In the first part of our blog in this series, we made the observation that, despite the environment of change we see in the manufacturing industry today, some things always stay the same. Like the basic requirement to control the 5Ms of manufacturing – material, man, machine, measure, and method – if you want to produce high quality products. Simple.
While “simple” does not always mean “easy,” the availability of technology today makes controlling the 5Ms a whole lot easier. The heart of the digital manufacturing enterprise, the Manufacturing Execution System (MES) is built to control the manufacturing process. But many Medical Device manufacturers still have not implemented an MES, continuing to operate with paper-based, open-loop systems.
Part 2 in this series focuses on the 2nd M – Man. The requirement of this area is to ensure that only qualified operators are working on the production process. When you consider that some research estimates 60% of all product recalls are due to human error, you understand how vital this requirement is.
The MES keeps track of operator certifications and training. An operator must be logged into the MES to perform assembly operations. The MES is able to determine whether the operator’s login credentials links him or her to the proper certification to perform the operation at hand. If the operator does not have the skills required to do the work, the system generates an error, and prevents the operator from continuing the operation.
Let’s look at an example. An operator is logged into the MES, and has a list of items in a dispatch queue to work on. The operator “moves in,” or starts the assembly operation by clicking on the next item in the queue. The system uses the operator’s login credentials to look up the proper certification required by the SOP for that particular part number. If the operator does not have the proper training, or the certification is not up to date, the system posts an error to the screen, with a clear visual warning indicator, and prevents the operator from performing work on that item.
An MES system today is a must have for manufacturers to ensure that operators are qualified to do the work at each step of the production process. Ensuring proper training is a basic necessity to prevent many human errors. Of course, the MES control over the other Ms also prevent human errors. We’ll continue to see how an MES does that as we continue our blog series.
While it is simple to understand that control of the 5Ms is required to produce high quality products, you need an MES to make it easier to do.
In the next blog, we will talk about the control of third M – Machine.