ISO 9000 Model 4 - OEMs Are Learning From Custom Moldmakers and Molders

For years moldmakers and molders have backed up their products with the most comprehensive service and support in the industry - and they guarantee it. Check their track record and their references - they want you, the OEM/end-user, to know who they are and how they do business.

Small businesses remain a basic key to the stability of our nation's economy. Their strength and vitality account for our continued growth and prosperity. This column on quality issues for the supply chain has been designed to assist you in determining what steps should be taken to expand and improve a business. The success of your business depends on careful planning and hard work. I hope you find this material useful and wish you success in your business endeavors.

Since customer and cost problems usually cross both functional and organizational boundaries, the challenge for today's moldmakers and molders and their management systems is to identify and solve such problems faster and more effectively. Their existing work procedures and detailed instructions account for approximately 80 percent of ISO 9001:2000 documentation requirements to achieve full customer satisfaction while producing at the most economical cost. The major problem is that surveys to date show most moldmakers and molders say what they do and do what they say, but it is not documented.

ISO 9000 has become an accepted and effective tool to document quality management practices in all types of marketing opportunities - serviced by a growing number of moldmakers and molding firms. While designers and moldmakers are confronted with manufacturability, survey results point out that cost reduction, again, is the top moldmaking challenge for 50 percent of engineers and designers. This same percentage of respondents identified low costs as the most important quality OEMs and end-users seek when choosing a supplier.

Underlying the cost concern is a move toward closer relationships between OEMs and suppliers. The trend toward systems integration has helped drive out cost and improve performance. The key to long-term growth for moldmakers and molders revolves around enhancing overall value-chain relationships. All suppliers in the value-chain need to be treated as partners to allow the industry to create competitive advantage and higher value for consumers.

Benefits of ISO 9001 include important marketing advantages and internal cost reductions. Even well-managed molders whose quality procedures already meet many ISO requirements have experienced such benefits as a result of industry-specific consultant certification. Both in North America and abroad, more and more buyers of molded parts are coming to respect the moldmakers and molding houses' ISO procedures as a purchasing specification. This is particularly true in the automotive, medical and defense industries. Applying ISO 9001 procedures in plastic molding operations poses some unusual problems because of the exceptional complexity of the moldmaking and molding process and the large number of variables that must be managed and controlled.

The ISO auditor seeks to determine whether a company meets four requirements:

1. It flowcharted all business activities.
2. It has defined the procedures needed to ensure that its products and services consistently meet a specified quality standard.
3. It has documented these procedures in a manual that is available for use by the responsible employees.
4. It can prove that these quality procedures are being followed reliably.

While these points may appear simple and straightforward, it takes considerable managerial effort and a highly disciplined organization to provide the assurances demanded for ISO certification. The role of quality management within a company must be clearly defined. Thus, one of the first requirements of ISO is that the lines of responsibility and authority within the organization be clearly documented, typically on an organization chart.

The chart should make it clear that the crucial quality control function has sufficient autonomy to protect it from any interference. The next step is to examine all major operating functions and verify that there are established procedures to ensure operational control and consistent quality in every phase. OEMs and end-user part designers appreciate support from the moldmaker and molder teaching them about moldmaking. It helps eliminate unnecessary complexity to the tool and determine if the part is manufacturable. When applied to an injection molding operation, quality management covers an especially wide spectrum of considerations. It encompasses every step, beginning with product design and resin selection, to meet requirements for functionality.

Subsequent steps include mold design, selection of the molding machine, purchase and quality assurance of incoming materials, determination of appropriate processing conditions, inspection of material in-process and of final parts, specification of testing procedure and testing equipment, maintenance of processing and testing equipment, identification and disposal of non-conforming product, and identification of finished parts and inventory control.

In order to serve the high-tech industries, a moldmaker and molder is required to use CAD/CAM, computerized mold filling and cooling simulation, advanced programmable machine controls, and real-time process and production monitoring.

Should You Get Outside Help?

The personnel who have created and implemented your current quality management practices may find it difficult to evaluate them with the necessary detachment and objectivity. That calls for an independent outside expert.

An outside specialist also may find it easier than company insiders to implement some basic rethinking of company structure, processes, technology and methods. If you decide to engage an outside consultant, it is important that he or she possess more than just expertise in the rules and regulations of ISO 9000. The consultant also must have in-depth knowledge of plastics processing in order to apply available technology effectively to reach your quality-control objectives.

The function of the outside consultant is to provide guidance, examples and working tools - e.g., sample quality manuals that may serve as models or prototypes. But it is essential that the company's management and employees take prime responsibility for creating the new procedures and writing the necessary documentation. This is the only way to ensure that the new quality management system will be practical, that it will be written using familiar terminology, and that employees will consider it their own creation and will thoroughly identify with it.

Conclusion

If properly implemented by industry specific professionals, ISO 9001 for the plastics supply-chain (tooling-processes-materials) takes you step-by-step through the mold purchasing process, aiding in the best possible purchase for a long, successful and profitable run on the molding machines employed. Everyone in the supply-chain, from the apprentice on the moldmaker's shop floor to an OEM/end-user buyer, could benefit.

After all, molds and molding plastic parts for automotive, medical, high-tech and others require the same basic rules - GMPs (Good Manufacturing Procedures).