This book contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a 9-step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system.
CAPA violations along with ineffective complaint investigations continue to be the number one cited violation of device warning letters for the past four years, leading the US Food and Drug Administration or FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CAPA activities. A review of FDA warning letters issued to pharmaceutical companies reveals that most of these warning letters resulted from recurring failures, ineffective investigations found, and missing or inappropriate corrective and preventive actions. Companies often make the mistake of fixing problems in their processes by revising procedures or more commonly by 'retraining' employees that may or may not have caused the problem. This is typically event-focused. Companies then will make the false assumption that the errors have been eradicated. In many cases they will also consider the steps taken as their Preventive Action. The reality is that the causes of the failure were never actually determined; therefore the same problem will recur over and over.
CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. CAPA is not just a quick-fix, simple approach. It is a process and has to be understood throughout organizations.
This book addresses all of the above issues, in a pragmatic, down-to-earth manner.
• The primary objective of this book is to provide an understanding of
the principles and techniques involved in the effective implementation of a
CAPA program: from the identification of the problem, to the verification of
preventive action using a 9-step systematic 'common sense' approach
• Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, which are explained in detail. In addition, the book provides effective methods which can be used with a Corrective Action system to help quality professionals ensure costly issues are identified, resolved quickly and appropriately and do not slip through the cracks
• The book provides readers with a system to categorize all types of failures, assign responsibility and track team activities conducted to resolve such problems. Readers also learn advanced skills in root cause analysis, problem prevention, continuous improvement, the identification of the characteristics and changes that often contribute to both simple and complex issues as well as how to address them. Finally, learners are provided with valuable tools and templates needed to capture all required data for the purpose of generating thorough, and most important of all, compliant CAPA reports
• This book provides a clear description of processes to apply risk management principles for determining needed investigation levels and how to effectively identify the potential failure mode cause (s) in order to prevent potential failures.
- Step-by-step basics on how to build a comprehensive CAPA program; how to use a 9-step CAPA process to effectively handle any product or quality system failures
- How to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner
- How to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk.
- How to use Failure Mode and Effect Analysis to identify potential failure modes
- How to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities
- Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
- Efficient used of root cause analysis tools
- Optimizing CAPA and RCA documentation procedures; essential SOPs and other documentation
- Review areas of common FDA's 483 inspection observations
- How to effectively identify and track deviations and non-conformances
- Learning to analyse and trend data to identify existing and potential causes of non-conformance
- Gathering, organizing and managing the correct data required to conduct and effective Root Cause Investigation
- Review the elements of a good investigation
- Integrating RCA and CAPA with other systems such as: internal auditing, deviations, Out Of Specification (OOS) and complaint handling
- Performing trend analysis and using effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
- How to use of statistical methodologies when performing Root Cause Analysis
- CAPA and the linkage to effective management review and annual product reviews
- Step-by-step basics on how to build your own comprehensive CAPA program
- Most important: review of the real benefits of an effective CAPA system
Medical device, pharmaceutical and biologic manufacturing facilities, research facilities, suppliers and subcontractor manufacturing facilities, raw materials manufacturing facilities, laboratories and testing contractors, ISO Certified manufacturing facilities, clinical sites and hospitals.
Ms Rodriguez, J. has over 28 years of experience that cover all facets of quality assurance and regulatory compliance. Ms Rodriguez is the President of Monarch Quality Systems Solutions, a consulting firm serving in the technical and regulatory compliance capacity for several Pharmaceutical, Biologics and Medical Device manufacturers. Her consulting activities place emphasis on all aspects of regulatory compliance, training, Mock FDA audits/assessments, regulatory affairs and various FDA-related activities.
Ms Rodriguez has published numerous compliance-related articles and has been a global industry speaker and presenter on several compliance topics. Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide. She has worked closely with CDRH's FDA HACCP team for both promotion of Risk Management, training of over 1000 individuals, and worked with the FDA in their pilot study created to introduce the new Hazardous Analysis and Critical Control Points (HACCP) Inspection Technique to the Medical Device Industry.