Most medical device developers are well aware of the importance of a Quality Management System, (QMS) but determining the best solution can be a challenge. A QMS can be very useful for providing the framework for how you design, develop, manufacture and distribute a product. It plays an integral part in how you continually improve your business and the end product. Ultimately, your Quality System defines how you do business.
If you are in the medical device industry, a QMS is required for device approvals in most countries. The two main regulations requiring a QMS are FDA 21CFR820 (US) and ISO13485 (OUS). FDA defines a Quality Management System as the organizational structure, responsibilities, procedures, processes and resources for implementing quality management1. ISO13485 is required to help ensure that products consistently meet applicable requirements and specifications2. The scope of these regulations include: Management Responsibilities, Production, Process, Material, Equipment and Facility Controls, Complaint Handling, Document and Product Change Controls, Design Controls, and Corrective and Preventive Actions.
Other than being required, having a QMS also provides a framework to deliver consistency and efficiency in your business. A QMS entails having documented procedures for most major areas of your business. Having documented procedures provides a baseline of instructions of what is required, which minimizes requirements from being missed, reduces time spent on determining what is considered a correct and incorrect action, facilitates uniformity of the process, and minimizes employees making up their own individual practices by enforcing the use of Standard Operating Procedures (SOPs).
Although the regulations require a QMS, it is up to the manufacturer to determine how to meet the requirements. So, if you are developing or modifying a QMS, here are some key things to consider. In order to build the right QMS, you have to know your business. It is your business needs (current and future) that will determine the framework of your QMS. Whatever QMS you put in place needs to be efficient and adaptable to your business. If it is not adaptable, employees will end up finding work arounds, which will ultimately derail any efficiency and consistency that was built into your QMS. It is also important to consider current regulations and trends in the industry.
A few trends to consider:
Risk-based QMS – Quality Management systems are no longer one-size-fits-all. Less product safety risks should lead to a less rigorous path to meet requirements. Your QMS should reflect the risk associated with your product.
Software-based QMS – Software-based Quality Management systems are often reserved for stable, mature and large corporations. 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.
Social Media – Social Media is not just for the Millennials. Even FDA has a Twitter account. Whether your company has a presence on social media or not, your company can be responsible for statements made on social networks, and it is important your QMS is poised to contend with social media.
Supplier Management – In this day of mergers and acquisitions, it is becoming harder and harder to know who your suppliers really are. 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.
Regulatory Environment – The past few years have ushered in a number of regulatory changes, both domestically and internationally. We have seen the introduction of Unique Device Identifiers (UDI), European Medical Device Regulations and Medical Device Single Audit Program. It is important to have a QMS that is flexible enough to adapt to a changing regulatory environment.
Patient-Centric Data-Driven Design – Recently, if you have had the opportunity to sit down with a regulatory auditing body, then you understand that regulations are meant to drive an organization to do what is right for the patient/end user. Inherently, the QMS must 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 allow the patient data collected, and any trends or analyses, to be dispersed to relevant parties within the organization. Often times, this data exists on different platforms (sales/customer service systems, ERP systems, complaint systems, servicing systems, etc.), which means the QMS system must account for various sources of data within the organization, and provide a means to collect the data across different platforms.
Selecting a System
When taking these trends into consideration, it is clear that many areas and processes need to be addressed before selecting a system. For example, when implementing a complaint handling system, make sure you understand both your business needs and the regulatory requirements. It is important to address what your business does, such as considering how many complaints you generally process and how many employees are involved.
Companies also need to consider the level of product risk, especially in the medical device field, and correlate complaint handling. It is important to look ahead a few years in the future to analyze if you anticipate more products, whether they will be high or low risk, or if they will be distributed to other countries. In addition, you will need to know what type of information you are required to capture based on the regulations you need to meet and the type of metrics you need to track, such as complaint trends and processing bottlenecks to help make improvements.
Once you have determined your complaint handling system requirements, you can choose and implement a software-based QMS solution. Some things to consider in the selection process include:
Understand your budget
- System cost
- Implementation and validation costs
- Maintenance, licensing and support costs
Understand the software’s capabilities and limitations
- How easy is it to use?
- How easy is it to make changes?
- What types of changes can be made by your in-house team?
- What types of changes can only be made by the Software QMS provider?
- How is access restricted or enabled to your employees?
- By person, by department, user profile, etc.
- Read/write, Read-only
Understand timing and resources
There are a variety of software QMS systems to choose from such as a “pure-play” solution, PLM-based and ERP-based. Selecting the system that is right for your organization takes some research. PLM-based solutions (Figure 1), which deliver an integrated Quality and Product Lifecycle Management (PLM) system, are certainly a growing trend due to PLM’s inherent 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. These systems also capture the ‘voice of the customer’ with feedback that goes directly to the engineer for product design improvements. A PLM-based system is very appealing to the small-to-medium sized space (SMB), because it eliminates the need to invest in multiple systems, helps to address quality issues early on to save money, and provides cost-effective and easy-to-adopt solutions. In addition, PLM ensures that SMBs have the proper processes in place to meet regulatory compliance guidelines.
After you have implemented your complaint handling system, and have experienced some run time with it, it is important to take a step back to observe how things are going. Is your system helping to identify complaint trends? If not, determine what additional information and/or reporting is needed.
Is your system feeding complaint information back into the quality system to facilitate continual product improvement? If not, determine what information needs to get to which part of the organization, and implement a clear process to ensure the transfer of information happens. Information can be transferred in a variety of ways: automated reports, periodic presentations, notification of received and/or investigated complaints.
Are you getting the efficiencies you expected? If not, identify the bottlenecks and determine what changes are needed. Sometimes, you have to simplify the system in order to make it efficient.
Lastly, is your system adapting to your business needs? If not, consider simplifying your system to provide the flexibility your business needs. You should periodically re-assess the system and continuously make improvements.
The Quality Management System 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, are captured and fed back into the system resulting in continual product improvement. When setting up a QMS it is important to know your business, consider current trends in your industry, and develop a process that is efficient and adaptable. Regulations require that you have a QMS, but it is up to you to design a QMS that works for your business.