\ .---Y"~SEM EI~E - TQM UNIT-5 - Ql1ALlTY SYSTEMS .

9ucstion~ & Answers

Part A

1. Briefly describe the purpose of an ISO 9000qualitysystcm. / What are objectives of QS9000? (What is a Quality system" Why are Quality Systems Ileeded" What is tht.~role of Quality standards'?) When an Org~nization wants to implement TQM, one of the ways is ISO 9000 quality system. The six principles ofTQM viz., top management commitment, Customer Satisfaction. Employee involvement, Continuous process improvement, supplier partnershi'p, performance measures were covered through the eight clauses of ISO 9000: 2090 quality system ... ~lodel ofagioce~s-based Quality Management System can be shown as

5. Managem.enl
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There The prim.!~~a,sqn is implementing quality system demanding to an ISO standard. are. vaijc1)u~L~sons for that customers aor marketing arethat conforms compliance to a qual~tisystenW0th~r reas~ns are needed 5mprovements in processes or systems and a desire for global dep19yment of prog:j.lctsand services. 2. What are the . .benefits of IS0900? ~. ~ In order to'maintain or increase marke~' ;.e, many organizations are,finding er internal benefits are they must be in conf~rmance with an ISO stand' ._ To improve internal quality which is m~asure,. y :the p~rcent of scrap, rework, and nonconformities at final inspection.
. . .

To increase production reliability that is measured by the number of breakdowns per month, percent of time dedicated to emergencies, and percent of downtime per shift. To improve extemal quality that is measured by product accepted by customers without inspections, claims of nonconforming product, and returned product. To improve time perfonnance that is measured by time to market, on-time delivery, and throughput time. To reduce cost 'of poor quality that is measured by external nonconformities, and rework. scrap,

\Vhile practicing the above quality systems prevention and appraisal costs are increased.

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hat is a quality policy statement'?

<ft.\ ..t.. policy statement is ~l Iuide for ~\"eryon~ in the orgnniza~ion by the ~ ~~rovldc ~.qllalit.y products and service to the cllstomers. It should be wntten as to how c..li.-Qvilh feedback from the work force and be approved by the quality council. Common characteristics are Quality is first among equals. Meet the needs of the internal and external customers, Equal or exceed the competition. Continually improve the quality. Top management shall insure that the quality policy (a) is appropriate to the organization's purpose or mission, (b) includes a commitment to comply with requirements and continually improve the effectiveness of the QMS, (c) provides a framework for establishing and reviewing the quality objectives, (d) is communicated and understood within the organization, and (e) is reviewed for continuing-'Stability. The quality policy gives the overall intention and direction of the organization related to quality .. .t. Diffcl"cntiatc bctwccn document & re~r':d' ,.~. Docume!lts are relatively longer life::peribd statements like 'Wality policy, q~Iality manual, and procedures to ensure effecti~e planning, operation, and control of .. . processes. Documents can be reviewed, updated, and re,:apptoye4~. Records shall be established and maintained to pnh'ide evidence of conformity to requirements and the effective operation of the OMS. They shall be legible, readily .identifiable, and retrievable. Controls needed for the.'f~.entification, storage, protection, retrieval, retention time, and disposition of records. Records can be. used to document traceability and to provide evidence of verification, preventive action, and corrective ) . action.(eg) plant operator log book. For example your degree certificate is a dq~urnent to be kept for a life long period. It can be upda\.ed with postgraduate deg~~~~,~d will stan.da~ eyidence for your commitment towards continual improvement. ~~t#f'communication received from the college with your unit ttst ma~ks is a record. It WiUbe useful; in that semester for verifying your sessional marks, at end of the semester. So it will be retained for that semester and disposed., '
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5. What is the pur~,?:~'\),~JP.scopeofISO 14000 standards?

The ISO 14000 Is:~~Vm)l1mental management system or EMS. EMS IS part of a comprehensive m'!Jlagemenfsystem that addresses how the o'lerall business activities, including its product~ and services, impact the environment.The EMS maximizes company participation in environmental performance now and in the future.

6. Explain the environment management systems model

Environmental Management System Model is given below.!t begins with the environmental policy, which is followed by planning, implementation and operation, checking and corrective action, and management review. The approach follows the PDSA cycle. There is a logical sequence of events to achieve continual improvement. Many of the require~nents may be developed ,concurrently or revisited at any time. The overall aim is to support environmental protection and prevention of pollution in balance I with socioeconomic needs.

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7. Define the following: :>;: ' Environment is defliied as the global surroundings in which an ()rganization

operates and include~",ai,r,. water, land, natural resources, flora, fauna, humans, and their interaction.,)"'::.,,, . Envir'i;i:;i'inental spect is define9 as an element of an organization's activities, a products. or sen;ices -'hiaf carl interCfctwi'~hthe environment. Exampks are wastewater dispb8;fge.pi;temissions, .. aI).ddnergyusage: ' ',' ' " ' , "',' ,-' , EnviI;Qn,me,ntal'impr;i'ct defined as any change, w~~ther adverse or beneficial, is wholly or partially resulting from an o~ganization's activities, products, or services. Exan1pl~sare impactsvsm'habi-~at, waf~r supply, and soil.erosion.' .. " Environmental ob)~(:tive ,IS 'an' overall envIronmental goal, ansmg from the
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policy statement, that an 6x:~~tion '~ets for 'itself and which quantified when practical. They,.defin~ howtl.t~fi'JY ;wUlbe achie'ved. For example,isan objective could ~asteVfater effluent. ' be to control th~ temp~ratUre Environmental target isfa detailed .perfonnance requirement and should be

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example the w(;lStewa~er temperature to be'me~',. ,l~~d Detwern 10 the objective. quantified w.' pni:c.ticaLIt needs should be eo;' \"~Id,.er.to achieve C and 14~ C. For hen ~ " PartB ... ,c'"
8. [i] Describe the four tiers of quality documentafi\on", [8] The system documentation can be viewed as a hierarchy containing four tiers, as .
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shown in following Figure. All documentation moves from o\nelevel to the next in a descending order. If the system is properly structured, changes at one level will seldom

alTcct the levels above it, but may affect tl~ose helm\'.
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Procedures WHEN WHERE

Work Instructions or Practices

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Policy : Th~ first tier of documentation is the poJicy manual. This is the document that defines what will be done and why. A quality policy manual ,should be written sO'it is clear, preci:;e, practical, and easy to understand. The whycal} be stated ju;:;tonce as a quality poli.:y statement. This, statement should be a:sho~, SImple definition of the , organizatio'l's quality intentions. For example: ',' "Quality is~he responsibility of each Tempset employee. We pledge to continuously prqvide products and services that meet or exceed custoJller expectations." 'Th.: remainder of the policy manual addresses w!1at will be done to comply with the staridarJbeing used. Another way of looking ,at the PQlicy manual is to think of it as thecommaadments of the system. Each element,',qfthe standard is addressed individually "j{r/'~~, , ", ,. , anci'usually 'requires one page or less. Procedure The second tier of documentaH6;91i~:me quality procedures. These procedures describe methods that will t,be used to'implement and perform the sfated . ........ , policies. T;le procedures define}Vh9 should perform specific tasks; when the task should w be done, ill td here docurI\yt!~a..~ioh ill be made showillg that-the task was performed. 5 Procedure'; should be 6ja-a~~tl 6 that they apply to all areas within the organization. <re~:f"'" " They dictate strategies th'at will be used to ensure the quality of the system. Procedures are more d.;:tarIed than the policies; however, they, too, should be written in a manner that will allow for easy understmrding. It should be noted tl:1atprocedures are not required for all, elemer..l:s.Many organizations combine the policy and procedures into one document. A procedure is needed if its absence would adversely affect the activity. Work Instructions: Work instructions are usmilly department, machine, task, or product oriented and spells out how a job will be done. These instructions are the most detailed of the documentation hierarchy. A work instruction' may be in the form of a detailed drawing, recipe, routing sheet, speci;fic job function (for example, turn nut four turns clockwise), photograph, video, or simply a sample for comparison of conformity. The employee who performs the task best carries out the writing of a work instruction. This person knows the process and the problems encountered in that process. However, a documentation specialist may be needed to do the actual writing. This method also creates a pride of ownership in the document, making it more likely to be carried out. Additionally, employee participation helps to ensure that future improvements will be

suggested. Not every task requires a work instruction. For example, you don't need to tell a computer specialist to turn on the PC., Records: R~cords are a way of documenting that the policies. procedures, and work illstrll~tions have been followed. Records may be forms that are lilled out, a stamp of approval on a product. or a signature and date on some typ~ of document, such as a routing sheet. Records are used to provide traceability of actions taken on a specific product or batch of products. They provide data for corrective action and a way of recalling products, if necessary. (8] (What is quality 9. Describe how a two-party audit system works auditing? Explain various types~of quality audits) (Multiple types of audits: environmental, quality, securitY'\fnd workplace safety)(Describe how the ISO auditing system works) (What is a Quality Auditing? Explain the process of ,auditing Quality Systems?) " 'In a two-partyiintemal audit system, the supplier of a product or service wou,ld develop a quality system that conformed to the standards. The customers would then audit th system for acceptability. There are five objectives of the two.:.party/mternal audit. They are to: Determine that acttialperformance 'conforms to the documented QMS. Initiate corrective actiona;ctivities in response !todeficiencies .. Follow up on noncompliance items from previous audits.' ",' ", Prov~de ~ontinued improvement inlthe system through feedback to management. Cause the 'auditee to think about th~ process, thereby encou:aging 'possible improvements.:
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Qualified indivitluals ,wpo have received training in c.uditifigptincipJes ,and procedures should performaudt!~~~l:{",'~.,": To be able to audi~~1~J5JY,~,individual shOuld possess good written and oral communication skills, be a;gi'd listener, and be good at taking notes. Other skills should include the a\Jility to concentrate on .th~\task at hand and not be distracted by other activities thataret*ing place at the same time, be,o~~~r,yant and questioning, and be able to separate The auditor should be objective, honest, arl-d:1-'fupat1ial. course, the auditor relevant 'facts from other information. Of should be prepared by being knowledgeable about the standards. \ Techniques . \ , During the actual audit, there are a [lumber oftechniques'that the auditor should employ. The objective is to collect evidence, and there are three methods: examination of documents, observation of activities, and interviews. The easiest method is to examine the documents. The auditor should start with the quality manual to determine that the policies cover the QMS standards, and that they are controlled and assessable. Next, the documents are examined in a systematic manner. For example,'the auditor would check the purchase orders to determine whether they were accurate and followed the procedures; all appropriate attachments were present; all orders were numbered, signed, and dated; only approved suppliers were used; and'so forth. Document control ensures that (1) documents are identified with a title, revision date, and responsible ownei; (2) documents are readily available to users; (3) a master list

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and records is appropriately and (5) changes follow a prescribed

located; (4) there are no obsolete documents procedure. Observation to evaluate

of activities is also an easy method that requires an aptitude for detail. For example. the reservation of product element the auditor would observe the identification.

handling. packaging,

storage. and protection

of the product. is by interviewing the employee or auditee,

The most difficult method of collecting

evidence

The interview should be done in non threatening

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little time as possible talking. Focus on the system, discuss the major issues. The auditor's job is to identify problems understands and allow the organization to determine solutions. Be sure that the auditee

the problem, agrees that it is a problem, and agrees that corrective action is necessary

Procedure
Before the audit takes I?laee, an audit plan and checklist should be prepared by the lead auditor. The audit itscJfhas During three parts, the pre audit meeting, the audit, and a ci-asing meeting. audit process, time table are discussed and recorded as the

the pre audit meeting

minutes of meeting and included meeting is recorded in the minutes. The object increased of the auditing

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The audit findings should be written out in detail from include the conforming as well as the nonconforming

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At the closing meeting, the lead auditor presents a summary of the audit findings along with the evidence that supports them.

Briefly explain the eight clauses / elements of ISO 9000 standard.

(16)
Quality Product that an

The standard has eight clauses: Scope, Normative References, Definitions, Management Systems. Management Responsibility, Resource Management, and/or Service Realization, and Measurement, Analysis, and Improvement. The first three clauses are for information while the last five are requirements organizatioil must meet.

4. Quality Management

System (QMS)

4.1 General requirements 4.2 Documentation, 4.2.1 General, 4.2.2 Quality Manual, 4.2.3 Control of Documents, 4.2.4 Control of Records, A quality manual shall be established and maintained. The QMS has to be documented in such a way continual improvement is ever achieved in the organization.

5. Management Responsibility Top management shall provide evidence of its commitment to the development, implementation, and continual improvement of the QMS by (a) communicating the need to meet customer, legal, and regulatory expectations (5.2) (b) establishing a quality poliey (5.3) (c) ensuring that quality objectives are established (5.4) (d) eonducting management reviews (5.5,5.6) and (e) ensuring the availability of resources. Management Representative (5.5.2) Top management shall appoint a member of management, regardless of his/her other duties, that shall have the responsibility and authority. 6. Resource Management 6.1 Provision of Resources: Resources may be people (6.2), infrastruewre (6.3), work environment (6.4), information, suppliers, natural resources, and financial resources. Resources can be aligned with quality objectives. 7. Product Realization 7.1 Planning of Product Realization: The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of QMS. 7.2 Customer-Related Processes 7.3 Design and Development - During the design and development planning, the organization shall dl:termine (a) the design and development stages, (b) the review, verification and validation that are appropriate to each design and development stage, and (c) the responsibilities andauthorities for design and development. 7.4 Purchasing, 7.5 Production and Service Provision, 7.6 Control Of Monitoring And Measuring Devices N. Measurement, Analysis, and Improvement' S.l General The organization shall plan and implement the monitoring, measurement, analysis, and The improvement processes needed (a) to demonstrate conformity of the product, (b) to .I:nsure conformity of the QMS, and (c) to continually improve the effeetiveness of the QMS. This shall include determination of applicable methods, including statistical techniques, and the extent of their use. 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction As one of the measurements of the performance of the QMS, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined .. 8.2.2 Internal Audit, 8.2.3 Monitoring and Measurement of Processes The organization shall "apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. 8.2.4' Monitoring and Measurement of Product and Service: The organization shall monitor and measum the characteristics of the product to verify that product requirements have been mct.

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8.3 CONTROL ~F ~ONCO~FORMI~G PI~ODli~T . The orgamzatlon shall ensure thalt product which do~s 110tcontorm to product r~q\liren}ents is identitied and c~)l1trolled,to prevent its unint~nded use or delivery. The controls and rdated responsibili\ies and duthortties fix dealing with nonconforming product shall be defined in a doc\unent p~ocedt.,lre. ANALYSIS OF DATA \ , ; The organization shall det~ine: collect, and analyze appropriate data to demonstrate the suitability and eff~9tive~ess of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. This shall include data generated as a result of monitoring and rpeasurement and from other relevant sources. The analysis of data shall provide inforr~lation,relating to (a) customer satisfaction, (b) confomiity to'product requirements, (c) characteristics and trends of processes and products, including opportunities for pr~ventive action. and (d) suppliers. 8.5 IMPROVEMENT :' 8.5.1 CQntinuallmprovement The"prganization shall continually improve the etTectiveness ofthe QMS through the~u~e of the quality policy, quality objectives, audit "results, analysis of data, correctiv~:and preve~tive actions, an::!management review. , 8.5.2 Corrective Actio The organization shall take action to eliminate the cause of non804

confonnities in order to prevent recurr9nce: Corrective actions shall be appropriate to the et'fects of the nonconfonnities. encountered. A documented procedure shall be established to define requirements for (a)'reviewin~ nom~onfomlities (including customer complaints), (b) detennining ~he causes of~lOnconformities, (c) evaluating the need for action to ensure that nonconformities do not ~ecur, (d) determining and implem~nting action needed, (e) records of the results of ac90n taken, and (t) reviewing corre~tive action 'J, j, ",,',' taken. 8.5.3 Preventive Action The org~niz~tion shall determinG action ~o eliminate.;the causes of potential nonconfonnities in.,()~#tJo prevent. their occurrence. Preyentive',actions shall be appropriate to the effects Q:tlii~~p:6t~ntialproblems. A documented procedure shall be established to define requireme~t#~or{a) 'detenn'ining potential nonconfomiities and their causes, (b) evaluating the need [o'r action to prev~nt occurrence of non tonformities, (c) determining and irnpleJ;l1entingaction needed, (d) reco~ds of results of action takep, and (e) reviewing preventive taken taken. Preventive ,:.~~)s while corrective action is action to prevent reoccurreh:c'e. taken to prevent occurtence Eight total quality mnnagement principles form the basis for the QMS standards. They are customer focus, leadership, emptpyee involvement, process approach, system approach to management, continual improvement, factual approach to decision-making, and mutually beneficial supplier relationships. These principles are similar to the core values of the Malcolm Baldrige National Quality Award.

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11. Explain the steps involved in obtaining ISO 9000 Certificate. (Explain the steps involved in getting ISO 9000-20000 certificate with the help of a case study. Take ssnce as example and explain) Steps involved in obtaining ISO 9000 Certificate 1. Top Management Commitment

The most important step in imp:knH.:nitinga quality system that will meet or exceed an ISO 9000 sltmdard is to acqtlirc the full support of t!pper management. The s;hief executive officer (CEO) must be ~villing to commit the resources necessary to achieve certification. This is critical to ithe success of the project. Without the CEO's support, the process may continuously ,run in~o unnecessary roadblocks or even be doomed to failure. Because top management 'is assigned specific responsibilities in the standard, it is necessary that theybe inyolved in its implementation. 2. Appoint the Management Reprcscntati~c Once the commitment has been l;nade, the process can proceed by adopting a project tearn approach and treating it the same as any other business undertaking. The next step is the appointment of a management representative. This person is responsible for coordinating the implementation and maintenance of the quality system and is the contact person for all parties involved in the process, both internal and external. The representative can be a member of the top management group who is able ' to ensure that , the quaHty system' is effectively implemented, documented, and maintained. The implementation of the quality system should ir.volve everyone in the organization. 3. Awareness" ... ,,;' This step requires an awareness program. Because the process is going to affect every member ofthe':orgariization as well as require their input, it stands to reason that evetyone should understand the quality system. They should know how it would affect day-to- day operations and the potential benefits. This information can b~ relayed through short, one-hour awar~ness training sessions. Be sure everyone knows the intent of the, standard. At the Cleveland Center for Joint Reconstruction, staff buy-in didn't happen' until they realized that the new system would allow them to make a difference in their '. day-to-day activities. 4. Appoint an Implementation T~am After everyone has-,beeij'!i~fo.i]i,1ed;oftheorganization's intentions to develop the quality system, an implementailBf\*-e~~ shoulclbe assembkd. This team should be drawn from all levels and areas oftheo,rgafiization so that it is representative. Committees for each of the five clauses may be used. The team should identifY the QMS processes fUld ' their sequence and interaction. It is impOJ;tantto keep J~~project visible for all employees. " ,':}'ii. 5. Training The implementation team, supervisors, and internal audit tearn should be trained. This activity can be accomplished by sending team leaders for training and having them train the other team members or by bringing the training in-house for all team members I through a one or two-day seminar. 6. Time Schedule This activity develops a time schedule for the implementation and registration of the system. This time frame will vary, depending on the size and type of organization and the extent of its existing quality system. Most organizations can complete the entire process in less than 1.5 years. 7. Select Element Owners The implementation team selects owners for each of the system elements. Many of these owners will be members of the implementation team. Owners may be assigned more than one element. Each owner has the option of selecting a tearn to assist in the proces~. The more people involved, the more effective the system.

, 8. Review the Prcscnt Systcm I'errortll a review or lhe present quality system. Copies of all thl: quality manuals. procedures, work instructions, and torms presently in use are obtained. These documents are sorted into the system elcments,to determine what is available and what is needed to complete the system. This activity is a gap analysis and can be performed by the clement owners ancl their teams or by an external consultant. 9. 'Write the Documents Prepare written quality policy ancl procedure nufnuals-they cml be combined into one document. Write apprOpriate work instructions to maintain the quality of specific functions. This process should involve every employee, because the best person to write a work instruction is the one who performs the job on a regular basis: 10. Install new system ' ,', Integrate the policies, procedures. and work instructions into' the day-to-day workings of the organization, and document what is being done. It is not necessary for all elements to be implemented at the. same time. ,Be sure all people are trained: , 11. Internal Audit ,:(:' Conduct tul internal audit of the quality sys.t~ll1.This st~pisnecessary to ensure that the system is working effectively and to provide mtula.g~p1~tltwithinformatio~ for thecomprehensive mtulagement review. Minor correctioris'to'thesystem are made' astlrey ~ occur. A cross-section of trained peaple s,hould beuse9for the audit team .. J 12. Management Review' .', " , , Cond~ct a IJlanageme~t review:The"manage~,e~t revie~"':,is,h1sed determine the to effectiveness of the system in achieving the 'statedqtiality goals. The system is revised as I needed .. , ' ,~t "f: 13. Pre assessment " ~~~';'-., ,",i~.
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, " This step has three parts: choosing a:teg{gif'ar; subrn.ittipKan applicationt and conducting the registrar's system, adait. Conside!&tlons in cho~sfng ,a" regislr,arinclude costt lead time, your customer's accep'tance df the registrar" thp' regis$'s accreditation, and familiarity withYQur'JitpustiY. The application for regi~tratiOD:~hould also include supplying the registrar witn;the policy and procedure m,anuaIs for their review. The time involved in the registrar's sxstem audit will vary dependhig' on the size an~ complexity of the orgartization'~fl:the l1\lmber of auditors involved. A re'gistrar's audit usually lasts one to three days and wiiI co'nsist of an opening meeting to describe the process the auditors will follow, the audit itself, tuld a closing meeting to discuss the findings of the audit. 12. What are-the ,~eatures of ISO 14000 (Write short notes on 18014000.)

There are four sectioris to the standard-scope, nonnative references, \ definitions, and EMS requirements and an iqfornmtive .mncx. The EMS requirements are given in Section 4 of the standard and are covered next. Requirements of ISO 14000

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improvement ideas, prevention information, land s~stem problems. ~ ~ ORGANIZATIONAL BENEFITS. According to ISO 14004, an organiz~tion benet its from an EMS in a number of ways as given below: '
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.:. Assuring customers of a commitmen~ to en:vironmental management. .:. Meeting customer requirements, the primary reason for organizations to become certified. ' .:. Maintaining a good public/cpmmunity relations image . :. Satisfying investor criteria anq impr,?ving access to capital. . Obtaining insurance at reasonable cost. ': .:. Increasing market share that results from a competitive advantage. After certification, Acushnet Rubber obtained more business from European customers.6 .:. Reducing incidents' that result in liability. United Chern-Con lnc.'s plant in Lancing, NC is seeing a reduced potential for acddental releases of hazardous materials.7 .:. Improving defense'pqsture in litigation . :. Conserving input materials and energy. Ford's Michigan truck facility reduced water consumption by almost ,one m~llion gaHons per day and also reduced energy consumption by replacing fluorescent bulb,s with metal halide bulbs at a savings of $66,000 per year. 8 .:. Facilitating the attainment of permits and authorization . :. Improving industry/gov~rQIIlent relations. ( In addition answer thequestiqns given in each chapter)