In my experience, I believe that staying informed about the industry is one of the most important aspects. The first and biggest reason is knowing your competition how one can make sure that our produ...

In my experience, the leadership and their motivation have been the biggest hurdle for the innovation and research for the company I work for. My company produces products that are widely used and ver...

Efficient and proper validation is key for proper functionality. The validation I have seen that very key in certain institutions are testing of every component in terms of material/functional validat...

I agree with your justification but to take a step further, I believe the reevaluation should be done as often as possible. Granted a full reevaluation can be costly and unnecessary but it can be prev...

I very much agree with your statement. Internal audits are essential for keeping an up to date quality system. Implementing CAPA as a result of internal audits issues will help keep the company out of...

I agree with hm243 that a reevaluation has more benefits than pitfalls when observing the various location of equipment use. However when multiple locations are set and frequent then a complete evalua...

I believe is always beneficial to be proactive rather than reactive. In a reactive system you solve matters as they arise, this can lead to possible beneficial changes. However, solving matters before...

I agree that technical writing is an essential skill that all engineers should have. Mandating classes that help students practice this skill will be a long-term benefit. Most communication especially...

I may be misunderstanding your question, but revised documents should always be updated. If any other document references the changed document, then that document should also be checked for any necess...

The FDA provides guidelines on validation processes with the purpose to ensure varied inputs lead to consistent and high-quality results. The process is tailored to each device. The customer and user ...

The point of a QMS helps coordinate and give instruction to an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency. Keeping that in mind...

A particular change order that occurred was that my companies supplier for a certain plastic was changed. The difference was very slight but however, proper protocol is very important. Therefore an EC...

When writing SOPs, detail is very important. Your manager is correct, a random person should be able to complete the procedure. However, the in-depth details should also be concise. A concise and deta...

SOPs contain the regularly recurring work processes that are to be conducted within an organization. It states the activities that are to be performed to facilitate consistency.The use of SOPs minimiz...

I agree with your method of using a regression test to save resources. But this might not always identify the issue. By using a less involved method first and then later a more involved re-executing f...