[Image courtesy of Sabri Tuzcu on Unsplash]
Rasean Butler, EarLens, and Chuck Cimalore, Omnify Software
What exactly is a Quality Management System (QMS) and why is it needed? FDA defines a Quality Management System as the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. ISO13485 requires it to help ensure that products consistently meet applicable requirements and specifications. The scope of these regulations includes: management responsibilities, production, process, material, equipment and facility controls, complaint handling, document and product change controls, design controls, and corrective and preventive actions.
The QMS is vital to any medical device company. It is not only a regulatory requirement but it sets the framework for how a device is designed, developed, manufactured and distributed. It also ensures that customer feedback, including complaints, is captured and fed back into the system resulting in continual product improvement. When setting up a QMS it’s important to know your business, consider current trends in your industry and develop a process that is efficient and adaptable. The regulations require that you have a QMS. It’s up to you to design a QMS that works for your business.
The two main regulations requiring a QMS are FDA 21CFR820 (U.S.) and ISO13485 (OUS). Outside of being required, having a QMS also provides a framework to deliver consistency and efficiency in your business. A QMS requires having documented procedures for most major areas of your business. Having documented procedures provides the baseline of what is required and instructions on what to do. This minimizes requirements from being missed, reduces time spent trying to figure out what the correct actions are, facilitates uniformity of process and minimizes employees making up their own individual practices by enforcing the use of Standard Operating Procedures (SOP)s.
Although the regulations require a QMS, it’s up to the manufacturer to determine how to meet the requirements. So, if you’re developing or modifying a QMS, what are some key things to consider? In order to build the right QMS, you have to know your business. It’s your business needs (current and future) that will determine the framework of your QMS. Whatever QMS you put in place, it needs to be efficient and adaptable to your business. If it’s not efficient, no one is going to want to follow it. If it’s not adaptable, employees will end up finding workarounds, which will ultimately derail any efficiency and consistency that was built into your QMS.
Changing landscape: trends, regulations and solutions
The landscape has changed for Quality Management Systems. Industry trends, regulations and available solutions are all impacting today’s QMS. With the rise in social media, your company is responsible for statements made on social media. It’s important that your QMS is poised to contend with social media.
In this day of mergers and acquisitions, it’s becoming harder and harder to know who your suppliers really are. And what about your supplier’s suppliers? The rise in outsourcing has made it much more difficult to ensure the quality of your supply chain. Your QMS has to be able to navigate these ever-changing waters. The past few years have also ushered in a number of regulatory changes both domestically and internationally. We’ve seen the introduction of Unique Device Identifiers (UDI), European Medical Device Regulations and Medical Device Single Audit Program, to name a few. There are more changes expected. It’s important to have a QMS that is flexible enough to adapt to a changing regulatory environment.
The design and development of a medical device has to center around the patient/end user’s needs. The QMS has to provide a method that tracks patient/end user needs as they are iterated and translated into design inputs, design outputs and then subsequently verified and validated. The QMS will also need to keep track of the patient risks associated with the design.
Patient/end-user feedback and complaints also play a significant role in making device improvements. The QMS needs to facilitate trending of various information received from customers:
- Feedback and complaints (type, frequency, event date, complaint date)
- End-user information (end user ID number, user facility name, how long device was in use, how many complaints have they had)
- Device information (make, model, serial number, manufactured date, expiration dates, etc.)
Additionally, the QMS has to enable the end user/patient data collected and any trends and analyses to be dispersed to the relevant parties within the organization. Often times, this data exists on different platforms (sales/customer service systems, ERP systems, complaint systems, servicing systems, etc). The QMS system has to account for the various sources of data within the organization and provide a means to collect the data across the different platforms.
The availability of software-based QMS solutions that can address the growing trends and regulations is expanding. Software-based QMS systems used to be reserved for mature, large corporations. But more and more software-based QMS solutions are turning up in mid-late stage start-up companies, largely because of the inherent efficiency, traceability and paper reduction they offer.
PLM-based software solutions, which deliver an integrated Quality and Product Lifecycle Management (PLM) system, are certainly a growing trend due to PLM’s ability to connect information to a single product record and ensure controlled processes. With a single system to manage both product and quality information, PLM-based quality management solutions provide a holistic view of the product across an organization which simplifies the aggregation of data for necessary reporting and analysis as described above. These systems also capture the voice of the customer with direct feedback to engineering to improve product design. A PLM-based QMS system is very appealing to companies large and small because it eliminates the need to invest in multiple systems, helps to address quality issues early on to save money and there are now cost-effective and easy to adopt solutions available.
Rasean Butler is director of quality at EarLens, and Chuck Cimalore is CTO of Omnify Software.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
