As Viraj mentioned, the CAPA itself is used to find the route cause of non-conformity and a method to address the NC, while creating a way to prevent it from happening again. During the CAPA execution...

We are actually doing an internal Audit either next week or the following. The biggest advantage about the internal audit is that potential issues can be addressed early before the outside auditor arr...

I have personally dealt with a non-conformity, on a material that we manufacture, the material failed one of the critical inspection areas within Quality assurance, which opened an investigation to fi...

Ambiguity of GMPs for start up companies are completing understandable, I believe that is is a learning curve for these types of companies, because their product is being initialized in production and...

In a No GMP aspect, I use to work for a company that did not utilize GMPs, and the process to upscale a potential product from lab to production became difficult at times, because methods that could r...

As technology improved, so has the ability to manufacture goods. I know from my experience, this improvement has constituted to an increase in areas of inspection or in other words inspection techniqu...

Based on the provided information, I agree with the assessments above, I believe that a change order would be needed and this change should be addressed with R&D and Quality. In addition, a risk a...

I have never personally done a design change from an initial design standpoint, but I have made Engineering Change Orders on documentations post the design change. Essentially these change orders have...

An example of risk that I have personally worked with was the creating of SOP's for in process checking, the SOP that was created ensured proper inspection of the manufactured product. We had to ensu...

In my opinion, I feel that Research and Development is probably your highest investment, you want to ensure that the product you are developing meets specific standards and criteria's, a project after...

As you mentioned, recalls may be detrimental to the reputation of a company. Particularly the possibility of litigation. Below I attached a link to an article about a lawsuit that is currently happeni...

I completely agree, to be in business you have to have an the knowledge of industry and most importantly the ability to speak and negotiate with potential buyers. I know I personally deal with a parti...

I agree with the comments above, it is difficult to point at which role would be the most critical for a project manager. If I were to take a guess, I assume that creating the story behind the product...

I have heard from fellow coworkers of projects being "killed" because of a shift within the market or money is shifted to another project due to unforseen circumstances. In this instance, the project ...

I personally never had experience dealing with recalls, but I assume that are some costly side effects from a recalls such as tainting of the company brand to potential litigation if the recall is bas...