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1 Lgistis Management Institute Cnstrutin Management Exellene Using ISO 9000 t Imprve Quality Systems CE501MR1 Jeffrey A. Hawkins "DISTRIBUTION STATEMENT A Apprved fr publi release; Distributin Unlimited."-. 1 Svi 181.,f\ JSLBBJIS JL, I '.1 A

2 Cnstrutin Management Exellene Using ISO 9000 t Imprve Quality Systems CE501MR1 Nvember 1995 Jeffrey A. Hawkins Prepared pursuant t Department f Defense Cntrat DACW31-94-D The views expressed here are thse f the Lgistis Management Institute at the time f issue but nt neessarily thse f the Department f Defense. Permissin t qute r reprdue any part exept fr Gvernment purpses must be btained frm the Lgistis Management Institute. ^STRIBÜfTÖrSTÄTEMENTXj Lgistis Management Institute Apprved fr publi release; I 2000 Crprate Ridge Distributin Unlimited \ MLean, VA m.0 QüiLiJPEE EIÖEEGTEB I

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4 CE501MR1/Nvember 1995 LOGISTICS MANAGEMENT INSTITUTE Cnstrutin Management Exellene: Using ISO 9000 t Imprve Quality Systems Exeutive Summary The U.S. Army Crps f Engineers (USACE) has been effetively managing military and ivil wrks nstrutin prjets fr many years. In the past, ustmers were satisfied with the servie they reeived and with the st f that servie. Hwever, the rules are hanging. The Crps' ustmers are demanding mre. As they fae the realities f smaller staffs, shrinking budgets, and mpressed shedules, they are asking the Crps t shulder sme f the burden. They still want their prjets t be mpleted as designed and t meet all envirnmental, industry, and safety standards; but they als want their prjets delivered faster and at a lwer st, and they want t be able t tailr the nstrutin management servies they reeive fr eah partiular prjet. The Crps, t, is faed with dwnsizing, budget uts, reengineering, and mdernizatin as well as inreasing mpetitin fr what used t be exlusive servies. T ensure that it remains the publi setr's nstrutin rganizatin f hie, the Crps must reevaluate its rprate ulture and its business methds. The future suess f its Cnstrutin Divisins depends n their ability t deliver the ttal quality prdut and servies their ustmers are nw demanding. The Crps Cnstrutin Divisins have begun t implement a number f ttal quality management initiatives and have instituted effetive quality assurane prgrams. Hwever, the nstrutin rganizatins still lak a mprehensive quality management system that enmpasses all aspets f the nstrutin management press. One suh system that the nstrutin rganizatins uld readily apply is the ISO 9000 quality system develped by the Internatinal Organizatin fr Standardizatin. Speifially, the Crps nstrutin rganizatins shuld implement the quality standards in ISO 9002, Quality Systems Mdel fr Quality Assurane in Prdutin and Installatin. By btaining ISO 9002 ertifiatin, the Cnstrutin Divisins wuld demnstrate that they have established a fundamental quality system and that they nsistently apply that quality system t meet their ustmers' requirements. The urrent quality system praties at USACE Cnstrutin Divisins and their resident and area ffies already inrprate muh f what is needed t mply with the requirements f ISO Hwever, t bring its quality system int full mpliane, a Crps Cnstrutin Divisin must develp a quality manual that utlines its quality system pliies and establishes the framewrk fr the quality system, and it must develp mre mprehensive dumentatin f its quality predures. In additin, it must assign a management representative with suffiient authrity and respnsibility t manage the quality system, m

5 develp a frmal internal quality system audit prgram, and frmalize its rretive and preventive atin system. Any Cnstrutin Divisin wishing t beme ISO ertified shuld develp an implementatin strategy. If aggressively managed, implementatin f an ISO-mpliant quality system will take abut 11 mnths; st abut $120,000 fr the neessary training, nsulting supprt, and registratin fees; and require between 200 and 300 staff-days. We remmend pursuing registratin at n fewer than tw Crps nstrutin rganizatins. Frm the experiene gained frm registering thse test sites, the Crps will be able t determine the sts and benefits f expanding the ISO registratin t all ther USACE nstrutin rganizatins. As mre nstrutin rganizatins gain experiene with the implementatin press, predures and dumentatin an be shared, resulting in a redutin in sts and time. The gal f every nstrutin rganizatin must be t establish a quality system that nsistently meets r exeeds all the ustmers' requirements; antiipates, prevents, and reslves prblems befre they ur; is respnsive t bth the ustmer and industry speifiatins; and fuses n ntinuus quality and prdutivity imprvement. The pursuit f verall peratinal exellene, r wrld-lass quality, will require exeutive-level Cnstrutin Divisin leadership, the dediated invlvement f nearly every member f the rganizatin, empwerment f the emplyees, rapid deplyment f hanging requirements and presses, management f innvatin, ustmer-fused planning, integratin f quality planning int business planning, and a mve tward mre flexible wrk envirnments. Implementing an ISO 9000-mpliant quality system is the essential first step that the Crps must take t make sure its quality bjetives are realized. But ISO 9000 registratin is nt the end f the quest fr wrld-lass quality in the Cnstrutin Divisins; it merely establishes the fundamentals, whih an then serve as the fundatin fr making further imprvements t prduts, presses, and servie. IV

6 Cntents Chapter 1. Intrdutin 1-1 Bakgrund 1-3 Reprt Organizatin 1-8 Chapter 2. Quality System Evaluatin 2-1 ISO Quality System 2-1 Existing Cnstrutin Quality System 2-4 Preliminary Quality System Assessment 2-6 Management Respnsibility (4.1) 2-7 Quality System (4.2) 2-8 Cntrat Review (4.3) 2-8 Design Cntrl (4.4) 2-9 Dument and Data Cntrl (4.5) 2-9 Purhasing (4.6) 2-9 Cntrl f Custmer-Supplied Prdut (4.7) 2-10 Prdut Identifiatin and Traeability (4.8) 2-10 Press Cntrl (4.9) 2-11 Inspetin and Testing (4.10) 2-11 Cntrl f Inspetin, Measuring, and Test Equipment (4.11) 2-11 Inspetin and Test Status (4.12) 2-12 Cntrl f Nnnfrming Prdut (4.13) 2-12 Crretive and Preventive Atin (4.14) 2-12 Handling, Strage, Pakaging, Preservatin, and Delivery (4.15) 2-13 Cntrl f Quality Rerds (4.16) 2-13 Internal Quality Audits (4.17) 2-13 Training (4.18) 2-13 Serviing (4.19) 2-13 Statistial Tehniques (4.20) 2-14

7 Cntents (Cntinued) Chapter 3. Implementatin Strategy and Csts 3-1 Prttype Implementatin Plan 3-2 Implementatin Team Frmatin 3-2 Distrit Implementatin Planning 3-6 Atin Plan Develpment 3-7 System Dumentatin and Implementatin 3-8 Quality System Registratin 3-12 Implementatin Csts 3-13 Appendix A. Memrandum n Ttal Army Quality Appendix B. ISO 9001 Standards Appendix C. Guidelines fr Cnfrmane with ISO 9002 Standards Appendix D. Critial Path Netwrk f ISO 9002 Implementatin Press VI

8 Illustratins 1-1. ISO 9000 Quality System Fundatin Wrldwide Aeptane f ISO ISO 9000-Series Arhiteture ISO 9000 Dumentatin Struture Implementatin Shedule Cnstrutin Divisin's Implementatin Team 3-3 Tables 2-1. Elements f ISO Quality System Csts f Implementing an ISO-Cmpliant Quality System, by Phase 3-13 Vll

9 CHAPTER 1 Intrdutin The Cnstrutin Divisins within the U.S. Army Crps f Engineers (USACE) have a lng traditin f prviding mpetent nstrutin management, quality assurane, and ntrat administrative servies t its military and ivil wrks ustmers. The Crps' fus n effetively delivering tehnially exellent failities and ivil prjets has earned the Crps its reputatin and has been suffiient t keep its ustmers satisfied. Hwever, the business limate is hanging rapidly. The Crps' ustmers are faed with shrinking prgram budgets and redued staffing. T fulfill their missins under these nditins, they are reengineering presses and predures and, in that new envirnment, are regnizing that there is mre t quality nstrutin than tehnially exellent results. Crps' ustmers are nw demanding a higher quality prdut nt by the Crps' definitin f quality, but by theirs. They still want a finished faility that meets the apprved design and that satisfies all envirnmental, safety, and industry des, but they als want their nstrutin prjets delivered faster, n shedule, and at lwer st, and they want t tailr the nstrutin management and ntrat administrative servies they need fr eah partiular prjet. Beause its ustmers an hse amng ther publi-setr agenies r even private-setr nstrutin firms, the Crps, t remain mpetitive, must prvide the higher quality servie its ustmers demand. And it must d s in an envirnment that is similar t that faed by its ustmers ne f dwnsizing and redued budgets. By imprving urrent praties, building new and better ustmer-respnsive systems, institutinalizing ttal quality praties in its daily peratins, and ntinually demnstrating its mmitment t quality, USACE an ensure that it remains a majr fre in the industry well int the future. The Crps understands that its future depends n its ability t effetively deliver nstrutin management servies t its ustmers, and it is nt taking that hallenge lightly. It has begun reevaluating its business ulture and presses, and it has established and dumented its visin fr the future: the Crps will be satisfied with nthing less than verall perfrmane and servie exellene and t remain the publi-setr's engineering and nstrutin rganizatin f hie. Mrever, the Crps has begun t takle imprtant quality-related issues in a number f targeted areas. Fr example, USACE has begun partnering with its ustmers and ntratrs, frming perative teams at the earliest stages f the design phase, and wrking with thse teams thrugh final nstrutin t avid nfrntatins that erde quality and turn ustmer relatins sur. 1-1

10 Beause it regnizes the imprtane f quality t future business suess, the Crps has als undertaken a ttal quality management (TQM) initiative t further imprve quality. In a 1993 memrandum, the Chief f Engineers expressed nern abut the future f USACE, given the unertainty under whih it wuld be perating, and remmended adpting a TQM apprah alled Ttal Army Quality (TAQ). (The memrandum is prvided in Appendix A.) Hwever, even with thse effrts underway, USACE has still nt satisfatrily addressed the issue f demnstrated mmitment t quality and prf t ustmers that bna fide quality systems are in plae. It is nt enugh that the Crps says it will meet its ustmers' requirements and exeed their expetatins fr servie; ustmers want prf that quality systems exist and that thse quality systems are wrking. If prperly implemented, an effetive quality system will assure Crps' ustmers f nsistent quality prduts, institute rprate visin and diretin, raise prdutivity, inrease effiieny, and prmte mpetitiveness. Frtunately fr the Crps, a fundamental and internatinally regnized quality system mdel already exists. That mdel the ISO 9000 quality system standards develped by the Internatinal Organizatin fr Standardizatin is rapidly beming the wrld's preferred mdel fr gauging the aeptability f an rganizatin's quality prgram and quality management system. The ISO 9000 standards are nthing mre than generi guidelines fr what nstitutes an aeptable quality system. The ISO standards speify the minimum essential elements f that quality system, but they d nt tell hw t d the jb nr d they refer t any speifi prduts. The standards are generi and an be applied t any prdut r servie and t any business r industry, whether in the private r the publi setr. As suh, the standards are, withut a dubt, appliable t USACE and its nstrutin management ativities. In fat, managers at USACE headquarters believe that the ISO 9000 quality system standards will prvide the mdel that Crps Distrits need t imprve quality management, enhane prdutivity, imprve mpetitiveness, and imprve ustmer relatins. ISO 9000 quality system standards will frm the fundatin that will enable USACE t establish itself as a wrld-lass engineering and nstrutin rganizatin while supprting urrent and nging quality initiatives (see Figure 1-1). The feasibility f, and justifiatin fr, USACE adpting and beming registered t ISO 9000 have already been dumented. 1 Mrever, the Crps has begun adpting the ISO 9000 standards at fur seleted USACE Distrits and is planning t seek ISO ertifiatin f the engineering rganizatins in thse Distrits. 2 The Crps nw wishes t seek ISO ertifiatin fr USACE nstrutin rganizatins, s it tasked the Lgistis Management Institute t develp a mplementary strategy fr implementing an ISO-9000-mpliant quality system in the Cnstrutin Divisins. (The fllwing setin prvides : LMI Reprt CE308R1, Tward a Wrld-Class Engineering Organizatin Making ISO 9000 the Fundatin t Quality Management, Jeffrey Hawkins and James L. Hathaway, April The ertifiatin press being adpted by USACE engineering rganizatins is based n an implementatin strategy develped by LMI. See LMI Reprt CE308RD1, Rad t Engineering Exellene: ISO 9000 Blueprint t Suess, Jeffrey A. Hawkins, April

11 Crps f Engineers Guide Spes Lessns Learned Partnering Fur-Phase Quality Cntrl m ISO 9000 Quality System Standards Figure 1-1. ISO 9000 Quality System Fundatin additinal bakgrund abut the ISO standards and summarizes the registratin press.) An ISO 9000-mpliant quality management system will prvide the USACE Cnstrutin Divisins with an internatinally regnized quality system framewrk that will enable them t establish a nsistent and stable quality assurane press and quality prdut delivery system. In additin, a nsistent quality system will prvide the USACE nstrutin rganizatins a fundatin upn whih they an make ntrlled and ntinuus imprvements. Ultimately, implementatin f suh a system will result in greater ustmer satisfatin and will further enhane USACE's image as an industry leader. BACKGROUND Based largely n U.S. Military Quality Speifiatins 9858-A, the ISO 9000 standards were develped by a Geneva-based rganizatin the Internatinal Organizatin fr Standardizatin with the help f an internatinal nsrtium f quality experts. Initially, the standards were develped in respnse t the frmatin f the Eurpean Enmi Cmmunity and the need t assure quality arss internatinal brders. But tday, nearly the entire industrialized wrld has adpted ISO 9000 standards in ne frm r anther (see Figure 1-2). In the United States, the standards have been implemented under the Amerian Natinal Standards Institute/Amerian Siety fr Quality Cntrl Q9000-series quality system standards. 1-3

12 Nte: Dark regins shw untries that have adpted ISO Figure 1-2. Wrldwide Aeptane f ISO 9000 Like traditinal definitins f quality, whih enter arund fitness fr use f a prdut r servie and relate the quality f that prdut r servie t ustmer speifiatins, the ISO 9000 standards ntend that quality is ahieved by eliminating nnnfrmity t the ustmer's requirements (r ntrat speifiatins). When an rganizatin btains ISO 9000 ertifiatin, it demnstrates t its ustmers, siety, and the rest f the wrld that it has established a fundamental quality system and that it nsistently applies that quality system t ntinually meet the ntratual requirements speified by its ustmers. Mst rganizatins already registered t the ISO standards (inluding engineering and nstrutin firms) have fund that the ISO 9000 quality system standards are quite easy t interpret and mst definitely apply t their speifi businesses. Used internally, nfrmane t the ISO standards indiate that a business has a legitimate and dumented quality system that is fully implemented and nsistently fllwed. Used fr external quality assurane, nfrmane t the standards prves that the existene f a quality system has been verified by an utside aredited registrar and that the rganizatin will likely nsistently deliver the quality prdut ustmers want. Basially, the ISO standards require an rganizatin t establish a quality management system that des the fllwing: Duments what the rganizatin des. Qualified rganizatins must establish and maintain a dumented quality system that desribes the presses and predures it uses t deliver the prdut r servie, demnstrates hw quality is ensured, and speifies hw ustmer requirements are nsistently met. The required dumentatin prvides the needed evidene (and basis 1-4

13 fr quality system audits) that an rganizatin has thrughly addressed and planned all predures that affet the quality f its prdut. Demnstrates that the rganizatin atually des what is dumented. The rganizatin must prve mat the persnnel r systems respnsible fr delivering quality prduts (r servies) are fllwing the system that it has planned and dumented. Auditrs will llet evidene f system nfrmane, usually vering three t six mnths, during n-site mpliane audits. Measures and keeps aurate rerds f the wrk that was perfrmed. Clleted evidene must shw that the qualified rganizatin has established required quality system rerds, that thse rerds are legitimate, and that quality has been part f the business ver the three- t six-mnth perid. Part f the burden f prf rests with effetively rerding elements f the business that affet the quality f the prdut. Evaluates and analyzes the results. The rganizatin must establish a system fr heking hw well its prdut perfrms with respet t these dumented predures and the ustmer's and ntratual requirements. Crrets system defiienies and ntinually imprves. The rganizatin must have a system that ensures urrent and ptential prblems are addressed and ultimately reslved. Reslutin f prblems may require hanging existing predures when it is st-effetive t d s and, when warranted, updating the relevant predural and quality system dumentatin. These quality system reviews and rretive and preventive atins are the fundatin fr the rganizatin's ntinuus imprvement effrts. When disussing the ISO 9000 quality system standards, we are really talking abut a family f individual duments mprising ntratual mdels, quality management mdels, and guidane (see Figure 1-3). There are three re quality nfrmane duments (ISO 9001, ISO 9002, and ISO 9003) that external entities use t verify an rganizatin's quality system (e.g., quality assurane). Others prvide supprting guidelines. Fr example, ISO 9004 expands n the ntratual mdels and ffers additinal vluntary guidane. ISO 9004 an be used fr internal evaluatin r fr implementatin f an rganizatin's quality management praties. 1-5

14 ISO 9000 Family Cntratual Mdels Quality Management Mdels Guidane ISO 9001 ISO 9002 ISO 9003 ISO 9004 ISO ISO ISO 8402 ISO ISO ISO ISO ,2,3 ISO ISO ISO 9001 Quality Systems Mdel fr Quality Assurane in Design/Develpment, Prdutin, Installatin, and Serviing. ISO 9002 Quality Systems Mdel fr Quality Assurane in Prdutin and Installatin. ISO 9003 Quality Systems Mdel fr Quality Assurane in Final Inspetin and Test. ISO 9004 Quality Management and Quality System Elements, Guidelines. ISO Quality Management and Quality System Elements, Part 2: Guidelines fr Servies. ISO Quality Management and Quality System Elements, Part 3: Guidelines fr Pressed Materials. ISO 8402 Quality Vabulary. ISO Quality Management and Quality Assurane Standards: Guidelines fr Seletin and Use. ISO Quality Management and Quality Assurane Standards Part 2: Generi Guidelines fr the Appliatin f ISO 9001, ISO 9002, and ISO ISO Quality Management and Quality Assurane Standards Part 3: Guidelines fr the Appliatin f ISO 9001 t the Develpment, Supply, and Maintenane f Sftware. ISO Guidelines fr Auditing Quality Systems. ISO Qualifiatin Criteria fr Quality System Auditrs. ISO Management f Audit Prgrams. ISO Quality Assurane Requirements fr Measuring Equipment Part 1: Metrlgial Cnfirmatin System fr Measuring Equipment. ISO Guidelines fr Develping Quality Manuals. Figure 1-3. ISO 9000-Series Arhiteture 1-6

15 Eah f the ISO 9000 ntratual mdels (9001, 9002, r 9003) applies t a speifi range f businesses, and nne f the mdels is nsidered better than anther. In seleting whih mdel t adpt, mst rganizatins simply refer t the guidane fund in the ISO 9000 standard, whih requires systemati nsideratin f the fllwing six fatrs: Design press mplexity. Hw diffiult is the design and/r preliminary develpment f the prdut r servie? Design maturity. Is the prdut unique r an a previusly develped design be used? Prdutin press mplexity. Hw mplex is the press fr develping the prdut r servie? Prdut r servie harateristis. Hw mplex is the prdut r servie and hw ritial are the interrelated harateristis f the prdut t its perfrmane? Prdut r servie safety. Hw stly are prdut failures? Enmis. Hw stly are the preeding fatrs relative t the sts f a nnnfrming prdut? Organizatins get registered t the standard best fitting their range and spe f business. Fr example, ISO 9001 applies t thse businesses prviding a full range f servies, inluding design and prdut develpment, prdutin, installatin, and pstinstallatin serviing. ISO 9002 is nearly idential exept it des nt inlude requirements fr design and prdut develpment. Therefre, an rganizatin that has mplete ntrl ver prdut design shuld register under ISO 9001, while an rganizatin with n mre than an anillary rle in prdut design and develpment shuld register under ISO Fr example, the primary rle f the USACE nstrutin rganizatins is t prvide nstrutin management servies. Design is managed by ther USACE rganizatins. Therefre, the ISO quality system mdel that applies best t USACE nstrutin rganizatins is ISO 9002, Quality Systems Mdel fr Quality Assurane in Prdutin and Installatin. Beming registered t the ISO 9000 quality system standards means that an rganizatin has met the minimum requirements and that an utside, independent, and aredited auditr, knwn as an ISO quality system registrar, has examined the rganizatin's quality system and fund that it mplies with its interpretatin f the ISO standards. 3 An examinatin f the rganizatin's quality system dumentatin will ensure that all elements f the ISO standards are effetively planned, adequately addressed, and suffiiently dumented, and then an n-site mpliane audit will ensure that thse dumented quality 3 Registrars are aredited in the United States thrugh a natinal entral authrity alled the Registratin Areditatin Bard, an affiliate f the Amerian Siety fr Quality Cntrl. 1-7

16 system presses and predures are nsistently implemented and that adequate rerds are kept. If the rganizatin meets the registrar's expetatins, then that mpany is granted a registratin t the ISO standard it seleted. Registratin des nt, hwever, guarantee the quality f the prdut; it simply means that quality presses are in plae t deliver that prdut. A suessful rganizatin reeives a ertifiate nting its amplishment. The registratin is published in a register available t the publi, and the rganizatin is then permitted t use its registrar's lg in its marketing and t display it in its advertising, statinery, and pakaging as evidene that its quality system meets the requirements f the ISO standard. ISO registratin is site speifi, s rganizatins with many sites must register eah site individually. In USACE, eah Cnstrutin Divisin shuld register as a single site that enmpasses its numerus field ffies. One a site bemes registered, its registratin is valid indefinitely as lng as it ntinually passes peridi surveillane audits. Organizatins that fail any reassessment risk lsing their registratin and the privileges that g with it. Thse rganizatins may rret thse defiienies and reapply fr registratin if s desired. REPORT ORGANIZATION The first step in develping a plan t implement a new quality system is t gain a thrugh understanding f the existing quality system. Therefre, in Chapter 2, we present an assessment f existing quality management praties utilized by USACE nstrutin rganizatins. We mpare urrent praties t thse presribed by ISO 9002, and we identify speifi quality system imprvement pprtunities that will bring the nstrutin quality system int mpliane with ISO In Chapter 3, we present a strategy fr btaining ISO 9002 registratin. The strategy inludes an implementatin plan that speifies required tasks, respnsibilities, and a shedule; we als disuss the fisal and staff resures needed t arry ut the plan. 1-8

17 CHAPTER 2 Quality System Evaluatin Befre we an develp an effetive implementatin strategy, we must first fully understand the quality system that USACE nstrutin rganizatins wuld like t put in plae. We must als evaluate the nditin f the existing quality system with respet t the desired system s that we an identify presses and predures that must be develped r mdified t ahieve the desired result. Envisining the desired quality system ISO 9002 is easy. The ISO quality system standards already define the desired end state. Of urse, eah site seeking registratin may need t ustmize the interpretatin f the ISO 9002 quality system t satisfy unique nditins. Evaluating the nditin f the existing quality system emplyed by Crps nstrutin rganizatins requires a bit mre effrt. Understanding where the urrent quality system is in relatin t the desired quality system means perfrming an assessment r internal audit f all the pliies, presses, and predures that enmpass the existing quality initiatives. Called a gap analysis within the industry, that internal assessment identifies shrtfalls, r nnnfrmities, with the ISO 9002 standards. That is, the differene between the existing system and the desired ne defines the gaps in the quality system that nstrutin rganizatins must address and bring int mpliane befre it seeks and is granted registratin. In the first tw setins f this hapter, we briefly desribe the ISO quality system requirements and summarize the existing elements f the quality system USACE nstrutin rganizatins have already put in plae. In the third setin, we present the results f a preliminary gap analysis nduted at tw USACE Cnstrutin Divisins (inluding area and resident ffies) that were seleted t represent typial Crps nstrutin rganizatins knwn t have effetive TAQ prgrams underway. ISO QUALITY SYSTEM In tday's ustmer-fused envirnment, servie prviders are ding whatever is neessary t understand and meet their ustmers' requirements. The presses and predures that rganizatins similar t USACE nstrutin rganizatins put in plae t make sure they meet thse requirements is alled a quality management system. Its purpses are t (1) make sure ustmers' requirements are fully understd befre wrk begins, (2) prvide ustmers with nging feedbak during prdut develpment, and (3) ensure that the finished 2-1

18 prdut satisfies the requirements established and agreed t by bth parties. In additin t earning satisfied ustmers, an effetive quality management system will imprve an rganizatin's prdutivity, and it will redue the sts assiated with ineffiient peratins and wasted effrts beause the rganizatin will d the right things right, the first time, all the time. The ISO 9000 quality management system mdel ntains 20 distint but related elements (see Table 2-1). The mst rigrus ntratual mdel ISO 9001 requires that an rganizatin mply with all 20 elements befre it an beme ertified. (ISO 9001 is reprdued in its entirety in Appendix B.) ISO 9002 the ntratual mdel appliable t USACE Cnstrutin Divisins is virtually idential t ISO 9001; the nly differene is that ne element, 4.4 Design Cntrl, des nt apply. Thus, an rganizatin wishing t beme ertified as mpliant with ISO 9002 must meet nly 19 f the 20 quality system elements. Table 2-1. Elements f ISO Quality System Quality system element Number Management respnsibility 4.1 Quality system 4.2 Cntrat review 4.3 Design ntrl 4.4 Dument and data ntrl 4.5 Purhasing 4.6 Cntrl f ustmer-supplied prdut 4.7 Prdut identifiatin and traeability 4.8 Press ntrl 4.9 Inspetin and testing 4.10 Cntrl f inspetin, measuring, and test equipment 4.11 Inspetin and test status 4.12 Cntrl f nnnfrming prdut 4.13 Crretive and preventive atin 4.14 Handling, strage, pakaging, preservatin, and delivery 4.15 Cntrl f quality rerds 4.16 Internal quality audits 4.17 Training 4.18 Serviing 4.19 Statistial tehniques

19 The 19 elements that USACE Cnstrutin Divisins must meet t mply with ISO 9002 affet virtually every aspet f the nstrutin management and ntrat administratin press and require full mpliane frm the Distrit ativities as well as area, resident, and prjet ffies. Appendix C explains the appliatin f the ISO 9002 elements t USACE nstrutin management ativities and prvides guidane nerning the spe and appliatin f the ISO 9002 standards t USACE nstrutin rganizatins; Appendix C als prvides referenes t ther required ISO and USACE guidane and defines ISO 9000 terms as they relate t typial nstrutin rganizatins. The bakbne f the quality system desribed by ISO 9002 is dumentatin. Any rganizatin applying fr ISO 9002 ertifiatin must dument its entire quality system t shw the auditrs that it has been suffiiently planned and that eah element f the standard has been addressed and suffiiently met yu must say what yu d. Registrars will take several days t examine the rganizatin's dumented quality system t ensure full mpliane with the requirements f the standards. If the dumentatin is insuffiient, the registrars will nte where dumentatin needs imprvement, but when the dumentatin is suffiient, the registrar will shedule a nfrmane audit t ensure the rganizatin praties what is dumented. During a tw- t fur-day n-site audit invlving three r fur auditrs familiar with USACE nstrutin ativities, the nstrutin rganizatins must then demnstrate t the auditrs that their praties nfrm t what they have dumented yu must d what yu say. Figure 2-1 illustrates the fur-level dumentatin struture suggested by the ISO 9000 standards. At the tp f the dumentatin pyramid is quality pliy as dumented in a quality manual. The quality manual must desribe the rganizatin's pliy with respet t eah f the 19 ISO 9002 elements and shuld be abut 20 t 30 pages lng. Level 2 dumentatin addresses the quality system predures and shuld relate t the pliy requirements as stated in the quality manual. While mst f USACE's quality predures are bradly desribed in diretives and regulatins, the ISO auditrs will be nerned with hw thse regulatins and statutes are implemented at the lal level. The desriptin f quality predures des nt need t be lengthy; it is enugh t desribe simply what is t be amplished. Keep in mind that dumentatin an never take the plae f training, eduatin, and experiene. Where staff members have the required skills and knwledge assiated with their eduatin and prfessinal knw-hw, n supplementing predures will be required. Level 3, wrk instrutins, deals with hw eah required predure is t be amplished. Thse instrutins frm the bulk f the dumentatin. Nt every predure needs assiated wrk instrutins, but wrk instrutins shuld be dumented fr any predures diretly affeting the quality f the prdut. Level 4 dumentatin mprises the rerds, r prf, that the rganizatin has implemented praties in ardane with the stated quality pliy and predures. The ISO 9000 standards ditate what rerds USACE nstrutin rganizatins must keep as a minimum. 2-3

20 LEVEL 1 The quality manual (pliy) LEVEL 2 Quality system predures ill * * r^~i J \ LEVEL 3 Wrk instrutins LEVEL 4 Rerds (prf) i r^ J } ri -i Figure 2-1. ISO 9000 Dumentatin Struture EXISTING NSTRUCTION QUALITY SYSTEM In ther industries and quality management irles, quality is ften defined as "the ttality f features and harateristis f a prdut r servie that bear n its ability t satisfy stated r implied needs." T USACE's Cnstrutin Divisin ustmers, that elabrate definitin an be stated mre simply: quality is getting prjets delivered n shedule, within budget, arding t tehnial speifiatins and funtinal requirements, and with exellent servie. Making sure their ustmers get the quality they are demanding is the burden f the Cnstrutin Divisins and their quality assurane presses and predures their quality management system. The Crps nstrutin rganizatins and the nstrutin ntratrs hired by USACE bth have a rle in ahieving quality. As the ustmer's agent and the gvernment's representative, USACE wants t make sure the ustmer gets the faility it needs n time and within budget but at a st that is reasnable t the gvernment and the Amerian taxpayer. At the same time, the ntratr wants t deliver a satisfatry faility that meets the ntrat requirements while making a reasnable prfit. Clearly, the respnsibilities f bth parties are mplementary. Thus, fr the USACE nstrutin quality management system t 2-4

21 be effetive, it must sueed in meeting the gals f the ustmer, the Crps, and the nstrutin ntratr. T satisfy thse seemingly nfliting gals, there must be a planned and systemati prgram f atins and an established line f authrity and respnsibilities arund the quality management system. In the existing quality system, a Crps nstrutin ntratr must demnstrate that it understands the ntrat requirements and an d the wrk, and it must ensure that the finished nstrutin prjet meets ntrat requirements. T prvide thse assuranes, USACE instruts the ntratr t prepare a quality ntrl plan. The quality ntrl plan must be develped early and be apprved by the Crps befre nstrutin wrk begins. In the plan, the ntratr must adequately address the fllwing: Capability f management staff t suessfully manage the rganizatin and the prjet as well as size and training f quality ntrl staff. On- and ff-site predures fr the ntrl, inspetin, and testing f the nstrutin prdut as well as qualifiatins and training f ntratr persnnel wh will perfrm thse ativities. The plan must list the tests t be perfrmed and must speify wh will be respnsible fr the results. The plan als must speify wh will be respnsible fr apprval f the reprts. The reprt frms must be mprehensive and frequeny f reprt submittals must be indiated. Predures fr pressing submittals alng with the apprval authrity. System fr traking defiienies during the nstrutin press t ensure timely rretive atins. Predures fr maintaining rerds f quality ntrl ativities and fr enabling the Crps t review thse rerds. A member f the Cnstrutin Divisin is assigned quality assurane respnsibilities. That persn meets with the nstrutin ntratr and the Crps' representatives t reslve all issues pertaining t the quality ntrl plan. Cnstrutin des nt begin until USACE is satisfied with the ntratr's quality ntrl plan. In additin t apprving the quality ntrl plan, the USACE nstrutin rganizatins als establish the tehnial and funtinal standards fr the nstrutin prjet, hek the adequay f the nstrutin ntratr's quality ntrl system, perfrm speified tests and inspetins as designated by the ntrat, reslve reprted nstrutin defiienies and mdifiatins, 2-5

22 analyze the nstrutin ntratr's laims, ntrl nstrutin prjet sts, and manage the prjet shedule. T assure the quality f the nstrutin prjets it manages, USACE has instituted predures fr ntrlling all definable features f the nstrutin prjet in eah f fur phases: preparatry phase, initial phase, fllw-up phase, and final aeptane phase. In additin, it has develped predures fr ntrlling all nstrutin materials, fabriated items, and installed equipment; verifiatin testing (all ther testing is the ntratr's respnsibility); nduting final inspetin and aeptane fr eah definable prtin f wrk; and ntrlling quality-related dumentatin. PRELIMINARY QUALITY SYSTEM ASSESSMENT The quality system used by USACE nstrutin rganizatins is generally impressive and has enabled USACE t make prgress tward ahieving sme f its ttal quality gals. Mrever, the existing quality system meets a signifiant prtin f the ISO 9002 quality system requirements and thus an serve as the bakbne f an ISO-mpliant quality system. Hwever, the existing system falls shrt f the ISO 9002 quality system in a number f areas. The fllwing are amng the majr nnnfrmities we identified during the gap analysis: An verall framewrk fr an ISO 9002-mpliant quality system that is, a tiered dumentatin struture as illustrated in Figure 2-1 is nt suffiiently established: We fund n evidene f a quality manual (as required by ISO 9002 element 4.2 that utlines the rganizatin's general pliies relative t eah ISO 9002 requirement and that establishes the framewrk fr the quality system by referening quality system predures and wrk instrutins. Dumentatin f required quality system predures is nt mprehensive enugh. (Hwever, required Level 3 dumentatin are, fr the mst part, suffiient t meet the requirements f the standard.) Exept fr thse unique rerds required by ISO 9002, the rerds management system is suffiiently planned, dumented, and implemented in ardane with the standard. We fund n evidene f a management representative with suffiient authrity and respnsibility t manage the quality system within eah Cnstrutin Divisin. 2-6

23 We fund n evidene f a frmal internal quality system audit prgram. Althugh the Cnstrutin Divisins take sme rretive and preventive atins, we fund n evidene f a frmal rretive and preventive atin system that has been planned and dumented in ardane with the standard. The existing dument ntrl systems d nt mply with ISO standards. Hwever, we fund evidene that the Cnstrutin Divisins are already wrking t imprve dument ntrl predures. In the fllwing subsetins, we prvide speifi bservatins pertaining t hw well the quality systems in plae at the tw Cnstrutin Divisins we assessed meet eah element f the ISO 9002 standards, and we identify the mst ntable nnnfrmities. Management Respnsibility (4.1) 1 The USACE Cnstrutin Divisins we examined have already established (during previus TAQ effrts) and dumented sme quality pliies and bjetives, and thse pliies and bjetives were apprved and distributed as required by ISO Hwever, we fund that thse existing pliies and quality bjetives are nt written in a way that an be easily understd by everyne in the rganizatin, nr are they speifially relevant t nstrutin management ativities. As a result, it wuld be virtually impssible t measure prgress tward meeting thse bjetives as is required by ISO In additin, the Cnstrutin Divisins d nt have an verall strategy fr making sure that their quality pliies and bjetives are knwn and understd by everyne in their rganizatins. Generally, the nstrutin rganizatins meet the ISO 9002 requirements fr an established rganizatinal infrastruture t manage, perfrm, and verify wrk affeting quality. In additin, we fund evidene that managers f the Cnstrutin Divisins make sure that adequate «resures are available t sustain an apprpriate level f quality thrughut the life f the nstrutin prjet prjet planning, design phase supprt, quality ntrl and quality assurane ativities, fur-phase ntrl, et. as well as t perfrm suffiient training within the nstrutin rganizatin. Neither f the nstrutin rganizatins we assessed have a management representative smene with exeutive respnsibility t versee the establishment and maintenane f the rganizatin's quality system. Any rganizatin seeking ISO 9002 ertifiatin is required t have suh an individual. Speifially, t mply with ISO 9002, the USACE nstrutin rganizatin must appint a management representative, grant that individual the authrity t establish and maintain the quality system, and infrm the rest f the rganizatin f that appintment. lumbers in parentheses refer t rrespnding elements in the ISO 9001 standards. 2-7

24 In additin t laking management representatives, the nstrutin rganizatins we assessed d nt ndut ffiial, planned, and peridi reviews f the dumented and implemented quality system nduted by the exeutive management. T mply with ISO 9002, the nstrutin rganizatins must keep rerds that demnstrate management is nduting reviews and that speify what atin is prpsed and taken. Quality System (4.2) T mply fully with the requirements f ISO 9002, the nstrutin ativities must ensure that eah element f the standard is adequately established, suffiiently dumented, and effetively implemented. We fund evidene that a gd number f thse elements were adequately addressed but thers were nt. And the system laks an verall struture, primarily beause f the absene f a quality manual that prvides the tp-dwn struture needed. The quality manual must be develped that duments the Cnstrutin Divisin's pliies with respet t eah f the standards and serves t establish the imprtant links between thse pliies, predures, and wrk instrutins. And, where quality system predures and wrk instrutin are absent frm the system, they t must be established and dumented (thse areas are disussed element by element in the fllwing subsetins). Cntrat Review (4.3) While the verall respnsibility fr establishing the nstrutin ntrat is beynd the authrity f the Cnstrutin Divisins, making sure they an deliver n their agreements is nt. We fund that, in sme ases, the Cnstrutin Divisin is prperly represented at prentrat meetings, but in ther ases, it is nt represented at all r is nt represented prperly. Mrever, we fund n dumented predures that utline the Cnstrutin Divisin's respnsibilities during prentrat and design phases. T mply with ISO 9002, the Cnstrutin Divisins must be invlved in the prentrat and design develpment phases f every prjet; nstrutability, biddability, and perability reviews are an integral part f the verall nstrutin prjet delivery press. Speifially, the Cnstrutin Divisins must make sure that the ustmer's requirements are prperly develped, that inhuse apabilities are suffiient t meet thse requirements, and that the results f the agreements between the ustmer and the nstrutin rganizatin are dumented. Mrever, the predures fr nduting ntrat reviews als must be dumented. The Cnstrutin Divisins must ndut all ntrat mdifiatins in ardane with guiding regulatins the Federal Aquisitin Regulatins (FAR), FAR supplements, and lal ntrating predures. ISO 9002 requires dumentatin f nly thse hanges rdered by the ustmer. Generally, we fund suffiient dumentatin f ntrat hanges that urred during nstrutin. 2-8

25 In fat, the nstrutin rganizatins exeed the requirements f ISO 9002 beause, typially, they dument all frms f hanges nt just thse requested by the ustmer. Design Cntrl (4.4) The requirement fr design ntrl is nt appliable t USACE nstrutin ativities and is nt required under ISO Hwever, when neessary, dumented predures shuld exist t demnstrate hw design hanges during nstrutin will be handled, authrized, rdinated, and implemented. We wuld expet t see that requirement addressed under 4.5.3, Dument and Data Changes. Dument and Data Cntrl (4.5) The Cnstrutin Divisins adequately ntrl ertain duments and data. In partiular, we fund evidene that the nstrutin rganizatins ntrl prjet-speifi duments and data in ardane with ISO Hwever, they d nt suffiiently ntrl externally prdued duments and data (e.g., regulatins, speifiatins, predures, and industry des frm USACE headquarters, Army, DD, and abve). In additin, we fund n evidene f an verall system fr dument and data ntrl. T mply with ISO 9002, the nstrutin rganizatin must develp a master list inluding the sure, latin, respnsibility, and urrent revisin status f all duments and data in its are, and it must establish predures t ntrl them. Examples f dumentatin that shuld be ntrlled are the quality manual, Army and USACE regulatins, lal predures, guide speifiatins, tehnial manuals, et. The ntrl predures shuld ensure that nly the mst urrent dumentatin is being used, that bslete dumentatin r data retained fr any reasn is s identified, that hanges are rretly rerded and issued where needed/and that utdated duments r data are remved frm irulatin. Cmpliane with ISO 9002 als requires that the dument and data ntrl system be fully dumented. Purhasing (4.6) The requirements f this element are nt appliable t thse nstrutin rganizatins with little r n influene in seleting subntratrs r purhased materials. Hwever, fr thse Cnstrutin Divisins that d have invlvement and sme authrity, dumented predures must ensure that all purhased materials and servies nfrm t preestablished requirements. They must als make sure that all ntratrs are seleted n their ability t deliver quality prduts t USACE's ustmers. Cnstrutin Divisins that purhase materials and servies utilize the nstrutin ntratr appraisal supprt system (CCASS) t ensure that ntratrs are seleted n the basis f their ability t deliver quality 2-9

26 prduts t USACE's ustmers and that purhases nfrm t preestablished requirements. When prperly used, the CCASS meets the requirements f ISO In additin, the Cnstrutin Divisins' respnsibilities and predures with respet t purhasing are suffiiently dumented. Cntrl f Custmer-Supplied Prdut (4.7) In USACE nstrutin rganizatins, ustmer-supplied prduts may refer t gvernment-furnished equipment, materials, supplies, r fixtures and furnishings prured by the ustmer fr use in the nstruted faility. It may als refer t any duments r data furnished by the ustmer and used by the nstrutin ativity fr any purpse. In either ase, the nstrutin ativity must have dumented predures fr ntrlling any ustmer-supplied materials r data t ensure that materials and data are verified befre being used, that thse items are apprpriately handled and stred, and that any lst r defetive items are reprted t the ustmer. Suh ntrl is needed t avid using smething frm a ustmer (e.g., engineering test results r as-built drawings) that is nt validated and thus pssibly inaurate. In additin, the standard requires that all suh materials and data be identified, and rerded, as ustmer supplied. Fr the mst part, nstrutin ativities d nt take pssessin f gvernment-furnished materials r equipment, s this element may nt be appliable. But, when they d r when the Cnstrutin Divisin assumes respnsibility fr any ustmer-supplied infrmatin r data, the rganizatin must develp dumented predures t make sure that the materials r data are verified befre being used, identified as ustmer supplied, and stred and handled prperly. Prdut Identifiatin and Traeability (4.8) The USACE Cnstrutin Divisins have a system in plae t identify its prduts by unique prjet r ntrat number. Hwever, smetimes the prduts are diffiult t trae t the riginal engineering prjets beause the numbering differs between engineering and nstrutin prjets. T mply with the traeability requirement f ISO 9002, USACE must develp a rss-referening sheme. We fund n evidene f the existene f dumented predures fr identifying and traing prduts. The Cnstrutin Divisins must develp that dumentatin t mply with the standard. 2-10

27 Press Cntrl (4.9) The USACE nstrutin rganizatins fully mply with the requirements fr press ntrl as stated in ISO Their system fr managing nstrutin thrughut the prjet life yle is effetive, partiularly fr military nstrutin prjets, and is suffiiently dumented. The rganizatin has identified steps needed t manage a nstrutin prjet, ensured that wrk is arried ut in a suitable envirnment and with adequate resures, develped press ntrl and wrk instrutins, established riteria fr aeptable perfrmane f the wrk, and identified the use f ritial equipment (e.g., quality assurane, testing, mputer-aided design and develpment wrkstatins, and varius sftware pakages). Inspetin and Testing (4.10) The Cnstrutin Divisins mply with all ISO 9002 inspetin and testing requirements. Speifially, the Cnstrutin Divisin has dumented predures fr reviewing and apprving its nstrutin prduts. Thse predures inlude validating all inming nstrutin materials and assuring that all physial testing and inspetins are perfrmed as required by the ntrat duments. The Cnstrutin Divisins als verify that all nstrutin ativities are arried ut in ardane with the prjet management plan and the quality assurane plan. In additin, Cnstrutin Divisin persnnel ensure that the finished faility satisfies all the requirements established by the mpleted design (alng with in-press hanges), the ntrat agreement, and all industry and regulatry des and praties. And nstrutin persnnel release prduts at eah stage in the press nly after the required inspetins and tests have been suessfully mpleted. Finally, they keep rerds f inspetins and tests alng with apprval authrities, as required by ISO Cntrl f Inspetin, Measuring, and Test Equipment (4.11) This element f the ISO 9002 standard des nt apply t Cnstrutin Divisin ffies at the Distrit level beause they have n need t ntrl inspetin, measuring, and test equipment. Hwever, this element des apply t the field ffies. At that level, inspetin, measuring, and test equipment is being effetively ntrlled in sme ases, but we fund n evidene f an verall ntrl system. T mply with the requirements f ISO 9002, eah nstrutin field ffie must maintain a list f all equipment that has a diret bearing n the quality f the finished prdut and indiating whether the equipment requires alibratin. All equipment that requires alibratin must be identifiable as ntrlled equipment, and the date f its last alibratin must be shwn. While nt required by ISO 9002, all equipment that is nt alibrated als shuld be identifiable as unalibrated. In additin t identifying equipment t be ntrlled, the rganizatin must establish pliy and predures fr sheduling and amplishing the 2-11

28 alibratin, and it must prvide evidene that the equipment is being alibrated arding t plan. Finally, the rganizatin must dument the pliy and predures it develps fr ntrlling all suh equipment. Inspetin and Test Status (4.12) The Cnstrutin Divisins have predures fr ensuring that the inspetin and test status f nstrutin management prduts is suitably identified. Hwever, we fund n evidene that the predures are dumented. T mply with ISO 9002, the nstrutin rganizatins must dument their predures. The dumentatin must inlude identifiatin f the apprval authrity respnsible fr releasing the finished r in-press prduts. Cntrl f Nnnfrming Prdut (4.13) The Cnstrutin Divisins have a defiieny traking system t prevent the use f deliverables r materials that d nt nfrm t speified requirements. When prperly used, that system satisfies the requirements f this element f ISO The nstrutin rganizatins als meet the ISO 9002 requirements fr predural dumentatin vering the appliatin f the defiieny traking system. Crretive and Preventive Atin (4.14) An effetive rretive and preventive atin system is imprtant t a gd quality management system beause it serves as the fundatin fr ntinuus imprvement effrts. Sme USACE nstrutin rganizatins belw the Divisin level have a lessns-learned system in plae and, in sme ases, use it effetively. Hwever, we fund n evidene that USACE nstrutin rganizatins have a frmalized system fr taking rretive and preventive atins. T mply with the requirements f ISO 9002, the Cnstrutin Divisins must establish a frmal system f rretive and preventive atins. The system shuld inrprate, fr example, lessns-learned prgrams. The rretive and preventive atin system that Cnstrutin Divisins put in plae must ensure that the auses f a prblem are investigated, that the neessary rretive atins are taken, and that predures are imprved s that the identified prblem will nt reur. The system als shuld ensure that atins taken are mmensurate with the risks invlved; rretive atins that st mre than the st f leaving the prblem unrreted annt be justified. In additin, the system must verify that rretive r preventive atin has been initiated and has slved the prblem. The nstrutin rganizatins must keep rerds f atins taken, and they must dument the pliy and predures fr arrying ut the rretive and preventive atin system. 2-12