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According to the United States Food and Drug Administration (FDA), the organization receives more than two million reports of suspected medical device associated deaths, serious injuries and malfunctions. These failures pose serious risk to patients and end users and reinforce the need for stringent quality practices within all of our organizations.

The medical device industry is not the only industry that shines a spotlight on regulatory quality standards and issues. The aerospace industry, for example, has been in the news due to highly visible failures in the field of mission-critical products. Both medical and aerospace OEMs and their supply chain partners share the responsibility for preventing these catastrophic failures and malfunctions.

Contract manufacturers that hold niche expertise in quality systems and processes for both aerospace and medical can give OEMs a significant competitive advantage. Experience across these highly regulated applications can lead to improved product performance and increased customer confidence. The expectations of quality for both industries lead to a culture of continuous improvement, operational efficiency and proactivity, fostering long-term growth.

Defining Quality for Medical and Aerospace Products

Quality can be defined in multiple ways depending upon your product’s design and functionality – not necessarily by its end use application. Commonly, quality may break down into three areas:

• Performance: Whether you’re molding components for a surgical device or an airplane engine, products must withstand intended use, wear and tear, and harsh environments (e.g., variable temperatures, pressure, moisture and more).
• Cosmetic Appearance: For some products, appearances are everything, driving controls to prevent issues like warping, surface defects (e.g., sink marks, flow lines or flash) and color variations. These seemingly surface-level flaws may also indicate underlying quality issues that impact product performance.
• Contamination: While mostly a concern in medical markets, contamination prevention is a non-negotiable. Products that don’t meet cleanliness standards can expose patients to unacceptable safety issues.

Medical and aerospace products share a critical need for flawless performance, impeccable appearance, and absolute contamination control. This shared emphasis on quality stems from the high stakes involved, as failures can have severe consequences, demanding rigorous standards and meticulous manufacturing processes.

Exploring Quality Regulations in Medical and Aerospace

The medical and aerospace industries have their own specific certifications and standards that teams must adhere to – but there is much overlap in requirements and standards that can be implemented within your organization.

For example, a medical device contract manufacturer may hold several ISO certifications to guide quality management systems, including:

• ISO 13485: 2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
• ISO 9001: 2015 – Quality management systems – Requirements

Medical quality standards prioritize patient safety and regulatory compliance with the above certifications as well as governance from agencies like the U.S. Food and Drug Administration (FDA), which regulates food, drugs, biologics and devices.

Aerospace products also have their own set of requirements, including AS9100, which builds on the requirements for a QMS as defined in ISO 9001:2015. Its counterpart to the FDA is the Federal Aviation Administration for Aerospace (FAA), which certifies manufactured goods with a focus on counteracting catastrophic failures and malfunctions.

Finding Commonalities in Quality Practices Across Markets

Before exploring how a contract manufacturer’s quality expertise translates across medical and aerospace markets, let’s examine the overlapping quality requirements that drive success in these demanding fields.

• Quality Management Systems: While individual standards for medical and aerospace QMS prioritize industry-specific requirements, these standards share a set of foundational goals that transcend applications, including a focus on customers, buy-in from company leadership, a process-based approach, continuous improvement, risk-based thinking, corrective and preventative actions (CAPAs), and document control.
• Process Control and Validation: While the scope of process control and validation will vary in medical or aerospace programs, both use IQ/OQ/PQ process validation principles and require comprehensive documentation.
• Traceability: Should a product fail in the field, traceability across your entire supply chain becomes critical in understanding any issues that arise through medical device recalls or aerospace component investigations.
• Risk Mitigation: Proactive risk assessments across all of your manufacturing processes and systems allow you to get ahead of potential failures.
• Continuous Improvement: Capturing and investigating data on benchmarks related to quality, efficiency and customer satisfaction drives continuous improvement initiatives that accelerate success for you and your customers.

While specific regulations vary, medical and aerospace industries prioritize user safety through Good Manufacturing Practices (GMP) and apply similar quality approaches, including both quality control (QC) and quality assurance (QA).

Quality control (QC) is a set of techniques to manage production standards once parts are manufactured. Teams make sure that parts are defect-free after they come off the press and before they are packaged and sent to the customer. Its counterpart, quality assurance(QA) is a proactive approach to quality, identifying and controlling issues as part of the product development process to ensure quality while preventing rework.

While your contract manufacturer maintains the goal of preventing bad parts from leaving its facility – both through QA and QC – there are important nuances when applying each approach to medical or aerospace. For example, QA in medical devices focuses on risk management, design controls and validation, safety and minimal variability, sterilization, and biocompatibility assessment. For aerospace, QA focuses on management of design changes for consistency and first article inspection to verify compliance with specifications. Both industries demand robust material control and traceability.

On the other hand, QC in medical focuses on in-process inspections throughout critical manufacturing stages, product testing, sterility testing and more. QC in aerospace may include nondestructive testing (NDT) methods to find flaws. Both prioritize dimensional inspection, functional testing, and material certification.

Leveraging Best Practices in Aerospace and Medical to Accelerate Success

By strategically leveraging cross-sector expertise, a contract manufacturer can help its customers gain significant advantages throughout the life of the product.

A contract manufacturer that takes a “medical” approach to manufacturing non-medical products applies the same stringent controls required by the medical device industry. All manufacturing and inspection processes are properly validated, documented and implemented; vendors and the raw materials/components they provide are strictly controlled, and records are thorough and accurate. And any changes are fully vetted and communicated to the customer in advance to jointly assess the impacts. The consistent quality that these controls provide helps to ensure customers’ expectations are routinely met. The same can be said about aerospace contract manufacturers.

For these contract manufacturers, taking a standardized approach to quality across markets can reap many benefits. While each market has its nuances, streamlining your quality processes can lead to benefits, including:

• Enhanced efficiency and productivity through consistent procedures, reduced overhead and simplified training needs for employees on a single QMS.
• Elevated part quality by ensuring all products meet the same high-quality standards while minimizing variability and minimizing the threat of defects.
• Reduced risk through the elimination of human error or consistencies through the implementation of varied quality standards.
• Stronger relationships with customers by building confidence that their programs will meet the most stringent requirements and regulations.
• Greater Continuous Improvement across teams with consistent data and cross-functional collaboration.

By leveraging cross-industry standards for quality management systems, for example, your contract manufacturer can establish a system that far exceeds baseline industry requirements through meticulous documentation, traceability and efficiency. This demonstrated expertise in demanding industries can give you peace of mind that your contract manufacturer has proven experience in mitigating risk without inflated costs, timeline delays or rework.

Your partner’s streamlined processes, ongoing continuous improvement efforts and employees who are empowered to take ownership of quality will accelerate your programs’ success with high-quality parts delivered on-time and to-spec.