There are multiple ways one can ensure that the quality of a project is being held to a certain standard and that the risks are being adequately mitigated to not throw off the entire project. One of the ways is to continuously monitor the project's performance, quality, and risks throughout the entire process. By doing so, one can adequately perform risk reporting, which is where the team is consciously communicating the potential risks and issues. Another way is to document every step taken during the project which allows the team to clearly understand what steps were taken during the process and to see the risks that had come up and how the team handled the risks. Additionally, it is also important to have risk response plans, which is where the team has clear, thought-out plans for risk management throughout the process. Lastly, it is important for the team to conduct detailed testing and verification processes that validate each step and the deliverables and ensure that they are up to standard. 

Traceability is a must, and I'm glad that you mention that. Quality is really cause and effect to a desired goal. Therefore documentation apps such as IFS can help catalog these measures and employ process to determine best parameters for best outputs. Additionally, in my experience with dealing with the machines parts directly, having tests that overlap onto each other is a good way to ensure mistakes don't ghost through a production line. Another way is to have DOE or ES within the cycle of the project so repeatability of a line is consistent to a specified process/groups of processes. Weekly meeting with the supervisors/engineers down to the individual operators/repairmen is a must as well. There are many other events to include such as FAIs or CAPA, but there a good spot to start if you wanted to enhance your answers to the question. 

Medical device manufacturers regulated by the FDA, EU, or any international regulatory agency must implement a quality management system for their medical device according to the applicable regulatory requirements, most often the FDA’s Quality System Regulations or ISO 13485.  But where do you begin with a medical Quality Management System?  Let’s explore how creating a Quality Management System for medical devices can help save you time and money while ensuring your company achieves regulatory compliance.  Quality Management Systems are a structured system to document business processes, procedures, and responsibilities to reach quality objectives.  It serves as a powerful tool that guides your team towards meeting customer demands and regulatory requirements while continuously increasing efficiency and effectiveness.  Quality systems, like healthcare quality management software, create the organizational structure for responsibilities, procedures, and resources for implementing quality management.  Procedures include document control, supplier management, corrective and preventive actions, and continuous improvement, to name just a few.  With quality control and quality assurance as provided by a Quality Management System in healthcare, testing and inspections are done on components and finished products beyond the basics of verification and validation. Benefits of a Quality Management System for a Medical Device: What is the value of a Quality Management System for medical devices?   Implementing a medical device Quality Management System can have a profound impact on the way your company does business.  Most companies find that when using tools like medical device Quality Management System software, product quality improves, errors are reduced, processes are controlled, waste is minimized, and overall efficiency increases.  In most cases, the ROI of an effectively implemented quality system exceeds the cost. The key benefits of a Quality Management System include access to greater visibility into performance data, improved efficiency due to elimination of unneeded steps and processes, lower operational costs due to saved time on unnecessary compliance tasks, decreased risk from potential nonconformance events, and a better handle on risk management.  Customizing Your Medical Device Quality Management System:  While you will eventually appreciate the benefits of a quality system can bring to your company, it is NOT meant to change the way you do business.  The goal is to ensure you meet, and continue to meet, the international regulations necessary to achieve sales in your target market(s).  A quality system can include the applicable regulatory requirements and be compatible with the way you run your business.  While there are specific regulations for a medical device Quality Management System, there is also significant room for you to insert your business practices into the procedures.  Implementing the Right Solution:  The goal is to implement a quality system that meets regulatory compliance without being burdensome for your company.  You must consider which markets you are planning to target for your sales, however, designing a medical device Quality Management System that meets US regulations and European requirements can allow for the addition of adhering to other international regulatory rules with little additional work.  The risk level of your device, whether you manufacture it, and the size of your company also play into designing the Quality Management System that is right for you.  Ensuring Compliance and Monitoring Results:  A quality system is not a series of documents that gather dust on a shelf. It needs to be continually nurtured and monitored.  Once your system is in place and functioning properly, you must continually monitor and assess your quality system’s effectiveness through a proper Quality Management System audit process.  Audit management is particularly important in the medical device industry.  The FDA can conduct facility inspections at any time and ISO 13485 certifications require regular Notified Body audits.  Taking necessary steps to address non-conformances in a timely manner will ensure you remain compliant and avoid potential problems.  Staying Ahead of Regulatory Changes:  Regulatory changes can be a difficult challenge for many businesses, especially in the ever changing medical device industry.  Companies must stay ahead of updates to quality standards and proactively address any evolving requirements to maintain regulatory compliance.  This includes the recently proposed updates to the FDA’s Quality System Regulations.  With the increasing complexity that comes with new regulations, it can often take up valuable resources, such as time and money, to successfully navigate this arena.  It is vital for businesses to have a plan and strategy in place to navigate these new regulations quickly and efficiently.

It is important to begin considering quality and risk management for a project as early as the planning phase to ensure the project remains on course. The planning phase should outline a specific quality management plan including applicable testing procedures and audits that set clear objectives and criteria for quality based on industry standards. During the execution phase, regular reviews and inspections must be done according to the plan to ensure that all procedures satisfy quality assurance standards. Comparing quality metrics to other similar project from the past could also be beneficial in this stage. If deviations are identified, corrective action should already be in place to handle them without throwing the project off course. For example, the project plan may account for 5% of products having some deviation from quality standards so that any deviations within that 5% do not affect the project timeline. This way of planning goes hand in hand with risk management. Potential risks should be identified in the planning phase along with the likelihood of each risk occurring and the impact it would have on the project. One or more budgeted contingency plans should be in place to deal with potential risks to keep the project on track.