Planning for Product Realization

You should take subclause 7.1 seriously.

Last month we reviewed the aspect of quality planning related to planning
the overall quality management system (QMS). Although planning for product realization is part of QMS planning and should be done in a manner that’s consistent with the other processes of the QMS, it’s a much more detailed effort. ISO 9001 subclause 7.1 addresses planning of product realization. It requires that the organization define the quality objectives for the product. It also requires that the organization plan the needed processes, documents, monitoring, inspection, and test activities to support product realization. Records that will be maintained must also be planned.

If the organization designs as well as produces the product, subclause 7.3.1 requires additional planning to determine the design and development stages, and the review, verification, and validation appropriate for each stage. Responsibilities for the design work must be defined, and plans are required to manage the project and control design interfaces.

Planning for product realization is usually an ongoing activity because plans must be updated continually as customers and products change.

Product objectives may come directly from the customer in the form of a request for proposal, or they may be defined from market research or direct user input. There are many possible scenarios:

• A hotel chain might establish objectives based on the expectations of a particular group of guests. In this case the product objectives for a hotel chain focused on business clientele are likely to be somewhat different from a resort chain focused on families. Detailed hotel and service designs would then be developed based on these objectives.

• A bicycle or tractor manufacturer may set product objectives for reliability, performance, and styling. In such cases, the detailed product characteristics would be determined during the design and development process.

• A machine shop may get detailed product requirements from customers’ parts drawings. Here the product objective might be simply to deliver machined parts meeting all drawing requirements on time and at an agreed-upon price.

The organization needs to define the processes for reviewing customer requirements and communicating with customers. These are processes to ensure that the organization clearly understands what customers want and need. These processes must also ensure that customers receive information so that they can understand the product, and what to do when problems arise. At the other end of the supply chain, the purchasing processes must be planned so that there’s confidence that supplier-furnished goods and services meet the organization’s technical, delivery, and cost requirements.

Most product disasters are the result of design problems. The best way to prevent design problems is to plan the design process rigorously and follow the plan. Many organizations have great difficulty doing this. Prior to the 2000 edition of ISO 9001, many organizations opted to use the old ISO 9002 because it didn’t include control of design and development. Even with the 2000 version, some organizations exclude design from their ISO 9001 QMS because they fear the rigorous controls of subclause 7.3. This is a shame because the discipline required by the subclause can save organizations loads of money over the long haul. Product design and development occur through a finite set of activities that have a start and a completion. In other words, design and development are tailor-made for project-management techniques. Planning requires that the stages of a design-and-development project be defined and the activities planned, so that they’re integrated and the ultimate product design meets customer needs.

There are many issues to take into consideration when planning for production and service delivery. For example, planning for product inspection and testing, and for service monitoring, must be integrated with production and service delivery planning. The basic objective is to plan for all production and service provisions to be conducted under controlled conditions. Using the staged development process of subclause 7.3 and associated verification and validation processes to manage production process development isn’t required but is a great idea. This was discussed in an earlier column (“Process Design Controls,” Quality Digest, July 2007).

Planning for product realization isn’t a trivial activity in any case, and, for many organizations with ever-changing product lines, it’s a critical, never-ending, and challenging task. If it’s done correctly, the result can be fast product development cycles and on-time delivery of excellent products and services that delight customers. It just takes work.

About the author
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