with the very act of forming ideas about a potential product or the "product concept" and may end only with the shipping of that product. In addition, support processes that affect the capability of the product realization process (e.g., procurement, staffing), QMS processes (e.g., internal audit, corrective and preventive action, document control) and business processes (e.g., marketing, advertising) will need to be identified, as shown in Figure 1 on the previous page.
The process map in Figure 1 is an example of what a manufacturing organization can develop to show the "sequence and interaction" of its processes. This is a requirement of both Clause 4.1b, Quality Management System-General Requirements, and Sub-clause 4.2.2c, documentation Requirements- Quality Manual. This map is helpful to under-standing how the processes in the organization are related to each other. An organization implementing ISO 9001:2000 will need to reorient its documentation and the QMS to understand that its business is a series of interrelated processes. We see this as a "culture change" within a company- the breaking down of the walls of the hierarchical organization and gaining of an understand-ing of the cross-functional nature of the business.
Documenting Processes
Even though procedurally documenting all these processes is not required, ISO 9001:2000 requires evidence to "ensure the effective planning, operation and control of its processes" (Sub clause 4.2.1b, Documentation Requirements-General). In addition, organizations will need to "ensure the availability of resources and information necessary to support the operation and monitoring of these processes" (Clause 4.1d, Quality Management System-General Requirements). Clause 4.1e also requires all processes to be measured, monitored and improved. |
This is a major new expectation, even for organizations registered to QS-9000 or TS 16949. Most well-managed automotive suppliers will recognize the need to document these processes. Your organization should consider using Process Review, a methodology that uses APQP tools to improve and control nonmanufacturing processes. Process Review employs Process Flow (PF), Process Failure Modes and Effects Analysis (PFMEA), a Control Plan and an improvement Plan for all the processes identified by the organization. Of course, the key to effectively |
improving this approach involves efficiently adapting these tools for service process flows, something that has been done effectively for several years in a wide variety of non manufacturing industries. These PFs can also be used to effectively document a process and serve as its written procedures, as shown in the example in Figure 2 below. Figure 2 shows a sample procedure that documents a process for corrective and preventive action. The flowchart shows each step of the process, who is responsible and any specific notes on each step. Each step of the process is investigated for |
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