Medical devices affect the lives of their users, either directly or indirectly. The necessity to understand the quality control process for medical devices stems from manufacturers’ desire to ensure the medical devices’ effectiveness. The primary goal of any medical device is to enhance the lives of its users. But what happens if a product fails to operate as expected? What happens if a device malfunctions or injures a patient? How can we be confident that medical devices function well and are safe to use?
The need for a Quality Management System (QMS) emerges. When medical devices are manufactured, they must be thoroughly inspected using appropriate measures as part of a Quality Control system, of which the Quality Control process is an important component. Let’s look more closely at what Quality Control implies for medical devices, why it’s important, and how you can enhance your own Quality Control approach.
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What Does a Quality Control Process for Medical Devices Look Like?
According to the definition, the quality control process for medical devices is both reactive and product-oriented. These procedures occur in manufacturing during and after production, as well as before product distribution to customers. A quality control technique ensures that individual products or batches satisfy product standards and are free of flaws or defects. The Quality Control department in medical device manufacturing uses several techniques and metrics to identify nonconforming goods. Any Quality Control method should focus on three main areas:
Acceptance criteria: The FDA requires Quality Control professionals to prepare a formal document detailing how they will determine if products fulfill product standards. Quality Control workers are also responsible for documenting stated acceptance and tracking which items or batches did and did not satisfy the criteria.
Product inspection, testing, and verification: Quality control staff are responsible for inspecting, testing, and determining if a product is ready for shipment. Medical device makers can build their own Quality Control tests under the FDA’s quality system regulation. However, the FDA requires sufficient paperwork to substantiate the verification’s performance.
Corrective and preventative action (CAPA) management: When Quality Control professionals find a nonconforming product, investigate the root cause, and discover a systemic problem that caused the nonconformance, these investigative events begin.
Who Is Involved in the Quality Control Process for Medical Devices?
ISO 9001 defines quality control as “An aspect of quality management focused on meeting quality requirements.” The worldwide standard goes on to enumerate key Quality Control process needs, one of which is competence, which includes staff knowledge, skills, experience, and certificates.
Quality control professionals’ major responsibility is to inspect equipment for cracks or broken components. Medical devices are complex; ensuring that these goods are not defective necessitates a team of skilled, competent, and dedicated inspectors, each with considerable knowledge as stipulated by the acceptance criteria document.
Quality Control VS Quality Assurance
Quality control and quality assurance are both part of the same quality management system, with similar roles and duties. Quality assurance is used to prevent faults in the production process of medical devices. Quality assurance is implemented throughout the medical device manufacturing process. Quality personnel seek for flaws in procedures that could result in nonconforming products.
However, quality control is primarily concerned with the product rather than the process. Quality control testing does not begin until a batch or lot of medical devices is ready for transportation, at which point this specialized team inspects and provides a last assessment to confirm that the devices are ready for sale.
How to Evaluate Your Quality Control Process?
Every medical device maker should carefully consider their approach to quality. Quality planning can be carried out in a variety of ways, including high-level notions regarding quality management or the construction of a formal quality system.
On-site examinations of physical products are typically more tangible. So, what should one look for when reviewing their own medical device company’s quality control process?
Establish a quality management plan: ISO 13485 necessitates the creation of a quality management plan, which is a document that describes “quality practices, resources, and activities relevant to devices that are designed and manufactured.” It will help to shed light on what is being tested by quality control, how quality control duties fit into the overall QMS, and which obligations each team member and department must fulfill.
Collaboration with product developers to gain quality control insights: Quality control methods can be significantly improved by discussing device specifics with the design team in the same spirit of collaboration. Few people understand a product’s inner workings better than its engineers, who will be able to explain device inputs and identify errors in your quality control tests.
Write descriptive acceptance requirements: Establishing effective acceptance criteria is crucial to the quality control process. Because this document offers precise guidelines for determining whether a device is fit for sale, it is crucial to evaluate the terminology used to specify the attributes your quality control team is considering. Requirements should be written clearly and simply, but they should also avoid information overload, which could result in testers identifying a product as nonconforming unnecessarily.
Create thorough documentation: Documentation, like all other aspects of the medical device life cycle, is essential for the quality control process. This is supported by regulatory requirements such as the FDA’s 21 CFR Part 11, which mandates quality control testing documentation. It’s also vital to maintain track of the inevitable changes that happen throughout the device’s lifecycle. Ensure that you are using a traceability matrix to track all design changes, inputs, outputs, and user needs. Your acceptance criteria may be influenced by changes in traceability. Keep track of any modifications to the acceptance criteria, and ensure that quality control personnel are properly trained on the new methods.
Empowering Medical Device Compliance: Expert QMS Certification Services
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