Quality Control and Regulatory Compliance

Quality control is often seen in the medical device or Pharma industries as a “must have” headache. In the more traditional established companies where quality assurance is operated as a completely independent department  it can create fiction between the Quality Assurance department and operations as their needs and desires can appear to be in conflict due time to such things as time constraints. My experience is that the integration of quality assurance and quality control such as documentation, measuring, testing etc. works far more efficiently if integrated within the business units. Whereby the business units are responsible and held accountable for maintaining an efficient and effective quality system. It can then become a very valuable tool that can help with the efficient operation of the business. Obviously there always has to be independent quality and regulatory oversight which has responsibility for the system through internal audits, training  etc.

Alan D Shortall