Quality Management Standards for Chemical and Process Industries R. A. Nadkarni Exxon Chemical Company PARAMINS Manufacturing Technology Division 1900 East Linden Avenue Linden, NJ 07036
Quality management is not just a strategy. It must be a new style of working, even a new style of thinking. A dedication to quality and excellence is more than good business. It is a way of life, giving something back to society, offering your best to others. George Bush, 1991 U.S. chemical and process industries have long enjoyed a leadership role in world markets. However, for continued success, particularly in E u rope, companies must address a critical area. Today, the performance of an individual company must be acceptable under internationally recognized quality assurance (QA) practices. Dealing with quality issues is not confined to quality professionals; it should be of equal importance to 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 © 1993 American Chemical Society
as well as its impact on U.S. chemical and process industries. With the completion of the European Community (EC) single market at the end of 1992, quality managem e n t h a s become increasingly important to all industries worldwide. The unified Western European market has 320 million consumers from 12 EC countries (Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, and the United Kingdom) and 30 million consumers from six European Free Trade Association countries (Austria, Finland,
REPORT Iceland, Norway, Sweden, and Switzerland) t h a t have bridging agreem e n t s with EC countries. Without d e m o n s t r a b l e QA p r a c t i c e s , U . S . chemical industries may face problems in exporting products to Western Europe. The keystone of quality m a n a g e ment is the concept of customer and supplier working together for their mutual advantage (1). Irrespective of
whether the managers of an 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. J o h n Oakland, a noted expert in t h e field of total quality m a n a g e ment, has defined a quality system as an assembly of components such as the organizational structure, responsibilities, procedures, processes, a n d r e s o u r c e s for i m p l e m e n t i n g quality management (2). These components interact and are interdependent in a given system; thus, the isol a t e d s t u d y of one c o m p o n e n t 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 parts: quality control (QC) for operational techniques and activities and internal QA to ensure t h a t the intended quality is achieved. When s t a t e d in t h e c o n t r a c t , s u p p l i e r s 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, and/or 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 to the standard for that 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 its Q101, Ql, and TQE certifications or by the U.S. 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 ISO?
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 Comité Européene de Normalisation (EEC), the Association Française de Normalisation, the Deutsche 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 National Standards Institute (ANSI), represents more than 250 domestic standards writing organizations.
Figure 1. Relationship of quality management concepts. (Adapted with permission from Reference 3.)
Table I. ISO equivalent national quality management standards3 Country
ISO 9000
3900 Australia (AS) Belgium 50-002-1 (NBN-X) Canada 2299.0 (CSA) European 29000 Economic Communitj( (EN) France 50-121 (NF-X) Germany 9000 (DIN) 10201-2 India (IS) Italy 29000 (UNI/EN) New 5600-1 Zealand (NZS) Spain 900 (UNE.66) Switzerland 9000 (SN) U.K. (BS) 5750-0-0.1 U.S.A. (Q) 90
ISO 9001
ISO 9002
ISO 9003
ISO 9004
3901
3902
3903
3904
50-003
50-004
50-005
50-002-2
2299.1
2299.2
2299.3
Q420
29001
29002
29003
29004
50-131
50-132
50-133
50-122
9001
9002
9003
9004
10201-4 29001
10201-5 29002
10201-6 29003
10201-3 29004
5601
5602
5603
5600-2
901
902
903
904
9001
9002
9003
9004
5750-1 91
5750-2 92
5750-3 93
5750-0-0.2 94
• Adapted with permission from Reference 4.
The technical work of ISO 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 final 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, ISO 9000-9004 standards were based on
388 A · ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15, 1993
British standards BS 5750-1979. The five ISO documents listed in the box on p. 389 A provide 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 ISO standards essentially in toto, sometimes only changing the designation numbers (e.g., the ANSI refers to ISO 9000 by Q90). A partial list of ISO equivalent na-
tional standards is given in Table I. By mid-1992, 53 countries had adopted the ISO 9000 standards as their national standards. What are the ISO 9000 standards?
The five documents in the ISO 9000 series are an interrelated set. Overall, there are 20 "elements" or criteria in the ISO 9000 series that encompass various aspects of quality management. These are listed in the box on p. 391 A with brief descriptions of content for each element. Not all criteria are necessary for each ISO 9000 standard. For example, ISO 9004 is a comprehensive package. Most of its parts are included in ISO 9001, somewhat fewer are included in ISO 9002, and even fewer are included in ISO 9003. ISO 9000 and 9004 are guidelines for building a quality system and use phrases such as "The quality system should " ISO 9001 through 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 ISO 9001, 9002, or 9003—not against ISO 9000 or 9004. To date, almost all organizations have been certified for ISO 9001 or 9002. ISO 9003, which concerns inspection and testing, is considered to be of limited value and has not been used extensively; only four of the approximately 400 U.S. registrations to date have been for ISO 9003 (5). In fact, the ISO is planning to delete the ISO 9003 standard. The interrelationship among these three standards is summarized in Table II (3). Brief descriptions of individual standards follow. ISO 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 (ISO 9004) and/or for external QA (ISO 9001 through 9003). The guideline calls for a quality policy statement from the top management. Achieving quality requires the participation of everyone in 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 guarantee of quality. ISO 9001. This standard is the model for QA in design/development, 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 an effective, documented quality system that outlines procedures and instructions. The supplier must have procedures for contract
ISO standards for quality management ISO standard
Category
Title
9000
Guidelines
9001
Model
9002
Model
9003
Model
9004
Guidelines
Quality Management and Quality Assurance Standards: Guidelines for Selection and Use Quality Assurance in Design/Development, Production, Installation, and Servicing Quality Assurance in Production and Installation Quality Assurance in Final Inspection and Testing Quality Management and Quality System 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. Test 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 protocols for purchasing, handling, storage, packaging, delivery, record keeping, and training form part of ISO 9001. ISO 9002. This standard is a model used by the supplier for QA in production and installation. Most requirements are the same for both ISO 9001 and ISO 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 products, corrective action, handling and post-production functions, document control, quality records, and the use of statistical methods. ISO 9003. This standard is used by the supplier as a model for QA in final inspection and testing. The requirements for most areas (e.g., quality system principles, material control and traceability, control of verification status, product verification, 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 ISO 9001 or ISO 9002. ISO 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 quality 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 · 389 A
REPORT quirements are similar to those of ISO 9 0 0 1 . O r g a n i z a t i o n , q u a l i t y manuals, and auditing parts are v e r y s i m i l a r in b o t h . T h e u s e of charts and statistical procedures is recommended for production control. Purchasing, maintaining, record keeping, and post-production h a n dling criteria are also very similar for ISO 9001 and ISO 9004. T h e d e c i s i o n a b o u t w h i c h ISO 9000 standard to apply for depends on the scope of an organization's activities. ISO 9002 is appropriate for most chemical and process industry manufacturing plants involved in design and specification activities and in manufacturing products from supplied raw materials. It includes the purchasing, testing, and distribution a c t i v i t i e s of t h e m a n u f a c t u r i n g plant. Some organizations have obtained ISO 9002 stand-alone certifications only for their QC/QA laboratories at their manufacturing sites. For R&D facilities, ISO 9001 may be more appropriate when product development, design, and service are involved in a d d i t i o n to o t h e r elements of ISO 9002.
m a n u a l s be w r i t t e n by t h e people who are doing the work rather than by t h e i r m a n a g e r s or supervisors. Responsibility for keeping the system up to date rests with these people; h o w e v e r , t o t a l s u p p o r t from m a n a g e m e n t — t h r o u g h words and concrete action such as resource alloc a t i o n — i s n e c e s s a r y to m o t i v a t e everyone to follow and keep up with the documented ISO system. Cost of ISO registration The cost of achieving and maintaining ISO registration varies, depend-
ing on the basic quality s t a t u s of a company. Generally, a registrar's fee would be $10,000 to $15,000, plus the a u d i t i n g team's travel and expenses for initial registration. This figure does not include future costs of r e c u r r i n g audits, nor does it include the vastly larger cost of preparation for and m a i n t e n a n c e of ISO systems. One to two years of preparation time is a reasonable estimate for a m e d i u m - s i z e d o r g a n i z a t i o n . When everything is t a k e n into account, the cost per plant could be as high as $200,000 to $300,000 (6).
Table II. Cross-reference list of ISO quality system elements8 Paragraph (or subsection) no. In Q94 4 5 5.4 6 7
How to obtain certification
8
Getting an ISO 9000 certification is a quintessential team effort requiring the blood, sweat, and t e a r s of company staff at every level of management as well as professionals, t e c h n i c i a n s , o p e r a t o r s , and o t h e r support staff working diligently toward a common goal. A broad plan (Figure 2) would involve • Dissemination of information to and indoctrination of the rest of the organization by top management • Preliminary i n t e r n a l audit and review to assess the site's potential and status for such a program • Planning and resources allocation to identify the team leaders, to start compiling the quality manual, and to start improving key areas • Detailed quality manual write-up involving site-wide effort and, if necessary, an outside consultant • Detailed internal audit and r e view by management and the consultant • Pre-audit and review by 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 ISO elem e n t s . It is i m p o r t a n t t h a t t h e s e
9 10 11 11.2 11.7 12 13
14 15 16 16.2 17 17.3 18 19 20 —
Title
Management Responsibility Quality System Principles Auditing the Quality System (Internal) Economics—Quality-Related Cost Considerations Quality In Marketing (Contract Review) Quality In Specification and Design (Design Control) Quality In Procurement (Purchasing) Quality In Production (Process Control) Control of Production Material Control and Traceability (Product Identification and Traceability) Control of Verification Status (Inspection and Test Status) Product Verification (Inspection and Testing) Control of Measuring and Test Equipment (Inspection, Measuring, and Test Equipment) Nonconformity (Control of Nonconforming Products) Corrective Action Handling and Post-Production Functions (Handling, Storage, Packaging, and Delivery) After-Sales Servicing Quality Documentation and Records (Document Control) Quality Records Personnel (Training) Product Safety and Liability Use of Statistical Methods (Statistical Techniques) Purchaser-Supplied Product
Corresponding paragraph (or subsection) nos . Q93 Q91 092 4.1 4.2 4.17
• • •
4.1 4.2 4.16
y • g
4.3
• • • • • •
4.3
•
—
4.5
•
—
4.8
•
—
4.8 4.7
• •
4.4
y
• • •
4.11
•
4.7
y
4.9
•
4.5
y
4.10
•
4.6
y
• • •
4.12
•
4.8
y
4.13 4.14
• •
4.9
4.4
•
4.3
y
4.15 4.17
• y
4.10 4.11
y D
4.18
•
4.12
4.6
•
4.4 4.6 4.9 4.9 4.8 4.12 4.10 4.11
4.13 4.14 4.15 4.19 4.5 4.16 4.18 — 4.20 4.7
• • • • • •
4.1 4.2
D y —
—
—
—
y —
—
— y —
"Adapted from Reference 3. The paragraph (or subsection) titles quoted in the table above have been taken from Q94; the titles given in parentheses have been taken from the corresponding paragraphs and subsections in HOI OQ9 s"^* rvio
Attention is drawn to the fact that the quality system element requirements in Q91 , Q92, and Q93 are in many cases, but not in every case, identical. Key: • full requirement; 0 less stringent than ANSI/ASQC Q91 D less stringent than ANSI/ ASQC Q92 — element not present.
390 A · ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15, 1993
20 elements of the ISO 9000 series standards 1. Management responsibility requires quality policy to be defined, documented, 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. 2. Quality 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. 4. Design 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 identification and traceability require product identification by item, batch, or lot during all stages of production, delivery, and installation. 9. 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. 11. Inspecting, measuring, and testing equipment 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 nonconformance to testing. 13. Control of nonconforming products to prevent their inadvertent use or installation requires formal procedures to review and dispose of such products. 14. Corrective action must be taken to investigate and eliminate nonconformance. 15. Handling, storage, packaging, and delivery procedures for products must be developed and maintained. 16. Quality records must be identified, collected, indexed, filed, stored, maintained, and disposed of in a documented fashion. 17. Internal quality audits must be planned, carried out, and communicated to management; any deficiencies are corrected. 18. Training needs are identified and training must be provided to all necessary personnel. Training records are maintained. 19. Servicing procedures, if required by contract, define the servicing activities to meet the requirements. 20. Statistical techniques are used to verify acceptability of the process, product, and service.
ISO audit The basic principles of ISO auditing s t a n d a r d s 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. • Justify/revise what you will do. A properly documented system is the heart of an ISO audit. Emphasis is also placed on taking timely and effective corrective action so t h a t nonconforming products are not shipped out to customers. The quality system is supported at 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 t h a t 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 t h a t the planned system is actually practiced. If the audit is successful, a registration is awarded. After registration After an organization receives ISO registration and the celebratory parties are over, the road to t h e total quality spiral with continuous improvement is just beginning. The quality system is maintained by r e g u l a r i n t e r n a l a u d i t s and r e views as well as two external audits per year. An awarded r e g i s t r a t i o n can be withdrawn if, in subsequent audits, the system no longer meets ISO standards. In the United Kingdom about 10 firms a year lose their ISO accreditation. ISO 9002 does not restrict change; in fact, it encourages the control and p r o p e r d o c u m e n t a t i o n of c h a n g e . However, the effort involved in these activities should not be u n d e r e s t i mated. Essentially, at least one fulltime person will be needed to carry out follow-up activities such as int e r n a l a u d i t s , d o c u m e n t a t i o n of changes, and management reviews. Additionally, all personnel have to spend t i m e to m a k e sure t h a t t h e documented protocols are met. ISO accreditors/auditors Third-party auditing or registration by a body providing recognition of conformity to t h e ISO 9000 s t a n dards is used in at least 32 countries. At one point, the BSI was the only
ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15, 1993 · 391 A
REPORT auditor authorized to register companies against ISO 9000 standards; thus far it has registered 14,000 organizations. 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 L a b o r a t o r i e s , 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 ISO registration sends an application form with a fee to t h e r e g i s t r a r . Usually t h e registrar makes a preassessment visit and, after suggested changes have taken root, the final audit occ u r s w i t h i n a few m o n t h s . If t h e company's quality systems conform to the desired ISO 9000 standard, a registration document is issued. Over the past five years, ISO consultation and r e g i s t r a t i o n h a s become a growth industry. In qualityrelated journals there is a plethora of advertisements from consultants and r e g i s t r a r s . Because some of t h e s e registering firms are not authorized to give ISO 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 h a s
formed the Registrar Accreditation B o a r d (RAB) to m e e t t h i s n e e d . There are similar organizations in other countries: AFNOR/AFAQ in France, Raad Voor de Certificatie in Holland, National Accreditation Council of Certification Bodies in the United Kingdom, and Ente Nazionale Italiano 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). ISO 10011 series audit standards should be used to establish auditor accreditation standards. It is hoped t h a t o r g a n i z a t i o n s such a s t h o s e listed above will bring independent verification of quality and lend credibility to t h i r d - p a r t y r e g i s t r a r s . In t h e U n i t e d S t a t e s , t h e RAB h a s based its criteria on ISO Guides 40 and 48, which direct the general r e quirements 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 acc r e d i t a t i o n t h a t is valid for four y e a r s . F o l l o w - u p a u d i t s a r e conducted after the first six months and
Figure 2. Route to ISO 9000 registration. 392 A · ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15, 1993
thereafter once a year. To date, the RAB has accredited seven registrars in the United States. The organization expects t h a t eventually about 100 registrars will be needed in the United States. A company needs to carefully consider which registrar it should contract with for ISO 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 ISO 9000 registrations, is recognized to give registration/certification in countries to which the company exports, h a s t h e expertise to m a t c h t h e scope of t h e company's products, h a s experience in ISO a u dits, h a s received favorable ratings from e a r l i e r c l i e n t s , a n d d e m o n s t r a t e s a willingness to work with the company. The selection of a competent regist r a r is i m p o r t a n t , because a fairly large amount of money and energy will be invested in the ISO 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 cases of incompatibility.
Benefits of ISO certification ISO certification offers two m a i n benefits: It has a positive impact on a company's bottom line a n d it improves quality throughout the company. ISO 9000 s e t s u n i v e r s a l l y a c cepted, uniform standards of quality management for all industries. Thus a company t h a t h a s been independently audited a n d certified by a n i n t e r n a t i o n a l s t a n d a r d s body can demonstrate to customers that it offers quality management. ISO certification assures that the right quali t y p r o d u c t will b e c o n s i s t e n t l y produced without preventing continuous i m p r o v e m e n t of a company's systems. Five to six y e a r s are r e quired to demonstrate the full economic benefits of ISO certification. However, there are several practical benefits. • It provides a route for a company to gain approval to use the CE (Comm u n a u t é E u r o p é e n e ) m a r k on i t s products. This m a r k meets product regulations in all EC countries. • It provides tangible evidence to the staff, customers, and suppliers t h a t the management is committed to quality practices. • It a s s u r e s c u s t o m e r s of a company's independently assessed high-
REPORT quality standards. • It facilitates sales to (large) customers who inherently require QA certification. The n u m b e r of such customers is steadily increasing. • It encourages customers to reduce their own testing and audits of products received from s u p p l i e r s w i t h ISO certification. • It provides leverage by which suppliers can improve their quality standards if they want to do business with an ISO-certified company. • It can provide, via a quality image in the marketplace, a commercial a d v a n t a g e t h r o u g h e n h a n c e d market share over competitors who are not ISO certified. • Economic b e n e f i t s a r e g a i n e d through better use of raw materials as well as reduced inspection costs and time spent on reworking, t h u s providing continuous improvement and elimination of waste. • The discipline imposed by ISO 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 i n t e r n a l a n d / o r e x t e r n a l failures. • It encourages correct application of national standards (such as those of ASTM and NIST) in laboratory calibration and QC, t h u s e n s u r i n g correct product testing. European nations and companies have pursued ISO 9000 certifications much more aggressively and for far longer t h a n have American compan i e s . For example, G r e a t B r i t a i n alone has more than 10,000 companies registered to ISO 9000 s t a n d a r d s out of an e s t i m a t e d 24,000 companies registered worldwide. It is widely believed t h a t ISO certification will be an essential requirement for doing business in the post-1992 EC. ISO 9000 s t a n d a r d s may well t u r n out to be a n o n b e n i g n t r a d e barrier in Europe! Many non-European nations have expressed concern about a post-1992 "Fortress Europe." Shortcomings of ISO standards ISO 9000 certification is not a panacea to economic success and true total quality management. The lack of usefulness of ISO 9003 has already b e e n m e n t i o n e d . In a d d i t i o n , t h e standards lack a requirement for either continuous improvement or customer satisfaction, which are essen-
ACHIEVING
ISO 9000 REGISTRATION IS NOT AN END IN ITSELF; IT IS ONLY
FOUNDATION FOR TOTAL QUALITY MANAGEMENT. t i a l for h o n o r s s u c h a s t h e U . S . Malcolm Baldrige National Quality A w a r d or t h e J a p a n e s e D e m i n g Prize. ISO standards are written for all industries, regardless of their type, size, or field. Sometimes the procedures developed for maintaining ISO s t a n d a r d s at a p a r t i c u l a r site are perceived as (and sometimes t r u l y are) bureaucratic, with unnecessary roadblocks for smooth quality operations without actually improving the q u a l i t y of t h e p r o d u c t s . B e c a u s e t h e r e are no specific directives in ISO standards for certain situations, different auditors (even those from the same auditing firm) could give contrary evaluations, causing unnecessary confusion. A n o t h e r c r i t i c i s m of ISO 9000 s t a n d a r d s is t h a t a site is audited against its documented system. For example, a laboratory can use an er-
394 A · ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15, 1993
roneous method for chemical analysis; however, if it documents and follows t h i s m e t h o d , a n ISO a u d i t o r (who is certainly not a n e x p e r t in myriad chemical and physical tests) will not identify this as an erroneous test for proving product quality. To overcome this problem, many companies (such as Exxon, for example) have instituted in-house quality auditing programs to complement the ISO 9000 requirements. An acknowledged quality leader nation, such as Japan, has yet to embrace wholeheartedly the ISO 9000 s t a n d a r d s , because it believes t h a t Japanese quality standards are more rigorous t h a n t h e ISO 9000 s t a n dards. Very few Japanese companies are working toward ISO 9000 registrations; however, that might change in t h e p o s t - 1 9 9 2 EC. Motorola, a 1988 Malcolm Baldridge N a t i o n a l Quality Award winner, has not pursued ISO 9000 registrations in the U n i t e d S t a t e s b e c a u s e it believes t h a t its i n t e r n a l quality system is much more stringent than ISO 9000. An ISO committee called Ad Hoc Task Force of ISO TC 176 was commissioned to prepare a strategic plan for i m p l e m e n t a t i o n a n d f u t u r e changes in the ISO 9000 standards. The t a s k 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 m a t e r i a l s , a n d services. However, Vision 2000 strongly discourages the production of industry/ economic-sector-specific generic quality s t a n d a r d s supplemental to, or derived from, ISO 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 t h a t ISO 9000 registration will be a critical requirement for American chemical m a n u facturers exporting to Western European markets. American exports to t h e EC were $72.4 billion in 1990 and $100 billion in 1991, and Americans can hardly afford to be excluded from this expanding m a r k e t . Some giant U.S. chemical corporations s u c h as Du P o n t (150 r e g i s t e r e d
sites) and Exxon Chemical (96 registered sites; 56 sites in progress) have been at the forefront of the ISO quality management drive because of the nature of their international chemical businesses. However, a recent survey of executives from 30 U.S. companies exporting products to E u r o p e generally found a lack of knowledge about ISO 9000 standards. Sixty percent of the companies had completed little or no planning toward implementing ISO 9000 standards (9). Another survey of mid-sized U.S. firms found t h a t 48% had not heard of ISO 9000 standards! Only 11% said t h a t they thought the standards would affect them a great deal, and only 8% were planning to become registered by the end of 1992. Out of six million companies in the United States, about 400 company sites are r e g i s t e r e d for ISO 9000 standards. Of these, 34% are chemical industries. These include Exxon, Du Pont, Dow, ICI, Amoco, Texaco, Ethyl, E a s t m a n Kodak, Hoechst Celanese, FMC, Monsanto, Union Carbide, Uniroyal, and Witco. The Chemical Manufacturers' Association has also endorsed the benefits of ISO 9000 r e g i s t r a t i o n to t h e U.S. chemical industry. Companies t h a t support analytical activities in ind u s t r i a l or academic l a b o r a t o r i e s have also started registering for ISO and using this advantage in their advertisements. These vendors include Fisher Scientific, M e t t l e r Toledo, Varian, J. T. Baker, Beckman, Canon Instruments, and E. Merck Science. The Department of Defense and NATO have included explicit use of ISO 9000 standards in their procurement procedures. Similarly, OSHA, EPA, and FDA are planning to adopt ISO 9000 s t a n d a r d s . A n u m b e r of other large nonchemical process industries, such as AT&T and Hewlett Packard, have also been fully involved in ISO 9000 implementation in their plants. Curiously enough, however, U.S. automakers have decided to c o n t i n u e with t h e i r own quality s t a n d a r d s r a t h e r t h a n use ISO standards. Some companies, such as Du Pont and AT&T, have so many of t h e i r sites registered with the ISO t h a t they have opened consulting services to help other companies acquire ISO registration. Du Pont, for example, has 150 ISO 9000 registrations at 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
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 ISO 9000 standards. Achieving ISO 9000 registration is not an end in itself; it is only a sound foundation for total quality management. ISO 9000 can be looked upon as the lowest common denominator of quality systems on which to base enhanced practices to a c h i e v e t o t a l q u a l i t y , lowered costs, increased customer satisfaction, and improved market share.
Be sure that the chemicals you make or use meet the latest ACS reagent specifications!
Reagent Chemicals, Eighth Edition New format!
R
References
(1) Nadkarni, R. A. Anal. Chem. 1991, 63, 675 A. (2) Oakland, J. S. Total Quality Management; Heinemann: Oxford, 1989. (3) International Organization for Standardization—ISO 9000 Standard (1987). (4) ANSI/ASQC Q90 ISO 9000 Guidelines; ASQC Quality Press: Milwaukee, WI, 1992. (5) Byrnes, D. Quality 1992, 19, October (6) Lofgren, G. Q. Quality Progress 1991, 24(5), 35. (7) Stratton, J. H. Quality Progress 1992, 25 (1), 67. (8) Marquardt, D.; Chove, J.; Jensen, K.; Petrick, K.; Pyle, J.; Strahle, D. Quality Progress 1991, 24(5), 25. (9) Constanzo, A. Quality 1992, September issue, 47. Suggested reading
Cottman, R. J. A Guidebook to ISO 9000 and ANSI/ASQC Q90; ASQC Quality Press: Milwaukee, WI, 1992. Hutchins, G. B. ISO 9000: A Comprehensive Guide; Oliver Wight Companies: Essex Junction, VT, 1993. Lamprecht, J. L. ISO 9000: Preparing for Registration; ASQC Quality Press: Milwaukee, WI, 1992.
R. A. Nadkarni recieved his Ph.D. from the University of Bombay. Prior to joining Exxon, he was a research associate at the University of Kentucky and a research manager of the Materials Science Center analytical facility at Cornell University. He currently coordinates the analytical QC activity and long-range analytical directions of 20 laboratories worldwide, and has been actively involved in the ISO 9000 registrations of all of them.
eagent Chemicals is the only resource of its kind that provides specifications and analytical procedures to assure the quality of your chemicals. ACS specified reagent chemicals are the choice of most organizations such as APHA. ASTM. FCC. SEMI, USP. etc.. and many regulatory agencies, such as the EPA. Improved and expanded, the eighth edition of this authoritative reference now comes in a user-friendly format that makes look-up quick and easy. In it you'll find all the necessary information on • • • • • • • • • • •
atomic absorption spectrophotometry chromatography colorimetry and turbidimetry direct electrometric methods gravimetric methods measurement of physical properties reagent solutions solid reagent mixtures solvents for special purposes specifications and tests standard volumetric solutions
• titrimetry New in this edition are a section on determining detection limits, the general elimination of boiling point and density specifications, 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 general methods for chromatography and atomic absorption have been extensively revised to reflect their practical use in today's typical analytical laboratory. 1815 pages (1993) Clothbound ISBN 0-8412-2502-8 S149.95 O
R D E R F R O American Chemical Society Distribution Office Dept. 51 1155 Sixteenth Street, NW Washington. DC 20036 Or CALL TOLL FREE
M
800-227-5558 (In Washington. DC, 872-4363) and use your credit card!
ANALYTICAL CHEMISTRY, VOL. 65, NO. 8, APRIL 15, 1993 · 395 A
