AS9100 Clause 8.5.1.2 – Validation & Control of Special Processes

AS9100 is a widely adopted and standardized quality management system for the aerospace industry. The standard is based on ISO 9001 and is supplemented by additional requirements specific to the aerospace sector.

Section 8.5.1.2, which deals with the Validation and Control of Special Processes, is an extension of the ISO 9001:2015 clause 8.5.1 on Control of Production and Service Provision.

Special processes are those for which the output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. In the aerospace industry, these can include processes such as welding, heat treating, and plating, among others.

According to the AS9100D (the version current as of my training cut-off in 2021), the standard requires organizations to:

1. Establish criteria for review and approval of the special processes.
2. Approve facilities for carrying out the special processes.
3. Determine the required qualification of persons performing the special processes.
4. Define the necessary equipment and its qualification/validation.
5. Document procedures and instructions for these special processes, where the absence of such would jeopardize product quality.
6. Monitor and control these processes to ensure that they are performed in accordance with these documented procedures and instructions.
7. Revalidate the ability of these processes to achieve planned results whenever changes occur that invalidate the original results.
8. Determine the method used to maintain process approval when production items are used for validation.
9. Use representative items from the first production run of a new process to verify that the process is capable of producing planned results (this is often referred to as first article inspection, FAI).
10. Document evidence of process validation.