A career in quality management can be lucrative depending on the approach. This field focuses on controlling, ensuring, and improving quality in business productivity and operations. It checks that the organizations, their products, and services are not changing. In other…   Read more»

Document control is an important aspect of quality management in both R&D and manufacturing processes. Here are some ways in which document control can be improved in R&D and manufacturing: Standardization of document formats and naming conventions: Having standardized document…   Read more»

Research and development (R&D) includes activities that companies undertake to innovate and introduce new products and services. It is often the first stage in the development process. The goal is typically to take new products and services to market and…   Read more»

Transvaginal mesh has been recalled numerous times. This medical device is used to treat pelvic organ prolapse. I would not say that the FDA is completely at fault. The FDA did approve the product but we are not certain of…   Read more»

A role that is available in quality management systems is a quality assurance test engineer. A quality assurance engineer identifies errors within the software using a test before a product is set to launch. The primary responsibility of a quality…   Read more»

In my opinion, the FDA does not guarantee safety but does take proper procedure and protocol to maximize the chances for things to be safe. This is why they have a very extensive and intensive procedure to get things approved…   Read more»

In my opinion, the FDA handled the COVID vaccine rollout in 2020-2021 terribly. When speaking to the public, you have to be able to put it in terms of which people who aren’t in your profession can understand and the…   Read more»

Document control has improved as technology has improved. Lab batch records or protocol have been written in simple word documents in the past and now they are generated in software that is layered with a SCADA program. SCADA is Supervisory…   Read more»

The FDA rolled out the COVID-19 vaccines with as much resource information as they could. I think their intentions were misconstrued and muddled as other media outlets began to provide information that was properly validated. I think if the public…   Read more»

The FDA using EUA on drugs and vaccines during public crisis is rather controversial. The race for a vaccine during COVID-19 brought about companies using EUA to accommodate the public’s need for a vaccine. However, the process of creating a…   Read more»

The FDA’s responsibility is to guarantee that medical products adhere to exacting safety and efficacy standards. This process, known as “full approval,” can take years. The FDA continues to maintain its strict standards even though that period of time is…   Read more»

Document control is a crucial component of an efficient internal control system, which is necessary for compliance with regulations like ISO 9001, ISO 13485, IATF 16949, etc. When done manually, document control includes maintaining relevant (i.e., current) versions of policies…   Read more»

Controlling document modifications and revisions entails keeping track of important versions of a company’s policies and procedures. When handled properly, this process requires a large amount of time. Since this can be done from anywhere, using a document management system…   Read more»

The FDA instructed all makers of surgery mesh goods used for pelvic organ prolapse (POP) repair to cease advertising and marketing their goods throughout the United States instantaneously in April 2019. Since the FDA reclassified these devices in class III…   Read more»

From a consumer standpoint I do not believe that FDA approval is finally or always right. The people that work at the FDA are scientific experts, however they are still human beings. Making mistakes as well as situations where information…   Read more»

In order to shorten the turn around of document control (documents reviewed by quality department) having to submit document electronically. Or even having an online portal where employees can review documents in one place. This will not only keep the…   Read more»

As a behavioral therapist I utilizing a form of root cause analysis on a daily basis. Change analysis of RCA is an approach where system performance has shifted and one must explore changes in people, equipment, environment, and information in…   Read more»

[quote data-userid=”18898″ data-postid=”13670″] Working in different sized teams has advantages and drawbacks to each. When working on a project do you prefer to have a small or large team? Within teams, people can have different backgrounds and areas of expertise…   Read more»

Currently, I work as a Registered Behavioral Therapist. Root Cause Analysis was used before and during my job because it is super important. Root Cause Analysis is “the process of discovering the root causes of problems in order to identify…   Read more»

I believe the people who see quality as a burden are the optimistic thinkers. They are the people who believe ‘it would never happen to me’.  This means they see quality as an unnecessary step to prevent a situation that…   Read more»