TOTAL QUALITY MANAGEMENT - II

Chapter – 12:

Quality Management System (QMS)

Dr. Shyamal Gomes Introduction: American National Standard Institute (ANSI) and American Society for Quality Control (ASQC) define that: Quality System is “The collective plans, activities and events that are provided to ensure that a product, process or service will satisfy the given needs”. Therefore,

It is an Integrated technical and managerial procedures that ensure / assure customer satisfaction and economical cost of quality

It is a powerful foundation for total quality control, organization –

wide and Total Quality Management

Quality Culture

Quality Actions of the

People

Quality Control

Initiatives

Quality Assurance

as per Customer

needs

Integration

The tools, techniques, methods and metrics (or measures) that aim at assisting in the planning, design, control and improvement of quality together comprise the quality system.

Phases of Quality System

Inspection Gap analysis and finding the error

Process Control Feedback control of the manufacturing system

Quality Improvement Aiming at prevention where worker’s involvement is the key

Quality by Design – designing quality into products and the manufacturing processes, starting with the initial concepts of the product.

What is Quality System Standard?

As quality became a major focus of business in competitive environment through out the world, successful organizations developed quality standard and their quality system called Quality system standard.

Quality system standards are used as minimum requirements of

quality systems in organizations. Types of Quality Standard: The Standards are set by national and international quality certification bodies as a guidance, development, or evaluation of quality system in an organization Quality Standards are of two types:

1. Generic Standards 2. Industry – related Standards

Generic Standard:

Generic’ means that the same standards can be applied to any organization – large or small, producing any product or service,

and in any sector of activity – it could be a business enterprise, public administration dept. or a government dept.

In India, we have the Bureau of Indian Standard (BIS) as a

national level and ISO 9000 in International level standard. ISO 14000 is a generic standard relating to establishing an environment management system in an organization

Industry – related standard:

These standards are set by purchasing bodies for a particular industry as the basic requirements for purchasing products / services.

For example, defense, aerospace, nuclear industries, etc. usually have a set of guidelines for purchasing due to overriding safety requirements.

Agmark is an industry related standard used in the grading and standardization of agriculture and allied commodities

Quality standards serve the following three purposes:

1. Quality standards provide guidance to an organization implementing a quality system for the first time.

2. QS are used for assessing the quality system already in place in an organization

3. Quality standards are used for creating quality assurance requirements to be specified in the contract with a supplier.

Why quality system standard is required for an organization

Customers or marketing are suggesting or demanding compliance to a quality system

Improvement in processes or systems and a desire for global deployment or products or services.

Increase Market share Registered organization require registered suppliers / sub

contractors, creating a snowball effect. Well documented quality system can far outweigh the external

pressures

ISO and ISO 9000:

An Overview of International Organization for Standardization (ISO): ISO is a non governmental organization with a central secretariat in Geneva, Switzerland, and represents a network of national standard organizations of 150 countries. BIS is also a member of ISO. ISO is the world’s largest developer of standards of various types’ especially in quality and was born on 23rd February 1947. Since its inception, ISO published over 15,000 international standards. In 2003, ISO published 995 new and revised international standards. ISO itself does not perform certification to its ISO 9000 and ISO 14001certificates. There are around 750 certification bodies active around the world those issues these certificates to the organizations after conducting audit of their quality/ environmental management systems.

What is ISO 9000?

A revolution occurred in 1987 in the management of quality world wide when the International Organization for Standards ( Geneva, Switzerland) bought out a set of standards pertaining not to the quality of products but rather to the practice of quality assurance methods with in a company. Termed as ISO 9000 standards, these proved their value rather quickly and went Global.

ISO 9000 is a series of international quality standards which serve as a guidance to suppliers and purchasers about the minimum requirements of a quality system.

The first edition of ISO 9000 standards was completed in 1986 by ISO Technical committee and it was published in 1987. Ralli Wolf was the first company in India to get ISO 9001 certified in the year 1988 by BSI, UK.

The basic principle behind ISO 9000 is stated in Section 1 – scope and Field of Application:

“The requirements specified are aimed primarily at achieving customer satisfaction by preventing non conformity at all stages from design through to servicing”

ISO 9000 is not a mandatory system nor it is a government regulation. However, it is a very important customer regulation. It provides assurance to a wide variety of customers about an organization’s quality assurance methods and quality management practices. The Objectives of ISO 9000: 1. Achieve, maintain, and seek to continuously improve product

quality (including services) in relationship to requirements 2. Improve the quality of operations to continuously meet customers’

and stakeholders stated and implied needs 3. Provide confidence to internal management and other employees

that quality requirements are being fulfilled and that improvement is taken place

4. Provide confidence to customers and other stakeholders that quality requirements are being achieved in the delivered product.

5. Provide confidence that quality system requirements are fulfilled ISO 9000 was originally issued as a series of six internationally agreed upon standards to guide and audit a company’s quality management practices. Three types of certification are there in ISO 9000 depending upon the activities of the organization seeking the certification. These are ISO 9001, ISO 9002 and ISO 9003. ISO provides two documents as guidance to organizations for understanding various aspects of a good quality system:

1> ISO 9000: This documents explains principle concepts and applications, and guide to selection and use and

2> ISO 9004: This document explains principle concepts and applications, guide to quality management, and quality system elements.

These standards are the minimum acceptable level of standards that a suppliers quality management practices should meet, in order to receive the “ ISO 9000 accreditation or certification”. ISO 8402 Terminology standard provides

definition of all terms, is a comprehensive glossary.

ISO 9000: Quality Management and quality assurance standards –guidelines for selection

Helps company determine which standard of ISO 9001, 9002 and 9003 applies.

ISO 9001: Quality systems Model for quality assurance in design, development, production installation, and servicing of products of services.

ISO 9002: Quality system Model for quality assurance in production and Installation

ISO 9003: Quality system Model for quality assurance in final inspection and testing.

ISO 9004: Quality measurement and quality system elements guidelines

The guidelines for applying the elements of the quality management system.

Structure of ISO Quality Standards ISO 9000:

Definition of concepts ISO 8402

Selection and use of the standards ISO 9000

ISO 9001 ISO 9002

Three Models for Quality Assurance

ISO 9003

Elements of ISO 9000: ISO 9000 standards focus on 20 key elements or requirements of a firm’s quality program. To get certification, the firm must pass a rigorous audit to assure compliance with all these standards.

Contractual Situations

Non Contractual Situations

Quality Management And Quality System Elements ISO 9004

The requirements are given below: Sl Element / Requirements ISO 9001 ISO 9002 ISO 9003 1. Management Responsibility X X1 X2 2. Quality System X X X2 3. Contract review X X -- 4. Design control X -- -- 5. Document and data control X X X2 6. Purchasing X X -- 7. Control of supplied products X X -- 8. Product identification and

traceability X X X2

9. Process control X X -- 10. Inspection and testing X X X2 11. Control of inspection, measuring

and test equipment X X X2

12. Inspection and test status X X X2 13. Control of non – conforming

products X X X2

14. Corrective and preventive action X X -- 15. Handling, storage, packaging,

preservation and delivery X X X2

16. Control of quality records X X X2 17. Internal quality audits of the

quality system X X1 X2

18. Training to employees that affect quality

X X1 X2

19. Servicing as required by customers X -- -- 20. Statistical Techniques X X X2 Note : X – Fully requirements X1 – less stringent requirement than ISO 9001 X2 – less stringent requirement than ISO 9002

Implementation and Registration: Since implementation of ISO 9000 is a tough task, support of the top management is essential. Employees must be well trained as they will be applying the procedures and taking care of the details. Managers and supervisors must be trained to enable them to understand the standards themselves and also to anticipate questions that might be asked to external auditors.

Key steps of Implementation: There are a number of steps that are necessary to implement a quality management system. The first step in this regard is to acquire the full support of upper management and we can consider it as Top management commitment to achieve ISO certification. Secondly, establish a steering committee with representatives from production, quality assurance, purchasing, engineering (design) and other functions like HR etc. The steering committee can coordinate project tasks such as collecting existing procedures, reviewing them and revising them as necessary. The other key steps are:

• Awareness programme on Quality Management system to all in the organization.

• Establishing a ‘ quality policy’ • Developing a ‘corrective action process’ to monitor and

control non – conformance. • Writing ‘ document control’ procedures ( generally

work instructions are available as a starting point) • Completing ‘drafts of detailed procedures’ for each

ISO element, reviewing them and approving them. • Completing the ‘quality manual’ this consolidates all

procedures. • Appoint an implementation team • Training all employees (implementation team) on the

quality policy and audit procedures of the company. • Select the element owner, for each of the system

elements. Owners may be assigned more than one element.

• Review the Present System and write the documents • Install the new system – policies, procedures and work

instructions gradually / one by one/ one element to another.

• Conducting internal audits • Management Review • Pre assessments and • Preparing for registration audit.

Registration: The ISO 9000 standards originally were intended to be advisory in nature and to be used for two party contractual situations (between a customer and supplier) and for internal auditing. However, they quickly evolved into criteria for companies who wished to ‘certify’ their quality management or achieve ‘registration’ through a third party auditor, usually a registration agency known as registrar. Registration Process: The steps are:

• Document review of the quality system documents or quality manual by the registrar.

• Pre- assessment which identifies potential non-compliance in the quality system or in the documentation

• Surveillance of periodic re audit to verify conformity with the practices and system registered.

Here it is very important to understand that the recertification is required every three years. Individual departments or divisions – not entire organization or companies – must achieve registration individually. All costs are borne by the applicants, so the process can be quite expensive. Basic Requirements for ISO-9000 Certification

Documentation: Documentation of procedures for carrying out any activity in the operation

Performance: Use the documentation as a working tool by doing everything that is written (achieved against planned)

Verification: The accepted written procedures are respected by all parties concerned.

Filling: A written trace of all procedures should be retained, kept updated and be available to all persons concerned

Advantages of ISO 9000 certification

Marketing Muscle: A company that is certified is able to offer a superior product or services and this will give the company marketing muscle.

Contractor selection: A partner has ISO certification can help for any situation whether it is European or American business

Suppliers: Selecting a new supplier can be time consuming or costly. If a potential supplier is ISO 9000 certified, then the selection process for a buyer firm can be considerably reduced.

Criticism of ISO 9000 certification

Bureaucratic Costly No guarantee that a company who is certified provides a quality

services or products ISO 9000 and TQM: ISO 9000 is not TQM , but it is a subcomponent of TQM and a good start on the sustainability of total quality management path. ISO 9000 is only the minimum required quality standard that a supplier must demonstrate to receive the ISO 9000 accreditation. TQM by contrast is much more comprehensive. TQM links quality to customer satisfaction by requiring action on four essentials:

• A strong customer orientation ( internal and external in all activities in the organization)

• Direct involvement of top management in the delivery of quality product / services.

• Total company – wide participation in the delivery of quality and

• The systematic analysis of quality problems focused on continuous improvement of quality performance and the prevention of quality problems.

Implementation Process and requirements for ISO 9001:2000 The internationally recognized ISO 9001:2000 standard is generic. It is not a product standard, but applicable to any manufacturing or service industry. Created by the International Organization for Standardization (ISO), its objective is to set international requirements for Quality Management Systems. Upgraded version ISO 9001:2000 is the latest version of the standard, issued December 15, 2000. The new edition has combined 1994 editions of ISO 9001, ISO 9002, and ISO 9003. What is different?

The new standard places more emphasis on continual improvement and customer satisfaction than the 1994 versions. It applies to the processes of an organization that influence quality. The major clauses in the new standard are: Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis, and Improvement Therefore, for third party certification, the company need to implement an effective Quality Management System complying with the requirements of the standard. The first and foremost objective is to get Certification: Certification, or registration, to a standard is the outcome of a successful assessment by an independent third party. After having decided on the management system the company wish to implement, there are certain steps to get company need to start. Here some important points that every company who are seeking certification must keep in their mind are as follows: 1. Make sure the process begin with the right attitude. 2. Have a complete understanding of the concept set forth in the standard, and use the standard as a guide template to everyone of the management system. 3. Know what application and implications of the standard will mean to that company. 4. Company must use the standard as a tool for improvement. 5. Have an understanding of the risks and processes that affect the organization's ability to realize its business strategy. Select the partner (certification body/registrar) carefully. What are the steps? To obtain the certificate the company / organization trying for certification, must follow the steps. There are 10 general steps that helps to get certification: Obtain a standard:

Obtain and read a copy of the standard to familiarize the company with the requirements. Think and finally decide if this certification/registration of standard makes good sense for the company or organization. Review literature and software: There is a large amount of published information available that is designed to assist the organization /company in understanding and implementing a standard. Assemble a team and define your strategy: The adoption of a management system needs to be the strategic decision of the whole organization. It is vital that your senior management is involved in the creation process. They decide the business strategy that an efficient management system should. In addition, the organization needs a dedicated team to develop and implement their management system. Determine training needs: The team members responsible for implementing and maintaining the management system(s) will need to know the full details of the applicable standard(s). There is a wide range of courses, workshops, and seminars available designed to meet these needs. Review consultant options: Independent consultants will be able to advise you of a workable, realistic, and cost effective strategy plan for implementation. Develop management systems manual: The management systems manual of the organization should describe the policies and operations of the company. Through the manual, they will provide an accurate description of the organization and the best practice adopted to consistently satisfy customer expectations. Develop procedures: Procedures describe the processes of your organization, and the best practice to achieve success in those processes. These procedures should answer the following questions about each process: Implement the management system: Communication and training are key to a successful implementation. During the implementation phase, the organization will be working according to the procedures that were developed to document and demonstrate the effectiveness of the management system. Consider a pre-assessment: The company can choose to have a preliminary evaluation of the implementation of the management system by a certification

body/registrar. The purpose of this is to identify areas of non-conformance and allow to correct these areas before company begin the accredited certification process. Receiving a non-conformance means that a particular area of the management systems is not compliant with the requirements of the standard. Select a certification body/registrar: The business relationship with the certification body/registrar will be in place for many years, as the certification has to be maintained. In this age of corporate scrutiny, it is imperative to choose a certification body/registrar with a reputation beyond reproach. Accreditation: Having a certified management system can be used as a competitive sales argument. It is also increasingly becoming a term of contract. But what is accredited certification and how does the certification process work? What is accreditation? Accreditation verifies the certification body/registrars competence. To fulfil the accreditation criteria, an accrediting authority assesses the certification body/registrar. This is to verify that the certification body/registrar complies with requirements. It is the authority’s way of auditing the auditors (certification bodies/registrars like DNV, a certified body of ISO). What is third party accredited certification? Accredited certification of management systems is used to demonstrate compliance to a standard. Third party certification bodies/registrars are auditing organizations that provide auditing services to companies that wish to obtain certification to specific standards. How do an organization /company become certified by Third party? The management system is always subject to change. A successful management system is one that is improved on a continual basis. However, if not maintained it is possible that a management system will become obsolete. Therefore, accredited certification consists of two stages: the primary certification and maintenance of the certificate thereafter. Initial visit Before the actual certification audit, the company can choose to have a preliminary visit to their organization. For an initial visit, the third party send a lead auditor to review the quality manual, check procedures,

facilities and briefly check the implementation of entire management system. In essence, this is a preliminary audit intended to uncover areas in organisation’s management system that might need special attention. During the initial visit the scope and audit program is agreed upon, as well. Documentation review External lead auditor evaluates the management system manual. The documentation review report summarizes any findings from this process. The report indicates if the organization is ready to proceed with the certification audit. Certification audit During the certification audit, the accreditation team will conduct informal interviews, examinations and observations of the system in operation. It provides them with essential information required for the certification process and assesses the degree of compliance of the company’s management system with the requirements of the standard. When found compliant, they issue the certificate. At this stage the company have completed the initial certification and can move on to maintenance of their certification. Periodic audits Each issued certificate has a three-year life period. Upon certification, they will create a periodic audit schedule for regular audits over the three-year period. These audits confirm the companys on-going compliance with specified requirements of the standard. At least one periodic audit per year is required. Re-certification audit After the three years are up, the certification will be extended through a re-certification audit.