes to boost productivity and encourage consistency that was devised by engineer Bill Smith at Motorola and championed by Jack Welch at GE.
• Software Validation Procedure: A method of ensuring that an application fits its purpose, reducing risk and liability for the developer.
• Statistical Process Control (SPC): Using analytics to monitor and track the production process to ensure manufacturing within specification and identify issue trends to proactively improve quality and boost production. Get the details on QAD CEBOS SPC.
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• Total Quality Management (TQM): A company-wide approach to operational excellence that promotes quality at every stage of product design and manufacturing. Read our blog on TQM in automotive manufacturing.
• Training Compliance Management: Tracking employee training education and skills and awareness to ensure that production employees have the ongoing training required for manufacturing process optimization. See what QAD CEBOS has to offer for Training Management.
Quality Control (QC)
Quality control (QC) is implemented as a means of fulfilling quality requirements, reviewing all factors involved in production. The business confirms that the good or service produced meets organizational goals, often using tools such as operational auditing and inspection. QC is focused on process output
• Procedures used in each assay to assure a test run is valid and results are reliable
• A system for verifying and maintaining a desired level of quality in an individual
test or process
• A generic term that refers to the monitoring and assessment of laboratory testing processes to identify problems and maintain performance
• The operational techniques and activities used to fulfil requirements for quality
Quality Assurance (QA)
Quality assurance is implemented as a means of providing enough confidence that business requirements and goals (as outlined in quality planning) for a product and/or service will be fulfilled. This error prevention is done through systematic measurement, comparison with a standard, and monitoring of processes
• A part of quality management focused on providing confidence that quality requirements will be fulfilled
• A formal and systematic exercise in identifying problems in medical care delivery, designing activities to overcome the problems, and carrying out follow-up monitoring to ensure that no new problems have been introduced and that corrective steps have been effective
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• A broad spectrum of evaluation activities aimed at ensuring compliance with minimum quality standards
• All actions taken to establish, protect, and improve the quality of health care
Quality Improvement (QI)
Quality improvement is implemented as a means of providing mechanisms for the evaluation and improvement of processes, etc. in the light of their efficiency, effectiveness, and flexibility. This may be done with noticeably significant changes or incrementally via continual improvement
• A formal approach to the analysis of performance and systematic efforts to improve it.
• Systematic and continuous actions that lead to measurable improvement in health care services and the health status of targeted patient groups.
• Defining standards of care, reassessing those standards periodically, and continuously improving the medical systems that support those standards.
• A set of techniques for continuous study and improvement of the processes of delivering health care services and products to meet the needs and expectations of the customers of those services and products. It has three basic elements: customer knowledge, a focus on processes of health care delivery, and statistical approaches that aim to reduce variations in those processes.
Quality Management (QM)
Quality management ensures that an organization, product or service is consistent. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. What a customer wants and is willing to pay for it determines quality. It is written or unwritten commitment to a known or unknown consumer in the market. Thus, quality can be defined as fitness for intended use or, in other words, how well the product performs its intended function
• The application of a quality management system in managing a process to achieve maximum customer satisfaction at the lowest overall cost to the organization while continuing to improve the process
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• Management activities and functions involved in determination of quality policy and its implementation through means such as quality planning and quality assurance (including quality control)
• Quality management is the act of overseeing all activities and tasks needed 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
• All activities of the overall management function that determine quality policy objectives and responsibilities; and implement them by means such as quality planning, quality processes, quality control, quality assessment, and quality improvement within the quality system
Quality Management System (QMS)
• Management system to direct and control an organization with regard to quality
• A formalized system that documents the structure, responsibilities and procedures required to achieve effective quality management. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis
• The organizational resources, processes and procedures to implement quality management, which is broader than both quality assurance (QA) and quality control (QC). Besides QA, the laboratory quality management system also includes management of equipment, supplies and inventories, management of capital, finances and budgeting, and providing training and continuous support of staff and customer service
• The organizational structure, resources, processes, and procedures needed to implement quality management
Total Quality Management (TQM)
• A management approach to long-term success through customer satisfaction
• A management philosophy that seeks to integrate all organizational functions (finance, production, customer service, etc.) to focus on meeting customer needs and organizational objectives
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• A business philosophy that the long-term success of a company comes from customer satisfaction. TQM requires that all stakeholders in a business work together to improve processes, products, services and the culture of the company itself
Quality planning – Quality planning is implemented as a means of “developing the products, systems, and processes needed to meet or exceed customer expectations.” This includes defining who the customers are, determining their needs, and developing the tools (systems, processes, etc.) needed to meet those needs.
Food quality
Food quality is the quality characteristics of food that is acceptable to consumers. This includes external factors as appearance, texture, and flavour; factors such as federal grade standards and internal. Food quality in the United States is enforced by the Food Safety Act 1990. Public analysts carry out scientific analysis on the samples to determine whether the quality is of sufficient standard. Food quality is an important food manufacturing requirement, because food consumers are susceptible to any form of contamination that may occur during the manufacturing process. Many consumers also rely on manufacturing and processing standards, particularly to know what ingredients are present, due to dietary, nutritional requirements, or medical conditions. Besides ingredient quality, there are also sanitation requirements. It is important to ensure that the food processing environment is as clean as possible in order to produce the safest possible food for the consumer. As the matter of fact is that it depends on individual as their quality standards may vary from person to person.
1.3 Quality & Quality Management Food quality is the quality characteristics of food that is acceptable to consumers. This includes external factors as appearance (size, shape, colour, gloss, and consistency), texture, and flavour; factors such as federal grade standards (e.g. of eggs) and internal (chemical, physical, microbial). Food quality in the United States is enforced by the Food Safety Act 1990. Members of the public complain to trading standards professionals, who submit complaint samples and also samples used
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to routinely monitor the food marketplace to public analysts. Public analysts carry out scientific analysis on the samples to determine whether the quality is of sufficient standard. Food quality is an important food manufacturing requirement, because food consumers are susceptible to any form of contamination that may occur during the manufacturing process. Many consumers also rely on manufacturing and processing standards, particularly to know what ingredients are present, due to dietary, nutritional requirements (kosher, halal, vegetarian), or medical conditions (e.g., diabetes, or allergies).
Raw Material Control
Raw materials are the basic ingredients used to create food products. These could be fruit and vegetables that are farmed and harvested; cows, chickens, pigs and sheep that are farmed for their meat, eggs and dairy products and various other items. Naturally, raw material control is directly related to process control as raw ingredients will need to meet certain guidelines before reaching processing phases.
Process Control
This principle relates to the process of food manufacturing. Ultimately, preventative measures are used alongside corrective measures – preventative strategies can only resolve a certain number of quality issues due to outside factors such as environment, storage and other such conditions. Many manufacturers work according to the Hazard Analysis Critical Control Point (HACCP) system as a result of this unpredictability. This system focuses on food safety as well as spoilage and other potential food risks. Total Quality Management (TQM) and ISO 9000 standards also relate to manufacturing processes and quality guidelines.
Finished Product Inspection
The third principle focuses on the final product – the packaged food that is then sold to consumers and suppliers. There are many forms of testing done at different stages – visual observation, physical tests and chemical tests are just some examples. Microbiological testing is very effective for determining health and sanitation controls, with a stringent monitoring process that incorporates records, data collection and the analysis of trends. External inspectors are also used alongside internal testers. Systems are designed for immediate corrective action when any products have raised red flags at any stage of the inspection, to reduce safety and hazard risks.
Quality management plays a vital role within the food industry, across many different stages of sourcing, processing and packaging. In addition to basic laws and regulations on nutritive value,
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quality levels also incorporate factors such as shelf-life, raw materials, taste, texture, use of preservatives and many other indicators too.
Not surprisingly, this makes it all the more important for food manufacturers to adhere to an efficient quality management system (QMS) in order to achieve standardisation and meet the demands of consumers and authorities.
When it comes to food quality, the definition can vary considerably in its use – some may use the term to define high end products such as caviar, while others may use the term in reference to basic quality of everyday items such as bread. In terms of quality control and management however, the term is used universally to ensure that all food products are processed according to strict guidelines.
Businesses may choose to obtain external recognition or accreditation of their FS & QMS for a number of reasons.
• Gain independent confirmation that the systems operated comply with industry standards and are sufficiently robust.
• Customer assurance.
• Serve as a continuous improvement initiative.
• Gain a competitive advantage and access to new markets.
• Demonstrate control and legal ‘due diligence’.
Benefit from related impacts of the improvement in general site efficiency.
Gaining accreditation of a recognised quality standard typically starts with the selection of the appropriate ‘scheme/standard’ for the manufacturing operation. Such standards include:
• Global G.A.P;
• IFS (International Featured Standards);
• BRC (British Retail Consortium);
• ISO 9001 Food quality management standard (International Organization for Standardization);
• ISO22000 FSMS-Food Safety Management System;
• Food Safety System Certification (FSSC) 22000.
Defining technical and quality standards, for further information with regard to the selection of appropriate food industry standards and certification schemes.
After the appropriate standard has been selected by the organisation, the standard will often contain hundreds of clauses requiring the business to operate extensive systems and procedures to assure
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ongoing and consistent control, all of which will have to be met before the site can achieve full approval/accreditation according to the standard. Therefore, a process cycle of gap analysis, procedure implementation and review can continue up to the point where the business feels sufficiently confident that all requirements of the chosen standard are met. At this point, the business should seek to secure the services of an accredited/authorised independent third-party audit body to assess the operation against the requirements of the standard.
Once the audit has been completed, and any nonconformances raised dealt with appropriately (and within the timescales required), then the operation can be awarded certification or approval against the selected standard.
Accreditation will often be on a graded basis and usually will be for a fixed period, after which another audit will be required to ensure that the operation continues to meet the requirements of the standard, including incorporating any updates or additions to the standard since the last site assessment.
Food fraud is a significant and growing problem, driven by globalization, economic opportunity, and the low probability and severity of punishment. Although food fraud is economically motivated, it may result in serious health consequences. Therefore, emerging food fraud issues are described in this chapter, including the usage of food fraud databases. Analytical verification of food fraud and food authentication is needed to support proper food safety management systems. However, due to time and money constraints, only a restricted number of samples can be analysed in a laboratory. For analysis outside the laboratory, rapid, non-destructive, nontargeted methods are needed. This can be either handheld equipment for food safety inspectors or in-line equipment for the food manufacturers.
1.4 Quality Control in the Food Industry– Defect Identification
Quality control (QC) is a set of activities for ensuring quality in products by identifying defects in the actual products produced. It’s a reactive process and aims to identify (and correct) defects in finished products.
QC can be achieved by identifying and eliminating sources of quality problems to ensure customer’s requirements are continually met. It involves the inspection aspect of quality management and is typically the responsibility of a specific team tasked with testing products for defects.
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Quality management is the act of overseeing all activities and tasks needed 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. It is also referred to as total quality management (TQM).
Specialisations
Within the master’s programme you can choose one of the following Specialisations to meet your personal interests.
• Quality Control and Assurance
• Quality and Food Logistics
• User-oriented Food Quality
• Quality Management and Entrepreneurship
Master’s Food Quality Management
The Food Quality Management Master of Science study programme offers an integrated approach to the study and assessment of quality processes in the agri-food chain through an exclusively developed techno-managerial approach. The whole supply chain is studied from the primary sector to the final consumer. Food, flowers and cattle are also discussed. This two-year MSc gives you the chance to analyse problems using both the social and life sciences. This allows you a higher level of approach on the topics of food quality, quality management, quality design, quality control, quality improvement, quality assurance, quality policy and business strategy.
Importance of Quality Control
We have identified a few reasons why brands dealing in food items must not ignore quality control:
Reduced production cost SE banner Square
By undertaking effective inspection and control in the production processes and operations, companies in the food industry can reduce their production costs considerably. Wastages and poor product quality further increase production costs. Quality control keeps tabs on the production of inferior products and wastages thereby bringing down the cost of production significantly.
Better goodwill
By producing goods of better quality and satisfying customer’s needs, quality control gives a boost to the goodwill of the company in the minds of people. This consequently results in a good brand reputation and positive word-of-mouth on both offline and online channels. A reputed concern can
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easily raise finances from the market. Furthermore, when a company has enhanced goodwill, the chances of its survival in the highly competitive market are also high.
Facilitates Pricing
By employing quality control measures, food industry companies can ensure that uniform products of the same quality are produced. This greatly facilitates the problem of price fixation for food products. This also eliminates the worry of constantly changing the prices of commodities.
Increase sales
Quality control ensures the production of good quality products which is immensely helpful in attracting more customers to the product thereby increasing sales. It is significantly beneficial in maintaining the existing demand and also creating new demand for the company’s products. Also, the rise in the use of social media has made it more essential for brands to be on their toes. Any negative comment or review by a customer could affect the brand image.
Improved techniques of production
Quality control ensures that commodities are produced at reasonable rates and the desired standards. By supplying technical and engineering data for the product and manufacturing processes, better methods and designs of production are contact Unsure by quality control.
Higher employee morale
An effective quality control system is greatly useful in increasing the morale of employees. When employees start to feel that they are working in a concern producing good and higher quality products their willingness and motivation to work towards the company’s objectives tend to increase. Also, these employees are more likely to keep up with the company’s standards of quality control in their operations.
1.5 Quality Management System
A Quality Management System (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
Quality management serves many purposes: –
• Improving processes
• Reducing waste
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• Lowering costs
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization wide direction
Requirements of quality management system: –
➢ Design
➢ Deploy
➢ Build
➢ Control
➢ Measure
➢ Review
➢ Improve
1. Design and Build: – The design and build portions serve to develop the structure of a QMS, its processes, and plans for implementation. Senior management should oversee this portion to ensure the needs of the organization and the needs of its customers are a driving force behind the systems development.
2. Deploy: – Deployment is best served in a granular fashion by breaking each process down into subprocesses and educating staff on documentation, education, training tools, and metrics. Company intranets are increasingly being used to assist in the deployment of quality management systems.
3. Control and Measure: – Control and measurement are two areas of establishing a QMS that are largely accomplished through routine, systematic audits of the quality management system. The specifics vary greatly from organization to organization depending on size, potential risk, and environmental impact.
4. Review and Improve: – Review and improve detail how the results of an audit are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit.
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Requirement of Quality Management System
Design and Build
The design and build portions serve to develop the structure of a QMS, its processes, and plans for implementation. Senior management should oversee this portion to ensure the needs of the organization and the needs of its customers are a driving force behind the systems development.
Deploy Deployment is best served in a granular fashion by breaking each process down into subprocesses and educating staff on documentation, education, training tools, and metrics. Company intranets are increasingly being used to assist in the deployment of quality management systems.
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Control and Measure
Control and measurement are two areas of establishing a QMS that are largely accomplished through routine, systematic audits of the quality management system. The specifics vary greatly from organization to organization depending on size, potential risk, and environmental impact.
Review and Improve
Review and improve detail how the results of an audit are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit.
Quality management systems serve many purposes, including:
• Improving processes
• Reducing waste
• Lowering costs
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization-wide direction
QMS Certification
QMS Certification Services are responsible for auditing and certifying thousands of organisations in a range of industries, across the world. By building a strong reputation for the highest quality service, market leading pricing and simplified client process, QMS are Australia’s most trusted accredited third-party International Certification Body.
QMS was formed with customer service and value in mind and these aims have been embodied into every internal and external process.
Our certification services are designed with a customer-first focus, to help us create and deliver value through everything we do. We strive to be proactive in enhancing the quality of our offerings, so we can proudly lead the market in certification services. Our teams are comprised of experienced professionals that have previously been involved in the development of quality management systems, either as auditors, auditees or trainers. This experience allows us to understand every aspect of management system and how to deliver optimal results consistently.
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1.6 Environmental Management System (EMS)
An environmental management system (EMS) is “a system and database which integrates procedures and processes for training of personnel, monitoring, summarizing, and reporting of specialized environmental performance information to internal and external stakeholders of a firm”.
The most widely used standard on which an EMS is based is International Organization for
Standardization (ISO) 14001.
An environmental management information system (EMIS) or Environmental Data Management System (EDMS) is an information technology solution for tracking environmental data for a company as part of their overall environmental management system.
Goals/Aim of EMS
The goals of EMS are to increase compliance and reduce waste. Compliance is the act of reaching and maintaining minimal legal standards. By not being compliant, companies may face fines, government intervention or may not be able to operate. Waste reduction goes beyond compliance to reduce environmental impact. The EMS helps to develop, implement, manage, coordinate and monitor environmental policies. Waste reduction begins at the design phase through pollution prevention and waste minimization. At the end of the life cycle, waste is reduced by recycling.
To meet these goals, the selection of environmental management systems is typically subject to a certain set of criteria: a proven capability to handle high frequency data, high performance indicators, transparent handling and processing of data, powerful calculation engine, customised factor handling, multiple integration capabilities, automation of workflows and question & answer processes and in-depth, flexible reporting.
Features of EMS
Serves as a tool, or process, to improve environmental performance and information mainly “design, pollution control and waste minimization, training, reporting to top management, and the setting of goals”. Provides a systematic way of managing an organization’s environmental affairs. The aspect of the organization’s overall management structure that addresses immediate and long-term impacts of its products, services and processes on the environment. EMS assists with planning, controlling and monitoring policies in an organization.
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Gives order and consistency for organizations to address environmental concerns through the allocation of resources, assignment of responsibility and ongoing evaluation of practices, procedures and processes. Creates environmental buy-in from management and employees and assigns accountability and responsibility. Sets framework for training to achieve objectives and desired performance. Helps understand legislative requirements to better determine a product or service’s impact, significance, priorities and objectives. Focuses on continual improvement of the system and a way to implement policies and objectives to meet a desired result. This also helps with reviewing and auditing the EMS to find future opportunities. Encourages contractors and suppliers to establish their own EMS. Facilitates e-reporting to federal, state and provincial government environmental agencies through direct upload.
EMS Model
An EMS follows a Plan-Do-Check-Act, or PDCA, Cycle. The diagram shows the process of first developing an environmental policy, planning the EMS, and then implementing it. The process also includes checking the system and acting on it. The model is continuous because an EMS is a process of continual improvement in which an organization is constantly reviewing and revising the system.
This is a model that can be used by a wide range of organizations — from manufacturing facilities to service industries to government agencies.
Other Meaning
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An EMS can also be classified as: A system which monitors, tracks and reports emissions information, particularly with respect to the oil and gas industry. EMSs are becoming web-based in response to the EPA’s mandated greenhouse gas (GHG) reporting rule, which allows for reporting GHG emissions information via the internet. A centrally controlled and often automated network of devices (now frequently wireless using z-wave and zigbee technologies) used to control the internal environment of a building. Such a system namely acts as an interface between end user and energy (gas/electricity) consumption.
Companies Providing Environmental Management Systems Wisdom business development agency workflow-based environmental management software NEMS environmental management suite Emisoft’s environmental management, reporting and compliance platform Medgate environmental management software Monitor Pro environmental data management system EsDat environmental data management system Enviance regulatory compliance system ERA Environmental’s environmental management system
ISO 14001:2015 AND ENVIRONMENTAL MANAGEMENT SYSTEMS
The purpose of the ISO 14001 management system standard is to specify general requirements and guidelines that, when followed, should provide reasonable assurance that the outputs from
the system will have minimal negative environmental impact and improved environmental performance. It should be noted that the ISO 14001 standard is no prescriptive; that is, it details what should be done, not necessarily how to do it.
The ISO 14001 standard is developed around the plan-do-check-act (PDCA) model of improvement, an iterative process that must be applied regularly to ensure benefits are being realized and the standard is being upheld. The primary operational components of an ISO
14001 EMS can be grouped as follows:
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1. Create/update environmental policy.
2. Plan:
1. Environmental aspects
2. Legal and other requirements
3. Objectives, targets, and programs
3. Do:
1. Resources, responsibilities, and authority
2. Competence, training, and awareness
3. Communication
4. Documentation
5. Control of documents
6. Operational control
7. Emergency preparedness and response
4. Check:
1. Monitor and measure
2. Evaluate compliance
3. Nonconformity, corrective and preventive action
4. Control of records
5. Internal audits
5. Act:
1. Management review
2. ISO 14001 audit
History of Environmental Management Systems
Quality approaches have traditionally maintained a fairly strict focus on business and customer issues, such as reducing defects and waste and improving efficiency, profitability, and customer satisfaction.
Environmental and sustainability goals for quality initiatives are relatively recent. Because the business world is accustomed to treating environmental practices as sources of added costs, the challenge for quality practitioners is to identify where environmental and sustainability quality issues, such as reduction of waste and use of renewable energy, also serve business and customer interests.
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In EMS the Bridge to Sustainability, a presentation available from the Energy and Environmental Division, Chris Spire of the ANAB Accreditation Council explains the characteristics of each stage in the evolution of compliance management to sustainability:
1990 to 1994: Compliance management (CM) meant focusing on regulation and relying on environmental departments to react to issues. 1994 to current: Environmental management systems (EMS) brought a more systematic, organization-wide focus on environmental issues. 1998 to current: Environmental information management systems (EIMS) involve using web- based systems and integrating multiple systems. 2002 to current: Environmental process management systems (EPMS) make use of quality tools, using a project focus to drive improvements. 2006 to current: Sustainability requires integrating environmental, social, and economic goals and using best practices to address risk and uncertainty.
In 2004, Larry R. Smith of Ford Motor Co. defined sustainability as “finding win/win/win solutions for both the short- and long-term effects of design on social responsibility, environmental performance and business results—the triple bottom line.”
Importance of EMS
It is expected that a company will know and meet all the environmental requirements that are specified for their operations, but not every company will look past this and work towards improving their operations with respect to reducing the negative impacts on the environment. This is the reason for having an environmental management system, and is the biggest selling point for why a company would want to implement such a system. Reducing your environmental impact can help gain market share in a world with ever growing environmental awareness.
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UNIT-2: System of Quality Management: TQM and TQM in Practice, Components of TQM Principles of TQM, Steps of TQM, Models of TQM, Implementation of TQM, Evaluation of TQM, Banners of TQM.
2.1 Total Quality Management (TQM)
Total Quality Management (TQM) is a concept created by W. Edwards Deming. It was originally introduced in Japan after World War II to assist the Japanese in re-building their economy. The main focus of TQM was and is continuous quality improvement in the areas of product or service, employer-employee relations and consumer-business relations. Total Quality Management is a management approach that originated in the 1950s and has steadily become more popular since the early 1980s.
ISO defined TQM as “A management approach of an organization centered on quality, based on participation of all its members and aiming at long term benefits to all members of the organization and society.”
TQM is “a system of continuous improvement employing participative management and centered on the needs of customers” (Jurow and Barnard, 1993)
Total Quality is a description of the culture, attitude and organization of a company that strives to provide customers with products and services that satisfy their needs. The culture requires quality in all aspects of the company’s operations, with processes being done right for the first time to eradicate defects waste from operations.
Total Quality Management is a method by which management and employees can become involved in the continuous improvement of the production of goods and services. It is a combination of quality and management tools aimed at increasing the business and reducing losses due to wasteful practices.
Total Quality Management (TQM) is an enhancement to the traditional way of doing business. It is a proven technique to guarantee survival in world-class competition. Only by changing the actions of management will the culture and actions of an entire organization be transformed. TQM is for the most part common sense. Analyzing the three words, we have:
Total: Makeup of the whole.
Quality: Degree of excellence a product or service provides.
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Management: Act, art, or manner of handling, controlling, directing, etc.
The Principles of Total Quality Management
1. Primary responsibility for product quality rests with top management.
2. Quality should be customer focused and evaluated using customer-based standards.
3. The production process and work methods must be designed consciously to achieve quality
conformance.
4. Every employee is responsible for achieving good product quality.
5. Quality cannot be inspected into a product, so make it right the first time.
6. Quality must be monitored to identify problems quickly and correct quality problems immediately.
7. The organization must strive for continuous improvement.
8. Companies must work with, and extend TQM programs to their suppliers to ensure quality inputs.
Following are the various models of total quality management:
1. Deming Application Prize
2. Malcolm Baldrige Criteria for Performance Excellence
3. European Foundation for Quality Management, and
4. ISO quality management standards
Total quality management (TQM) consists of organization-wide efforts to “install and make permanent climate where employees continuously improve their ability to provide on demand products and services that customers will find of particular value.”[1] “Total” emphasizes that departments in addition to production (for example sales and marketing, accounting and finance, engineering and design) are obligated to improve their operations; “management” emphasizes that executives are obligated to actively manage quality through funding, training, staffing, and goal setting. While there is no widely agreed-upon approach, TQM efforts typically draw heavily on the previously developed tools and techniques of quality control. TQM enjoyed widespread attention during the late 1980s and early 1990s before being overshadowed by ISO 9000, Lean manufacturing, and Six Sigma.
Steps in Total Quality Management
Clarifying Vision
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If a business wants to be known for quality, it must start by defining “quality.” Is it a lack of mistakes in providing a product or service, for example? Or is it the greatest return on investment for customers? Everyone in the business must know what it does and where it wants to go to help it reach its destination.
Defining Success
TQM initiatives should be actionable and measurable. Identifying critical success factors like customer satisfaction and market share allow companies to align their actions with their objectives. Then they can track their progress by monitoring metrics, like customer satisfaction ratings and market share percentages.
Engaging Everyone
In TQM, customer satisfaction isn’t confined to one department. Nor is it the responsibility of management alone. All employees contribute to the cause. So, businesses must inform employees of their roles and solicit their input before planning an approach.
Planning an Approach
Once a company targets the desired improvement, like increasing customer satisfaction ratings, it takes steps like:
• Defining the problem: Customers aren’t happy.
• Collecting related data: Customer survey responses for the past three months.
• Finding the root cause: Customers wait too long on the phone for service.
Doing the Work
Total quality management helps businesses to systematically tackle problems and seize opportunities through steps like:
• Developing a solution: Automatically routing calls to the next available customer service representative.
• Picking a measurement: Hold time for customers.
• Implementing changes: Start automatically routing calls.
Checking the Results
Companies can gauge the effectiveness of their TQM initiatives by comparing data from before changes were made to after. If automatically routing calls to the next available service representative is successful, then the company should see shorter h old times for customers. Satisfaction scores should increase as well.
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Acting on the Findings
A business can reap long-term benefits by documenting the results of successful TQM initiatives and sharing them throughout the organization. When the customer service team improves its performance, that can help sales and marketing do better as well because they can point to those same improvements when working with prospective customers.
Systematizing Improvements
Also, the process that was used to increase customer satisfaction scores could be applied to other problems, perhaps with refinements based on lessons learned. For example, the production department might be able to compare pre-change and post-change data to measure the effectiveness of its efforts to reduce the number of defective products.
Sustaining Success
Just as everyone shares in the work, everyone should share in the rewards. If the company achieves its goal of improving customer satisfaction, it might pay employees bonuses for reaching the targets it has set for individuals, departments and the organization as a whole
Management Models
Total Quality Management is a combined effort of both top-level management as well as employees of an organization to formulate effective strategies and policies to deliver high quality products which not only meet but also exceed customer satisfaction.
Total Quality management enables employees to focus on quality than quantity and strive hard to excel in whatever they do. According to total quality management, customer feedbacks and expectations are most essential when it comes to formulating and implementing new strategies to deliver superior products than competitors and eventually yield higher revenues and profits for the organization.
Credits for the process of total quality management go to many philosophers and their teachings. Drucker, Juran, Deming, Ishikawa, Crosby, Feigenbaum and many other individuals who have in due course of time studied organizational management have contributed effectively to the process of total quality management.
There are many models of total quality management and it is really not necessary that every organization should select and implement the same model.
Following are the various models of total quality management:
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▪ Deming Application Prize
▪ Malcolm Baldrige Criteria for Performance Excellence
▪ European Foundation for Quality Management, and
▪ ISO quality management standards
Customers and their feedbacks are the foundation of every Total Quality Management model. In simpler words, Total Quality Management begins with understanding customers, their needs and what they expect from the organization. Design fool proof processes and systems to collect customer data, information to further study, analyse and act accordingly. Such activities not only help you understand your target customers but also predict customer behaviour.
As a business marketer, you need to know the age group of your target customers, their preferences and needs. Employees need to know how their products or services can fulfil customer needs and demands.
Total Quality Management model requires meticulous planning and research. Every total quality management model integrates customer feedbacks with relevant information and plans accordingly to design effective strategies to achieve high quality products.
Strategies formulated to yield better quality products need to be evaluated and reviewed from time to time. Remember, customers are satisfied only when products meet their expectations, fulfil their needs and are value for money. Their overall experience with the organization needs to be pleasant for them to be happy and return to the organization even the next time.
Continuous improvements, changes and modifications in the existing processes according to customer expectations are necessary to yield higher profits. Processes can’t be same always. If a customer complaint about a particular product of yours, find out the root cause of problem. Understand and implement necessary total quality management models to rectify the problem, remove the defect for a high-quality product.
The successful implementation of Total quality Management model needs extensive planning and most importantly participation of every single member who is benefitted out of the organization (Management, suppliers, clients and even customers). Without the participation of each and every employee, total quality management model would be a complete failure.
Total Quality Management model begins with research and collecting information about end-users followed by planning and full participation of employees for successful implementation. Top level Management needs to make other team members aware of the benefits of total quality management
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process, importance of quality to survive in the long run and how they can implement various TQM models by prioritizing their customers and their feedbacks.
Steps to Creating a Total Quality Management System
1. Clarify Vision, Mission, and Values
Employees need to know how what they do is tied to organizational strategy and objectives.
All employees need to understand where the organization is headed (its vision), what it hopes to accomplish (mission) and the operational principles (values) that will steer its priorities and decision making.
Develop a process to educate employees during new employee orientation and communicate the mission, vision, and values as a first step.
2. Identify Critical Success Factors (CSF)
Critical success factors help an organization focus on those things that help it meet objectives and move a little closer to achieving its mission.
These performance-based measures provide a gauge for determining how well the organization is meeting objectives.
Some example CSF:
• Financial Performance
• Customer Satisfaction
• Process Improvement
• Market Share
• Employee Satisfaction
• Product Quality
3. Develop Measures and Metrics to Track CSF Data
Once critical success factors are identified, there needs to be measurements put in place to monitor and track progress.
This can be done through a reporting process that is used to collect specified data and share information with senior leaders.
For example, if a goal is to increase customer satisfaction survey scores, there should be a goal and a measure to demonstrate achievement of the goal.
4. Identify Key Customer Group
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Every organization has customers. Those that understand who the key customer groups are can create products and services based on customer requirements.
The mistake a lot of organizations make is not acknowledging employees as a key customer group.
Example Key Customer Groups:
• Employees
• Customers
• Suppliers
• Vendors
• Volunteers
5. Solicit Customer Feedback
The only way for an organization to know how well they are meeting customer requirements is by simply asking the question.
Create a structured process to solicit feedback from each customer group in an effort to identify what is important to them.
Organizations often make the mistake of thinking they know what is important to customers and ask the wrong survey questions. This type of feedback is obtained through customer focus groups.
6. Develop a Survey Tool
Next, develop a customer satisfaction survey tool that is based on finding out what is important to customers.
For example, customers might care more about quality than cost but if you are developing a product and trying to keep the cost down and skimping on the quality, you are creating a product that might not meet the needs of the customer.
7. Survey Each Customer Group
Create a customized survey for each customer group. This survey will help to establish baseline
data on the customers’ perception of current practice.
Now you will have a starting point for improvements and will be able to demonstrate progress as improvement plans are implemented.
8. Develop Improvement Plan
Once the baseline is established you should develop an improvement plan based on customer feedback from each group.
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Improvement plans should be written in SMART goals format with assignments to specific staff for follow through.
• Process improvement initiatives: such as customer call hold times
• Leadership Development: Walk-the-Talk
• Management Training/Development: How to manage employees in a quality environment
• Staff Training/Development: Customer Service
• Performance Management: Setting expectations, creating job descriptions that support the vision and holding staff accountable.
9. Resurvey
After a period of time (12-18 months), resurvey key customers to see if scores have improved. Customer needs and expectations change over time so being in-tune to changing needs and expectations is critical to long-term success.
10. Monitor CSF
It is important to monitor CSF monthly to ensure there is consistent progress toward goals. This also allows for course correction should priorities and objectives change during the review period.
11. Incorporate Satisfaction Data into Marketing Plans
Once you’ve achieved some positive results with your satisfaction data, use it as a marketing tool!
A lot of successful organizations miss the boat by not letting others know what they do well. Customers want to know how an organization’s internal processes work, especially if those processes help to deliver an outstanding product or service!
12. Technology
Make sure technology is user-friendly and supports targeted improvements. For example, a website should be easy to navigate as well as easy to find (SEO) and the content should be easy to understand.
Final Thoughts
Make sure employees understand the vision as well as their role in supporting it. Look for ways to ensure that all internal processes are standardized and that employees receive the training to understand the standardization.
Evaluation:.1920s
• Some of the first seeds of quality management were planted as the principles of scientific management swept through U.S. industry.
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• Businesses clearly separated the processes of planning and carrying out the plan, and union opposition arose as workers were deprived of a voice in the conditions and functions of their work.
• The Hawthorne experiments in the late 1920s showed how worker productivity could be impacted by participation. quality.
1950s• Walter Shewhart developed the methods for statistical analysis and control of
• W. Edwards Deming taught methods for statistical analysis and control of quality
to Japanese engineers and executives. This can be considered the origin of TQM.
• Joseph M. Juran taught the concepts of controlling quality and managerial breakthrough.
• Armand V. Feigenbaum’s book Total Quality Control, a forerunner for the present understanding of TQM, was published.
•Philip B. Crosby’s promotion of zero defects paved the way for quality improvement in
many companies.
•The Japanese named their approach to total quality “companywide quality control.” It is around this time that the term quality management systems arises.
• Kaoru Ishikawa’s synthesis of the philosophy contributed to Japan’s ascendancy as a
quality leadern Today
• TQM is the name for the philosophy of a broad and systemic approach to managing organizational quality.
• Quality standards such as the ISO 9000 series and quality award programs such as the Deming Prize and the Malcolm Baldrige National Quality Award specify principles and processes that comprise TQM.
• TQM as a term to describe an organization’s quality policy and procedure has fallen out of favor as international standards for quality management have been developed. Please see our series of pages on quality management systems for more information.
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UNIT-3: ISO 9000 AND 14000 FOR QUALITY ASSURANCE: Origin and History of ISO 9000, Implementation of ISO, ISO 9000 Registration Process, ISO and World Trade, ISO in Developing countries, who develops ISO SFDS, How ISO standards are developed, Auditing Standards Disadvantages to adopting ISO 9000 requirement, ISO 14000- History Who and what do the standards apply to, ISO 14000 Family, EMS Mood, Elements of ISO 14001 standards, Total Quality Environmental Management.
3.1 International Organization for Standardization (ISO)
The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is headquartered in Geneva, Switzerland and works in 164 countries.
It was one of the first organizations granted general consultative status with the United Nations Economic and Social Council. It is the world’s largest developer of voluntary international standards and facilitates world trade by providing common standards between nations. Over twenty thousand standards have been set covering everything from manufactured products and technology to food safety, agriculture and healthcare.
Use of the standards aids in the creation of products and services that are safe, reliable and of good quality. The standards help businesses increase productivity while minimizing errors and waste. By enabling products from different markets to be directly compared, they facilitate companies in entering new markets and assist in the development of global trade on a fair basis. The standards also serve to safeguard consumers and the end-users of products and services, ensuring that certified products conform to the minimum standards set internationally.
International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a process with six steps:
1: Proposal stage
2: Preparatory stage
3: Committee stage
4: Enquiry stage
5: Approval stage
6: Publication stage
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ISO is funded by a combination of:
• Organizations that manage the specific projects or loan experts to participate in the technical work.
• Subscriptions from member bodies. These subscriptions are in proportion to each country’s gross national product and trade figures.
• Sale of standards.
The International Organization for Standardization is an international standard- setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is headquartered in Geneva, Switzerland, and works in 164 countries.
It was one of the first organizations granted general consultative status with the United
Nations Economic and Social Council.
What is ISO 9001?
❖ Full form of ISO- international organization system
❖ It’s a quality management system that can be adopted by any kind of organization.
❖ The system focuses towards meeting the customer requirements and enhancing of customer satisfaction.
❖ It was published in the year 2005
❖ Its formation took place on 23 February 1947.
❖ Its headquarters lies in geneva
❖ There are 63 countries as its members
Use of the standard aids in the creation of products and services that are safe, reliable and of good quality. The standards help businesses increase productivity while minimizing errors and waste.
The standards also serve to safeguard consumers and the end users of products and services, ensuring that certified products conform to the minimum standards set internationally HISTORY:
The organization today known as ISO began in 1928 as the International Federation of the N during World War II, but after the war ISA was approached by the recently formed United Nations Standards Coordinating Committee (UNSCC) with a proposal to form a new global standards body. In October 1946, ISA and UNSCC delegates from 25 countries met in London
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and agreed to join forces to create the new International Organization for Standardization; the new organization officially began operations in February 1947.
STRUCTURE:
ISO is a voluntary organization whose members are recognized authorities on standards, each one representing one country. Members meet annually at a General Assembly to discuss ISO’s strategic objectives. The organization is coordinated by a Central Secretariat based in Geneva.
A Council with a rotating membership of 20 member bodies provides guidance and governance, including setting the Central Secretariat’s annual budget. The Technical Management Board is responsible for over 250 technical committees,
who develop the ISO standards? IEC joint committees
ISO has formed two joint committees with the International Electro technical Commission (IEC) to develop standards and terminology in the areas of electrical and electronic related technologies
ISO /IEC JTC2
ISO/IEC Joint Technical Committee 1 (JTC 1) was created in 1987 to “[d]evelop, maintain, promote and facilitate IT standards”, where IT refers to information technology.
ISO/IEC JTC 2
ISO/IEC Joint Technical Committee 2 (JTC 2) was created in 2009 for the purpose of
“tandardization in the field of energy efficiency and renewable energy sources”
MEMBERSHIP:
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ISO member countries with a national standards body and ISO voting rights. Correspondent members (countries without a national standards body). Subscriber members (countries with small economies).
ISO has 163 national members.
ISO has three membership categories
• Member bodies are national bodies considered the most representative standards body in each country. These are the only members of ISO that have voting rights.
• Correspondent members are countries that do not have their own standards
organization. These members are informed about ISO’s work, but do not participate in standards promulgation.
• Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standards.
Participating members are called “P” members, as opposed to observing members, who are called “O” members.
STANDARDIZATIONPROCESS:
A standard published by ISO/IEC is the last stage of a long process that commonly starts with the proposal of new work within a committee. Here are some abbreviations used for marking a standard with its status
• PWI – Preliminary Work Item
• NP or NWIP – New Proposal / New Work Item Proposal
• AWI – Approved new Work Item
• WD – Working Draft
• CD – Committee Draft
• FCD – Final Committee Draft
• DIS – Draft International Standard
• FDIS – Final Draft International Standard
• PRF – Proof of a new International Standard
• IS – International Standard
Abbreviations used for amendments
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• NP Amd – New Proposal Amendment
• AWI Amd – Approved new Work Item Amendment
• WD Amd – Working Draft AAmendmen
• CD Amd / PDAmd – Committee Draft Amendment / Proposed Draft Amendment
• FPDAmd / DAM (DAmd) – Final Proposed Draft Amendment / Draft Amendment
• FDAM (FDAmd) – Final Draft Amendment
• PRF Amd
• Amd – Amendmen
Other abbreviations
• TR – Technical Report
• DTR – Draft Technical Report
• TS – Technical Specification
• DTS – Draft Technical Specification
• PAS – Publicly Available Specification
• TTA – Technology Trends Assessment
• IWA – International Workshop Agreement
PRODUCTS NAMED AFTER ISO:
The fact that many of the ISO-created standards are ubiquitous has led, on occasion, to common use of “ISO” to describe the actual product that conforms to a standard. Some examples of this are:
• Many CD images end in the file extension “ISO” to signify that they are using the ISO 9660 standard file system as opposed to another file system—hence
CD images are commonly referred to as “ISOs”. Virtually all computers with CD-
ROM drives that can read CDs use this standard. Some DVD-ROMs also use ISO 9660 file systems.
• Photographic film’s sensitivity to light (its “film speed”) is described
by ISO 6, ISO 2240 and ISO 5800. Hence, the film’s speed is often referred to by its
ISO number.
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• As it was originally defined in ISO 518, the flash hot shoe found on cameras is often called the “ISO shoe”.
• ISO 11783, which is marketed as ISOBUS.
• ISO 13216, which is marketed as ISOFIX.
International Standards and other publications:
ISO’s main products are international standards. ISO also publishes technical reports, technical specifications, publicly available specifications, technical corrigenda, and guides.
International standards
These are designated using the format, where nnnnn is the number of the standard, p is an optional part number, yyyy is the year published,
and Title describes the subject. IEC for International Electrotechnical
Commission is included if the standard results from the work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee). ASTM (American Society for Testing and Materials) is used for standards developed in cooperation with ASTM International. yyyy and IS are not used for an incomplete or unpublished standard and may under some circumstances be left off the title of a published work.
Technical reports
These are issued when a technical committee or subcommittee has collected data of a different kind from that normally published as an International Standard, such as references and explanations. The naming conventions for these are the same as for standards, except TR prepended instead of IS in the report’s name.
For example:
• ISO/IEC TR 17799:2000 Code of Practice for Information Security Management
• ISO/TR 19033:2000 Technical product documentation — Metadata for construction documentation
Technical and publicly available specifications
Technical specifications may be produced when “the subject in question is still under development or where for any other reason there is the future but not immediate possibility of an agreement to publish an International Standard”. A publicly available specification is usually
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“an intermediate specification, published prior to the development of a full International Standard, or, in IEC may be a ‘dual logo’ publication published in collaboration with an external organization”. By convention, both types of specification are named in a manner similar to the organization’s technical reports.
For example:
• ISO/TS 16952-1:2006 Technical product documentation — Reference designation system — Part 1: General application rules
• ISO/PAS 11154:2006 Road vehicles — Roof load carriers
Technical corrigenda
ISO also sometimes issues “technical corrigenda” (where “corrigenda” is the plural of corrigendum). These are amendments made to existing standards due to minor technical flaws, usability improvements, or limited-applicability extensions. They are generally issued with the expectation that the affected standard will be updated or withdrawn at its next scheduled review.
ISO guides
These are meta-standards covering “matters related to international standardization”. They are named using the format
For example:
• ISO/IEC Guide 2:2004 Standardization and related activities — General vocabulary
• ISO/IEC Guide 65:1996 General requirements for bodies operating product certification
Document copyright
ISO documents are copyrighted and ISO charges for most copies. It does not, however, charge for most draft copies of documents in electronic format. Although they are
useful, care must be taken using these drafts as there is the possibility of substantial change before they become finalized as standards. Some standards by ISO and its official U.S. representative (and, via the U.S. National Committee, the International Electrotechnical Commission) are made freely available.
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UNIT-4: QUALITY CONTROL CIRCLES: Define and Objectives, Principles of QCC, Benefits of QCC, Implementation of QCC, Steps invoiced in QCC, Quality Management in the food Industry-HACCP and development of HACCP, Steps of HACCP, Principles and Implementation HACCP, Similarity and Differences in ISO 9000 & HACCP.
4.1 Quality Control Circles
Participate methods in the workplace are one way to improve both the work environment for employees and productivity and quality for the company. Quality Circle is one of the employee participation methods.
It implies the development of skills, capabilities, confidence and creativity of the people through cumulative process of education, training, work experience and participation. The creation of facilitative conditions and environment of work, which creates and sustains their motivation and commitment towards work excellence.
This resulted in the Quality Circle concept being accepted all over the world as a very effective technique to improve the total quality of work life.
Concept of QCC
Participative Management Technique Suggestion Effecting Workplace Performance Related Problems Organizes. It is based upon recognition of the value of the worker. As a human being. As someone who willingly activists on his job, his wisdom, intelligence, experience, attitude and feelings.
3 Major Attributes:
1. Quality Circle is a form of participation management.
2. Quality Circle is a human resource development technique.
3. Quality Circle is a problem-solving technique.
I
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A quality circle or quality control circle is a group of workers who do the same or similar work, who meet regularly to identify, analyze and solve work-related problems.
It consists of minimum three and maximum twelve members in number.
Normally small in size, the group is usually led by a supervisior or manager and presents it’s solutions to management where possible, workers implement the solutions themselves in order to improve the performance of the organization and motivate employees.
Quality circles were at their most popular during the 1980s, but continue to exist in the form of kaizan groups and similar worker participation schemes.
Quality circles are typically more formal groups. They meet regularly on company time and are trained by competent persons (usually designated as facilitators) who may be personnel and industrial relations specialists trained in human factors and the basic skills of problem identification, information gathering and analysis, basic statistics, and solution generation.
METHODOLOGY This program involves a wide range of learning approaches, including self – assessments, case studies, small group activities, discussions, interactive lectures, experimental learning group assignments, exercises, presentations and critiques. It will also include computer simulations to help reinforce participant’s understanding of the QC tools functions in problem solving cycles.
Quality circles were originally described by W. Edwards Deming in the 1950s, Deming praised Toyota as an example of the practice. The idea was later formalized across Japan in 1962 and
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expanded by others such as Kaoru Ishikawa. The Japanese Union of Scientists and Engineers (JUSE) coordinated the movement in Japan. The first circles started at the Nippon Wireless and Telegraph Company; the idea then spread to more than 35 other companies in the first year. By 1978 it was claimed that there were more than one million quality circles involving some 10 million Japanese workers. Quality circles have been implemented even in educational sectors in India, and QCFI (Quality Circle Forum of India) is promoting such activities. However, this was not successful in the United States, as the idea was not properly understood and implementation turned into a fault-finding exercise – although some circles do still exist. Don Dewar together with Wayne Ryker and Jeff Beardsley established quality circles in 1972 at the Lockheed Space Missile factory in California
BASIC QUALITY IMPROVEMENT TOOLS
There are seven basic quality improvement tools that circles use:
1. Cause-and-effect diagrams (sometimes called Ishikawa or “fishbone” diagrams)
2. Pareto charts
3. Process mapping, data gathering tools such as check sheets
4. Graphical tools such as histograms, frequency diagrams, spot charts and pie charts
5. Run charts and control charts
6. Scatter plots and correlation analysis
7. Flowcharts
Quality Circle Process
Most quality circles will work through a set process with each meeting. In general, this will follow the Plan, Do, Check, Act process, which is ideal for continuous improvement projects.
Following this process not only makes it easier to identify potential solutions and implement them, but it also has an established flow for moving from one process improvement to the next. This is
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important because this type of group meeting is scheduled to take place on a regular basis, with new problems being identified and resolved on a regular basis.
4.2 HACCP
“HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food. “HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world.”
HACCP is emerging as an industry-driven concept that the firm should take a proactive role in assuring the food processing procedure will lead to a safe product.
• HACCP is considered an alternative to traditional government inspections; but the government retains a role in the overall process by using its regulatory authority to assure that businesses have adequate HACCP plans and that the plan is being appropriately implemented.
• HACCP allows (requires) each business to focus on their operation and its unique characteristics rather than having a standardized inspection process that may not offer the flexibility to consider the uniqueness of each business and each food product. The focus of HACCP is not on having a standardized production process but on having a monitoring
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process that is adequate to assure each business (regardless of its manufacturing process) is producing a safe product by minimizing the risk of a food safety problem.
Seven principles of HACCP;
• Principle 1: Conduct a hazard analysis.
• Principle 2: Determine the critical control points (CCPs).
• Principle 3: Establish critical limits (CL).
• Principle 4: Establish monitoring procedures.
• Principle 5: Establish corrective actions.
• Principle 6: Establish verification procedures.
• Principle 7: Establish record-keeping and documentation procedures.
HACCP also can generally be implemented with a 12-step process
Step #1 Assemble a HACCP Team
• A commitment from management.
• Multidisciplinary membership.
• Know the manufacturing process and the products
• Know how to take corrective action.
• Understand the HACCP principles.
Step #2 Processing and Distribution of Foods
• A separate HACCP is needed for each product.
• What method will be used for distributing the product?
• Is the product refrigerated, frozen or shelf-stable?
• What safety hazard or quality issue are associated with this food product?
Step #3 Intended Use and Consumers
• What impact will the product have on the general public?
• Are you targeting a specific segment of the market? Particular consumers? Are you targeting a wholesale or retail market?
• What are the ingredients? Do any ingredient pose a food safety risk?
• Does the food offer specific characteristics, such as, a low fat products
Step #4 Develop a Flow Diagram
• The diagram or flow chart must cover all steps of the manufacturing process.
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• It is not an engineering drawing.
• Verify the accuracy and completeness of the flow diagram.
• Take the diagram to the production floor to assure/verify its accuracy.
Step #5 Conduct a Hazard Analysis
• Are you concerned about microbiological, chemical or physical hazards (again, this list is expanding)?
• Identify steps in the manufacturing process where a hazard can happen.
• Consider risk (probability) of the hazard and severity if the hazard occurs.
• Remember — hazard is limited to safety; it does not focus on quality issues (even though they may be related).
• Identify preventative measures that can be applied.
Step #6 Critical Control Points (CCP)
• CCP — any place in the manufacturing and distribution process where control can be applied to prevent a hazard.
• GMPs can and should control many hazards.
• A CCP for one product many not be a CCP for another product.
Step #7 Critical Limits (CL)
• Limit that must be met to ensure safety of the product.
• Exceeding the CL means a health hazard exists.
• CLs can be derived from regulatory standards (e.g., dairy), guidelines, studies, experts, etc.
• Examples of CLs: temperatures (for some products it may be what is too high and for other products it may be what is too low), time, pH, residues, kind and count of bacteria.
Step #8 Monitoring/Inspection
• Planned sequence of observations or measurements.
• Must control CCP’s
• Must be effective.
• Monitoring intervals must be reliable.
• Must be rapid, no lengthy analysis.
• Adequate plan to see that the monitoring is carried out.
Step #9 Corrective Actions
• Specify procedures to be taken when deviations occur.
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• Corrective actions must be documented.
• Eliminate actual or potential hazards.
• Be prepared to put products on hold if a problem is identified.
• Make changes to prevent future occurrence.
Step #10 Records
• Must include every part of the HACCP program, from team membership through all actions — steps #1 – 12
Step #11 Verification
• Consists of methods, procedures or tests used in monitoring compliance.
• CCP’s are under control
• Necessary changes have been made.
• All records are complete.
• Sample analysis to verify.
• Training and knowledge.
Step #12 Evaluation and Revision
• At least an annual review.
• Anytime manufacturing process is changed or products are changed.
• Anytime new raw materials or sources are used.
• Anytime formulation is changed.
• Anytime new equipment is installed; in some cases, even adjusting the performance of the equipment may necessitate are review of the HACCP.
• Anytime there is a change in personnel or shifts.
• Anytime there is a changes in storage or distribution.
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UNIT 5 CODEX ALIMENTARIUS COMMISSION (CAC), FSSAI AND BUREAU OF INDIAN STANDARDS: Introduction, Role, Actions, Motive of establishment, Consumer Protection Law, Legal Meteorology and Standards, Management of Advertisements
5.1 Codex Alimentarius:
The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety.
Its name is derived from the Codex Alimentarius Austriacus. Its texts are developed and maintained by the Codex Alimentarius Commission, a body that was established in early November 1961 by the Food and Agriculture Organization of the United Nations (FAO), was joined by the World Health Organization (WHO) in June 1962, and held its first session in Rome in October 1963. The Commission’s main goals are to protect the health of consumers and ensure fair practices in the international food trade. The Codex Alimentarius is recognized by the World Trade Organization as an international reference point for the resolution of disputes concerning food safety and consumer protection.
The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety. Its name is derived from the Codex Alimentarius Austriacus.
The regulations of the codex refer to food hygiene and quality, including microbiological standards, food additives, pesticide, and residues from veterinary drugs, contaminants, food labelling and marketing, methods for sampling and hazard analysis, food import and export, certification system, etc.
It also ensures that product complying with codex standard can be sold on the international market without compromising health or interest of consumer. Codex standard ensure product is safe internationally
Scope of Codex Alimentarius
The Codex Alimentarius covers all foods, whether processed, semi-processed or raw. In addition to standards for specific foods, the Codex Alimentarius contains general standards covering matters such as food labelling, food hygiene, food additives and pesticide residues, and procedures for assessing the safety of foods derived from modern biotechnology. It also contains guidelines
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for the management of official i.e. governmental import and export inspection and certification systems for foods.
Codex Commission
Develop codex in 1962, subsidiary of food and agriculture organisation (FAO), united nations (UN) and world health organization (WHO)
Joint venture between FAO and WHO to formulate internationally accepted food safety standard for protection of human health and to ensure fair trade practices.
• Coordination of all food standards
• Initiation and supervision of draft standard
• Finalisation of food standard
• Publication of standard worldwide
• Amend standard in face of new technology
Scope
The Codex Alimentarius includes standards for all the principle foods, whether processed, semi-processed or raw, for distribution to the consumer. Materials for further processing into foods should be included to the extent necessary to achieve the purposes of the Codex Alimentarius as defined. The Codex Alimentarius includes provisions in respect of food hygiene, food additives, residues of pesticides and veterinary drugs, contaminants, labelling and presentation, methods of analysis and sampling, and import and export inspection and certification.
Purpose
The Codex Alimentarius is a collection of internationally adopted food standards and related texts3 presented in a uniform manner. These food standards and related texts aim at protecting consumers’ health and ensuring fair practices in the food trade. The publication of the Codex Alimentarius is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade
Role
The significant contributions of Codex have historically centered on its effort to protect consumer health and safety; the Codex impact on international trade has been believed by many to be of secondary importance. While one of the major goals of Codex continues to be focused on consumer protection, recent events have brought new attention to the role of Codex in assuring fair practice
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in food trade. In 1995, establishment of the World Trade Organization (WTO) highlighted a place for Codex in the WTO Sanitary and Phytosanitary Committee (SPS) dispute settlement process. Codex was referenced by the SPS document as the international body to be used for scientific advice on food matters brought before the WTO under SPS.
Structure
The Codex Alimentarius Commission consists of the following main organizational elements:
• Commission
• Executive Committee
• Codex Secretariat
• Codex subsidiary bodies
With the exception of the Codex Secretariat, all these elements are made up of Codex Members (i.e. national delegations and representatives of “observers”) , endeavouring to reflect stakeholder views as appropriate.
The Commission
• The decision-making body of the Joint FAO/WHO Food Standards Programme
• Consists of member governments, as well as a number of international government (IGOs) and nongovernment organizations (INGOs) which have official observer status with the Commission
• Presently meets annually, with meetings alternating between Rome (FAO Headquarters) and Geneva (WHO Headquarters)
The Executive Committee
• Executive Committee is established by CAC – CCEXEC acts as the executive organ of CAC.
• Responsible for managing the standards development process, developing the draft strategic plan, reviewing applications for observer status and making other recommendations about the general direction of the Commission’s work.
• The Commission elects executive officers for a period starting at the end of the session in which elected until the end of the following regular session.
• Elected officials include a chairperson and three vice-chairpersons elected among the delegates of the Members of the Commission. (These officers are chairperson and vice-chairpersons of the CAC & CCEXEC).
• The CCEXEC meets between Commission sessions.
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• The Executive Committee is geographically balanced – one member country elected from each geographic regions: 1.Africa 2.Asia 3.Europe 4.Latin America and the Caribbean 5.Near East 6.North America 7.The Southwest Pacific
• The Regional Coordinators of the six regions
• Chair is same as of CAC
• The total membership of the CCEXEC is 17
The Secretariat
• The Codex Secretariat assists the CAC in the implementation of the Joint FAO/WHO Food Standards Programme
• Reports to the Director-Generals of FAO and WHO.
The Codex Secretariat is located at FAO headquarters in Rome.
The Subsidiary Bodies
Under its Rules of Procedure, CAC is empowered to establish four kinds of subsidiary bodies:
• General Subject Committees (sometimes referred to as horizontal), which establish standards and guidelines applicable to all foods;
• Commodity Committees (sometimes known as vertical), which prepare standards for specific commodities;
• FAO/WHO Coordinating Committees, through which regions or groups of countries coordinate food standards activities in the region, including the development of regional standards;
• Intergovernmental Task Forces, which are time-limited and prepare standards and guidelines on specific issues.
Codex General Subject Committee
• General Principles – France
• Food Additives – China
• Contaminants in food – Netherlands
• Food Hygiene – USA
• Food Import and Export Inspection and Certification Systems – Australia
• Methods of Analysis & Sampling – Hungary
• Pesticide Residues – China
• Residue of Veterinary Drugs in Foods – USA
• Food Labelling – Canada
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• Nutrition and Foods for Special Dietary Uses – Germany
Codex Alimentarius Commission and Member Countries
• Most of Members use some of Codex Standards/ texts as the basis of their legislation/ regulations/ guidelines etc.
. • Because – Internationally recognized – Based on sound science
Management of Codex Activities at National Level
1) Strengthening National Codex capacity through improving familiarity and understanding of Codex structures and processes – establishment and strengthening of NCCP, NCC, Codex Country Manual/ working procedures, websites;
2) Providing practical guidance on how to participate in Codex committees;
3) Support networking and collaboration at the national level bringing together all interested parties – National Codex Committee,
Codex Procedural Manual
• Intended to help Member Governments participate effectively in the work of the joint FAO/WHO Food Standards Programme
• Outlines the agreed set of rules to ensure the Commission and its subsidiary bodies work in a uniform manner
• Contains – Statues of CAC – Rules of Procedure – Additional procedures for the elaboration of Codex standards & related texts, basic definitions and guidelines for the operation of CAC & its subsidiary bodies (Codex committees)
Statutes of Codex
The Statutes of the Codex Alimentarius Commission
: • provide the legal basis for the Commission’s work;
• provide its mandate or terms of reference;
• describe the formal operating procedures; and
• reflect the concepts behind and reasons for the establishment of Codex.
The Statutes can be found in Section I of the Codex Procedural Manual
Statutes of Codex-Mandate
The mandate of the Codex Alimentarius Commission is clearly specified in the first article of its Statutes:
Article 1 – Mandate
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(a)protecting the health of the consumers and ensuring fair practices in the food trade;
(b)promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations;
(c) determining priorities and initiating and guiding the preparation of draft standards through and with the aid of appropriate organizations;
(d)finalizing standards elaborated under (c) above and publishing them in a Codex Alimentarius either as regional or worldwide standards, together with international standards already finalized by other bodies under (b) above, wherever this is practicable; (e)amending published standards, as appropriate, in the light of developments.
Statutes of Codex Membership
Article 2 – Membership
Membership of the Commission is open to all Member Nations and Associate Members of FAO and WHO that are interested in international food standards. Membership shall comprise such of these nations as have notified the Director-General of FAO or of WHO of their desire to be considered as Members.
Membership conditions to become a Member of the CAC, two conditions must be met: 1) The country must be a Member of either FAO or WHO. 2) The country must notify either the Director-General of FAO or of WHO of its wish to become a Member.
Codex Commodity Committees
• Commodity Committees that are active: – Milk and Milk Product – New Zealand – Fish And Fishery Products – Norway – Fats And Oils – Malaysia – Sugars – Colombia – Processed Fruits and Vegetables – USA – Fresh Fruits And Vegetables – Mexico – Cereal, Pulses and Legumes – USA – Spices and Culinary Herbs – India
• Commodity Committees that have been adjourned: – Meat Hygiene – New Zealand – Natural Mineral Water – Switzerland – Vegetable Proteins – Canada – Cocoa Products and Chocolates – Switzerland
In summary, practically all the work of Codex has had, and is having, a positive impact on safeguarding consumers and international trade. Harmonization of regulatory systems, including certification systems that promote increased competition in world trade while maintaining the highest level of protection for consumers, will result in a safer and less costly food supply
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throughout the world. Significant progress has been made in many of these areas through Codex Alimentarius but there is still much work to be done.
5.2 FSSAI (Food Safety and Standards Authority of India)
Food Safety and Standards Authority of India (FSSAI) is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. The FSSAI has been established under the Food Safety and Standards Act, 2006 which is a consolidating statute related to food safety and regulation in India. FSSAI is responsible for protecting and promoting public health through the regulation and supervision of food safety.
The FSSAI is headed by a non-executive Chairperson, appointed by the Central Government, either holding or has held the position of not below the rank of Secretary to the Government of India. FSSAI has its headquarters at New Delhi. The authority also has 6 regional offices located in Delhi, Guwahati, Mumbai, Kolkata, Cochin, and Chennai.
The FSSAI consists of a chairperson & 22 members. The FSSAI is responsible for setting standards for food so that there is one body to deal with and no confusion in the minds of consumers, traders, manufacturers, and investors.
The following are the statutory powers that the FSS Act, 2006 gives to the Food Safety and Standards Authority of India (FSSAI).
• Framing of regulations to lay down food safety standards
• Laying down guidelines for accreditation of laboratories for food testing
• Providing scientific advice and technical support to the Central Government
• Contributing to the development of international technical standards in food
• Collecting and collating data regarding food consumption, contamination, emerging risks etc.
• Disseminating information and promoting awareness about food safety and nutrition in India
The FSSAI functions under the administrative control of the Ministry of Health and Family
Welfare. The main aim of FSSAI is to
• Lay down science-based standards for articles of food
• To regulate manufacture, storage, distribution, import and sale of food
• To facilitate safety of food
The FSSAI has prescribed standards for following food products:
• Dairy products and analogues
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• Fats, oils and fat emulsions
• Fruits and vegetable products
• Cereal and cereal products
• Meat and meat products
• Fish and fish products
• Sweets & confectionery
• Sweetening agents including honey
• Salt, spices, condiments and related products
• Beverages, (other than dairy and fruits & vegetables based)
• Other food product and ingredients
• Proprietary food
• Irradiation of food
FSSAI FSSAI stands for Food Safety and Standards Authority of India which is an organization that monitors and governs the food business in India. It ensures the food products undergo quality checks thereby curtailing the food adulteration and sale of sub-standard products. It is responsible for the registering and licensing of the food business operators (FBO) in India and it lays down the rules and regulation for running the food business in India.
Importance FSSAI Enrollment
Each nourishment business administrator associated with the assembling, preparing, capacity dispersion and clearance of nourishment items should obligatorily get FSSAI Enrollment or Permit. FSSAI Enrollment is not quite the same as FSSAI Permit as in relying upon the size and nature of the business, FBO ought to acquire the essential enlistment or permit.
It is a 14-digit enlistment or a permit number which is imprinted on all the nourishment bundles. This enrollment technique is intended to make greater responsibility on the FBO to keep up the nature of the nourishment items.
FSSAI Enlistment/Permit System
FSSAI enlistment or permit depends on the business volume and premises. Contingent on the introduced limit or turnover or area, candidate premises are qualified for the permit, for example, focal permit, state permit, enlistment, railroad and so forth
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FSSAI Enlistment Prerequisites
FSSAI Enlistment is a fundamental permit and it is required for all the FBO engaged with the little scale nourishment business. This class covers the accompanying business
1. Any FBO with a yearly turnover of not more than Rs. 12 Lakhs
2. Petty retailer managing in nourishment items
3. Any individual who fabricates or sells any nourishment article independent from anyone else
4. Food deal is finished by the impermanent slow down holder
5. Any person who appropriates nourishment in any strict or get-together with the exception of a cook
6. Small-scale or bungalow ventures managing in the nourishment business and the accompanying:
Methodology for Getting FSSAI Enrolment
1. FSSAI enrollment is started by submitting Structure An (application) to nourishment and wellbeing division.
2. This application can be acknowledged or it might be dismissed by the Division inside 7 days from the application date and the reality must be suggested to the candidate recorded as a hard copy
3. If the application is acknowledged, at that point the division will give an enrollment authentication with the enlistment number and the photograph of the candidate.
4. FBO ought to unmistakably show the declaration of enrollment at the spot of business during the business hours.
Regular reports required for getting FSSAI enrollment
1. Form B – finished and marked
2. Photo Character of FBO
3. Proof of ownership of premises (eg. Tenant contract)
4. Partnership Deed/Endorsement of Joining/Articles of Affiliation and so on
5. List of nourishment items to be managed
6. Food security the executive’s framework plan
FSSAI Permit Necessity
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For all other FBO separated from little scale business, FSSAI permit must be acquired. FSSAI Permit can be characterized into two classifications for example State FSSAI Permit and Focal FSSAI Permit dependent on the size of the business whether it is a medium scale or enormous scale business.
For the most part, FBO who are enormous makers, merchants, exporters managing in huge scale nourishment business need to acquire FSSAI enlistment from focal government and FBO with little to medium measured assembling units, transporters, advertisers, brokers, and so forth., need to take FSSAI enrollment from the state government.
Documents required for obtaining the central license:
1. Form B properly finished and marked
2. Plan of the handling unit demonstrating the measurements and activity astute region allotment
3. List of Chiefs/Accomplices/Owner with address, contact subtleties, and picture ID
4. Name and rundown of hardware and apparatus utilized with the number and introduced limit
5. List of nourishment classification to be made
6. Authority letter from maker named a dependable individual name and address
7. Analysis report of water to be utilized in the process to affirm the movability
8. Source of crude material for milk, meat and so on
9. Recall plan any place relevant
10. Ministry of Trade Declaration for 100% EOU
11. NOC/Dad record gave by FSSAI
12. IE code record gave by DGFT
13. Form IX
14. Certificate from Service of The travel industry
15. Proof of ownership of premises
16. Partnership deed/affirmation of ownership
17. NOC and duplicate of Permit from the producer
18. Food wellbeing the board framework plan or testament
19. NOC from the district or neighborhood body
20. Supporting report for confirmation of turnover and transportation
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21. Declaration structure
Reports required for the acquiring the state permit:
1. Form B appropriately finished and marked
2. Plan of the preparing unit demonstrating the measurements and activity savvy territory assignment
3. List of Executives/Accomplices/Owner with address, contact subtleties, and personal ID
4. Name and rundown of hardware and apparatus utilized with the number and introduced limit
5. List of nourishment class to be fabricated
6. Authority letter from producer designated a capable individual name and address
7. Analysis report of water to be utilized in the process to affirm the conveyability
8. Proof of ownership of premises
9. Partnership deed/sworn statement of ownership
10. NOC and duplicate of Permit from the producer
11. Copy of testament acquired under Coop Act 1861/Multi state Coop Act 2002
12. Food wellbeing the executive’s framework plan or authentication
There are various structures and reports which are required to be submitted transformation, recharging, and adjustment of permit.
BIS (Bureau of Indian Standards) BIS stands for Bureau of Indian Standards. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways – providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties etc. through standardization, certification and testing. It is headquartered at New Delhi and has five regional offices which are located at Chandigarh, Mumbai, Chennai, Kolkata, and Delhi. As of 2015, Smt. Alka Panda is the Director General of BIS.
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Bureau of Indian Standards (BIS) came into existence, through an Act of Parliament on 1 April 1987, with a broadened scope and more powers taking over the staff, assets, liabilities and functions of erstwhile Indian Standards Institution (ISI) with following objectives. • Harmonious development of activities of standardization, marking and quality certification • To provide new thrust to standardization and quality control • To evolve a national strategy for according recognition to standards and integrating them with growth and development of Industrial production and exports. BIS is involved in multifarious activities like Standards Formulation, Certification, Product/Schemes. Laboratory Services, International Activities, Consumer – related Activities, Promotional Activities, Training Services, Information services, Sale of Standards & Publication. Standards Formulation Under Standards formulation, it is engaged in formulation of Indian Standards for 14 sectors namely Chemicals, Food and Agriculture, Civil, Electrical, Electronics & Telecommunications and Information Technology, Mechanical Engineering, Management & Systems, Metallurgical Engineering, Petroleum, Coal & related Products, Medical and Hospital Planning, Textile, Transport engineering and Production and General Engineering, Water Resources under Division Councils which have 308 Sectional Committees working under them. As on 31 March 2008, 18424 Standards formulated by BIS, are in force. These cover important segments of economy, which help the industry in upgrading the quality of their goods and services. BIS formulates need-based Indian Standards in line with the national priorities as a time-bound programme. Product Certification Scheme
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BIS Product Certification Scheme is basically voluntary in nature. However, keeping in view the health and safety of the consumer, it has been made mandatory for 68 items by the Government through various statutory measures such as Prevention of Food Adulteration Act, Coal Mines Regulations and Indian Gas Cylinders Rules besides BIS Act. Some of the items brought under mandatory certification on consideration of health and safety are milk powder, packaged drinking water, LPG cylinders, oil pressure stoves, clinical thermometers etc. As on 31 March 2008, 20025 certification marks licences are in operation under the Scheme, covering about 1000 different items ranging from food products to electronics. All foreign manufacturers of products who intend to export to India are required to obtain a BIS product certification licence. Towards this, BIS launched its Product Certification Scheme for overseas manufacturers in the year 1999. Under the provisions of this scheme, foreign manufacturers can seek certification from BIS for marking their product(s) with BIS Standard Mark. Under this scheme, about 101 licences of foreign manufacturers in about 15 countries are in operation as on 31 March 2008. Under the scheme for Indian importers, Certification Marks Licence can be granted to Indian importers for the product imported into the country and are not covered under Regulatory Requirements. Indian importers can apply for BIS licence on such products and they are treated as Indian manufacturers. Three licences are in operation under this scheme. BIS also runs other certification schemes like IECEE-CB, IECQ and IECEs Schemes of IBC under different provisions. India is a certifying member of the IEC System of Quality Assessment of Electronic Components (IECQ) and IEC System for Conformity Testing to Standards for Safety of Electrical Equipment (IECEE). Further, BIS has taken new initiatives like simplification of procedure for grant of licence, basically to reduce the procedural time. This has yielded some encouraging results. Laboratories To support the activities of product certification, BIS has a chain of 8 laboratories. These laboratories have established testing facilities for products of chemical, food, electrical and mechanical disciplines. Approximately, 25000 samples are being tested in the BIS laboratories every year. In certain cases where it is economically not feasible to develop test facilities in BIS laboratories and also for other reasons like overloading of samples, equipment being out of order, the services of outside approved laboratories are also being availed. Except for the two labs,
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all the other labs are NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited. BIS has recognized about 116 laboratories for product certification purposes. BIS has undertaken the project of modernization of all its testing laboratories in order to increase the in-house capacity of testing of samples as well as to reduce the time taken in testing. Hallmarking Hallmarking of Gold Jewellery started in April 2000 on voluntary basis under BIS Act 1986. It is aimed at to protect the consumer’s interest and providing third party assurance to consumers on the purity of gold. Till 31 Mar 2008, 91 hallmarking centres have been recognized. Since the launch of the scheme, over 5403 gold jewellers have taken licence from BIS, a figure which stood at 186 in the year 2001-02. So far, over 381 lakh jewellery articles have been hallmarked. The list of hallmarked jewellers with BIS licence and BIS recognised hallmarking centres has been hosted on BIS website. Under a similar scheme of Hallmarking of Silver, 405 licences have been granted since its launch in October 2005. Management Systems Certificate BIS runs other important systems certification schemes under the Management Systems Certification. Under Quality Management System Certification Scheme (QMSCS), which was launched in September 1991, the total number of operative licences as on 31 Mar 2008 is 1161 which has grown from the figure of 916 in 2001-2002. BIS Quality Management System Certification has been accredited by Raad voor Accreditatie (RvA) Netherlands for 23 major economic activities. • Under Hazard Analysis and Critical Control Point Certification (HACCP) Integrated Scheme, 64 certified companies are under operation as on 31 March 2008. Under the Environmental Management Systems Certification Scheme (EMSCS), the total number of operative licences as on 31 March 2008 is 131 which has grown from a figure of 61 in 2001-02. Under the Occupational Health & Safety Management System (OH & SMS) Certification Scheme, which was launched in January 2003, the total number of operative licences as on 31 Mar 2008 is 35. • Among the new Schemes, BIS has launched public Service Delivery Management systems as per IS 15700-2005 “Quality Management Systems – Requirements for Service Quality by Public Service Organizations.” in order to ensure minimum standards of service delivery in all sectors pertaining to or influenced by the government.
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Enforcement activity • With the growth and popularity of the BIS Certification Marks Scheme, there have been instances of misuse of BIS Standard Mark also. BIS, therefore, lays emphasis on enforcement activity to stop misuse of Standard mark, enforcement raids are carried out and prosecution cases filed in the court of law wherever legally tenable. To strengthen this activity, two outsourced agencies have been engaged for providing intelligence and assisting in carrying out raids against offending parties for an initial period of one year in selected locations. The number of search and seizures operations carried out in 2007-08 stand at 125. International Activities • Since its inception in 1947, the then ISI and now BIS has been an active member of international organisations namely, ISO and International Electronical Commission (IEC). BIS represents India as Member Body in ISO and IEC. It holds Participating Membership (P) status in 259 Technical Committees/ Sub-committees of ISO and 62 Technical Committees/ Sub-committee of IEC, whereas it is Observer Member (O) on 308 Technical committees/ Sub-committees of IDO and 84 Technical Committees/Subcommittees of IEC. It participates in various policy-making committees of these international standards bodies. BIS also holds secretariat of some of the important ISO/IEC Committees which are of trade interest of India. As member of ISO, BIS also takes active part in the development of International Standards with a view to protect the interests of Indian trade & industry. BIS is actively involved is Regional and Bilateral Cooperation Programmes pertaining to standardization, conformity assessment & accreditation etc. It has signed MoU/MRA with 16 countries/organizations including ISO and American National Standards Institute (ANS) of USA to this effect. Consumer protection • To meet with the growing expectations of consumers in the country, BIS has established a separate department with a specific mandate of providing consumer protection and welfare and dealing with public grievances. This department maintains liaison with Central Consumer Protection Council and consumer associations and coordinates with the Ministry of Consumer Affairs and Public Distribution on consumer issues. It is guided in its activities by a Consumer Policy Advisory Committee which advise BIS on all policy
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matters relating to efficient discharge of the functions and for making standardization and certification activities user-friendly. A well-defined procedure has been established for handling complaints. The complaints can also be lodged on line, and are monitored regularly. • Promotion of Indian Standards assumes great significance and has been a prime objective of BIS . All standards are generally voluntary in nature. Promotional activities are, therefore, essential to implement the standards for deriving the desired benefits. • The promotion of standardization involves varied interests ranging from ordinary consumers to educational institutions. To propagate the concept of standardization and quality systems among small scale industries, discussions and video film shows are organised where the participants are exposed to the concepts of standardization, quality system, product certification and other BIS activities. Rajiv Gandhi National Quality Award • With a view to encourage manufacturers and service organizations to strive for excellence, Rajiv Gandhi National Quality Award was instituted by the Bureau in 1991. This annual award compares well with similar international awards, such as, Malcolm Baldrige National Quality Award of USA and European Quality Award. The assessment for this award is made based on parameters, such as, Leadership, Policies objectives and Strategies; Human Resources Management; Resources, Processes; Customer Focus; Employees’ Satisfaction; Business Results and Impact on Environment and Society. Information & SSI Facilitation Cell • Marching further ahead on the path of ‘total customer satisfaction’ BIS had set up a single window Information & SSI Facilitation Cell at its headquarters in New Delhi which became operational since 1997 with the aim of providing variety of information/assistance. Several entrepreneurs, consumers and professionals visit this centre. National Institute of Training for Standardization (NITS) • To impart training to technical and management personnel from industry, consumer organizations, public sector undertakings, government bodies and developing countries, BIS has established, the National Institute of Training for Standardization (NITS) at NOIDA (U.P.)
Indian Culinary Institute, Noida
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• NITS conduct training on Quality Management Systems as per IS/ISO 9001, Environment Management Systems as per IS/ISO 14001, Occupational Health and Safety Management Systems as per IS 18001, Food Safety Management Systems as per IS/ISO 22,000, Hazard Analysis and Critical Control Points (HACCP) and Laboratory Management Systems as per IS/ISO/IEC 17025. It also conducts International Training Programmes in Standardization and Quality Systems and on Management systems for developing countries of Asia, Africa, Europe and Latin America every year since 1968. NITS also conduct training programmes for BIS employees. On an average, about 630 personnel have been trained/retrained every year since last six years. Library • BIS Technical Library is a national resource centre for information on standards and related matters and meets the needs of industry, trade, government, researchers and consumers. It is the largest library of standards in the South Asian Region, covering a floor area of 1000 square meters. The collection includes about 6 lakh standards from all over the world and 50,000 technical books. The Bureau’s library system comprises the Headquarters’ Library (New Delhi) and four Regional Office Libraries at Mumbai, Kolkata, Chandigarh and Chennai. BIS has also been designated as WTO/TBT Enquiry Point by the Ministry of Commerce, Government of India under the Technical Barriers to Trade Agreement of World Trade Organization. • BIS has brought out all Indian standards on CD-ROMs through a franchisee with a view to computerize its sales points as well as to provide standards in electronic form directly to the customers. The product has been well received by the industry and provides excellent full text searching facility in over 18,000 standards formulated by the Bureau. • BIS has a website with domain name www.bis.org.in which includes its Hindi version also. Information of interest to the Indian industry as well as consumers, relating to various activities and schemes of the Bureau, such as certification, standards formation, consumer affairs, various application forms, laboratory services and other support services, is available on the website. Finance & Account
Indian Culinary Institute, Noida
Food Quality Management Note 63 | P a g e
For over a decade now, BIS is self-reliant in meeting its non-plan expenditure without any budgetary support from the Government of India. Financial resources of BIS are broadly mobilized under the following heads: • product Certification • Management System Certification • Hallmarking • Sale of BIS Standards and Publications • Training Institute.
Question Bank for Food Quality Management
Write a detail note on
Quality Control Circle
Codex Alimentarius
FSSAI
TQM
Quality Assurance
Importance of quality management in the organization
Advantages of ISO certificate
legal meteorology department
Quality Control
• What is HACCP? Explain the principle and implemented process of HACCP
• Write an essay on International Organization for Standardization (ISO).
• What do you understand by QCC
• What is the role of FSSAI
• Responsibilities of codex Alimentarius commission (CAC).
• Basic tools of quality management