ISO CERTIFICATION PAYS OFF IN QUALITY IMPROVEMENT

Frederik J. G. Vermeer
Brooks Instrument
Statesboro, Ga.

By obtaining and maintaining International Standards Organization (ISO) 9001 certification, a company can improve its quality control system, cut waste, and motivate its employees.

In so doing it improves its competitive position in both international and domestic markets.

The success of a number of countries (notably Japan) in the world markets has focused the attention of the industrialized countries on improving quality levels and striving for a unified, worldwide quality standard. This has been particularly true in Europe; with several countries competing in a single market, a common quality standard has been a highly desirable goal for decades.

One of the first multinational quality standards evolved in the European Community, which is estimated to become a single market with a gross national product of $4.5 trillion by 1992. As a consequence, in 1987 the International Standards Organization created ISO 9000, a single standard to ensure uniform quality in products and services offered with this growing market.

U.S. companies must recognize and implement the ISO 9000 standards or possibly lose international markets. If the present worldwide trend towards ISO 9000 continues (and there is no reason to believe that it will not), the standards will be just as important in the domestic market.

In some cases, ISO 9001 is already replacing MIL-Q-9858A and AQAP-1 as a contractual requirement and is rapidly gaining recognition in the U.S. Table I lists a few national standard systems that are in the same categories as the ISO standards.

The implementation of ISO 9001 requires a massive effort from every employee, but this effort pays off in both the short and longterm. Because a successful ISO 9001 program involves everybody at the plant, it motivates employees and gives them the pride of ownership. It is no longer a case in which an inspector okays or rejects a product. With ISO 9001 in place, every employee becomes an inspector, making sure that his actions result in something of which he can be proud.

One cannot merely inspect quality into a product, it has to be built in. The program helps create a better work environment (a quality product cannot be made in a nonquality environment), resulting in more positive attitudes in the employees.

A frequently asked question is, "How much does it cost to get ISO 9000 certification?" Surprisingly, it costs little considering the benefits. The quality products help justify the program in a variety of ways. The amount of scrap and rework is reduced dramatically. Product returns from the field are virtually nonexistent, and warranty costs are practically eliminated.

The company's competitive posture improves significantly, and an ISO 9001-certified plant can market its products worldwide because customers in distant locales can be reasonably confident that the products bought in the U.S. from ISO 9000-certified plants meet certain world-class quality levels.

ISO 9000 STANDARDS

Perhaps the most important feature of the ISO 9000 series of quality standards is that, unlike many previous quality control standards, it goes far beyond the attempt to ensure product quality through an inspection of finished end products rolling off a production line. Instead, the ISO standards attempt to build in quality through an examination of the entire design, development, and manufacturing process together with shipping and after-sales service. By ensuring the soundness of the entire raw-materials-to-user cycle, it is reasonable to expect that the resultant products will have sufficient levels of quality automatically built in.

The ISO 9000 series standards include the following:

ISO 9001--A quality systems model for design, development, production, installation, and servicing.
ISO 9002--A quality systems model for production and installation.
ISO 9003--A quality systems model for final inspection and testing.
ISO 9004--A quality systems guideline for improving company quality without contractual obligation to its customers.

Of these, ISO 9001 is the most stringent and most comprehensive standard. Certification means that the system, including the documentation and implementation of plant procedures, has been carefully examined and approved to conform to ISO 9001 standards by an independent agency.

Det norske Veritas (DnV), a Norwegian-based firm authorized by the International Standards Organization (ISO) to perform audits, audited Brooks Instrument's plant in Statesboro, Ga.

In practical terms, the implementation of the quality process includes all operations from sales and marketing, design and engineering, customer order entry, receipt of raw materials, all areas of manufacturing, assembly, calibration, final inspection, shipping, and extended product service support.

A regimented program of control, inspection, and certification, further enhanced by random audits, helps meet the specifications and assures the customer that a superior quality product has been purchased.

Considering that about 15,000 companies in Europe are ISO certified, it is reasonable to assert that domestic companies should obtain ISO certification or they may not have success in competing in Europe in the near future. Because ISO 9000 is recognized throughout most of the world and is rapidly gaining recognition in the U.S., it is thought that it will become the quality standard of the future within the U.S. and most other countries.

OBTAINING CERTIFICATION

Rosemount Corp. (parent company of Brooks Instrument) began investigating ISO certification about 3 years ago, immediately after the development of the ISO 9000 series. The first Rosemount company to be certified is in The Netherlands, the second is in the U.K., and third is Brooks Instrument in Statesboro, Ga.

It found the basic ingredient for successful certification to be a team effort. A company cannot just establish a quality assurance department and charge it with implementing ISO 9001. No single group or department within a company can do it alone.

The company must have a positive attitude about the quality system requirements because the cooperation of every department head and everyone within each department is paramount. This is necessary for maintaining the quality system and ISO 9001 certification because ISO requires an audit every 6 months.

During each of these subsequent audits, the auditor will not just meet with the quality assurance manager but may contact any employee performing any function. Each of these audits is completely random and takes about 2 days, which is enough time to sample a company's procedures and processes.

For example, the auditor may ask a machine operator to show him or her the operating process and procedure for running the machine. The auditor looks for logs to establish traceability, signatures, and closing of the operating loop.

In welding operations, for instance, welding rods must be stored at a certain temperature for quality welds. The auditor might ask a welder, "Where and at what temperature are the welding rods stored? What is the welding procedure?" If certified welders are employed in the plant, the auditor will ask to see their logs to check when they were last certified.

While auditing the human resources department, the auditor may ask for a log of training, lists of employees sent for training, lists of outside courses taken, and copies of the training policy.

Thus, obtaining certification should not be taken lightly.

PLANT CERTIFICATION

The Brooks Instrument manufacturing plant in Statesboro, Ga., was opened in 1956 and has a total of 168,000 sq ft of manufacturing and office area, plus 12,000 sq ft of warehouse space for rough stock storage. The facility designs, develops, and manufactures a broad line of flow measurement equipment and accessories for a variety of industries, including the petroleum and chemicals industries.

Because the manufacture of measurement equipment involves a large amount of machining of many kinds of metals, the machine shop is equipped with some of the most modern metalworking machine tools. These include a number of computer numerically controlled (CNC) machines, CNC lathes, state-of-the-art CNC machining centers, and CNC oval gear hobbers. These machines can hold 0.0002-in. tolerances and can machine virtually any type of metal.

The manufacturing plant is the largest flow calibration facility in the world and includes gravimetric prover systems of various sizes, mechanical displacement provers, volumetric provers, comparison-type automated master meter provers, small-volume provers, valve test stands, propane volumetric provers, and run-in test stands.

The overall process of obtaining ISO certification for this plant began in February 1988 with the issuance of a quality assurance manual. Table 2 presents the flow of events through 1990 when the plant received certification. Table 3 lists various activities performed during this period for obtaining ISO 9001 certification.

Fig. I shows the organization chart of the quality assurance department. The variety of quality assurance functions performed at the plant are summarized below:

Quality assurance engineering provides guidance and support to all quality-related activities. It assists in the areas of welding, nondestructive testing (NDT), inplant and vendor audits, quality procedures, and customer quality-related requirements.
Statistical process control is responsible for the operator process control (OPC) program, The objective is to manufacture the highest quality product the first time around (i.e., right on the shop floor).
Quality control electronics provides guidance and assistance in the calibration and maintenance of electrical and temperature standards, setting and adjustments of production electronic equipment, and inspection of electronics at all stages of manufacturing.
Receiving control checks incoming materials to ensure conformance to engineering documents and purchase orders.
In-process auditing checks the machine shop and assembly areas.

These audits are random and documented to ensure compliance with engineering drawings, route sheet traveler, and customer requirements.

Inspection equipment control maintains a system for providing calibration and preventive maintenance for all measuring and test equipment used daily. It also maintains standards used for calibration of test equipment and, measuring devices that are accuracy traceable to the National Institute of Standards and Technology (NIST) and an internationally recognized source.
Calibration standards control obtains and maintains the accuracy and traceability of the dimensional, pressure, and electronic primary standards as well as secondary standards test equipment.
Flow calibration performs flow testing and hydrostatic pressure testing of liquid measuring meters, provers, valves, strainers, and other equipment. Flow tests are conducted in accordance with published test standards prepared by engineering and quality assurance using prover standards that are traceable to the NIST.
Nondestructive testing and welding primarily involves methods of providing information on the integrity and soundness of weldments. NDTs such as radiographic, ultrasonic, liquid penetrant, and magnetic particle testing are performed using certified individuals in accordance with ASME Section V. All welding at Brooks is performed by certified welders and welding operators in accordance with ASME Section IX.
Welding procedures are qualified in accordance with ASME Section IX.
Product audit inspection selects products randomly prior to shipping and subjects them to additional tests in accordance with engineering testing standards and specifications. When requested in the sales order, inspection is performed in the presence of the customer's representative.
Final inspection is responsible for checking all equipment prior to shipment to ensure that all customer requirements have been met.
Quality documentation, such as calibration reports, hydrostatic test certificates, material test certificates, and certificates of conformance, are provided when required by the customer.

IMPLEMENTATION

Fig. 2 demonstrates the application of all the quality functions to the overall production process. On the basis of the production plan and depending on the customer's needs, the material control group will obtain the required material either from another Rosemount plant or an approved source.

All materials received must go through receiving inspection. The amount of inspection given in each case depends on past history data, and acceptance can be based upon the following:

Sample inspection per MIL-STD-105D
Past history data
Vendor inspection performed by quality assurance personnel
Documented evidence provided by the vendor
Sample inspection based upon an accepted statistical method.

Nonconformances discovered will be reported to the source with the issuance of a nonconforming material report (NMR). All nonconformance dispositions are determined by the material review board (MRB).

Upon acceptance, materials are turned over to manufacturing. Fig. 3 shows the overall manufacturing functions, which are briefly described below.

Production scheduling, using a computer, is responsible for generating production orders.

The production order contains an itemized parts list and the routing. This routing is used in conjunction with engineering drawings and specifications.

The machine shop draws parts and materials according to the production order from the warehouse/stockroom. Welding, NDT, gauge control, and in-process auditing occur in parallel with machine shop operations. The machine shop uses state-of-the-art statistical process control methods, i.e., the operator process control (OPC). The associated data processing equipment produces realtime data for x-bar charts, range charts, and histograms that are monitored at the process.

All measuring and test use control in equipment (gauge control in Fig. 3) is controlled and calibrated periodically. The associated control and recall system is fully computerized, and calibrations are traceable to the NIST.

In-process auditing is random throughout the manufacturing process. These audits are documented and, where necessary, corrective action reports are issued. The assemblers are certified and documented, and the assembly operations are supported by an engineering staff.

Hydrotesting and calibration performs hydrostatic pressure tests on all pressure-containing units by using test equipment that is traceable to the NIST.

Final inspection ensures that all customer requirements are met.

This inspection includes a product audit which involves retesting randomly selected units. At this point, the final inspector will request any quality documentation that is required by the customer, as stipulated in the production order.

Fig. 4 shows a typical product flow which explains how these various functions integrate with manufacturing procedures. This procedure is rigidly applied to the manufacture of all products. Fig. 4 is a shorthand demonstration of how the quality is built in by following the ISO 9001 procedures.