Our Consultants

Our consultants have extensive experience in the pharmaceutical, medical device and biotech industries. Our consultants have a minimum of two decades of industry specific experience in the areas of quality systems, GMP, and ISO standards. They are well-credentialed and have held strategic management positions which have enabled their respective companies to achieve phenomenal growth and implement sustainable compliance strategies. Our many years of experience coupled with extensive knowledge in the governing regulations serve to ensure that your company's regulatory and compliance needs are met and an established system of sustainable compliance is implemented.

Marie Florestal

Founder & C.E.O. of Florestal Consulting & Associates

Background:

Marie holds an MPA from Seton Hall University. She founded Florestal Consulting & Associates after 12 years of Pharmaceutical industry experience.

Areas of expertise

Conducting effective Quality Systems Investigations
Conducting effective GMP Investigations

Victor L Algarin

C.O.O

Background:

Victor is a candidate for a doctorate of medical humanities (D.M.H) at Drew University. Victor holds a Master's of Sacred Theology and a Master's of Divinity. He has been working with Florestal Consulting & Associates since 2002.

Areas of expertise

Specialization in the interplay between medical ethics and society

Contact Us or Make an Appointment

For answers to your questions or to schedule an appointment, please call:

1 973 280 6614

Or send us an email.

News & Events

http://investigations101.blogspot.com/

Problem Solving Tool Selection

Previously, I discussed some key elements to Problem Solving involving the analysis of several key components of root cause determination in order to effectively solve the problem. Namely, an Accurate Determination of the Problem, Selecting the Appropriate Problem Solving Tool(s), and an analysis of when to use each tool. Here, I will provide you with 3 additional tools that may be used in order to effectively determine the root cause of a given nonconformance:

1. Affinity Diagram

Affinity diagram is another great tool to use because it allows the team to brainstorm a significant number of ideas relating to an issue and then group and summarize them in order to fully understand the essence of the problem, hence the solutions. I like to use Affinity Diagrams as a problem solving tool because it gives each team member the opportunity to be completely open to ideas that one may not necessarily be aware of. It is also a great tool for overcoming team stagnation.

2. Check Sheet

Check Sheets are best used in counting and accumulating data associated with a process. It allows team members to systematically record and compile data in order to effectively identify trends. This compilation of data creates a clear picture of the elements of the process and allows patterns in the data to become clearly and quickly evident.

3. Histogram

Histogram is a great tool to use in summarizing data from a process over a period of time. This data is then graphically presented in bar form showing the frequency distribution. Histogram is a great tool to use when you want to display large amounts of data in tabular form. This may prove to be of great benefit because graphical representation of data may sometimes be difficult to interpret and having this data represented in a tabular format renders it more easily understood. Histogram also quickly illustrates the underlying distribution of the data which in turn may provide useful information for predicting future process performance.

Which tool to use? Depends on the nature of the nonconformance. Happy Investigating!