10 June, 2014 by David R. Butcher, Marketing Communications, MasterControl
Documenting the complete process involved in CAPA is critical for companies having to meet the current regulatory requirements demanded by U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO). Proper CAPA documentation not only demonstrates that a company’s quality system is effective, but also enables the organization to identify problems quickly and implement effective corrective and preventive actions.
|Does your company adequately document the
actions it takes to ensure quality success?
A formal Corrective Action/Preventive Action (CAPA) can be a powerful tool for meeting current regulatory requirements. Done right, the systematic investigation of the root causes of identified problems or identified risks will prevent their occurrence or recurrence. For many companies, however, a crucial obstacle to CAPA success persists: adequate documentation of actions taken to achieve quality success.
The following is a general overview of steps necessary to complete and document CAPA efforts successfully:
Step 1: Identification – The initial step begins with clearly defining the potential or actual problem, nonconformity or incident, and describing the situation as it currently exists. The complete written description of the problem should include the specific source of the information that initiated the action, as well as a detailed explanation of the problem and the available evidence that a problem exists.
Step 2: Evaluation – The problem described and documented in Step 1 should be evaluated to determine the need for action and the level of action required. The potential impact of the problem and the actual risks to the company and/or customers must be determined and documented. The document, while concise, must contain sufficient information to ensure that the problem is easily understood.
Step 3: Investigation – A procedure should be written for conducting an investigation into the problem, helping to ensure that the investigation is complete and nothing is overlooked. The procedure should include, among other elements: an objective for the actions that will be taken; the procedure to be followed; the personnel that will be responsible and any other necessary resources anticipated.
Step 4: Analysis – The procedure created in Step 3 should be used to investigate the cause of the problem. The primary goal of this analysis is to determine the root cause of the problem described, but any contributing causes are also identified. This process involves collecting relevant data, investigating all possible causes and using the information available to determine the cause of the problem.
Step 5: Action Plan – Based on the analysis from Step 4, an action plan to correct and/or prevent the problem should be developed. The plan should list, as appropriate: actions to be completed; document or specification changes; process, procedure or system changes; employee training; monitors or controls for preventing recurrence of the problem; and the person/persons responsible for completing each task.
Step 6: Action Implementation – The corrective/preventive action plan created in Step 5 can now be implemented. All of the required tasks listed and described in the action plan should be initiated, completed and documented, creating a complete record of the actions taken to correct the problem and ensure it will not recur. Modified documents or specifications should be listed in documentation.
Step 7: Follow-Up – A thorough follow-up evaluation serves multiple functions, including: verifying that implementation and completion of all changes, controls and training, et al.; ensuring that the actions taken were effective; and adding additional information or comments that may be helpful in understanding CAPA actions. After the follow-up, there should be a formal indication that it has been completed.
We've only scratched the surface here, but this overview serves as the foundation of how to create a well-documented CAPA initiative that will meet regulatory requirements and significantly improve any organization’s quality process. For a more in-depth look at how to successfully document the complete CAPA process, check out MasterControl’s free white paper, Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan.
David Butcher has been writing about business and technology trends in the industrial B2B space for nearly a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends newsletter and blog and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions magazine. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.