A process change is any change to how a part is made or inspected without changing the part's definition: a machine, tool, fixture, program, method, sequence, material source, special process, location, inspection method or arrangement of people. AS9100D 8.5.6 asks that production changes be reviewed and controlled, with records of who authorized them. In practice, process changes are where most uncontrolled change happens, because most of them are improvements.
The Manufacturing Process Change Assessment (E13) asks nine risk questions of every process change: key characteristics, special processes, form, fit or function, product safety, inspection method, customer-approved processes, PFMEA and control plan, new equipment or gauges, and training. A Yes is not a reason to stop; it says what the validation and approval must cover.
Validation
- Write the criterion before the trial. In numbers, agreed with the approver: what will be measured and what result means it worked.
- Trial on the real process. Production machine, program, tooling and operator.
- Capability on key characteristics. Five good trial parts say the process can make it; thirty values from production say it will keep making it. Record them on D16.
- Watch the first lots. Set how many before closing. Some effects, such as tool wear, take time to show.
The customer and the FAI
Read each customer's quality clauses for the process changes they want to hear about or approve: often key characteristics, special processes, sources, machines or sites. Send the notice before production, and record the answer. AS9102 names changes to the manufacturing process, location, tooling, inspection method and source among the events that may call for an FAI; check it and the customer's clauses for each change, and record the decision on E13.
Temporary changes
A temporary change, such as running a job on a backup machine during a repair, is still a process change. Give it an end date and an owner on E13. On the end date it is either reversed or assessed as permanent; it never simply becomes the process.
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A management aid, not certification or a registrar audit. Using it does not by itself show conformity to AS9100D or any other standard, and your customers' requirements may add to it.
Clause numbers refer to AS9100D (SAE AS9100 Rev D) unless another document is named. The standards' text is not reproduced here: use your own licensed copy.
Aegis Insights are our own guidance, labeled wherever they appear: how we approach this work, not a requirement of any standard or customer.