Quality Assurance and Certification

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Sau. KSK alias KAKU College of Food Technology, Beed
KSK CFT
FMS - 367 (2+1)
Quality Assurance and Certification
B.Tech (Food Technology)
6th semester
【 Email :- tkdhulgand@gmail.com 】
FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.
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(1-2) Introduction to Quality: Defining quality, Dimensions of quality, Quality control &quality assurance, Quality
Gurus’ Contribution
 Quality :-
it has been said, should make a product what it is, conforming to requirements or specifications. In this context, quality
may be defined in different manners depending on the interest of the manufacturers, or how they want to impress it upon
their customers. One difficulty in using this approach is that the definition of quality is neither precise nor consensual.
Quality-like terms such as effectiveness, satisfaction, and leadership, are descriptors rather than concepts, and no
objective referenceIntroduction: Concepts exists. Its definition is in the minds of the definers, so no single definition is
correct for every circumstance. In each case, quality has always been used as a qualifier in describing some product or
service: high-quality product, high-quality education, high-quality art, high-quality health care, etc.9
Thus, in industrial manufacturing practices, quality can have several definitions, as follows:
Product-based. Based on features or attributes of the product that enhance quality, e.g., organically manufactured food
products as opposed to regular products.
User-based. The user determines the quality of the product. Joseph Juran defines this user-based quality as “fitness for
use,” e.g., ready- to-eat microwaveable dinners as opposed to other forms of manufactured dinners.
Manufacturing-based. Conformance to specifications. Manufacturing engineering specifies the product characteristics and
the more closely manufacturing can conform to those requirements, the better the quality of the product.
Value-based. The element of price is introduced into the definition of quality. Quality is the degree of excellence at an
acceptable price and the control of variability at an acceptable cost. Value comprises price and quality of product and
service.
 Dimensions of Quality :-
The definition of quality also must take into consideration its dimensions, which include strategic as well as operational
aspects that play an impor-tant role in characterizing the product presented to customers. In this context, there are two
types of quality:
Design. This determines the market segment. It is not only an engineering decision, but involves customers, manufacturing,
and other stakeholders.
Conformance. David A. Garvin10,11 came up with eight dimensions of quality to link customer requirements to engineering
design.
1. Performance. Refers to the primary operating characteristics of the product or service; they are usually measurable, e.g.,
miles per gallon, number of rooms, baths, etc. in a house.
2. Features. Additional characteristics that enhance the product’s or service’s appeal to the user, e.g., deleaded ink used
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for news-papers, glare-reducing coatings on bulbs, etc.
3. Reliability. The likelihood that a product will not fail within a specific time period, e.g., services that guarantee mail
delivery (certified mail, etc.).12 Quality Assurance for the Food Industry: A Practical Approach
4. Conformance. The precision with which the product or service meets the specified standards. Approaches such as using
prespecified tolerance limits.
5. Durability. Measures the length of a product’s life, e.g., shelf life of food products, light bulbs. When a product can be
repaired, estimating durability is more complicated.
6. Serviceability. The speed with which the product can be put into service when it breaks down, as well as the competence
and behavior of the service person. The speed of service can be measured by response time and mean time to repair
(MTTR).
7. Aesthetics. The subjective dimension indicating the kind of response a user has to a product. It represents the
individual’s personal preference — the ways an individual responds to the look, feel, sound, taste, and smell.
8. Perceived quality. Also a subjective dimension; it is the quality attributed to goods or services based on indirect
measures. Inferring the quality of an airline by the cleanliness of the flipdown tray. Well-maintained tools and an
immaculate workplace may indicate a good workman.
In summary, the term quality, without being defined by some standard, means very little. As stated by Gould and Gould,
industry defines quality as a measure of purity, strength, flavor, color, size, maturity, workmanship and conditions, or any
other distinctive attribute or characteristic of the product. On the other hand, the trade generally uses the term in the sense
of the finest product attainable.
Food processors have learned that consumers recognize brands that maintain their quality at the standard set for that
particular product, and on this basis, high-quality products never fail to sell; the attainment of such quality is the outgrowth
of good, sound QA practices.
In recent years, the focus on quality has changed and, more and more, quality has begun to take on the appearance of
organizational performance. Managers have become converted to the pursuit of quality as the single most important
organizational objective.
 Quality Control and Quality Assurance :-
Many well-established companies give product quality a primary role in the organization. This effort requires a special
group of professionals that the companies include under a vice president of quality assurance who reports directly to the
president. Quality assurance (QA) describes and manages the activities of control, evaluation, audits, and regulatory
aspects of a food processing system. A QA program consists of an in-house consulting organization; it evaluates the
quality program and gives advice, suggestions, and instructions for its improvement. The QA department should report
directly to top management in order to have independence in serving the organization. If quality is to be the primary goal of

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a food manufacturing company, the head of quality assurance should have the title of vice president and report directly to
the president of the enterprise. In headquarters, there should be a staff to assist the vice president, with quality
professionals reporting to a director of QA and supporting quality efforts in each corporate division. QA is an advisory
function, not a police function. It is not responsible for the quality program, it does not operate the system, and it does not
do quality control. QA may audit the system and provide assistance in making improvements, but the planning, organizing,
staffing, directing, and controlling of the quality program are in the hands of upper and production management. A
divisional quality control (QC) staff promotes quality in the division and assists and consults with production as required;
the responsibility for the quality of divisional products rests directly with production. In particular, QA is not responsible for
the quality of the products the organization provides to its customers. The QC professionals of the company are staff
personnel with responsibility for assisting production in quality-related matters. They should report to the division director
of QA, with a strong link (“dotted line” relationship) to plant management (Figure 3.1). The divisional QC personnel look to
the vice president of QA for direction and assistance, and support his programs.

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According to Burrill and Ledolter,1 a vice president for QA is charged with specific responsibilities that include:
 Serving as a focal point for quality matters, including corrective action and continual improvement activities
 Formulating and recommending company policies, strategies, tactics, and goals and objectives relating to quality
 Reviewing and helping to coordinate quality aspects of design of line plans
 Assisting and counseling top managers on quality matters Exercising authority over QA groups in different plants
Concurring with the appointment of QA directors for different plants Serving as a resource for information in the
quality area, including regulatory and competitive information
 Coordinating the efforts of standards committees, quality improvement teams, and other groups whose activities
touch on the quality area
 Monitoring quality and reporting to top managers on the status of quality in the enterprise
 Providing leadership for the quality function as necessary Fostering awareness of quality and helping to gain
credibility for the quality improvement effort
 Interacting on quality matters with external organizations, e.g., government agencies, professional associations,
etc.
QA is a relatively new area of activity in the food industry, beginning in the late 1950s to early 1960s with the advent of
concepts such as Hazard Analysis and Critical Control Points (HACCP) as a means of preventing, rather than correcting,
the occurrence of defects and contamination or the presence of foreign substances during product manufacture. Although
more than 40 years have passed since then, the concept of a QA program is still not well understood by many and is
confused with QC. Unfortunately, these two terms have been used indiscriminately and the difference between them is
blurred. Many companies refer to their QA program, but when discussing it, or through inspection, what it comes out is that
it is a QC program. This occurs particularly with mid- and small-size food manufacturing plants and with many companies
in the dietary supplements industry. QC constitutes a fundamental part of a QA program, but is normally associated with
the production line to regulate it to some standard.2 So, a distinction needs to be drawn between QA and QC. According to
the International Standards Organization (ISO 8402 – Terminology), QA is “all those planned and systematic actions
necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.” In other
words, QA is a strategic management function that establishes policies, adapts programs to meet established goals, and
provides confidence that these measures are being effectively applied. QC, on the other hand, is “the operational
techniques and activities that are used to fulfill requirements for quality” (ISO 8402 — Terminology), i.e., a tactical function
that carries out the programs established by the QA. During the last 2 decades, further changes have been taking place in
the area of QA, particularly with the development of the concepts and applications of Total Quality Management (TQM), the
empowerment and training of the line operator, and the practices for the control of quality on the production line, reducing
the work of the QC laboratory. By empowering the line operator to control his unit operation to given specifications — as
part of this process — the quality of the product can be more uniform and consistent. The work of QC, a fundamental part of

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a QA program, in all manufacturing unit operation steps of a process, and the evaluation of the final product at the end of
the line, or in the market, together with human management, and management of regulatory aspects of the food industry
are what in modern terms constitute the QA field.
FUNCTIONS OF A QUALITY ASSURANCE PROGRAM :-
Information on food quality and food manufacturing is currently more readily available to consumers through the mass
media. In many countries, the safety and quality of foods are becoming a matter of increasing concern and consumers are
considerably more aware of existing and potential risks in their food from various sources: pesticides, food poisoning, and
a poor diet. Demonstrating the impact of this greater awareness, consumers often prefer to buy foods that are made by
larger, more recognizable manufacturers, because larger companies are supposed to have better quality products or
manufacture their products under optimum conditions of quality, although many mid-size and small companies produce
equally excellent quality foods. Irrespective of the specific nature of the food-processing unit, food processors are
responsible for the quality and safety of the food they produce. This obliges corporations to emphasize quality as the most
important factor in their business, something they can only obtain through a well-established QA program.
What then are the functions of a QA department? QA functions involve establishing and managing the company’s quality
organizations, designing operating procedures, discussing the quality direction with top management, introducing them to
the fundamentals of quality, and making certain there is consistency in management pronouncements. The minimum
requirement is for food processors to apply good sanitation practices, which include the design and layout of the premises,
provision of adequate facilities, and programs for cleaning and sanitation (pest control), as set out in the Code of Federal
Regulations 21 CFR Part 110 of the United States and in Codex General Principles of Food Hygiene of the United Nations.
Additional QA programs, such as Hazard Analysis and Critical Control Point (HACCP), audits of several areas of
manufacturing, of sanitation, and of the product in the market are also the responsibilities of a QA department. QA
programs enable the application and verification of control measures intended to assure the quality and safety of food.
They are required at each step in the food production chain to ensure safe food and to show compliance with regulatory
and customer requirements. The programs are a set of controls implemented and verified by the responsible person(s) at
each step in the chain (e.g., producers, farmers,fishermen, food processors, retailers, distributors, storage and transport
personnel, etc.). Governments have an important role in providing policy guidance on the most appropriate QA programs
and verifying and auditing their implementation as a means of regulatory compliance. Selection and application of QA
programs can vary depending on the step in the food production chain, size of the food business, type of product produced,
etc., and may include Good Manufacturing Practices (GMPs), Good Agri- cultural Practices (GAPs), Good Laboratory
Practices (GLPs), HACCP systems, and HACCP-based systems.
Regulatory agencies and food companies are improving QA programs to meet the demands for safe, high-quality foods.
Successful management programs that enable food processors to address global marketplace opportunities while
maintaining high quality and safety are more common.
The primary function of a QA department is to provide confidence for management and the consumer — the person a
company must satisfy and who actually establishes the level of quality of the products a company manufactures. The
function of QA in this sense is never ending. A company builds its product specifications and legal requirements around
consumer preferences, and only by having an integrated and well-planned quality program can a food company succeed in

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supplying the customer with the desired products. The role of the QA department and the professional in this area is to
guarantee that the consumer receives what he desires and that the company makes the profit it deserves. The QA
department must also maintain monitoring activities on the available growing literature on concepts, techniques, and
programs related to quality issues, to select the best ideas and bring them to management’s attention.
Some companies assign the QA department additional functions in product development, plant sanitation, waste disposal,
and research on processes, equipment, ingredients, etc. These are all specialized areas and require expertise for success.
Perhaps the most significant aspect of a QA program is the fact that through its functions, upper management is able to
monitor, at all times and through all stages of manufacturing, the level of quality of its product, as well as keeping in line
with industry trends.
By reporting directly to upper management, the QA professional is provided with the necessary independence to be
effective in his or her functions. In turn, the QA professional needs to be competent and knowledgeable in the various
aspects of the food industry, including regulatory, processing, sanitation, safety, and human relations. Thus, the selection,
training, and respect given to QA professionals are very important factors of the company’s quality program. The QA
department’s personnel should be considered as in-house consultants, advisors, and trainers for the company, to help the
production of quality products through audits, to make recommendations for improvements, and to provide assistance in
making such improvements.3 To reach and maintain these goals, a QA program is built around three fundamental functions:
Quality Control :-
A program established around a processing operation to regulate a resulting product by some standard, the function of QC
is associated with the production line, i.e., with specific processes and unit operations. QC activities are the operator’s
tools that help him to maintain a production line in accordance with predetermined parameters for a given quality level.
Quality Evaluation :-
Describing or appraising the worth of a product, quality evaluation generally means taking a measurement of the product to
the QC laboratory to evaluate the performance of incoming materials, products in process, or finished products. The
finished product can be evaluated as offered in the market, ready for the consumer. This is carried out by product quality
audits.
Quality Audits :-
Quality audits are programs designed to verify or examine a product or manufacturing process over time. These can be
classified as manufacturing quality audits, sanitation/GMPs audits, HACCP audits, product quality audits, and other special
types of audits. A quality audit is a fundamental part of a QA program. It allows for quality verification of a product during
manufacture, in the warehouse, in the distribution system, and in the market to assess performance over time or for
comparison to competitor brands.
Each person with responsibility for a portion of the program should conduct regular assessments or reviews of the
effectiveness of the quality program and its operation. Such assessments are a normal part of good process management.
In addition, there should be a systematic review of the quality program by an authority that is not directly responsible for

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the process or its operations; such a review is a quality audit. A quality audit is a planned, systematic examination of a
manufacturing program and its implementation to determine its adequacy and the degree of conformance to it. It
concentrates on quality-related aspects of production.

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(3-5) Total Quality Management: Objectives, principles, implementation; Deming’s 14 points on TQM, Benefits of
TQM, Quality Tools, Quality Circle
The Concept of Total Quality Management :-
Total Quality Management (TQM) is based on a number of ideas. It means thinking about quality in terms of all functions of
the enterprise, and it can be viewed as a management-led approach in which top management commitment is essential, a
start-to-finish systems approach that integrates interrelated functions at all levels. TQM considers every interaction
between the various elements of the organization. The emphasis is on quality in all aspects and functions of the company
operation, companywide, not just the manufacturing function or provision of a major service to the external end-customer.
Employee awareness and motivation are essential. All are responsible for ensuring quality in terms of satisfying the
customer in all they do, and the approach is one of prevention of errors and faults rather than detection and correction.
Thus, the overall effectiveness of the system is higher than the sum of the individual outputs from the subsystems.
The subsystems include all the organizational functions in the life cycle of a product, such as design, planning, production,
distribution, and field service. Management subsystems also require integration, including strategy with a customer focus,
the tools of quality, and employee involvement (an important linking process that integrates the whole). A corollary is that
any product, process, or service can be improved, and a successful organization is one that consciously seeks and exploits
opportunities for improvement at all levels. The load-bearing structure is customer satisfaction. The watchword is
Continuous Improvement. Following the Japanese, most TQM programs extensively employ teamwork to provide improved
planning analysis and problem solving, communication, motivation, and collective responsibility. The 1990s were set to be
the decade of quality. Preoccupation with quality improvement as a competitive force swept across North America and
established bridgeheads in Europe in the 1980s. Some of the American quality gurus, such as Armand Feigenbaum, went as
far as identifying quality as the single most important force in organizational success and growth for the 1990s and for the
new millennium.
The Basis for Superior Quality Performance :-
By the mid- to late-1980s, TQM was all the rage. Billions of dollars were invested in training, consulting, and management
education efforts in an attempt to close the quality gap between the U.S. and Japan. The concept and principles, though
simple, seemed to be creeping into existence by bits and pieces through the evolution of the ISO 9001 Management Quality
System standard. Companies that implemented TQM included Ford Motor Company, Phillips Semiconductor, SGL Carbon,
Motorola, and Toyota Motor Company. In 1987, Congress created a national quality award competition named in honor of
Commerce Secretary Malcolm Baldrige. The Baldrige Award has been a central element both in promoting American quality
progress and providing a framework for evaluating an organization’s management effectiveness. This latter aspect is even
more prominent with major changes that have been made in the 1997 award criteria, emphasizing business results, markets,
and strategic planning. One of the keys to implementing TQM can be found in its definition and in the fact that TQM is a
structured system. Describing TQM as a structured system means it is a strategy derived from internal and external
customer and supplier wants and needs determined through daily management and cross-functional management.
Pinpointing internal and external requirements allows continuous development, improvement, and maintainence of quality,
cost, delivery, and morale. TQM is a system that integrates all of these activities and information.

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TQM Objective :-
 Total customer satisfaction
 Totality of functions
 Total range of products and services
 Addressing all aspects of dimensions of quality
 Addressing the quality aspect in everything – products, services, processes, people, resources and interactions.
 Satisfying all customers – internal as well as external
 Addressing the total organizational issue of retaining customers and
 Improving profits, as well as generating new business for the future.
 Involving everyone in the organization in the attainment of the said objective.
 Demanding total commitment from all in the organization towards the achievement of the objective.
THE PRINCIPLES OF TQM :-
TQM’s primary objective is to achieve customer satisfaction by involving everybody dealing with product manufacturing,
directly or indirectly. To do this, TQM operates on the basis of the following principles:
1. Involve and respect people: everyone associated with the organization, including personnel, customers, and suppliers.
Management must be involved by providing leadership.
2. Processes, not people, are the problem.
3. Every employee is responsible for quality.
4. Everyone is a customer and a supplier.
5. Prevent problems. Do not wait for them to occur and then fix.
6. Involve the processes of preparing and delivering products and services to customers.
7. Quality improvements must be continuous.
8. Quality can and must be managed.
9. Plan and organize for quality improvement.
10. The quality standard is: defect free.

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11. Goals are based on requirements, not negotiated.
12. Life cycle costs, not front end costs.
The 10 Steps to TQM :-
Maintenance of these principles is based in turn on 10 steps recognized as fundamental to a TQM program.
1. Pursue new strategic thinking
2. Know your customers
3. Set true customer requirements
4. Concentrate on prevention, not correction
5. Reduce chronic waste
6. Pursue a continuous improvement strategy
7. Use structured methodology for process improvement
8. Reduce variation
9. Use a balanced approach
10. Apply to all functions
IMPLEMENTING TQM SYSTEMS :- 12 steps
1. Top management learns about and decides to commit to TQM. TQM is identified as one of the organization’s
strategies.
2. The organization assesses current culture, customer satisfaction, and quality management systems.
3. Top management identifies core values and principles to be used, and communicates them.
4. A TQM master plan is developed on the basis of steps 1, 2, and 3.
5. The organization identifies and prioritizes customer demands and aligns products and services to meet those
demands.
6. Management maps the critical processes through which the organization meets its customers’ needs.
7. Management oversees the formation of teams for process improvement efforts.
8. The momentum of the TQM effort is managed by the steering committee.

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9. Managers contribute individually to the effort through hoshin planning, training, coaching, or other methods.
10. Daily process management and standardization take place.
11. Progress is evaluated and the plan is revised as needed.
12. Constant employee awareness and feedback on status are provided and a reward/recognition process is
established.
WeDeming 14 Points on Quality Management :-
1. Create a constant purpose toward improvement :-
 Plan for quality in the long term.
 Resist reacting with short-term solutions.
 Don't just do the same things better – find better things to do.
 Predict and prepare for future challenges, and always have the goal of getting better.
2. Adopt the new philosophy :-
 Embrace quality throughout the organization.
 Put your customers' needs first, rather than react to competitive pressure – and design products and services to
meet those needs.
 Be prepared for a major change in the way business is done. It's about leading, not simply managing.
 Create your quality vision, and implement it.
3. Stop depending on inspections :-
 Inspections are costly and unreliable – and they don't improve quality, they merely find a lack of quality.
 Build quality into the process from start to finish.
 Don't just find what you did wrong – eliminate the "wrongs" altogether.
 Use statistical control methods – not physical inspections alone – to prove that the process is working.
4. Use a single supplier for any one item :-
 Quality relies on consistency – the less variation you have in the input, the less variation you'll have in the output.
 Look at suppliers as your partners in quality. Encourage them to spend time improving their own quality – they
shouldn't compete for your business based on price alone.

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 Analyze the total cost to you, not just the initial cost of the product.
 Use quality statistics to ensure that suppliers meet your quality standards.
5. Improve constantly and forever :-
 Continuously improve your systems and processes. Deming promoted the Plan-Do-Check-Act approach to process
analysis and improvement.
 Emphasize training and education so everyone can do their jobs better.
 Use kaizen as a model to reduce waste and to improve productivity, effectiveness, and safety.
6. Use training on the job :-
 Train for consistency to help reduce variation.
 Build a foundation of common knowledge.
 Allow workers to understand their roles in the "big picture."
 Encourage staff to learn from one another, and provide a culture and environment for effective teamwork.
7. Implement leadership :-
 Expect your supervisors and managers to understand their workers and the processes they use.
 Don't simply supervise – provide support and resources so that each staff member can do his or her best. Be a
coach instead of a policeman.
 Figure out what each person actually needs to do his or her best.
 Emphasize the importance of participative management and transformational leadership.
 Find ways to reach full potential, and don't just focus on meeting targets and quotas.
8. Eliminate fear :-
 Allow people to perform at their best by ensuring that they're not afraid to express ideas or concerns.
 Let everyone know that the goal is to achieve high quality by doing more things right – and that you're not
interested in blaming people when mistakes happen.
 Make workers feel valued, and encourage them to look for better ways to do things.
 Ensure that your leaders are approachable and that they work with teams to act in the company's best interests.
 Use open and honest communication to remove fear from the organization.
9. Break down barriers between departments.

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 Build the "internal customer" concept – recognize that each department or function serves other departments that
use their output.
 Build a shared vision.
 Use cross-functional teamwork to build understanding and reduce adversarial relationships.
 Focus on collaboration and consensus instead of compromise.
10. Get rid of unclear slogans :-
 Let people know exactly what you want – don't make them guess. "Excellence in service" is short and memorable,
but what does it mean? How is it achieved? The message is clearer in a slogan like "You can do better if you try."
 Don't let words and nice-sounding phrases replace effective leadership. Outline your expectations, and then praise
people face-to-face for doing good work.
11. Eliminate management by objectives :-
 Look at how the process is carried out, not just numerical targets. Deming said that production targets encourage
high output and low quality.
 Provide support and resources so that production levels and quality are high and achievable.
 Measure the process rather than the people behind the process.
12. Remove barriers to pride of workmanship :-
 Allow everyone to take pride in their work without being rated or compared.
 Treat workers the same, and don't make them compete with other workers for monetary or other rewards. Over time,
the quality system will naturally raise the level of everyone's work to an equally high level.
13. Implement education and self-improvement :-
 Improve the current skills of workers.
 Encourage people to learn new skills to prepare for future changes and challenges.
 Build skills to make your workforce more adaptable to change, and better able to find and achieve improvements.
14. Make "transformation" everyone's job :-
 Improve your overall organization by having each person take a step toward quality.
 Analyze each small step, and understand how it fits into the larger picture.
 Use effective change management principles to introduce the new philosophy and ideas in Deming's 14 points

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Total quality management benefits and advantages:
1. Strengthened competitive position
2. Adaptability to changing or emerging market conditions and to environmental and other government regulations
3. Higher productivity
4. Enhanced market image
5. Elimination of defects and waste
6. Reduced costs and better cost management
7. Higher profitability
8. Improved customer focus and satisfaction
9. Increased customer loyalty and retention
10. Increased job security
11. Improved employee morale
12. Enhanced shareholder and stakeholder value
13. Improved and innovative processes
14. Cost reduction. When applied consistently over time, TQM can reduce costs throughout an organization, especially in
the areas of scrap, rework, field service, and warranty cost reduction. Since these cost reductions flow straight through to
bottom-line profits without any additional costs being incurred, there can be a startling increase in profitability.
15. Customer satisfaction. Since the company has better products and services, and its interactions with customers are
relatively error-free, there should be fewer customer complaints. Fewer complaints may also mean that the resources
devoted to customer service can be reduced. A higher level of customer satisfaction may also lead to increased market
share, as existing customers act on the company's behalf to bring in more customers.
16. Defect reduction. TQM has a strong emphasis on improving quality within a process, rather than inspecting quality into
a process. This not only reduces the time needed to fix errors, but makes it less necessary to employ a team of quality
assurance personnel.
17. Morale. The ongoing and proven success of TQM, and in particular the participation of employees in that success can
lead to a noticeable improvement in employee morale, which in turn reduces employee turnover, and therefore reduces the
cost of hiring and training new employees.

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 TOTAL QUALITY MANAGEMENT TOOLS :-
In the quality management field, there are statistical methods for analyzing numerical data focusing on results. However, in
the world of business, it is also crucial to analyze language data such as customer requirements and ideas, and thus focus
on processes. In both fields, the practice of24 Quality Assurance for the Food Industry: A Practical Approach
TQM uses tools that help to reach the desired goals and results that characterize success. According to the experts, the
seven statistical quality control tools for analyzing and interpreting numerical data include: (1) data sheet, (2) cause-and-
effect diagram, (3) scatter diagram, (4) flowchart, (5) Pareto chart, (6) histogram, and (7) control chart
Statistical Analysis Tools :-
1. Data Sheet
Data from a table, form, query, view, or stored procedure displayed in a row-and-column format.
2. Cause-and-Effect Diagram
Kaoru Ishikawa, who pioneered quality management processes and in the process became one of the founding fathers of
modern management, created the cause-and-effect diagram. Causes are arranged according to their level of importance or
detail, resulting in a depiction of relationships and hierarchy of events. This helps to identify areas where there may be
problems, and allows for comparison of their relative importance. Cause-and-effect diagrams are typically constructed
through brainstorming techniques. Causes in a cause-and-effect diagram are frequently arranged into the four most
common major categories. i) Manpower, methods, materials, and machinery (for manufacturing) Equipment, policies,
procedures, and people (for administration and planning). ii) The cause-and-effect diagram (Figure 2.1) is also known as
“Ishikawa diagram” or “fishbone diagram” because it was drawn to resemble the
skeleton of a fish, with the main causal categories drawn as bones attached to the spine of the fish.

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3. Scatter Diagram
A scatter diagram or scatter chart (Figure 2.2) is similar to a line graph, except that the data points are plotted without a
connecting line drawn between them. Scatter charts are suitable for showing how data points compare to each other. At
least two measured objects are needed for the query (one for the x-axis and one for the y-axis).
Scatter diagrams are used to study possible relationships between two variables. Although these diagrams cannot prove
that one variable causes the other, they do indicate the existence of a relationship, as well as the strength of that
relationship. In a scatter diagram the horizontal axis contains the measured values of one variable and the vertical axis
represents the measurements of the other variable.
The purpose of the scatter diagram is to display what happens to one variable when the other variable is changed. The
diagram is used to test the theory that the two variables are related. The slope of the diagram indicates the type of
relationship that exists. More than one measure object can be used for the y-axis as long as the objects are of the same
type and scale; i.e., number of 16-oz bottles and number of 8-oz bottles.
4. Flowchart
A flowchart (Figure 2.3) is defined as a graphic representation employing standard graphic icons, usually a series of blocks
with each block representing one major process, that describes an operation that is studied or is used to plan stages of a
project. Flowcharts provide an excellent form of documentation for a process operation, and often are useful when
examining how various steps in an operation work together. A flowchart is an important project development and
documentation tool; it visually records the steps, decisions, and actions of any manufacturing or service operation and
defines the system, its key points, activities, and role performances. In a flowchart, the description of each process is
written inside the blocks. Any other significant information is usually written outside the blocks. Each block is connected
with an arrow to show where that process leads.

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5. Pareto Chart
Alfredo Pareto was an Italian sociologist who suggested that “80% of all wealth in this country is owned by 20% of the
people.” This supposition, known as the “Pareto Principle” was further developed by business and industry leaders who
found that most of the quality problems were confined to a small number of machines or workers. In other words, “80% of
problems come from 20% of the equipment or workforce.” The Pareto Principle is used by business and industry to work to
continually improve quality, whether it is a product or a service. Quality improvement involves tackling one issue at a time.
By addressing the ones causing the most difficulty (the 20% that are causing 80% of the problem), improvements can be
made and monitored for continuous progress. Pareto charts are used to decide what steps need to be taken for quality
improvement. A Pareto chart (Figure 2.4) graphically summarizes and displays the relative importance of the differences
between groups of data. A Pareto chart can be constructed by segmenting the range of the data into groups (also called
segments, bins, or categories). The number of data points in each group is determined and the Pareto chart constructed;
however, unlike the bar chart, the Pareto chart is ordered in descending frequency magnitude. The groups are defined by
the user.
6.Histogram :-
A histogram (Figure 2.5) is used to graphically summarize and display the distribution of a process dataset. It can be
constructed by segmenting the range of the data into equal-sized bins (segments, groups, or classes). The vertical axis of
the histogram is the frequency (the number of counts for each bin), and the horizontal axis is labeled with the range of the
response variable. The number of data points in each bin is determined and the histogram constructed. The user defines
the bin size. A histogram can help answers questions such as: What is the most common system response? What
distribution (center, variation, and shape) do the data have? Do the data look symmetric or skewed to the left or right? Do
the data contain outliers?
7. Control Chart :-
Control charting is one of the most technically sophisticated tools of statistical quality control. Dr. Walter A. Shewhart of
the Bell Telephone Labs developed it in the 1920s as a statistical approach to the study of manufacturing process variation
for the purpose of improving the economic effectiveness of the process. These methods are based on continuous
monitoring of process variation. A control chart (Figure 2.6) is a graphical display of a quality characteristic that has been
measured or computed from a sample vs. the sample number or time. The chart contains a center line that represents the
average
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value of the quality characteristic corresponding to the in-control state. Two other horizontal lines called the upper control
limit (UCL) and the lower control limit (LCL) are also drawn. These control limits are chosen so that if the process is in
control, nearly all of the sample points will fall between them. As long as the points plot within the control limits, the
process is assumed to be in control and no action is necessary. A point that plots outside of the control limits is interpreted
as evidence that the process is out of control; investigation and corrective action are required in such a case to find and
eliminate the causes responsible for this behavior. The control points are connected with straight-line segments for easy
visualization. Control charts are universally used to present quality data. They are sufficiently simple to interpret so that
misunderstandings are avoided. Regardless of type, control charts all contain a few fundamental characteristics:
 They contain upper and lower control limits within which all observations will lie if the process is under control.
 They contain a center line which is usually considered the target value for the process.
 They generally show numbers along the vertical axis to define the values of the control limits and observations.
Control charts are used as a proven technique for improving productivity, as an effective tool in defect prevention, to
prevent unnecessary process adjustments, to provide diagnostic information, and to provide information about process
capability. A typical example of a control chart in the food industry is that used for net weight control.
8. X-Bar and R Charts :-
The X-bar and the R charts (Figure 2.7 and Figure 2.8) are the most commonly used of the control charts and the most
valuable. They are easy to prepare, simple to understand, and extremely useful in locating problems. They are ideal tools to
improve product quality and process control and can help to drastically reduce scrap and rework while assuring the
production of only satisfactory products. In the food industry they can be used for controlling every step of a production
process, for the acceptance or rejection of lots, and for early detection of equipment or process failures.The X-bar and the
R charts are used for control of variables that are expressed in discrete numbers such as inches, pounds, pH units,
angstroms, percent solids, or degrees of temperature.

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 Quality Circles:
Conceptually Quality Circles can be described as a small group of employees of the same work area, doing similar work
that meets voluntarily and regularly to iden tify, analyse and resolve work related problems.
This small group with every member of the circle participating to the full carries on the activities, utilising problem solving
techniques to achieve control or improvement in the work area and also help self and mutual development in the process.
The concept of the Quality Circle is based on “respect for the human individual” as against the traditional assumption
based on suspicion and mistrust between management and its em ployees.
Quality circles built mutual trust and create greater understanding between the manage ment and the workers. Cooperation
and not confrontation is the key element in its operation. Quality Circles aims at building people, developing them, arousing
genuine interest and dedication to their work to improve quality, productivity, cost reduction etc.
Thus we can say that a quality circle is a group of 5 to 8 employees performing similar work, who volunteer themselves to
meet regularly, to identify the cause of their on-the-job problems, employ advanced problem-solving techniques to reach
solutions and implement them.
The concept is based on the premise that the people who do a job everyday know more about it than anyone else and hence
their voluntary involvement is the best way to solve their work related problems.
The Quality Circle concept provides an opportunity to the circle members to use their wis dom, creativity and experience in
bringing about improvements in the work they are engaged in by converting the challenging problems into opportunities
and it contributes to the develop ment of the employees and in turn benefits the organisation as well. The concept
encourages the sense of belongingness in circle members and they feel that they have an important role to play in the
organisation.
Characteristics of Effective Quality Circles:
1. The atmosphere should be informal, comfortable and relaxed. The members should feel involved and interested.
2. Everyone should participate.
3. The objectives should be clear to the members.

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4. The members should listen to each other.
5. The group should feel comfortable even when there are disagreements.
6. The decisions should generally be taken by a kind of consensus and voting should be minimum.
7. When an action is required to be taken, clear assignments should be made and ac cepted by all the members.
8. The leader should not dominate the group. The main idea should not be as to who controls but how to get the job done.
9. Until a final solution is found and results are attained feedback is necessary.
Objectives of Quality Circles:
Some of the broad objectives of the Quality Circle are:
(i) To improve quality, productivity, safety and cost reduction.
(ii) To give chance to the employees to use their wisdom and creativity.
(iii) To encourage team spirit, cohesive culture among different levels and sections of the employees.
(iv) To promote self and mutual development including leadership quality,
(v) To fulfill the self-esteem and motivational needs of employees.
(vi) To improve the quality of work-life of employees.

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(6-7) Other Management Philosophies: 5S, Six sigma, Lean manufacturing, JustIn-Time (JIT),
Kanban
 5s :-
5S represents Japanese words that describe the steps of a workplace organization process. English equivalent words are
shown in parenthesis
 Seiri (Sort)
 Seiton (Straighten, Set)
 Seiso (Shine, Sweep)
 Seiketsu (Standardize)
 Shitsuke (Sustain)
In simple terms, the five S methodology helps a workplace remove items that are no longer needed (sort), organize the
items to optimize efficiency and flow (straighten), clean the area in order to more easily identify problems (shine),
implement color coding and labels to stay consistent with other areas (standardize) and develop behaviors that keep the
workplace organized over the long term (sustain).
Here is a breakdown of each ‘S’
1. Sort (seiri) – Distinguishing between necessary and unnecessary things, and getting rid of what you do not need
 Remove items not used in area – outdated materials, broken equipment, redundant equipment, files on the
computer, measurements which you no longer use
 Ask staff to tag all items which they don’t think are needed – this improves understanding about need and use
 Classify all equipment and materials by frequency of use to help decide if it should be removed – place ‘Red Tag’
on items to be removed
 Establish a ‘holding area’ for items that are difficult to classify – hold item for allotted period to enable others not
on 5S team to review
2. Straighten (seiton) – The practice of orderly storage so the right item can be picked efficiently (without waste) at the
right time, easy to access for everyone. A place for everything and everything in its place.
 Identify and allocate a place for all the materials needed for your work

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 Assign fixed places and fixed quantity
 Make it compact
 Place heavy objects at a height where they are easy to pick from
 Decide how things should be put away, and obey those rules
3. Shine (seiso) – Create a clean worksite without garbage, dirt and dust, so problems can be more easily identified (leaks,
spills, excess, damage, etc)
 Identify root causes of dirtiness, and correct process
 Only one work activity on a workspace at any given time
 Keep tools and equipment clean and in top condition, ready for use at any time
 Cleanliness should be a daily activity – at least 5 minutes per day
 Use chart with signatures/initials shows that the action or review has taken place
 Ensure proper lighting – it can be hard to see dirt and dust
4. Standardize (seiketsu) – Setting up standards for a neat, clean, workplace
 Standardization of best practices through ‘visual management’
 Make abnormalities visible to management
 Keep each area consistent with one another
 Standards make it easy to move workers into different areas
 Create process of how to maintain the standard with defined roles and responsibilities
 Make it easy for everyone to identify the state of normal or abnormal conditions – place photos on the walls, to
provide visual reminder
5. Sustain (shitsuke) – Implementing behaviors and habits to maintain the established standards over the long term, and
making the workplace organization the key to managing the process for success
 Toughest phase is to Sustain – many fall short of this goal
 Establish and maintain responsibilities – requires leader commitment to follow through
 Every one sticks to the rules and makes it a habit
 Participation of everyone in developing good habits and buy-in
 Regular audits and reviews

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 Get to root cause of issues
 Aim for higher 5S levels – continuous improvement
 Six Sigma :-
Six Sigma is:
A Business Strategy: Using Six Sigma Methodology, a business can strategize its plan of action and drive revenue increase,
cost reduction and process improvements in all parts of the organization.
A Vision: Six Sigma Methodology helps the Senior Management create a vision to provide defect free, positive environment
to the organization.
A Benchmark: Six Sigma Methodology helps in improving process metrics. Once the improved process metrics achieve
stability; we can use Six Sigma methodology again to improve the newly stabilized process metrics. For example: The Cycle
Time of Pizza Delivery is improved from 60 minutes to 45 minutes in a Pizza Delivery process by using Six Sigma
methodology. Once the Pizza Delivery process stabilizes at 45 minutes, we could carry out another Six Sigma project to
improve its cycle time from 45 minutes to 30 minutes. Thus, it is a benchmark.
A Goal: Using Six Sigma methodology, organizations can keep a stringent goal for themselves and work towards achieving
them during the course of the year. Right use of the methodology often leads these organizations to achieve these goals.
A Statistical Measure: Six Sigma is a data driven methodology. Statistical Analysis is used to identify root-causes of the
problem. Additionally, Six Sigma methodology calculates the process performance using its own unit known as Sigma unit.
A Robust Methodology: Six Sigma is the only methodology available in the market today which is a documented
methodology for problem solving. If used in the right manner, Six Sigma improvements are bullet-proof and they give high
yielding returns.

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 Lean Manufacturing :-
Lean manufacturing is a methodology that focuses on minimizing waste within manufacturing systems while
simultaneously maximizing productivity.
The benefits of lean include reduced lead times, reduced operating costs and improved product quality, to name just a few.
Five principles of lean manufacturing
A widely referenced book, Lean Thinking: Banish Waste and Create Wealth in Your Corporation, which was published in
1996, laid out five principles of lean, which many in the field reference as core principles. They are value, the value stream,
flow, pull and perfection. These are now used as the basis for lean implementation.
1. Identify value from the customer's perspective. Value is created by the producer, but it is defined by the customer. In
other words, companies need to understand the value the customer places on their products and services, which, in turn,
can help them determine how much money the customer is willing to pay.
The company must strive to eliminate waste and cost from its business processes so that the customer's optimal price can
be achieved at the highest profit to the company.
2. Map the value stream. This principle involves recording and analyzing the flow of information or materials required to
produce a specific product or service with the intent of identifying waste and methods of improvement. The value stream
encompasses the product's entire lifecycle, from raw materials through to disposal.
Companies must examine each stage of the cycle for waste -- or muda in Japanese. Anything that does not add value must
be eliminated. Lean thinking recommends supply chain alignment as part of this effort.
3. Create flow. Eliminate functional barriers and identify ways to improve lead time to ensure the processes are smooth
from the time an order is received through to delivery. Flow is critical to the elimination of waste. Lean manufacturing
relies on preventing interruptions in the production process and enabling a harmonized and integrated set of processes in
which activities move in a constant stream.
4. Establish a pull system. This means you only start new work when there is demand for it. Lean manufacturing uses a pull
system instead of a push system.
With a push system, used by manufacturing resource planning (MRP) systems, inventory needs are determined in advance
and the product is manufactured to meet that forecast. However, forecasts are typically inaccurate, which can result in
swings between too much inventory and not enough, as well as subsequent disrupted schedules and poor customer service.
In contrast to MRP, lean manufacturing is based on a pull system in which nothing is bought or made until there is demand.
Pull relies on flexibility and communication.
5. Pursue perfection with continual process improvement, or kaizen. Lean manufacturing rests on the concept of
continually striving for perfection, which entails targeting the root causes of quality issues and ferreting out and
eliminating waste across the value stream.

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Wastes of Lean Manufacturing :-
 unnecessary transportation;
 excess inventory;
 unnecessary motion of people, equipment or machinery;
 waiting, whether it is people waiting or idle equipment;
 over-production of a product;
 over-processing or putting more time into a product than a customer needs, such as designs that require high-tech
machinery for unnecessary features; and
 defects, which require effort and cost for corrections.
 Waste of unused talent and ingenuity
Lean vs. Six Sigma
Both lean and Six Sigma seek to eliminate waste. However, the two use different approaches because they see the root
cause of waste differently.
In the simplest terms, whereas lean holds that waste is caused by additional steps, processes and features that a customer
doesn't believe adds value and won't pay for, Six Sigma holds that waste results from process variation. Still, the two
approaches are complementary and have been combined as Lean Six Sigma.
 JIT ( Just in Time ) :-
JIT approach has the capacity, when adequately applied to the organisation, to improve the competitiveness of the
organisation in the market significantly by minimizing wastes and improving production efficiency and the product quality.
Why JIT concept matters?
The main focus of JIT is to identify and correct the obstacles in the production process. It shows the hidden problems of
inventory. Just In Time method prevents a company from using excessive inventory and smoothens production operations
if a specific task takes longer than expected or a defective part is discovered in the system. This is also one of the main
reason why the companies (which are opted for JIT) invest in preventive maintenance; when a part/equipment breaks down,
the entire production process stops.
The prime objective of JIT is to increase the inventory turnover and reduce the holding and all connected cost. This
concept was made applicable again by the Japanese firms, placing an order for the material, the same day for the

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production of the product.
Thus, the Just In Time approach eliminates the requirement to carry voluminous inventories and incur heavy carrying other
related costs to the manufacturer. In order to avail the benefits of JIT system, there should be an optimum synchronization
between the manufacturing cycle and delivery of material. Just In Times requires a good understanding of the supplier and
the manufacturer in terms of the quantity and delivery of the material. In the event of any misunderstanding between the
manufacturer and supplier of the material, the entire production process may come to a halt.
One example of JIT system is a car manufacturer, a manufacturer of the cars operates with bare minimum inventory levels,
as there is a strong reliance on the supply chain to deliver the parts required to manufacture cars. The parts required in the
manufacturing of cars do not arrive before or after they are needed; rather, they arrive only when they are needed.
Successful JIT implementation wholly depends on how the manufacturer manages its suppliers. A lot of pressure is
exerted on them, as the supplier of the materials have to be ready with an ample quality material, as the need arises.
Elements involved in JIT :-
Continuous improvement:
 Attacking fundamental problems and anything that does not add value to the product.
 Devising systems to identify production and allied problems.
 Simplicity: Simple systems are simple & easy to understand, easily manageable and the chances of going wrong
are very low.
 A product: oriented layout for less time spent on materials and parts movement.
 Quality control at source to ensure every worker is solely responsible for the quality of their own produced output.
Eliminating waste: There are seven types of waste:
 Waste from product defects.
 Waste of time.
 Transportation waste.
 Inventory waste.
 Waste from overproduction.
 Processing waste.
Waste minimization is one of the primary objectives of Just In Time system. This needs effective inventory management
throughout the whole supply chain. Initially, a manufacturing entity will seek to reduce inventory and enhance operations
within its own organization. In an attempt to reduce waste attributed to ineffective inventory management, SIX principles in

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relation to JIT have been stated by Schniededans and they are:
 Reduce buffer inventory.
 Try for zero inventory.
 Search for reliable suppliers.
 Reduce lot size and increase the frequency of orders.
 Reduce purchasing cost.
 Improve material handling.
Advantages & Disadvantages of Just-In-Time Systems
Advantages of Adopting Just-In-Time include:
 Just-in-time approach keeps stock holding costs to a minimum level. The released capacity results in better
utilization of space and bears a favourable impact on the insurance premiums and rent that would otherwise be
needed to be made.
 The just-in-time approach helps to eliminate waste. Chances of expired or out of date products; do not arise at all.
 As under this management method, only essential stocks which are required for to manufacturing are obtained,
thus less working capital is required. Under this approach, a minimum re-ordering level is set, and only when that
level is reached, order for fresh stocks are made and thus this becomes a boon to inventory management too.
 Due to the abovementioned low level of stocks held, the ROI (Return On Investment? of the organizations be high in
general.
 As this approach works on a demand-pull basis, all goods produced would be sold, and thus it includes changes in
demand with unanticipated ease. This makes JIT appealing today, where the market demand is fickle and
somewhat volatile.
 JIT emphasizes the ‘right-first-time’ concept, so that rework costs and the cost of inspection is minimized.
 By following JIT greater efficiency and High-quality products can be derived.
 Better relationships are fostered along the production chain under a JIT system.
 Higher customer satisfaction due to continuous communication with the customer.
 Just In Time adoption result in the elimination of overproduction.

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Disadvantages of Adopting JIT Systems :-
 JIT approach states ZERO tolerance for mistakes, making re-work difficult in practice, as inventory is kept to a
minimum level.
 A successful application of JIT requires a high reliance on suppliers, whose performance is outside the purview of
the manufacturer.
 Due to no buffers in JIT, production line idling and downtime can occur which would have an unfavourable effect on
the production process and also on the finances.
 Chances are quite high of not meeting an unexpected increase in orders as there will be no excess inventory of
finished goods.
 Transaction costs would be comparatively high depending upon the frequency of transactions.
 JIT may have certain negative effects on the environment due to the frequent deliveries as the same would result in
higher use and cost of transportation, which in turn would consume more fossil fuels
 Kanban :-
Kanban is one of the Lean tools designed to reduce the idle time in a production process. The main idea behind the Kanban
system is to deliver what the process needs exactly when it needs it.
In Japanese, the word "Kan" means "visual" and "ban" means "card," so Kanban refers to visual cards. Lean uses visual
cards as a signaling system that triggers an action to supply the process with its needs either from an external supplier or
from a warehouse.
It was originally invented as a part of the famous Toyota Production System. It is associated with the design of pull
systems and the concept of delivering just-in-time goods.
A pull system is where processes are based on customer demand. The concept is that each process manufactures each
component in line with another department to build a final part to the exact expectation of delivery from the customer.
Because your production process is designed to produce only what is deliverable, your business becomes leaner as a result
of not holding excessive stock levels of raw, partly-finished, or finished materials.
Just-in-time is a "pull" system of production, so actual orders provide a signal for when a product should be manufactured.
Demand-pull enables a firm to produce only what is required in the correct quantity and at the correct time. This means that
stock levels of raw materials, components, work in progress and finished goods can be kept to a minimum. This requires a
carefully planned scheduling and flow of resources through the production process.
Modern manufacturing firms use sophisticated production scheduling software to plan production for each period of time,
which includes ordering the correct stock. Information is exchanged with suppliers and customers through an Electronic
Data Interchange (EDI) to help ensure that every detail is correct

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Six Rules for an Effective Kanban System
 To ensure a proper setup of Kanban in the workplace, Toyota has provided us with six rules for an effective Kanban
system:
 Customer (downstream) processes withdraw items in the precise amounts specified by the Kanban.
 Supplier (upstream) produces items in the precise amounts and sequences specified by the Kanban.
 No items are made or moved without a Kanban.
 A Kanban should accompany each item, every time.
 Defects and incorrect amounts are never sent to the next downstream process.
 The number of Kanbans is reduced carefully to lower inventories and to reveal problems.

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(8-10) International Organization for Standardization (ISO): Introduction, ISO standards, benefits,
procedure, generic management systems. ISO 9000,
 International Organization for Standardization (ISO) :-
Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is
headquartered in Geneva, Switzerland,[3] and works in 164 countries
The International Organization for Standardization is an independent, non-governmental organization, the members of
which are the standards organizations of the 164[1] member countries. 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.
In a global marketplace, checks and balances need to be in place. Otherwise, it would be difficult to maintain consistency
and quality across industries and nations. International standards help to keep a level playing field, and one such
organization is ISO.
What is ISO Certification? :-
ISO certification certifies that a management system, manufacturing process, service, or documentation procedure has all
the requirements for standardization and quality assurance. ISO (International Organization for Standardization) is an
independent, non-governmental, international organization that develops standards to ensure the quality, safety, and
efficiency of products, services, and systems.
ISO certifications exist in many areas of industry, from energy management and social responsibility to medical devices
and energy management. ISO standards are in place to ensure consistency. Each certification has separate standards and
criteria and is classified numerically. For instance, the ISO certification we currently hold at Mead Metals is ISO 9001:2008.
ISO 9001 Definition
The certification ISO 9001:2008 includes three components: ISO, 9001, and 2008. Here's what each component represents:
ISO :- As mentioned above, ISO refers to the International Organization for Standardization. This organization develops the
standards, and it does in order to certify businesses or organizations. Certification is handled third-party and tested
annually.

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9001
The number appearing after ISO classifies the standard. All standards within the ISO 9000 family refer to quality
management. ISO 9001 is among ISO's best-known standards, and it defines the criteria for meeting a number of quality
management principles. It helps businesses and organizations be more efficient and improve customer satisfaction.
2008
The final number in an ISO certification refers to the version of the standard that's being met and is represented by the
calendar year those standards were launched. 2008 is the fourth edition of ISO 9001. The newest version, ISO 9001:2015,
was launched in September 2015, and Mead Metals is currently updating its processes to meet the specifications of this
newest version.
What Does ISO 9001 Certification Mean? :-
If an organization bills themselves as "ISO 9001 Certified," this means that the organization has met the requirements
designated under ISO 9001 (which you can read in full here). ISO 9001 requires organizations to define and follow a quality
management system that is both appropriate and effective while also requiring them to identify areas for improvement and
take action toward those improvements.
As a result, it's typically understood that an organization claiming ISO 9001 certification is an organization with products
and services that meet quality standards.
ISO Certification Explained :-
In order to sell to certain industries, being ISO 9001 certified is required - the automotive industry is a popular example. We
were certified to ISO in 1998, and it's helped our organization in numerous ways.
ISO standards have given us a layout of what needs to be done on every order. We know the standards that need to be met,
and we have the tools in place to ensure quality, consistency, and safety. What we do, how we check for quality, and what's
required of us is all laid out by ISO.
ISO certification standards also help keep our products and services relevant. When the standards change, we change
along with them. When we work with new customers, we send them our certification details so they know they can expect
ISO standards be met.

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Objective of ISO certification :-
The aim of getting ISO certification is to advance the improvement of standardisation in the technology of an organisation.
 Advantages of ISO Certification
International credibility: ISO Certification plays a vital role in helping the organisation to build credibility in overseas
business.
Customer Satisfaction: ISO standards are intended to make organisations to serve their customers in a better way that
would simultaneously increase customers’ satisfaction
Government Tenders: ISO Certification is quite essential to bid for Government Tenders.
Business Efficiency: Functional efficiency of organisations is improved by obtaining ISO Certification. SOP (Standard
Operating Procedures) and work instructions can be developed with the help of ISO Certification Agency. Implementation
of ISO in an organisation manages the resources efficiently.
Product Quality: By obtaining ISO Certification, the product quality matches up the international standards, it will reduce
the risk of product order rejections that may occur due to the flawed products.
Marketability: ISO Certification improves the business credibility, and it helps the business marketing directly.
 Applicable Fee for ISO Certification
Fee for ISO certification in India varies from organisation to organisation. The ISO certification body will compute the fee
for ISO certification by considering the below mentioned different parameters:
 Size of an organisation
 Number of employees
 Processes of Organization
 Level of risk associated with the scope of services of the organisation
 The complexity of the management system
 The number of working shifts
ISO Certification Processing Time
ISO certification processing time also varies from organisation to organisation. The ISO certification body will notify the
details processing time for completion of ISO certification after assessing the size of an organisation.
Prerequisite :- The precondition for processing ISO certification or ISO registration is explained in detail below:

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Selecting the Type of ISO Certification :-
First of all, the entrepreneur needs to choose the type of ISO certification required for the business. There are various types
of ISO certification are available such as listed below:
1. ISO 9001:2008- Quality Management System
2. OHSAS 18001 – Occupational Health & Safety Management System
3. ISO 37001 – Anti-bribery management systems
4. ISO 31000 – Risk Management
5. ISO 27001 – Information Security Management System
6. ISO 10002 – Compliant Management System
7. ISO 14001:2015 – Environment Management System
8. ISO 26000 – Social Responsibility
9. ISO 28000 – Security Management
10. ISO 22008 – Food Safety Management
11. SA 8000 – Social accountability
12. EnMS EN 16001 ISO 50001 – Energy Management
13. SO/IEC 17025 – Testing and calibration laboratories
14. SO 13485 – Medical devices
15. ISO 639 – Language codes
16. ISO 4217 – Currency codes
17. ISO 3166 – Country codes
18. ISO 8601 – Date and time format
19. ISO 20121 – Sustainable events
20. SO/IEC 27001 – Information security management
Selecting an ISO Certification Body (ISO Registrar)
As stated above ISO does not provide companies’ certification. It needs to be done by the external certification bodies.
Thus it is mandatory to recognise the credible certification body. When selecting a certification body, the entrepreneur has
to follow the things listed below.
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 Evaluate several certification bodies
 Check if the certification body uses the relevant CASCO standards
 Check whether the certification body is accredited.
Note: Accreditation is not compulsory; however, the companies should meet the ISO accreditation bodies’ requirements.
To find an accredited certification body in our country, contact the National Board of Accreditation (NBA), India.
 ISO Certification Process in India
The process for obtaining ISO certification in India is explained in detail below:
1. Make an Application :-
Once the entrepreneur or application has selected the ISO standard and ISO certification body, need to make an application
in a prescribed form (depends on the ISO registrar). The application should contain rights and obligations of entrepreneur
and certification body parties and includes liability issues, confidentiality, and access rights.
2. Documents Review by Registrar :-
The ISO certification body will review all the quality manuals and documents related to various policies and procedures
being followed in the organisation. Review of existing works will help the ISO registrar to identify the possible gaps against
the requirements stipulated in the ISO standards.
3. Determination of Pre-assessment Needs :-
The Pre-assessment is an initial review of the Quality Management System in an organisation to identify any significant
weakness or omissions in the system and registrar will provide the organisation with an opportunity to correct the
deficiencies before the regular registration assessment is conducted.
4. Prepare an Action Plan :-
After the ISO registrar notified the existing gaps in the organisation, the applicant or entrepreneur has to prepare an action
plan to eliminate these gaps. The action plan should contain the list of the required tasks to be performed to meet the
Quality Management System
Note: The entrepreneur may need giving training to employees to work efficiently to achieve quality management system.
Make all the employees in the organisation to aware of the ISO standards concerning work efficiency and quality standards.
5. Onsite Inspection or Audit :-
The ISO registrar will conduct a physical onsite inspection to audit the changes made in the organisation.
During the audit, if the registrar finds anything that does not meet with the requirements of the ISO standards, registrar
determines the severity and issue findings. Audit findings are usually called as nonconformities and fall into one of two
categories depending on severity.
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 A Minor Non-conformance – It deals with minor infractions of procedures or minor failures of the system in
meeting the ISO standards.
 A Major Non-conformance – It deals with issues where the nonconforming products are likely to reach the
customers or where there is a breakdown in the quality system that results in an inefficient system in meeting the
requirements of the standards.
6. Final audit :-
The registration cannot proceed until all significant nonconformities are closed and verified by the Registrar. This usually
involves a re-audit of the affected areas and, of course, the associated costs.
Note: Minor nonconformities require a corrective action plan and that will be closed at the first surveillance.
7. Get ISO Certificate :-
After all, non-conformities are addressed, and all the findings are updated in the ISO audit report, the registrar will grant the
ISO certification.
8. Surveillance Audits :-
Surveillance audit will be conducted primarily to ensure that the organisation is maintaining ISO quality standards. It will be
performed from time to time.
 ISO MANAGEMENT SYSTEM :-
THE ISO MODEL: AGREED BY EXPERTS
ISO management system standards (MSS) help organizations improve their performance by specifying repeatable steps
that organizations consciously implement to achieve their goals and objectives, and to create an organizational culture that
reflexively engages in a continuous cycle of self-evaluation, correction and improvement of operations and processes
through heightened employee awareness and management leadership and commitment.
The benefits of an effective management system to an organization include:
 More efficient use of resources and improved financial performance,
 Improved risk management and protection of people and the environment, and
 Increased capability to deliver consistent and improved services and products, thereby increasing value to
customers and all other stakeholders.
 MSS are the result of consensus among international experts with expertise in global management, leadership
strategies, and efficient and effective processes and practices. MSS standards can be implemented by any
organization, large or small.

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THE INTEGRATED USE OF MANAGEMENT SYSTEM STANDARDS (IUMSS) :-
The second edition of the handbook has been published to help organizations of any sector or industry and size, integrate
requirements of multiple MSS into their management systems.
MSS AND RELATED STANDARDS: THE BIG PICTURE
This picture explains what are the different types of ISO documents supporting the management of an organization and
what these documents deal with. Examples of standards for each quadrant are also provided.
AUDITS :-
Audits are a vital part of the management system approach as they enable the company or organization to check how far
their achievements meet their objectives and show conformity to the standard.
In order to help the auditing related to these standards, ISO has released ISO 19011:2018 providing specific guidance on
internal and external management system audits.

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 ISO 9000 :-
The ISO 9000 family of quality management systems (QMS) is a set of standards that helps organizations ensure they meet
customers and other stakeholder needs within statutory and regulatory requirements related to a product or service.[1] ISO
9000 deals with the fundamentals of quality management systems,[2] including the seven quality management principles
that underlie the family of standards.[2][3][4] ISO 9001 deals with the requirements that organizations wishing to meet the
standard must fulfill.[5]
Third-party certification bodies provide independent confirmation that organisations meet the requirements of ISO 9001.
Over one million organisations worldwide[6] are independently certified, making ISO 9001 one of the most widely used
management tools in the world today. However, the ISO certification process has been criticised[7][8] as being wasteful
and not being useful for all organizations.[9][10]
ISO Principles :-
The ISO 9000 series are based on seven quality management principles (QMP)[34]
The seven quality management principles are:
QMP 1 – Customer focus
QMP 2 – Leadership
QMP 3 – Engagement of people
QMP 4 – Process approach
QMP 5 – Improvement
QMP 6 – Evidence-based decision making
QMP 7 – Relationship management
Principle 1 – Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, should meet
customer requirements and strive to exceed customer expectations.
Principle 2 – Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal
environment in which people can become fully involved in achieving the organization's objectives.

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Principle 3 – Engagement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the
organization's benefit.
Principle 4 – Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
Principle 5 – Improvement
Improvement of the organization's overall performance should be a permanent objective of the organization.
Principle 6 – Evidence-based decision making
Effective decisions are based on the analysis of data and information.
Principle 7 – Relationship management
An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually
beneficial relationship enhances the ability of both to create value.

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(11-14) PRP for Food Safety: GAP – objectives, principles, benefits; GLP – need, history, objectives, principles,
bodies; GHP – objectives, principles; GMP –objectives, GMP in food industry.
PRP :- IS0 22000:2005 can be defined as follows. Prerequisite program (PRP) defines the “basic conditions and activities
that are necessary to maintain a hygienic environment through the food chain suitable for the production, handling, and
provision of safe end products and safe food for human consumption.”
OPRP is a “PRP identified by the hazard analysis as essential in order to control the likelihood of food safety hazards
and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment.”
There is much discussion relating to the protocol for determining which factors separate a PRP from an OPRP from a CCP.
It is important that we focus this article on basic prerequisite programs.
PRP Crosses Product Lines :-
Prerequisite programs generally cross all product lines affecting all operations, not just one specific process line or
product. PRPs are usually managed system wide compared to CCPs, which are product or line specific. Examples of PRPs
include good manufacturing practices (GMPs), pest control, supplier approval, and water treatment. A deviation in a
prerequisite program rarely requires actions against a specific product, whereas a deviation in a CCP results in an action
against the product, such as placing product on hold or performing a product recall. A deviation in an OPRP may or may not
result in an action against the product, depending on the specific deviation.
Well-designed prerequisite programs provide a solid foundation for an effective HACCP program. HACCP programs do not
stand alone. The National Advisory Committee on Microbiological Criteria for Foods states that the production of safe food
products requires that the HACCP program be built upon a solid foundation of prerequisite programs, because “prerequisite
programs provide the basic environment and operating conditions necessary for the production of safe, wholesome food.”
The role of the PRP is to control or eliminate hazards wherever possible. Without well-defined, effective prerequisite
programs, the HACCP program will fail.
Some PRPs are required for certain food processing segments under HACCP regulations for the U.S. Food and Drug
Administration and the U.S. Department of Agriculture-Food Safety and Inspection Service. With the advent of HACCP
regulations, some HACCP experts have suggested that the phrase prerequisite programs be used only for those programs
required under regulation, in order to distinguish them from precursory programs, which are programs that have been
deemed necessary but are not required under regulations. For the purpose of this discussion, the term prerequisite
program applies to those programs that have been identified as necessary to control or eliminate a hazard in any HACCP
program, whether it has been deemed regulated or not.
 GAP - Goods Agricultural Practices :-
Good agricultural practice (GAP) are specific methods which, when applied to agriculture, create food for consumers or
further processing that is safe and wholesome. While there are numerous competing definitions of what methods
constitute good agricultural practice there are several broadly accepted schemes that producers can adhere to.

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GAP :-
A multiplicity of Good Agricultural Practices (GAP) codes, standards and regulations have been developed in recent years
by the food industry and producers organizations but also governments and NGOs, aiming to codify agricultural practices at
farm level for a range of commodities. Their purpose varies from fulfilment of trade and government regulatory
requirements (in particular with regard to food safety and quality), to more specific requirements of specialty or niche
markets.
Definition :-
Good Agricultural Practices are "practices that address environmental, economic and social sustainability for on-farm
processes, and result in safe and quality food and non-food agricultural products" (FAO COAG 2003 GAP paper)
These four 'pillars' of GAP (economic viability, environmental sustainability, social acceptability and food safety and quality)
are included in most private and public sector standards, but the scope which they actually cover varies widely.
Concept :-
The concept of Good Agricultural Practices (GAP) has evolved in recent years in the context of a rapidly changing and
globalizing food economy and as a result of the concerns and commitments of a wide range of stakeholders about food
production and security, food safety and quality, and the environmental sustainability of agriculture. GAP applies
recommendations and available knowledge to addressing environmental, economic and social sustainability for on-farm
production and post-production processes resulting in safe and healthy food and non-food agricultural products. A broadly
accepted approach using GAP principles, generic indicators and practices will help guide debate on national policies and
actions and on the preparation of strategies to ensure that all stakeholders participate in and benefit from the application
of GAP in the food chain. The implementation of GAP should therefore contribute to Sustainable Agriculture and Rural
Development (SARD).
Objectives :-
 Ensuring safety and quality of produce in the food chain
 Capturing new market advantages by modifying supply chain governance
 Improving natural resources use, workers health and working conditions, Creating new market opportunities for
farmers and exporters in developing countries.
Benefits :-
 Farmers and their families that will obtain healthy and good quality food to assure their nutrition and nourishment,
generating a value added in their products to access markets in a better way.
 Consumers, that will enjoy better and safe quality food, with sustainable production.
 The population in general, that will benefit from a better environment.

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 Appropriate adoption and monitoring of GAP helps improve the safety and quality of food and other agricultural
products.
 It may help reduce the risk of non-compliance with national and international regulations, standards and guidelines
(in particular of the Codex Alimentarius Commission, World Organisation for Animal Health (OIE) and the
International Plant Protection Convention IPPC regarding permitted pesticides, maximum levels of contaminants
(including pesticides, veterinary drugs, radionuclide and mycotoxins) in food and non-food agricultural products, as
well as other chemical, microbiological and physical contamination hazards.
 Adoption of GAP helps promotes sustainable agriculture and contributes to meeting national and international
environment and social development objectives.
Principles of GAP :-
1. Soil :- Good agricultural practicewill:
• Establish a detailed knowledge of the nature, properties, distribution, and potential uses of soils of the farm.
• Avoid mechanical soil tillage to the extent possible.
• Maintain or improve soil organic matter through the use of soil building crop rotations
• Maintain soil cover to minimize erosion loss by wind and/or water.
• Avoid contamination with agrochemicals, organic and inorganic fertilizers and other contaminants by adapting quantities,
application methods and timing to the agronomic and environmental requirements.
• Maintain a history of the annual use, inputs and outputs of each individual land management unit.
2. Water :- Good agricultural practice will:
• Maximize water infiltration and minimise unproductive efflux of surface waters from watersheds.
• Manage ground and soil water by proper use or avoidance of drainage where required and by build-up of soil structure and
soil organic matter.
• Avoid the contamination of water resources with production inputs, waste or recycling products of organic, inorganic and
synthetic nature caused directly by inadequate handling practices and technologies and indirectly by erosion and leaching.
• Adopt techniques to monitor crop and soil water status and prevent soil salinization.
• Avoid unproductive irrigation water losses and adopt water-saving measures and re cycling where possible.
• Enhance the functioning of the water cycle to increase soil moisture storage and minimize runoff of water and associated

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contaminants. This may include monitoring of water status, monitoring and proper use of irrigation water, establishing
permanent cover, or maintaining or restoring wetlands as needed.
• Manage water tables to prevent excessive extraction or accumulation.
• Provide adequate, safe, clean watering points for livestock.
• Increase soil organic matter levels to maximize moisture retention and root penetration
3. Crop Production :- Good agricultural practice will:
• Decide on interventions following consideration of all possible methods and their short and long-term effects on farm
productivity and environmental implications in order to minimize the use of agrochemicals, in particular promote integrated
pest management (IPM).
• Use resistant cultivars and varieties, crop sequences, associations, and cultural practices that maximize biological
prevention of pests and diseases.
• Maintain regular and quantitative assessment of the balance status between pests and diseases and beneficial organisms
of all crops.
• Apply pest and disease forecasting techniques where available.
• Store and use agrochemicals according to legal requirements, e.g. registration for individual crops, rates, timings, and pre
-harvest intervals.
• Assure that agrochemicals are only applied by specially trained and knowledgeable persons
• Assure that equipment used for the handling and application of agrochemicals complies with established safety and
maintenance standards.
• Maintain accurate records of agrochemical use.
• Adopt successful organic management practices where and when applicable.
4. Animal Health :- Good agricultural practice will:
• Minimize risk of infection and disease by good pasture management, safe feeding, appropriate stocking rates and good
housing conditions.
• Keep livestock, buildings and feed facilities clean and provide adequate, clean bedding under housed conditions.
• Seek appropriate veterinary advice to avoid disease and health problems.

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• Ensure good hygiene standards in housing by proper cleansing and disinfection.
• Monitor disease incidence and treat sick or injured animals promptly in consultation with a veterinarian.
• Purchase, store and use only approved veterinary products in accordance with directions and regulations.
• Comply with withdrawal periods for veterinary medicinal products.
• Keep detailed records of all sickness, medical treatments and mortality
5. Human Welfare, Health and Safety :- Good agricultural practice will:
• Direct all farming practices to achieve an optimum balance between economic, environmental, and social goals.
• Provide adequate household income and food security
• Establish and adhere to safe work procedures with acceptable working hours and allowance for rest periods.
• Instruct workers in the safe and efficient use of tools and machinery.
• Pay reasonable wages and not exploit workers, especially women and children.
• Buy inputs and other services from local merchants if possible.
6. Energy and Waste Management :- Good Agricultural Practice will :-
• Establish input-output plans for farm energy, nutrients, and agrochemicals so as to ensure efficient use and safe disposal.
• Adopt energy saving practices in building design, machinery size, maintenance, and use (e.g. zero or minimum tillage).
• Investigate alternative energy sources to fossil fuels (wind, solar, biofuels), and adopt them where feasible.
• Identify and recycle most organic wastes and inorganic materials, where possible.
• Minimize non-usable wastes and dispose of them responsibly.
• Store fertilizers and agrochemicals securely and in accordance with legislation.
• Maintain accurate records of energy use, and of storage and disposal.
• Establish emergency action procedures to minimize the risk of pollution from accidents

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 GLP - Goods Laboratory Practices :-
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management
controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility,
quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties
through acute to chronic toxicity tests.
Importance or Need of GLP :-
Good Laboratory Practice (GLP) is a set of principles that guides how laboratory studies are planned, performed, monitored,
recorded, reported and archived. This is different from laboratory safety standards (such as appropriate clothing). GLP
helps to ensure the credibility and traceability of data submitted, thereby addressing the issue of non-reproducibility in
many biopharmaceutical experiments. GLP is intended to minimise adverse drug effects and improve human health and
environmental safety profiles. GLP also helps to improve accountability and precision of data through the transparent and
detailed documentation of laboratory work while assigning responsibility at various steps in the experiment. In addition, the
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has
mentioned GLP as a pre-requisite for the successful international registration of pharmaceuticals.
History of GLP :-
GLP was first introduced in New Zealand and Denmark in 1972.[2] GLP was instituted in US following cases of fraud
generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. Industrial BioTest Labs (IBT) was
the most notable case, where thousands of safety tests for chemical manufacturers were falsely claimed to have been
performed or were so poor that police investigators could not piece together what work had been done...even though IBT
superficially delivered the test results their contracts with the manufacturers specified. [3]
These issues were made public in the hearings at the US Congress, which led to the FDA's publication of Proposed
Regulations on GLP in 1976, with establishment of the Final Rule in June 1979 (21 CFR 58). The Environmental Protection
Agency (EPA) had also encountered similar problems in data submitted to it, and issued its own draft GLP regulations in
1979 and 1980, publishing the Final Rules in two separate parts (40 CFR 160 and 40 CFR 792) in 1983.[4]:5
Objectives of GLP :-

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Principles of Goods Laboratory Practices :-
GLP principles include
1. Organization and Personnel
 Management-Responsibilities
 Sponsor-Responsibilities
 Study Director-Responsibilities
 Principal Investigator-Responsibilities
 Study Personnel-Responsibilities
2. Quality assurance program
 Quality Assurance Personnel
3. Facilities
 Test System Facilities
 Facilities for Test and Reference Items
4. Equipment, reagents and materials
5. Test systems
 Physical/Chemical
 Biological
6. Test and reference items
7. Standard operating procedures
8. Performance of study
 Study Plan
 Conduct of Study
9. Reporting of results
10. Archival - Storage of Records and Reports

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 Goods Handling Practices :-
Objective :- 1) To avoid damages of food during the handling after harvesting.
2) To provide good quality raw material for manufacturing.
Principle s :- 1) Maintaining Personal Hygiene.
2) Avoid Contamination.
3) Well Equipped Storage Facility.
4) Maintaining Suitable Environmental Conditions.
Difference in GAP, GLP, GMP and GHP :- GAP is for agricultural product before harvesting and GHP is for agricultural
products after harvesting till manufacturing. GMP is for to protect agriculture goods during manufacturing and GLP is for
testing the qulity of manufactured products and raw agricultural goods before processing.
बाक चं काही सापड ं नाही , तु हा ा सापड ं तर please send or message on Ȳ tkdhulgand@gmail.com ( for any
recommendation).

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 Goods Manufacturing Practices :-

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50
(15-18) HACCP: Introduction, History of HACCP, Definitions related to HACCP system, Principles
of HACCP, Application of HACCP system, Implementation steps for HAACP system, Benefits of
HACCP.
Introduction :-
Hazard analysis and critical control points, or HACCP (/ˈhæsʌp/[citation needed]), is a systematic preventive approach to
food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to
be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards
rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all
stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food
and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP
programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are
regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that
are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of
2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-
based preventive controls (HARPC) plans.
HACCP is believed to stem from a production process monitoring used during World War II because traditional "end of the
pipe" testing on artillery shells' firing mechanisms could not be performed, and a large percentage of the artillery shells
made[where?] at the time were either duds or misfiring.[1] HACCP itself was conceived in the 1960s when the US National
Aeronautics and Space Administration (NASA) asked Pillsbury to design and manufacture the first foods for space flights.
Since then, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a
modern, science-based, food safety system. Based on risk-assessment, HACCP plans allow both industry and government
to allocate their resources efficiently by establishing and auditing safe food production practices. In 1994, the organization
International HACCP Alliance was established, initially to assist the US meat and poultry industries with implementing
HACCP, and now its membership has been spread over other professional and industrial areas.[2]
Hence, HACCP has been increasingly applied to industries other than food, such as cosmetics and pharmaceuticals. This
method, which in effect seeks to plan out unsafe practices based on science, differs from traditional "produce and sort"
quality control methods that do nothing to prevent hazards from occurring and must identify them at the end of the process.
HACCP is focused only on the health safety issues of a product and not the quality of the product, yet HACCP principles are
the basis of most food quality and safety assurance systems. In the United States, HACCP compliance is regulated by 21
CFR part 120 and 123. Similarly, FAO and WHO published a guideline for all governments to handle the issue in small and
less developed food businesses.

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History :-
Hazard Analysis and Critical Control Points (HACCP) is a systematic approach to hazard identification, assessment of risk,
and control. It is used by many facilities in the food industry to ensure that all food that is consumed is safe to eat.HACCP
originated in the 1960’s, when the National Aeronautics and Space Administration (NASA), the Pillsbury Company, and the
U.S. Army Laboratories collaborated together to provide safe food for upcoming space expeditions. It was decided that
NASA’s engineering management requirements, Critical Control Points, would be used as a guideline for this food safety
initiative. Critical Control Points (CCP) was used to test weapon and engineering system reliability and by using CCP, NASA
and Pillsbury were able to hire contractors to identify and eliminate the “critical failure areas” in the food processing
procedures.
After the success of NASA providing safe food for their space expeditions, Pillsbury had a recall on a product called Farina,
which is a cereal used in infant food. They were finding glass pieces and remnants in the food, which caused contamination.
A microbiologist at Pillsbury, Howard Baumann, who also helped in the NASA initiative, advocated for the company to adopt
a HACCP plan. Because of this outbreak and Baumann’s success with HACCP, a panel discussion was held in 1971 at the
National Conference on Food Protection that examined Critical Control Points and Good Manufacturing Practices (GMP) in
producing safe food. The outcome of this meeting lead to the FDA asking Pillsbury to establish and manage a training
program for the inspection of canned foods for FDA inspectors. The program was first held in September 1972 for 21 days,
with 11 days of classroom lecture and 10 days of canning plant evaluations. The name of this class was titled, “Food Safety
through the Hazard Analysis and Critical Control Point System”, and this was the first time HACCP was used to educate
other food facilities in the industry.
Today, training for developing and implementing HACCP Food Safety management systems are offered by several food
safety companies. DFA of California is an accredited HACCP trainer through the International HACCP Alliance and is
qualified to perform nationally recognized HACCP training according to Codex Alimentarius. This is a benefit to the Dried
Fruit & Tree Nut and Fresh Produce industry because DFA knows the ins and outs of our member’s facilities. Secondly, we
currently have the resources to train and conduct HACCP verification audits on your time-table.
Since the signing of the FSMA (Food Safety Modernization Act) in 2011, companies in the food industry have been making
drastic changes in order to comply with the regulation. The proposed Produce Safety and Preventive Controls rules are
expected to be finalized in 2014 with staggered dates for compliance. One of the requirements of the rules is Preventive
Controls (HACCP). “HACCP is important because it prioritizes and controls potential hazards in food production. By
controlling major food risks, such as microbiological, chemical and physical contaminants, the industry can better assure
consumers that its products are as safe as good science and technology allows. By reducing foodborne hazards, public
health protection is strengthened” (International HACCP Alliance). HACCP is a program that government agencies and food
facilities have relied on for years and will be a program that continues to have an impact on food safety and in the food
industry for years to come.

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Definitions :-
CCP Decision Tree: A sequence of questions to assist in determining whether a control point is a CCP.
Control: (a) To manage the conditions of an operation to maintain compliance with established criteria. (b) The state in
which correct procedures are being followed and criteria are being met.
Control Point: Any step at which biological, chemical, or physical factors can be controlled.
Corrective Action: Procedures followed when a deviation occurs.
Criterion: A requirement on which a judgment or decision can be based.
Critical Control Point: A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or
to reduce it to an acceptable level.
Critical Limit: A maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled
at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of a food safety hazard.
Deviation: Failure to meet a critical limit.
HACCP: A systematic approach to the identification, evaluation, and control of a food safety hazard.
HACCP Plan: The written document that is based on the principles that is based on the principles of HACCP and that
delineates the procedures to be followed.
HACCP System: The result of the implementation of the HACCP plan.
HACCP Team:The group of people who are responsible for developing, implementing, and maintaining the HACCP system.
Hazard:A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its
control.
Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under
consideration to decide which are significant and must be addressed in the HACCP plan.
Monitor: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to
produce an accurate record for future use in verification.
Prerequisite Programs: Procedures, including Good Manufacturing Practices that address operational conditions providing
the foundation for the HACCP system.
Severity: The seriousness of the effect(s) of a hazard.
Step: A point, procedure, operation, or stage in the food system from primary production to final consumption.
Validation: That element of verification focused on collecting and evaluating scientific and technical information to
determine whether the HACCP plan, when properly implemented, will effectively control the hazards.
Verification: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is
operating according to the plan.

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Principles of HACCPs :- Total 7 Principles for the HACCP which looks like step for HACCP
Principle 1 - Conduct a Hazard Analysis :- The application of this principle involves listing the steps in the process and
identifying where significant hazards are likely to Occur. The HACCP team will focus on hazards that can be prevented,
eliminated or controlled by the HACCP plan. A justification for including or excluding the hazard is reported and possible
control measures are identified.
Principle 2 - Identify the Critical Control Points :- A critical control point (CCP) is a point, step or procedure at which control
can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels. The HACCP team
will use a CCP decision tree to help identify the critical control points in the process. A critical control point may control
more that one food safety hazard or in some cases more than one CCP is needed to control a single hazard. The number of
CCP's needed depends on the processing steps and the control needed to assure food safety.
Principle 3 - Establish Critical Limits :- A critical limit (CL) is the maximum and/or minimum value to which a biological,
chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the
occurrence of a food safety hazard. The critical limit is usually a measure such as time, temperature, water activity (Aw),
pH, weight, or some other measure that is based on scientific literature and/or regulatory standards.
Principle 4- Monitor CCP :- The HACCP team will describe monitoring procedures for the measurement of the critical limit
at each critical control point. Monitoring procedures should describe how the measurement will be taken, when the
measurement is taken, who is responsible for the measurement and how frequently the measurement is taken during
production.
Principle 5 - Establish Corrective Action :- Corrective actions are the procedures that are followed when a deviation in a
critical limit occurs. The HACCP team will identify the steps that will be taken to prevent potentially hazardous food from
entering the food chain and the steps that are needed to correct the process. This usually includes identification of the
problems and the steps taken to assure that the problem will not occur again.
Principle 6 - Verification :- Those activities, other than monitoring, that determine the validity of the HACCP plan and that
the system is operating according to the plan. The HACCP team may identify activities such as auditing of CCP's, record
review, prior shipment review, instrument calibration and product testing as part of the verification activities.
Principle 7 - Recordkeeping :- A key component of the HACCP plan is recording information that can be used to prove that
the a food was produced safely. The records also need to include information about the HACCP plan. Record should include
information on the HACCP Team, product description, flow diagrams, the hazard analysis, the CCP's identified, Critical
Limits, Monitoring System, Corrective Actions, Recordkeeping Procedures, and Verification Procedures.

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Benefits of HACCP :-
HACCP based procedures provide businesses with a cost effective system for control of food safety, from ingredients right
through to production, storage and distribution to sale and service of the final consumer. The preventive approach of
HACCP based procedures not only improves food safety management but also complements other quality management
systems. The main benefits of HACCP based procedures are:
 Saves your business money in the long run
 Avoids you poisoning your customers
 Food safety standards increase
 Ensures you are compliant with the law
 Food quality standards increase
 Organises your process to produce safe food
 Organises your staff promoting teamwork and efficiency
 Due diligence defence in court.
1. Maximizing product safety.
2. is cost =effecting control.
3. Facilitate international trade.
4. Can integrated in the quality management system.
5. Complies with legal requirements.
6. Use in The event of litigation.

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HACCP Program Implementation :-
A sequence of events must occur in the implementation of HACCP as are discussed briefly. HACCP Team Assembly Initial
program development involves the designation of an HACCP team, consisting of members with specific knowledge and
expertise appropriate to the product and process. Selection criteria should emphasize production and quality assurance
knowledge; however, marketing and communication expertise may be appropriate if these employees have an appreciation
and understanding of the product and process. The team should include employees who are involved in daily manufacturing
as they are more familiar with the variability and limitations of the operation. Furthermore, those involved with the process
should be involved to foster a sense of ownership among those who must implement the plan. Involvement from experts
outside of the
organization may be beneficial to provide additional expertise, but they must have the support of production employees.
Experts who are knowledgeable about the product and process may serve more effectively in verification of the
completeness of the hazard analysis and the HACCP plan. According to Stevenson and Bernard (1995), these individuals
should have the knowledge and experience to correctly: (1) identify potential hazards, (2) assign levels of severity and risk,
(3) provide direction for monitoring verification and corrective actions when deviations occur, and (4) assess the success
of the HACCP plan.
Food Description and Distribution Method A separate HACCP plan should be developed for each food product that is
manufactured in the plant. Product description should include the name, formulation, method of distribution, and storage
requirements.
Intended Use and Anticipated Consumers :-
If the food is targeted for a specific segment of the population, such as infants, immunocompromised people, or those in
other categories, the intended group should be identified.
Flow Diagram Development Describing the Process :-
Each step of the operation should be identified through a simple description of the operation that occurs. This diagram is
essential for hazard analysis and assessment of CCPs.The diagram serves as a record of the operation and a future guide
for employees, regulators, and customers who must understand the process for verification. The flow diagram should
include steps that take place before and after the processing that occurs in the plant and should contain words rather than
engineering drawings.
Flow Diagram Verification The HACCP team should check the operation to verify the accuracy and comprehensiveness of
the flow diagram. Modifications should be made if and when necessary. The verification of the effectiveness of sanitizing
has received additional attention during the past decade because of pathogens that cause foodborne illness (Slade, 2002).
Thus, additional emphasis is being placed on ensuring that cleaning, with cleaning compounds is followed by sanitizing, a
lethal step to eradicate remaining invisible microorganisms or debris on surfaces and equipment.

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(19-21) ISO 22000: Introduction, History, Benefits, Objectives, ISO 22000 family of standards
series, ISO standard document, Role of BIS in ISO 22000
 Introduction and History :-
By the early 2000s, a number of standards have been developed by different private and national organizations around the
world. This led to complications when companies started using their own in-house developed codes to audit their suppliers.
Different audit criteria made it nearly impossible for suppliers to fulfill all requirements in the global market.
In 2001, the International Organization for Standardization (ISO) started working on an auditable standard for Food Safety
Management System (FSMS). This international FSMS standard, known as ISO 22000, was finally published on September 1,
2005. It is a framework that combines prerequisite programs, the HACCP principles and application steps as described by
the Codex Alimentarius Commission and elements of the ISO 9001:2000 standard.
Within two years, the standard has been implemented by organizations in more than 50 countries as an alternative to more
than 20 food safety schemes developed by individual companies in the sector for auditing their suppliers.
ISO 22000 intends to define the Food Safety Management System requirements that companies need to meet in order to
comply with food safety regulations all over the world.
ISO 22000:2005 takes a food chain approach to food safety. It defines a set of general food safety management
requirements that apply not only to food producers and manufacturers, but to all the organizations that participate in the
food supply chain.
ISO 22000 specifies the requirements for an FSMS that combines the following key elements to ensure food safety along
the food chain:
— Interactive communication. Communication along the food chain is essential to ensure that all relevant food safety
hazards are identified and adequately controlled at each step within the food chain. This implies communication between
organizations both, upstream and downstream in the food chain.
— Management system. ISO 22000 can be applied independently of other management system standards. Its
implementation can be aligned or integrated with existing related management system requirements, while organizations
may utilize existing management system(s) to establish a food safety management system that complies with the
requirements of ISO 22000.
— HACCP principles and prerequisite programs. ISO 22000 integrates the principles of the Hazard Analysis and Critical
Control Point (HACCP) system and by means of auditable requirements, it combines the HACCP plan with prerequisite
programs (PRPs). Prerequisite programmes comprise all basic conditions and activities necessary to maintain a hygienic
environment throughout the food chain suitable for the production, handling and provision of safe end products.

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 Benefits of ISO 22000 Certification
Food related businesses across the world use the framework of ISO 22000 and HACCP as the basic tools for their food
safety management programmes.
Benefits of ISO 22000
 Reduction in food safety incidents and cost.
 Compliance with legal and Codex HACCP principle.
 Lower risk of liability.
 Fewer errors and customer complaints.
 Continual improvement in products & processes.
 Resource optimization – internally and along the food chain.
 Sustainable food safety performance.
 Improves consumer / supplier /regulator confidence and relationships.
 Platform for process and management control and improvement.
 Competitive advantage in the marketplace.
 Promotes international trade.
 Improved overall performance
 Objectives of ISO 22000 :-
ISO 22000:2018 sets out the requirements for a food safety management system and can be certified to. It maps out what
an organization needs to do to demonstrate its ability to control food safety hazards in order to ensure that food is safe. It
can be used by any organization regardless of its size or position in the food chain.
THE FOOD SAFETY OBJECTIVES :- Any objectives must be SMART.
S- Specific
M-Measurable
A-Achievable
R-Realistic
T-Timely
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One can develop company-wide objectives or narrow down to individual departments within your scope of the food safety
management system.
Specific- One uses their data and target to areas of improvement within their scope of operation.
Measurable– One must determine compliance through some sort of solid metric system. This means that one must
associate actual targets to the objective.
Achievable- They ensure that everything is in place and that if the person does not reach the goals they cannot reasonably
point the finger elsewhere
Realistic – They are closely aligned to making your food safety objectives achievable. ***They should be realistic to your
food business not someone else’s.
Timely- This aspect motivates us to achieve the outcome. All objectives should have a time limit otherwise nothing ever
gets done. Time restrictions are a catalyst for goal achievement.
 ISO 22000 and Family Standard Series :-
The ISO 22000 international standard specifies the requirements for a food safety management system that involves the
following elements:
 interactive communication
 system management
 prerequisite programs
 HACCP principles
Critical reviews of the above elements have been conducted by many scientists.[1][2][3][4] Communication along the food
chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step
within the food chain. This implies communication between organizations both upstream and downstream in the food chain.
Communication with customers and suppliers about identified hazards and control measures will assist in clarifying
customer and supplier requirements.
Recognition of the organization's role and position within the food chain is essential to ensure effective interactive
communication throughout the chain in order to deliver safe food products to the final consumer.
The most effective food safety systems are established, operated and updated within the framework of a structured
management system and incorporated into the overall management activities of the organization. This provides maximum
benefit for the organization and interested parties. ISO 22000 has been aligned with ISO 9001 in order to enhance the
compatibility of the two standards.
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ISO 22000 can be applied independently of other management system standards or integrated with existing management
system requirements.
ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps
developed by the Codex Alimentarius Commission. By means of auditable requirements, it combines the HACCP plan with
prerequisite programmes. Hazard analysis is the key to an effective food safety management system, since conducting a
hazard analysis assists in organizing the knowledge required to establish an effective combination of control measures.
ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may
be associated with the type of process and facilities used, are identified and assessed. Thus it provides the means to
determine and document why certain identified hazards need to be controlled by a particular organization and why others
need not.
During hazard analysis, the organization determines the strategy to be used to ensure hazard control by combining the
prerequisite programmes and the HACCP plan.
ISO is developing additional standards that are related to ISO 22000. These standards will be known as the ISO 22000
family of standards. At the present time, the following standards will make up the ISO 22000 family of standards:
 ISO 22000 - Food safety management systems - Requirements for any organization in the food chain.
 ISO 22001 - Guidelines on the application of ISO 9001:2000 for the food and drink industry (replaces: ISO
15161:2001).
 ISO/TS 22002- Prerequisite programmes on food safety—Part 1: Food manufacturing; Part 2: Catering; Part 3:
Farming; Part 4: Food packaging manufacturing; Part 6: Feed and animal food production
 ISO TS 22003 - Food safety management systems for bodies providing audit and certification of food safety
management systems.
 ISO TS 22004 - Food safety management systems - Guidance on the application of ISO 22000:2005.
 ISO 22005 - Traceability in the feed and food chain - General principles and basic requirements for system design
and implementation.
 ISO 22006 - Quality management systems - Guidance on the application of ISO 9002:2000 for crop production.
ISO 22000 is also used as a basis for the Food Safety Systems Certification (FSSC) Scheme FSSC 22000. FSSC 22000 is a
Global Food Safety Initiative (GFSI) approved scheme.

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 ISO 22000 Documentation Requirements:
• Food Safety Policy
• Hazard Control Plan
• FSMS or Management Manual
• Procedures
• Food Safety Improvement Plan (monitoring food safety objectives and targets)
• Emergency Plan
• Records for OPRP & CCP monitoring
• Registers for nonconformances and corrective action.
Documenting processes provides control and consistency of how processes are performed.
Food Safety Management System Documentation :-
Your system will need to be documented in the form of policies, objectives, procedures and records. The typical
documented management system is made up of four levels of documentation: Food Safety Management System Manual
(with policies), Procedures, Work Instructions, and Forms and Records. View our ISO 22000 Document Template Package.
No need to begin with a blank page!
 Documenting your processes :-
You will need to document procedures called out by the standard as well as those required to ensure control of other
processes in your FSMS.
This means that your FSMS will have more documented procedures than just those specifically named in the standard but
these procedures will be useful documents. They will ensure that processes are being done as management planned and
approved. Conversely, they will ensure that management knows how processes are being performed.
Specific procedures required by the standard are:
Control of Documents, Control of Records, Control of unsafe product, Corrections, Corrective Actions, Withdrawals and
Internal Audits.
Documented procedures will also make sure that different people perform the process the same way. You will not be
writing the procedure and putting it in a book on the shelf to collect dust, you will be building a system where documented
procedures and work instructions will become an important and integral part of your system.

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Simplifying your documentation project :-
If you have decided to set up ISO 22000 in your company then you know that you will need to write procedures and forms
that document your food safety system. We put a complete ISO 22000 Food Safety Management System at your fingertips.
You will easily know what needs to be done to achieve compliance and certification. And you can do all this without hiring
an expensive consultant. Feel positive as you achieve results.
 ISO 9001 vs ISO 22000 :-
In comparison with ISO 9001, the standard is a more procedural orientated guidance than a principle based one. Apart from
that, ISO 22000 is an industrial-specific risk management system for any type of food processing and marketing, which can
be closely incorporated with the quality management system of ISO 9001. The detailed similarities and differences of the
two standards can be found elsewhere.
 Difference between HACCP and ISO 22000 :-
Besides the fact that HACCP is a food safety system, and ISO 22000 is a food safety management system standard,
differences between these two include the following:
 ISO 22000 allows the development of a food safety management system by external experts for any company, and
this includes implementation and verification of all or part of activities involved in the system.
 ISO 22000 also refers to good practices in sectors and general hygiene rules published by Codex Alimentarius.
 Besides the internal communication, external communication is also a condition for establishing, implementing
and updating the FSMS according to ISO 22000.
 ISO 22000 demands risk analysis to evaluate each food safety hazards identified.
 ISO 22000 demands documentation of PRPs.
 HACCP uses the traditional concept of dividing control measures into two groups: prerequisites and measures
applied at critical control points (CCPs). In the case of ISO 22000, these concepts are reorganized in a logical order
by adding a group of control measures named operational prerequisite programs (oPRPs).
 ISO 22000 demands monitoring system and planning of corrective actions for operational PRPs, as for CCPs.
 ISO 22000 demands analysis and improvement according to the outcome of monitoring of oPRPs and HACCP plan.
 ISO 22000 also requires the review and identification of specifications, formulation and origin for input and end-
products.
 ISO 22000 separates and clarifies verification activities and validation activities.
 Allergen control is a required prerequisite program in ISO 22000; however it is not mentioned in HACCP.
 ISO 22000, new terms have been developed, such as “potentially unsafe product” and the term “withdrawal” for
product recall and product recollection activities.
 ISO 22000 requires continual improvement and updating of the management system.

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 Food Safety Management System Requirements –
a Food Safety Management System (FSMS) requires organisations to:
• understand external & internal issues, and interested parties, relevant to food safety
• develop a Food Safety Policy – typically one page document declaring commitment to food safety
• appoint a Food Safety Team
• develop a Hazard Control Plan
• develop a FSMS or Management Manual briefly addressing the clauses of ISO 22000
• implement food safety practices to address the respective pre-requisite program (PRP)
• develop procedures, particularly for each of the critical control points (CCPs) and operational pre-requisite programs
(OPRPs)
• implement record keeping for monitoring of the CCPs and OPRPs
• develop and monitor food safety objectives and targets
• embrace food safety risks and opportunities, and consider the need for a Food Defence Plan and Food Fraud Vulnerability
Plan
• monitor food safety performance
• plan responses to food safety emergencies
• ensure staff are competent and understand their food safety responsibilities
• control food safety nonconformances and take corrective action for significant or repetitive nonconformances
• ensure internal and external communication of food safety issues
• implement evaluation and monitoring of external providers
• implement verification of the Hazard Control Plan and PRPs
• conduct internal audits of the food safety management system
• ensure senior management strategically review the food safety management system.
Benefits of Food Safety Management System:

• demonstrated due diligence
• meeting regulatory and customer requirements
• enhanced company profile and reputation, and stakeholder confidence
• greater marketing opportunities leading to higher profits
• enhanced food safety in supply chain
• minimised risk and food safety related incidents
• improved food safety performance

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• greater protection from spurious food poisoning allegations
• food safety culture embedded and employees empowered
• easily integrated with other management systems.

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(22-26)GFSI, FSSC 22000, IFS, SQF, AIB, GRMS, PAS 96
 GFSI :-
The Global Food Safety Initiative (GFSI)[1] is a private organization, established and managed by the international trade
association, the Consumer Goods Forum[2] under Belgian law in May 2000. The GFSI maintains a scheme to benchmark
food safety standards for manufacturers as well as farm assurance standards.
About GFSI :-
The Global Food Safety Initiative is a business-driven initiative for the continuous improvement of food safety management
systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI provides a platform for
collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service
companies, service providers associated with the food supply chain, international organizations, academia and government.
The initiative was launched in 2000 following a number of food safety crises when consumer confidence was at an all-time
low. Since then, experts from all over the world have been collaborating in numerous Technical Working Groups to tackle
current food safety issues defined by GFSI stakeholders.
Key activities within GFSI include the definition of food safety requirements for food safety schemes through a
benchmarking process. This process is thought to lead to recognition of existing food safety schemes and enhances
confidence, acceptance and implementation of third party certification along the entire food supply chain.
GFSI's current focus is on extending the requirements to cover all scopes of the global food supply chain "from farm to
fork". Other important current activities include the development of a capacity building programme for small and/or less
developed businesses to facilitate their access to local markets and a continuous focus on food safety auditor competence
to bring industry experts in collaboration with key stakeholders to a common consensus on the skills, knowledge and
attributes that a competent auditor should possess.
The GFSI objectives are to:
 Reduce food safety risks by delivering equivalence and convergence between effective food safety management
systems
 Manage cost in the global food system by eliminating redundancy and improving operational efficiency
 Develop competencies and capacity building in food safety to create consistent and effective global food systems
 Provide a unique international stakeholder platform for collaboration, knowledge exchange and networking
GFSI Benchmarking :-
Within GFSI, benchmarking is a “procedure by which a food safety-related scheme is compared to the GFSI Guidance
Document".[3]

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Back in 2000, food safety was a top of mind issue for companies due to several high-profile recalls, quarantines and
negative publicity about the food industry. There was also extensive audit fatigue through the industry, as retailers
performed inspections or audits themselves or asked a third party to do this on their behalf. These were often carried out
against food safety schemes that lacked international certification and accreditation, resulting in incomparable auditing
results.
CEOs of global companies came together at The Consumer Goods Forum (CIES at the time) and agreed that consumer trust
needed to be strengthened and maintained through a safer supply chain. GFSI was created to achieve this through the
harmonisation of food safety standards that would help reduce audit duplication throughout the supply chain. At the time,
there was no existing scheme that could be qualified as “global” that could be adopted by all. GFSI therefore chose to go
down the route of benchmarking, developing a model that determines equivalency between existing food safety schemes,
whilst leaving flexibility and choice in the marketplace.
This benchmarking model is based on the GFSI Guidance Document, a multi-stakeholder document that was drafted with
input from food safety experts from all over the world, and defines the process by which food safety schemes may gain
recognition by GFSI and gives guidance to these schemes. GFSI drives continuous improvement through the Guidance
Document, which is updated on a regular basis with global industry input to ensure that the requirements for food safety
management schemes are robust. GFSI does not undertake any certification or accreditation activities.
 FSSC 22000 :-
The Food Safety System Certification (FSSC 22000) for food and feed safety/quality management is an internationally
recognized scheme for food safety certification applicable to all organizations in the food chain, regardless of size and
complexity. This scheme sets out requirements to develop, implement and operate a food safety management system.
BSI certification to the scheme provides global industry recognition for:
 Processing of perishable animal products

 Processing of perishable plant products
 Processing of perishable animal and plant products (mixed products)
 Processing of ambient stable products
 Production of food packaging and packaging material
 Production of (bio)chemicals
Version four of the FSSC 22000 requirements reflect industry best practice and are made up of a series of separate
components audited as a single system including:
 ISO 22000 Food Safety Management System - requirements for any organization in the food chain
 Industry-specific ISO and PAS Pre-requisite Programs (PRPs)
 Additional scheme requirements for site services, personnel, supplied materials, food defense, food fraud
prevention, allergen management and food labelling

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FSSC 22000 V5 :- published 3 June 2019
FSSC published version 5 of FSSC 22000 on 3 June 2019. The main reasons for publishing a revised version include:
 Publication of the new ISO 22000:2018 standard

 Inclusion of the board of stakeholders list of decisions
 Compliance with GFSI requirements
 Continual improvement process
Benefits of FSSC 22000 :-
Certification to FSSC 22000 demonstrates a commitment to food safety delivers a variety of benefits that will impact
different parts of your organization.
FSSC 22000 implementation benefits :-
 Provides a systematic methodology to effectively identify and manage food safety risks
 ISO-based certification model can be used across the whole food supply chain
 Recognized by the GFSI and by the European cooperation for Accreditation (EA)
 Flexibility allowing you to determine how your business will meet the scheme requirements for the structure and
documentation of your food safety management system.
What is the difference between ISO 22000 and FSSC 22000?
 ISO 22000 is not recognized by GFSI. (what is GFSI?)
 ISO 22000 is broad in scope.
 FSSC 22000 is recognized by GFSI.
 FSSC has a more limited scope. Current scopes included are: farming, perishable animal products, food processing,
feed production, food ingredients and food packaging material manufacturing.
 Most companies will benefit by choosing FSSC 22000 and achieving a GFSI recognized certification. This is
because many companies require that their suppliers be certified to a GFSI recognized standard. ISO 22000 is not
recognized by GFSI.

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 IFS :- what is IFS ? - IFS = International featured/food standard.
The IFS Food Standard is a GFSI (Global Food Safety Initiative) recognized standard for auditing food manufacturers. The
focus is on food safety and the quality of processes and products. It concerns food processing companies and companies
that pack loose food products.
IFS Food applies when products are “processed” or when there is a hazard for product contamination during primary
packing. The Standard is important for all food manufacturers, especially for those producing private labels, as it contains
many requirements related to the compliance with customer specifications.
The Standard supports the production and marketing departments in their efforts for brand safety and quality. IFS Food has
been developed with full and active involvement of certification bodies, retailers, food industry and food service companies.
International Featured Standard (IFS) Food is a GFSI-recognised standard for certifying the safety and quality of food
products and production processes.
The standardized IFS Food evaluation system helps to reduce the need for repeat audits, which saves you time and money.
The programme also helps to improve the understanding of quality and safety processes across your organisation and
throughout your entire supply chain, providing standards that deliver uniformity and transparency.
What is the process of becoming IFS certified?
1. Decide which standard is more suitable for the company (IFS Food or IFS Logistic)
2. Order the most recent version of the standard
3. Evaluate the current status (by the company)
4. Select the certification body (quotation, decision and signature of contract)
5. Determine the audit date, the audit times and the audit scope
6. Voluntary: pre-audit to get the status quo
7. Realise the on-site audit at the determined audit date by an auditor competent for the respective product category

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 SQF (Safe Quality Food) :-
SQF Definition: SQF is a Food Safety Management Certification Scheme, created and managed by SQF Institute, used to
control food safety risks. Once your food safety management system is implemented it is audited and certified by a third-
party certification body. The Food Safety Certification requirements provide a rigorous system to manage food safety risks
and provide safe products for use by companies in the food industry. It is a GFSI recognized food safety certification. This
allows your customers to have confidence in your food safety program and know that you have a rigorous food safety
system in place.
 What Are The Benefits?
Managing Risk :-
First and foremost, building your food safety management system will provide your company with effective management of
food safety hazards by creating an environment capable of producing safe product and a management system to
continually manage, monitor, validate and improve the system.
Maintain Current Customers :-
Statistics show that approximately 1 out of 4 certified companies are asking their suppliers to achieve certification.
Chances are that if you have not been asked yet, you will be asked in the near future. Starting on your certification can help
you stay competitive and qualified to work with your current customers.
Increase Your Market Reach :-
Large retailers and multinational manufacturers or processors are also demanding certification of their suppliers. SQF
Certification means you are qualified to supply these organizations or their suppliers, opening up a large market for your
products.
Prepare for New Regulations :-
Countries across the globe are making changes to food safety regulations, including the United States and its Food Safety
Modernization Act (FSMA). The newest version, Edition 8, prepares your organization to meet many or most of the FSMA
requirements.
What Is Edition 8? :-
Edition 8.1 is the newest version of the Safe Quality Food Code. This version of the code, became effective January 1, 2018.
Companies are expected to begin their transition to the new edition. What is New? An overview summary of the changes
SQF has updated the code with 4 goals in mind.
 to better fit the needs of industry sectors,

 to take into account the latest regulatory requirements such as FSMA,
 to encourage continuous improvement
 to meet requirements in the new GFSI Benchmarking Requirements in GFSI V. 7.

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 AIB :-
AIB International, formerly the American Institute for Baking, was founded in 1919 to “put science to work for bakers.”
Since then, AIB has grown into one of the world’s foremost training organizations on food safety, setting AIB standards for
quality and safety.
In the warehousing and logistics industry, we hear of AIB mostly in the context of warehouse inspections. AIB is not a
government agency, so company’s elect to invite AIB to do a yearly inspection that ensures facilities and processes uphold
product integrity, comply with the Food Safety Modernization Act (FSMS), and achieve Global Food Safety Initiative (GFSI)
recognition.
AIB Standards :-
Food manufacturing and distribution are highly regulated functions, and rightly so. Food contamination during the supply
chain journey can have catastrophic consequences for consumers. And the cost to companies can cripple profitability and
shareholder confidence.
According to a May, 2016 Fortune magazine article, 18% of international companies surveyed said the financial hit from a
recall and related lost sales was between $30 million and $99 million; 5% said the impact was $100 million or more. The
long-term reputational damage to companies, post recall, can have an even steeper price tag.
These same companies impacted by food safety gaffes rely heavily on third-party logistics providers to maintain safe
handling and shipping practices while products are in their care (e.g., food warehousing). For these manufacturers, having
an objective, expert party like AIB confirm that food safety practices are adequate at the logistics facility is an important
part of a vetting process for logistics providers.
An AIB Standards Inspection: The Basics :-
AIB standards include the following five categories, which form the basis of inspection steps. Some apply more to the
manufacturing environment than distribution.
Operational Methods and Personnel Practices – the receipt, storage, monitoring, handling, and processing of raw materials
to manufacture and distribute safe final product. Facilities need to be confident that people, processes, and conditions do
not introduce a food safety concern.
Maintenance for Food Safety – the design, upkeep, and management of equipment, buildings, and grounds to provide a
sanitary, efficient, and reliable manufacturing environment. AIB standards here provide best practices for optimizing the
design and care of the facility and equipment so that they are easy to manage and do not create sanitation issues.
Cleaning Practices – the cleaning and sanitizing of equipment, utensils, and buildings to provide a wholesome and safe
processing environment. The AIB inspection will look at the methods of cleaning, the types of chemicals used, the
frequency of cleaning activities, and the control of microbes.
Integrated Pest Management – the assessment, monitoring, and management of pest activity to identify, prevent, and
eliminate conditions that could promote or sustain a pest population. The inspection considers both removal of any pests
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and measures to prevent pests from ever having the opportunity to thrive in a food environment.
Adequacy of Prerequisite and Food Safety Programs – this standard is largely about documentation. AIB wants to ensure
that all departments are working together to deliver a safe product. It is not enough to have programs in place, the
programs must be formalized through designing, planning, management, documentation, and review.
Benefits of an AIB Inspection
Adhering to AIB standards through an inspection process leads to the following benefits:
 Identify root causes, not just on symptoms
 Educate personnel through interaction with an inspector
 Identify, reduce, eliminate, and prevent food hazards in a facility
 Prevent expensive and damaging recalls
 Comply with government regulation
 Improve and maintain a healthy, sanitary environment for food handling
 Produce safe food products
 What is Global Red Meat Standard (GRMS) :-
GRMS is an accredited and independently audited scheme that was launched in 2006 by the Danish Agriculture and Food
Council in collaboration with the Danish Meat Research with the objective to promote certified standards notably tailored to
the meat industry. More specifically GRMS is an EN45011 (European Standard for Product Certification) that develops
requirements focusing on the slaughtering, deboning, cutting and selling of red meat including pork and beef only. GRMS is
contemplated to assess meat companies’ activities and procedures by an independent certified body.
GRMS is owned and managed by the Danish Agriculture and Food Council. Being a total supply chain initiative, GRMS
standards apply to all aspects of transport, lairage, stunning, slaughtering, deboning, cutting, and handling of meat and
other meat products.
What products are covered by GRMS :- China Organic Product Certification standard covers crops, mushrooms, wild plants,
livestock and poultry, aquaculture products, beekeeping products and their unprocessed product among others.
What are the key features of GRMS
• Meat safety and quality – which is the foundation of the GRMS - is accomplished through the application of unique Danish
standards in the areas such as salmonella control and residue surveillance.
•GRMS focuses on 19 different areas which all play an important role in allowing the maintenance of high standards:

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Quality Management System; Management Responsibilities;HACCP systems;Internal Audit;Purchasing;Sales;Product
Specification;Non-Conformance Procedures;Traceability;Product Recall Procedures;Complaints Procedures;Buildings,
External Areas, Process Layout, Equipment; Product Handling, Animal Welfare; Process Management and Production
Monitoring;Dispatch and External Storage;Cleaning Programmes, Environment;Measuring Equipment;Personnel, Visitors,
External Labour;Training.
GRMS : facts and figures
• In October 2009 the GRMS scheme was recognized by the Global Food Safety Initiative (GFSI) and received the equivalent
status of other commercial standards already recognized by GFSI.
• GRMS certification was published on the 1st July 2011, is valid from the 1st September and will be compulsory from the
1st January 2012.
• ISACert B. V. is the first certification body approved by GRMS.
• ISACert has granted certificates to 18 companies operating in Europe for having fulfilled GRMS’ requirements.
 PAS 96 :-
Protect your food and beverage products from deliberate attack
Defending your food and agri-food products is essential to your business’s reputation and survival. While you have various
Food Safety Management Systems in place to prevent accidental contamination, a deliberate attack can often bypass food
safety protocols – getting past even the most rigorous systems. With the competition in the food industry growing,
deliberate attacks have become more common. This is why BSI has developed the Publically Available Standard (PAS) for
preventing deliberate attack on food and drink, PAS 96.
The purpose of PAS 96 is to improve the resilience of all parts of production and supply chain against attack. PAS 96
covers types of attackers and addresses a number of specific threats including:
 Extortion
 Malicious Contamination
 Cybercrime
 Espionage
 Economically motivated adulteration
 Counterfeiting

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To address these types of attacks, PAS 96 introduces Threat Assessment Critical Control Points (TACCP), a risk
management framework closely aligned with HACCP. TACCP should be used by food businesses as a part of a broad risk
management strategy to:
 Reduce the likelihood of a deliberate attack
 Reduce the impact of an attack on your food business
 Reassure stakeholders about the safety of your production and supply chain
Who needs PAS 96?
PAS 96 is intended for use by all organizations involved in the food and agri-food sector. Businesses who run in a
competitive space in the market would want to ensure their competitors cannot sabotage their reputation. Organizations
who operate in areas with very little legal protection will find this standard to be critical. Finally, businesses with large,
varied and widely-sourced supply chains will be required to implement this standard.
What are the benefits of PAS 96?
Implementing PAS 96 and TACCP into your business ensures your production and supply chain is safe from deliberate
attacks.
Implementing TACCP allows you to:
 Demonstrate your commitment to food safety
 Enhance your brand reputation
 Provide assurance to stakeholders
 Better manage your risks, both now and in the future
This PAS was jointly sponsored by the Department for Environment, Food & Rural Affairs (DEFRA) and the Food Standards
Agency (FSA). Its development was facilitated by BSI Standards Limited and it was published under license from The
British Standards Institution. It came into effect on 31 October 2014.

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(27-28) Accreditation and Certification: Introduction, Benefits, accreditation organizations,
Certification, Types of certifications, Certification Bodies in India, BIS, AGMARK
 Accreditation and Certification ? :-
For organizations :-
First of all, ISO standards are published by the International Organization for Standardization – this is an international body
founded by governments around the world. Its purpose is to publish standards as a way to deliver knowledge and best
practice – as of now, almost 20,000 standards are published in total, and they are recognized in every country.
ISO management standards are only part of these 20,000 standards, which were created primarily as a help for companies
to improve their operations in certain areas (e.g., ISO 9001:2015 for quality management, ISO 27001 for information
security management, etc.) – this is why most of the talk about these standards is related to companies and their
registration, certification, and accreditation.
Certification vs. registration :-
When you want to say that a company has implemented a standard (e.g., an Information Security Management System
according to ISO 27001), has successfully completed the certification audit, and the certification body has issued the
certificate, you would normally call this registration or certification.
In North America, the term “registration” is most commonly used, while in the rest of the world it is usually called
“certification.” So, is there a difference? Technically, yes; but essentially, no.
Certification is when a certification body issues the certificate proving that a company is compliant with a standard;
registration is when this certificate is registered with the certification body. So, basically, it comes down to the same thing
– a company got a certificate that is formally recognized.
By the way, the International Organization for Standardization recommends usage of the term “certification” (see the ISO’s
explanation here), so I’ll use this term from this point forward in this article.
Certification body vs. registration :-
This is the terminology difference that directly arises from the usage of certification/registration terms – in North America
people usually use the term registrars, while in the rest of the world they are called certification bodies.
But, again, this is one and the same thing – those are the companies that perform the certification audits and issue the
certificates. Here, also, the ISO recommends using the term “certification body”.
Accreditation vs. certification :-
What is the accreditation, then? In order for certification bodies to able to perform the certification audits and issue the
certificates, they need to get a license – and this license is called accreditation. So, certification bodies are getting
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accredited, while companies are getting certified. (The certification body needs to be compliant with the standard ISO
17021 if they want to get accredited for certifying management systems.)
There is usually only one accreditation body for each country (e.g., UKAS for the United Kingdom), while there are several
certification bodies operating in each country – ranging from small local certification bodies to large multinational
corporations like SGS, BSI, DNV, BV, etc.
The good thing about accreditation bodies is that they usually publish the list of accredited certification bodies in their
countries
 Accreditation Bodies in India :-

1) QCI :-
Quality Council of India (QCI) was set up as a non-profit autonomous society registered under Societies Registration Act
XXI of 1860 to establish an accreditation structure in the country. QCI is governed by a Council comprising of 38 members
and has an equal representation of Government, Industry and other Stakeholders. The Council is the apex level body
responsible for formulating the strategy, general policy, constitution and monitoring of various components of QCI
including the accreditation boards with objective to ensure transparent and credible accreditation system.
Main functions of QCI are :-
i) To develop, establish & operate National Accreditation programmes for various service sectors such as education,
healthcare, environment protection, governance, social sectors, infrastructure sector, vocational training etc., in
accordance with the relevant international standards & guides for the conformity assessment bodies certifying products,
personnel, management systems, carrying out inspection and for the laboratories undertaking testing & calibration and
such other areas of organized activities that have significant bearing in improving the quality of life and well being of the
citizens of India.
ii) To develop accreditation standards to support accreditation programs where such standards are not available at the
national/international level.
QCI has four Accreditation Boards involved in accreditation programmes. Each board is functionally independent and works
within their core area of expertise.
 National Accreditation Board for Certification Bodies (NABCB)
 National Accreditation Board for testing & calibration Laboratories (NABL)
 National Accreditation Board for Hospitals and healthcare providers (NABH)
 National Accreditation Board for Education & Training (NABET)

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2) NABCB :-
National Accreditation Board for Certification Bodies(NABCB) provides accreditation to the Certification Bodies (CB) and
Inspection Bodies (IB) established as legal entities anywhere in the world in accordance with relevant International
Standards/Guidelines. All countries under WTO mutually accept products/services certified / inspected from accreditated
agencies only. NABCB is a member of International Accreditation Forum (IAF) and Pacific Accreditation Cooperation (PAC)
as well as signatory to its Multilateral Arrangements (MLA)s for QMS, EMS, FSMS & Product certification. NABCB is also a
Full member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation
Cooperation (APLAC) as well as signatory to its Mutual Recognition Arrangements (MRA)s for inspection.
NABCB currently offers the following accreditation programmes:
 Quality Management Systems (QMS)

 QMS for Medical Devices
 QMS for Aerospace Industry
 Environmental Management Systems (EMS)
 Occupational Health & Safety Management Systems (OHSMS)
 Food Safety Management Systems (FSMS)
 Energy Management Systems (EnMS)
 Information Security Management Systems (ISMS)
 Road Traffic Safety Management Systems (RTSMS)
 Information Technology Service Management Systems (ITSMS)
 Inspection Bodies
 Product Certification Bodies
 Personnel Certification
3) NABL
National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body set up under the
aegis of Department of Science & Technology, Government of India and is functioning as the accreditation body for Testing
and Calibration Laboratories.
NABL provides laboratory accreditation services in India and abroad, regardless of their ownership, legal status & size that
are performing tests / calibrations in accordance with ISO/IEC 17025:2005 / ISO 15189:2007 / ISO/IEC 17043 in the
following areas:
 Testing laboratories
 Calibration laboratories
 Medical laboratories

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 Proficiency testing provider
 Reference material producers
4) NABH :-
National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India,
set up to establish and operate accreditation programme for healthcare organisations on patient safety and quality of
healthcare based uponnational/international standards.
NABH is an institutional member of the International Society for Quality in Health Care (ISQUA). ISQUA is an international
body which grants approval to Accreditation Bodies in the area of healthcare as mark of equivalence of accreditation
program of member countries.
NABH is engaged in the Accreditation of Health care facilities that so far cover the following facilities:
 Hospitals
 Small Health Care Organisation(SHCO) - having bed strength upto 50 beds
 Blood banks/ blood centres and blood transfusion services
 Medical Imaging Services (MIS) - It includes conventional radiation based diagnostic radiology as well as a wide
variety of specialised techniques including Ultrasound scans, Doppler studies, Bone densitometry, CT, MRI, PETCT,
SPECT, Radionuclide imaging and therapy etc.
 Dental Health Care Service providers (DHSP)
 Oral Substitution Therapy (OST) Centres - developed for National AIDS Control organisation (NACO) to improve
health status of Injectile Drug Users (IDUs) and prevent spread of HIV AIDS.
 Allopathic Health clinics
 AYUSH (Ayurveda, Homeopathy, Unani, Siddha and Yoga & Naturopathy)
 Primary & Community Health Centres (PHC/CHC)
 Wellness Centres
5) NABET :-
National Accreditation Board for Education and Training (NABET)is a constituent Board ofQuality Council of India.NABET
provides accreditation to schools, training course providers and auditors that meet the Board’s criteria and also offers a
mechanism for their international recognition. The Board comprises of Seventeen members including the Chairman. The
Seventeen members represent different groups of stakeholders. The accreditation programmes of NABET mainly
categorized under certain distinct verticals in the following areas:

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Formal Education Excellence Division (FEED) :-
o Accreditation of Schools
o Accreditation of 3 Day Training Course for Preparing School for Accreditation
Skill Training :-
o Industrial Training Institute (ITI) /Vocational training organizations
o It is mandatory for seeking National Council for Vocational Training (NCVT) affiliation under Ministry of Skill
Development and Entrepreneurship (MSDE) since 2012. Directorate General of Employment and Training (DGE&T)
Field Institutes imparting training in various activities
Skill Certification :-
o Personnel Certification Bodies under ISO 17024
o Skill Assessing Bodies under DGE&T MES Scheme
Environment :-
o Environment Impact Assessment (EIA) Consultant :- It has been adapted as minimum requirement by Ministry of
Environment, Forests & Climate Change.Click here to view the list of accredited EIA consulting organizations with
the accredited sectors.
o Environment, Health & Safety (EHS, ISO 14001 and OHSAS 18001) consultant organisation
MSME(Micro Small and Medium Enterprises) :-
o Lean
o BMO(Business Membership Organisation)
Laboratory Management System (LMS) Training Institutions :-

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Types of Certification in India :-
Their are many local, Private as well as Government certification bodies which are accredited by one or more of the above
accreditation bodies in India. ACCREDITED certification bodies can give certificate to the food processing industry and
others also. So various types of certificates are available in India for same thing/indication. Hence some standard
certificates are considered as main certificate , if any food industry have those certificates then they does not need any
other type of certificates.
1) BIS :- The Bureau of Indian Standards (BIS) is the national Standards Body of India working under the aegis of Ministry
of Consumer Affairs, Food & Public Distribution, Government of India. It is established by the Bureau of Indian Standards
Act, 1986 which came into effect on 23 December 1986.[2] The Minister in charge of the Ministry or Department having
administrative control of the BIS is the ex-officio President of the BIS.
The organisation was formerly the Indian Standards Institution (ISI), set up under the Resolution of the Department of
Industries and Supplies No. 1 Std.(4)/45, dated 3 September 1946. The ISI was registered under the Societies Registration
Act, 1860.
A new Bureau of Indian standards (BIS) Act 2016 which was notified on 22nd March, 2016, has been brought into force with
effect from 12th October, 2017. The Act establishes the Bureau of Indian Standards (BIS) as the National Standards Body
of India.
As a corporate body, it has 25 members drawn from Central or State Governments, industry, scientific and research
institutions, and consumer organisations. Its headquarters are in New Delhi, with regional offices in Eastern Region at
Kolkata, southern Region at Chennai, Western Region at Mumbai, Northern Region at Chandigarh and Central Region at
Delhi and 20 branch offices. It also works as WTO-TBT enquiry point for India
Who should apply for BIS Certification?
Generically speaking, manufacturers of products in India can apply for BIS certification on a voluntary basis except for
certain products that are mandatorily required to be registered with the Bureau before being sold, distributed, marketed,
imported or exported commercially. These products fall under the Compulsory Registration Scheme (CRS). The scheme is
further sub-divided into two sub-parts – Scheme I or the ISI Mark Scheme and Scheme II also called the Registration
Scheme
Documents required for BIS Certification :-
The checklist of documents that are required for obtaining the certificate include –
 The address proof of the registered office of the business – either the business license or any other Government
documents need to be submitted
 Proof of submission of the Government fees – a copy of NEFT details or the Demand Draft along with a copy.
 Authorization letter from the CEO/Owner of the company if documents are signed by authorized personnel.
 Completed Form VI

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 Copy of proof of registering the brand – either the registration certificate or authorization letter from the owner of
the brand in case the brand is owned by another person.
 Test report from a BIS Approved Lab, in original along with an undertaking.
 The authorisation of Indian Representative and Affidavit to the effect –
 For Indian Manufacturers – Affidavit on the prescribed format (Format C) along with an authorization from CEO in
case the Affidavit is signed by an authorized person and his ID proof.
 For Foreign Manufacturers –in case the liaison office is already registered in India, then a copy of the Registration
certificate along with an affidavit cum undertaking from the CEO/MD of the liaison office as per Format A. In case
the Affidavit is signed by an authorized person, an authorization letter from the CEO/MD along with the ID proof of
the signatory. In case the foreign manufacturer has a nominee of his brand in India and if the brand owner does not
have a nominee of the brand in the country, there are some additional documents that are required to be submitted
by the owner.
 BIS might ask for additional information on a case-to-case basis for evaluation of the application.
BIS Certification Process :-
In order to obtain the certification from the Bureau for their products, manufacturers need to follow the following process-
 The manufacturer needs to apply online here for the certificate. They need to first register at this site to be able to
complete the application process. Registered users can then fill up Form VI.
 Before filing for online application, manufacturers need to submit a sample of the finished good to a BIS
recognized lab for testing. Different standards have different approved labs to carry out the testing. For IS
616:2010* there are about 52 approved labs in the country. The testing charges are as below:-
 Foreign manufacturers who have no liaison/branch office in the country need to first appoint an Authorized Indian
Representative as per BIS regulations. The Authorised Indian Reps need to submit an affidavit cum undertaking as
per prescriber Format A or B as applicable.
 Indian manufacturers need to submit an affidavit cum undertaking as per Format C.
 All required documents need to be submitted online along with the application.
 The appropriate and applicable fee needs to be deposited. The government fee or the BIS Certification cost for the
products being discussed is as below:-

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 It is mandatory that the hard copy of the application Form along with all documents be submitted to the BIS head
office at New Delhi within 15 days of online submission. In case the hard copies fail to reach within the stipulated
time period, the application will be closed.
 After submission, all documents and the application are reviewed and scrutinized by BIS.
 In case of additional information and an inquiry from BIS, the applicant can revert back online.
 In case of shortcomings pointed out by BIS, the applicant needs to address them on an immediate basis.
 Once BIS is satisfied with all reverts the BIS registration is granted. The approval is uploaded on the portal.
2) AGMARK :-
AGMARK is a certification mark employed on agricultural products in India, assuring that they conform to a set of
standards approved by the Directorate of Marketing and Inspection an attached Office of the Department of Agriculture,
Cooperation and Farmers Welfare under Ministry of Agricultural & Farmers Welfare an agency of the Government of
India.The AGMARK Head Office at Faridabad (Haryana) is legally enforced in India by the Agricultural Produce (Grading and
Marking) Act of 1937 (and amended in 1986).[1] The present AGMARK standards cover quality guidelines for 222 different
commodities spanning a variety of pulses, cereals, essential oils, vegetable oils, fruits and vegetables and semi-processed
products like vermicelli.
The entire system of Agmark, including the name, was created by Archibald MacDonald Livingstone, Agricultural and
Marketing Advisory to the Government of India, from 1934 to 1941. He was supported by a staff of several hundred. The
system was designed to benefit local growers throughout India who were, in the absence of a certification as to quality,
exposed to receiving less for their produce from dealers than its true worth.
Agmark Testing Laboratories :-
The Agmark certification is employed through fully state-owned Agmark laboratories located across the nation which act
as testing and certifying centres. In addition to the Central AGMARK Laboratory (CAL) in Nagpur, there are Regional
AGMARK Laboratories (RALs) in 11 nodal cities (Mumbai, New Delhi, Chennai, Kolkata, Kanpur, Kochi, Guntur, Amritsar,
Jaipur, Rajkot, Bhopal).[9] Each of the regional laboratories is equipped with and specializes in the testing of products of
regional significance. Hence the product range that could be tested varies across the centres
FSSAI vs AGMARK :-
FSSAI (Food Safety and Standards Authority of India) regulates and monitors the products in the food business to make
sure that the food consumed is safe. On the other hand, AGMARK, which is a quality certificate issued on products that
meet the guidelines mentioned by the governing authority. From here, you would have got to know that both these
standards are meant to assure good health and hygiene.

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Agmark Certification :-
Agmark-Agricultural sector plays a very important role in Indian economy. To effectively market the agriculture products in
international market and in domestic markets in India standard for agricultural produce & products were required.
Government of India through its agency Directorate of Marketing and Inspection (DMI) lays down standards for agricultural
products which is implemented at State level. The quality certification for the agriculture produce which assures that the
products conforms to the standards laid down by the Government of India is called Agmark Certification. Thus, Agmark is a
quality certification for agricultural products provided by the Government of India which assures that the product
containing the Agmark is good in terms of quality and produced in hygienic condition thereby fit for human consumption. It
is useful both for consumers and producers, marketers and traders.
Agmark certification – Is Mandatory :-
Agmark certification is voluntary but for some products it has been made compulsory vide Food Safety and
Standards( Prohibition and Restriction on Sales) Regulation 2011.These are as under:
 Blended Edible Vegetable Oil
 Fat Spread
 Kangra Tea
 Ghee
 Til Oil
 Honey
 Light Black Pepper
As of now Directorate of Marketing and Inspection formulated standards for 213 commodities of agricultural products.
Important points in Agmark Certification :-
1. Agmark is a quality certification for agricultural produce by Government of India, under Agricultural Produce
Grading and Marketing Act, 1937 amended in 1986. Agmark certified product must bear an Insignia of Agmark
prescribed by the Directorate of Marketing and Inspection(DMI), an agency of Government of India.
2. Agmark certification is a voluntary certification unless it is made compulsory as per provision of Food Safety and
Standards (Prohibition and Restriction on Sales) Regulation 2011.
3. It is product specific certification provided in Agriculture Produce (Grading and Marking) Act. Government of India
fixes varied grading standards for different agriculture products which is implemented on state level.
4. To make the products comparable in international market the grading standards are fixed keeping in view the
requirements of WTO.
5. The products bearing Agmark must conform to the standard laid down by Directorate of Marketing and
Inspection(DMI), any contravention to this may require free replacement of graded products by the producer.

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Requirement of Agmark Application Proceedings :-
 Copy of test report(s), duly authenticated, from independent Agmark recognized laboratory.
 Document authenticating establishment of the firm, such as Registration by Company Registrar
 State Authority or Memorandum of Article in case Applicant Firm is a Limited Company
 Partnership Deed in case the applicant firm is under Partnership.
 Name of the products .
 Name of the applicant
 Name of the Firm/ Company
 Address of the Firm/ Company
 Sample of the product(in pouch of 500gm.1kg.
 Statrted Time period of product(specify exact Date/Month/year)
 Total gross product in K.g.(for last year)
 Turnover of last year

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(29) Documentation
Documentation for food safety :-
A series of sector specific Food Safety Management System (FSMS) Guidance Documents have been
developed/underdevelopment with the intent to provide implementation guidance to food businesses (especially the small
and medium businesses) involved in manufacturing, packing, storage and transportation to ensure that critical food safety
related aspects are addressed throughout the supply chain.
These documents are based on Schedule 4 of Food Safety & Standards (Licensing & Registration of Food Businesses)
Regulation, 2011 and lay down general requirements on good hygienic practices to be followed by Food Business Operators
& indicate practical approaches which a business should adopt to ensure food safety. The documents are recommendatory
in nature and also provide the basic knowledge and criteria for implementation of Hazard Analysis and Critical Control
Point (HACCP) system by the food businesses. Sample HACCP Plans have been taken from some established practising
industries. These plans could be used as reference by the industry and modified or altered based on their operations.
Inspection checklists for Food Business Operator to audit their facility & operations are also included in these documents.
The FBOs can evaluate themselves based on the indicative scoring. Also, these documents provide important templates
and forms to facilitate the FBOs to maintain the records. These include mandatory forms as prescribed by FSSAI & few
templates for maintaining records of processes critical for food safety.
Record Keeping :-
Another legal requirement is that food firms maintain records relating to the manufacture, processing, packing, distribution,
receipt, holding, or importation of food products. The purpose is to assist in determining whether anything has happened to
the food or been done to the food that would render it unsafe (i.e., adulterated). Accordingly, firms must maintain records
and government authorities may access the records.
The food industry also is demanding that food businesses retain records which buyers (other food processors?) can access
or rely on to assure that the seller has taken reasonable steps to reduce the risk of a food borne problem. Although this
web site focuses on the expectations imposed by statutory and regulatory law, it is important to realize that food buyers
also are imposing contractual expectations on food sellers, including the expectation that the seller have records to
adequately document how the product being sold had been handled by the seller.
The Reason for Records :-
Food businesses maintain detailed records for several reasons, such as, document how the food was handled and labeled
to establish that the food was not adulterated or misbranded while under the control of the food business. Food
businesses also maintain records of who they received the food from (previous source) and who received the food from the
business (immediate subsequent recipient). This second purpose of records is to facilitate traceability.

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This page introduces U.S. federal statutes and regulations mandating food businesses to maintain records. The discussion
intertwines the two purposes for maintaining records, but historically the law first focused on records to address
adulterated and misbranded foods; more recently, the law has added the concept of maintaining records to facilitate
traceability. The law also authorizes the FDA and USDA to access the records of the businesses the agencies oversee.
The law generally does not detail what records have to be maintained; instead, the law takes the approach that "the firm
needs to be able to document that the food is not adulterated or misbranded and its history can be traced; the firm can
decide what information it wants to maintain as documentation to accomplish these purpose; whatever documents are
maintained (with some exceptions) can be accessed by the FDA or USDA; and failure to maintain records to substantiate
that the food was not adulterated or misbranded will result in the suspect food being treated as adulterated or misbranded
and thus cannot be sold. Food firms -- you know what needs to be done and you know the consequence of not doing it; now
it is up to you to figure out how you want to maintain records for your business."

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(30-32) Auditing and Surveillance: Introduction, Definition, Objectives of auditing, Types of Audit,
Principles of Auditing, Audit Program Procedures, Audit Activities, Audit Competencies, Lead
Auditor, Surveillance. Recent Update on the subject (if any)
Their are two types of audits Surveillance audit and Certification audit
The certification audit and its limitations :- During the first (initial) certification audit the certification auditor will check
whether all the main elements of the management system are in place – all the documentation, all the required records, all
the processes, etc. The auditor will also check whether the main processes are working as they are described in the
documentation, but such check will be limited because at that point in time the management system will have been in place
for only a few months, or even only a few weeks. (To read more about the certification process, read this blog post: How to
get certified against ISO 27001?)
On the other hand, the certificate is issued for a period of three years – so, for instance, if the initial certification audit was
performed in November 2012, this means that the certificate will be valid until November 2015. Since the certification body
guarantees that the management system will be in place throughout the validity of the certificate, the only way for the
certification body to check out whether it really works is to send the certification auditor periodically to check out how
things are going. And these are called the surveillance visits – they have to be performed at least once a year, or in some
cases they are performed twice a year.
In cases where they are performed once a year, and using the previous example of a certification audit in November 2012,
the first surveillance visit would be in November 2013, and the second (and last) surveillance visit in November 2014. After
this, in November 2015, the certificate would expire and a company could go for the recertification audit.
The purpose of surveillance visits
So the main purpose of the surveillance visits is for the certification body to find out whether your management system
really works in everyday operations, or not. It will focus on things that the certification audit wasn’t able to check: for
instance, whether all the incidents are recorded, whether all the measurements are made, whether all corrective and
preventive actions are properly recorded and implemented, whether the top management really supports and cares about
the system, etc.
A surveillance visit will also focus on issues that were identified as weak in the certification audit or previous surveillance
visit – minor nonconformities, as well as areas where the auditor has made some observations.
The point is, during the surveillance visit the certification auditor will pay far less attention to the documents themselves,
and far more attention to how the key processes are performed, how they are measured, and how they are improved – in
other words, whether your system really works.
So don’t relax after your certification audit is over – the certification body is highly interested in finding out whether your
management system is really functioning, and this is exactly what the surveillance visits will be focused on. And this is one
more reason why you shouldn’t implement the standard only for the purpose of certification – the idea should be that the
procedures and policies are really used in everyday operations

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Example of ISO 9001 Surveillance Audit :-
Early on, when you are implementing a Quality Management System (QMS) using the requirements of ISO 9001:2015, you
will need to talk to a certification body to find out what you need to do to certify your management system as compliant
with the requirements. During your discussions you will be told about the documentation audit, the certification audit, and
the cycle of surveillance audits until your recertification audit; but, what does all of this mean? Here’s how this works.
How do certification and the certification audit cycle work?
The three-year certification cycle is used for companies certified against ISO 9001, although there are some modifications
possible as described below. When you have implemented your QMS and are having your first certification, you will start
with a documentation audit. This is where an auditor from your certification body will review all of your documentation, and
compare it to the ISO 9001:2015 standard requirements, to verify that what you have documented meets the requirements
of the standard.
Once the documentation is confirmed, you will schedule your certification audit. This is where the certification body will
perform an on-site audit of all of your QMS processes, and then issue your ISO 9001:2015 certification (when you have
completely addressed any corrective actions that were found). You will then have on-site surveillance audits for the next
two years, until your re-certification audit on the third year of your cycle, which will start you into the next three-year cycle.
Most certification bodies conduct one surveillance audit a year, but this could be more often if you negotiate this between
your organization and your certification body.
Below is a graphic of how this works, with the link back to the surveillance audit after the re-certification. As long as you
are maintaining your current certification with the same certification body, you will not need to go back to the certification
audit. However, if you change certification bodies or your version of the ISO 9001 standard (as companies are now
changing from ISO 9001:2008 to ISO 9001:2015), you will then have a transfer audit. This is much like starting back at the
certification audit step, where a full audit is performed and then old certificates are withdrawn and new certificates are
issued.
 ISO 9001 certification audit cycle and surveillance process
What is specific about a surveillance audit?
So, you are probably asking what the difference is between the surveillance audit and the certification/re-certification
audits. All three are on-site audits done by the certification body, will have corrective actions issued that need to be
addressed, and will have an audit report issued to your company as a record of the audit. The difference is the number of
hours devoted to processes in the audit.
For the certification/re-certification audit, the certification body auditors will look at the implementation of every process
within your QMS to check for conformance to the ISO 9001 standard, as well as your company documentation, process
effectiveness, and continual improvement. This audit will often take several auditors many days to complete, depending on
the size of your company and the number of processes within your QMS.

87
By comparison, the surveillance audit will spend less time on only some portions of your QMS processes, rather than
everything. They will start each time by looking at your key processes (such as management review, internal audit, and
corrective actions), and will then only look at some of the remaining processes within your QMS. They may also only look at
a portion of the whole organization, such as only one out of two production lines, or even only certain sites chosen by the
auditors, rather than multiple sites. There is a recommended rule to use a square root of all possible locations; for example,
if there were a total of 16 retail stores in the scope of the certification, then at least four should be audited in a surveillance
audit.
Since the auditors will be spending less time on fewer of your QMS processes, these surveillance audits will take less time
to perform than the original certification audit. The goal for the certification body is to audit all of the processes and
business sites at least once within the QMS during the two-year surveillance cycle.
Types of Audit :-
1. External Audit Objective: Financial Statements that are prepared by the Management are providing a true and fair
view. Financial Statements are prepared as per applicable Accounting and Auditing Standards.
2. Internal Audit Objective: To Check Internal Control over financial reporting, compliance of Policies, compliance of
Legal Aspects such as the applicability of Companies Act.
3. Forensic Audit Objective: Recognize fraud cases, Control and decrease cases of fraud through the application of
suggestions and recommendations and internal Audit control in the entity,
4. Statutory Audit Objective: To check that Entity is following rules and regulations of Act under which that entity is
registered and as per that Act they have to appoint the statutory auditor and who will conduct the statutory audit.
5. Financial Audit Objective: To get reasonable assurance that the financial statements are free of material
misstatement.
6. Tax Audit Objective: Proper maintenance of the Books of Accounts and other records of similar nature and to
Maintain Proper records of Income and tax expenses and deductions of the Taxpayers.

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7. Special Audit Objective: Such type of Audit is conducted as per Laws and objectives are vary as per laws.
Advantages :-
 Board can check that principals and policies formulated and designed by them are implemented and following by
manpower or not.
 Financial Statements that are prepared by the management as per applicable financial reporting and auditing
standards.
 Internal audit Team can be verified that the Policy of Internal Audit Control is implemented or not which is
designed by them.
 Recognize fraud Cases and decrease the % of fraud Cases through strong Internal audit control.
 Provide a better representation of Financial statements and give a true and fair view.
 Evaluation of capacity and efficiency of all level Management of the entity.
 The audit helps for the rehabilitation of sick units, reconstruction of entity, merger, and amalgamation among the
companies.
 An external audit can be fruitful if the internal auditor is not reliable.
 The audit protects the interest of the Owner of the Entity.
Disadvantages :-
 The process of Audit is very costly as the entity bears expenses like auditor’s remuneration, there living cost during
the audit including staff; reimburse the official traveling expenses incurred during an audit by them.
 All the Data, Reports and information relevant to the audit process are provided by the management.
 The auditor conducts the audit on the sampling basis method due to this some errors can’t be identified.
 Auditors have limited time to conduct the audit and they need to submit the audit report to the owner of the entity
within a stipulated time.
 Results of internal audits do not publish to externals and their results only provide to management.
 This is not possible for the auditors to find all errors and frauds in the Books of accounts and accounting records.

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Limitations of Audit Objectives :-
 It does not cover audit of many important aspects of an entity such as Management efficiency, Finances, and
Business ethics.
 Clever manipulation and fraud in books of accounts and accounting records etc. are not disclosed by audit.
 Audit of Financial Statement does not provide exact confirmation of additional information and explanations which
is taken by the auditor for an audit opinion.
 Design of Audit techniques and formulate of an Audit program for the collection of evidence may not be the same
as the nature of Business.
 Explanations, data, reports and other information provided by the management may not be correct and may affect
the auditor for an audit opinion.
 There some type of audits which governs as per laws, in such audits, Auditors appoint by regulating authority so
there is no independence of auditors.
 Financial Statements are prepared basis number of judgments depending on such elements which may vary.
 Audit of Books of Accounts may not be fully reliable as the evidence provided by the management.
 Audited Financial statements may not provide a true and fair view and exact position if the auditor takes faulty
judgment/ Decision/ Opinion.
 Auditor can’t expert in all the verticals of the entity, he should believe upon a judgment of other experts like
Valuers, Lawyers.
 There are some entities that can’t bear the expenses of the audit.
Important Points to Note :-
 The target of audit objective is to form and express of True and fair view of financial statements and audit is
performed to get assurance that Financial Statements are free from all material misstatement.
 To check that Financial Statements are prepared as per accounting guidelines and reporting frameworks (IFRS) by
the management.
 Employees, who will provide assistance to auditors and their staff, should have sufficient knowledge of Audit:- How
is an audit to be conducted, what are the documents to be asked, what are the information, data, and report to be
provided to auditors.
 It may be changed as per the requirement of an audit.

90
Principles of Auditing :-
1] Integrity, Independence and Objectivity :-
The auditor has to be honest while auditing, he cannot be favoring the organization. He must remain objective throughout
the whole process, his integrity must not allow any malpractice.
Another important principle is independence. So the auditor cannot have any interest in the organization he is auditing,
which allows him to be independent and impartial at all times.
2] Confidentiality :-
The auditor has access to a lot of sensitive financial information of the organization. It is important that he respect the
confidential nature of such information and documents.
He cannot disclose any sensitive information to any third party unless it is a requirement by law. And he must also be very
careful with documents, certificates etc. that the organization entrusts to him.
3] Skill & Competence :-
The auditor must be experienced and trained in the procedures of auditing, i.e. must be qualified as an auditor. And as a
professional, he must be up to date on recent changes, announcements, rules etc.
If necessary he can undergo training and workshops to stay up to date with the recent auditing and accounting procedures.
For example, after GST was introduced, auditors had to update their knowledge.
4] Work Performed by Others :-
The scope of audit at times can be very vast. So an auditor has employees, delegates and other people who work under him.
However, the auditor will continue to be fully responsible for the work done by these people working for him. So the auditor
must carefully supervise and review such work and be reasonably sure of the accuracy of such work.
5] Documentation :-
In most cases the auditor maintains an audit notebook, an audit plan and auditing file. It is important the auditor keeps a
record of important documents with respect to his audit work, as it is evidence of the work the auditor has done. And the
client is inclined to these documents and files if he wishes to inspect the work.
6] Planning :-
An audit plan allows the auditor t plan out his work and enables him to be more efficient and timely. Every audit plan is
different as it has to be customized according to the type of organization, the kind of business they conduct, the scope of
the audit, the efficiency of the internal controls etc.

91
7] Audit Evidence :-
The auditor must collect enough evidence to support his final opinion. This collection of such evidence is done by
compliance and substantive procedures. There are two sources of this evidence – internal and external. Also, external
sources of evidence are always more reliable.
8] Accounting Systems and Internal Controls :-
The auditor has to assure that the accounts of the organization are accurate and represent a true and fair picture of the
financial status of the company. Also, the auditor must ensure that all material information has been recorded in the
accounts. Testing the internal controls system is also important as it helps determine the same.
9] Audit Conclusions and Reporting :-
After the auditor collects all evidence he must now form his opinion on the basis of the following criteria,
i. all relevant accounting standards were applied at all times
ii. financial statements are in compliance with all regulations and statutory requirements
iii. all material information has been disclosed
 Auditing Process :-
6 Step Audit Process :-
An audit is a formal check of financial accounts of an individual, business or organization. An internal audit is conducted by
members of the same organization or business, and an external audit may be conducted by a regulatory agency or
governmental agency. There are six specific steps in the audit process that should be followed to ensure a successful audit.
1. Requesting Financial Documents :-
After notifying the organization of the upcoming audit, the auditor typically requests documents listed on an audit
preliminary checklist. These documents may include a copy of the previous audit report, original bank statements, receipts
and ledgers. In addition, the auditor may request organizational charts, along with copies of board and committee minutes
and copies of bylaws and standing rules.
2. Preparing an Audit Plan :-
The auditor looks over the information contained in the documents and plans out how the audit will be conducted. A risk
workshop may be conducted to identify possible problems. An audit plan is then drafted.
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3. Scheduling an Open Meeting :-
Senior management and key administrative staff are then invited to an open meeting during which the scope of the audit is
presented by the auditor. A time frame for the audit is determined, and any timing issues such as scheduled vacations are
discussed and handled. Department heads may be asked to inform staff of possible interviews with the auditor.
4. Conducting Onsite Fieldwork :-
The auditor takes information gathered from the open meeting and uses it to finalize the audit plan. Fieldwork is then
conducted by speaking to staff members and reviewing procedures and processes. The auditor tests for compliance with
policies and procedures. Internal controls are evaluated to make sure they're adequate. The auditor may discuss problems
as they arise to give the organization an opportunity to respond.
5. Drafting a Report :-
The auditor prepares a report detailing the findings of the audit. Included in the report are mathematical errors, posting
problems, payments authorized but not paid and other discrepancies; other audit concerns are also listed. The auditor then
writes up a commentary describing the findings of the audit and recommended solutions to any problems.
6. Setting Up a Closing Meeting :-
The auditor solicits a response from management that indicates whether it agrees or disagrees with problems in the report,
a description of management's action plan to address the problem and a projected completion date. At the closing meeting,
all parties involved discuss the report and management responses. If there are any remaining issues, they're resolved at
this point. Audit Plan vs Audit Program :-

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Audit Activities :-
Audit planning and preparation: Audit preparation consists of planning everything that is done in advance by interested
parties, such as the auditor, the lead auditor, the client, and the audit program manager, to ensure that the audit complies
with the client’s objective. This stage of an audit begins with the decision to conduct the audit and ends when the audit
itself begins.
Audit execution: The execution phase of an audit is often called the fieldwork. It is the data-gathering portion of the audit
and covers the time period from arrival at the audit location up to the exit meeting. It consists of multiple activities
including on-site audit management, meeting with the auditee, understanding the process and system controls and
verifying that these controls work, communicating among team members, and communicating with the auditee.
Audit reporting: The purpose of the audit report is to communicate the results of the investigation. The report should
provide correct and clear data that will be effective as a management aid in addressing important organizational issues.
The audit process may end when the report is issued by the lead auditor or after follow-up actions are completed.
Audit follow-up and closure: According to ISO 19011, clause 6.6, "The audit is completed when all the planned audit
activities have been carried out, or otherwise agreed with the audit client." Clause 6.7 of ISO 19011 continues by stating
that verification of follow-up actions may be part of a subsequent audit.
Corrective action :- is action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable
situation in order to prevent recurrence (reactive). Corrective action is about eliminating the causes of problems and not
just following a series of problem-solving steps.
Preventive action :- is action taken to eliminate the causes of a potential nonconformity, defect, or other undesirable
situation in order to prevent occurrence (proactive).
 Auditing Competencies :-
Technology has so captivated the auditing sphere that at first glance, it seems machines seem to be stealing the spotlight
from humans. But technology, while it can undoubtedly make jobs easier and more efficient, doesn’t replace the unique
skills that human intellect, judgment and leadership bring to the table.
While humans’ continued involvement in the auditing process goes without saying, auditors need to master, or improve
upon, certain competencies that will ensure their continued success. These competencies are fundamental to advancing
audit quality and need to be used in conjunction with innovation. Here are five competencies we see as essential.
1. Strong communication skills. The KPMG/Forbes Insights report “Audit 2025” surveyed 200 respondents, including
audit committee chairs, CFOs and controllers. Collectively, they named communication as one of the top skills they seek in
an auditor. In fact, it’s core to an attribute that clients value most: the ability to articulate a clear point of view on the issues
(picked by 62% of respondents, compared with 46% just two years previous). In fact, communication skills (66%) were
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ranked virtually as important as technology skills (67%), making it one of the two top-ranked qualities auditors of the future
must possess.
What do communication skills look like in action? For the successful auditor, it means clearly conveying thoughts, ideas
and suggestions during meetings, presentations, interviews, and negotiations with audit clients and executives. As “Audit
2025” notes, “Long gone are the days when auditors said, ‘You are in compliance. End of report.’”
2. Emotional intelligence. Just because auditors approach their work with a level head doesn’t mean their clients are in
the same place. Whether they’re frustrated over disorganized financial records or anxious about uncovering a potential
fraud, clients need the steady hand of an auditor who excels at keeping composure and making sure the bull’s eye—an
accurate, exhaustive audit—remains squarely in sight.
A study published in March 2018 by the International Journal of Auditing, and conducted by business school researchers
from Longwood University and Virginia Commonwealth University, concluded that emotional intelligence improves audit
quality. The researchers add that “the moderating influence of emotional intelligence…is a significant mechanism that
moderates the effects of different types of pressure on auditors’ judgments.”
3. Critical thinking and business acumen. This equates to objective analysis and evaluation of the information and facts
contained in an audit that can produce actionable insights—or in many cases, the questions that inspire them.
“I’m impressed when auditors ask the right questions and make suggestions that show they understand the industry their
client is in and how the organization functions,” says Jeffry Haber, accounting professor and department chair at Iona
College. In keeping with this ability to ask the right questions, a successful auditor also needs to have business acumen
and be able to connect the dots, bringing lessons from his or her own experience, to help a particular client.
4. Professional skepticism. In its 2018 document “Enhancing Audit Quality and Transparency,” KPMG delineates the role
skeptical thinking plays in the design and execution of an audit engagement: “KPMG’s judgment framework addresses how
to recognize and overcome biases in making judgment and applying appropriate professional skepticism.”
Above all, professional skepticism requires the strength of character to avoid shortcuts and reexamine facets of the audit if
anything seems amiss. For example, it’s easy to automatically accept all the information provided by a client as gospel
truth. Skeptical auditors will ask themselves, “Am I getting the true picture?” and carefully follow the chain of audit
evidence for assurance.
“To produce a high-quality audit, auditors must exhibit professional skepticism,” says Jeffrey Cohen, professor of
accounting at Boston College. “They must be able to question clients in an objective and constructive way.”

95
5. Interpersonal skills. For all the technical acumen, compliance knowledge and numerical exactitude auditing demands,
at its core, it is also very much a business of people—of dealing with all types of clients in all types of situations. For the
successful auditor, exceptional people skills are a must. Empathy, for example, allows an auditor to better understand the
client’s perspective as the audit operation progresses.
Another facet of superior interpersonal skills—especially for auditors—is the ability to listen. Some financial services
professionals refer to this as the “80/20 rule,” named for the ideal ratio of time dedicated to listening versus talking. Active
listening that seeks to understand and comprehend also proves invaluable within audit teams and within the firm. In fact,
“auditor” derives from the Latin word that means “listener” and “hearer.”
【 Email:- tkdhulgand@gmail.com.】

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1

Sau. KSK alias KAKU College of Food Technology, Beed

 Quality Control and Quality Assurance :-

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

 Reviewing and helping to coordinate quality aspects of design of line plans

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

FUNCTIONS OF A QUALITY ASSURANCE PROGRAM :-

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

The Concept of Total Quality Management :-

The Basis for Superior Quality Performance :-

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

 Total customer satisfaction

 Total range of products and services

 Addressing all aspects of dimensions of quality

 Satisfying all customers – internal as well as external

 Addressing the total organizational issue of retaining customers and

 Improving profits, as well as generating new business for the future.

 Involving everyone in the organization in the attainment of the said objective.

THE PRINCIPLES OF TQM :-

2. Processes, not people, are the problem.

3. Every employee is responsible for quality.

4. Everyone is a customer and a supplier.

7. Quality improvements must be continuous.

8. Quality can and must be managed.

9. Plan and organize for quality improvement.

10. The quality standard is: defect free.

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

12. Life cycle costs, not front end costs.

The 10 Steps to TQM :-

1. Pursue new strategic thinking

2. Know your customers

3. Set true customer requirements

4. Concentrate on prevention, not correction

5. Reduce chronic waste

6. Pursue a continuous improvement strategy

7. Use structured methodology for process improvement

9. Use a balanced approach

10. Apply to all functions

IMPLEMENTING TQM SYSTEMS :- 12 steps

4. A TQM master plan is developed on the basis of steps 1, 2, and 3.

7. Management oversees the formation of teams for process improvement efforts.

8. The momentum of the TQM effort is managed by the steering committee.

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

10. Daily process management and standardization take place.

11. Progress is evaluated and the plan is revised as needed.

WeDeming 14 Points on Quality Management :-

1. Create a constant purpose toward improvement :-

 Plan for quality in the long term.

 Resist reacting with short-term solutions.

2. Adopt the new philosophy :-

 Embrace quality throughout the organization.

 Create your quality vision, and implement it.

3. Stop depending on inspections :-

 Build quality into the process from start to finish.

4. Use a single supplier for any one item :-

FMS-367 (2+1) Only for exam Purpose. - Tushar K. D.

5. Improve constantly and forever :-

 Emphasize training and education so everyone can do their jobs better.

6. Use training on the job :-

 Train for consistency to help reduce variation.