Introduction
In the aerospace and medical device manufacturing industries, there exist select processes that cannot be verified by the usual means of compliance. These special processes are placed under an extra layer of scrutiny in both AS9100 and ISO 13485.
Special processes often confuse newer quality professionals because they’re an extra layer of technical knowledge on top of already complex standards. Special processes, like most things in quality assurance training, require a diligent mind prepared to think outside the four walls of a manufacturing plant.
What are Special Processes?
Special processes are any production steps where you cannot fully verify the result after the product is finished. They appear in manufacturing, inspection, and validation activities where the outcome of the process remains embedded in the material or assembly itself.
Inside a quality system, these processes exist within production controls, equipment management, training, and validation planning because the only way to ensure consistent output is to control the conditions under which the work is done.
Imagine you’re a baker pulling a fresh loaf of bread out of the oven. Once outside the oven, there’s no way you can know what the inside looks like. You cannot cut the loaf without destroying the marketable product. As a baker, you have to trust the temperature of the oven, the timing of the bake, and the ingredients inside the loaf were correct because the customer will be the first one to slice the bread. The same logic applies to processes within a QMS.
Special processes can often confuse newer quality professionals because they’re discussed differently within each standard. While they might be directly mentioned in AS9100, ISO 13485 doesn’t utilize the same language, thus creating a rift between the two disciplines.
Regardless of language, the idea remains identical. If you cannot confirm product safety or performance after production, the process needs tighter control.
Why Special Processes Matter
Special processes carry a built-in risk. Nobody can fully confirm that elements such as heat treat, sterilization, welding, anodizing, and soldering haven’t altered the end product by visuals alone. Once the material has been influenced, it cannot be undone for the sake of inspection. The only way to guarantee consistency is to guarantee the specifics of the process.
This is where the standards converge. Even though the wording might differ, the expectation remains the same. Each organization must take demonstrable steps to establish clear requirements, qualify the process, train the operators, record the conditions, and monitor the results over an extended period of time.
Where AS9100 and ISO 13485 Align
Here’s the simplest way to think about the shared requirements:
Identify processes you cannot effectively verify until after production. Use operator competency, environmental monitoring, clear work instructions, and documented evidence that each run met the defined parameters.
That single list captures most of the overlap. The details vary, but the backbone is stable across both industries.
Where Aerospace and Medical Devices Divert
Tending to stress process validation, aerospace failures can prove catastrophic while simultaneously untraceable to a single operator’s actions. Additionally, AS9100 mentions process control under the umbrella of production management and usually expects external qualifications such as NADCAP when the inherent risk is high or when customer contracts demand it.
Medical device manufacturers flirt with the same ideas within process validation. ISO 13485 places emphasis on validation, specifically when the output cannot be verified through subsequent inspection and testing. Elements such as sterilization, packaging, and bonding are observed with scrutiny. Software-driven conditions commonly fall into the special processes category. The difference is mostly vocabulary.
The Real Problem Companies Face
Most organizations struggle not because the rules are complicated, but because they overexert themselves trying to apply them everywhere. Not every process requires full-scale validation and documentation. While better than the alternative, over-qualifying a low-risk step can create unnecessary paperwork and slow production and efficiency. Inversely, under-qualifying high-risk steps will create costly compliance gaps. The key to both scenarios is correct identification.
APEX QA offers tailored auditing services to any organization looking to shore up their systems. Whether you’re preparing for a certification audit, updating your floor to meet the newest compliance specs, or you just need a new set of eyes, we have qualified auditors all over the country ready to help you out.
A special process is special because failure cannot be seen until it is too late. It’s Schrodinger’s cat, for anyone who’s studied quantum physics. Once a company accepts and utilizes the overarching idea, the rest is a matter of discipline. Write the requirements. Train people. Document every run. Prove that the process works. Reverify when the process changes. It’s simple enough, right?
What You Can Do Now
As the standards march into new eras, industries are trending toward tighter evidence requirements. Customers want more transparency. Regulators and auditors want clearer justification for why a process was labelled special or not. The tools to document and observe efficiency are there.
As mentioned before, training operators is a crucial step in identifying and maintaining special processes in any given QMS. Thankfully, APEX QA offers risk training for both medical devices and aerospace. For anyone looking to be qualified in their own team, give our brochure a look. It might be the difference when it comes time to future-proof your company.
A good special process program protects the operator, the end user, and the organization every step of the way. It removes guesswork from investigations and reduces the number of repeat problems. Done correctly, it’s a complete win for everyone involved.
Final Thoughts
A strong special process program is not about meeting two different standards. It is about creating a production environment where risk is understood, parameters are controlled, and results are predictable.
Whether the requirement comes from AS9100 or ISO 13485, the goal is identical. Build processes that stand on evidence, not assumptions. When special processes are treated with the same rigor across both industries, manufacturers reduce variability, improve compliance, and protect the people who depend on their products.