Process Design Controls
Speed has become a critical element in new product introduction. For many products, organizations have little time between determining customer needs and introducing the product to the marketplace. If that interval is too great, customers will have moved along to the next generation of needs.
Last month we looked at effective implementation of ISO 9001, subclause 7.3—"Design and development." Subclause 7.1, note 2, indicates that "the organization may also apply the requirements given in 7.3 to the development of product realization processes." Certainly these techniques can be used for developing such processes, but their use in developing processes for subclause 7.5—"Production and service provision" should be a primary consideration. In fact, ISO/TS 16949—"Quality management systems—Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations" requires organizations to use subclause 7.3 processes for production-process development.
Why go to such trouble? Isn't it enough to apply this degree of rigor to product design, and leave process design to be done the way it always has? The reason might surprise you: It's speed! But, you may counter, won't applying the same rigors to process design that we do for product design just increase total development time? Actually, the answer might be yes if the two are viewed as independent activities, and if process development is started only as the design is being readied for release. But that "throw-it-over-the-wall-to-production" approach was debunked decades ago. What's needed is a fast, disciplined, and highly integrated process for developing product and process design together. The tools stipulated in subclause 7.3 can provide a structure for just such a development process.
Three elements are needed for fast, successful product and process development:
• Treat each design as a project. Use structured project management with clearly developed phases, including clear progress checkpoints and criteria. Conduct frequent and honest project reviews. By requiring that design stages are identified and that review, verification, and validation activities are performed at each stage, ISO 9001 encourages an organization to use project management techniques.
• ISO 9001 subclause 7.3.1 requires the organization to "manage the interfaces between different groups involved... to ensure effective communication and clear assignment of responsibility." When managing communications, simplicity is the most important objective; complexity is probably the most significant enemy to success. Simple, small, integrated design teams may be the answer. At the very least, minimize the interfaces and reduce the complexity of communications.
• Integrate development of the production or service-delivery process with the design of the product or service. There's nothing in ISO 9001 that requires this, but the better an organization can manage it, the faster the product will be released to customers.
All of this involves more than just changing a company's design-and- development manual, setting up a few teams, and buying project management software. To become speedy at development, an organization must integrate these new methods into the company culture. This means that top managers must participate in developing the new system so that they'll understand and support it. It means that team members and other key people must understand the new system, which implies training and briefings during initial projects. Top managers must periodically review the effectiveness and efficiency of the projects underway to determine what changes or improvements should be made to the new development system.
We all know that cultural change is difficult. Normally it can't be changed directly but must be achieved by getting people to change their behaviors and activities. Top management needs an implementation plan that addresses the technical aspects of integrated product and process design. More important, the planning should identify behaviors that must be changed and how those changes will be implemented. Perhaps the most important change is to make the changes so substantial that falling back into old habits becomes nearly impossible.
The result of implementing such a development system should be faster introduction of products that meet customer requirements and command higher market shares and sales margins. To do this, an organization needs integrated, fast, highly disciplined development processes. Much of what's needed to achieve this is described in ISO 9001.
John E. (Jack) West is a consultant, business advisor, and author with more than 30 years of experience in a wide variety of industries. From 1997 through 2005, he was chair of the U.S. TAG to ISO/TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 series of quality management standards. He remains active in TC 176 and is chair of the ASQ Standards Group.
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