AS9100 Clause 8.3: When Is It Applicable?

Clause 8.3 of AS9100 states that organizations must set up a “development process that is appropriate to ensure the subsequent provision of products and services.”

The scope of application of this clause, however, is not always clear, and we often come across misunderstandings as to who must apply it and who is permitted to exclude it.

The answer is complicated and is best stated as “it depends.” A good place to start is the clarification document on the 9100:2016-Series that the International Aerospace Quality Group (IAQG) updates regularly with answers to key questions from the industry.

Regarding clause 8.3, one of the questions was: if the organization must develop a process to achieve the results, is it, in turn, required to use the design and development process to develop that very process?

The answer from IAQG was negative: “9100 series requirements are for design and development of products and services, not of processes.”

In other words, while 8.3 can be used for process development, it doesn’t have to be. For example, if a machine shop has a process on how they’re going to convert raw metal into a shape with predetermined features, they won’t need to use 8.3 in the creation of that conversion process.

Another doubt on the scope of clause 8.3 revolves around the manufacturing of parts based on reverse engineering of an existing part. A common interpretation in the industry is that because the manufacturer doesn’t own the design, they shouldn’t be responsible for it. IAQG clarified that this interpretation is wrong: “Reverse engineering of a customer sample is considered to be engineering or design. Some level of clause 8.3 would be applicable to the product.”

Along the same line, another key clarification was offered within the 9100 clause 4.3 section of the clarification document. The question reads as: “Is an Aerospace manufacturer or assembler that builds and delivers parts to customer engineering requirements (Build-to-Print organization) able to justifiably have clause 8.3 as not applicable if they contract, design, make, and sell the tooling to the customer? Tooling could consist of tooling to verify parts or fixtures to assist in production of flight hardware.”

IAQG response was as follows: “No, the tooling in the clarification request is considered a product that is contracted, designed, material procured, and manufactured for a customer. If the tooling is not contracted or sold to the customer, then the development of tooling is an enabler to product build and not be confused with the actual product being delivered to the customer. The development and making of tooling in this instance are covered under clause 8.5.1d and 8.5.1.1.”

In short, if the tooling is contracted and becomes deliverable, then the organization would be both a tooling designer / producer (requiring 8.3 applicability) and a maker of the associated widgets. This would apply to a variety of organizations, but becomes especially prevalent with those with molds, dies or other high-cost non-recurring expenses for the tooling. If said tooling is designed by the certified organization and used for the purposes of manufacturing / inspection, but is retained by the certified entity, then non-application of 8.3 clause would be justifiable.

In summary, clause 8.3:

• Won’t apply exclusively to a traditional product design that owns the “cradle to grave” aspects of said product.
• Is applicable to the provision of engineering services (e.g., reverse engineering).
• Is also applicable to the design of deliverable tooling that becomes property of another entity (e.g., customer, government, etc.).