Medical Device Quality Control vs Quality Assurance

by Gilero January 20, 2021

The last thing a medical device manufacturer wants is for a piece of equipment to malfunction once it gets into the hands of a clinician, patient or caregiver. With such high stakes, the emphasis on quality when it comes to this form of design and manufacturing is critical. Medical device quality control and quality assurance can seem easily lumped together, but if you’re not putting the proper effort into each, you could end up with an incredibly costly issue.

The difference between quality assurance and quality control can be confusing. They do fall under the same umbrella and have the same goal: to ensure a safe and effective product is created. Both are part of the Quality Management System (QMS) process. However, they focus on very different elements of quality management, so proper attention needs to be paid to both in order to protect medical device manufacturers and patients.

What are the Differences Between Quality Control and Quality Assurance?

Though they appear similar, medical device quality control and quality assurance refer to two different functions. Put simply, quality control focuses on the product, while quality assurance emphasizes the process. Both are equally important to ensuring the manufactured result meets specifications.

Quality Assurance

Quality assurance (QA) takes place throughout the manufacturing process and is usually performed by several team members. Those tasked with monitoring quality assurance assess each step of the manufacturing process from beginning to end, making sure nothing is done in a way that could lead to product defect or underperformance. If a problem is found, the QA team is responsible for correcting the process. This team also looks for general process inefficiencies and works to optimize operations to ensure both internal company standards and goals, as well as those set forth by regulators like the FDA and ISO, are met.

Those who work in quality assurance typically use a method known as the PDCA cycle, coined by W. Edwards Deming. Using the PDCA cycle, QA evaluators assess processes using these four basic steps:

1.  Plan – Establish quality objectives and processes required to achieve desired results.
2.  Do – Perform those objectives by applying new quality processes or adjusting processes as needed
3.  Check – Assess results and compare them to the objective.
4.  Act – Adjust the process to properly meet the objective by implementing any necessary improvements.

This cycle repeats until all defects are corrected and the best product result is achieved. QA teams also rely on four common testing tactics, including:

• Audits – Quality audits are performed routinely in the medical device industry to make sure internal and regulatory requirements are being met.
• Process definitions – QA staff must define in detail what each quality process looks like and understand how they work in order to recognize when a process veers away from this course.
• Tool evaluation – The QA team evaluates each tool used in the process to determine if it’s the most efficient option for the process. Certain tools may need to be tested regularly or adhere to a calibration maintenance schedule.
• Training – QMS training occurs routinely in regulated industries to ensure everyone responsible for quality assurance knows exactly what to look for. All staff members in a medical device company, even those not on the quality team, must undergo some form of training. If product nonconformances begin to occur, training will be increased.

Quality Control

Medical device quality control comes into play once product development is complete in order to assess product performance and accuracy. Quality control (QC) is the final line of defense in medical device manufacturing between a defective product and the end-user. Once a product batch is ready for distribution, the person or team in charge of quality control will carefully evaluate the product for any defects and will perform tests to make sure the product conforms to the required specifications. This role is highly critical to ensuring no product goes to market that could be ineffective or cause harm. If quality assurance is done properly, quality control should be carried out fairly easily without many products being deemed unfit for distribution. Once a product passes quality control evaluations, it will be marked ready for shipment.

Quality control teams rely on three primary tactics:

• Acceptance criteria – The FDA requires quality control teams to document how they will define whether or not a product meets required specifications. The QC team will evaluate products against this criteria to determine if the product or batch will be accepted or rejected.
• Product testing – QC teams must also define how they will test and approve a product as ready to distribute. FDA requires documentation for this part of the process as well.
• Corrective and preventive action (CAPA) management – When a nonconforming product is identified, quality control team members will initiate an investigation to analyze how and why the defect occurred.

Why QA & QC Are So Important in the Medical Device Industry?

Quality is paramount in the design, development and manufacturing of medical and drug delivery devices. A defective medical device can have huge implications on patient outcomes, as well as on the reputation of manufacturers and medical professionals. Quality control and assurance both intersect under QMS processes, but they are not one in the same. Not spending the right amount of time and effort on these important aspects of medical device manufacturing can lead to irreparable consequences.

Improving patient outcomes is central to our mission at Gilero. We emphasize all aspects of quality as we design, develop and manufacture medical devices from start to finish. Our dedicated engineers are committed to ensuring that all Gilero projects meet internal and external quality specifications and regulatory requirements. To ensure your product is in the hands of a team you can trust, contact Gilero to learn more about our regulatory support services and see how we can work together.

About the Author

Gilero Gilero specializes in the design, development, and contract manufacturing of medical, drug delivery, and diagnostic devices, bringing innovative healthcare solutions to market. The team combines engineering expertise with a deep understanding of regulatory requirements.