Essence Of Quality Management

I am writing this blog for all those has many misunderstanding about Quality Management System's influence in their field of activity or those who are ignorant about ISO. ISO standards are generic in nature. Nonetheless, when correctly interpreted becomes technical. ISO is regarded as equivalent to CMMI-Level 3. ISO is a practical approach to management which is very simple to understand.
Difficulty lies in its interpretation in one's own field of activity. Therefore, mostly, ISO is concluded with six mandatory procedures, which made the system looks stupid and its value is alarmingly degraded by different franchisees and their unqualified certified consultants. It is my personal recommendation, with out any prejudice to franchisees, You should select the Certifying body of international repute, like BSI, or BVQI, DNV,TUV- NORD etc, whose certificates are internationally acknowledged. Besides their auditors can provide you with valuable inputs.





ISO 9001 DEFINITIONS

Conformity:Conformity is all about meeting requirements. ISO 9001 2000 lists many quality system requirements. If your organization meets these requirements, you can say that it conforms to these requirements.


Continual improvement:

Continual improvement is a set of activities that an organization routinely carries out in order to enhance its ability to meet requirements. Continual improvement can be achieved by carrying out internal audits, performing management reviews, analyzing data, and implementing corrective and preventive actions.


Contract review:

Contract review is a set of activities that an organization carries out in order to make sure that customer orders and contracts specify all the requirements that must be met, and in order to establish that the organization can actually meet these requirements.
Corrective actions:

Corrective actions are steps that are taken to remove the causes of an existing nonconformity or to make quality improvements. Corrective actions address actual problems. In general, the corrective action process can be thought of as a problem solving process.
Customers:

A customer is anyone who receives products or services from a supplier. A customer can be either external or internal to the supplier organization.

Customer satisfaction:
Customer satisfaction is a perception. It is also a question of degree. It can vary from high satisfaction to low satisfaction. If customers believe that you've met their requirements, they experience high satisfaction. If they believe that you've not met their requirements, they experience low satisfaction.


Design review:
A design review is a set of activities whose purpose is to evaluate how well a potential product (a design) meets all quality requirements. During the course of this review, problems must be identified and solutions must be developed.

Design validation:

Design validation is a process whose purpose is to examine products and to use objective evidence to confirm that these products meet user needs.

Design verification:
Design verification is a process whose purpose is to examine design outputs and to use objective evidence to confirm that outputs meet input requirements.

Document:
The term document refers to information and the medium
that is used to bring it into existence. A document can be digital or physical. ISO identifies five types of documents: specifications, quality manuals, quality plans, records, and procedure documents.

Entity:
An entity could be a product, process, person, activity, machine, service, system, department, company, institution, or organization.
Infrastructure

The term infrastructure includes buildings, work spaces, equipment, hardware, software, information, utilities, and support services such as transportation and communication.

Internal quality audit:
Internal audits are carried out by your personnel. Internal quality audits examine the elements of a quality management system in order to evaluate how well these elements comply with quality system requirements.
Management review

The purpose of a management review is to evaluate the overall performance of an organization's quality management system and to identify improvement opportunities. These reviews are carried out by the organization's top managers and are done on a regular basis.

Nonconforming products:
When one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product. When a product deviates from quality requirements, it fails to conform.
Nonconformity ISO 9001 2008 lists quality management system requirements. When your organization deviates from these requirements, a nonconformity occurs. When a product, process, procedure, system, or structure deviates from ISO requirements, a formal nonconformity exists.

Organization:
An organization is a company, corporation, firm, or institution that has its own functions and administration. It can be either incorporated or unincorporated, privately or publicly owned.

Organizational structure:
The structure of an organization is the pattern of responsibilities, authorities, and relationships that control how people perform their functions and govern how they interact with one another.

Preventive actions:
Preventive actions are steps that are taken to remove the causes of potential nonconformity or to make quality improvements. Preventive actions address potential problems, ones that haven't yet occurred. In general, the preventive action process can be thought of as a risk analysis process.

Procedures:
Quality procedures control processes or activities. A well defined procedure controls a logically distinct process or activity, including the associated inputs and outputs.Procedures can be very general or very detailed, or anywhere in between. While a general procedure could take the form of a simple flow diagram,
a detailed procedure could be a one pageform or it could be several pages of text.
A detailed procedure defines the work that should be done, and explains how it should be done, who should do it, and under what circumstances. In addition, it explains what authority and what responsibility has been allocated, which supplies and materials should be used, and which documents and records must be used to carry out the work. While quality procedures may be documented or undocumented, ISO usually expects them to be documented.

Process:
In general, a process uses resources to transform inputs into outputs. In every case, inputs are turned into outputs because some kind of work, activity, or function is carried out. Processes can be administrative, industrial, agricultural, governmental, chemical, mechanical, electrical, and so on. An ISO 9001 Quality Management System is made up of the following types of processes:
• Purchasing process.
• Production process.
• Product design process.
• Product protection process.
• Service provision process.
• Document control process.
• Record keeping process.
• Internal audit process.
• Planning process.
• Training process.
• Monitoring process.
• Measurement process.
• Market research process.
• Regulatory research process.
• Continual improvement process.
• Internal Communications process.
• Customer Communications process.
• Customer needs assessment process.
• Non-conformance management process.

Process approach:
The process approach is a management strategy.
When managers use a process approach, it means that they control the processes that make up their Quality Management Systems, the interaction between these processes, and the inputs and outputs that glue these processes together.
It means that they manage by focusing on processes.

Product:
A product is an output that results from a process. Products can be tangible or intangible, a thing or an idea, hardware or software, information or knowledge, a process or procedure, a service or function, or a concept or creation. Please note that when ISO uses the term product they also mean service.

Product inspection:
Product inspection is an activity that compares product characteristics with product requirements in order to establish conformity. More precisely, product inspection is an activity that compares one or more characteristics of a product with specified requirements in order to determine if the product meets these requirements.
Product nonconformity When one or more characteristics of a product fail to meet specified requirements, they are referred to as product nonconformity.

Product realization:
A product starts out as an idea. The idea is realized or actualized by following a set of product realization processes. So product realization refers to all the processes that are used to bring products into being.

Quality:
A quality is a characteristic that a product or service must have. For example, products must be reliable, usable, and repairable. These are some of the characteristics that a good quality product must have. Similarly, service should be courteous, efficient, and effective. These are some of the characteristics that a good quality service must have. In short, a quality is a desirable characteristic.
However, not all qualities are equal. Some are more important than others. The most important qualities are the ones that customers want. These are the qualities that products and services must have.
So providing quality products and services is all about meeting customer requirements. It's all about meeting the needs and expectations of customers. So a quality product or service is one that meets the needs and expectations of customers.


Quality assurance:
Quality assurance (QA) is defined as a set of activities whose purpose is to demonstrate that an entity meets all quality requirements. QA activities are carried out in order to inspire the confidence of both customers and managers, confidence that all quality requirements are being met.
Quality audits

Quality audits examine the elements of a quality management system in order to evaluate how well these elements comply with quality system requirements.

Quality control:
Quality control is defined as a set of activities or techniques whose purpose is to ensure that all quality requirements are being met. In order to achieve this purpose, processes are monitored and performance problems are solved.

Quality improvement:
Quality improvement refers to anything that enhances an organization's ability to meet quality requirements.

Quality management:
Quality management includes all the activities that managers carry out in an effort to implement their quality policy. These activities include quality planning, quality control, quality assurance, and quality improvement.

Quality management system (QMS):
A quality management system (QMS) is a web of interconnected processes. Each process uses resources to turn inputs into outputs. And all of these processes are interconnected by means of many input-output relationships. Every process generates at least one output, and this output becomes an input for another process. These input-output relationships glue all of these processes together - that's what makes it a system.

Quality manual:
A quality manual documents an organization's Quality Management System. It can be a paper manual or an electronic manual.

Quality planning:
Quality planning is defined as a set of activities whose purpose is to define quality system policies, objectives, and requirements, and to explain how these policies will be applied, how these objectives will be achieved, and how these requirements will be met. It is always future oriented.

Quality plan:
A quality plan explains how you intend to apply your quality policies, achieve your quality objectives, and meet your quality system requirements.

Quality policy:
A quality policy statement defines or describes an organization's commitment to quality.

Quality record:
A quality record contains objective evidence which shows how well a quality requirement is being met or how well a quality process is performing. It always documents what has happened in the past.

Quality requirement:
Quality requirement is a characteristic that an entity must have. For example, a customer may require that a particular product (entity) achieve a specific dependability score (characteristic).

Quality surveillance:
Quality surveillance is a set of activities whose purpose is to monitor an entity and review its records to prove that quality requirements are being met.
Quality system requirement A quality is a characteristic. A system is a set of interrelated processes, and a requirement is an obligation. Therefore, a quality system requirement is a characteristic that a process must have.

Record:
A record is a document that contains objective evidence which shows how well activities are being performed or what kind of results are being achieved. It always documents what has happened in the past.

Requirement:
A requirement is a need, expectation, or obligation. It can be stated or implied by an organization, its customers, or other interested parties. There are many types of requirements. Some of these include quality requirements, customer requirements, management requirements, and product requirements.

Resources:
Resources include people, money, information, knowledge, skill, energy, facilities, machines, tools, equipment, technologies, and techniques.

Service:
Service is a customer-oriented result. This result is produced when an organization performs activities that are oriented towards meeting customer needs and expectations.

Service delivery:
Service delivery is a customer-oriented activity. Service delivery activities are carried out by organizations and are oriented towards meeting customer needs and expectations.

Special process:
A special process is any production or service delivery process that generates outputs that cannot be measured, monitored, or verified until it's too late. It's often too late because deficiencies may not be obvious until after the resulting products have been used or services have been delivered. In order to prevent output deficiencies, these special processes must be validated in order to prove that they can generate planned results.

Standard:
A standard is a document. It is a set of rules that control how people develop and manage materials, products, services, technologies, processes, and systems.
ISO's standards are agreements. ISO refers to them as agreements because its members must agree on content and give formal approval before they are published.
ISO standards are developed by technical committees. Members of these technical committees come from many countries. Therefore, ISO standards tend to have very broad support.

Supplier:
A supplier is an organization that provides products or services to customers. Customers can be either internal or external to the supplier organization.

Total quality management:
Total quality management is defined as a management approach that tries to achieve and sustain long-term organizational success by encouraging employee feedback and participation, satisfying customer needsand expectations, respecting societal values and beliefs,and obeying governmental statutes and regulations.

Work environment:
The term work environment refers to all the factors that influence work. In general, these include social, cultural, psychological, physical, and environmental conditions. The term work environment includes lighting, temperature, and noise factors, as well as the whole range of ergonomic influences. It also includes things like supervisory practices as well as reward and recognition programs. All of these things influence how work is performed.



QUALITY MANAGEMENT PRINCIPLES


Introduction

This document introduces the eight quality management principles on which the quality Management system standards of the revised ISO9000:2000 series are based. These principle s can be used by senior management as a frame work to guide their organization towards improved performance. The principles are derived from the collective experience and knowledge of the of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards.

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

KEY BENEFITS:
Increased revenue and market share obtained through flexible and fast responses to market opportunities.
Increased effectiveness in the use of the organization’s resources to enhances customer satisfaction.
Improved customer loyalty leading to repeat business,
Applying the principle of customer focus typically leads to :
Researching and understanding customer needs and expectations,
Ensuring that the objectives of the organization are linked to customer needs and expectations,
Communicating customer needs and expectations throughout the organization,
Measuring customer satisfaction and acting on the results.
Systematically managing customer relationships,
Ensuring a balanced approach between satisfying customers and others interested parties (such as owners, employees, suppliers, financiers, local communities and society as a whole.)

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
KEY BENEFITS:
People will understand and be motivated towards the organisation’s goal and objectives.
Activities are evaluated, aligned and implemented in a unified way.
Mis-communication between levels of an organization will be minimized
Applying the principle of leadership typically leads to :
Considering the needs of all interested parties including, customers,owners, employees,suppliers financiers, local communities and society as a whole.
Establishing a clear vision of the organization’s future,
Setting challenging goals and targets,
Creating and sustaining shared values, fairness and ethical role models at all levels of the organization.
Establishing trust and eliminating fear.
Providing people with the required resources, training and freedom to act with responsibility and accountability,
Inspiring, encouraging and recognizing people’s contributions,



Principle 3- Involvement 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
KEY BENEFITS:
Motivated, committed and involved people with the organization
Innovation and creativity in furthering the organisation’s objectives,
People being accountable for their own performance,
People eager to participate in and contribute to continual improvement,
Applying the principle of involvement of people typically leads to:
People understanding the importance of their contribution and role in the organization,
People identifying constraints to their performance,
People accepting ownership of problems and their responsibility for solving them,
People evaluating their performance against their personal goals and objectives,
People actively seeking opportunities to enhance their competence, knowledge and experience,
People freely sharing knowledge and experience,
People openly discussing problems and issues,
.
Principle 4 Process approach
A desired result is achieved more efficiently when activities and related
Resources are managed as a process.
KEY BENEFITS:
Lower costs and shorter cycle times through effective use of resources,
Improved, consistent and predictable results
Focused and prioritize improvement opportunities.
Applying the principle of process approach typically leads to:
Systematically defining the activities necessary to obtain a desired result,
Establishing clear responsibility and accountability for managing key activities,
Analyzing and measuring of the capability of key activities.
Identifying the interfaces of key activities within and between the functions of the organization,
Focusing on the factors such as resources, methods, and materials that will improve key activities of the organization,
Evaluating risks, consequences and impacts of activities on customers, suppliers and other intrested parties,

Principle 5: System approach to management.
Identifying, understanding and managing inter-related processes as a system, contributes to the organization’s effectiveness and efficiency in achieving its objectives,
KEY BENEFITS:
Integration and alignment of the processes that will best achieve the desired results.
Ability to focus effort on the key processes,
Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization,
Applying the principle of system approach to management typically leads to:
Structuring a system to achieve the organization’s objectives in the most effective and efficient way.
Understanding the interdependencies between the processes of the system,
Structured approaches that harmonize and integrate processes
Providing a better understanding of the roles and responsibilities necessary for achieving, common objectives and thereby reducing cross-functional barriers,
Understanding organizational capabilities and establishing resource constraints prior to action.
Targeting and defining how specific activities within a system should operate.
Continually improving the system through measurement and evaluation,

Principle 6 Continual improvement
Continual improvement of the organization’s overall performance should be a permanent objective of the organisation.
KEY BENEFITS:
Performance advantage through improved organizational capabilities,
Alignment of improvement activities at all levels to an organization’s strategic intent
Flexibility to react quickly to opportunities,
Applying the principle of continual improvement typically leads to:
Employing a consistent organization-wide approach to continual improvement of the organization’s performance,
Providing people with training in the methods and tools of continual improvement,
Making continual improvement of products, processes and systems an objective for every individual in the organization,
Establishing goals to guide, and measures to track, continual improvement,
Recognizing and acknowledging improvements.

Principle 7 Factual approach to decision making.
Effective decisions are based on the analysis of data and information
KEY BENEFITS:
Informed decisions,
An increased ability to demonstrate the effectiveness of past decisions through referance to factual records,
Increased ability to review, challenge and change opinions and decisions,
Applying the principle of factual approach to decision making typically leads to:
Ensuring the data and information are sufficiently accurate and reliable.
Making data accessible to those who need it,
Analysing data and information using valid methods,
Making decisions and taking action based on factual analysis, balanced with experience and intuition,

Principle 8 Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value
KEY BENEFITS:
Increased ability to create value for both parties,
Flexibility and speed of joint responses to changing market or customer needs and expectations,
Optimization of cost and resources,
Applying the principles of mutually beneficial supplier relationships typically leads to:
Establishing relationships that balance short-term gains with long term considerations,
Pooling of expertise and resources with partners,
Identifying and selecting key suppliers clear and open communication,
Sharing information and future plans.
Establishing joint development and improvement activities,
Inspiring, encouraging and recognizing improvements and achievements by suppliers,
The next step:
This document provides general perspectives on the quality management principles underlying the ISO 9000:2000 series. It gives an overview of these principles and show how, collectively, they can form a basis for performance improvement and organizational excellence.
There are many different ways of applying this quality management principle,
The nature of the organization and the specific challenges it faces will determine how to implement them. Many organizations will find it beneficial to set up quality management systems based on these principles.
The requirements of quality management systems are supporting guidelines are given in the ISO 9000-Selection and use.




FREQUENTLY ASKED QUESTIONS (FAQ’S)


In developing this list of Frequently Asked Questions (FAQ’s), input has been obtained from experts and users of the ISO 9000 standards from around the world. The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is indented that this list will also provide a good source of information for new users of the standards.
What are the ISO 9000 standards?
The ISO 9000 standards are a collection of formal International Standards, Technical Specification, Technical Reports, Hand books and web based documents on Quality Management and Quality Assurance. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis.

Who is responsible for developing the ISO 9000 standards?
ISO Technical Committee (TC) number 176(ISO/TC 176), and its Sub-committees, are responsible for the development of standards. The work is conducted on the basis of “consensus” among quality and industry experts nominated bt the National Standards Bodies, representing a wide range of interested parties.
Where should an organisation go if it needs clarification or interpretation of the standards?
The starting point for an interpretation should be with your National Standards Body. ISO Central Secretariat and ISO/TC176 cannot accept direct request from individuals for interpretations of the ISO 9000 standards. Instead, ISO/TC 176 has established a Working Group for interpretation, with a formal procedure to provide answers to the questions that are forwarded by the National Standards Bodies. Details of agreed interpretations are now being published on the ISO/TC 176.
What happened to the 1994 editions of ISO 9001, ISO 9002 and ISO 9003?
Following extensive consultation with users and National Standards Bodies, it was agreed that the 1994 editions of ISO 9001, ISO 9002 and ISO 9003 should be consolidated into a single revised document, which is now represented by ISO 9001:2000.
What are the main benefits to be derived from implementing an ISO 9000 quality management system?
The ISO 9000 standards give organizations an opportunity to increase value to their activities and to improve their performance continually, by focusing on their major processes. The standards place great emphasis on making quality management systems closer to the processes of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the satisfaction of customers and other interested parties.
The management of an organization should be able to view the adoption of the quality management system standards as a profitable business investment, not just as a required certification issue.
Among the perceived benefits of using the standards are:
• The connection of quality management systems to organizational processes
• The encouragement of a natural progression towards improved organizational performance, via:
- the use of the Quality Management Principle
- the adoption of a “process approach”
- emphasis of the role of top management
- requirements for the establishment of measurable objectives at relevant functions and levels
- being orientated toward “continual improvement” and “customer satisfaction, including the monitoring of information on “customer satisfaction” as a measure of system performance,
- measurement of the quality management system ,processes, and product
- Consideration of statutory and regulatory requirements.
- Attention to resource availability
• The concept of a “consistent pair” of standards; with ISO9001establishing initial requirements and ISO 9004 for going beyond the requirements to further improve the performance of the organization.
• Consideration of the needs of all interested parties.
• The concept of organizational self-assessment as a driver for improvement (see ISO 9004:2000)

What benefits are there to an organization implementing ISO 9004?
If a quality management system is appropriately implemented, utilizing the eight Quality Management principles, and in accordance with ISO 9004, all of an organization’s interested parties should benefit.
For example:
Customers and users will benefit by receiving the products (see ISO 9000:2000) that are:
Conforming to the requirements
Dependable and reliable
Available when needed
Maintainable
People in the organization will benefit by:
Better working conditions
Increased job satisfaction
Improved health and safety
Improved morale
Improved stability of employment
Owners and investors will benefit by:
Increased return on investment
Improved operational results
Increased market share
Increased profits
Suppliers and partners will benefit by:
Stability
Growth
Partnership and mutual understanding
Society will benefit by:
Fulfillment of legal and regulatory requirement
Improved health and safety
Reduced environmental impact
Increased security

Are the standards compatible with national quality awards criteria?
The standards are based on 8 Quality Management Principles, which are aligned with the philosophy and objectives of most quality award programs. These principles are:
1. Customer focus,
2. Leadership,
3. Involvement of people,
4. Process approach,
5. System approach to management,
6. Continual improvement,
7. Factual approach to decision making, and
8. Mutually beneficial supplier relationships.
ISO 9004:2000 recommends that organizations perform self-assessments as part of their management of systems and processes, and includes an annex giving guidance on this approach. This is similar to many quality awards programmes.
Do the standards address financial issues?
Financial issues are not directly addressed in ISO 9001:2000, but may be inferred through the requirements for the provision of resources ISO 9004:2000 gives guidance that emphasizes the financial resources needed for the implementation and improvement of a quality management system.ISO/TR 10014:19988”Guidelines for managing the economics of quality also gives further guidance.
How will implementation of the standards help an organization to improve its efficiency?”
ISO 9001:2000 aims at guaranteeing the effectiveness (but not necessary the efficiency) of an organization. For improved organizational efficiency, however, the best result can be obtained by using the guidance given in ISO9004;2000 in addition to ISO 9001:2000. Additionally, the guiding Quality Management principles are intended to assist an organization in continual improvement, which should lead to efficiency throughout the organization.

Why is the requirement for monitering “customer satisfaction” included in ISO 9001?
“Customer satisfaction “is recognized as one of the driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations,it is necessary to monitor the extent of customer satisfaction .Improvements can be made by taking action to address any identified issues and concerns.
Can the standards improve “customer satisfaction”?
The quality management system details that are described in the standards are based on Quality Management principle that include the “process approach’ and “customer focus”. The adoption of these principles should provide customers with a higher level of confidence that products will meet their needs and increase their satisfaction.


What is the process approach”?


The “process approach” is a way of obtaining a desired result, by managing activities and related resources as a process. The ‘process approach” is a key element of the ISO9000 standards.
Can the “process approach be applied to other management systems?
Yes. The “process approach” is a generic management principle, which can enhance an organization’s effectiveness and efficiency in achieving defined objectives.
How can the PDCA cycle be used in the “process approach”?
The PDCA cycle be used in the “process approach”?
The PDCA cycle is an established, logical, method that can be used to improve a process. This requires:
• (P) planning (what to do and how to do it),
• (D) executing the plan (do what was planned),
• (C) checking the results (did things happened according to plan) and
• (A) act to improve the process (how to improve next time).
The PDCA cycle can be applied within an individual process, or across a group of processes.
Can any organisation apply the “process approach”?
Yes. Many organizations already apply a “process approach” without recognizing it. They could achieve additional benefits by understanding and controlling it.
Why should an organization apply the “process approach”?
By applying the “process approach”, an organization should be able to obtain the following types of benefits:
• The integration and alignment of its processes to enable the achievement of its planned results.
• An ability to focus effort on process effectiveness and efficiency.
• An increase in the confidence of customers and other interested parties as to the consistent performance of the organization.
• Transparency of operations within the organization.
• Lower costs and shorter cycle times through effective and efficient use of resources.
• Improved, consistent and predictable results.
• The identification of opportunities for focused and prioritized improvement initiatives.
• The encouragement and involvement of people, and the clarification of their responsibilities.
• The elimination of barriers between different functional units and the unification of their focus to the objectives of the organization.
• Improved management of process interfaces.


What is meant by the “sequence” of processes and their “interactions”? The “sequence “of processes shows how the processes follow, or link, to each other to result in a final output.
For example, one process may become the output of the next process or processes
The “interactions” show how each process affects or influences one or more of the other processes.
For example, the monitoring or controlling of a process may be established in a separate process.
How can the processes in an organization be determined?

Identify all process inputs and outputs, along with the suppliers and customers, who may be internal or external.
Identify the sequence and interactions of the processes
Should an organization define and document all its processes?
The main purpose of documentation is to enable the consistent and stable operation of an organization’s processes.
Although statutory, standards’ or customer requirements may requirements may require certain documentation, there is no defined “catalogue,” or list of processes that has to be documented in ISO 9001, apart from the 6 indicated ones.
The organization should determine which processes are to be documented on the basis of:


• The size of the organization and type of its activities,
• The complexity of its processes and their interactions,
• The criticality of the processes and
• Availability of competent personnel.
A number of different methods can be used to document processes, such as graphical representations, written instructions checklists flow charts visual media, or electronic methods.
How much details are required in process documentation?
The extent of detail is likely to depend upon factors such as :
• The size of an organization and its type of activities,
• the complexity of its processes and their interactions, and
• the competence (level of education, training, skills and experience)of its personnel.
Is there a standard way of describing a process?
No, there is no standard way to describe a process. It depends on the culture, management style, staff literacy, personal attributes and their interactions.
A process may be described using a flow chart, block diagrams, responsibility matrix, written procedures or pictures.
Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment, resources, information, people and decision making interact and /or interrelate in a logical order.
What should an organization do to adopt the “process approach”?
To adopt the “process approach” an organization should apply the following steps:
• Identify the process of the organization,
• Plan the processes ,
• Implement and measure the processes,
• Analyze the processes,
• Improve the processes
What is a “process owner”?
A person who is given the responsibility and authority for managing a particular process is sometimes referred to as the “process owner”.
It may be useful for an organization’s Management to appoint individual “process owners” and to define their roles and responsibilities; these should include the responsibility for ensuring the implementation, maintenance and improvement of their specific process and its interactions.
It should be noted, however, that ISO9001:2000 does not specifically require the appointment of “process owners.”

How can a process be measured?
There are various methods of measuring process controls and process performance, ranging from simple monitoring systems up to sophisticated statistically based systems (e.g. Statistical process control, or SPC, systems) The selection and use of any particular method will be dependent on the nature and complexity of an organizations processes and products. The effectiveness of an individual process may be measured by the conformity of its output or product to customer requirements. Its efficiency may be measured from its use of resources. In all cases the measurement of the process determines if its (measurable) objectives have been achieved. Sometimes it only requires monitoring to confirm process operation.
Typical factors that are useful to consider when identifying measures of process control and process performance include:
• Conformity with requirements,
• Customer satisfaction,
• Supplier performance,
• On time delivery,
• Lead times,
• Failure rates,
• Waste,
• Process costs,
• Incident frequency
What is the difference between a “process” and a “procedure”?
A ”process” may be explained as a set of interacting or interrelated activities ,which are employed to add value. A ”procedure “is a method of describing the way in which all part of that process is to be performed.
ISO 9000:2000 defines a procedure as a “specified way to carry out an activity or a process,” which does not necessarily have to be documented.
An organization has a well –established set of procedures. Can these procedures be used to help describe its processes?
Yes, if the procedures describe inputs and outputs, appropriate responsibilities, controls and resources needed to satisfy customer requirements.
What is meant by “continual improvement”?
ISO 9001 requires an organization to focus on continually increasing the effectiveness of its quality management system, to fulfill its policies and objectives. One way of doing this is for the organization to improve its processes. The organization may also wish to consider improving the efficiency of its processes, for which ISO9004:2000 provides guidance. Continual improvement (where “continual “highlights that an improvement process requires progressive consolidation steps) responds to the growing needs and expectations of customers and ensures a dynamic evolution of the quality management system.


Economics of Quality Assurance
Prevention costs- planning, Training
Appraisal Cost- inspection,test, internal failure cost
External failure cost

Direct failure( warranty, customer return..)

Indirect failure( loss of good will)

Management Practices for success
Satisfy customer
Make quality an intrinsic value
Clearly articulate quality values
Cultivate an open and responsive culture
Empower the workers
encourage continuous systematic improvement
Enlist suppliers in the effort
Manufacturing excellent categories
Management ( leadership drive)
Planning ( future vision)
Continuous improvement ( be better)
Quality ( excellence)
Cost ( affordable)
Delivery ( on time ahead of schedule)
Customer Satisfaction ( delighted customer)
Technology ( superior product)
People and culture ( trained/ motivated employees)
Health and safety ( environmental concerns)
Stakeholders ( return on concerns)
Flexibility ( adaptability)
Operations and systems ( processes /flow defined and documented)
Supplier development and certification (supplier partnership)

Quality Management Principles:
Customer satisfaction- A perfect interface must be achieved between company performance and customer needs in all aspects that customers consider to be important.

Leadership
- quality improvement is primarily a task and responsibility of management as a whole.


Total Involvement- There must be total involvement of all employees at all levels and in all functions. Equally important is the complete involvement of all suppliers of goods and services.
Integrated ApproachIntegration must be achieved between functions and between levels. Traditional organizational barriers must be removed.

Systematic Approach to any activity should include:
-Prevention
-Sustained continious improvement
-Problem measurement
-Goal/benchmark settings
-Innovation/uniqueness.

Deployment should include
Customer supplier involvement
Cross functional teams
Employee involvement
Management involvement

Results should include
Customer/supplier benefits
Relative improvement per goal/bench mark
Sustained game
comparison

Highest achievable quality
Variability Reduction
Through understanding of the customers

Involvement of employees
Consistency of goals
Long term orientation

Process driven ,not people driven

Organization's success first
visibility and active participation of management
True partnership with suppliers and customers
Needs understood by all
Creation of positive environment
Solid implementation plan
Strong commitment
Prevention-rather than detection/reaction
Systematic- disciplined ways to do things

Management by fact-based on objectives, reliable information
-assure things go as intended
-root causes of process upsets
Learning-use of process feedback for improvement



Approach- A Systematic approach must start with a clearly defined business strategy which is then translated into an improvement policy,objectives,and priorities.Thease must be followed by detailed planning, implementation and monitoring of progress.

Defect prevention- Defects must be prevented from occurring.Performance must be the result of built in capabilities
Continuous Improvement- The approach should not have a charecter of a campaign or a project.Excellence can only be achieved by continuously investing in improvement, step by step, year after year.

Maximum quality- Long term objectives must be set which reflect the will to strive for excellence. The path towards excellence must be marked by challenging but achievable and acceptable targets.

For further learning please write to me at kartha.nandakumar@gmail.com