Quality management in the design process of a new or improved product ensures that the final product meets the requirements and specifications of its intended use. This is achieved by focussing on the process, where all actions are planned, developed, conducted, validated and verified. These actions should also be properly documented and periodically reviewed. The process if often referred to in a design plan. 

 

If there is an ISO 9000 type Quality Management System available and implemented, then the path through the design process is reasonably clear. For example, ISO 9001 & ISO 13485 (Medical devices) or ISO 16489 (Automotive industry). However these standards only provide the framework within which the new product must be developed. It is also essential from the beginning of the design process for a new product to define (among other things):

• What is its purpose?

• In what environment will it be used?

• Who are the customers, what is the market?

• What are the applicable regulatory requirements?

• What price will be acceptable to the market?

• Do you have the in-house competence and resources for development and manufacture?

 

The design plan is useful during the design process to document specific actions, reviews and requirements. It will outline product design targets, timelines, product requirements and specifications as well as tracking project milestones. The design plan should include all actions necessary right from initial development through to product realisation. It must be backed up with documented test reports to provide objective evidence that both the product and the manufacturing process  meet all requirements and specifications. A good design plan also includes risk management actions to avoid foreseeable risks. 

 

The manufacturing process is covered by the design plan. This is particularly important if you intend to use an external manufacturer, as it is necessary to provide evidence that the chosen supplier is properly qualified and the product is delivered meeting all required specifications. 

 

Finally, before the product goes to market, it may be necessary to register it for a specific country or market. This may include providing documentation, test results or test samples to the relevant regulatory body.

 

On completion of the design process, when all the actions in the design plan have been implemented, the last phase is to conduct a thorough final design review. Once reviewed and approved by responsible participants this may also release the product for serial production.

 

If this quality management in the product design process seems overwhelming, it is worth considering the potential consequences of a failure of an important aircraft part while in operation. Such a failure could possibly be traced back to a failure in the design process, such as insufficient testing which should have been part of every design plan in the aircraft or automotive industry. The failure could be something as simple as a washer that was not heat treated as required, or manufactured from incorrect material. 

 

Many years working in industries where products are designed for a specific intended use have shown me that lack of quality management in the product design phase, results in a much greater risk of product failure in the market. In today’s marketplace, manufacturers are increasingly responsible (liable) for the performance of their products, so it is imperative to reduce the risk that products can disappoint or harm a customer. 

 

With my experience across multiple industries where products are especially designed and manufactured for international markets, I can provide full support to you through the design process of a new product.