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AS9100 to IA9100: Key Changes to Product Safety, Supplier Oversight and Counterfeit Part Prevention

Mike Varney and Christian Reyes, pictured, discuss the transition from AS9100 to IA9100 in this episode of the QT9 Q-Cast.
IA9100 Key Changes | QT9 Q-Cast
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As aerospace manufacturers continue preparing for the transition from AS9100 to IA9100, much of the conversation has centered on quality culture, leadership accountability and audit evidence.

In Part 2 of QT9 Q-Cast’s recent discussion with aerospace auditor and consultant Mike Varney, the focus shifts from management systems to day-to-day operations, including current expectations for product safety, counterfeit part prevention, supplier oversight and production process validation.

While the final IA9100 standard has not yet been published, Varney emphasized that organizations should focus less on creating new processes and more on ensuring their existing quality management systems produce objective, defensible evidence.

Contents

Product safety extends beyond product design

Existing quality processes may already support product safety

Counterfeit part prevention requires more than an approved supplier list

Sub-tier supplier oversight should be based on risk

Process validation requires more than first article inspection 

The growing importance of data credibility

Take advantage of your QMS to prepare for IA9100

How QT9 helps aerospace meet AS9100 - IA9100 requirements

Watch the full conversation

Product safety extends beyond product design

One of the biggest misconceptions surrounding IA9100 product safety is that it only applies to organizations responsible for product design. In reality, product safety applies throughout the supply chain, even for manufacturers that simply build to customer specifications.

Many AS9100-certified organizations operate as “build-to-print” manufacturers and, therefore, may not consider design and development compliance requirements. Varney points out that beyond ensuring products are manufactured according to requirements, production teams are still responsible for documenting events that could affect product integrity and communicating potential issues to the customer.

“When we talk about product safety, it’s about building to the print,” said Varney. “It’s about if there’s any confusion about the requirements from the customer, getting that clarification and retaining evidence of that communication trail.”

He offered a practical example. If a part falls from a forklift during production, it may appear undamaged and still meet specification. However, without design authority, the manufacturer cannot determine whether the impact of the fall could affect the product's safe use in the field.

"That would be a situation where we want to document that event,” said Varney, “communicate that with the customer, say, 'Hey, we had an incident, it still meets the spec. What do you want us to do?'"

That mindset should extend to every stage of production. Rather than assuming the product is acceptable, manufacturers should think beyond the shop floor and consider the people relying on the finished product.

"We need to make sure that we're doing our due diligence to do everything that we can to think about that person on the tail end," said Varney. "Think about that person who's installing that part in an aircraft, the person that's using that part in a defense environment."

Existing quality processes may already support product safety

Some aerospace organizations are wondering whether IA9100 will require new product safety documentation. According to Varney, many companies already have the necessary framework in place.

"I don't think most companies will need an actual log to keep track of this stuff," he said. "If you have a good system in place, if you have a strong QMS, the QMS already has the tools in place to be able to address this."

Risk management, customer communication, nonconformance management, change control and CAPA processes can already support product safety when they are used consistently and product safety considerations are clearly incorporated.

For organizations with design authority, those activities may rely more heavily on engineering review. Build-to-print manufacturers, meanwhile, may need stronger customer communication when questions arise.

Counterfeit part prevention requires more than an approved supplier list

Supplier approval has long been an important part of aerospace quality management, but Varney believes under IA9100, organizations should expect greater scrutiny around counterfeit part prevention, an area historically delegated to procurement.

"I would expect now that we are going to need to see more than just ‘we have an approved supplier list,’" said Varney, also noting that organizations should evaluate if any of their approved suppliers include distributors, as they often source material from multiple locations that can change week-to-week.

Beyond supplier status, Varney said organizations should be prepared to demonstrate that incoming supplier documentation is reviewed. “What we’re going to need to prove now, going forward, is that once we receive product in, that we’re actually evaluating the documentation that comes with that product.”

Raw material, hardware and electronics carry the highest historical risk of being counterfeit, he noted, and may warrant closer review or third-party verification.

“There are some things that are higher risk than others," he said. "Raw material, hardware and electronics are the three most likely areas that we see nonconforming or counterfeit events generally, historically. So we’re going to want to make sure that when we’re buying these products, the documentation is actually reviewed.”

Sub-tier supplier oversight should be based on risk

Many manufacturers outsource critical processes, such as heat treating, coating or subcontract machining. Once work leaves an organization's facility, visibility into how that work is performed naturally decreases. "We have great control. We have an awesome QMS. We know that everything is rock solid here in our facility," said Varney. "Where that falls apart is when it leaves our facility."

Rather than auditing every supplier, Varney recommends a risk-based approach. For many companies, that may include:

  • Requiring suppliers to maintain certifications, such as AS9100, ISO 9001 or NADCAP, where appropriate.
  • Performing additional oversight, such as on-site audits, for higher-risk suppliers.
  • Increasing communication with suppliers performing critical processes.
  • Evaluating supplier criticality as part of supplier risk management.

"I expect that we're going to want to see some sort of a risk evaluation done on those vendors and some tools in place," said Varney.

Process validation requires more than first article inspection 

Validation of production processes will likely require more than first article inspection (FAI) under IA9100. FAI is when a first, representative piece is pulled from a production run to demonstrate that a process can meet requirements.

But Varney pointed to a common flaw for process validation: first articles are often built under controlled conditions that do not reflect an actual production environment, run by engineers rather than the operators who will run the job, and measured with equipment that will not be used again once production begins.

“So all of a sudden, the concept of a first article inspection falls apart as a production process validation, because you’re not actually validating a production process. You validated an isolated event that was overseen by engineering.”

Rather than treating a first article as the finish line, Varney said organizations should shift their focus. “Focus on proving the process versus proving that we made one good part one time,” he said.

Six steps for better process validation

Varney offered six manageable steps organizations can use to build a stronger validation event:

  1. Identify what’s important. Determine which characteristics are critical before validation begins.

  2. Validate under real production conditions. Run the part on the actual machine, with the actual operator who will produce it, rather than in a lab under engineering oversight.

  3. Verify your measurement method. Confirm that the tooling used to measure the part is capable of doing so accurately, supported by a basic gauge R&R.

  4. Run multiple parts, not just one. Check parts beyond the first piece — the fifth, the tenth — to see how the process trends over time.

  5. Monitor your critical characteristics. Track the characteristics identified in step one with strong, consistent data.

  6. Establish ongoing controls. Put controls in place to keep those trends flat over the long term.

“I think those are manageable steps to actually build a program with some defensible evidence that is stronger than a first article inspection,” Varney said. “A first article is a component of it, but there’s more than just a first article.”

The growing importance of data credibility

Another area Varney expects aerospace auditors to examine more closely is data credibility. Organizations have long tracked customer satisfaction, supplier performance and quality objectives. Varney expects IA9100 auditors to look more closely at how those metrics are developed and whether they truly reflect customer priorities.

"I think what we're going to see a lot more of is, ‘show me how we got there,’" said Varney. “Look at those trends over time. If you’re evaluating four different metrics to come up with your customer satisfaction data, how are you weighing those metrics?”

Rather than simply reviewing whether an organization met its KPI targets, auditors may ask:

  • How were performance metrics weighted?
  • Why were those metrics selected?
  • Do they reflect what customers value most?
  • How are trends influencing management decisions?

"The customer cares about on-time delivery and product quality," said Varney. "If that's what's important to your customer, then we should be weighing it accordingly."

Take advantage of your QMS to prepare for IA9100

As the discussion concluded, Varney offered some advice that applies not only to organizations preparing for IA9100, but to every company already certified to AS9100.

Simply having documented procedures or implementing quality software is not enough. Organizations should be using the capabilities already available within their quality management system to identify risks, document events, manage supplier quality, monitor performance and generate the objective evidence auditors increasingly expect.

"You can have the best system in the world," said Varney. "You can show the best procedures to an auditor. That doesn't make the system good in practice."

He also emphasized that documented procedures alone do not demonstrate compliance.

"Just because it's documented doesn't mean it's implemented. And just because it's implemented doesn't mean it's effective."

As organizations prepare for IA9100, the goal should not be to create more documentation or new processes. Instead, they should evaluate whether their existing quality management system is being fully utilized to support consistent execution, continual improvement and defensible audit evidence.

How QT9 helps aerospace meet AS9100 - IA9100 requirements

QT9 QMS helps organizations manage the quality processes that support AS9100 compliance today and can help them prepare as IA9100 requirements become final. Document control, audit management, risk management, CAPA, nonconformance, training, change management and supplier quality records are maintained within a connected quality environment, making it easier to demonstrate how processes are controlled and how issues are addressed.

Aerospace manufacturers can use QT9 QMS to:

  • Maintain controlled procedures, specifications and work instructions with revision histories, electronic approvals and audit trails.
  • Link risks, nonconformances, CAPAs, audits and change records to create a traceable history of quality decisions and follow-up actions.
  • Evaluate supplier performance, maintain approval status and document supplier corrective actions and audit results.
  • Assign required training, verify employee competency and retain qualification records.
  • Monitor quality objectives and performance data through dashboards and management review tools.
  • Document engineering and process changes with approvals and complete traceability.

In addition, with native integration between QT9 ERP and QT9 QMS, aerospace manufacturers can connect operations and quality records. A nonconformance can be tied to the affected part, lot, serial number, supplier or work order, while inspection results, certifications and corrective actions remain connected to the same product history.

QT9 ERP adds the operational records needed to connect quality requirements to the way products are manufactured. The system supports production planning, inspection and test documentation, material certifications, approved supplier controls, receiving inspection and lot and serial traceability from incoming material through final shipment.

For more information about how QT9 Software can help your aerospace or defense organization, contact us today.

Watch the full conversation

This article highlights Part 2 of QT9's recent discussion with aerospace auditor Mike Varney about the upcoming transition from AS9100 to IA9100.

Watch the full QT9 Q-Cast episode and find other insights from Mike Varney to learn how aerospace organizations can prepare for the next evolution of aerospace quality management.  

FAQ: AS9100 Transition to IA9100

What is AS9100?

AS9100 is an internationally accepted quality system standard for the aviation, space and defense industries. It was created by the International Aerospace Quality Group (IAQG) in conjunction with industry representatives from the United States, Canada, Latin America, Europe and Asia/Pacific.

The standard is built off of the general quality management system standards outlined in ISO 9001, with the addition of important industry-specific guidelines. The goal of the standard is the safe development, production and distribution of high-quality, reliable aerospace parts and products.

What is IA9100?

IA9100 is the anticipated next revision of AS9100, the internationally recognized quality management system (QMS) standard for the aviation, space and defense industries. It is expected to succeed AS9100 Rev D while continuing to incorporate ISO 9001 requirements along with additional aerospace-specific requirements.

Although the final standard has not yet been published, current guidance suggests it will place greater emphasis on objective evidence, quality culture, leadership accountability, information security and risk-based decision-making.

What is the difference between AS9100 and IA9100?

AS9100 Rev D is the current aerospace quality management standard, while IA9100 is the expected next revision. Based on current industry discussions, IA9100 is not expected to be a complete rewrite. Instead, organizations should anticipate updated requirements and greater expectations for demonstrating that quality management processes are effective through objective evidence.

Will companies need to completely rebuild their quality management systems for IA9100?

No. Current expectations indicate that most aerospace organizations will not need to redesign their entire quality management system. Instead, companies should focus on ensuring existing processes produce measurable results and that they can provide objective evidence demonstrating those processes are working as intended.

Will IA9100 replace ISO 9001?

No. IA9100 is expected to continue building upon ISO 9001 rather than replacing it. Like AS9100 today, IA9100 is anticipated to include all applicable ISO 9001 requirements while adding aerospace-specific requirements for aviation, space and defense organizations.

What are the biggest expected changes in IA9100?

While the standard has not yet been finalized, current expectations include increased emphasis on:

  • Objective evidence during audits
  • Quality culture and ethical behavior
  • Leadership accountability
  • Production process validation
  • Information security within the quality management system
  • Counterfeit part prevention

Organizations should monitor official IAQG communications as the final standard is released.

When will IA9100 be released?

Based on current industry expectations, ISO 9001 is anticipated to be released first, with IA9100 expected to follow. Publication of ISO9001 updates is expected by the end of 2026. Organizations should continue monitoring updates from the International Aerospace Quality Group (IAQG) and their certification bodies for official transition timelines.

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