Quality in the World of Medical Device Contract Manufacturing

Having an effective quality management system (QMS) is required for any medical device company. Having a focus on the safety, function, and efficacy of the product you manufacture is how you are successful within your QMS. The regulations of the Food and Drug Administration (FDA) and International Standards Organization (ISO) will require your compliance to be able to manufacture medical devices. FDA and ISO standards are written clearly but with little detail as to the ‘How-To’s’ of applying the standard. There are many guidance documents and white paper guidelines that can help with the application of the standards. The most important guideline to creating an effective QMS is assembling the proper quality group for ideal support of the QMS. Creating your QMS and quality group to fit your organization and device is pivotal. In my experience, your QMS systems are primarily based around branches, with your systems spread across the branches. If you can assign branches and systems within your company properly, it allows you to organize what is needed to follow the regulations. The branches and systems of the QMS can be defined no matter the size of the organization or the class of device. When it comes to branches, bucketing your group into quality systems, quality engineering, and quality control can allow you to isolate your systems and become more effective.

Quality Systems Branch

Ensures all support operations of the manufacturing floor for quality are maintained and effective. Some examples of what would be managed within this branch are documentation control, calibration, training, corrective action management, non-conforming product management, environmental controls, and complaint management. Some titles include doc control clerks, calibration tech, and quality systems engineer.

Quality Engineering Branch

Ensures all engineering efforts of quality are maintained and effective. Some examples of what would be managed within this branch are engineering change support, maintaining PFMEAs and control plans, supplier change support, project support, scrap reduction efforts, investigations of nonconforming products, and complaint investigations. Some titles include quality engineer, supplier quality engineer, and quality technician.

Quality Control Branch

Ensures your production floor is supported and controlled. This is your direct group that supports the device itself coming off the production line. Some examples of what would be managed within this branch are inspections of devices, compliance with clean room requirements, release of product that is ready to ship, and labeling of devices. Some titles include quality control inspector, incoming/receiving inspectors, quality control lead, and quality control supervisor.

With the branches defined, you can assemble your job descriptions and org chart accordingly. Depending on the size of the organization, there can be a leader to each branch to allow layers within your org chart. These layers will allow heightened focus on each branch. It gives each branch a focal point with a structured view. This allows each branch/leader to not be so overwhelmed with the entire QMS. They have their own contribution to maintain, and they can also work cross-functionally where necessary to ensure the efficiency of the QMS.

I have recently taken on two divisions at my company as the divisional director of quality. These divisions have essentially the same QMS but require different structuring of the branches based on the size. One division is half the size in headcount than the other; there are also some fundamental differences as one has a larger R&D and transfer project base, and the other has a larger manufacturing platform. As all those differences are considered, you can successfully bucket the groups accordingly. There may be exceptions depending on employees, skills, customer needs, etc. Nothing has to be concrete; just give every decision some good thought and structure consideration behind it, and you can adjust accordingly where needed. Below is an example of how to branch the org chart to cover your branches and systems properly.