23 February, 2016 James Jardine, Marketing Communications Specialist, MasterControl
Every day, companies in regulatory environments are amplifying their efforts to avoid the seemingly inescapable consequence of an egregiously oversaturated corrective and preventive action program, or, as it’s commonly come to be known, “Death by CAPA”. A recent MedTech Intelligence article by CAPA guru Ken Peterson speaks to the evolution of CAPA, discusses the refinement of effective CAPA programs and hints at what is on the CAPA horizon in the future.
Knowing Your Finish Line
Companies that are evading Death by CAPA are able to do so because they have effective risk gateways (see an example in the image above) and clear paths for managing quality events. If a company is able to appropriately respond to issues raised through these types of gateways, it is better able to grasp the correlated risks and lead quality events through the proper channels of management and disposition. However, in order to completely address risk issues in their CAPA programs, the organization must be willing and able to dedicate adequate resources to its most serious problems.
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Does Your CAPA Need a CAPA?
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Where is CAPA Headed?
In an era where many companies are still failing regulatory inspections, it is apparent that late stage CAPA processes are not being executed as effectively as they should be. Evidently, the most common reasons for these failures involve insufficient risk investigations and inadequate corrective responses. Moving forward, the key to a company’s CAPA success lies within its ability to maintain a risk management system that is commensurate with evolving regulatory guidelines.
James Jardine is a marketing communications specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.