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Whether it is Six Sigma, EPA, OSHA, or FDA, the requirements for Corrective Actions and Preventive Actions (CAPA) are the same. You need to be able to associate a Corrective Action to a particular nonconformance; audit finding, incident, or exceedance. Being able show results, root cause and completion of the action items is vital.
Because these actions are generated from different drivers, multiple departments can be responsible for ensuring these items get completed. Tracking these items through internal systems, phone calls and e-mails becomes very time consuming. Appropriate prioritization is not always accomplished because risk rankings are not consistent across the different business silos. Reporting becomes difficult because corporate standards for root causes are not utilized by the different departments. Manipulation of the information has to occur to have any chance of analyzing trends.
How nice would it be to be able to visualize root causes with corresponding contributing causes by driver type? You could drill down into details to see trends and make effective decisions to drive compliance. The most critical items will be completed first based on their risk ranking. Realize true cost savings by standardizing and centralizing actions.
Your company will have better reporting because everyone is using the same standards. Higher cost savings will result in a better bottom line for the company. Breeze through third party audits by having CAPA details at your finger tips.
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