Are you a supporter/visitor of this blog?

Dear supporters/visitors of this blog,

Greetings.

If you are a supporter/visitor of this blog, please advise following details by sending an email to me at keshavsinghalajmer@gmail.com mentioning subject 'Blog on Quality Concepts and ISO 9001:2008 QMS Awareness':
- Name
- Profession and Current Position
- Address
- Email
- Your comments about the contents of this blog
- Your suggestions

Happy Christmas,

Keshav Ram Singhal

Value Added Approach in Determining ‘Statutory and Regulatory Requirements in ISO 9001:2008 QMS’

One of the magazines published an article on ‘Statutory and regulatory requirements in ISO 9001:2008 QMS’ in its March 2012 issue (this article can also be seen at this blog post dated 23 Feb 2012 at http://iso9001-2008awareness.blogspot.in/2012/02/statutory-and-regulatory-requirements.html) and one of the readers of this article has made comments stating, “I was reading the Mar 12 issue and article on statutory requirements under ISO 9001. On p.10, self regulation has been stated to be regulatory requirement which is not correct.” Since the above comments have made by a top management executive working in an accreditation board, and such comments cannot be ignored, so as a co-author of the earlier published article, I decided to clarify authors’ point of view. I request my readers to please consider with the following:
i. Both statutory and regulatory requirements are those requirements that are required by law.
ii. Statutory refers to laws passed by a state and/or central government, while regulatory refers to a rule issued by a regulatory body appointed by a state and/or central government.
iii. A regulatory requirement can be termed as administrative legislation that constitutes or constraints rights and allocates responsibilities. It is somewhat different from the statutory legislation enacted by passing the law in the legislative assembly or parliament.
iv. There can be following types of regulations applicable on an organization – (i) Legal restrictions or responsibilities promulgated by a government authority, (ii) Self regulation by an industry through trade associations.

I wish to clarify that regulations on an organization can be of two types. We look at "regulatory" as something that is limited by an authoritative group, and that authoritative group may include (i) group appointed by state/central government, (ii) group formed by an industry through trade associations. In this competitive world, we see many codes, regulations and rules (formed by trade associations) takes the status of necessary regulations (as equivalent to law) required to be followed. I would like to clarify our point of view with examples given here in below.

Examples of group appointed by state/central government

First example, Securities and Exchange Board of India (SEBI) is a body appointed by central government through an ordinance. Its regulations are necessary to be followed by organizations dealing in securities.

Second example, Insurance Regulatory and Development Authority (IRDA) is a body appointed by central government. Its regulations are necessary to be followed by organizations dealing with insurance.

A list of a few regulatory bodies appointed by government may be seen at http://india.gov.in/govt/studies/annex/8.1.1.pdf.

Examples of group formed by an industry through trade association

First example, in banking, certain regulations and rules are issued by Indian Banks Association that is required to be followed by bank branches in India. ‘Indian Banks Association’ (IBA) can be termed as a trade association of banking industry comprising of public sector banks, private sector banks, foreign banks having offices in India and urban cooperative banks. Indian Banks’ Association (IBA) is not appointed by any state or central government. ‘Fair Practice Code’ or many other rules and guidelines framed by the Indian Banks Association can be termed as those necessary requirements, as equivalent to regulatory requirements, for the banking industry.


Second Example – Foreign Exchange Dealers’ Association of India (FEDAI) is a group of banks that deals in foreign exchange in India as a self regulatory body. FEDAI is not appointed by state or central government and it can be termed as a trade association of foreign exchange dealers. The role and responsibilities of FEDAI includes – (i) Formulation of FEDAI guidelines and FEDAI rules for Forex (foreign exchange) business, (ii) Rules of FEDAI also include announcement of daily and periodical rates to its member banks. Please note that FEDAI guidelines play an important role in the functioning of the foreign exchange dealers (banks) and its guidelines can be termed as those necessary requirements as equivalent to regulatory requirements.

There are so many self-regulatory bodies in India that are not appointed by any government. Please note that the self-Regulatory authority of a business or profession is a select Body of its members, which is responsible for growth and development of the profession in the background of its responsibility towards customers, society and State. A few more examples of self-regulatory bodies in India are Bar Council of India, Medical Council of India, Institute of Chartered Accountants of India, Institute of Cost and Works Accountants of India, Institute of Company Secretaries of India, Council of Architecture.

I request, please don’t go alone by a dictionary meaning or a limited meaning of the ‘regulatory’. Please consider a broader meaning of the term ‘regulatory’ in the interest of implementing an effective quality management system in an organization. The purpose of the quality management system is to have an effective quality management system that provides product/service to customer. If you refer to ISO 9001:2008 QMS Standard and/or its normative reference document, ISO 9000:2005, you will notice that the term ‘statutory and regulatory requirements’ has not been clearly clarified in any of the standards, although it has been stated in note 2 of the clause 1.1 of ISO 9001:2008 QMS Standard that statutory and regulatory requirements may be termed as legal requirements. Simply stating the term ‘statutory and regulatory’ as ‘legal’ does not clarify the meaning of the term in a broader way and this may be the reason why people look to this term differently. Even the term ‘legal’ has different meaning to different people. In one opinion a contract entered between two private parties can be termed as a ‘legal’ contract as it is legally binding on both parties.

There may be two approaches in implementing ISO 9001:2008 QMS Standard, first, a bureaucratic approach, and second, a value-added approach. To me, the approach of the reader, who made the above comments, appears to be a bureaucratic approach. Our emphasis is on a value-added approach to implement an effective quality management system in an organization to gain maximum benefits from the quality management system. I would request my readers, please don’t keep a bureaucratic approach, instead keep a value-added approach. A certification body or an accreditation body may have a bureaucratic approach as they are purely related to ‘certification’ business. My concern is to apply a value added approach.

The reader of the article also stated, “The article also does not clarify what statutory/regulatory requirements are to be considered. An organization may be subject to many laws – Income Tax, Excise, product related, fire safety, occupational health and safety etc. It would have been useful to clarify what is to be considered under ISO 9000.”

In this connection, I thank the reader who has provided us an opportunity to clarify the issue in relation to above query. I would like to clarify the following:
(i) ISO 9001:2008 QMS Standard is a generic quality management system standard that can be implemented by all organizations, regardless of type, size and product provided. So it is very difficult to provide a common example of statutory/regulatory requirements. However, please see a few examples* pertaining to organization specific given here in below to understand the issue in a better way.
(ii) ISO 9001:2008 QMS Standard – clause 7.2.1 (d) – stipulates determination of the statutory and regulatory requirements applicable to the product. Clause 7.2.1 (d) comes under product realization and has a direct effect on the product realization process of the organization and also on the product provided to customer.

ISO 9001:2008 QMS Standard requires an organization to determine and control the statutory and regulatory requirements applicable to the products (including services). It is up to the organization how to do this within its quality management system. We believe that a methodology as suggested in the article is followed; then the organization will be on the right path in establishing, implementing and maintaining an effective quality management system. I hope that readers will agree to authors’ point of view.

For an organization, implementing ISO 9001:2008 QMS Standard, should demonstrate that the statutory and regulatory requirements applicable to its products/services have been properly determined, are available and easily retrievable. The term ‘statutory and regulatory requirements’ is invisible in clause 8 of ISO 9001:2008 QMS Standard, however, internal auditors need to be aware of the general and specific statutory and regulatory requirements applicable to the products/services included within the scope of the quality management system.

Examples*:
(i) For the purpose of quality management system of a consulting organization providing financial, income tax, excise consultancy services; determination of income tax rules and regulations, financial rules and regulations, excise rules and regulations may be relevant statutory and regulatory requirements applicable to the product. But for the purpose of quality management system of other organizations, these may not be relevant. (ii) For the purpose of quality management system of an organization manufacturing children toys, then legal requirements related to the health and safety of children from toys may be the relevant statutory and regulatory requirements applicable to the product. But for the purpose of quality management system of other organizations, these may not be relevant.

‘ISO 9001 Auditing Practice Group’ has issued a guidance paper on ‘Auditing statutory and regulatory requirements’ (can be seen at the websites of ‘International Organization for Standardization’ and ‘International Accreditation Forum’) that states that nonconformities should be issued only in situations where identification has been made of the system deficiencies or of direct violation in respect of statutory and regulatory requirements applicable to the products/services of the organization. However, if nonconformities with other kinds of statutory requirements (e.g. health and safety, environment, etc.) are co-incidentally, detected during the audit, this fact cannot be ignored by the audits. It should be reported without delay. Accordingly, I feel that if any internal auditor comes to know noncompliance of any of the legal requirements during internal audit, it must be reported as CAR (corrective action request) as a measure to add value in the internal audit and such action will help the organization in improving the effectiveness of the organization’s systems including the quality management system.

As a co-author of the earlier article published, I hope, I have clarified authors’ point of view in this write-up. However, if any readers still have any different opinion that may be brought out to our information.

- Keshav Ram Singhal

Happy Diwali Greetings

With best wishes,

Keshav Ram Singhal

Understanding Total Quality Management

Keshav Ram Singhal

An American, W. Edwards Deming, developed the concept of Total Quality Management (TQM) after World War II for improving the production quality of goods and services. TQM is a philosophy of management based on total quality and customer satisfaction. Fulfilling customer requirements and improving the way work is done to improve performance is TQM.1 U.S. Department of Defense (1991) states Total Quality Management (total quality approach) as: “TQM consists of continuous activities involving everyone in the organization in a totally integrated effort toward improving performance at every level. This improved performance is directed towards satisfying such cross-functional goals as quality, cost, schedule, mission need and suitability. TQM integrates fundamental management techniques, existing improvement efforts and technical tools under a disciplined approach focused on continued process improvement.”2

Dr. K. K. Anand (Past President, National Centre for Quality Management) describes TQM, “Total Quality Management as understood by me is a comprehensive concept underpinning excellence. It involves coordination amongst various levels/layers and parts for an organization. An organization cannot achieve excellence, unless there is this coordination between its resource and talent at various segments.”3 Suresh M Mody tries to explain TQM, “Total Quality Management is quality everything one does. It concerns not only the quality of products and services provided to the ‘external’ customers, but quality in everything one does. Thus it concerns the quality of the output of all processes, not just manufacturing processes, which was the focus of traditional quality control/assurance.”4

In 1993 when India was passing through many economic problems, some due to adverse balance of trade, D. L. Shah categorically suggested, “If we can make ‘Made in India’ label a certificate of quality, our exports will certainly pick up. To achieve this, our industries need to take up Total Quality Management (TQM) on a war footing.” He suggested, “The need of the hour is Total Quality Management.”5 Total Quality Management as a management strategy to achieve and improve quality suggested by D. L. Shah is relevant today for Indian industry.

Gopal K. Kanji says, “TQM is about continuous performance improvement. To improve performance, people need to know what to do and how to do it, have the right tools to do it, be able to measure performance and to receive feedback on current levels of achievement (Kanji, 1998).”6 Dr. R. H. G. Rau, Past President, National Centre for Quality Management opines, “Changes in the market place may leave any business floundering. TQM can alert the business to these changes when it is focused based on customers’ expectations. It helps in our always knowing what customer wants and needs.”7

Total Quality Management (TQM) has two major attributes. First, the customer is the final judge of quality and second, that quality is built into the design of a product rather than merely having it inspected after the product has been manufactured. The major objective of TQM is customer satisfaction with products and services. Dr. Mahesh Chandra says that innovative customer driven organizations are using Total Quality Management (TQM) to provide customers with quality products and services in a fast and responsive manner.8

ISO 8402:1994 defined TQM as the management approach of an organization, centred on quality, based on participation of all its members and aiming at long-term success through customer satisfaction, and benefits to all members of the organization and to society. TQM brings to quality concepts a long-term global management strategy and the participation of all members of the organization for the benefit of the organization itself, its members, its customers and society as a whole. TQM is a concept that goes beyond ISO 9000. ISO 9001:2008 QMS standard and TQM are not two different alternatives, nor is there any contradiction between them. ISO 9001:2008 QMS standard provides a strong base on which an organization can build a TQM culture with a focus on the customer involving all employees and demanding continual improvement. It is advisable for organizations to first provide a formal quality framework in the form of an ISO 9001:2008 QMS standard to create stability in the organization and achieve consistency in quality. When the system is well in place and has attained certification, the organization can start using advanced concepts and tools to enhance employee motivation and operational efficiency. Organizations can use ISO 9004:2009 standard, which provides guidelines on managing for sustained success of an organization. ISO 9004:2009 standard provides guidance to support the achievement of sustained success for any organization in a complex, demanding and ever-changing environment, by a quality management approach.9

Total Quality Management (TQM) is an enhancement to the traditional way of doing business. It is a proven technique to guarantee survival in world-class competition. Dale, Carol and Glen, the authors of Total Quality Management (Third Edition, 2010) analyze three words as: Total – Made up of the whole, Quality – Degree of excellence a product or service provides, Management – Act, art, or manner of handling, controlling, directing, etc. Therefore, the authors sum up, “TQM is the art of managing the whole to achieve excellence.” TQM requires six basic concepts: (1) A committed and involved management to provide long-term top-to-bottom organizational support. (2) An unwavering focus on the customer, both internally and externally. (3) Effective involvement and utilization of the entire work force. (4) Continuous involvement of the business and production process. (5) Treating suppliers as partners. (6) Establish performance measures for the processes.10

Total Quality Management is a comprehensive and integrated way of managing any organization in order to: (a) meet the needs of the customer consistently; (b) achieve continuous improvement in every aspect of the organization’s activities. TQM is fundamentally about change. For some organizations this may be very slight, perhaps only shifting the emphasis. For other organizations the change may be massive.11 Thus we come to a conclusion: “Total Quality Management is a demanding, disciplined yet humane way of managing an organization.”11

P. N. Mukherjee suggests eleven TQM steps to be a world-class organization – (1) TQM overview, (2) Set mission, (3) Identify customers, (4) Identify customer’s needs, (5) Define critical process and measures, (6) Set organizational vision, (7) Develop strategic plan for 10-20 years, (8) Develop annual plan for breakthrough, (9) Revise roles and responsibilities, (10) Form ‘quality council’ to set change strategy, (11) Annual review.12

Courtesy References:
1. Article – Management Education – A Challenge: TQM as a solution, Habiba Abbasi and Pratiksha Rai, Quality Management Practices, Excel Books, New Delhi, 2008, p. 450
2. Article – Imbibing Ethics in Technical Education: The TQM Approach, M. G. Bhatt, Quality Management Practices, Excel Books, New Delhi, 2008, p. 418
3. Pearls From The President, Quality Striving for Excellence, National Centre for Quality Management, Mumbai, May-June 1999, p.1
4. Article – Total Quality Management in Financial Sector, Suresh M Mody, Quality Striving for Excellence, National Centre for Quality Management, Mumbai, May-June 1999, p.6
5. Foreword, Total Quality Management, National Centre for Quality Management, Mumbai, May 1993, p. 3
6. Article – Excellence in Business Excellence Models, Gopal K. Kanji, Quality Striving for Excellence, National Centre for Quality Management, Mumbai, November-December 2000, p. 17
7. Article – Customer Sovereignty Management, Dr. R. H. G. Rau, Quality Striving for Excellence, National Centre for Quality Management, Mumbai, November-December 2000, p. 27
8. Article – Technological Innovations and TQM, Dr. Mahesh Chandra, Quality Striving for Excellence, Mumbai, March-April, 1999, p. 10
9. Implementing ISO 9001:2008 Quality Management System – A Reference Guide, Divya Singhal and Keshav Ram Singhal, PHI Learning Private Limited, New Delhi, p. 10-11
10. Total Quality Management, Dale H. Besterfield, Carol Besterfield and Mary Besterfield-Sacre, Pearson, 2010, p. 13-14
11. Total Quality, David Jeffries, Bill Evans and Peter Reynolds, Crest Publishing House, New Delhi, 2005, p. 2-3, 19
12. Total Quality Management, P. N. Mukherjee, Prentice-Hall of India Private Limited, New Delhi, 2006, p.48-50

Request - Please make your reaction to the write-up. Thanks.

‘Correction’ and ‘Corrective Action’

There has been confusion among many people about the terms ‘correction’ and ‘corrective action’ as both terms relate to an action that is taken on a nonconforming product.

‘Correction’ is an action to eliminate the detected nonconformity. There may not be any necessity to do root cause analysis. Just eliminate the detected nonconformity, so that product conforms to requirements. Take an example – it is observed that the length of the rods manufactured is 3.001 meter, while the customer desired rods of length 3.000 meter. A further process of cutting the extra made length of rods will make the rods conforming to the requirements. This can be stated as ‘correction.’ As per Clause 8.3 (control of nonconforming product) of ISO 9001:2008 QMS Standard, the organization may deal with the nonconforming product by taking action to eliminate detected nonconformity.

‘Corrective action’ is an action that is taken to eliminate the cause of detected nonconformity or other undesirable situation. Accordingly, it is an action that is taken to prevent the existing problem from recurring. It requires root cause analysis of the problem. You should ask the question in the instant case – why rods are manufactured 3.001 meter instead of 3.000 meter? When you inquire why, you get an answer. You come to know that the manufacturing process is using a equipment/scale that is not measuring correct length. The equipment/scale requires calibration and verification. This action of calibration and verification when taken can be said to be an action to prevent the existing problem to happen again. This can be stated as ‘corrective action.’ Corrective action is a requirement of ISO 9001:2008 QMS Standard (Clause 8.5.2).

With best wishes,

Keshav Ram Singhal

Please make your reaction to the above post. It will take a few seconds. Comments are also invited. Thanks.

Document and Record in ISO 9001:2008 QMS

ISO 9000:2005 Standard on ‘Quality management systems – Fundamentals and vocabulary’ has defined document and record (please see definitions in 3.7.2 and 3.7.6). According to ISO 9000:2005 Standard, a document is defined as ‘information (meaningful data) and its supporting medium. In simple terms, we can say that a document provides guidance and/or direction for performing a work, making a decision or rendering judgement. A document may be written, video tape, physical sample, sample drawing, computer programme or otherwise. According to ISO 9000:2005 Standard, a record is defined as a document stating results achieved or providing evidence of activities performed. Records are a special types of documents (please see clause 4.2.3 – ISO 9001:2008 QMS Standard). Accordingly, we may construe the following:
- All documents are not records.
- All records are documents.

People generally confuse with document and record. To make the difference clear between document (other than record) and record, following will provide you the clear difference:
- A document (other than record) is a live paper, while a record is a dead paper.
- A document (other than record) mentions how to carry out an activity, while a record mentions how the activity is carried out.
- Documents (other than records) are subject to change, records are evidence of the activity performed and not subject to change.
- Documents (other than records) are approved and issued (or released) by designated authorities before issue. Records are generated and approved after the activity is over by designated authorities.
- Retention period of documents (other than records) generally are not mentioned as these are live paper, however we can specify the retention period of records.
- The changes in documents (other than records) are identified by Revision number/Issue number. Records are identified by format numbers.

Clause 4.2.3 of ISO 9001:2008 QMS Standard mentions requirements for control of documents and clause 4.2.4 of ISO 9001:2008 QMS Standard mentions requirements for control of records.

With best wishes,

Keshav Ram Singhal

Request – Please make your reaction to the above write-up. It will take a few seconds. Thanks.

Need for a Mandatory Standard for Quality School Governance

Dr. Divya Singhal
&
Keshav Ram Singhal


Courtesy - Quality Striving for Excellence, April - June 2012

Power of education

Education is power. Education has power to change everything. Education is empowerment in many ways. It has power to eradicate ignorance, poverty and make individuals become independent. Education is the pathway to any nation-building in many ways:
• Education creates an enlightened society, a society build by responsive and responsible citizen
• Education enables the nation with ‘meritocratic’ bureaucracy with competent human resources to carry out day-to-day affairs of the state
• Education increases democratic participation of people as it enables people with more awareness
• Education increases people level of understanding that is very crucial to unite in diversity
• Education creates large number of professionals that are important resources for a strong society, a society set for development
• Education shapes the attitudes and behaviours and attitudes of citizens

Education alters an individual’s and even community’s collective perceptions, aspirations’ goals as well as the ability and the means to attain them. The level and spread of education has not only been an important precondition for sustained economic growth, both in the developed and the developing countries, but it has also played a critical facilitative role in the demographic, social and political transition of these Societies.Education is both an input and an output of the human development process. As input, education is indispensable for progress in all spheres of human development. As output, education is the axiom for building-up human capabilities, a focal interest of human development, given its primary role in enabling people to fully participate in socioeconomic and political development.


Accordingly, education correlates with nation-build. A nation cannot be built without education.

S. P. Punalekar writes that, "Education is considered pivotal for socioeconomic development strategies". Education is now conceived as Human Resource Development. He stated "Above all we need equalization of educational including opportunities and enrichment of social content in education including curricular restructuring. Social and cultural distance among the sections of students must be minimized.”

We cannot live without worthwhile access to education. If we look to developed nation, we find that these nations are set to impart knowledge through varied technology means. The future of a country depends largely upon the future of education. Reforms in education as the most important vision that we need to implement in order to reap its dividends.

Education, as fundamental right

In India, our policy makers have realized the importance of declaring education as the fundamental right. The Right of children to Free and Compulsory Education Act, 2009 (also known as Right to Education Act – RTE), passed by the Indian parliament on 4 August 2009, has come into force from 1 April 2010. The Right of children to Free and Compulsory Education Act, 2009 provides norms and standards to be fulfilled by every school related to: (i) Pupil teacher ratios at primary and upper-primary level, (ii) building norms to provide for all weather building, barrier free access, separate toilets for boys and girls, safe drinking water, kitchen facility, play ground etc., (iii) Minimum number of working days, (iv) Minimum number of working hours per week per teacher, (v) teacher learning equipment, (vi) Library, (vii) play material, games and sports equipment. This Act also requires all private schools to enroll children from weaker sections and disadvantaged communities in their incoming class to the extent of 25% of their enrollment by simple random selection.

It is required to provide education to every child for nation building, for which we need to set some standardized norms in education sector and in this regard Right to Education Act is helpful in many ways. Following are the key points of the legislation that expects to empower the nation through education:
1. Free and compulsory education to all children of India in the 6 to14 age group
2. No child shall be held back, expelled, or required to pass a board examination until completion of elementary education (up to class eight)
3. A child who completes elementary education (up to Class 8) shall be awarded a certificate
4. Calls for a fixed student-teacher ratio;
5. The Act applies to all over India except Jammu and Kashmir
6. There will be 25 percent reservation for economically disadvantaged communities in all private and minority schools
7. The reservation for economically disadvantaged communities to start with Class One beginning 2011
8. Mandates improvement in quality of education;
9. School teachers will need adequate professional degree within five years or else will lose job;
10. School infrastructure (where there is problem) to be improved in three years, else recognition cancelled;
11. Financial burden will be shared between state and central government on the basis of ‘Sarva Shiksha Abhiyan’ (Education for All).
12.. Private schools will have to face penalty for violating provisions of RTE Act.

Sixty-three years after independence, India has finally realized the importance of declaring education as our fundamental right. The notion of a fundamental right has great value in overcoming the objections and excuses that are consistently invoked to continue postponing the goal of universal elementary education. (PROBE Report)

Transforming education in India

While the government is making its efforts providing education to every child of the country, however, there is a challenge before the Indian authorities, how the education management can successfully address the need for quality education, and ensure its access even to those segment of population that are hard to reach. In this connection, NCQM past President Dr. R. H. G. Rau has rightly opined, “The challenge can be squarely met only when the country knits together the policy makers and the deployment contributors of the policies. We need to critically deliberate, discuss and debate on the initiatives taken so far and their measurable outcomes toward quality education across the country. Further, we need to arrive at what works to improve quality in both the existing and upcoming schools and colleges in all identified areas. This surely calls for a scientific and systematic study through better understanding of the global; initiatives that have shown positive results, and their adoption to Indian conditions.” (Quality Striving for Excellence, March-June 2010)

We have come across the infrastructure requirements for schools seeking CBSE affiliation. It states the following requirements:
- The school must have about 2 acres or as otherwise permitted measurement of land (owned by the school or the society running the school, or on lease for a minimum period of 30 years) and a building constructed on a part of land and proper playgrounds on the remaining land
- The school should have proper facilities commensurate with its requirements
- The school should provide minimum floor space of 1 square meter per student in the class-room
- The school will also provide proper facilities for physically challenged students
- The school should have suitable furniture in the class-rooms
- The school should have office equipments commensurate with the strength of students and staff
- The school should have needed equipment and facilities for science, home science, technical subjects, vocational subjects etc.
- The school should scrupulously observe prescription from local authority regarding safety, safe drinking water and sanitation
- The school should have at least 1 computer lab with minimum 10 computers or computer and students ratio of 1:20 and internet connection
- The school should have a well-equipped and spacious library with minimum of 1500 books and at least 15 magazine
- The school should maintain pupil-book ratio of 1:5

However, we notice that these are the requirements for schools that seek CBSE affiliation, not for all schools. At primary level education, schools are not required to seek CBSE affiliation, so it is required that the national policy makers should set minimum requirements for management and infrastructure of schools. Such framed requirements should be covered under statutory and/or regulatory requirements against which it should be mandatory for schools undergo yearly system audit.

During the National Quality Conclave of Quality Council of India (QCI), held on 9-10 February 2007 in New Delhi, the then President of India Dr. A. P. J. Abdul Kalam, gave the QCI a Seven-Point Action Plan, the first of which was developing benchmarks for schools. The then President referred to Quality of life encompassing Quality education with value system and productive employment. Accordingly, the QCI set before itself the task of developing a standard for accreditation supported with a rating system. The QCI, which provides the national accreditation structure to our country, entrusted the task to the Board that offers registration services for personnel and training courses. The Board’s education committee, after receiving inputs fro
m various interested parties, like educationists, administrators, Quality experts, teachers, parents and others, drafted the Educational Quality Management Standards (EQMS) for Schools.

The standard was developed by the QCI with a view to define and implement systems to:
• Provide educational services that aim to enhance satisfaction level of all interested parties,
• Provide a basis for assessing and, where required, rating the effectiveness of an educational Quality management system, and
• Develop Quality consciousness among interested parties involved in school activities.

QCI has issued ‘Accreditation Standard for Quality School Governance’ having requirements under following clauses –
Clause 4 – Educational quality management system
Clause 5 – Governance and management
Clause 6 – Resource management
Clause 7 – Educational service realization
Clause 8 –Measurement, analysis and improvement


ISO 9001:2008 QMS Standard is implemented by many schools for demonstrating the quality of educational services provided by the school and many schools in India are implementing accreditation standard for quality school governance developed by Quality Council of India, however it is observed that both standards, ISO 9001:2008 QMS Standards and Accreditation Standard for quality school governance, are generic in nature and voluntary for schools to implement. Schools generally implement ISO 9001:20008 QMS and/or QCI Standard to gain financial and other benefits. Quality in education in schools in India can be improved if we have a mandatory standard to follow by schools. Standards are vehicle for good governance, sharing of knowledge, technology and good governance. If we want sustainable development, we have to look forward for the quality education in our country.

There is a need to revamp the entire education system in our country, for which following need to be looked in to:
1. There is a need to create awareness for the RTE Act.
2. All schools should have basic infrastructure, including proper building, class-rooms, play ground, laboratories, library etc.
3. Every school should have dedicated and qualified teachers
4. Massively investment is needed in education of girls and women
5. Every school should have adequate number of teachers
6. There should be transparent and fair system to evaluate the performance of teachers
7. Raise investment in education
8. Bringing practical learning into school education system and creating an interest in learning is also very important aspect.

Times of India, 16 March 2012, reported a news item stating that a government primary school in Makhupura has no building and lacks basic amenities like drinking water and toilet. According to the report, students of the school sit in the mud all through the day to learn their lesson as their school building exists only on paper. However, their teachers are better off, as they have a table and a chair, which they keep in the nearby temple after school hours. The school has no provision for drinking water or toilet facilities and the students cross the highway to get water from nearby residents. There are nearly 80 students and two teachers in the school. This school is hardly 10 kilometers from Ajmer.

Many schools (specifically government schools) do not have proper infrastructure. What is needed in this regard is application of ‘Plan-Do-Check-Act’ cycle. Accordingly, at national level it requires to make standards for basic infrastructure and number of teachers. The standard should be a specific standard for education system that should define area of class-room, cleanliness, light and air, sitting facilities, black-board (or writing board) in the class-room, number of teacher criteria, evaluation criteria for teachers etc. The national standard should also define the responsibility – who will provide or do what? Next point is implementation of standard requirements for which necessary infrastructure, human resources, and financial support should be provided by the government. It may require huge amount of investment towards basic infrastructure that may be fulfilled by raising investment in education to at least 5% of the GDP. The third point is to check implementation at periodical intervals that should be done by internal monitoring and measurement processes, but there must be an independent body also to check the educational system of schools. The independent body should have trained and experienced assessors to check the school system and raise CA (corrective action) and thus the body should certify that basic infrastructure and availability of teachers in the school are as per standard’s requirements. The fourth point is to act on the basis of the results of check (monitoring and measurement) and if any correction or improvement is required that should be done without delay.

"Change does not necessarily assure progress, but progress implacably requires change. Education is essential to change, for education creates both new wants and the ability to satisfy them." - Henry Steele Commager

Courtesy:
- PROBE Team, Public Report on Basic Education in India (New Delhi, Oxford University Press, 1999)
- Eleven things that can transform education in India, ArindamChaudhuri, The Sunday Indian (8 January 2012)
- Quality Striving for Excellence, March – June 2010
- The Times of India, 16 March 2012
- RTE, 2010
- http://www.icbsc.com
- ISO Website
- QCI Website

Determining customer needs in a school

There is an interesting discussion in one of the linkedin groups, that ask two questions in this discussion - (i) How do you establish customer needs for a school? (ii) Who is the customer? To this discussion I replied briefly - (i) As a school authority I will establish customer needs by reviewing the admission form by which customer makes his requirements as regard to the admission sought in a class and the elective subjects communicated by him. (ii) Customers of a school are students and parents.


One of the members of the group commented, “Keshav: I understand that you would REVIEW customer needs by means of the admission form (a contract review process). What I am trying to establish is how you would initially define customer needs (as input to the design process). These are the customer needs which should be established in order to design organization structure, infrastructure, training methods and processes, measurement systems... even the information to be requested on the admission form).”


When we implement a quality management system in a school, following types of requirements are required to be determined in order to implement and maintain an effective quality management system:
- Customer requirements,
- Organization’s own requirements, and
- Statutory and regulatory requirements.


The question is how to determine customer requirements. Customer requirements are those requirements that are communicated by customer and what I feel that in the case of a school, customer requirements are communicated by customer initially at the time of taking admission and thereafter when he interacts with school authorities.

Generally customer requirements from a school are:
- Seeking admission to a particular class
- Seeking particular elective subjects
- The knowledge, abilities and competencies delivered to its students by the educational institution consistently meet statutory and regulatory requirements.
- Opening of new courses


So in order to design organization structure, infrastructure, training methods and processes, measurement systems, the school is required to meet customer requirements, organization’s own requirements and statutory and regulatory requirements.


In order to determine customer requirements:
- The school authorities should determine the customer requirements at the time of admission by review of the admission form
- The school authorities should determine effective methods of communication with students, parents and the society so that their requirements may be known to the school from time to time.


Sometimes, parents may complain or give suggestion with regard to a particular process or non availability of resource, then such communication are an effective means of establishing customer requirements. So for determination of customer requirements, the school authorities should have good communication methods in which monthly parent-teacher meetings may also play an important role.


With best wishes,

Keshav Ram Singhal

Why you implement or wish to implement ISO 9001:2008 QMS?

All over the world organizations are implementing ISO 9001:2008 QMS. The ISO Survey reveals that by end of December 2010, at least 1,109,905 ISO 9001:2008 certificates had been issued in 178 countries and economies. This indicates the universality of ISO 9001:2008 QMS. Just think and try to answer the question: "Why you implement or wish to implement ISO 9001:2008 QMS in your organization?" Please make your comments.

With best wishes,

Keshav Ram Singhal

A survey covering quality management system development, certification, accreditation and economic benefits

UNITED NATIONS INDUSTRIAL DEVELOPMENT ORGANIZATION (UNIDO) has published a survey report 'ISO 9001 — Its relevance and impact in Asian Developing Economies' in 2012. The report is available online at the website of UNIDO at www.unido.org.

Thanks,

Keshav Ram Singhal

Quality Objectives

An exercise to the readers of this blog

Quality objectives are the basis of improvement and growth. ISO 9001:2008 QMS standard requires organization to establish measurable quality objectives at relevant functions and levels (i.e., just everywhere) in the organization. The quality objectives must be consistent with the quality policy of the organization.

We wish our readers to suggest a few quality objectives that should be specific, measurable, achievable, realistic and time-bound. You can mention the same in the comments of this post.

With best wishes,

Keshav Ram Singhal

Example - Quality objectives for a school - (i) 90%+ examination result, (ii) Minimum 25% students getting 75% or more marks.

Auditing Purchasing in ISO 9001:2008 QMS

Purchasing is a general process that every organization carries out and it is that activity of an organization that has an effect on the product the organization produces. Purchasing is a formal process of buying goods and services. The purchasing process can vary from one organization to another, but there are some common key elements. The process usually starts with a demand and ends with the fulfillment of that demand. ISO 9001:2008 QMS standard specifies its requirements for purchasing under clause 7.4, which is sub-divided as under:

7.4.1 – Purchasing process
7.4.2 – Purchasing information
7.4.3 – Verification of purchased product

Auditing purchasing in an organization requires certain objective evidences to look for and in this regard the auditor involved should be well prepared and vigilant in auditing purchasing activities in the organization.

According to the requirements of ISO 9001:2008 QMS standard, the organization needs to ensure that purchased product conforms to specified purchase requirements. To ascertain whether the organization ensures that purchased product conforms to specified purchase requirements, an auditor should look for relevant evidences. In the beginning, the auditor should ask people involved in the purchasing process:

- How the purchasing process is being carried out in the organization? What is the established process? Whether the organization follows centralized purchasing or individual departments carry out purchases?
- How the purchasing order is given to supplier?
- How the conformity of the purchased product is checked? What are the types and extent of controls applied to the supplier and the purchased product?

It is also required as per ISO 9001:2008 QMS standard to evaluate and select suppliers for which the organization needs to establish criteria for selection, evaluation and re-evaluation of suppliers. It means that the organization should purchase product from its selected suppliers. Selection and ongoing evaluation of suppliers are important activities in an organization. So inquire from people involved in purchasing the established criteria for selection, evaluation and re-evaluation of suppliers and ask for the records showing results of evaluation, and any necessary action arising from such evaluation. The suitability of suppliers plays an integral role in organization’s success. So, obtain evidences that only approved suppliers are used for purchasing.

ISO 9001:2008 QMS standard requires an organization to communicate purchasing information describing appropriate details of the product to be purchased and other requirements including approval of product, procedures, processes, equipment, qualification of the personnel to the supplier. The organization is also required to ensure the adequacy of specified purchased requirements prior to their communication to the supplier. Therefore, ascertain from people involved in purchasing activities:

- How the organization ensures adequacy of specified purchase requirements prior to their communication to the supplier?
- How the organization communicates purchasing information to the supplier?
The auditor should look for the supporting evidences for the above.

As per ISO 9001:2008 QMS standard, it is necessary that the organization must establish and implement the inspection and other activities necessary to ensure that purchased product meets specified purchase requirements. So it for the auditor to ascertain the following:

- What methods have been established to check the product?
- How the established methods used in the organization to check the product?

In case the auditor observes that verification activities are performed at the supplier’s premises, then he should inquire whether such arrangement is mentioned in the purchasing information.

Any observations or nonconformance to the requirements of ISO 9001:2008 QMS standard should be reported as ‘corrective action request’ (CAR) that will provide an opportunity to the organization to improve its process and implementation.

 Keshav Ram Singhal

How you like the article? Please make your comments. Thanks.

PLEASE SEND YOUR COMMENTS TO BLOG POSTS

Dear visitors to this blog,

Greetings!

I am happy to note that more than 49,000 visitors have visited this blog from more than 115 countries, but disappointed by not receiving adequate visitor's comments/reactions.

I request visitors of this blog to let me know:

What you feel about the blog posts?
Should I continue this blog or close it?
Is this blog useful in creating awareness on 'ISO 9001:2008 QMS' or not?
What type of articles or information you need on QMS?

Your comments/reactions will enable me to review this blog's objectives.

Thanking you,

Keshav Ram Singhal

Validation of Processes

ISO 9001:2008 QMS standard requires validation of processes only where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequent deficiencies (incompleteness or inadequacy) in the product become apparent (known) only after the product is in use or the service has been delivered. The relevant clause in this regard is clause 7.5.2 of ISO 9001:2008 QMS standard that mentions requirements. This clause is for those processes where an organization is not able to easily measure the resulting output. The normal example is how do you test a gun-bullet or tear-shell? If you try and test a gun-bullet or tear-shell, then you will destroy the gun-bullet or tear-shell. So there is a need of the system for validating the processes that the gun-bullet or tear-shell was manufactured correctly and the gun-bullet or tear-shell will not fail.

Validation must demonstrate the ability of such process to achieve planned results. An organization must establish effective arrangements, for such process, including:
- Defining acceptance criteria for review and approval of the process
- Approval of appropriate equipment
- Approval of qualification of personnel, so that trained and qualified personnel are able to handle the process
- Use of specific methods and procedures
- Requirements for records
- Requirements for re-validation

So an organization needs a standard operating procedure (SOP) for that process where the organization is not able to measure the resulting output. And the organization needs to establish effective arrangements, how the organization validates such processes and what records will be kept. Keeping a documented procedure for such standard operating procedure (SOP) is not a mandatory requirement, however the organization may think of determining a documented procedure for such SOP to ensure the effective planning, operation and control of the process included in the SOP. Without having a documented procedure for such SOP, the organization has to prove that the organization has such processes in place.

Please post your comments. With best wishes,

Keshav Ram Singhal

Quality Policy

Clause 4.2.1 of ISO 9001:2008 QMS standard includes documented statement of quality policy as part of the organization's QMS documentation. Clause 5.3 of ISO 9001:2008 QMS standard mentions requirements for quality policy. It is the responsibility of the top management of the organization to ensure framing of quality policy of the organization.

What is in a quality policy?

Quality policy is a QMS documentation that provides a commitment to comply with requirements and continually improve the effectiveness of the quality management system and also to have a framework for establishing and reviewing quality policy. ISO 9000:2005 standard defines quality policy as overall intentions and direction of an organization related to quality that is formally expressed by the top management of the organization.

What are the requirements related to quality policy in ISO 9001:2008 QMS standard?

As per requirements mentioned in clause 5.3 of ISO 9001:2008 QMS standard the top management of the organization must ensure that:
(i) - the quality policy is appropriate to the purpose of the organization
(ii)- a commitment to comply with requirements of the quality management system is included in the quality policy
(iii)- a commitment to continually improve the effectiveness of the quality management system is included in the quality policy
(iv)- a framework for establishing quality objectives is provided in the quality policy
(v) - a framework for reviewing quality objectives is provided in the quality policy
(vi)- the quality policy is communicated within the organization
(vii)- the quality policy is understood within the organization
(viii)- the quality policy is reviewed for continuing suitability

The requirements as mentioned in (i) to (v) above are useful in developing or framing a quality policy.

First Sample 'Quality Policy'

"Our organization is committed to enhance customer satisfaction by achieving our organization's quality objectives through the effective application, review and continual improvement of our quality management system."

Second Sample 'Quality Policy'

"We, the employees of ABC Organization, are committed to meet customer requirements as well as applicable legal requirements by achieving our quality objectives through the application, review and continual improvement of our management systems."

With best wishes,

Keshav Ram Singhal

Newly released book on 'Implementing ISO 9001:2008 Quality Management System - A Reference Guide'

Please see more details at http://phindia.com/bookdetails/implementing_iso_9001_2008_quality_management_system_a_reference_guide_by-singhal_divya_singhal_k_r_-isbn-978-81-203-4574-4. You can buy print edition and/or eBook edition.

With best wishes,

Keshav Ram Singhal

Steps to Implement ISO 9001:2008 QMS Without Seeking Consultant’s Help

- Dr. Divya Singhal & Keshav Ram Singhal

A few days back one of the authors of this write-up received a phone call from an executive of an organization stating that his organization wishes to implement ISO 9001:2008 QMS standard and asked whether engaging a consultant was necessary to implement the standard and how his organization could implement ISO 9001:2008 standard without engaging a consultant.

Due to high cost involved in implementing any of the management systems standards, organizations generally hesitate to implement management systems standards. Although appointing a consultant may be worthwhile investment for an organization, however appointing a consultant to implement any management systems standards is not necessary. Many organizations in the world have implemented ISO 9001 QMS standard without engaging consultants and successfully got ISO 9001 certification. However, many organizations find it difficult to implement the standard without consultant. It depends on the level of competency available in the organization. An organization, wish to implement any management systems standards, should determine whether a consultant is required. Why organizations generally engage consultants? We find, there may be following reasons:

1. Consultants have the experience, expertise and time that employees may not. Organizations generally engage consultants to fill the knowledge and time gaps.
2. Consultants provide flexibility of time. Consultants work any time, including nights, weekends and holidays.
3. Consultants offer the latest and objective point of view. Consultants bring the latest and unbiased ideas from their vide experience.
4. Consultants are more efficient and focus on assigned project with sincerity. So they help you fast track your way to an effective QMS.

If competency level in the organization is adequate and people are well aware of the organization’s systems, then organization can think implementing ISO 9001:2008 QMS standard without consultant. One should be very clear that ISO 9001:2008 standard is a generic standard in terms of its requirements, but not generic in terms of its implementation. So, while implementing the standard, the emphasis should be on the objectives and processes of the organization.

When organization plans to implement ISO 9001:2008 QMS Standard without consultant, the top management of the organization has important and relevant role in implementation. Through leadership and their actions, the top management is able to create an environment in the organization – (i) where people are fully involved, and (ii) in which a quality management system can operate effectively. The top management should demonstrate its commitment and determination to implement ISO 9001:2008 QMS Standard by involving themselves actively in the following tasks –

(i) Ensuring people in the organization understand the importance of meeting customer requirements and also statutory and regulatory requirements.
(ii) Defining organization’s quality objectives and commitment to quality and ensuring that everyone in the organization understands the ‘quality policy’ and how it applies to their work.
(iii) Performing ‘management reviews’ regularly to see the continuing suitability, adequacy and effectiveness of the quality management system.
(iv) Providing necessary resources to all quality activities.

The following step-by-step approach may be useful in implementing ISO 9001:2008 QMS Standard –

Step 1 – Appointing management representative

Management representative is important personnel in quality management system structure, who should have responsibility and authority to (i) implement the requirements of ISO 9001:2008 QMS, (ii) report back to the top management on the performance of the quality management system, and (iii) promote awareness of customer requirements throughout the organization. ISO 9001:2008 QMS Standard also requires appointment of a management representative (clause 5.2.2). Accordingly, the top management should appoint a member of organization’s management as management representative. It should be noted that the responsibility and authority of management representative cannot be assigned to an outside person.

Step 2 – Setting up a steering committee

When organization is thinking to implement ISO 9001:2008 QMS without consultant, it is better if the top management set up a steering committee. The chief executive or a senior officer of the organization should head the steering committee. Functional heads and management representative should be the members of the steering committee. The committee should be responsible for the overall planning of ISO 9001:2008 QMS implementation process, giving directions and allocating resources. The committee should also decide the scope for ISO 9001:2008 QMS.

Step 3 – Setting up a task force

The top management or steering committee should set up a task force. The management representative should be the coordinator of the task force. Persons having good knowledge of the organization’s processes and good communication-writing skills should be included as members of the task force. The task force should be allocated the timeframe task of developing documentation, such as, quality manual, procedures, work instructions etc.

Step 4 – Obtaining information about ISO 9001 QMS

The management representative should collect information about ISO 9001:2008 QMS and related standards. For general information, it is better to visit ISO website and IAF website. Purchase of the following may be useful –

• ISO 9000:2005 Quality management systems – Fundamental and vocabulary,
• ISO 9001:2008 Quality management systems – Requirements,
• ISO 9004:2009, Managing for the sustained success of an organization – A quality management approach,
• ISO 19011:2002, Guidelines on quality and/or environmental management systems auditing,
• Various others publications / literatures providing knowledge on ISO 9001:2008 QMS.
Internet is useful source for obtaining information on ISO 9001:2008 QMS for which various websites and blogs may be visited.

Step 5 – Organizing awareness programme

ISO 9001:2008 QMS awareness programme should be organized to communicate to the employees the aim of ISO 9001:2008 QMS, the advantage it offers (to employees, customers and the organization), how it will work, and employees’ roles and responsibilities within the system. This programme may be conducted by the management representative, any of the task force members or outside faculty.

Step 6 – Training

Training is important for improving the competency level of employees. Training programmes should be organized for different categories of employees – senior managers, supervisors and workers. It will be better if the top management also attend ISO 9001:2008 QMS related training, seminar or presentation.
The training should cover the basic concepts of quality management systems and their overall impact on the strategic goals of an organization, quality management principles, the processes, requirements and the likely work culture implications of the system.

Initial training may also be necessary on developing documentation, QMS auditing, laboratory management techniques, statistical tools, calibration, measurement and testing procedures etc.

The steering committee can decide organizing such trainings as in-house programmes or alternatively personnel may be nominated to external training programmes.

It is suggested that a few people of the organization (including the management representative) should undergo Lead Auditor Training. A few people selected as internal auditors should be provided internal audit or lead auditor training.

Step 7 – Formulating action plan

The steering committee should formulate a timeframe action plan for implementation of ISO 9001:2008 QMS. The action plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities.

Step 8 – Carrying out initial status survey

It is better to know the gaps between the systems of the organization and the requirements of the ISO 9001:2008 QMS Standard. A self-assessment initial status survey may be carried out by the management representative or any other personnel who have undergone QMS auditor training or lead auditor training. After conducting initial status survey, the organization will be in a position to know the gaps and what is required to do for implementation.

Step 9 – Developing documentation

ISO 9001:2008 QMS Standard requires developing QMS documentation and developing documentation is the most important activity in the implementation process. Members of the task force should be given training on developing documentation. It will be better if a few of them are trained as lead auditors. They should be well versed with the requirements of ISO 9001:2008 QMS Standard and also with the processes of the organization. As earlier pointed out, members of the task force involved in developing documentation should have good communication-writing skill. While developing documentation, reference to ISO 9001:2008 QMS, ISO 19011:2002 (on auditing) and ISO 10013 (on documentation) Standards would be better.

Organizations implementing ISO 9001:2008 QMS need to develop and establish documentation (including quality policy, quality objectives, quality manual, procedures etc.) and also to keep records of information that is useful in operation and assessment of the organization’s quality management system.

The quality management system documentation of the organization needs to include the following documents:

i. Documented statement of quality policy,
ii. Documented statements of quality objectives,
iii. A quality manual,
iv. Documented procedures required by the Standard,
v. Documents (= including documented procedures, work instructions, forms) determined by the organization,
vi. Records required by the Standard,
vii. Records determined by the organization.

Out of the above first five types of documents are required to be developed and rest two types are records of information that is useful in operation and assessment of the organization’s quality management system.
For developing organization’s quality policy, quality objectives and quality manual, compliance to requirements mentioned in clauses 4.2, 5.3 and 5.4.1 of ISO 9001:2008 QMS Standard should be adhered to.

QMS documentation is the basis for establishment, implementation and maintenance of the quality management system of the organization. An organization can combine all documentation in one manual or can have more manuals.
As stated earlier developing QMS documentation is the most important activity in the implementation process. A list of documents to be prepared should be drawn up and the the responsibility for writing the documents should be assigned to members of the task force concerned with various functional departments. This will lead to better understanding of requirements and also provide a sense of responsibility (including the involvement and ownership by personnel involved in developing documentation). The responsibility to develop QMS documentation (for example: procedures, work instructions) should be given to those persons, who are involved in the processes and activities. This will lead to ownership of documents and better understanding of the organization’s processes.

As the coordinator of the task force, the management representative should follow following steps –

• Make a list of all existing QMS related documents and obtain a copy of each documents for reference,
• Study each process and prepare a flow chart of activities,
• Examine interfaces and lack of interfaces between the processes,
• Review the process flow charts and identify duplication or omissions in the information or process flow,
• Map out what is to be written,
• Verify the presence of all the required elements (requirements) of ISO 9001:2008 QMS Standard in the current system,
• Allocate responsibilities for preparing drafts of relevant parts to various members of the task force,
• Circulate the completed drafts to persons concerned for comments,
• Consider comments received and incorporate necessary corrections,
• Take action to prepare final manuscript of the documentation

Step 10 – Implementation

The organization needs to close the gaps as identified in step 8 (initial status survey), the steering committee should allocate resources to perform actions and implementation, assign responsibilities and establish a final time-frame to complete the needed actions.

It will be good practice to implement the procedures being documented, as the documentation is developed, although this may be more effective in larger organizations. In small size organizations, the implementation of the QMS documentation is done at once throughout the organization. When phased implementation takes place, the effectiveness of the system in selected area can be evaluated. It would be a good idea initially to evaluate areas where the chances of positive evaluation are high, to main confidence of both management and staff in the merits of implementing the quality management system as per ISO 9001:2008 QMS Standard. Make efforts for effective implementation and make sure that what has been written in QMS documentation is being carried out.

Step 11 – Internal audit

As per the requirement of ISO 9001:2008 QMS Standard, the organization needs to conduct internal audits at planned intervals. The purpose is to ensure that the quality management system of the organization conforms to the planned arrangements, to the requirements of the ISO 9001:2008 QMS Standard and to the requirements established by the organization. A few staff members should be trained to carry out internal auditing. Even after the system stabilizes and start functioning, internal audits should be planned and performed as a regular strategy.
Make sure that non-conformances pointed out in the internal audit are resolved by ensuring corrective actions and turned to conformances. Make sure to maintain records of the audit and its results.

Step 12 – Management Review

When implementation of the documented QMS has been operating for three to six months and an internal audit has been conducted, a management review should be conducted by the top management of the organization by considering following inputs:

• Internal audit results,
• Customer feedback,
• Process performance,
• Product conformity,
• Status of corrective and preventive actions,
• Changes that could affect the QMS and recommendations for improvement.

Management review forms an integral part of the quality management system and it should be conducted at planned intervals. Make sure to maintain records from the management review.

Conclusion

Accordingly, by carrying out above steps an organization can implement ISO 9001:2008 QMS Standard without seeking consultant’s help, however, it is important to note that the training and awareness is very important in implementing management systems standards.

Certification is not a requirement of ISO 9001:2008 QMS Standard and many organizations in the world are implementing the standard without obtaining certification. However, if an organization wishes to obtain certification, then a pre-assessment audit should be arranged with an independent and qualified auditor that would provide a degree of confidence in the implementation. When the quality management system as per ISO 9001:2008 QMS Standard has been in operation for a few months and has stabilized, the organization can go for the process of third party certification.

Courtesy - Quality World, New Delhi - November 2010



Where can I get more articles?
This article is included in ‘Awareness Series on QMS’ containing more than 50 articles edited by KESHAV RAM SINGHAL. You can get this series by sending your subscription that is very nominal. You should send an email to keshavsinghalajmer@gmail.com asking subscription details of the Awareness Series on QMS.

I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

Your Feedback is valuable
If you feel this article is informative or if you would like to provide us your feedback, do send us an email with your comments or write your comments in the space provided below the article. If you feel this blog could help your supplier, customer or other business associate, feel free to refer this blog to them.

Let us learn from a Quality Guru - Philip Crosby

Philip Crosby
18 June 1926 – 18 August 2001)

American Quality Guru Philip Crosby contributed to management theory and quality management principles. He was the person, who initiated ‘Zero Defects’ programme at the plant of Martin Company, Florida, USA. He was the person, who put the belief among the industrial world that quality is free. ‘Doing it right the first time’ is his principle to respond to any quality crisis.



Education – Graduated (1944) from Triadelpha High School, Honorary Law Degree from Wheeling College, Honorary Law Degree from Rollins College, Honorary Doctor of Corporate Management from the University of Findlay

Crosby work life details

Crosby served in World War II and the Korean War. After serving in WWII and the Korean War, he worked for Closley, Martin-Marietta and ITT. He was the corporate vice president of ITT for 14 years. In the Korean War he served as a Marine Medical Corpsman.

1952 – Crosby started his career as a quality professional. Joined Croseley Corporation (Richmond, Indiana) as a junior electronic test technician, where he was directed to join the American Society for Quality Control and thus he entered in to the field of quality.

1955 – Moved to South Bend, Indiana and joined Bendix Corporation as a reliability technician, where he was associated with the work to investigate defects found by the testers and inspectors

1957 – Joined Martin Marietta Company in Orlando, Florida as a senior quality engineer and worked there for eight years. During this period, he developed his ‘Zero Defects’ concepts and also wrote many articles for various journals. He also started his speaking career.

1965 – He joined International Telephone and Telegraph as a vice president in charge of corporate quality.

1979 – Started a management consultancy organization ‘Philip Crosby Associates Inc.’ He published his first book ‘Quality is Free’.

1991 – Retired from Philip Crosby Associates and founded a new company named ‘Career IV, Inc.’ helping people to grow.

Crosby in Indian context

Philip Crosby visited India in 1996 and he talked with a few software folks at NIIT. As a nonexecutive chairman of ‘India Quality Management Foundation’, Crosby wrote a story about the eighth grade and quality management.

Crosby books

• Cutting the Cost of Quality (1967)
• Quality is Free: The Art of Making Quality Certain (1979)
• Quality Without Tears: The Art of Hassle-Free Management (!984)
• Running Things: The Art of Making Things Happen (1986)
• The Eternally Successful Organization (1988)
• Let’s Talk Quality (1989)
• Leading: The Art of Becoming an Executive (1990)
• Completeness: Quality for the 21st Century (1992)
• Reflections on Quality (1995)
• Quality IS Still Free (1996)
• The Absolutes of Leadership (1997)
• Quality and Me : Lessons of an Evolving Life (1999)

The Principle – ‘Doing it right the first time’

‘Doing it right the first time’ is Crosby’s principle to respond to any quality crisis. He defined following four quality absolutes:

i. Quality is conformance to requirements (requirements meaning both product requirements and customer’s requirements), not as ‘goodness’ or ‘elegence’
ii. The system of quality is prevention, not appraisal
iii. The performance standard must be zero defects (relative to requirements), not ‘that’s close enough’
iv. The measurement of quality is the price of nonconformance (PONC), not by indices

The above four absolutes originally coined by Crossby in his famous book ‘Quality is Free’. Four years after the death of Philip Crosby, Pilip Crosby Associates, a consulting organization founded by Philip Crosby, added another absolute, which states – “The purpose of quality is to ensure customer success, not customer satisfaction.”

Philip Crosby’s 14-Step Quality Improvement Process

Step 1 – Management commitment
Step 2 – Quality improvement teams
Step 3 – Measurement
Step 4 – Cost of quality
Step 5 – Quality awareness
Step 6 – Corrective action
Step 7 – Zero defects planning
Step 8 – Education
Step 9 – Zero Defects Day
Step 10 – Goal setting
Step 11 – Error cause removal
Step 12 – Recognition
Step 13 – Quality councils
Step 14 – Do it over again

‘Quality is Free’

‘Quality is Free’ communicates powerful messages
i. Senior management must commit to quality if things are to change
ii. Doing things right the first time adds absolutely nothing to the cost of a product or service
iii. Quality is free, but it is not a gift
iv. An organization that established a quality programme will see savings more than pay off cost of the quality programme.

With best wishes,

Keshav Ram Singhal

Let us learn from a Quality Guru - Joseph M. Juran

Joseph M. Juran
(24 December 1904 – 28 February 2008)

Joseph Moses Juran, a leading quality guru, who had written several influential books on quality and quality management. Born in Romania, but he spent most of his life in America. He is often known as ‘Father of Quality’.



A few awards received by Juran includes – (i) Second Order of the Sacred Treasure Award from the Emperor of Japan.

Education – B. S. in Electrical Engineering (1925) – University of Minnesota

Juran’s Work Life details

1925 – Started working with Western Electric in the Inspection Department of the Hawthorne Works, Chicago, USA.

1926 – Attended training programme designed to implement new tools and techniques, and thereafter, from a group of 20 trainees, Juran became one of two engineers for the Inspection Statistical Department.

1928 – Juran wrote a paper ‘Statistical Methods Applied to Manufacturing Problems’

1937 – Juran became the Chief of Industrial Engineering at Western Electric in New York. His work involved visiting other organizations and discussing methods of quality management. Juran created the ‘Pareto Principle’ which managers rely on to help separate the ‘vital few’ from the ‘useful many’ in their activities. This is now commonly referred as the 80-20 principle and also referred to as Juran’s Pareto Principle.

During World War II – Juran’s leave of absence from Western Electric for a period of four years, during this time he served as an assistant administrator for the Land-Lease Administration in Washington. By the end of the war, Juran was a well-known and highly-regarded Statistician and industrial engineering theorist in America.

1945 and thereafter – Left Washington and did not join Western Electric. Juran chose to devote the remainder of his life to the study of quality management. Joined New York University as Chairman of the Department of Administrative Engineering, where he taught for many years. He devoted his tome mostly in the development of his management philosophies. The Union of Japanese Scientists and Engineers invited Juran to Japan in 1954, where he taught them the principles of quality management and thus helped Japanese rebuilt their economy. In 1979 he founded Juran Institute.

Juran is famous for his quality management ideas known as Quality Trilogy. Quality Trilogy includes three distinct phases: (i) Quality Planning – Identify your customers, determine needs of your customers, translate their needs in your own language, and develop a product that can respond to customer needs, (ii) Quality Improvement – Develop a process which is able to produce a product, and optimize the process, (iii) Quality Control – Prove that the process can produce the product under operating conditions with minimal inspection, and transfer the process to operation.

Juran in Indian context

Indian Merchants’ Chamber (IMC) initiated an award named ‘IMC Juran Medal’, which has become a benchmark for quality leaders in India.

Famous work of Juran

• Juran’s Pareto Principle
• Quality Control Handbook (First released in 1951)
• Managerial Breakthrough – A collection of Juran’s lectures (1964)
• Juran’s Quality Trilogy (First published in 1986)
• Foundation of Juran Institute (1979)

Juran’s Pareto Principle

Juran’s Pareto Principle, suggested by Joseph M. Juran, is also known as the ’20-80 Rule’, ‘the law of vital few’ and ‘the principle of factor sparsity’. It emphasizes that for many phenomena 80% of consequences stem from 20% causes. Juran framed this principle after he adopted an idea from the Italian economist Vilfredo Pareto that stated the 80% of property in Italy was owned by 20% of the Italian population. Thus, Juran was able to frame that ‘20% of clients are responsible for 80% of sales volume’. The Juran’s Pareto Principle is helpful in future decision making. The 20-80 Rule means that in anything a few (20%) are vital and many (80%) are trival.

Juran’s definition for quality

Juran defines quality as ‘fitness for use’ (1988). Note: The customer defines the fitness.

Juran offers two definitions of quality in his must-have reference, Juran’s Quality Handbook:
• Quality means those features of products, which meet customer needs and thereby provide customer satisfaction.
• Quality means freedom from deficiencies – freedom from errors that require doing work again (rework) or that result in field failures, customer claim and so on.

Juran’s Quality Improvement Tools

Juran suggests following 10 steps to quality improvement:
i. Build awareness of opportunity to improve
ii. Set your goals for improvement
iii. Organize yourself to reach goals
iv. Provide training
v. Carry out projects to solve problems
vi. Report progress
vii. Give recognition
viii. Communicate results
ix. Keep score
x. Maintain momentum by making annual improvement plan of the regular systems and processes of the organization

With best wishes,

KRS

Let us learn from a Quality Guru - W. Edward Deming

W. Edward Deming (14 October 1900 – 20 December 1993)

W. Edward Deming was an American quality guru, who had significantly contributed in building Japan. He taught – (i) How to improve design (and thus product/service), (ii) Product quality, (iii) Testing, (iv) Sales through various methods, (v) Application of statistical methods.



A few awards received by Deming includes – (i) Second Order Medal of the Sacred Treasure (1960) awarded by the Emperor of Japan, for his contribution for improvement of quality and of Japanese economy through statistical quality control, (ii) Shewhart Medal (1955) from the American Society for Quality Control, (iii) Samuel S. Wilks Award (1983) from the American Statistical Association, (iv) Taylor Key Award, American Management Association (1983) (v) ‘National Medal of Technology’ (1987) awarded by the US President Reagan, (vi) ‘Distinguished Career in Science Award’ (1988) from the National Academy of Sciences, USA .

Deming was popularly considered as a hero in Japan.

Education – B. Sc. (Electrical Engineering) from the University of Wyoming (1921), M. S. from University of Colorade (1925), Ph. D. from Yale University (1928), Internship at Bell Telephone Laboratories while pursuing Ph. D.

Famous work of Deming:

(i) Book ‘Out of Crisis’ (1982-1986)
(ii) Book ‘The New Economics for Industry, Government, Education’ (1993)
(iii) System of Profound Knowledge
(iv) 14 Points for Management
(v) Foundation of W. Edwards Deming Institute in Washington (1993)


The Deming System of Profound Knowledge

The Deming System of Profound Knowledge teaches us –

i. The prevailing style of management must undergo transformation (change). A system cannot understand itself. The transformation requires a view from outside – a lens that Deming called it a system of profound knowledge.
ii. A map of theory by which to understand the organizations that people work in.
iii. The first step is transformation of individual. This transformation is not continuous. This transformation of individual comes from understanding of the system of profound knowledge.
iv. The individual transformed will perceive new meaning to his life, to events, to numbers of interactions between people.
v. Once the individual understands the system of profound knowledge, he will apply its principles in every kind of relationship with other people.
vi. Once the individual understands the system of profound knowledge, he will have a basis for judgement of his own decisions and for transformation of organizations that he belongs to.
vii. Once the individual is transformed, he will set an example, he will be a good listener but will not compromise, he will continually teach other people and he will help people to pull away from their current practices and beliefs and move into the new philosophy without a feeling of guilt about the past.

Deming advocated that all managers must to have a System of Profound Knowledge. A system of profound knowledge consists of four parts: (i) Appreciation of a system, (ii) Knowledge of variation, (iii) Theory of knowledge, (iv) Knowledge of psychology. Accordingly, a manager must have the understanding of the overall processes including suppliers, producers, and customers (or recipients or end users) of goods and services. He must have knowledge of the range and causes of variation in quality and use of statistical techniques in measurements. He must understand the concepts explaining different things and limits. He must have the knowledge of concepts of human nature, thus he should be an expert in psychology. Deming explained his concept on the system of profound knowledge and stated that one need be eminent neither in any part nor in all four parts in order to understand it or apply it. Deming puts the 14 points for management in industry, education and government to follow as application for transformation. The System of Profound Knowledge is the basis for application of Deming’s famous 14 points for management.

Deming in Indian context

Deming visited India as a delegate from the A. A. A. S. to the Indian Science Congress, New Delhi in January 1947. He worked as a consultant in sampling to the Government of India during January – February 1947, December 1951 and March 1971.


Deming’s 14 points for management

Deming’s book ‘Out of the Crisis’ mentioned Deming’s famous 14 points for management for transforming business effectiveness, which are as under:
1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive, stay in business and to provide jobs.
2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change.
3. Cease dependence on inspection to achieve quality. Eliminate the need for massive inspection by building quality into the product in the first place.
4. End the practice of awarding business on the basis of a price tag. Instead, minimize total cost. Move towards a single supplier for any one item, on a long-term relationship of loyalty and trust.
5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs.
6. Institute training on the job.
7. Institute leadership. The aim of supervision should be to help people and machines and gadgets do a better job. Supervision of management is in need of overhaul, as well as supervision of production workers.
8. Drive out fear, so that everyone may work effectively for the company.
9. Break down barriers between departments. People in research, design, sales, and production must work as a team, in order to foresee problems of production and usage that may be encountered with the product or service.
10. Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force.
11. a. Eliminate work standards (quotas) on the factory floor. Substitute with leadership.
b. Eliminate management by objective. Eliminate management by numbers and numerical goals. Instead substitute with leadership.
12. a. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be changed from sheer numbers to quality.
b. Remove barriers that rob people in management and in engineering of their right to pride of workmanship. This means, inter alia, abolishment of the annual or merit rating and of management by objective.
13. Institute a vigorous program of education and self-improvement.
14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody's job.

Deming’s Seven Deadly Diseases and Lesser Category of Obstacles

Deming described ‘Seven Deadly Diseases’ as under:

1. Lack of constancy of purpose
2. Emphasis on short-term profits
3. Evaluation by performance, merit rating, or annual review of performance
4. Mobility of management
5. Running a company on visible figures alone
6. Excessive medical costs
7. Excessive costs of warranty, fueled by lawyers who work for contingency fees

‘A Lesser Category of Obstacles’ include the following:

1. Neglecting long-range planning
2. Relying on technology to solve problems
3. Seeking examples to follow rather than developing solutions
4. Excuses, such as, ‘Our problems are different.’
5. Obsolescence in school that management skill can be taught in classes
6. Reliance on quality control departments rather than management supervisors, managers of purchasing and production workers
7. Placing blame on workforces who are only responsible for 15% of mistakes where the system designed by management is responsible for 85% of the unintended consequences
8. Relying on quality inspection rather than improving product quality

Deming modified PDCA Cycle

Plan-Do-Check-Act (PDCA) cycle was made popular by Dr. W. Edwards Deming, referring it as ‘Shewhart Cycle’, later he modified this cycle to ‘Plan-Do-Study-Act’ (PDSA) cycle because Deming felt that ‘check’ emphasized inspection over analysis.

With best wishes,

KRS