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

5 whys analysis
Information | Understanding | Best Practice.
The objective of a 5 whys analysis approach to problem solving is to be able to move past seeing the symptoms of a problem and getting to the true root cause of the problem.

It has been found that by the time you ask why 5 times, and get 5 well considered answers, you can normally see where the problem originated, thereby enabling you to t...
 
5 whys analysis
software verification
Information & Understanding. | Software Validation.
The V shaped software validation lifecycle model is a variant of the Waterfall model to software validation with an emphasis on both verification and validation of the end product. The critical aspect of the V shaped model is that the testing of the product is planned in parallel with a corresponding phase of development.

 ...
 
software verification
Information & Training. | SPC & Statistical Process Improvement
Statistical process control is a method of applying charts to track the performance of pre-determined critical quality attributes against defined performance criteria. The defined performance criteria are usually detailed in product or process performance specifications, for example, dimensions, weight, frequency, v...
 
FDA Medical Device requirements.
Information & Training. | Medical Device Validation, Regulation, ...
FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, the CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ul...
 
FDA Medical Device requirements.
Validation Qualifications IQ OQ PQ
Information | Understanding | Best Practice.
Installation Qualification (IQ)
The objective of the Installation Qualification is to see if the process or product is established (or set-up or installed) correctly.

Important IQ considerations are:

• Equipment design features (i.e. construction materials, cleanability, etc.)
• Installation conditions (wiring, utilities, function...
 
Validation Qualifications IQ OQ PQ
Information | Understanding | Best Practice.
 

Scatter diagrams can be utilized to analyze two variables to determine if there is any form of relationship between them. If a relationship is identified, then the possibility arises that one variable may be controlled by varying the other variable. The strength of the scatter diagram lies in simplicity, however, it is important tha...
 

MedicalDeviceValidation-small_03
Information & Training presentations. … …