Hello and welcome to another week of MedTech Compliance Chronicles! Last week we learned about what a Quality Management System (QMS) is and how it’s broken up. This week we will begin to learn about QMS requirements, as directed by the US FDA and ISO 13485:2016.
One of the most fundamental concepts in quality management is the use of the process approach to all activities in your organization. This is a natural starting point for a system that is designed for ensuring an organization meets all the requirements it needs to. The process approach ensures you thoroughly think out each step of all the activities you must do in your organization. Today, we will learn what you, as a medical device manufacturer, will need to do to fulfill your responsibilities related to this concept.
The Process Approach
The process approach is a simple enough concept. Essentially, you have inputs into a set of activities that turn those inputs into outputs and that’s a process. For some real world examples you can think about installing a new machine. You have the packaged, disassembled machine and maybe some tools as your inputs. You then go through the set of activities of putting the parts (inputs) together and end up with the assembled machine, the output. In general, any set of work activities you do without a necessary stop can usually be defined as a process.
The critical part of the process approach that is fundamental to the success of the organization is that it forces you to fully define everything you must do in order to produce product that conforms to your requirements. For every process you must identify all of your required inputs, from raw materials and tools to required access to computer systems, software or information. After determining inputs you must then record every single step that needs to happen to turn those inputs into the outputs of the process including any movement, assembly, disassembly, machining, data entry, etc. Finally, you need to define your outputs or what exactly you need to have at the end of every process. It is very important to predefine acceptance criteria (what defines a failure/passing of inspection) for outputs to make sure that you really dial your processes into your product needs as opposed to letting your product quality drift due to poor process capability.
Bringing all of this back to the world of medical devices, it is non-negotiable that manufacturers of medical devices go through at least the effort to completely define everything they need to do to produce their product. You cannot establish conformity with requirements if you have not first established the requirements. Complete knowledge of the manufacturing steps necessary to produce a finished, ready-to-ship device is a primary source of establishing your requirements.
Now that we have learned about the background of what the process approach is, let’s take a look at what will actually be required from us in regards to this concept.
Overall Requirements
From a high level view, at a minimum, you will be required to determine what processes your organization must perform, determine the sequence and interactions of all of the processes and apply a risk based approach to each process and the system as a whole.
Determining all of the processes and their sequences will help ensure you have your entire organizational system mapped out in as much detail as you have for each individual process. Most work generally follows a fairly logical pattern up to a certain point where it makes sense to halt work for one reason or another. In practice, this is typically how work becomes separated into different processes. You will first determine all of the different processes required within your QMS, which will include all of the processes required to actually produce your device. Next, you must determine their sequence and interactions. Process sequences are generally more logical and intuitive to figure out. The sequences would be the order in which the processes occur, including any loops necessary. An important thing to remember when determining process sequences is which processes are required to be finished before others can start, which generally manifest as processes outputs being the inputs to other processes.
It is important to determine the interactions of processes for many reasons but from a regulatory compliance standpoint, it becomes critical in maintaining traceability requirements and proper identification of product throughout production. The basics to determining interactions of processes you have already started in determining their sequences, you figured out which processes were dependent on others! Other parts of determining process interactions could be determining appropriate storage locations and conditions between processes. You should also determine if operating conditions of certain processes can affect the performance of another, this could be industrial machinery requiring too high a voltage or another piece of equipment to be used on the same outlet or heating process like welding or powder coating being right next to a cooling process.
Applying a risk based approach is something that will come up time and time again. There will be an entire post on risk management during this QMS segment of the blog series so I will not go into too much detail here. Essentially, the effort you need to go through to control your processes is proportional to the risk that process poses to the safety and effectiveness (remember everything is about safety and effectiveness) to the finished device.
After you determine your processes and their interactions, there are certain requirements for each individual process as well.
Process Requirements
There are a few general requirements for all processes. First you must know, in detail, everything you need to do (for the process to be complete). Then you must actually do what needs to be done. Finally, you check that you’ve done it right and keep track of how you are doing over time.
It seems simple enough and it really is. The key is to remember to be as detailed as humanly, or technologically, possible. When I say know what you need to do it encompasses every single step of the actual procedure of the process, as well as, the required tools, the required environment (temperature control, cleanroom, humidity control, etc.), required safety procedures, and anything else that is required to ensure your process operates as expected and produces an acceptable and predictable output. Similarly, you must then execute each action to ensure the process operates effectively in as much detail. You must make sure any tools necessary are purchased, adequate for the job and available at the locations where they are needed. You must make sure procedures are clear, fully describe the process and employees have been adequately trained on them. You must make sure appropriate inspection points have been identified and tools, personnel and anything else necessary to carry out the inspections are present. The basic requirements are simple but great detail must be taken at each step to be sure that you have fully thought out the process and everything required to effectively operate it.
The final process requirement is that it be documented. Like risk management in the prior section, we will not go into detail here as next week’s topic will be on documentation requirements. All you should know for now is that all processes are required to be documented. Tune in next week for the specific requirements around that!
Conclusion
Hopefully now you have a solid foundation on what the process approach is. If you do not, I encourage you to ask questions on this post or to me directly as this is a most critical concept moving forward. When going deeper into QMS requirements it will be assumed that all work performed within the scope of your QMS is formally defined as a process.
Join me next week for a discussion on documentation requirements!
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