Quality Mana ernent Standards for Chprlnical an Process Industries
3
R. A. Nadkarni Emon Chemical Company PARAMINS Manufacturing Technology Division 1900 East Linden Avenue Linden, KI 07036 Quality management is not just a strategy. It must be a new style of working, even a new style of thinkiw. A dedication to quality and excellence is more than good business. It is a way of fife, giving something back to society, offeringyour George Bush,1991 best to others.
as well as its impact on US.chemical and proeess industries. With the completion of the European Community (EC) single market at the end of 1992, quality management has become increasingly important to all industries worldwide. The unified Western European market ha8 320 million consumers from 12 EC countries (Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, and t h e United Kingdom) and 30 million consumers from six European Free Trade Association countries (Austria, Finland,
US.chemical and proeess industries have long enjoyed a leadership role in world markets. However, for continued success, particularly in Europe, wmpanies must address a critical area. Today, the performance of an individual company must be acceptable under internationally rewgnized quality assurance (QA) practices. Dealing with quality issues is not wnfined to quality professionals; it should be of equal importance t o all practicing chemists and chemical engineers. In this REPORT, I will discuss an internationally accepted QA certification and registration system 0003-2700/93/0365-387A/$04.00/0 0 1993 American Chemical Society
REPORT Iceland, Norway, Sweden, and Switzerland) that have bridging agreements with EC countries. Without demonstrable &A practices, US. chemical industries may face problems in exporting products to Weste m Europe. The keystone of quality management is the wncept of customer and supplier working together for their mutual advantage ( I ) . Irrespective of
whether the managers of a n organization believe they are operating under a quality system, it must be demonstrably visible to the customer that the organization is indeed operating under such a system. In other words, beauty is in the eye of the beholder. John Oakland, a noted expert in the field of total quality management, has defined a quality system as a n assembly of components such as the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management (2). These components interact and are interdependent in a given system; thus, the isolated study of one component in detail will not necessarily lead to understanding or improvement of the whole system. This concept is illustrated in Figure 1(3). It is the function of management to determine and implement a quality policy. A quality system consists of two p a r k quality wntrol (QC) for operational techniques and activities and internal QA t o ensure that the intended quality is achieved. When stated i n t h e contract, suppliers must assure purchasers of the qual-
ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15,1993 * 387 A
REPORT ity by following the quality management practices mentioned above. Quality audits Normally a purchaser checks the quality of a supplier through an audit of the product, the manufacturing facility, andlor the management practices. An audit is an evaluation of actual practice compared with a concept of good practice. It is an independent review conducted to see whether quality performance measures up t o the standard for t h a t performance. Companies use quality audits to evaluate their own activities and those of their suppliers, licensees, and agents. Regulatory agencies use these audits to judge the quality activities of the organizations they oversee. Customers assure the quality of suppliers via audits. There are many well-documented audit formats, such as those used by Ford Motor Company in ita QlOl, Q1, and TQE certifications or by the US.military for MIL certifications. There have been similar national standards in many North American and Western European nations. However, to create a focused standardization for these requirements, international standards were issued five years ago by the International Organization for Standardization (ISO). What is IS07 ISO, which is based in Geneva, Switzerland, was organized in February 1947 "to promote the development of standardization and related activities in the world with a view to facilitating international exchange of goods and services, and to develop cooperation in the sphere of intellectual, scientific, technological, and economic activity." At present there are 90 member bodies, each representing the primary organization that sets standards in the respective countries. A short list of members includes Australian Standards, the British Standards Institute (BSI), the Can dian Standards Association, the Comite Europbene de Normalisation (EEC), the Association Franpise de Normalisation, the Deutache Institut fur Normung, the Indian Standards Institute, the Japan Industrial Standards Committee, the Singapore Institute of Standards and Industrial Research, and the South African Bureau of Standards. The U.S.member body, the American Natipnal Standards Institute (ANSI),represents more than 250 domestic standardswriting organizations.
I
. . .
Figun
(Adapted with permission lmm Reference 3.)
Table 1. IS0 equivalent national quality management standards' cwntry
lsom
Australia 3900 1ASI -, Bel ium 50-002-1 (&N-X) Canada 2299.0 (CW European 29000 Economic Community (EN) France 50-121 (NF-X) Germany 9OOO (DIN) lnciia(is) 10201-2 ltal 29000 (LNIEN) NW 5600-1 Zealand
lsowol
1509002
lsowos
IsoWM
3901
3902
3903
3904
50-003
50-004
50-005
50-002.:
2299.1
2299.2
2299.3
0420
29001
29002
29003
29004
50-131
50-132
50-133
50-122
9001
9002
9003
9004
10201-4 29001
10201-5
10201-6
10201-3
29002
29ooo
29004
5601
5802
5603
5600-2
901
902
903
904
9001
9002
9003
9004
5750-1 91
5750-2 92
5750-3 93
5750-0-0.2
~
Spain
900 (UNE,66) Swikedand 9OOO (SN) U.K. (BS) 5750-0-0.1
USA.
(a)
90
94
.Adapted with permisaim fmm Reference 4.
The technical work of IS0 is conducted by technical committees (TCs), which in turn may establish subcommittees and working groups. TC 176 on QA studied the issue of standardization of quality standards during the period 1983-86. The fmal standards issued in 1987 are not necessarily innovative. They were based on quality practices approved in many European nations and in North America. In large part, I S 0 9000-9004 standards were based on
388 A * ANALYTICAL CHEMISTRY, VOL. 65. NO. 8, ARRIL 15,1993
British stand& BS 5760-1979. The five IS0 doeuments listed in the box on p. 389 A pmvide information for building a quality system (i.e., guidelines) and for contracts between supplier and purchaser (i.e., models). Rather than reinvent the wheel, authorities in many countries accepted the IS0 standards essentially in toto, sometimes only changing the designation numbers (e+, the ANSI refers to IS0 9000 by Q90). A partial list of IS0 equivalent na-
tional standards is given in Table I. By mid-1992, 53 countries had adopted the IS0 9000 standards as their national Standards. What are the IS0 go00 standards? The five documents in the IS0 9000 series are an interrelated set. Overall, there are 20 “elements” or criteria in the I S 0 9000 series that encompass various aspects of quality management. These are listed in the box on p. 391 A with brief descriptiom of content for each element. Not all criteria are necessary for each IS0 9000 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. IS0 9000 and 9004 are guidelines for building a quality system and use phrasen such as “The quality system should.. . .” IS0 9001 thmugh 9003, on the other hand, are models for contracts between a supplier and a purchaser and use phrases such as “The supplier shall. . . .” Thus organizations are audited against I S 0 9001, 9002, or 9003-1kt against IS0 9000 or 9004. To date, almost all organizations have been certified for I S 0 9001 or 9002. IS0 9003, which concerns inspection and testing, is considered to be of limited value and has not been used extensively; only four of the apprmdmately 400 US.registrations to date have been for IS0 9003 (5).In fact, the IS0 is planning to delete the IS0 9003 standard. The interrelationship among these three standards is summarized in Table I1 (3). Brief descriptions of individual standards follow. IS0 9000. This standard defines
the principal quality concepts and provides guidance for selecting appropriate standards to assure conformance to contract requirements that can be used for internal quality management purposes ( I S 0 9004) andlor for external QA ( I S 0 9001 through 9003). The guideline calls for a quality policy statement from t h e top management. Achieving quality requires the participation of everyone i n the organization, but quality management is the responsibility of top managers. Quality management includes planning, resources, operations, and all “systematic activities for quality.” Contracts and audits may mandate demonstration of a quality system. QC involves monitoring processes and eliminating causes of poor performance to achieve economic effectiveness. QA consists of the planned and systematic actions needed to provide adequate confidence that a product or service will satisfy quality requirements. QA is both a management tool and the customer’s marantee of quality. IS0 9001. This standard is the model for QA in designldevelopment, production, 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 maintain a quality policy. A separate group of internal auditors and a management representative are responsible for evaluating the effectiveness of the quality system. Suppliers implement this standard through a n effective, documented quality system that outlines procedures and instructions. The supplier must have procedures for contract
--
Meow
nu.
9000
Guidelines
9001
Mc
QualityManagement and QualityAssurance Standards: Guidelines for Selection and Use Quality Assurance in DesigrdDevelopment. Prcduction, Installation, and servicing Quality Assurance in PrOducIlon and
stan
I
9002
Installation .. . ..
9003
..n
9004
GI,
IS
QualityAssurance in Final Inspection and Testing QualityManagement and QualitySystem Elements: Guidelines
review, coordinate 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 updated and fully documented. Incoming and outgoing materials must be inspected. Teat equipment must have adequate accuracy and precision, and appropriate procedures must be used to calibrate equipment with national standards. Data must be recorded and available for audits. A nonconforming product must not be released or installed without documented procedures. The supplier must establish, document, and maintain procedures for corrective actions. Other protmols for purchasing, handling, storage, packaging, delivery, record keeping, and training form part of IS0 9001. I S 0 900% This standard i s a model used by the supplier for QA in production and installation. Most requirements are the same for both I S 0 9001 and I S 0 9002: management responsibility, quality system principles, internal auditing, contract review, purchasing, process control, production control, material control and traceability, inspection and test status, product inspection and testing, control of test equipment, control of nonconforming producta, corrective action, handling and post-production functions, document control, quality records, and the use of statistical methods. IS0 900% This standard is used by the supplier as a model for QA in f u d inspection and testing. The requirements for most areas (e.g., quality system principles, material control and traceability, control of verification status, product veriiication, control of measuring equipment, control of nonconforming products, handling and post-production functions, document control, quality records, and use of statistical techniques) are less stringent than those for IS0 9001 or IS0 9002. IS0 9004. This standard provides guidelines for quality management as a way to prevent, reduce, or eliminate quality deficiencies. Customers need to be confident in the ability of the company to deliver and maintain the desired quality. Companies need quality management systems to attain and maintain the desired qnality at an optimum cost. This standard describes a basic set of elements by which quality management systems can be developed and implemented, but it is not intended as a checklist for compliance with a set of requirements. Many re-
ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15,1993
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389 A
REPORT quirements are similar to those of I S 0 9001. Organization, quality manuals, and auditing parts are very similar i n both. The use of charts and statistical procedures is recommended for production control. Purchasing, maintaining, record keeping, and post-production handling criteria are also very similar for IS0 9001 and IS0 9004. The decision about which IS0 9000 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 specification activities and in manufacturing producta from supplied raw materials. It includes the purchasing, testing, and distribution activities of t h e manufacturing plant. Some organizations have obtained IS0 9002 stand-alone certifications only for their QCIQA laboratories a t their manufacturing sites. For R&D facilities, IS0 9001 may be more appropriate when product development, design, and service are involved in addition to other elements of IS0 9002. How to obtain certification Getting an IS0 9000 certification is a quintessential team effort requiring the blood, sweat, and tears of company staff a t every level of management as well as professionals, technicians, operators, and other support staff working diligently toward a common goal. A broad plan (Figure2)would involve Dissemination of information to and indoctrination of the rest of the organization by top management Preliminary internal audit and review to assess the site’s potential and status for such a program Planning and resources allmation to identify the team leaders, to start compiling the quality manual, and to start improving key areaa Detailed quality manual write-up involving site-wide effort and, if necessary, an outside consultant Detailed internal audit and review bv manaeement and the consultan; Pre-audit and review hv an auditor Correction of shortcomings discovered in the pre-audit Registration audit by an independent auditor. A considerable effort is necessary for identifying, installing, and documenting the quality system. A number of manuals are needed to detail each aspect of applicable 20 IS0 elements. It is important that these
manuals be written by the people who are doing the work rather than by their managers or supervisors. Responsibility for keeping the system up to date rests with these people; however, total support from management-through words and concrete action such as resoume allocation-is necessary to motivate everyone to follow and keep up with the documented IS0 system. Cost of IS0 registration The cost of achieving and maintaining IS0 registration varies, depend-
ing 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 figure does not include future costs of recurring audits, nor does it include the vastly larger cost of preparation for and maintenance of I S 0 systems. One to two years of preparation time is a reasonable estimate for a medium-sized organization. When everything is taken into account, the cost per plant could be as high as $200,000to $300,000(6).
Management Responsibility Qualitv Svstem Principles Auditik &e Cuality System flntemal) Economics-Quality- Related Cos1Consideralions Quality In Marketing (Contract Revw) iliation and Q%I$?Egn control) Quality In Procurement (Purchasing) Quality In Prcduction (Pmcess
4 5 5.4
6
Control) Control of Production
2
Material Control and Traceability Product ldentihcatlon and fraceability) ’ Control of Verification Status (Inspection and Test Status) Product Verification (Inspection and Testina) Control 01 M&unng and Test Equipment (In Measuring, a n x ? Equipment) Nonconlormity (Control of Nonconforming Products) Corrective Action Handling and Post-Production Functions (Handlin ,Storage. Padwing, and De Iww) .~ After-SaiesServidng Quality Documentaton and Records (DocumantControl) Quality Records Personnel (Training) Product Safety and Liability Use of Statislicai Methods (Statistical Techniques) Purchaser-SuppliedProduct
4.1 4.2 417
H H H
4.3
H
44
H
Q
4.1 4.2 4.16
4.1 4.2
0
-
Q
-
-
4.3
-
4.6
4.5
4.9
4.8
H
4.9 4.8
4.8 4.7
H H
4.12
4.11
4.10
4.9
4.4
”
7
2
-
3
-
390 A * ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15,1993
B
4.7
H
4.5
4.1 I
H
4.10
4.13
fl
4.12
H
4.8
4.14 4.15
H
4.13 H 4.14 H
4.9
4.19 4.5
H H
-
4.4
4.16 H 4.18
4.15 4.17
4.20
H
4.18
4.7
H
4.6
-
4.6
H
m -
4.3
Q
4.10
@ 0
4.11
4.12
H
Q
-
Q
-
20 elements of the IS0 go00 series standards 1. Management responslblilty requires quality policy to bed
mented, communicated, implemented, and maintained. Responsibilities of personnel dealing with quality must be defined; in-house resources must be used for verification, and a management representative must periodically review the quality system to assure its suitability and effectiveness.
I
2. Quallty system should be documented as a manual and implemented.
3. Contract review requires review of purchase orders and contracts for adequate definition of requirements and the ability of the company awarded the contract to meet them.
I
4. Deslgn control requires planning the design project, defining design input and output parameters, verifying the design, and controlling design changes. 5. Document control requires procedures for controlling generation, distribution, and changes in documents.
6. Purchased products have to conform to specified requirements. This is achieved through subcontractor assessments, clearly defined requirements, and verification of the purchased product's quality. 7. Supplied product needs must be verified, stored. and maintained by documented procedures.
8. Product identiflcation and traceabllity require product identification by item, batch, or lot during all stages of production, delivery, and installation.
S. Process control procedures are needed for production or installation. This requires documented instructions, monitoring and control of processes and equipment, and criteria for workmanship. 10. Procedures for Inspecting and testing incoming materials, products as they are processed, and final products are required. Records of inspection, test data, and disposition of products must be maintained.
I
11. Inspectlng, measurlng, and testing equlpment requires procedures
for calibrating, checking, controlling, and maintaining test and measuring equipment. 12. Inspection and test status requires markings, stamps, or labels on products as they move through various processing steps to indicate conformance or nonconformanceto testing.
I
1 8 Control of nonconforming productsto prevent their inadvettent use or
installation requires formal procedures to review and dispose of such products. 14. Corrective action must be taken to investigate and eliminate noncon
ng, storage, packaging, and dellvery procedures for product be developed and maintained. records must be identified, collected, indexed, filed, stored, ined, and disposed of in a documented fashion. uality audits must be planne management; any deficiencies
needs are identified and trainin personnel. Training records are
is0 audlt The basic principles of IS0 auditing standards are not complicated. In each area, your organization needs to Say what you do. Justify what you do. Do what you say. Record what you did. Review what you did. Justifylrevise what you will do. A properly documented system is the heart of an IS0 audit. Emphasis is also placed on taking timely and effective corrective action so that nonconforming products a r e not shipped out to customers. The quality system is supported a t all levels of supervision within the manufacturing organization. Once the internal organization is satisfied that the quality system is in place, an external auditing organization (registrar) intensively audits the system, checking to make sure that the actual practice is consistent with the documented 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 practiced. If the audit is successful, a registration is awarded.
After registration After an organization receives IS0 registration and the celebratory parties are over, the road to the total quality spiral with continuous improvement is just beginning. The quality system is maintained by regular internal audits and reviews as well as two external audita per year. An awarded registration can be withdrawn if, in subsequent audits, the system no longer meets IS0 standards. In the United Kingdom about 10 fmms a year lose their IS0 accreditation. IS0 9002 does not restrict change; in fact, it encourages the control and proper documentation of change. However, the effort involved in these activities should not be underestimated. Essentially, a t least one fulltime person will be needed to carry out follow-up activities such as internal audits, documentation of changes, and management reviews. Additionally, all personnel have to spend time to make sure that the documented protocols are met. IS0 accreditors/audltors Third-party auditing or registration by a body providing recognition of conformity to the IS0 9000 standards is used in a t least 32 countries. At one point, the BSI was the only
ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15, 1993 * 361 A
REPORT auditor authorized t o register companies against IS0 9000 standards; thus far it has registered 14,000organizations. Since then a number of other auditors (usually called registrars) have entered this field. Examples include Lloyd's of London, Und e r w r i t e r s Laboratories, ABS Quality Evaluation, Inc., Det Norske Veritas, Intertek, BQS Inc., Quality Systems Registrar, BVQI, American Registrar, Vincotte USA, American Gas Association Laboratories, 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 final audit occurs within a few months. If the company's quality systems conform to the desired IS0 9000 standard, a registration document is issued. Over the past five years, IS0 consultation and registration has become a growth industry. In qualityrelated journals there is a plethora of advertisements from consultants and registrars. Because some of these registering firms are not authorized to give IS0 certifications in all fields or all countries, the need to regulate activities has become apparent. In the United States, the American Society for Quality Control has
formed the Registrar Accreditation Board (RAB) to meet t h i s need. There are similar organizations in other countries: AFNORIAFAQ in France, Raad Voor de Certificatie in Holland, National Accreditation Council of Certification Bodies in the United Kingdom, and Ente Nazionale Italian0 di Unificazione in Italy (7).Three additional groups are being formed in Japan, Germany, and New Zealand. There is also a proposal to make the U. s. National Institute of Standards and Technology (NIST) an accrediting body similar to the RAB. Government involvement is probably a useful development in the accreditation process (5). IS0 10011 series audit standards should be used to establish auditor accreditation standards. It is hoped that organizations such a s those listed above will bring independent verification of quality and lend credibility to third-party registrars. In the United States, t h e RAB has based its criteria on IS0 Guides 40 and 48, which direct the general requirements for acceptance of thirdparty registrations. After a registrar makes application, the RAB evaluates the basic organization; conducts a company audit; and, if it finds the company satisfactory, grants an accreditation t h a t is valid for four years. Follow-up audits are conducted after the first six months and
I
I
I
rigure 2. Route to IS0 9000 regisrrarion. 392 A
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ANALYTICAL CHEMISTRY, VOL. 65. NO. 8, APRIL 15,1993
I
thereafter once a year. To date, the RAB has accredited seven registrars in the United States. The organization expects that eventually about 100 registrars will be needed in the United States. A company needs to carefully consider which registrar it should contract with for IS0 9000 registration, because different 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 9000 registrations, is recognized to give registrationlcertification in countries to which the company exports, has the expertise to match the scope of the company's products, has experience in IS0 audits, has received favorable ratings from earlier clients, and demonstrates a willingness to work with the company. The selection of a competent registrar is important, because a fairly large amount of money and energy will be invested in the IS0 registration effort. It is sound business practice to use a registrar who is compatible with the company, and it is not uncommon to switch from one registrar to another in cams of incompatibility. Benefits of IS0 certification
IS0 certification offers two main benefits: It has a positive impact on a company's bottom line and it improves quality throughout the company. IS0 9000 s e t s universally accepted, uniform standards of quality manaeement for all industries. Thus a company that has been independently audited and certified by an international standards body can demonstrate to customers that it offers quality management. IS0 certification assures that the right quality product will be consistently produced without preventing continuous improvement of a company's systems. Five to six years are required to demonstrate the full economic benefits of IS0 certification. However, there are several practical benefits It provides a route for a company to gain approval to w e the CE (Communaute Europkene) mark on its products. This mark meets product regulations in all EC countries. It provides tangible evidence t o the staff, customers, and suppliers that the management is committed to quality practices. It assures customers of a company's independently assessed high-
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ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15,1993 * 393 A
REPORT quality standards. It facilitates sales to (large) customers who inherently require QA certification. The number of such customers is steadily increasing. It encourages customers to reduce their own testing and audits of products received from suppliers with IS0 certification. I t provides leverage by which suppliers can improve their quality standardsif they want to do business with an ISO-certified company. It can provide, via a quality image in the marketplace, a commercial advantage through enhanced market share over competitors who are not IS0 certified. 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 elimination of waste. The discipline imposed by IS0 9000 should minimize the likelihood of expensive errors and provide the means for prompt and effective corrective action in instances of nonconformance. It leaves no dead ends in the flow chart of processes. It reduces the overall cost of quality. There may be higher initial prevention costs, but they will be offset by lower inspection costs and lower costs for internal and/or external failures. It encourages correct application of national standards (such as those of ASTM and NIST) in laboratorv calibration and QC, thus correct Product testine. European nations and compani : have pursued IS0 9000 certifications muchmore aggressively and for far longer than have American companies. For example, Great Britain alone has more than 10,000 companies registered to IS0 9000 standards out of a n estimated 24,000 companies registered worldwide. It is widely believed that IS0 certification will be an essential requirement for doing business in the post-1992 EC. IS0 9000 standards may well t u r n out to be a nonbenign trade barrier in Europe! Many non-European nations have expressed concern about a post- 1992 Tortress Europe.”
Shortcomings of IS0 standards IS0 9000 certification is not a panacea to economic success and true total quality management. The lack of usefulness of IS0 9003 has already been mentioned. In addition, t h e standards lack a requirement for either continuous improvement or cuatomer satisfaction, which are essen394 A
IS0 4000
t i a l for honors such as t h e U.S. Malcolm Baldrige National Quality Award o r t h e J a p a n e s e Deming Prize. IS0 standards are written for all industries, regardless of their type, size, or field. Sometimes the procedures developed for maintaining IS0 standards at a particular site are perceived as (and sometimes truly are) bureaucratic, with unnecessary roadblocks for smooth quality operations without actually improving the quality of t h e products. Because there are no specific directives in IS0 standards for certain situations, different auditors (even those from the same auditing firm) could give contrary evaluations, causing unnecessary confusion. Another criticism of I S 0 9000 standards is that a site is audited against its documented system. For example, a laboratory can use an er-
ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15,1993
roneous method for chemical analysis; however, if it documents and follows this method, a n IS0 auditor (who is certainly not a n expert in myriad chemical and physical tests) will not identify this as an erroneous test for proving product quality. To overcome this problem, many cornpanies (such as Exxon, for example) have instituted in-house quality auditing programs to complement the IS0 9000 requirements. An acknowledged quality leader nation, such as Japan, has yet to embrace wholeheartedly the I S 0 9000 standards, because it believes that Japanese quality standards are more rigorous than the I S 0 9000 standards. Very few Japanese companies are working toward IS0 9000 registrations; however, that might change in the post-1992 EC. Motorola, a 1988 Malcolm Baldridge National Quality Award winner, has not pursued IS0 9000 registrations in the United States because i t believes that its internal quality system is much more stringent than IS0 9000. An IS0 committee called Ad Hoc Task Force of IS0 TC 176 was commissioned to prepare a strategic plan for implementation a n d f u t u r e changes in the IS0 9000 standards. The task force report is commonly referred to as Vision 2000” (8).The major revisions, which will be issued in 1996, should address many of the deficiencies. The planned changes include specific language; inclusion of continuous improvement; and evidence of a satisfactory track record of performance in product quality, delivery, and customer satisfaction. There will be guidance documents for software, processed materials, and services. However, Vision 2000 strongly discourages the production of industry/ economic-sector-specific generic quality standards supplemental to, or derived from, IS0 9000 standards. Thus the product-specific standards containing necessary technical details and specific product test methods will have to be developed within the analogous industry sectors.
Concluding remarks There is little doubt that IS0 9000 registration will be a critical requirement for American chemical manufacturers exporting to Western 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 from this expanding market. Some giant U.S.chemical corporations such as Du Pont (150 registered
sites) and Exxon Chemical (96 registered sites; 56 sites in progress) have been at the forefront of the IS0 quality management drive because of the nature of their international chemical businesses. However, a recent survey of executives from 30 US. companies exporting products to Europe generally found a lack of knowledge about IS0 9000 standards. Sixty percent of the companies had completed little or no planning toward implementing IS0 9000 standards (9). Another survey of mid-sized U.S.firms found that 48% had not heard of IS0 9000 standards! Only 11%said t h a t they thought the standards would affect them a great deal, and only S% were olannine to become reeistered bv the knd of G92. Out of six million comoanies in the United States, about 400 company sites are registered for IS0 9000 standards. Of these, 34% are chemical industries. These include Exxon, Du Pont, Dow, ICI, Amoco, Texaco, Ethyl, Eastman Kodak, Hoechst Celanese, FMC, Monsanto, Union Carbide, Uniroyal, and Witco. The Chemical Manufacturers' Association has also endorsed the benefits of IS0 9000 registration to the U S . chemical industry. Companies that support analytical activities in industrial or academic laboratories 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 Instruments, and E. Merck Science. The Department of Defense and NATO have included explicit use of IS0 9000 standards in their procurement procedures. Similarly, OSHA, EPA, and FDA are planning to adopt IS0 9000 standards. A number of other large nonchemical process industries, such a s AT&T and Hewlett Packard, have also been fully involved in IS0 9000 implementation in their plants. Curiously enough, however, US. automakers have decided to continue with their own quality standards rather than use IS0 standards. Some companies, such as Du Pont and AT&T, have so many of their sites registered with the IS0 that they have opened consulting services to help other companies acquire IS0 registration. Du Pont, for example, has 150 IS0 9000 registrations a t sites throughout the world, including more than 70 in the United States. The company has set up a joint venture with P-E International to collaborate on I
developing and marketing Du Pont's expertise in this area. To do business in Europe in the immediate future, and in the rest of the world in the long range, U S . chemical industries will require the adoption of IS0 9000 standards. Achieving IS0 9000 registration is not an end in itself; it is only a sound foundation for total quality management. IS0 9000 can be looked upon as the lowest common denominator of quality systems on which to base enhanced practices to achieve total quality, lowered costs, increased customer satisfaction, and improved market share.
Eighth Edition Reagent -
Chemlcals
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References (1) Nadkami, R. A. Anal. Ckem. 1991, 63,
675 A.
(2) Oakland, J. S. Total Quality Management Heinemann: Oxford, 1989. (3) International Or anization for Standardization-IS8 9000 Standard (1987). (4) ANSI/ASQC Q W I S 0 WOO Guidelines;
ASQC Quality Press: Milwaukee, WI, 1992.
(5) Byrnes, D. Quality 1992, 19, October
issue.
(6) Lofgren, G . Q. Quality Progress 1991, 244(5),35. (7) Stratton, J. H. Quality Progress 1992, 7 2 , l l C? Y . .
I " \A,,
Marquardt, D.; Chove, J.; Jensen, K.; Petrick. IL; Pyle, J.; Strahle, D. Qualify
(8)
Propress 1991. 24(5).25. (9) &nstanzo; A. Qiality 1992, September issue, 47.
Suggested reading Cottman, R. J. A Guidebook lo I S 0 9ooo and
ANSI/ASQC Q W , ASQC Quality Press:
Milwaukee, WI, 1992. Hutchins, G. B. I S 0 9 m : A Comprehnrcivo Guide; Oliver Wight Companies: Essex Junction, VT, 1993. Lamprecht, J. L. I S 0 WOO: Preparing for Regislrafion; ASQC Quality Press: Milwaukee, WI, 1992.
tion5 and analytical procedures to assure the quality of your chemicals ACS specified reagent chemicals are the choice of most oroanizations such as APHA. >~ ASTi.~CC?. X U , LSP. erc. and many re$ atory aqerc.6 sLrn as tne E>A. :niprovec diid expanaed. me eignth edition of fh s asnor rat ve reference now comes in a user-friendly format that makes look-upquick and easy. In it you'll find all the necessary information on ~~~~~~~~
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stomlc absorption SpFFtrophotometry chromatography colorimetry and turbldlmetry direct electrometrlc methods gravlmetric methods measurement of physical proprtles reagent SOlutlonS
solid reagent mixtures solvents for speclal purposss speclflcationsand tests standard volumetric solutions tltrimetry NPWin this.Pditinn .. . are ..a .%tion on deteriin.ng oetection Itmiti the general elimination of boiling pint and oensity sp?cic rations the use of LC in assay determinations. and a section on preparation of volumetric solutions. Twenty-four new reagents have been added Updated methods include gas chromatography where capillary columns are now used. water determinations where coulometric methods have been added. and the replacement of flame emission techniques by atomic absorption for metal determinations. In addition, the oeneral methods for chromatwraohv and i t o m c atmrpt on nave t e n extensively revised to ref ect their practical .se in tcday s typica analytica labrator) 1815 pages (1993) Clothbound _
R. A. Nadkarni recieued his Ph.D. from the Univently ofBombay. &or lo joining Enon, he was a rpsearrh associate at the University of Kenlucky and a research manager ofthe Materials Science Cenler analytical facility a / Contell Uniuenity. He currently roordinates lhe onalytiral QC artiuify and lonprange analytical directions of20 laboratorips worldwide. and has been active/) involued in lhe I S 0 9ooo regislrations o/all ofthem.
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ISBN 0-8412-2502-8 $149.95
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ANALYTICALCHEMISTRY. VOL. 65, NO. 8. APRIL 15,1993
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