Mark Hammar One question that keeps coming up is whether a company can exclude the design and development requirements of AS9100 Rev D from their aerospace Quality Management System (QMS), and the rules have changed around what exclusions are and are not acceptable. So, what does this mean to your company? In this article I will talk about what has changed and what has remained the same in the design and development process requirements of AS9100 Rev D.
Has the design and development process changed?
While the wording and structure of the design and development requirements in AS9100 Rev D have changed slightly, the actual process of design and development has remained very much the same. Your design and development process still needs to have the following elements:
- Planning – What activities, reviews, controls, resources, and customer involvement are necessary for the design and development of this product or service?
- Inputs – Ensure that you have all of the design and development requirements from functional requirements, similar designs, legal requirements, standards or codes of practice, etc.
- Controls – Make sure your plan includes all controls needed to evaluate the ability of the resulting product or service to meet requirements, verification and validation activities, actions for problems found in reviews, documented information, and authorization to progress to the next stage.
- Testing – When you need to perform testing to verify or validate, ensure that the testing is adequately planned, controlled, reviewed, and documented.
- Outputs – Design outputs need to meet the inputs and be adequate for the production processes, including acceptance criteria when applicable, and proper approval by authorized personnel prior to release.
- Change – When design and development outputs are changed, this needs to be properly managed and approved to ensure no adverse effects from the changes.
For more on design verification and validation in AS9100 Rev D, see this article: Design verification vs. design validation in AS9100 Rev D.
What has actually changed?
So, if the design and development process is essentially the same, what has actually changed? It may surprise you that the change is in one small word. In the previous version of the AS9100 standard, the word “product” was used with a note stating that the word “product” can also mean “service.” So, if a company provided a service to their customers, they would apply the requirements of AS9100 to their service; essentially, where the standard said “product” it was read as “product or service.”
In the AS9100 Rev D standard they have removed the confusion caused by the note, and used the term “products and services” throughout the standard. So now, instead of the design and development requirements applying to the “products or services” of the company, they apply to the “products and services” of the company.
In the past, a company that provided mainly customer-designed products could easily exclude the design and development requirements from their QMS. However, now each company needs to consider all products and services provided to the customer when they consider excluding QMS requirements. Even if you provide mainly products, you also have services you provide, such as shipping products to the customer, and these services will need to go through the design and development process when they are newly created.
What does this mean for my company?
If you are a company that provides products to your customers, you will first have to identify the services that you also provide, such as delivery of your product if you choose the carrier. If you have services already in place, then you will already have controls over these services, and any changes will need to be considered as design changes. However, you will not need to re-create the design and development activity that originally created the service in the past.
I think it might be clearer if I give some examples:
- Example 1: A machining company takes the design and CAD files from their customers, uploads them to their machines, and cuts metal. They have thus far been able to claim an exclusion from design and development, and would still be able to do so under AS9100 Rev D.
- Example 2: A machining company takes their customers’ designs, and provides the service of turning these into CAD files so that they can be uploaded to a machine to cut metal. They have been able to claim an exclusion for the design and development of this service in the past. Because the service is already in place (already designed) and is controlled within the QMS, they do not need to re-design the service now; however, any changes to the service should be controlled as a design and development change.
- Example 3: A machining company that currently takes CAD files from customers and cuts metal has previously excluded design and development from their QMS. However, if they decide to add the service of creating CAD files for their customers, the design and development of this new service needs to go through the design and development process per AS9100 Rev D.
The one complication is in knowing if a new process is a service being provided to a customer, or an internal process. In example 3 above, this is clearly a service that is provided to make the deliveries to the customer; however, if you were implementing a new process for financial management, which included invoicing to the customer, it might be argued that this is an internal process not requiring the design and development process; internal processes are controlled through clause 8.3 of AS9100 Rev D.
What do we need to do?
The most important thing to do when you begin your transition to AS9100 Rev D is to identify what products and services you actually provide to your customers. Then, you will be able to identify which requirements of the AS9100 standard are applicable to you, and which are not. By only applying the requirements that apply to you, you will have a more appropriate QMS that meets your needs, which is a better investment for your company.
Find out more about the AS9100 Rev D design and development requirements in this white paper: Clause-by-clause explanation of AS9100 Rev D.
