Most common I'd say would be communication problems. basically, poor communication between the quality department and other teams which leads to misunderstandings and delays in addressing quality issues. This could be fixed by simply fostering a culture of open and transparent communication at the company.  

I work in a medical device company that manufactures surgical products and one of the main problems we have is when we scrap more material that we need to because the whole process that was fully optimized. Since this was not done, the quality of some parts was sacrificed causing even more scrap and loss of product and money.

Usually, an IQ, OQ, and PQ is done on a new machine before it goes into manufacturing to develop products but some parameters on this machine, which was the scrap rate, were not fully studied because it was not something that was established before-hand. So, when this new problem arised in the manufacturing stage, some steps needed to be taken to address this issue of excessive material waste. 

So we conducted a root cause analysis to figure out which factors contributed to the waste. This included planning and conducting a study to understand how certain parameters affected this scrap rate and recording data to map out the effect of these parameters on the defects found. Once the trends related to the material waste was analyzed, we were able to decrease this rate by a ten fold factor allowing us to create a good quality part at the same time of reducing the amount of time and money lost in the process. After this, a continuous monitoring system was established to make sure that the rate does not rise again and to ensure good quality parts were made. 

The most common problem I face as a quality engineer intern are challenges due to document control. In other words, updating procedures, specifications, and records among different teams and ensuring that the correct standards are being followed. This issue also goes hand in hand with problems that arise regarding production delays. Discrepancies in documentation leads to issues with materials, manufacturing, and even production. In order to address this, as discussed in class, it is important to establish a detailed document control system that is supported by real time updates. These updates include new regulations, version tracking, and established communication between teams. Implementation of a digital database for these documents can reduce the amount of discrepancies that occur in the system and also help minimize errors. With the coming of age of Artificial Intelligence (AI) technology, this documentation process can be made much easier with the automation of updates to the system. Companies in the future should aim to invest in the automation of this system especially in quality control to produce more safe and efficient products. 

In my professional work experience at a biomedical equipment manufacturer, I have gotten insight into the issues that are commonly encountered within the Quality Department. The main issue being a lack of communication between the department and upper management. It's common that upper management is hyper-focused on more general business objectives and can at times neglect focusing on strategy, including maintaining consistent communication with Quality. Additionally, communication is sometimes problematic within the Department itself. At times, the engineers have a hard time identifying what is considered a priority project over another. To solve both of these communication issues, routine meetings should be implemented, including those from the Quality Department, as well as upper management. 

Additionally, Quality tends to be under-equipped at the company I work for and will often have to borrow equipment and tools from other departments. To resolve this issue, Quality team members should consult upper management to review their budget and request certain equipment be purchased for their department, budget permitting. 

Working in R&D in a medical device manufacturer, in the past I've noticed that the main issue with quality is that each QE may have a different interpretation for how something should be done. I.e. you're filling out an operational validation protocol and have to hand that off to QE ton have them sign off; they might have a nitpick on something or demand documentation for something that wasn't an issue for you to deal with in the past. To an extent, this is a human/experience issue; some QE's may have background work experience in different fields, so what is acceptable to them may differ from one to another. 

However, this issue becomes more evident and severe in cases where upper management for them--i.e. the director of quality, does not provide a clear or consistent directive in some cases for how to handle a quality issue. This issue is best solved when its insured the original QMS is being stuck to from the top down-including the procedures and work instructions, and anything missing form the QMS, should be filled in and communicated and trained the team to to fill in gaps. This consistent communication and filling in the QMS, ensures more consistency in QE's across the board.