Have you ever scanned through AS9100 Clause 8.1.1 and scratched your head at the mention of “critical items”?
If so, you’re not alone. This seemingly important term gets tossed around requirements with minimal definition. Regardless of how much they’ve told you about critical items, AS9100’s expectation is clear: when you work in aerospace, identifying, monitoring, and controlling both problems and potential problems is integral to success.
But where do you start? How can you stay compliant? At first glance, critical items can be an overwhelming cocktail of questions that can send you spiraling.
Let’s make it simple.
The Standard Uses the Term But Doesn’t Define It
Let’s start somewhere we’re already familiar.
In Clause 8.1.1 of AS9100, the standard states the expectation of organizations is to “determine product and process requirements for the prevention of counterfeit or suspect counterfeit part use and their inclusion in the product(s) delivered to the customer.” Shortly thereafter, there’s an addendum to “identify and manage critical items, including key characteristics, in accordance with risk management.”
Despite not being a long, wordy clause, this chapter of the standard packs a hefty punch. It introduces a big question: what’s a critical item, and who decides?
The answer is easier than you might think: you do.
Because the standard needs to contain thousands of different organizations making completely different products, it doesn’t explicitly define what a critical item is. As an example, what’s considered critical in a fighter jet won’t share a resemblance to what’s critical in a satellite or a commercial airliner.
Instead, the responsibility of designation falls to your team. And even that process isn’t complicated. It falls to one question: “How can this part’s failure jeopardize product safety, performance, or compliance?” If the implications point to an overwhelmingly unacceptable outcome, you might have a critical item.
Digging Deeper: Where Are Critical Items Found?
As mentioned previously, a critical item refers to any part of your build where failure could lead to an unacceptable outcome.
These outcomes vary in scope and implication. They could be safety-related, such as a loose fastener that holds part of a wing in place. It could also be functional; a malfunctioning sensor in charge of feeding data to a flight computer could cause serious issues. It could even be regulatory, like a traceable component missing its labeling and material requirements.
Critical isn’t synonymous with flashy. It’s also worth noting these items aren’t limited to completed goods. Subcomponents, raw materials, and process controls are all eligible for that designation. It might be a tiny screw charged with holding internal components in place, or a seal that, if even slightly off, could let moisture incapacitate parts vital to proper functioning.
Critical items are yet another example of where risk-based thinking occurs and why it matters. An item’s importance isn’t decided by an insignificant size or cost; it’s defined by the inherent consequences of its absence.
Common Critical Item Pitfalls
The most common mistake a company makes with critical items is in the assumption that it’s the customer’s responsibility to tell them what’s critical. It is not. While some customers may tell you, more often, they do not.
If your audit is right around the corner and you can’t show any record of how your team identifies and controls critical items, it’s a serious problem. Auditors always want to know how your team makes that call, what criteria they’ve used, and how that information is then communicated to the operators, engineers, and inspectors associated with each respective item.
An additional misstep is in the thought process that key characteristics and critical items are the same. While there are minor overlapping details, they’re not identical. A key characteristic refers to a measurable facet of the build with tight control limits. A critical item can involve more abstract factors such as special handling, source approval, and shelf life.
What Does Standard Want to See With Critical Items?
Even when AS9100 doesn’t define the term, it still expects to see that you’ve done the homework. This looks like applied risk analysis, keen documentation of conclusions, and controls built and structured around what matters the most in your processes.
This doesn’t mean you need a dedicated “critical item” tag in your resource planning. However, it does mean your team should readily be able to point to a list of parts, materials, or process elements that your team has deemed critical while showing how they’ve attained that status throughout your production process.
Auditors may ask:
- How was this deemed a critical item?
- What risk does this critical item’s failure pose?
- Where and how is this risk being controlled?
These questions aren’t meant to throw you for a loop. They’re systemic checks for how well your system understands its responsibility. When customers potentially trust their lives to the product, there’s 0 tolerance for unacknowledged risk.
How We Can Help
With feedback-driven training and AS9100 consultants all over the U.S., APEX QA has long since been a trusted distributor of top-tier AS9100 training.
Our most comprehensive course, AS9100 Lead Auditor (Probitas Certified) offers training in both live-online and in-person sessions, making sure you’re interfacing with instructors who care for training that lasts.
Interested in only AS9100 Risk Management? We’ve got you covered in a shorter, more budget-friendly package.
If training’s not your thing, every instructor who takes a Lead Auditor training through us becomes another name in our consultant Rolodex. We’re happy to connect you with a professional who has the training to get you where you need to be.
Final Thoughts
AS9100 doesn’t call on you to treat everything as a potential disaster. It’s asking you to prioritize what’s critical and to control accordingly.
This sort of diligence doesn’t constitute a new deluge of paperwork. It’s clarity. Which components carry a serious risk in the event of their failure? Which processes need additional attention to keep the error margins small?
The clearer your team is on what’s critical, the more trust your company builds with customers. Simple as.
If you’re not sure whether you’ve drawn that line well, we can help you sharpen it.
