Design input

Fumes are defined as solid airborne particulates that have been produced by a change of state. Many industrial operations produce fumes which affect both the indoor environment and the outdoor environment. For many operations, fumes are generated by a high-temperature process. The gas stream containing the fume is usually of high temperature and contains combustibles. The combustibles may form an explosive mixture, thus necessitating specialized design inputs for most fume control ventilation systems. The major elements of a fume control system are pictured in Fig. 13.28. 

Requirement for process design input requirements to be identified, documented, and reviewed... 

Requirement for process design output to be expressed in terms that can be verified and validated against process design input... 

Requirement for product life, durability, and maintainability objectives to be included in design inputs... 

Do the design controls ensure that design inputs are documented and reflect customer needs and expectations ... 

The standard requires the supplier to identify, document, and review the process design input requirements. 

The standard requires that design input requirements relating to the product be identified and documented and product life, reliability, durability, and maintainability objectives be included in the design inputs. 

This requirement appears low down in the list of requirements and should ideally have been the first requirement that the standard addressed under design control. Until you have a design input you cannot carry out your design and development planning. 

Design input requirements may in fact be detailed in the contract. The customer may have drawn up a specification detailing the features and characteristics product or service needs to exhibit. (See Part 1 Chapter 1 on Quality characteristics and Part 2 Chapter 3 under Ensuring that the requirements are adequately defined and documented.) Alternatively, the customer needs may be stated in very basic terms for example ... 

You should note that these requirements do not require that design input requirements... 

To identify design input requirements you need to identify ... 

In addition to customer requirements there may be industry practices, national standards, company standards, and other sources of input to the design input requirements to be taken into account. You should provide design guides or codes of practice that will... 

The standard requires that the design input requirements include applicable statutory and regulatory requirements. 

The standard also requires that the selection of design input requirements be reviewed fay the supplier for adequacy. 

Impact of the results of contract reviews on design input (4.4.4.1)... 

The standard requires that design input take into consideration the results ofang contract review activities. 

Expressing the requirements in terms of requirements that can be verified and validated has two meanings. You need to be able to verify that both the design input requirements and user requirements (if different) have been achieved in the product so they need to be expressed in appropriate terms. The vehicle to contain such requirements is usually a product or service specification. You also need to be able to verify that the design output meets the design input and to achieve this you will need to document your calculations and analyses. 

Expressing the design output in terms that can be verified and validated means that the requirements for the product or service need to be defined and documented. The design input requirements should have been expressed in a way that would allow a number of possible solutions. The design output requirements should therefore be expressed as all the inherent features and characteristics of the design that reflect a product which will satisfy these requirements. Hence it should fulfill the stated or implied needs, i.e. be fit for purpose. 

Ensuring that design output meets design Input requirements (4.4.5.1a)... 

The techniques of design verification identified in clause 4.4.7 can be used to verify that the design output meets the design input requirements. However, design verification is often an iterative process. As features are determined, their compliance with the require-... 

Produce procedures which regulate the specification of design (input) requirements and the documentation of product specifications and drawings. 

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