GLOSSARY

QA Systems

Quality assurance (QA) systems are central to the effective functioning of any medical device QMS - they include the processes that ensure that medical device companies manufacture products which conform to the specifications intended to ensure the safe and effective functioning of the device.

For the entire history of manufacturing, there has always been a need to establish and maintain some kind of quality standard for the results of production. Whether you're a medical device manufacturer making in-vitro diagnostic devices that will be used in thousands of hospitals, or a factory making bricks that will be used in thousands of homes, quality and consistency throughout the production process leads to quality and consistency in your products. This limits your liability and ensures a positive relationship with the customer. Quality assurance systems are used to measure the results of each part of the manufacturing process, and help improve the consistency with which conforming devices can be produced.

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The difference between quality assurance and quality control

Throughout the medical device industry, you'll hear product development engineers using the terms quality assurance and quality control interchangeably. And that's fine - the two processes are intimately connected - but they do have slightly different definitions that are useful to understand.

Quality assurance is a process management activity that focuses on ensuring that the processes used to create a product produce as few defects as possible. QA activities are conducted with the goal of ensuring that processes are consistent and effective at producing their desired outcome.
Quality control deals with the finished product and is a set of processes for ensuring that defective products do not reach the customer. Inspecting and sampling the products that come out of the manufacturing process are core aspects of quality control.

The most important quality assurance practices for medical device companies

Quality assurance encompasses a set of policies and procedures for ensuring quality in the manufacturing process and continuously improving the consistency with which conforming products can be produced. Here are some of the most important procedures that can comprise an effective QA system:

Failure/Stress Testing - In this type of product testing, manufacturers test the product under different conditions with the goal of making the product fail. Exposing the product to heavy vibrations, high or low temperatures, repetitive use, dropping, and other factors allows engineers to anticipate how the customer might break the device or cause a malfunction. This knowledge drives manufacturing process improvement when failures are deemed unacceptable.
Statistical Analysis - The goal of process improvement is to reduce the frequency of defects, so it makes sense to use some kind of numerical modeling to understand how frequently defects occur. Quality managers can use a Pareto chart or diagram to display the frequency and causes of various part defects. Tracking the occurrence of quality events is important because it allows medical device company to measure their improvements.

Greenlight Guru's QMS Software supports core processes for QA Systems

Continuous improvement is an overarching theme of 21 CFR Part 820, the quality system regulations that are mandated for medical devices companies in the United States, as well as the International Standard for medical device quality systems, ISO 13485. The most important requirements for QA systems are actually written into these standards explicitly for medical device companies to follow:

The CAPA Process - Companies must establish a process for taking corrective and preventive actions when the root cause of a non-conforming product can be identified. The CAPA process essentially mandates continuous improvement through quality assurance, and there are many tools that quality managers can use to identify the root causes of quality problems.
Internal Audits - Internal auditing feeds into the CAPA system, but it's worth mentioning that internal audits are the best way to uncover quality issues and their potential sources. If your quality team can isolate potential sources of defects before they result in a non-conforming product, your QA systems are working effectively.
Supplier Controls - Even things like controlling the manufacturing environment, inspecting raw materials shipments, and managing relationships with suppliers can fall under the QA umbrella. The systematization and control of the manufacturing process is central to ensuring a high level of conformity with specifications in your warehouse - remember, systems produce predictable results.

Greenlight Guru's QMS Software provides a central hub for all of your medical device company's quality assurance activities. It's never been easier to securely store and access your internal audit results, CAPA files, product testing documentation, and other QA items, and you'll find FDA audits happen very smoothly when you invest in ensuring the organization and accessibility of all your QA documents.

Greenlight Guru’s QMS Software also makes it easy for your quality manager to quickly sort through all of the quality data related to your product, meaning faster and more timely process improvements and effective continuous development of quality practices that help your product succeed.