Validation is not a necessary activity in design and development stage, if the test performed in Engineering phase is enough to ensure the product is designed/manufactured according to requirement. The spirit of Validation is to ensure the product could provide good user experience.

As the product which already pass all test, including dimensional (all dimensions of the device are within design drawing spec.), physical (drop, aging, transportation…etc.), functional (operate the enough sample size of device and the results are as per expected.). The validation activity could start. While apply the product to enough sample size of end customer. As long as they “feel” un-confutable with the product, the product fails the validation. Manufacturer shall review, adjust, or may re-develop the product.

• According to the design requirement, the automotive needs to reach 100km/hr. in 4 seconds. If the test in the engineering phase is well ensured this requirement, the capability of acceleration may be an object of the final product that does not require validation activity.

• Every automotive equipped with air conditioning system (AC). Although the AC could change the air condition properly according to the design requirement. but it could not satisfy all customer in the world. The weather is very different at area with different latitude. Some customer requires AC to reduce temperature and some customer requires AC to generate heat. After the validation of the automotive’s AC system. designer re-developed the AC system for the automotive according to different region of the world. The AC may be an object of the final product that requires validation activity.

Automotive industry is a giant industry, a final product could be consisted of many components from different supplier. Except the last manufacturer who sells the final product, Intermediate supplier don’t reach the end user. Still, all intermediate suppliers are part of the automotive industry, they could also perform validation activity to their product.

• Every automotive equipped with tires. Although the tire could overcome different weather and road condition properly according to the design requirement, but the noise during driving may lead to bad user experience. After the validation of the tire, designer re-developed the tire design. Validation activity of the product (tire) may be a requirement in supplier development.

In stead of the final product and the sub-assembly/ component, the manufacturing process of the same may also requires validation as well. In order to not only concentrating the quality of the manufacturing result, but also the manufacturing process. ”If any individual process is controllable, the process/equipment could be validated. If not, then 100% inspection shall be applied to the subsequent component/ sub-assembly/product of individual process.”  Following examples demonstrate the decision of performing validation:

• An egg manufacturer cannot control the situation of each chicken(process), Therefore the manufacturer is not able to perform validation to the process. According to customers requirement (weight 50~55g/per egg), the manufacturer could measure the weight of each egg before shipment.
• A component manufacturer can control the process including raw material (consistency), equipment (setting/performance), process (manufacturing steps), environment (temperature/humidity) …etc. According to the regulatory requirement, 100% inspection of all components before shipment or validation could be performed.

Generally, most of the manufacturing process are controllable/measurable. In the cost point of view, 100% inspection is usually higher than validation. Since only one validation of each process/equipment shall be performed, then review periodically. 100% inspection of components requires lots of human resource, space, and time (the inspection needs to perform as long as the production is ongoing).

Validation is a higher-level test that concentrates at not only the result/output but also the intermediate process. Although it is not a necessary activity, still more and more manufacturers in electric/sports… industry starts to perform validation nowadays.