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 Effective CAPA Systems can improve the bottom line of medical device companies

As the debate continues on whether the 2.3 percent tax on medical devices that came into effect earlier this year should be repealed or not, an effective Corrective and Preventive Actions (CAPAs) system can be part of the solution, according to Robert Mitchell, Vice President, Quality and Regulatory, Sechrist Industries.  

"Companies cannot just pass that 2.3 percent tax on to customers. They need to figure out how they can share those costs or work to further improve efficiencies to pass on the savings to offset the costs. CAPA can be part of the solution," said Mitchell, the Chairman of the upcoming marcus evans Sustainable Effective CAPA Systems Conference.  

"CAPA is always on the back end of a quality system, with design control at the front end. If design control and manufacturing transfer are done right, then the CAPA system should be pretty light in terms of cost. But that is not always the case. Most of the time CAPA catches issues that do not get caught at the front end. An effective CAPA system catches and deals with issues early. An ineffective CAPA system can add to the costs. In that regard, an effective CAPA system can certainly be an improvement to the bottom line as companies continue to struggle with the tax that was imposed on them recently," Mitchell went on to say.  

The biggest challenge that organizations are facing today with implementing and documenting CAPAs is linked to organizational culture change, he highlighted. "The biggest challenge is the culture change that is required to migrate from the typical culture you would find in medical device companies, where quality is responsible for everything, to a culture where senior management is totally enrolled in the program, who totally understand, support and take ownership of the system. Without that level of involvement from senior management, it is a challenge."  

To set up this culture, the senior executive should draw a line with his or her values, and make sure that policies, goals, objectives and decisions are all in line with them. He has to be willing to listen to others, while gently taking actions to move the culture in the desired direction.  

Given that it is crucial to overcome re-occurrences of non-conformance, Mitchell revealed that he tests out CAPA that is submitted to him for review with cause and effect logic trees.  

"Repeat CAPAs are not good as they demonstrate that your problem-solving processes did not work. I find simple cause and effect tools that comes out of the theory of constraints, what some people call the cause and effect logic tools, to be the most effective way of ensuring CAPA is effective. Even if I just do it in my head."  

Mitchell concluded: "If your CAPA system is ineffective, then it is highly likely that most if not all other quality system elements will not be performing optimally. An ineffective CAPA system will almost always yield less than desired results from FDA or ISO audits. When putting the system together, make sure it is not too complicated, but in your simplicity, do not overlook the verification of cause and effect relationships and the plans to address them. Keep it simple but effective."  

The marcus evans Sustainable Effective CAPA Systems Conference will take place at the Westin San Diego, in San Diego, California, July 10-11, 2013.  

For more information, please visit the event website

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