howellrmRenee Howell
Principal Scientist, Design Quality Systems, Medical Scientific and Statistical Affairs


Dr. Howell is currently a principal in design quality systems with Siemens Healthcare Diagnostics. Dr. Howell is a molecular biologist with 17 years of experience in IVD and life sciences product development and operations. She has also worked for Qiagen, Digene, SeraCare and Life Technologies. She is an active member of  AACC, AMP, and volunteers with the Clinical Laboratory Standards Institute. Dr. Howell has a BS in Medical Technology and a Ph.D. from Rutgers University and the University of Medicine and Dentistry of New Jersey where her dissertation research focused on genetic variation in HIV-1.


Renee will be one of the distinguished speakers at the 6th Annual Diagnostic Quality Assurance Conference.


Why is the 6th Annual Diagnostic Quality Assurance Conference important for quality assurance executives?
The top two reasons to attend this conference are to keep updated on the QA horizon, or what’s next as seen by participants across the industry, and to hear about real world examples of what efforts professionals have used to help improve quality in their organizations.


What initiatives are on the horizon at your organization for the quality assurance department in 2015-2016?
One of the most interesting  quality initiatives we are considering  is working with customers to look at real time performance data of our products as they are used in their labs. It is really difficult for a manufacturer to simulate the conditions our end-users experience and through this we believe we can learn new ways to improve quality assurance and control.


Are there any sessions or topics you’re looking forward to discussing at this year’s conference?
Yes, the panel discussion on best risk management practices and case studies on root cause analysis. It is always interesting to see what problems others have encountered and how they solved them – and how they measured success. I always learn a lot from these interactive sessions. Also if there are any meaningful updates to LDT regulation.


How has your organization improved risk management within the quality assurance department?
We have been providing training to employees who have never conducted formal risk management and we assign individuals who have experience in risk assessment to sit on our product teams who are able to provide guidance. One exercise we are discussing, as we have recently introduced new risk assessment tools, is to take an existing product through the new tools and see if we would get the same result. The thinking is it would help us understand how we would like to execute the new tool.


How do you believe that advanced technologies impact quality management systems?
There are two ways advancing technologies will greatly impact quality management systems. First, as advanced technologies are introduced in new products (Next Gen Sequencing, cloud computing for instance), quality systems will have to evolve to handle this. Quality professionals will need to have a thorough understanding of new technology to be able to design effective quality management systems. We’ll need to develop better and different tools and use new perspectives to assess risk. Secondly, hopefully quality management will benefit directly from advancements in computer software  that can help track and manage complex advanced product designs during product development and manufacture.


What are your/your team’s goals for the coming year?
One of our team’s major initiatives is to implement a QbD process for risk analysis in product development.


What are three key areas to examine when selecting quality management systems?

  • Will it provide improved quality for your company/product?  Is it the right system?
  • Is the system one that makes sense to the end-users? Often quality organizations put systems in place, but many other departments use the system (ie R&D, Manufacturing), and the right individuals are not asked to participate in the decision. Many times the management of these functions are involved and they look for certain features. However, when you consider those individuals who have to use the system on a daily basis you get a different view.
  • Is it auditable? Can a new person or an auditor walk in your door and follow your process? Are the connections transparent?  Is it streamlined or do you need a human (or a computer!) to explain all the complexities?


And finally, what keeps you up at night?
When the execution of quality assurance/management processes gets in the way of quality. Most cases of this arise when the quality process is separated from the technical or measurable basis of quality. For example, I have seen organizations draft protocols hundreds of pages long and the length is due mainly to required “verification” signatures at every single step, or protocols that require pictures to be taken of something simple like the indicator light of an instrument going on, or requiring a battery of tests be done because they exist, even if they do not inform quality. Doing something because it can be done does not mean it should be done, especially when it interferes or detracts from something of value.