Esin Coskuner- 503091330 (4th week unanswered word)

5. New-Design Control(Production Control System)

Previous definition(better and general)

New-design control involves the establishment and spesification of the necessary cost-quality, performance-quality, safety-quality, and reliability-quality for the product required for the intended customer satisfaction, including the elimination or location of possible sources of quality troubles before the start of formal production.

Techniques used in new-design control include analysis of product function, quality research, enviromental and end-use tests, classification of quality characteristics, establishment of quality levels and quality standarts, process-capability studies, tolerance analysis, quality-ability analysis, failure mode and effect analysis, design review, log of prototype inputs, prototype tests, establishment of process parameters, product evaluation, safety studies, manufacturing-process review, establishment of reliability standarts, development of maintainability and service-ability standarts, and pilot runs.

(Total Quality Control, Armand V. Feigenbaum Page 65,67)

New definition:

Design controls may be applied to any product development process. The simple example shown in Figure 1 illustrates the influence of design controls on a design process.

Figure 1 - Application of Design Controls to Waterfall Design Process (figure used with permission of Medical Devices Bureau, Health Canada)

The development process depicted in the example is a traditional waterfall model. The design proceeds in a logical sequence of phases or stages. Basically, requirements are developed, and a device is designed to meet those requirements. The design is then evaluated, transferred to production, and the device is manufactured. In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of product development. However, this detail has been omitted from the figure to make the influence of the design controls on the design process more distinct.

The importance of the design input and verification of design outputs is illustrated by this example. When the design input has been reviewed and the design input requirements are determined to be acceptable, an iterative process of translating those requirements into a device design begins. The first step is conversion of the requirements into system or high-level specifications. Thus, these specifications are a design output. Upon verification that the high-level specifications conform to the design input requirements, they become the design input for the next step in the design process, and so on.

(Design Control Guidance For Medical Device Manufacturers,This Guidance relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001,March 11, 1997, pg3)