Production lines based on normative.
How important is the Operations Department?
Within Kenko Solutions, the Manufacture Department is one of the divisions of the Operations Department which, as its name indicates, is responsible for the manufacturing of the medical devices that the organization commercializes. Its main role is the assembly line specialized in the manufacture of electromechanical products.
During all stages of product development, it is of utmost importance that a member of the operations team supports the process to suggest improvements in the replicability of the device and its manufacturing feasibility, since it may be that an idea is simple to prototype but when it goes into production it is very complex and/or generates a lot of expenses that make its sale unfeasible. If you want to know more about the importance of the team you can check it out in our last post.
It is important to know the industrial sector to which your company belongs since the norms and guidelines that will govern your processes depend on this.
In the specific case of Kenko Solutions, our manufacturing processes are governed by the NOM-241 which is the Mexican Official Standard of Good Manufacturing Practices for establishments dedicated to the manufacture of medical devices.
Why is NOM-241 important?
Anyone would think that simply setting up an assembly line is enough to manufacture a product, when in fact it is necessary to take care of very specific parameters such as the flow of people, the flow of inputs and products in the areas, how the waste will be disposed of, how to supply the inputs, how the materials entering the warehouse are stored, etc.
What are the consequences of marketing products without certification?
The simple answer is that it has legal repercussions, but apart from these, what is really important are the consequences generated by the use of the products, the seriousness of which varies depending on the company's line of business. In some cases, everything can end up at the disposal of the product because it had a very short life, but in others, it can put the lives of the people involved at risk. Regardless of whether the use of the device was erroneous, most of the problems lie with the manufacturing company.
Who regulates compliance?
In order to comply with the established requirements and ensure that they are met, there is a governmental organization (COFEPRIS) that is in charge of validating that each of the points established in the standard is correctly fulfilled. If all this provides a favorable result to the company, the Good Manufacturing Practices (GMP) certificate can be obtained, with which it can be guaranteed that the products marketed by the company comply with the quality required for the Mexican market.
Is it easy to comply?
No, it is definitely not an easy job, but if there is one thing that stands out, is that with the support of all the team members in complying with the established processes on a daily basis, everything becomes easier as they get used to living with them.
In conclusion, something that we as entrepreneurs do not usually take into account is that even if the idea is good, if the product is not replicable or there is no market for it, it would not be worth the efforts put into the creation of all the documentation involved in being a certified company.