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• A Look Back into History• Beginning of CAPA• Corrective/Preventive Comparison
• Risk Management and Resilience• Risk-Based Thinking• The Risk Assessment Process• How Risk Management Drives Preventive Action and Continual Improvement
• Characterize – Identify the problem & assemble the right team• Investigate – Research the problem and identify Root Cause• Analyze – Perform a thorough assessment• Action Plan – create a list of required tasks• Implementation – Long term permanent action• Follow Up – Verify and assess the effectiveness
A preventive action is a process for predictingpotential problems or nonconformances and eliminating them. The process includes:• Identify the potential problem or nonconformance • Risk assessment• Develop a plan to prevent the occurrence• Implement the plan• Review the actions taken and the effectiveness in preventing the problem
• Regulatory Requirements•Regulatory bodies such as FDA, EPA and virtually every ISO standard requires an active CAPA program as an essential element of a management system.
• Customer Satisfaction• The ability to correct existing problems or implement controls to prevent potential problems is essential for continued customer satisfaction
• Good Business Practice• Quality problems can have a significant financial impact on a company
•Properly documented actions provide important historical data for a continual improvement plan and are essential for any product that must meet regulatory and ISO requirements.
• Those events that are systemic issues and pose a potential adverse impact on the business• Any event that deviates from expected performance•When planned results are not achieved, correction and corrective action shall be taken, as appropriate ~ ISO 9001 8.2.3 Monitoring ~
Characterize the problem & assemble the right team
• The initial step in the process is to clearly define the problem or potential problem.• This should include:• The source of the information and data• A detailed description of the problem• Any documentation of the available evidence that a problem exists.
•A description of the problem is written, concise and complete •The description must contain enough information so that the specific problem can be easily understood and data is easily translated
•Root Cause is the fundamental breakdown or failure of a process which, when resolved, prevents a recurrence of the problem
Or, in other words:• For a particular product problem, Root Cause is the factor that, when you fix it, the problem goes away and doesn’t come back• Root Cause Analysis is a systematic approach to get to the true root causes of our process problems
• Follow a defined investigation strategy• Assignment of responsibility and required resources – Owner• You need a complete review of all circumstances that could have contributed to the problem:
Business dictionary: Preventive ActionAn action taken to reduce or eliminate the probability of specific undesirable events from happening in the future. Preventative actions are generally less costly than mitigating the effects of negative events after they occur, but may also be seen as a waste of resources if the predicted event does not take place. Risk analysis and assessment techniques are used to calculate the probability of specific negative events, in order to determine the cost-effectiveness of potential preventative actions.
“FDA agrees that the degree of corrective and preventive action taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encountered…FDA does expect the manufacturer to develop procedures for assessing the risk, the actions that need to be taken for different levels of risk, and how to correct or prevent the problem from recurring, depending on that risk assessment.”
“FDA agrees that the degree of corrective and preventive action taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encountered…FDA does expect the manufacturer to develop procedures for assessing the risk, the actions that need to be taken for different levels of risk, and how to correct or prevent the problem from recurring, depending on that risk assessment.”
• A common, collaborative approach toward controlling the process greatly influences how operational risk and management system control are planned, executed, tested, measured, monitored and managed to the end objective of greater effectiveness, efficiency, and reduced risk exposure.