Quality System

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Our consultants will work with your team to ensure that sound judgment and applicable QS regulations are applied in developing or challenging the quality system. Our extensive experience in this area will help to ensure that manufactured devices are safe, effective and meet the quality system requirements.

Our services at a glance:

Establishing the Requirements for a Quality Management System
Establishing the requirements for Quality Manual
Defining Management Responsibility
Resource Management
Competence Evaluation and Training
Measurement, Analysis and Improvement
Internal Audit
Control of Nonconforming Product
Implementation of Corrective and Preventive Actions
Effectivity Monitoring
Analysis, optimization and Implementing effective corrective and preventive actions (CAPAs)
Performing root cause investigations
Internal auditing and evaluation of procedures

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!