f

hcmi cii 1 and process in dus t ri ( >s in the t S liaivc> long enjoycd a leiltler- sh ip rolc3 i n world miirkets. I lo\\ c’\ c’r, for continuctl siiccc~sb, 1)iirticiilarly in Iihrope, cornpanic.; must ;iddress ii critical arc’ii. Totfa!, thcs porfornmancc of an intlivitluitl

conipan> must 1~ :icceptahle under intc~n;i- tionall!. rccognimtl quality iisstiriinw (QA) practices. Dealing with quality issues is not confincd to qunlity profession&; it should l)cl of c~lrial importance to a l l practicing chemists and chemical enginrws. I n this articlc, I nil1 d iscuss an internationally acceptcd Q,\ cclrtification and registration s!stcm as n c d l as its impact on 1% chcmic;il and proccss industricks.

\\.it11 the c.omplc~tion o f the 1’:uropc:ui Community (EC) singlc markct at Uic end o f 1992, quality m;in;iggcrnc~nt has become incrc)iisitigly important t o a l l industries n o r l t h itle. ‘ I l i c ~ unified \vcstcwi ISuropean marl\c,t has :<20 niillion consiinicm from t\\ c.l\ Ec‘ countries (Iklgium, I)<>~i~~iitrk, I ~ ~ r a n c ~ ~ , Germany, Greece, Ircland, Italy, I.u\criil~ourg, ’ffie Netherliintls, I’ortugal, Spitin, i t n d the United Kingdom) and 30 million cwnswners from six I.luropcw1 Free ‘fra d c~ \ s S O ci at i on cou n t ri e s (.\us t ria, 1-i n Ian d , I c-e 1 and , Sonvay, Sweden, and S\\it/clrliind) that havc 1)ridging agreements I\ i t l i I:c‘ countries. \\’ittiout demoiistrahle 0.1 practices, I S chemical industries face problems in exporting products to western Europe.

lines) and for contracts between supplier and purchaser &e., models). Rather than reinvent the wheel, authorities in many countries accepted the IS0 standards e4 sentially in toto, sometimes only chang- ing the designation numbers (e.g., ANSI refers to IS0 9OOO by Q90). A partial list of IS0 equivalent national standards is given in Table 1. By mid-1992, fifty-three countries had adopted the IS0 9OOO stan- dards as their national standards.

THE I S 0 9000 STANDARDS The five documents in the IS0 9OOO s e ries are an interrelated set Overall, there are twenty “elements” or criteria in the IS0 9OOO series that encompass various aspects of quality management These are listed in the box on p. 26 with brief descriptions of content for each element

Not all criteria are necessary for each IS0 9OOO standard. For example, IS0 9004 is a comprehensive package. Most of its parts are included in IS0 9001, somewhat fewer are included in IS0 9002, and even fewer are included in IS0 9003.1S09oooand9004areguidelinesfor building a quality system and use phrases such as “The quality system should.. . .” IS0 9001 through 9003, on the other hand, are models for contracts between a

1 8 TODAY’S CHEMIST AT WORK, NOVEMBEWDECEMBER 1993

iARY IF IN THE STATES -

supplier and a purchaser and use phras- es such as "The supplier shall. . . ."Thus organizations are audited against IS0 9001, 9002, or 9003-not against IS0 9000or9004.

To date, almost all organizations have been certised for IS0 9001 or 9002. IS0 9003, which concerns inspection and testing, is considered to be of limited val- ue and has not been used extensively; only four of the approximately 400 US registrations to date have been for IS0 9003 (5). In fact, the IS0 plans to delete the IS0 9003 standard. The interrelation- ship among these three standards is

Summanzed in Table 2 (3). Brief descrip tions of individual standards follow.

I S 0 WW. 'This standard defines the principal quality concepts and provides guidance for selecting appropriate stan- dards to assure conformance to contmct requirements that can be used for inter- nal quality management purposes (IS0 9004) and/or for extemal QA (IS0 9001 through 9003). The guideline calls for a quality policy statement from the top management Achieving quality requires the participation of everyone in the orga- nization, but quality management is the responsibility of top managers.

Quality management includes plan- ning, resources, operations, and all "- kmatic activties for quality." Contracts and audits may mandate demonstration of a quality system. QC involves monitor- ing processes and eliminating causes of poor performance to achieve economic effectiveness. QA consists of the planned and systematic actions needed to pro- vide adequate coniidence that a product or service will satisry quality require ments. QA is both a management tool and the customer's guarantee of quality.

I S 0 9001. 'This standard is the model for QA in desigddevelopment, produc- tion, installation, and servicing. It is used during several stages when the supplier must assure conformance to specified requirements. It calls for management to define, document, implement, and main- tain a quality policy. A separate group of intemal auditors and a management rep resentative are responsible for evaluat- ing the effectiveness of the system.

Suppliers implement this standard through an effective, documented quali- ty system that outlines procedures and instructions. The supplier must have procedures for contract review, coordi- nate the review with the purchaser, and document the review. The supplier also

must control the design process and test the design, which must be continually u p dated and fully documented. Incoming a d outgoing mateds must be inspected. Test equipment must be accurate and p d s e , and appropriate procedures must be used to calibrate equipment with na- tional standards. Data must be mded and available for audits. A nonconfomhg p d u c t must not be released or installed without documented procedures. The supplier must establish, document, and maintain procedures for corrective ac- tions. Other protocols for purchasing, handling, storage, packaging, delivery, record keeping, and training form part of IS0 9001.

I S 0 W Z . This standard is a model used by the supplier for QA in produc- tion and installation. Most requirements are the same for both IS0 9001 and IS0 9002: management responsibility, quality system principles, internal au- diting, contract review, purchasing, process control, production control, ma- terial control and traceability, inspec- tion and test status, product inspection and testing, control of test equipment, control of nonconforming products, cor- rective action, handling and post-pro- duction functions, document control, quality records, and the use of statisti- cal methods.

I S 0 W3. This standard is used by the supplier as a model for QA in ihal inspection and testing. The require- ments for most areas (e.g., quality s p tem principles, material control and traceability, product verification, control of measuring equipment, control of non- conforming products, handling and post- production fundions, document control, quality records, and use of statistical techniques) are less stringent than those for IS0 9001 or IS0 9002.

I S 0 9004. This standard provides guidelines for quality management as a way to prevent, reduce, or eliminate quality deficiencies. Customers need to be contident in the ability of the company to deliver and maintain the desired quali- ty. Companies need quality manage- ment systems to attain and maintain the desired quality at an optimum cost This standard describes a basic set of

elements by which quality management systems can be developed and imple- mented, but it is not intended as a checklist for compliance with a set of re qkments. Many requkments are simi- lar to those of IS0 9001. Organization, quality manuals, and auditing parts are VerY *in both. Usingcharts and s b tistical procedures is recommended for Production control. bhas ing , maintain- ing, record keeping, and post-production

hading criteria are ais0 very similar for I S 0 9001 and IS0 9004.

The decision about which IS0 9OOO standard to apply for depends on the scope of an organization’s activities. IS0 9002 is appropriate for most chemical and process industry manufacturing plants involved in design and s@ca tion activities and in manulktwhg prod- ucts from supplied raw materials. It

includes the purchasii, testing, and dis triiution activities of the man- plant Some organizations have obtained IS0 9002 stand-alone certiilcations only for their QC/QA laboratories at their manulktwhg sites. For R&D olcilities, IS0 9001 may be more appropriate when product development, design, and ser- vice are involved in addition to other ele ments of IS0 9002.

MDAY’S CHEMIST AT WORK, NOVEMBEWDECEMBER 1993 23

o~AININO CERTIFICATION Getting an IS0 9O00 certification is a qdtessential team effort requiring the b i d , sweat, and tears of company staff at every level of management as well as professionals, technicians, operators, and other support staff working diligent- ly toward a common goal. A broad plan @&gm 2) would involve 0 Dissemination of information to and indoctrination of the rest of the organh- tion by top management

preliminary internal audit and review to assess the site’s potential and status for such a program 0 planning and resources allocation to identi@ the team leaders, to start compil- ing the quality manual, and to start im- proving key areas 0 Detailed quality manual writeup in- volving sitewide effort and, if necessary, an outside consultant 0 Detailed internal audit and review by management and the consultant 0 Preaudit and review by an auditor 0 Correction of shortcomings discov- ered in the preaudit

Registxition audit by an independent auditor.

Considerable effort is necessary for identiljhg, installing, and documenting the quality system. A number of manu- als are needed to detail each aspect of the applicable twenty IS0 elements. It is important that manuals be written by those who are doing the work rath- er than by their managers or supervi- sors. Responsibility for keeping the system up to date rests with these pee ple; however, total support from man- agement-through words and concrete action such as resource allocation-is necessary to motivate everyone to fol- low and keep up with the documented IS0 system.

The cost of achieving and maintaining IS0 registration varies, depending on the basic quality status of a company. Generally, a registrar’s fee would be $10,000 to $15,000, plus the auditing team’s travel and expenses for initial registration. This &me does not include future costs of recurring audits or the vastly larger cost of preparation for and maintenance of IS0 systems. One to two years of preparation time is a rea- sonable estimate for a medium-sized organization. When everything is taken into account, the cost per plant could be as high as $200,000 to $300,000 (6):.

The basic principles of IS0 a u d h g standards are not complicated. In each area, your organization needs to

Say what you do. JUS^ what you do. Do what you say.

Record what you did. Review what you did. Jus@/revise what you will do. A properly documented system is the

heart of an IS0 audit. Emphasis is also placed on taking timely and &&e cor- rective action so that nonconforming products are not shipped out to custom- ers. The quality system is supported at all levels of supervision within the manu- fadwing organization.

Once the internal organization is salis- fied that the quality system is in place, an external auditing organization (regis- trar) intensively audits the system, checking to make sure that the actual practice is consistent with the document- ed standards. Usually an audit team of three to four auditors, including a lead auditor, visits a site and spends two or three days going over the documented system to see that the planned system is actually p d c e d . If the audit is suaes+ ful, a registration is awarded.

After an organization receives IS0 registration and the celebratory parties are over, the road to the total quality spi- ral with continuous improvement is just begiruing.

The quality system is maintained by regular internal audits and reviews as well as two external audits per year. An awarded regisbtion can be withdrawn if, in subsequent audits, the system no

longer meets IS0 standards, In the Unit- ed Kingdom about ten h s a year lose their IS0 accreditaton. IS0 9002 does not restkt change; in

fact, it enmurages the control and proper documentation of change. However, the effort involved in these aciivities should not be underestimated. Essentially, at least one full-time person will be needed

intemal audits, documentation of chang- es, and management reviews. AU person- nel must spend time to ensure that the documented protocols are met

to any Out follow-up activities such as

1 8 0 ACCREDITORS/AUDmRS lXdpar@ auditing or registration by a body providing recognition of conformi- ty to the IS0 9OOO standards is used in at least thirty-two countries. At one point, the BSI was the only auditor authorized to register companies against IS0 9OOO standards; thus far it has registered 14,000 organizations. Since then a num- ber of other auditors (usuaIly d e d reg- islrars) have entered this field. b p l e s include Lloyd’s of London, Underwriters Laboratories, ABS Quality Evaluation, Inc., Det Norske Veritas, Intertek, BQS, Inc., Quality Systems Registrar, BVQI, American Registrar, Vincotte USA, American Gas Association Labomtories, Quality Management Institute, and ETL Testing Laboratories.

A company desiring IS0 registration . sends an application form with a fee to the registrar. Usually the registrar makes a preassessment visit and, after suggested changes have taken root, the hal audit occurs within a few months. If the company's quality systems conform to the desired IS0 9OOO standard, a regis-

tration document is issued. Over the past iive years, IS0 consulta-

tion and registration has become a growth indusm. In quality-related jour- nals there is a plethora of advertisements from consultants and registrars. B e cause some of these registering firms are not authorized to give IS0 certilk

26 TODAY'S CHEMIST AT WORK, NOVEMBEWDECEMBER 1993

tions in all fields or all countries, the need for regulation has become a p p n t

In the US, the American society for Quality Control has formedthe Registrar Accreditation Board (RAB) to meet this need. "here are similar organizatons in other countries: AFNOR/AFAQ in France, Raad Voor de CertiEcatie in Hog land, National Accreditation Council of Certi6cation Bodies in the United King- dom, and Ente Nazionale Italian0 di Uniiicazione in Italy (7). l'hree addition- al groups are being formed in Japan, Germany, and New Zealand. There is also a proposal to make the US National Institute of Standards and Technology (NIS) an accrediting body similar to the RAB. Government involvement is probably a useful development in the ac- creditation process (5).

IS0 10011 series audit standards should be used to establish auditor ac- creditation standards. It is hoped that or- ganizations such as those listed above will bring independent vefication of quality and lend crediiity to third-party registrars. In the US, the RAE3 has based its criteria on IS0 Guides 40 and 48, which direct the general requirements for acceptance of third-party registra- tions. After a registrar makes application, the RAE3 evaluates the basic organ& tion; conducts a company audit and, if it hdsthecompanysatisfacW,gmtsau accreditation that is valid for four years. Follow-up audits are conducted after the h t six months and thereafter once a year. To date, the RAB has accredited seven registran in the US. The organb tion expects that eventually about 100 registran will be needed in the US.

Acompany needs to carehlly consid- er which registrar it should contract with for IS0 9OOO registmtion because differ- ent registrars have different auditing standards. Before selecting a registrar, the company should clarify whether that registrar is registered with a national body to issue IS0 9OOO registrations is recognized to give registration/cert%ca tion in countries to which the company exports, has the expertise to match the swpe of the company's products, has ex- perience in IS0 audits, has received b vorable ratings h m earlier clients, and demonstrates a willingness to work with the company.

The selection of a competent registrar is important, because a lot of money and energy will be invested in IS0 regisba tion. It is sound bushes practice to use a registrar who is compatible with the company, and it is not uncommon to switch from one registrar to another in cases of incompatibility.

continued on p . 28

I S 0 9000fiom p . 26 BENPFITS OF CE#nFICATlON IS0 certiilcation offers two main bene fits: It has a positive impact on a com- pany’s bottom line and it improves quality throughout the company.

IS0 9OOO sets universally accepted, uniform standards of quality manage ment for all industries. ?bus a company that has been independently audited and certilied by an international standards body can demonstrate to customers that it offers quality management. IS0 certifi- cation assures that the right quality prod- uct will be consistently produced without preventing continuous improvement of a company’s systems. Five to six years are required to demonstrate the full ece

It facilitates sales to (large) customers who inherently require QA cerliiication. ‘Ihe number of such customers is steadi- bin-.

It encourages customers to reduce their own testing and audits of products received from suppliers with IS0 ce& ! cation.

’ It provides leverage by which suppli- ers can improve their quality standards if they want to do business with an ISO- certitied company.

It can provide, via a quality image in

.._ - _ _ no& benefits of IS0 certitication. How- ever, there are several practical benefits.

It provides a route for a company to gain approwd to use the CE (Commun- aute Europbe) mark on its products. This mark meets product regulations in all EC countries.

It provides tangible evidence to the staf€, customers, and suppliem that the management is committed to quality.

It assures customers of a company’s independently assessed high-quality standards.

the marketplace, a commercial advan- tage through enhanced market share over competitors who are not certilied.

Economic benefits are gained through better use of raw materials as well as reduced inspection costs and time spent on reworking, thus providing continuous improvement and elimina- tion of waste. The discipline imposed by IS0 9ooo

should minimize the likelihood of expen- sive errom and provide the means for

continued on p. 37

UNIQUE INNOVATION & NEW PRODUCTS FOR CHROMATOGRAPHY

I t LAIALWG HAS BEEN REMOVED, ClRCLt I-ftAUtH 3 t H V l b t 22 tUH YUUH WWN PERSONAL COPY.

28 TODAY’S CHEMIST AT WORK, NOWMBEWDECEMBER 1993

. I leaves no dead ends in the flow chak of

DroCeSSeS. {eightand 1

prompt and &&e corrective action in instances of nonconformance. It

It reduces the overall cost of quality. There may be higher initial prevention 1 costs, but they win be offset by lower in-

lr

t were designed to rial height for per-

3 I glass for unifor . conical pull-point- le permitting more

ed Of any springs ' to lift and hold *hi we have it automatically a1 sedles we have bottom-out". Usin

speclion costs and lower costs for inter- 1 nal and/or external Edilures. Mers Are It encourages correct application of

tion and QC, thus ensuring corred prod- UCtteSting.

European nations and companies have pursued IS0 9OOO certiiications much more aggressively and for far longer than have American companies. For example, Great Britain alone has more than 10,000 companies registered to ISO 9000 standards out of an estimat- ed 24,OOo companies registered world- wide. It is widely believed that IS0

national standards (such as those Of and M s ) in laboratory calibra-

y ensure that the )ermit almost

IS0 9OOO certitieation is not a panacea to economic success and true total quality management The lack of usefulness of I s 0 9003 has already been mentioned. In addition, the standads lack a requite ment for either continuous improvement or customer satisktion, which are e4 senw for honors such as the US Mal- colm Baldrige National Quality A d or the Japanese Deming prize.

IS0 standardsarewritknforallindus tries, regardless of their type, size, or field. Sometimes the procedures devel- oped for maintaining IS0 standards at a particular site are perceived as (and sometimes in& are) bureaucratic, with unnecessary roadblocks for smooth quality operations without actually im- proving the quality of the products. B e cause there are no specific directives in IS0 standards for certain situations, dif- ferent auditors (even those from the same firm) could give contrary evalua- tions, causing unnecem confusion.

Another criticism of IS0 9O00 stan- dards is that a site is audited against its documented system. For example, a lab oratory can use an erroneous method for chemical analysis; however, if it docu- ments and follows this method, an I s0

Ec- 9000 Standards m y wen out to be a nonbenign trade barrier in Europe! Many non-European nations have expressed concern about a post- 1992 "F'ortress Europe."

auditor (who is certainly not an expath myriad chemical and physical tests) v d ~ not identify this as an erroneous test for: proving product quality. To overcome this problem, many companies (such as; Exxon) have instituted in-house qudw auditing programs to complement the, IS0 90oO requirements. Japan, an acknowledged quality leader

nation, has yetto embracewholeheattedy the IS0 9OOO standards, because it b e lievesthatJapanesequalitystandardsm more rigorous than the IS0 9OOO stan- dardS.VeryfewJapanesecompaniem working toward IS0 9ooo registrations; however, that might change in the post- 1992 EC. M~toroh, a 1988 Malcolm Bac drige National Quality Award winner, has not pilusued IS0 9OOO &&ations in the US because it believes that its intemal quality system is much more stringent thanIsO9ooo.

An IS0 committee called Ad Hoc Task Force of IS0 E 176 was co"i+ sioned to prepare a strategic plan for im- plementation and iuture changes in the Is0 90oO standards. ?he task force re port is commonly referred to as "vision 2000" (8). The major revisions, which will be issued in 1996, should address many of the dekiencies.

CIRCLE 40 ON READER SERVICE CARD - ---. -

The planned changes include specific language; inclusion of continuous im- provement; and evidence of a satishe tory track record of performance in product quality, delivev, and customer satisfaction. There will be guidance doc- uments for software, processed materi- als, and services. However, Vision 2OOO strongly discourages the production of industry/economic-sector-specific ge- neric quality standards supplemental to, or derived from, IS0 9OOO standards. Thus the product-s@c standards con- taining necessary technical details and speciilc product test methods will have to be developed within the analogous in- dustry sectors.

IS0 REAUllES There is little doubt that IS0 9OOO regis tration will be a critical requirement for American chemid manufacturers ex- porting to westem European markets. American exports to the EC were $72.4 billion in 1990 and $100 billion in 1991, and Americans can hardly afford to be excluded h m this market. Some giant US corporations such as DuPont (150 registered sites) and Exxon Chemical (ninety4x registered sites; @-six s i b in progress) have been at the forefront of the IS0 quality management drive b e cause of the nature of their international chemical businesses.

However, a recent survey of execu- tives from thirty US companies export- ing products to Europe genedy found a lack of knowledge about IS0 9OOO stan- dards. S i percent of the companies had completed little or no planning to ward implementing IS0 9OOO standards (9). Another survey of mid-sized US firms found that 48 percent had not heard of IS0 9OOO standards! Only 11 percent said that they thought the stan- dardswouldaffectthemagreatdeal,and only 8 percent were planning to become registered by the end of 1992.

Out of six million companies in the US, about 400 company sites are regis tered for IS0 9ooo standards. Of these, 34 percent are chemical industries. ?hese include Exxon, Wont , Dow, ICI, A”, Texaco, Ethyl, Eastman Kodak, Hoechst Celanese, FMC, Monsanto, Union Carbide, Uniroyal, and Witco. The CMA has also endorsed the benefits of IS0 9OOO registration to the US chemical industry. Companies that support analyt- ical activities in industrial or academic labonhies have also started registering for IS0 and using this advantage in their advertisements. These vendors include Fisher scientific, Mettler Toledo, Varian, J. T. Baker, Beckman, Canon Instru- ments, and E. Mer& Science.

The Department of Defense and NATO have included explicit use of I s0 9O0Ostandardsintheirprocurementpro- cedures. Similarly, OSHA, EPA, and FDA are planning to adopt IS0 9OOO standards. A number of other large nonchemid process industries, such as AT&T and Hewlett Packard, have also been rully involved in IS0 9OOO imple- mentation in their plants. Curiously, however, US automakers have decided to continue with their own quality stan- dards rather than use IS0 standards.

Some companies, such as DuPont and AT&T, have so many of their sites regis tered with the IS0 that they have opened consulting semices to help other compa- nies acquire IS0 registraiion.

DuPont, for example, has 150 IS0 9OOO registrations at sites throughout the world, including more than seventy in the US. The company has set up a joint venture with P-E International to collabo- rate on developing and marketing DuPont‘s expertise in this area. To do business in Europe in the immediate fu- ture, and in the rest of the world in the long range, US chemical industries will require the adoption of IS0 9ooo stan- dards. Achieving IS0 9OOO regidration is not an end in itsee it is only a sound foundation for total quality management I s0 9OOO can be looked upon as the low- est common denominator of quality sys tems on which tobase enhand practices to achieve total quality, lowered cost& in- creased customer satisfaction, and im- pmdmarketshare.

\

c c -

References (1) Nadkami R A M C k m 1991,63,675A. (2) Oakland, J. S. Total Qualib Management,

Heinemann: Oxford, 1989. (3) International Organization for Standardin-

tion--Iso 9OOO Standard (1987). (4) ANSI/ASQC 990 IS0 9000 Guidelines;

ASQC Quality Press: Milwaukee, WI, 1992. (5) B~rnes, D. Quality 1992, October issue, 19. (6) Lofgren, G. Q. Quality h g r m 1991,24(5),

35. (n Stratton, J. H. Quality Progrm 1992,25(1), 67.

(8) Marquardt, D.; Chove, J.; Jensen, IC, Pet- rick, IC; &le, J.; Strahle, D. QualityprogresS 1991, 25.

(9) Constanzo, A. Qmlity 1992, September is- sue, 47.

sw3- reading Cothan, R J. A &&book to IS0 9ooo and

ANSI/ASQC 990; ASQC Quality Press: Mil- waukee, WI, 1992.

Hutchins, G.B. IS0 9ooo: A Comprehensive Guide; Oliver Wght Companies asex Junc- tion, Vr, 1993.

Iamprecht, J. L. IS0 9ooor Preparing& Regis- truth; ASQC Quality Press: Milwaukee, WI, 1992.

Adapted from Analytical Chemistry, Vol. 65,

R A N ~ K A R N I received his B.D. &m the Univm$y of Bombay. PTim to joiniw E”, he was a mearch associate at the Universi& of Kentucky and a research mnuger of the Materials Science Center anal*al ficility at Come11 Unive“&. He currently coordinates the analytical QC activity and long.range a n u l w l di- rections of twenty labomtories wwwlde, and h a been actively involved in the I S 0 9ooo registmtims of aU of them.

No. 8.15 April 1993.

38 TODAYS CHEMIST AT WORK, NOVEMBEWDECEMBER 1993