Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation efforts, do you know which quality function demands the attention, or should you make improvements to both?
More often than we may like to admit, a vast majority of medical device professionals do not have a full grasp on the acronyms and meanings of core industry terminology relevant to their role.
Quality assurance and quality control are complementary parts of a quality management system (QMS), yet serve very distinct roles with different purposes. Without knowing how the two quality functions differ and intersect, your QMS processes will struggle, and more importantly, you'll struggle to ensure your medical device is safe and effective.
This article will clear up any lingering confusion around the two terms quality control and quality assurance, explain how they differ from one another and how they intersect, and how professionals in these roles can leverage certain tools and methodologies to successfully control quality and assure quality.
quality assurance and quality control for Medical Devices
The main difference between the two terms? Quality assurance is proactive and process-focused. Quality control is reactive and product-focused.
Quality assurance prevents flaws in the way a medical device is manufactured. Quality assurance happens throughout the medical device manufacturing process. Quality staff look for problems in processes that might result in nonconforming products, and fix those processes that would otherwise cause defects.
Quality control finds flaws in products after they’ve been manufactured but prior to distribution into the marketplace. Quality control tests products or batches of products to see whether they conform to product specifications. The goal is to catch defective products before they’re shipped to the end user.
The combination of the two is what gives your medical device company the greatest likelihood of attaining the highest level of quality.
Defining quality assurance vs. Quality Assurance
Understanding the definition of quality assurance and the definition of quality control is clearest when you understand the process during which each occurs.
Quality assurance happens throughout the product lifecycle. Quality control occurs after a physical product is ready to be shipped.
Quality assurance (QA)
The primary focus of quality assurance is the process.
Processes can be healthy or unhealthy, effective or ineffective, efficient or inefficient. It’s the job of quality assurance to maintain and improve those processes such that your company can better ensure final products that are high-quality.
Quality assurance isn’t a single step, method, or tactic. Quality assurance involves many different methods performed ongoing for flaw prevention. The end goal is process improvement of product development and quality management, such that any flaws are reduced significantly if not completely.
Quality control (QC)
The primary focus of quality control is the product.
Despite product teams best efforts, supported by quality assurance helping hew to good processes, some flaws manage to slip by undetected. When the product is finally complete, it’s time for quality control to step in.
Quality control is the final line in the medical device manufacturing process. Quality control checks whether the soon-to-be delivered product is actually free of flaws. If it is, then you can be more confident in its success. If it’s not, you can feel relief knowing your quality control team found a defect before a patient experienced one.
Role of quality assurance and quality control in Medical Device Companies
Quality assurance and quality control professionals share the same goal—ensuring the production, manufacture and delivery of high-quality medical devices—but assume different roles within a medical device company.
On average, a company will have multiple people dedicated to quality assurance and at least one person dedicated to quality control.
Quality assurance responsibilities
Quality assurance staff oversee the medical device manufacturing process to ensure that it meets external standards from regulatory bodies, such as FDA and ISO, as well as internal standards from your company.
Staff in charge of quality assurance testing generally stick to a formula called the Deming Cycle—also known as the PDSA Cycle. The latter name comes from the names of its four-step process: Plan, Do, Study, and Act.
Quality assurance responsibilities can be summarized in these primary steps:
Plan by setting quality objectives and determining how they’ll meet them
Do by implementing new processes or changing older processes
Study by monitoring these processes and modifying them if they aren’t meeting the predefined objectives
Act by implementing any of the improvements they found necessary
The primary methodology that quality assurance staff use is called quality assurance testing.
Quality assurance testing monitors the medical device manufacturing process to determine whether all requirements are being met. The goal is to identify and correct product flaws, eventually leading to an overall decrease in defects.
Quality assurance testing highlights why we refer to quality assurance as process-oriented. The PDSA Cycle runs continuously, giving quality assurance staff the chance to renew their objectives and implement improved ways of meeting those renewed objectives.
There are four common quality assurance testing tactics that quality assurance staff use:
Quality audits: where quality staff inspects internal manufacturing procedures and verify whether regulatory requirements are being met. These types of audits typically take place at predetermined times.
Process definitions: where quality staff determines exactly what a process looks like and how it works. Clarity here is essential to conducting testing processes that deliver consistent results.
Tool identification and selection: when quality staff selects new equipment or tests existing equipment. For instance, quality staff might test whether a particular manufacturing tool is reliable and whether it can consistently create parts that meet requirements.
Staff training: how quality staff ensure staff across the organization are adequately prepared to handle the processes they’re in charge of. Quality staff can recommend more training if nonconformances indicate it’s necessary.
Combined with the PDSA Cycle, quality staff can use these tactics to offer continuous process improvements.
Quality Control Responsibilities
Unlike the assurances for continuous process improvement described above, quality control begins after product development is complete. Quality control staff’s primary concern is the product, instead of the processes that generated the product.
Quality control staff have a variety of tools at their disposal. Generally, these methods involve either testing or inspecting the manufactured products to determine whether they conform with predefined product requirements.
Quality control testing doesn’t begin until a batch or lot of medical devices is ready for shipment. Quality control staff are responsible for inspecting and giving final review of the batch or lot to ensure that the devices therein are, in fact, ready for sale.
Quality control staff use three primary quality control tactics to find and isolate nonconforming products:
Acceptance criteria: quality control staff are required by FDA to establish a formal document detailing how they will determine whether products conform to product specifications. Quality control staff are also responsible for documenting said acceptance and tracking which products or batches met this criteria and which did not.
Product testing: how quality control staff inspect, test, and verify whether a product is ready for shipping. Under FDA’s quality system regulation, medical device manufacturers have the freedom to design their own quality control tests, but FDA requires detailed documentation that proves the efficacy of this verification.
Corrective and preventive action (CAPA) management: These investigative events are triggered when quality control staff find a nonconforming product, perform a root-cause analysis, and discover a systemic flaw that led to the nonconformance.
CAPA is the most important tool quality control staff have. With this being the case, over-utilizing CAPAs can occur when quality control staff become too CAPA happy, meaning they’re too quick to initiate a CAPA for any and every issue found. Remember that though CAPA is effective, it’s best suited for defects that reveal potential systemic flaws.
QC vs. QA vs. QMS: How they differ and intersect
QC, QA, and QMS: three Q terms that are easy to mix up. Part of the confusion between these terms is due to how and where they intersect. If you keep a few things in mind, however, you can maintain clarity and use the terms correctly.
Both QC and QA are carried out in various quality management system (QMS) processes, but your QMS processes involve more than just the functions of quality control and quality assurance.
Beyond QA and QC, a QMS formalizes all the policies, procedures, and processes used by medical device companies to ensure safe and effective products.
A QMS is the engine that powers pre- and post-market processes like document control and CAPA, respectively, as well as key company artifacts like a quality manual, design specifications, standard operating procedures (SOPs), and much more.
Similarly, your QMS has many roles—assuring and controlling quality among them—but the larger goal is to manage quality at the planning and execution stages. QA teams will use the QMS as one of their tools.
Your QMS documents the quality policies and procedures that your company uses to make your medical devices. This documentation covers things like purchasing controls that dictate the standards for raw materials, and production controls that dictate the standards for consistent manufacturing processes.
QA staff will use a QMS to assure quality, but that doesn’t mean the QMS falls under quality assurance. A QMS is just one of the tools that quality assurance teams will use.
Enable the Best Quality Outcomes with the best QMS Solution
For medical device manufacturers that take quality assurance and quality control seriously, leveraging the best QMS software is essential.
Here are just a few benefits to consider for what a medical device QMS solution can offer your company:
Your QMS documents product specifications. With the best QMS software, quality assurance staff can easily and immediately access this data, using it to ensure a product meets every necessary requirement.
Your quality system manages document, purchasing, production, and supplier controls. With the best QMS software, you make it easy for your quality assurance staff to oversee these processes, ensure everyone is following the most up-to-date processes, and are able to make necessary improvements instantly.
Your QMS is core to your ability to conduct internal audits. The best QMS software offers audit management that enables teams to proactively catch quality issues before they reach the quality control stage.
Your QMS stores CAPA documents and procedures. The best QMS software makes those documents and procedures accessible and useful for whoever needs them through one fully connected system.
Greenlight Guru’s medical device QMS (MDQMS) software makes it easy to assure and control quality because it’s the only quality management solution made by medical device professionals for medical device professionals. Get your free personalized demo of our software today!
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