ISO-9000 is gold for processors.

Plastics manufacturers are now seeing the financial benefits of winning certification under this international quality standard, which is becoming the de facto baseline for customer evaluation.

What does ISO 9000 really mean for plastic processors?

For many, it could make the difference in winning a contract from a major customer or expanding into international markets. For some, it may mean survival in the face of mounting global competition. But certainly for most companies, it will mean a change in the way they do business.

For plastics processors, ISO 9000 symbolizes the arrival of international quality standards in their own backyards. Certification under ISO 9000 (and the equivalent ANSI/ASQC Q90 Series) means committing time and resources to document quality-management and work procedures. Established in 1987 by the International Organization for Standardization which is located in Geneva, Switzerland, ISO 9000 certifies that a company has a formal quality-management system in place that conforms to basic international standards. It does not endorse the quality of any product or service.

Two years ago, when PLASTICS TECHNOLOGY first reported on ISO 9000, the emphasis was on certification for resin suppliers and the resulting gains in material quality and consistency that would be passed along to processors (see PT, Jan., 91, p. 53). Today, the thrust is on certification for processors and the impact ISO 9000 will have on their future as suppliers for customers doing business in world markets.

IS ISO 9000 |FOR REAL'?

As ISO 9000 gathers momentum in the U.S., many processors are struggling with questions of its authenticity: Is this a "real" industry standard? What is the driving force behind this movement? Why does my company need to adopt it?

ISO 9000 already is a basic business standard in Europe, and it's being adopted by a rapidly accelerating number of resin suppliers, machinery producers, and end-user manufacturers in the U.S. The Food and Drug Administration is expected to harmonize its quality standards with ISO 9000.

The ISO 9000 movement in the U.S. is being driven by end-user manufacturers, most of which find themselves operating in a global market and thus need a baseline for verifying quality standards of their suppliers. ISO 9000 often is viewed as a starting point for more stringent supplier-quality reviews conducted by customers in various markets. While not an enforceable requirement, ISO 9000 is emerging as a de facto minimum quality standard, and appears to have benefit as a marketing tool for suppliers competing for business with world-class customers.

"Every day, more companies realize they do need ISO certification," according to James Venditti, an associate with the Polymer Processing Institute, a research center located at Stevens Institute of Technology, Hoboken, N.J. He says ISO 9000 represents nothing less than a call to arms for domestic processors. "Quality requirements and competition are going up for everyone. The small custom molder who's content to just keep plodding along the same old way is a mythical creature."

Richard L. Garthwaite, president of A.L. Hyde Co., Grenloch, N.J., says ISO 9000 is now being pushed by customers down through the supplier chain. Hyde is a medium-size custom injection molder and extruder now working towards ISO 9002 certification by mid1994. "Our customers are in global markets--we are not. But there is a domino effect for suppliers," he says. "Global quality standards run up and down the supply chain."

Anthony Chicoyne of the Capital Goods Business Group of AMP Inc., a large custom molder of electrical/electronic components in Winston-Salem, N.C., says his firm recognized the need to adopt international quality standards in the late 1980s as opportunities grew for exporting parts to Europe. AMP was certified under ISO 9001 early last year following a five-month effort.

Chicoyne says his firm already has seen a "tremendous payback" for adopting ISO 9000, in terms of greater processing efficiencies, reduced scrap and out-of-spec parts, and overall customer satisfaction. "Today's business is global, and the best customers are looking for more quality from their suppliers. Quality is a requirement; if you don't improve, you won't survive."

TOO TEPID A RESPONSE?

Not everyone is satisfied that processors have really gotten the message on ISO 9000. Robert A. Eckersberg of Eckersberg & Associates Consultants, Homewood, Ill., who advises companies on how to prepare for ISO 9000 certification, says he's been disappointed by the tepid response to ISO he's seen from processors at recent technical conferences and trade shows. "Too many manufacturing companies are taking a wait-and-see attitude," Eckersberg laments. "Europe already is ahead of us. Processors who resist accepting ISO will only get bogged down in the future. Do it at your own speed and in your own comfort zone, but embark on it now. Your competition isn't waiting. OEMs are reducing their supplier bases."

Eckersberg, who has a client list of 40% plastic processors and 60% metalworking firms, says that when discussing ISO 9000, "you should forget about the word |quality.' ISO is a methodology for good business practices. It represents change for everyone at a company, not just the quality manager."

Aside from resistance to change, processors balk at ISO 9000 mainly because of the requirements of formally documenting quality-management systems and processing operations, according to Eckersberg. "Some manufacturing companies think documentation isn't important," he says. "Initially, it rubs them the wrong way. Fifteen years ago, molders were telling me it was impossible to incorporate statistical process control (SPC) on their shop floor. They resisted SPC back then; just look at what's happened in the last 15 years. Compared with SPC, adopting ISO is easy to do."

Garthwaite of A.L. Hyde agrees that ISO 9000 represents a major--but necessary--change in business culture for many processors. "It really goes against the old autocratic ways of the family-owned molding shop," he admits. "Adopting ISO means new training for employees and managers. They must be convinced that this is a systematic approach to improving the company and that it's something positive. The typical first response is: |What's wrong with the way we've been doing things?' Management must be patient and stay committed. You can't force this on a company--it comes from within. Your company's business culture must change at its own pace."

WHERE DO YOU START?

The first step for any processor interested in learning more about ISO 9000 is contacting the American Society for Quality Control (ASQC) in Milwaukee at [phone], or the American National Standards Institute (ANSI) in New York City at [phone]. These are the two dominant umbrella groups overseeing ISO certification in the U.S. Both organizations can provide manuals and videos on the topic.

Other groups providing background information include the National ISO 9000 Support Group, Caledonia, Mich., [[phone]] and the Society of the Plastics Industry (SPI) Inc., Washington, D.C. [contact Drew Fleming at [phone]].

As explained in our earlier introductory article, ISO 9000 embodies four levels of quality certification, designated ISO 9001 through 9004. The consensus among consultants and manufacturers is that plastics processors should seek certification under ISO 9001 (Q91), the most comprehensive level, which includes quality-management certification of manufacturing as well as design, service and delivery. ISO 9001 includes 20 points of review, while ISO 9002 has 18 (all those in 9001 except protocol 4.4 for Design Control and 4.19 for Servicing--see chart).

After sorting through the requirements, a second step usually is hiring a consultant--one that is knowledgeable about specific needs of plastics processors. "A consultant can help get you started and lead you through the process, but ultimately the responsibility comes down to a company's commitment to the program," Eckersberg says.

The third step is to report formally on four tiers of your company's operations. ISO certification requires a company to produce a series of manuals that document quality-management procedures, work procedures and other related business practices.

* The first tier describes what your company does. Says Eckersberg, "The |what' is a basic policy statement about your company, the products and services you provide, and a profile of your customers. This usually is not proprietary information."

* Tier two is documentation on how your company operates and usually contains highly confidential information. The "how" is a procedural manual on a firm's entire operations, mapping out specific job functions and responsibilities from the receiving of sales invoices to placing orders for supplies, to handling engineering changes from customers, to determining quality procedures, to establishing a protocol for management responsibilities.

Tier two is where the skill of a consultant can be critical in taking a fresh look at a business and spotting glitches and inefficiencies. Once all those procedures are laid out in a formal document, Eckersberg says, a typical reaction from processors is: "I didn't realize we still do things that way."

* Tier three involves documenting specific work instructions and quality procedures on the shopfloor. According to Eckersberg, "Typically, the attitude is to resist documenting this kind of information. Plastics processors seem to be more comfortable relying on the experience of a particular operator or foreman. But what happens to that processing expertise if that worker becomes disabled or leaves the company for another job?"

* The fourth tier involves documenting the control and tracking of inventory as it moves throughout the plant. This includes everything from order entries for raw materials to packaging and shipment of finished parts.

After evaluating your procedures, implementing new ones where necessary, and documenting the four tiers of information, the final step is the review by an accredited auditor. Processors may contact ANSI or ASQC for a listing of auditors.

He says about 70% of companies receive ISO certification on the first try. The length of the auditing process, including document review and on-site plant inspection, will vary depending on the company, but six to eight days is an average range.

Once certified, a company is subject to spot-check reviews about twice a year. You must repeat the formal review process every three years to ensure continued compliance.

WHAT'S THE PRICE TAG?

Molders and consultants interviewed for this story estimate the average cost for ISO 9000 certification at about $15,000. That figure includes a $2000 registration charge plus auditor fees (an average daily rate of about $1600). However, the $15,000 estimate does not include consulting fees, work on internal documentation, employee training or investments in new production and testing equipment.

"If a processor truly does a full cost analysis of ISO 9000 and tries to understand the value and payback it provides to a business, he or she will lose the idea that the cost for certification is a penalty," says Chicoyne.

Much of the investment in training and technical support that processors will need to make to prepare for ISO 9000 certification involves work to calibrate production equipment. This involves the purchase of pressure transducers and other testing and measuring equipment to calibrate thermocouples on processing equipment; machine hydraulics; pump pressure setpoints; pump response times; fill, pack and hold points; and timer accuracy. All of these calibration procedures must conform to guidelines established by the National Institute of Standards and Testing (NIST), Gaithersburg, Md.

|Foreign' Quality Standards?

ISO 9000 actually has its origins in the U.S., according to Anthony J. Chicoyne, associate director of total quality leadership for the Capital Goods Business Group of AMP Inc., a custom molder in Winston-Salem, N.C. Chicoyne says his research indicates that ISO 9000's evolution began with a vintage 1959 B.S. military business standard (Mil Q 9858) that established guidelines for the procurement of products and services. over the years. European quality manuals adopted and expanded on the protocol, which eventually resulted in the formation of ISO 9000 by the International Organization for Standardization in Geneva.

ISO 9001 Targets

Processors must document quality management for these 20 protocols to be certified under ISO 9001.

4.1   Management Responsibility
4.2   Quality System
4.3   Contract Review
4.4   Design Control
4.5   Document Control
4.6   Purchasing
4.7   Purchaser Supplied Product
4.8   Product
4.9   Process Control

4.10 Inspection and Testing 4.11 Inspection, Measuring/Test

Equipment 4.12 Inspection and Test Status 4.13 Control of Non-Conforming

Product 4.14 Corrective Action 4.15 Handling, Storage,

Packaging, Delivery 4.16 Quality Records 4.17 Internal Quality Audits 4.18 Training 4.19 Servicing 4.20 Statistical Techniques