What ISO 9000 quality standards mean for processors.
The mandate for delivering quality parts is becoming more stringent for processors, given the complex backdrop of global competition, and they in turn must be equally diligent in their choice of raw-material suppliers to ensure that quality is there from the start. But efforts to verify materials consistency have resulted in confusion over definitions and methods, redundant procedures, mounds of paperwork, delays, and additional cost.
It's here that the ISO 9000 Series quality standard, established by the International Organization for Standardization in Geneva, Switzerland, can benefit plastics processors, offering the assurance that a resin producer is conforming to at least basic principles of internationally accepted quality management.
The ISO 9000 Series of standards--and the equivalent ANSI/ASQC Q90 Series from the American National Standards Institute (ANSI) in N.Y.C. and American Society for Quality Control (ASQC) in Milwaukee--represents a "front-end" quality management system, designed to provide a framework for documenting quality procedures at every step of a manufacturing operation, as opposed to "back-end" quality control (testing a product for quality after it has been made).
The ISO 9000 Series was first published in England in 1987. Its use spread rapidly among European manufacturers and is now reaching North American producers. Over 30 countries and 10,000 companies have adopted the standards, with each nation chartered to develop a corresponding version of the standard (such as ANSI/ASQC Q90 in the U.S.).
Materials suppliers endeavoring to conform to the standards say processors will see more consistent product from them and, consequently, less variation in their processes. Others describe it as a partial answer, at best.
Proponents of the ISO 9000 Series also say processors can use the standards to support quality management in their own operations. Documentation of such efforts surely will be important in the '90s as molders themselves are called upon more frequently by their customers to submit to a host of quality audits in order to be approved as reliable component suppliers.
WHAT EXACTLY IS ISO 9000?
Harrison M. Wadsworth, chairman of the ASQC standards committee and a professor of Industrial and Systems Engineering at Georgia Institute of Technology in Atlanta, characterizes ISO 9000 as the first internationally recognized standards for quality management in industry. He explains the goal of the standard is complete documentation of a company's quality management system and definition of quality protocol during daily operations.
He says the standards have been designed to help identify responsibility for quality management at each phase of operation> establish procedures and mechanisms by which a company can maintain quality goals> and to detail methods of corrective action when a product, process or service is found to be in nonconformity with established quality standards.
ISO 9000 offers no major technology breakthroughs in terms of implementing quality assurance. Actual methods used to monitor quality within the framework of ISO 9000 or to fine-tune a manufacturing operation, such as statistical process control, are determined by each company.
There are several components of the overall ISO 9000 (Q90) Series of different levels of comprehensiveness to address various types of manufacturing and service companies:
* ISO 9000 (Q90) is an overview, offering general comments on how to use the standards.
* ISO 9001 (Q91) is the most comprehensive standard, dealing with a company that carries out design, manufacturing, service and delivery, covering quality assurance for all four functions.
* ISO 9002 (Q92) is a quality system for production and installation functions only, where the company has no responsibility or input in the design phase.
* ISO 9003 (Q93) is a quality model covering only inspection and testing of components and systems.
* ISO 9004 (Q94) is the final level of the ISO series, and applies to internal elements of a company's own quality management system, serving as a guide to quality management methods.
ISO 9001, 9002 and 9003 (Q91, 92 and 93) generally are referred to as the three "contractual" standards as they relate to quality-assurance requirements between companies, where one firm is a supplier to another. They are also the only parts of the ISO 9000 Series that can be audited in order to certify a company's conformance (discussed below).
Using Q91 as an example to illustrate the level of detail in these documents, the standard literature opens with an introduction, giving scope and field of application, as well as references and definitions. The heart of the standard begins in Section 4.0: Quality System Requirements. It's under this heading that actual points of quality management are addressed. Points covered include: management responsibility> quality policy> organizational responsibility and authority> verification of resources and personnel> management review> establishing a documented quality system> contract review> design control> design development planning> organizational and technical interfaces> design input and output> design changes and verification> document control> document changes and modifications> purchasing> assessment of subcontractors> purchasing> data and verification of purchased product> product identification and traceability> process control> inspection and testing> in-process inspection and testing> final inspection and testing> inspection and test records> inspection, measuring and test equipment> control of nonconforming product> nonconformity review and disposition> corrective action for nonconformity> handling, storage, packaging and delivery> quality records> internal quality audits> training> servicing> and statistical techniques.
WHAT IT MEANS TO BE
For processors, dealing with a resin supplier that has been certified under ISO 9000 is yet another measure by which they can assess minimum quality standards for materials they purchase. To be certified under the ISO 9000 (or Q90) standards, firms must demonstrate they have a system in place at every point in their operation to ensure that correct procedures are used to attain a prescribed level of quality in their product as demanded by customers.
To obtain certification under the ISO 9000/Q90 standards, a company first must submit its own quality management manual to an independent, accredited registration agency for review and possible revision. When the manual has been reviewed, on-site inspection of the manufacturing facility takes place to verify that the described quality system is in place, procedures are being followed with proper documentation, and that the end-product or service meets customer requirements.
Once a company is certified under the standard, regular surveillance audits as well as spot audits are performed by registrars to ensure a supplier is maintaining the system. Companies may publicize certification of the standard through their marketing efforts and advertising. (Many purchasing agents reportedly are already looking for ISO 9000 in buying resins and chemicals.)
ISO 9000 and Q90 are not meant to replace more demanding industry-specific quality requirements, like those that exist for automotive vendors. ISO 9000/Q90 certification simply carries the recognition that a company adheres to minimum standards of quality management. It is not a "seal of approval" on the quality of any specific product or service the company provides.
CONSISTENT RESIN QUALITY
Numerous major domestic resin producers are taking steps to have their operations certified under the standard. ISO 9000 rapidly is becoming a de facto standard for the 1992 European Economic Community (EEC) and is already widely considered established protocol for doing business in Europe.
One of the first domestic resin-producing installations to be certified under the ISO 9000 standard was the Bishop, Texas, facility of the Engineering Plastics Div. of Hoechst Celanese Corp., which was certified in 1986 by the British Standards Institute (BSI) in Milton Keynes, England. (The plant was certified under a BSI standard that was an immediate predecessor of ISO 9000.) Many other resin producers, such as Du Pont Co., Dow Chemical U.S.A., GE Plastics, and ICI Americas, have undertaken programs to qualify their various facilities under the standards.
As resin producers continue to adopt and implement the ISO 9000 and Q90 quality standards, processors stand to benefit through better, more consistent polymers for their manufacturing operations, according to J.C. Rubiano, quality assurance coordinator for ICI Americas in Fayetteville, N.C. Earlier this year, ICI's Fayetteville PET resin plant was certified under ISO 9000.
Rubiano says by conforming to the ISO 9000 quality standard in its PET production, ICI has "opened up new lines of communication with our customers. They will have better access to our quality data." He says that as ICI manages its quality better through ISO 9000, processors "will see a more consistent product, less variation in their processes, lower scrap rates and downtime, and less time spent on testing and verifying our resin quality."
Implementation of ISO 9000 standards will also allow the Engineering Plastics Div. of ICI Americas to deal with growing demands of quality audits from processors, according to Len Harvey, fluoropolymer specialties R&D group leader for ICI's Advanced Materials unit, Exton, Pa. Demand for SPC/SQC data has been especially strong from molders that process components for the automotive industry, he says.
"Processors want to be sure a resin company has its process under control--with a quality management system in place--and that material specifications can be met," Harvey notes. "Several years ago, the plastics industry talked about quality in a very superficial way. But when a company commits itself to the ISO 9000 standards, you can prove your quality with hard data."
ICI is expecting to have its Exton and Thorndale, Pa., facilities certified under ISO 9002 by the end of 1991.
Bernie Miller, manager of quality assurance for Dow Chemical U.S.A. in Midland, Mich., says even with the ISO 9000 standard in place, premier companies will further distinguish themselves through the use of statistical methods. He describes ISO 900 as a "minimum standard" representing only part of a company's total quality assurance program, pointing especially to the fact that currently there's no SPC/SQC requirements in ISO 9000. He does note that when the standards are due to be updated in 1992, they "probably will require some use of statistical methods."
(ANSI/ASQC Q91 has only this to say under Section 4.20: Statistical Techniques, "Where appropriate, the supplier shall establish procedures for identifying adequate statistical techniques required for verifying the acceptability of process capability and product characteristics.")
Major resin producers have spurred the initial interest in ISO 9000 quality standards for the U.S. plastics industry, a movement that is soon expected to trickle down to the processor market. Many see ISO 9000/Q90 certification as an opportunity for plastics processors to improve quality in their own operations. In fact, in England, where the ISO standard originated, medium-sized processors were the first to adopt ISO 9000, realizing its benefits as a marketing tool, as well as a means to manage quality within their organizations and have closer ties to suppliers. The framework for ISO 9000 was based upon an earlier British series of quality standards known as BS 5750.
It was the processors in Britain that pushed the ISO standard "upward," compelling resin suppliers to adopt the system. This lesson from the British indicates that an opportunity does exist for U.S. processors willing to pioneer in adopting the ISO 9000 standard here.
"In England, the trend for ISO 9000 started with smaller companies looking to gain an advantage over larger firms," according to Rodney Cure, section controller, inspectorate, for BSI. "In the plastics business, it started with independent injection molders> they required their suppliers to qualify for the standard. They saw a sound, commercial reason for accepting ISO 9000."
Cure points to the "human element" as another benefit of adopting the standard: the new awareness it builds of quality as force to shape a business. Documenting internal quality procedures to meet ISO 9000 tends to "tighten up the loose ends" of an organization, he says. "The idea is that being more concerned with quality makes all the employees perform just a little better than before, and that can make a big difference in a company's success."
THE COST: PAY NOW OR LATER
Industry sources estimate that the price tag for a processor to be audited and certified for ISO 9000 runs in excess of $20,000> that figure does not include the internal investments made by a company to document systems, hire new personnel, re-evaluate quality policies, upgrade equipment, and retrain staff.
"Obtaining an ISO 9000 certification is expensive and certainly doesn't help your immediate profit margin, but it does offer economic benefits in the long run," advises a v.p. at one resin producer, referring to benefits such as improved product quality and a more efficiently run company overall. Other executives, looking ahead to business opportunities in the 1990s, say they consider it a worthwhile long-term investment, despite the immediate intrusion on a company's bottom line. Quality, in other words, is not "free," but it pays.
William H. Sherman, a director and certified quality engineer at ASQC, as well as director of quality assurance for Hilti Inc. of Tulsa, Okla., a producer and distributor of industrial fastening systems and devices, predicts that many smaller manufacturers eventually will be compelled to adopt the standard to document quality assurance, as demands for compliance come from end-users and government contracts. (Some sources believe that the Department of Defense plans to mandate that U.S. suppliers conform with the ISO 9000 equivalent of DOD's MIL-Q 9858A standard).
Others agree that the spread of ISO 9000 appears inevitable as it ultimately requires every vendor, material producer, part supplier and subcontractor in the supply chain for a given manufactured system to be certified. Even if a processor isn't currently directly doing business with a European customer, the processor could, in the near future, find itself as a subcontractor or vendor to a company planning to market overseas.
A MOLDER GOES FOR IT
One processor looking to gain certification under the ISO 9000 standard is Textek Plastics Inc., San Antonio, Texas. Textek recently struck a cooperative production agreement with an accredited European injection molder, Van Niftrik in Putte, NEtherlands, which established Textek's need to gain certification under the standard.
Dean R. Perra, Textek's quality assurance manager, says the company should win certification by mid-year. "ISO 9000 can help small to mid-sized processors install the management tools needed to produce higher-quality product. We're not an international company, but we want to compete on an international, world-class standard of quality."
Perra says ISO 9000 provides a framework for quality management for processors that may have outgrown their original management structure. He observes that while many processors start small and eventually expand their customer base and production capacity, their system for maintaining quality often doesn't keep pace with the evolution of their business.
The ISO 9000 standard also sets the stage for the company's quality philosophy to permeate all phases of production, says Perra. "Quality becomes a continuous auditing function, rather than a final inspection function," he says.
The best tip offered by Perra for processors considering certification under ISO 9000/Q90 is to clearly explain its potential benefits to all management and production employees, and patiently address the natural objections and resistance that often come from proposing changes in an established system. He also suggests hiring or appointing a fulltime manater to oversee coordination of the quality system that complies with ISO 9000/Q90.
INSPECTING THE INSPECTORS
Accreditation procedures for third-party auditors that will perform the Q90 inspection/certification process remain unsettled, but are expected to be finalized this quarter. The group responsible for certifying potential Q90 registrars is the Registrar Accreditation Board (RAB) Inc., a Milwaukee-based subsidiary of ASQC. As a separate certification activity, BSI has recognized Underwriters Laboratories (UL) Inc., Northbrook, ILL., as a registrar for the ISO 9000 standard in the U.S.
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|Title Annotation:||International Organization for Standardization|
|Author:||Gabriele, Michael C.|
|Date:||Jan 1, 1991|
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