Risk Management

Through our extensive experience in Quality Systems and GMP investigations, our consultants will work to effectively assess risk. We will analyze data and apply strategic problem solving tools and techniques to identify product risk.

Our services at a glance:

Analysis of the nonconformance and identification of appropriate containment
Identify and eliminate the causes of existing nonconforming product
Identify and eliminate the causes of potential nonconforming product
Verify and validate actions
Implementing meaningful metrics
Proper documentation to support investigation plan
Monitoring for effectiveness
Forward information to management review

Common Industry Challenges:

· Pattern of failure to clearly identify root cause of a non-conformance and implement effective corrective and preventive actions

· Pattern of failure to verify or validate the corrective and preventive action to ensure that such action is effective

· Pattern of failure to establish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems,

· Pattern of failure to a have an adequate investigations tracking system to assure that systemic problems are evaluated and trended

· Pattern of failure to provide documented evidence which established a high degree of assurance that the manufacturing processes were effective and could consistently produce a product meeting its predetermined specifications and quality attributes.

Who to contact:

Marie Florestal

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!