INTRODUCTION:
In the world of manufacturing, producing a “good quality product” is something all companies strive for. However, a lot goes into manufacturing a “good quality product” behind the scenes that not everyone is aware of. For instance, how does a company ensure that each individual final product is the same? Does the company test every product before sending it out to customers? What happens if the products are not the same? Can the company trace such things as what raw materials were used in a product, who assembled the product, and how the product was packaged and delivered? Regardless of the type of product, every customer wants and deserves a product that they can rely on. To ensure such good quality products are manufactured, there are various sets of standards laid out by different organizations, such as the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO), that manufacturers must meet when producing products (1). This is where implementing a Quality Management System, commonly referred to as a QMS, becomes necessary.
QUALITY MANAGEMENT SYSTEMS (QMS):
A QMS can be considered both simple and complex as it is essentially the core of a company. A company’s QMS should document every aspect of the company including its policies, forms, operating procedures, manufacturing work instructions, specific product requirements, and much more all in one place (1). By following standards such as ISO 9001: Quality Management Systems – Requirements (2), or ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes (3), and FDA CFR 21 Part 820 – Quality System Regulation (4) for medical devices, companies across the globe can build and implement an effective QMS while also tailoring their system to their needs.
While a QMS allows for managing company related policies and procedures, the system can also focus on specific product requirements through design controls – which is extremely important when manufacturing medical devices. Design controls lay out all requirements identified by the user, the device design itself, how it operates, and how all the requirements set by the user are met (1). Ultimately, the design controls ensure that a good quality product is manufactured and meets all the intended uses asked for. But what if the manufactured product does not meet these requirements? Well, a QMS can manage that as well through the uses of nonconformance events and corrective and preventive actions (CAPAs) (1). Monitoring of these events and actions allow companies to keep track of manufacturing errors, the steps used to correct the errors, and the assurance that the errors will not be repeated.
IMPLEMENTING A QMS:
Implementing a QMS is a challenging effort for all companies. These systems contain a vast amount of information. It is critical to implement a system that is easy to use and allows for easy recall of that information. Utilizing an electronic QMS (eQMS) platform, such as Greenlight Guru, helps companies like BioSurfaces and many others develop and implement a QMS entirely and almost seamlessly. For BioSurfaces, using Greenlight Guru has allowed our company to manage documentation, training, nonconformances, CAPAs, and more, all in one place, while also providing the training resources necessary to learn as we go (1). Overall, we’ve been able to focus our quality system on the specific products we manufacture ensuring that we are creating products that our customers can rely on every time – like they deserve.
Written By:
Emily Pacheco
Director of Quality Assurance
REFERENCES
1. Greenlight Guru. (2024). QMS (Quality Management System). Greenlight Guru. https://www.greenlight.guru/qms
2. International Organization of Standards. (2021). Quality Management Systems – Requirements. International Organization of Standards. https://www.iso.org/standard/62085.html
3. International Organization of Standards. (2020). Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. International Organization of Standards. https://www.iso.org/standard/59752.html
4. U.S. Food & Drug Administration. (2024, March 22). Code of Federal Regulations Title 21 Part 820 – Quality System Regulation. U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
5. SimplerQMS. (2021, October 12). What is an Electronic Quality Management System (eQMS)? Medium. https://medium.com/@jksimplerqms/what-is-an-electronic-quality-management-system-eqms-2e9238679102
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