In layman terms, the biggest difference is that a Corrective is immediate fix and is more of a one time or a defect of a process. Whereas a corrective action is a method of solving a reoccurring issue that is meant to improve the processes of a company and find the root problem. A current Corrective action I am apart of is a CAPA in classifying…[Read more]

During the maturity, stage sales will plateau, and the profit margins of your products will begin to decline. This is typically caused by a number of factors come this can be market saturation or other alternative solution to what said product implements (especially because competition of products can highly dependent on the price of…[Read more]

The most expensive phase I believe is the development phase and only slight lead to the introduction phase. The development phase takes the most resources when It comes to new flagship products. The phase needs ample testing and qualification which takes tremendous interdepartmental resources. to make sure the market and customer need are met…[Read more]

A procedure that I have noticed that has seemed to work is market research on each product line the company offers. The research is presented to of concern departments and an assessment is taken. Products that have shown a decline and no real strategy for change are usually had obsolete. Which makes sense, why waste resources on a product that is…[Read more]

A person business and technical acumen are very important in term of relation to deals. Each party is taking a risk for each other to work together, and the knowledge provides confidence that the deal will be executed effectively. The interpersonal add the quality factor into a deal. For example, when interviewing for a job the interviewer also…[Read more]

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 product is best in its market. Second, and something directly related to the current situation of my company is being up to date with the industry…[Read more]

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 very successful in their niche. This has been due to the innovation that the leadership has provided. However, they have been in that mindset and…[Read more]

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 validation, leak functionality, various chemical coating functionality and shelf life. The procedure that it followed is very important, but the proper…[Read more]

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 preventative for future issues. Just how reevaluations are done at specific time intervals and during recalibrations, I also think that it should be done…[Read more]

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 trouble. If for example, a remediation occurs: reactive measures will be taken (hiring and preparing, etc) however the preparation and executing…[Read more]

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 evaluation may not be necessary. If the equipment is evaluated each time the location is placed with proper results and the same performance then an…[Read more]

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 they become an issue will generally lead to optimization and aid any reactive changed needing to be made. According to the FDA Sec. 820.100 explains…[Read more]

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 interdepartmental paper-work uses written documentation as a primary communication tool. Concise and objective comprehension is important when…[Read more]

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 necessary changes. No document should be outdated, especially in a heavy FDA regulated industry. Outdated documentation can lead to safety issues and…[Read more]

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 need to be complied with. The safety and outcome of the device need to be known and most importantly clarity of the thought and instructions.…[Read more]

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 I believe that the organization that utilizes the 5 different steps would be more beneficial. Assuming that this process is used by a larger o…[Read more]

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 ECO was issued due to the change in the product. This lead to every department being notified about the change. Due to the modifications the regulatory…[Read more]

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 detailed procedure is more efficient that unnecessary words. However, it is also very important to have the document reviewed by as many people as you…[Read more]

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 minimizes variation and promotes through repeatable results. These guidelines are excellent for research because results need to be repeatable, if the…[Read more]

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 full verification and validation protocols if not solved. However, the changes that are made can also involve the proper track to take. A minor change…[Read more]