Automotive Quality Systems Handbook, Second Edition

The standard requires the organization to plan and carry out production and service provision under controlled conditions.
What does this mean?
The process referred to in this section of the standard is the result-producing process, the process of implementing or replicating the design. It is the process that is cycled repeatedly to generate product or to deliver service. It differs from the design process in that it is arranged to reproduce product or service to the same standard each and every time. The design process is a journey into the unknown whereas the production process is a journey along a proven path with a predictable outcome. The design process requires control to keep it on course towards an objective; the production process requires control to maintain a prescribed standard.
There are two ways in which product quality can be controlled: by controlling the product that emerges from the producing processes or by controlling the processes through which the product passes. Process control relies on control of the elements that drive the process, whereas product control relies on verification of the product as it emerges from the process. In practice it is a combination of these that yields products of consistent quality. If you concentrate on the process output to the exclusion of all else, you might find there is a high level of rework of the end product. If you concentrate...