Best Practice in Product and Process Improvement. Current and Emerging Regulations & Standards. Etc. …

Information | Understanding | Best Practice.
The Risk Management Process can be summarized as follows:

Step 1 - Identify the hazards via performing a risk analysis.
Step 2 - Estimate and evaluate the risks identified during the risk analysis.
Step 3 - Implement a process to reduce and control the identified risks.
Step 4 - Monitor the effectiveness of the controls implemented.

Process Improvement Training
Information & Training.| Improving Process Performance.
There are a number of approaches to improving Process Performance. The optimum approach depending on the skills, capabilities, background and preferences of the individuals and the organization involved in driving process improvement. The common “generic” process improvement methodologies are Lean, Just In Time, Statistical...
Process Improvement Training
DMAIC - Define, Measure, Analyze, Improve, Control.
Information| Understanding | Best Practice.
DMAIC relates to the stages of Define, Measure, Analyze, Improve, Control which are applied to solve a problem, or to improve a process.
Define phase:
This phase explains the problem & customer expectations of the process. Often referred to as the CTQ's attributes (critical to quality) and the VOC (Voice of the customer)...
DMAIC - Define, Measure, Analyze, Improve, Control.
Information & Training. | Medical Devices.
The following are definitions of medical devices as detailed by regulatory bodies in the United States, Australia, Canada, European Union, New Zealand, South Africa, by the World Health Organization and the International Medical Device Regulators Forum (formerly the GHTF).

Definition of a Medical Device. US FDA (Food and Drugs Ad...
Process Improvement via Bottleneck Analysis
In Bottleneck Analysis we are seeking to understand imbalances within a process, which cause delays, inventory build-up’s, process stoppages. Ideally, we want a smooth continuous, even process flow, however, in reality process input flows can at times exceed the throughput capability of a process. In some situations, it can be relatively eas...
What is Statistical Process Control
Information & Training | SPC and Statistical Methods for Process Improvement.
Statistical Process Control (SPC) has been in use since 1924 when a young engineer Walter Shewhart developed his first control chart at Bell Laboratories. SPC is the use of statistical techniques, e.g. collecting and analyzing data, so as to understand how a process is performing and using the knowledge ga...
What is Statistical Process Control

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