UNIT 4 ROLE OF IS0 AND OSHA IN QUALITY

Structure

4.1 Introduction

Objectives

4.2 What is 1SO 9000?

4.2.1 History o f IS0 9000

4.2.2 Necessity o f Management Standard

4.3 Components of IS0 9000

4.4 Benefits of IS0 9000

4.5 Requirements of IS0 9000-9004

4.6 Documentation for IS0 9000 QMS

4.7 Implementation of IS0 9000 QMS

4.8 Need for Safety and Health in Industry

4.9 Safety Approaches and Safety Management as per OSHA

4.10 IS0 14000

4.1 1 Summary

4.12 Key Words

4.13 Answers to SAQs

4.1 INTRODUCTION

The business environment has changed during the past few decades. Rising expectations worldwide and open market economies are now forcing businesses to compete with each

r other. This open competition has created new enterprises, reputed brand names, and superior product designs. The improved performance of today's automobiles, plastics, and machine tools, for example, are noteworthy. The vigor in trade across national borders has placed the customer in a strong position where he can ask for better gains for what he pays. In fact, businesses are desperate to conform to customers' needs and make them satisfied. All these developments have made quality a strategic choice for many producers. However, the approaches to provide quality products and services still vary significantly around the world. This is because different industries have different perceptions and requirements of quality. These differences become especially apparent when a producer attempts to cany trade across borders. In such instances, standardization, formation of association, special arrangements for contract management, andprofessionally managed transfer of technology have evolved as solutions. The IS0 9000 standards for quality management, in particular, were proposed to meet the growing needs for international standardization by the joint action of 26 of the largest consumer and producer nations including India, under the sponsorship of the ISO. These standards embody comprehensive quality management concepts and guidance. The recent years have also seen a growing concern for safety of employees in the industries. This has evolved into strict norms for provision of safe-accident free environment in the work place.

In 1987, a revolution occurred in the management of quality worldwide when the International Standards Organization (Geneva) brought out a set of standards pertaining not to the quality of products but rather to the practice of quality assurance methods within a company. Termed as IS0 9000 standards, these proved their value (particularly to buyers) rather quickly and went global. Today, over 90 countries have recognized

Quality Systems these standards. Many,countries including India have adopted them as their own standards for-benchmark quality management practices. Today this series covers-varied activities such as design, manufacturing, software development, service gctivities, auditing, and methods for improving quality on the shop floor.

This module begins with the background and evolution of ISO. The succeeding section brings in the principlesof Quality Management Systems (QMS) and its relation to IS0 9000. Next, the components of IS0 are discussed followed by the benefits of IS0 9000. The details for establishment of IS0 9000 are provided under the section QMS implementation. The last three sections will bring the issue of safety and health in industry and what are the approaches to implement safety management. This unit ends with the description of IS0 14000.

Objectives -

After studying this unit, you should be able to

understand the QMS system,

explain the types of IS0 9000 standards,

know the requirements for implementation of IS0 9000,

appreciate the necessity for safety and health in industry, and . -

describe ISO. I 4000.

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4.2 WHAT IS I S 0 9000?

IS0 is the word that represents the International Organization for Standardization. It is the worldwide fqderation of national standards bodies-for approximately 130 countries. IS0 has been developing voluntary technical standards over almost all sectors of business, industry and technology since 1947. T h a e standards are documented ,-.

agreements containing technical specifications to be used consistently as rules; guiddines, or definitions of characterisfics to ensure that materials, products, processes and services are fit for the purpose of customer. The vast majority of ISO standards are highly specifx to a particular product, material, or process.

IS0 9000 is primarily concerned -with "quality management". Quality management is< that aspkct of the company's overall management functi'on that determines and implements,the company's quality policy. Quality Policy isthe overall quality intentions apd direction of an organizatibn as regards quality, as formally expressed by the top ma'nagement. A Quality Management Standards (QMS) covers the areas of procedures, tools, the assessment of capability, documentation procedure, etc. IS0 9000 is a generic management system standard. Generic means that the same standard3 can be applied to any organization, large or small, whatever its product, including servicelin any sector of activity. It also applies to a-business enterprise, a public administration or a government department.

4.2.1 History of IS0 9000

In the 1970s, many major organizations published their own quality management standards (Ford's QIOi, for example). It introduced the idea that confidence in aproduct could be gainedfrom an approved quality management system and quality manuals. By the late 70s it was decided that, for the first time, there would be a national standard on what c6nstftuted a quality system. This led to the development of BS5750 series (British Standard). By 1980s, there was a need for some kind of internati6nally recognized quality system. In 1987, BS5750 series was also issued as IS0 9000 and EN 2900 (Euro- norm series in the European Union). Several additional standards have been issued subsequently by ISO, including a major revision of the original series done in 1994 also known as IS0 9000:1994. IS0 9000 was originally issued as a series of six

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internationally agreed upon standards. They were named as IS0 9000, IS0 9001, IS0 9002, IS0 9003, IS0 9004, and IS0 8402 respectively.

4.2.2 Necessity of ~anagement Standard

In a very ;mall organization, it may not be necessary to document the working procedure of the system, because the manager or owner runs the organization as he wishes. The larger the organization, and more the people involved, greater the likelihood that there will be some written procedures, instructions, forms or records. Management system. standards provide the organization with a model to follow in setting up and operating the management system. This model incorporates the features on which exper@ in the field have reached a consensus as ~epresenting the international state of the art. Some of the- important features of a management standard are as follows :

(i) The standards help ensure that the organization goes about its business in an orderly and structured way, so that time, money and other resources are utilized eflciently.

(ii) A systematic approach ensures that nothing important is left out and that everyone is clear about who is responsible for doing what, when, how, why and where.

(iii) The need for management systems is needed most in large organizations. Companies in such fields as automobiles, defense, or health care services have been operating management systems for years.

(iv) The customer demands special inspections and checks to make sure that what he receives from a supplier, meets his own requirements. A standardized QMS addresses procedures, tools, assessment of capability, documentation methods, etc. Hence, it reduces the burden of cost of the

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supplier, which in turn the buyer ends up paying.

IS0 9000 is not a product standard. It only concerns the way an organization goes about its work, and does not concern the result of this work. IS0 9000 is not a mandatory system nor is it a government regulation. However, it is a very important customer regulation. The development and adoption of this system of standards have been motivated by the need to provide assurance to the widest variety of customers about an organization 's quality assurance methods and management practices.

(a) Explain the term quality management system.

(b) Why is adanagement standard necessary?

4.3 COMPONENTS OF I S 0 9000

The IS0 9000 series of quality management system consists of six distinct standards. The first, I S 0 8402, is the terminology stanssrd. The next document is the 'IS0 9000 standard', which provides the basic concepts such as what is quality, what is meant by a quality policy, what is traceability, etc. This section explains four standards 9001, 9002, 9003 and 9004.

I S 0 9001 specifies quality system requirements for use where a contract between the supplier and the buyer requires the demonstration of the supplier's capability in designing and developing products or services,

Role of I S 0 and OSHA in Quality

Quality Systems production, installation and servicing. The requirements aim primarily at preventing nonconformity at each of these steps. Conformity means that there is an agreement between the desired specifications of customer and the produced item by manufacturer. A key role can be played here by statistical Quality Control methods. The documentation of quality management procedures used in the company is another important requirement.

IS0 9002 is used in a situation when only production and installation conformance is to be ensured. It is the appropriate standard for organizations that do not design and develop products. It requires demonstration of the supplier's ability to control the process that determines the acceptability of products supplied. The focus is on detecting any nonconformity during production and installation, and the implementation of the means to prevent the recurrence of nonconformity. Again, statistical Quality Control methods will play an important part here.

IS0 9003 is the least detailed standard and it only requires that conformance in final test and inspection be ensured. IS0 9003 is the appropriate standard for an organization whose business processes do not include design control, process control, purchasing or servicing. It focuses on inspection and testing to ensure that final products and services meet specified requirements.

IS0 9004 contains guidelines on the technical, administrative and human factors affecting the quality of products and services for internal use only. IS0 9004 describes the elements by which a company can develop good quality management systems and implement them. A quality system includes the organizational structure, responsibilities, procedures and resources for implementing quality management.

In the 1990s, IS0 9000 was increasingly criticized on the grounds that it did not really assure the delivery of a quality product or service since organizations could comply simply by demonstrating that they had consistently followed the procedures laid down in their quality manual. A review process resulted in the publication of IS0 9001 :2000. Three previous standards, IS0 9001,9002 and 9003 have been reduced to one standard, IS0 9001 :2000 for certification purposes. The twenty main elements of IS0 9000: 1994 were reduced to four main sections covering :

Management Responsibility

Resource Management

Product Realization

Measurement, Analysis and Improvement

The new family of quality management standards comprises three individual standards :

(i) IS0 9000:2000

(ii) IS0 900 1 :2000

(iii) IS0 9004:2000

IS0 9000:2000 is the logical starting point. It begins with an explanation of the overall approach to developing a quality management system. The main part of ISQ 9000:2000 is its comprehensive vocabulary section, which contains definitions of all the terms used in IS0 900 1 :2000 and IS0 9004:2000.

IS0 9001:2000 specifies the requirements for a quality management system that can be used for certification or contractual purposes. It could also be used internally as a sound basis for managing quality without ever having a system audited or assessed by any

external body. It is designed to facilitate assessment and is the standard to which one must demopstrate compliance if he wishes to be certified by an accredited assessment body.

I S 0 9004:2000 was developed to complement IS0 9001 :2000. IS0 9004:2000. It takes the organizations beyond IS0 9001 and should be viewed more as an advisory document than as, a specification. It is not intended to be used as a guideline for how to implement IS0 9001 :2000 but as a source of information, ideas and advice about how the organization can move beyond the requirements of IS0 9001 :2000.

4.4 BENEFITS OF I S 0 9000

Role of I S 0 and OSHA in Quality

The gains of an organization receiving IS0 9000 certification are numerous. First and foremost, the organization becomes sure of its own capabilities, its commitment to quality, assurance of consistency in quality, timely delivery, and the reduced incidence of product failure. Such an organization is accepted by most customers internationally. Several other benefits are 1isted.below.

Improvement in Business

Most companies implementing IS0 9000 report increases in business process efficiencies, reductions in waste, and improved product quality. The preparation for certification forces combing of most shop practices of the organization. This process streamlines operations which results in the measurement and control of waste, re-work, etc. This is the 'by-product' impact of implementing IS0 9000.

Simplified Purchasing Decisions

Working with an IS0 9000 accredited company greatly simplifies purchasing decisions. The customer saves time and money by eliminating numerous vendor assessments such as incoming inspections.

Qualify for New Customers

Many corporations see IS0 9000 certification as an essential requirement for conducting business with a new vendor. To enter global markets, IS0 9000 standards are required in many countries.

Educational Experience

It is a response of many organizations that the registration process is a very good educational experience and creator of teamwork. It allows employees to understand the overall work process and their roles in it.

Improved Image in Market

Industry studies indicate that an IS0 certified company experiences positive cultural changes, and increased productivity and efficiency. These changes encourage greater quality awareness with the effect that marketing positioning of the company is improved.

Competitive Tool

The competitive market created by the globalization of trade across continents has necessitated IS0 9000 certification. IS0 9000 facilitates mutual recognition of products legally produced in one country to be accepted in another country. This is possible due to a uniform technical specification.

Organizational Renovation

IS0 9000 is the way forward for an organization seeking renovation. IS0 9000 certification rids companies of numerous obsolete documentation and procedures. Instead, they have fool-proof systems of instrument calibration and excellent systems for traceability to troubleshoot customer problems.

- Quality Systems 4.5 REQUIREMENTS OF I S 0 9000-9004

The requirements of IS0 9060-are presented in sections 4 to 8 of IS0 900 1 :2000. In this section of the unit, the following cantents of IS0 9001 :2000 shall be discussed :

Systematic Requirements

Management Requirements

Resource Requirements '

Realization Requirments

Remedial Requirements

Systematic Requirements . - -- I

Establish Quality System

In order to establish a quality system, the tasks of development, implemeiltation and improvement are done in the following ways.

The processes that make up the quality system are identified and . quality management processes are described.

The quality management system (QMS) is implemented by use of quality system processes and managing process performance.

Process performance is continuously monitored to improve QMS.

Document the Quality System

This includes hveloping documents that reflect what the organization does. The tasks associated with preparing a document are as follows :

The operation procedures are documented in order to prepare a quai* system.

The proQesses of interaction between several activities and how they affect the operation of the organization are also documented.

' The correct version of documents is provided at points of use. Those documents that come from external sources are carefully ponitored

, and then integrated with the quality system records of organization.

Management Requirements-

Management requirements shall include the following :

Support Quality

The import&ce of quality can be focused by management by promoting the need to meet customer requirements and regulatory requirements. The personnel must be encouraged to meet quality system requirements.

-- . Establish a Quality Policy

When defining and documenting its quality policy, management should consider the following points:

The quality policy should be expressed in easy to understand language.

The quality policy should be relevant to the organization, its other policies, the products or services provided, and the organization's people.

The objectives should be ambitious and achievable.

Demonstrating Commitment Role of I S 0 and OSHA in Quality

The management should demonstrate commitment by activities such as :

Ensuring that concerned people understand the organization's quality policy.

Initiating, managing, and following up on the implementation of the quality policy, including implementation of the quality system.

Not accepting deviations from quality policy or wasted resources in any part or aspect of the organization.

Carry Out Quality Planning

The management should ensure that objectives are set for hnctional areas. They must take into account that objectives will facilitate product realization and that the objectives are measurable.

Control Quality System

In order to support the improvement of QMS, management representative must be appointed that reports status of the improvement and pace of activities. A proper communication channel must be established throughout the organization.

Perform Management Reviews

A management review is performed to evaluate whether the present quality system should be improved. The inputs required from a review can be gathered from information based on purchaser feedback, internal feedback (such as results of internal audits), process performance, and product (including services) performance. Based on these facts, management can generate review outputs to improve quality system. The quality system review process and the reasons behind it should be known and understood by the organization.

Resource Requirements

Supporting a quality system requires providing quality resources. The resources should be used by competent personnel with adequate experience. The various tasks associated with resource requirements are :

Delivering training and awareness programmes to achieve acceptable levels of competence and evaluating effectiveness of training.

Providing quality environment in order to ensure products requirements.

Providing quality infrastructure: This includes providing workspace, equipment, utilities, support services, hardware and software.

Realization Requirements

The tasks associated with planning the product realization processes include :

Control Realization Planning

This means identifying the needs and requirements of product realization, developing methods to control quality during product realization and documenting the process.

Control Customer Processes

It includes identifying customers' product requirements and reviewing requirements before accepting orders from customers. For this purpose, it is essential to develop a process to control communications with customers.

Quality Systems Control Product Development

There are several stages in product design and development phase. First and foremost, it is essential to clarify design and development responsibilities. Interactions between design and development groups need to be managed effectively. The changes in product design and development must be recorded. Equally essential is to perform product design and development verifications.

Control Purchasing Function

The purchased products must meet specified requirements. Equally important is to ensure that suppliers also meet requirements such as timely delivery and after sales services. The purchased products must be verified at the premises of organization and if required at the premises of the supplier.

Control Operational Activities

The factors that need to be kept in control during actual production are information, equipments and measurement activities. The proof of capability must be demonstrated by producing planned outputs through process equipments. In case property is supplied by customers it must be safeguarded properly. The products must be preserved during internal processing and final delivery.

Control Monitoring Devices

Choice of monitoring and measuring devices must meet the operation requirements. Periodic calibration is very essential. Moreover, devices must

I be protected from unauthorized adjustment and improper environment. Before using monitoring and measuring software, they must be properly validated.

Remedial Requirements

Remedial tasks are essential to assure conformity of products to requirements. They should be used to improve quality management system. The various methods of remedial procedures are:

Monitor and Measure Quality

This is the task of monitoring customer satisfaction by conducting surveys. Performing internal audits can help discover flaws that normally remain undeteqted. Prompt action must be taken when processes fail to achieve planned results.

1, Control Non-conforming products

The first task is to define how non-conforming products should be identifikd. Once detected, action must be taken to prevent the delivery or use of non-conformingproducts. After the events that led to a

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non-conforming product have been traced out, corrections must be initiated. A proof must be generated that corrected products now meet requirements. A record of non-conforming products must be maintained.

Make Quality Improvements

The information needed to improve the QMS are obtained from audits, quality policy, quality objectives, and management reviews. The corrective actions undertaken must prevent recurrence. For this purpose, it is essential that the effectiveness of actions be carefully examined and recorded.

The rest of the sections in I S 0 9000 deals withintroduction and vocabulary. I S 0 9002 is now obsolete and replaced by I S 0 9000:2000.-In the next section, the documentation procedure of IS0 shall be discussed in detail.

4.6 DOCUMENTATION FOR I S 0 9000 QMS

The implementation of IS0 9001 require an organization to "establish, document, implement, and maintain aquality management system and continually improve its effectiveness in accordance with the requirements of this International Standard". In the terminology of IS0 9001:2000, document refers to information and its supporting medium. The documents may be in the form of paper, magnetic, electronic or computer disc, photograph and master sample. The documentation includes :

A Quality Manual

This is a document specifying the quality management system of an organization. The quality policy and quality objectives are also mentioned in this manual. The format and structure of the manual is a decision for each organization, and.will depend on the size, culture and complexity of the organization. For example, a small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.

Documented Procedures

The International Standard specifically requires a "documented procedure". A procedure is a specified way to carry out an activity or a process. The procedure has to be established, documented, implemented and maintained. IS0 9001:2000 specifically requires the organization to have "documented procedures" for the following six activities :

(i) Control of documents

(ii) Control of records

(iii) Internal audit

(iv) Control of non-conforming product

(v) Corrective action

(vi) Preventive Action

Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, Internal audits).

Documents Needed by the Organization to Ensure Effective Planning, Operation and Control of its Processes

These include specifications in form of a document stating requirements. The Quality plans are documents specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract. Document control should include those documents, pertinent to design, purchasing, work execution, quality standards, inspection of materials and documents of suppliers. The supplier's documents are accompanied with materials. These are written procedures with all the contents that describe how documentation for these functions should be controlled, who is responsible for the control, what is to be controlled and where and when the control is to take place. Other than documented procedures, it may be necessary to develop other documents to demonstrate the effective implementation of its QMS.

Records

These are documents required by International Standard that state results achieved for providing evidence of activities performed. Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system. The records as required by ISO:9000 are :

Role of I S 0 and OSHA in Quality

Quality Systems Management ~ v i e w s .

. Education, training, skills and experience.

Evidence that the realization processes and resulting product fulfill requirements.

Results of design and development, verification and validation relating to product requi~ments.

Results of supplier evaluations and any necessary actions arising from the evaluations.

Customer property that is lost, damaged or otherwise found unsuitable for use.

Results of calibration and verification of measuring equipment. Validity of the previous measuring results when the measuring equipment is found not to conform to requirements. Basis used for calibration or verification of measuring equipment where no internatiorial or national measurement standards exist.

Internal audit results and follow-up actions.

Indication of the person(s) authorizing release of product.

Nature of the product non-conformities and any subsequent actions taken, including concessions obtained.

Results of corrective action as well as preventive action.

The IS0 9000 series of standards was revised last in 2000. IS0 900 1 :2000 has significantly reduced the documentation requirements and is much less rigid than the 1994 version of the standard. It allows an organization more flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. Following are some of the main objectives of an organization's documentation :

Communication of Infonmation

The documentation serves as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization's products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

Evidence of Conformity

The presence of documents is a mark of evidence that what was planned has actually been done.

Knowledge Sharing

Documentation is necessary to publicize and preserve the organization's experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

Simplified Set of standards

One of the most important objectives in the revision of the B O 9000 series of standards has been to develop a simplified set of standards to achieve the desired results of process activities of the organization.

Role of I S 0 and OSHA in Quality

While implementing IS0 9000, the changes in methods, practices, record keeping, etc., will be substantial. The effort and investment involved are generally large, but market conditions may not leave a company much of a choice. Implementation progresses through installing the task force, a review of the existing operations, developing the quality-~lanual, conducting internal audit, rectifying deficiencies, and obtaining the certification through third party assessment. The details of implementation may vary from company to company but the following steps are generally followed :

Exposure and Training

The first step in IS0 implementation is to conduct IS0 9000 and quality management familiarization sessions for everyone in the organization. This should be extended to familiarization with certified vendors. The attractive dissemination of the implementation plans if Quality System should be made known to all employees of the company. An IS0 9000 booklet for internal distribution serves many a purpose.

Developing the Company's Draft Quality Manual

In order to properly draft a quality manual, an internal study of all existing quality related systems and existing practices need to be carried out. This includes collection of all charts, records, reports, data sheets, related to the above documented practices.

Internal Audit of the Existing SystemsIPractices and Incorporating I S 0 9000

The auditing process involves the formation of task groups to study the important aspects of the IS0 9000 standards. Checklists are prepared to enable verification of existing practices with IS0 9000 standards as well as removing items or practices not conforming to IS0 9000. A revision of the quality manual and operating manuals is carried out to reflect changes.

Audit by the External Certifying Agency

After internal audit and necessary rectifications, company should deliver a complete quality manual to its chosen assessing agency. If agency is satisfied with the manual, it will respond with a questionnaire. After the questionnaire has been submitted back to the external agency, the inspectors from that agency will schedule a visit to audit the company's premises and system.

The implementation procedure for IS0 9000 depends upon the state of QMS existing in the organization. Basically three types of such organizations exist :

Organizations Preparing to Implement a QMS

For organizations that are in the process of implementing or have yet to implement a QMS, the IS0 9001 :2000 emphasizes aprocess approach. This includes :

Identifying the processes necessary for the effective implementation of the quality management system.

Understanding the interactions between these processes.

Documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of IS0 9001 :2000.)

Organizations Wishing to Adapt an Existing QMS

Some organizations might have been certified as IS0 9001 according to 1994 requirements. In order to facilitate transition to IS0 9000:2000, the organization need to incorporate some modifications. These are :

Quality Systems An organization with an existing QMS should not need to rewrite all of its documentation in order to meet the requirements of IS0 9001 :2000. This is particularly true if its QMS is based on a process approach. In this case, the existing documentation may be adequate and can be simply referenced in the revised quality manual.

An organization that has not used a process approach in the past will need to pay particular attention to the definition of its processes, their sequence and interaction. Because IS0 900k2000 is less prescriptive than the 1994 versions of the standard, an organization may be able to cany out some simplification of existing documents, in order to simplify its QMS.

Organizations Wishing to Demonstrate Conformity with IS0 9001:2000

For organizations wishing to demonstrate conformity with the requirements of IS0 900 1 :2000, for the purposes of certificationlregistration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS. In order to claim conformity with IS0 9001 :2000, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. "Objective Evidence" refers to "data supporting the existence or verification of something" which may be obtained through observation, measurement, test, or other means. Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, it is acceptable for this activity to be conducted using as a basis the relevant clause of IS0 9001 :2000. In these situations, both internal and external audits may use the text of IS0 9001 :2000 for the purposes of conformity assessment.

SAQ 2

(a) List down five major benefits of implementing IS0 9000.

(b) What are the different types of documents required for IS0 9000 certification?

(c) Explain the generally required steps for implementing IS0 9000.

4.8 NEED FOR SAFETY AND HEALTH IN INDUSTRY

It has been observed that a lot of industrial accidents occur due to a lack of safety awareness. Job-related accidents also occur due to unsafe conditions of operation. Often such negligence results in loss of human life or disable a healthy worker. In fact, statisticians have calculated that person-days lost from job-related disabilities are ten times of loss due to strikes. Apart from negligence on this matter in the industry, the . protection of workers from risks related to exposure to chemical, physical and biological agents are not guaranteed. This is commonly observed in industries of developing nations. For example, in small fabrication industries, spray painting workers are not provided with protective equipments such as air masks, gloves and eye-protection glasses. Negligence from the worker is a persistent problem although it is the duty of supervisor in the shop floor to understand that safety is a practice of good management. Excessive working hours in the shop floor, inadequate rest or disruptive working patterns cause adverse effects on the health of the workers. Today, several institutes are creating databases of occupational diseases arising from problems and trends in working life and

making them available to public. In absence of a safety effort, all lost production and ole of ISO and

wages, medical expenses and disability compensation are directly subtracted from OSHA in Quality

profits. In 1970, the Occupational Safety and Health Act was passed by United States Congress to set mandatory occupational safety and health standards applicable to industries. Under the Act, Occupational Safety and Health Administration (OSHA) was set up within the Department of Labor to :

encourage employers and employees to reduce workplace hazards and to implement new or improve existing safety and health programs,

erovide for research in occupational safety and health to develop innovative ways of dealing with occupational safety and health problems,

establish "separate but dependent responsibilities and rights" for employers and employees for the achieveqent of better safety and health conditions,

maintain a reporting and record keeping system to monitor job-related injuries and illnesses,

establish training programs to increase the number and competence of occupational safety and health personnel,

develop mandatory job safety and health standards and enforce them effectively, and - provide for the development, analysis, evaluation and approval of state occupational safety and health programs.

OSHA safety standards are designed to reduce on-the-job injuries; health standards to limit workers' risk of developing occupational disease. Most OSHA standards cover hazards which exist in a wide variety of industries. These are compiled as the OSHA General Industry standards, OSHA construction standards, OSHA agriculture standards, and OSHA maritime sectors standards. In general the OSHA s;andar,ds fall into the following four categories :

Specification Standards ,

Specific proportions, locations and warning symbols for signs to be displayed.

Performance Standards

The minimum and maximum limits of achievements are specified.

Particular Standards (Vertical)

The standards relating to particular industry for individual operations.

General Standards (Horizontal)

Standards related to workplace spe~ifying environmental control, walking surface, . exits, illumination etc.

4.8.1 Benefits arising from OSHA

The gains resulting from good safety and health efforts help form good community relations, lower employee absenteeism, better employee morale, and steadier work. Employers can expect OSHA to :

help them identify and control workplace hazards, and

focus agency inspections ofl the most significant hazards in dangerous workplaces. The nuclear industry is one such area where hazards from radiation exposure are a threat to every worker.

Employees can expect OSHA to :

promote employee participation in the development and implementation of worksite safety and health programs and in OSHA interventions such as work~lace ins~ections,

Quality Systems respond promptly to employee's request for correction of serious hazards at workplaces, and

advise employees of their safety and health rights and responsibilities, and complete investigations within 90 days for those employees who believe they have been discriminated for exercising their rights to requests or participation in inspections.

The general public can expect OSHA to :

make regulations and interpretations user-friendly,

work in partnership with business and labor to develop new standards that make real sense to real people,

expand training opportunities for private sector employees, and

provide better access to OSHA information through publications and online materials.

To prevent accidents and occupational ill-health, rules have to be enforced, safe and hygienic work conditions should be developed and workers should be trained to do the job safely. Any safety programme will be ineffective without first creating a proper safety philosophy, teaching safety principles, and eliminating misconceptions about the causes of accidents. In the next section, the tools devised by OSHA to assess an effective safety and health program shall be discussed.

4.9 SAFETY APPROACHES AND SAFETY MANAGEMENT

It is generally considered that safety awareness can be developed by having meetings, posters, safety booklets, special classroom sessions, etc. Though theoretically it seems correct that these training techniques should make employees judge what is an unsafe practice and what is not, experimental study shows that this mass educational methods fail to apply to the actual work situations. The existing rules of safety practices in most industries do not cover individual risks. In general, the following points are essential to evaluate the effectiveness of safety practices :

The Perception of Employees of the Rules : The employee must appreciate the new safety rules and must not think that the rules were imposed from above.

Keeping Pace : Safety rules should keep pace with changes in technology, work schedules and emergency situations.

Safety rules should not cause unnecessary inconvenience to the employees. At least, the worker must not be womed of meeting safety measures in lieu of the actual assigned work.

Safety rules should be objective in nature, i.e. the rules should not be broad or very general having no real meaning to empfoyees.

4.9.1 Methods and Tools for Assessing Effectiveness Safety and Health Program

OSHA states three basic methods for assessing safety and health program effectiveness :

Checking Documentation of Activity

The checking of documented manuals can also be used to determine the quality of certain activities, such as self-inspections. These inspection.yecords can reveal the evaluator whether serious hazards are being found, or whether the same hazards are being found repeatedly. If certain hazards recur repeatedly after being corrected, someone is not taking responsibility for keeping those hazards under

control. Either the responsibility is not clear, or those who are responsible are not being held accountable.

Interviewing Employees at all Levels for Knowledge, Awareness, and Perceptions

Talking to randomly selected employees at all levels will provide a good indication of the quality of employee training and of employee perceptions of the program. If safety and health training is effective, employees will be able to relate about the hazards they work with and how they protect themselves and others by keeping those hazards controlled. Every employee should also be able to say precisely what he is expected to do as part of the program.

Reviewing Site Conditions and Root Causes of Hazards

Looking at site conditions and practices is a well established technique for assessing the effectiveness of safety and health programs. Examining the conditions of the workplace can reveal existing hazards. It can also provide information about the breakdown of the management systems meant to prevent or control these hazards. Another way to obtain information about safety and health program management is through root analysis of observed hazards. This approach to hazards is much like the most sophisticated accident investigation techniques, in which many contributing factors are located and corrected or controlled.

The tools used by OSHA for assessments of safety and health programs are :

(i) Management leadership and employee involvement.

(ii) Worksite analysis.

(iii) Hazard prevention and control.

(iv) Safety and health training.

In the following sub-sections, we shall see how the method of documentation, interviews and site condition reviews are utilized with the help of these tools.

Assessing the Key Components of Leadership, Participation, and Accountability

Worksite Policy on Safe and Healthful Working Conditions

The review of documented policies can help the investigator from OSHA to separate the priority of worker safety and health over organizational values such as production. Interview with employees can reveal if the written policy is visible in work, and whether they are treated as a resource more valuable than production quantities. Previous records on hazards reveal if the employees did not understand the importance of safety precautions.

Visible Top Management Leadership

Documents cover all written programs which involve top-level management in safety and health activities. For example, top management can receive and approve on inspection reports either after each inspection or in a quarterly summary. These reports can then be posted for employees to see. Top management can provide time once in a week or a month for employees to come in to discuss safety and health concerns. Such a document is a valuable resource to prove the management initiatives on safety. Interview with employees can give further proof of the managers' involvement with safety, such as wearing personal protective equipment when in shop floor.

Employee Participation

The presence of employee inspection reports, minutes of joint employee-management or written guarantees of employee protection from harassment resulting from safety and health program involvement are a proof of employee participation in decisions affecting their safety and health. If employees are not comfortable during an interview regarding their

Role of I S 0 and OSHA in Quality

Quality Systems participation, it is a clear indication that employees do not count safety measures as an achievement.

Accountability of Managers, Supervisors, and Hourly Employees

Documented evidence of employees being held accountable for safety and health responsibilities, including safe work practices is a substantial proof that managers and supervisors include importance relating to safety and health protection. If the employee responds that managers do not follow rules the complaints against supervisors regarding safety precautions are justified. The cause of the hazards might be because managers are not being held accountable for the safety of employees.

Assessing the Key Components of Worksite Analysis

Comprehensive Surveys, Change Analysis, Routine Hazard Analysis

Checking documents provide comprehensive analysis of all potential hazards on work site, new facility, equipment, material, or process and the means for eliminating or controlling such hazards. In case of nuclear power, documents that discuss the potential hazards such as nuclear leak must exist.

Reporting of Hazardr by Employees

Employees must know whom to contact and what to do if they see something they believe to be hazardous for themselves or for their coworkers. Such information can be collected through interviews.

Assessing the Key Components of Hazard Prevention and Control

Documents related to inspection are a proof that vigilant action is taken to prevent avoidable hazards. Such documents also contain information of the corrective action taken. If the contents also state that by inspection the management discovered a potential hazard in an unlikely area, it is a further proof of good safety practice. This provides the inspectors to evaluate the appropriateness of corrective actions.

Assessing the Key Components of Safety and Health Training

An interview on general safety with the employees is a quick indicator of the safety practices in the organization. Regular training has to be provided to workers on health and safety. From time to time, their awareness about health and safety measures has to be asbessed.

The IS0 14000 is a set of standards concerning the ways in which an organization's activities affect the environment throughout the life of its products. These activities range from production to ultimate disposal of the product. It includes effects on the environment such as pollution, waste generation, noise, depletion of natural resources and energy use. At present, many countries and regional groupings are generating their own requirements for environmental issues, and these vary between the groups. The existence of the standards will ensure that there are no conflicts between regional interpretations of good environmental practices. The IS0 14000 specifies that an Environmental Policy, fully supported by senior management must exist. The IS0 14000 standards are designed to cover environmental management systems, environmental auditing, environmental performance evaluation, environmental labeling and life-cycle assessment. It requires that the environmental policies of the company should be brought to the notice of not only staff but also to the public.

The key aspects of IS0 14000 are that it is voluntary and flexible. It pushes continual improvement, encourages cost saving by integrating environmental requirements into the overall company systems (design, manufacturing, etc.) and can provide a substantial market advantage. A primary component of the IS0 14000 standard, as mentioned earlier, is the "Environmental Policy" which must be defined by an organization's top management. These environmental policies must include a commitment to both compliance with environmental laws and company policies, continual improvement and prevention of pollution. A system is then created (or if already existing, documented) which ensures that the environmental policy is carried out by the organization. This involves planning, implementation and operations, checking and corrective action, and management review.

SAQ 3

(a) Explain how OSHA safety standards are beneficial to the employer, employee and community.

(b) Write a short note on IS014000.

4.11 SUMMARY

In this unit, the I S 0 9000 family of standards is introduced as the world-wide accepted quality standard. The various requirements of implementing a quality management system are discussed in detail. The practice of documentation is very important in establishing IS0 standards. Health and safety are integral part of total quality management. Organizations like OSHA are in the forefront of guiding the management as well as worker community for occupational safety and health practices. The recent years have also seen a growing concern for environment issues and the impact of industries through their products directly or indirectly. The IS0 14000 was formulated to bring a uniform conduct in good environmental practices.

4.12 KEY WORDS

Role of I S 0 and OSHA in Quality

Document

Generic

: In the terminology of IS0 9000, document refers to information and its supporting medium in the form of paper, magnetic tape, computer disc, photograph, etc.

: The term generic with respect to a quality standard means that the same standards can be applied to any organization, whatever its product, including service in any sector of activity.

: IS0 is the word that represents the International Organization for Standardization, which frames various sets of quality policies that are to be followed by an organization.

: IS0 9000 is concerned with "quality management". This means what the organization does to enhance customer satisfaction.

Quality Systems I s 0 14000

OSHA

Management System Standards :

Quality Management

Quality Management System :

Record

IS0 14000 is concerned with "environmental management". This means what the organization does to minimize harmful effects on the environment caused by its activities.

Occupational Safety and Health Administration is an active body in USA, authorized to assure safe and healthful working conditions for every worker in the industry.

A management system standard provides the organization with a model to follow in setting up ,

and operating the management system.

It is that aspect of the company's overall management function that determines and implements the company's quality policy.

The quality management system standards of the revised IS0 9000:2000 series contains the principles that can be used by senior management as a framework to guide their organizations towards improved performance.

A record is any document required by International Standard that states results achieved for providing evidence of activities performed.

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4.13 ANSWERS TO SAQs

Please refer the preceding text for Answers to SAQs.

FURTHER READING

Crosby, Phillip B., 2001, Quality Without Tears, New York, McGraw Hill Book Company.

Henley, Esnest J. and Hiromitsu Kumamoto., 1999, Reliability Engineering and Risk Assessment, Englewood Cliff, N. J., Prentice Hall, Inc.

Jwcan Jospeh, M (ed.), 2000, Quality Control Handbook, 31d, New York, McGraw Hill Book Company.

L. Grant Eugene, S. Leavenworth Richard, 1990, Statistical Quality Control, McGraw Hill Book Company.

Oakland S. John, 2000, Total Quality Management, Butterwort-Heinemann.

Ishikawa, K. 1995, What is Total Quality Control? The Japanese Way, Prentice-Hall, Englewood Cliffs, N. J. (USA).

Ryan, Thomas P., 1989, Statistical Methods for Quality Improvement, New York, Wiley.

Banks, Jeny, 1989, Principle of Quality Control, New York, Wiley.

Bounds, Greg, Lyle Yorks, Mel Adams and Gipsie Ranney, 1990, Beyond Total Quality Management : Towards the Engineering Paradigm, New York : McGraw Hill Book Company.

Denton D., Keity, 1989, Quality Service, Houston, Gulf Publishing Company.

Juran, Joseph M., 1988m Juran on Planning for Quality, New York, Free Press.