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Effective Use of CAPA in Remediating Quality Management Systems

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Solutions Delivery Manager Sarah R. Mott addresses effective use of CAPA in remediating quality management systems.

Date: February 25, 2016

Published in: Science
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Effective Use of CAPA in Remediating Quality Management Systems

  1. 1. Effective Use of CAPA in Remediating Quality Management Systems February 25, 2016
  2. 2. The Role of CAPA in Quality Remediation 4 Building a CAPA Culture within Your Organization 10 What to Do When Your CAPA System Needs a CAPA 13 Lessons Learned and Next Steps if Your CAPA Fails 17 Presentation Topics 2©2016 Maetrics. All Rights Reserved.
  3. 3. The Role of CAPA in Quality Remediation 4 Building a CAPA Culture within Your Organization 10 What to Do When Your CAPA System Needs a CAPA 13 Lessons Learned and Next Steps if Your CAPA Fails 17 Presentation Topics 3©2016 Maetrics. All Rights Reserved.
  4. 4. ©2016 Maetrics. All Rights Reserved. 4 The Role of CAPA in Quality Remediation  Definition  The correction of something bad or defective, reversal or stopping of damage  Righting a wrong, correcting a fault  Common aspects of Quality remediation  Revision/establishment of requirements  Historical review of previous records to check for non-conformances  Correction of non-conforming records  Confirmation of adherence to new standard What is Remediation?
  5. 5. ©2016 Maetrics. All Rights Reserved. 5 The Role of CAPA in Quality Remediation  CAPA is a methodology and vehicle for change  Provides the framework to conduct all aspects of remediation  Establishes timelines  Defines ownership and accountability  Allows for documentation using objective evidence  Visibility and accessibility of information regarding the problem and solution  Traceability for historical context Use of CAPA in Remediation
  6. 6. ©2016 Maetrics. All Rights Reserved. 6 The Role of CAPA in Quality Remediation  Identify and investigate product and quality problems  Collect and analyze information  Develop corrective/preventive actions (CAPA)  Verify actions  Communicate actions  Management review  Documentation Purpose of CAPA CAPA builds the business case for change
  7. 7. ©2016 Maetrics. All Rights Reserved. 7 The Role of CAPA in Quality Remediation  Ensure compliance to standards and regulations  Identify issues  Correct issues  Address and contain issues before they become widespread problems  Prevent recurrence of issues Intent of the CAPA Program and the Associated Quality System Problems are bad… CAPAs are good
  8. 8. ©2016 Maetrics. All Rights Reserved. 8 The Role of CAPA in Quality Remediation  Implementation of systemic solutions  Development and revision of procedures  Additional training  Retrospective review to close identified gaps  Continuous improvement Result of Remediation
  9. 9. The Role of CAPA in Quality Remediation 4 Building a CAPA Culture within Your Organization 10 What to Do when Your CAPA System Needs a CAPA 13 Lessons Learned and Next Steps if Your CAPA Fails 17 Presentation Topics 9©2016 Maetrics. All Rights Reserved.
  10. 10. ©2016 Maetrics. All Rights Reserved. 10 Building a CAPA Culture within Your Organization  Focus on the patient and the solution  Requires support by all levels of the organization  Drive solutions  Involve appropriate skill sets ‒ Education and mentoring  Promote honesty and transparency  Encourage problem solving and innovation  Teamwork  Appropriate tools available Effective Remediation is Dependent on a Healthy CAPA Culture
  11. 11. ©2016 Maetrics. All Rights Reserved. 11 Building a CAPA Culture within Your Organization  Thorough independent investigation  Objectivity  Proper application of tools  (Example: 5 why, ishikawa, 6M analysis, 3x5 why, 8D, is/is not, DMAIC)  Honest and accurate problem statements  Systemic evaluation and solutions  Appropriate understanding of containment, bounding, impact to product  Effective interim controls and corrective actions  Involvement of appropriate owners and stakeholders  Management support of CAPA and remediation efforts Essential Elements of CAPA Culture
  12. 12. ©2016 Maetrics. All Rights Reserved. 12 Building a CAPA Culture within Your Organization  Ensures consistency of the process  Provides an independent objective viewpoint and perspective for investigation and root cause analysis  Creates a quality mentoring atmosphere  Leads to an environment of continuous CAPA process improvement  Allows for escalation when needed Importance of Quality Oversight of the CAPA Process
  13. 13. The Role of CAPA in Quality Remediation 4 Building a CAPA Culture within Your Organization 10 What to Do When Your CAPA System Needs a CAPA 13 Lessons Learned and Next Steps if Your CAPA Fails 17 Presentation Topics 13©2016 Maetrics. All Rights Reserved.
  14. 14. ©2016 Maetrics. All Rights Reserved. 14 What to Do When Your CAPA System Needs a CAPA  CAPA is one of the most frequently requested documents during an FDA inspection  Any FDA QSIT audit (Inspection level 1 or 2, abbreviated or comprehensive) will include the CAPA subsystem  A significant number of FDA inspection findings are related to CAPA*  In 2014 FDA issued 121 warning letters to medical device manufacturers, 109 (90%) included citations for the CAPA subsystem ‒ 21 CFR 820.100(a) was the most frequently cited (77 total)  In 2014 FDA issued 1,106 Form 483s (from 2,213 QSIT audits), out of the 3,740 observations for QSR deficiencies, 1,148 (31%) were CAPA subsystem ‒ 21 CFR 820.100(a) was the most frequently cited (376 total) Statistics – You are Not Alone *Data from CDRH, Office of Compliance
  15. 15. ©2016 Maetrics. All Rights Reserved. 15 What to Do When Your CAPA System Needs a CAPA  Using CAPA to remediate the CAPA systems can cause greater issues for the whole remediation  Critical when remediation efforts include multiple QMS elements in parallel  Important not to have CAPA issues lead to failure of the remediation effort  Prioritization should allow for up front CAPA work if necessary so that the tool used for remediation will be effective Challenges to Remediation in a Broken CAPA System
  16. 16. ©2016 Maetrics. All Rights Reserved. 16 What to Do When Your CAPA System Needs a CAPA  Managing the remediation effort while the CAPA system is changing will be vital to the success of the project  Understand and ensure completion of fundamental elements  Engage stakeholders and establish a plan  Manage to success  Implementing solutions to stop the gaps  Focus on the findings to ensure your interim process does not lead to repeat failures  Understand the end goal of the changes to minimize rework  Establishing well defined metrics Challenges to Remediation in a Broken CAPA System
  17. 17. The Role of CAPA in Quality Remediation 4 Building a CAPA Culture within Your Organization 10 What to Do When Your CAPA System Needs a CAPA 13 Lessons Learned and Next Steps if Your CAPA Fails 17 Presentation Topics 17©2016 Maetrics. All Rights Reserved.
  18. 18. ©2016 Maetrics. All Rights Reserved. 18 Lessons Learned and Next Steps if your CAPA Fails The CAPA Failed…Now What?
  19. 19. ©2016 Maetrics. All Rights Reserved. 19 Lessons Learned and Next Steps if your CAPA Fails  Start over with a clean slate and open a new CAPA  If your CAPA was done poorly and there is nothing that you can salvage  Need a new investigation and root cause analysis  Ensure traceability  Maintain current CAPA  Add new actions (investigation, root cause, effectiveness monitoring)  Only parts of the CAPA failed  CAPA will withstand investigator scrutiny  Always, always always…  Consider options and use what is appropriate for situation providing traceability The CAPA Failed…Now What?
  20. 20. ©2016 Maetrics. All Rights Reserved. 20 Lessons Learned and Next Steps if your CAPA Fails  Being too close to the process to do an objective CAPA investigation and root cause analysis  Enlist an independent/quality viewpoint to support this effort  Volumes of objective evidence added to CAPA with little or no value  Include what evidence is and where it can be found, tell a story and allow the CAPA to stand alone Common Pitfalls and Lessons Learned
  21. 21. ©2016 Maetrics. All Rights Reserved. 21 Lessons Learned and Next Steps if your CAPA Fails  Documentation  Remember – the records are all you will have when it comes to defending CAPAs  Have a well defined problem statement (What , when , where, how much, who )  Do a thorough RCA using appropriate tools  One tool does not handle every problem  Collect data as needed for before and after comparisons  Make sure all records are stored appropriately  Make sure objective evidence is easily found and properly labeled  Provide a trace matrix on big problems (Cause – Action – Evidence) Common Pitfalls and Lessons Learned (continued)
  22. 22. ©2016 Maetrics. All Rights Reserved. 22 Lessons Learned and Next Steps if your CAPA Fails  Maintain the change  Procedural changes made during remediation are not maintained with subsequent revisions  Use the change control system and revision history to document the purpose of procedural changes  Pockets of improvement are made but not evident globally or systemically  CAPAs should drive systemic thinking  Stakeholders are not aware of changes made  Communicate changes to all that are involved Common Pitfalls and Lessons Learned (continued)
  23. 23. ©2016 Maetrics. All Rights Reserved. 23 Lessons Learned and Next Steps if your CAPA Fails  CAPA timelines are not met leading to a snowball effect for other related CAPAs/actions  Set realistic and reasonable timelines for remediation work  Don’t determine when before you know what and how  Global/systemic procedural changes are too high level to be meaningful or value add  Involve the appropriate process/system owners to get to a meaningful level of detail  Ignoring issues identified during the process because they are unrelated to the identified issue  Any additional issues identified during the process should be managed Common Pitfalls and Lessons Learned (continued)
  24. 24. ©2016 Maetrics. All Rights Reserved. 24 Lessons Learned and Next Steps if your CAPA Fails  Conducting training instead of implementing a compliant process where a gap was originally identified  Correct the process and train to that process  Training and operator error are identified as the root cause - but most often are not  Verifying that CAPA actions were completed instead of verifying that original findings have been corrected  Both should be verified because if the root cause was not properly identified the actions implemented may not have corrected the problem  Close the loop, ensure that effectiveness monitoring goes back to the original observation or issue Common Pitfalls and Lessons Learned (continued)
  25. 25. ©2016 Maetrics. All Rights Reserved. 25 Summary  A compliant CAPA system can be an effective tool in quality remediation  CAPA conscious cultures are an asset to any quality organization  CAPA systems themselves may require remediation before further remediation work can continue  CAPA problems are common, avoid the pitfalls to drive success and continuous improvement Summary
  26. 26. ©2016 Maetrics. All Rights Reserved. 26 Lessons Learned and Next Steps if your CAPA Fails Questions
  27. 27. Thank You ! 27 The contents of this presentation are copyright ©2016 Maetrics. All rights reserved. This presentation contains information in summary form and is intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Maetrics LLC cannot accept responsibility for loss occasioned to any person, firm, company or corporation acting or refraining from action as a result of any material in this publication. On any specific matter, reference should be made to the appropriate professional advisor. ©2016 Maetrics. All Rights Reserved.
  28. 28. ©2016 Maetrics. All Rights Reserved. 28 Building a CAPA Culture within Your Organization  Learn from past so as not to repeat it  Consideration of regulators perspective of repeat findings  Regardless of your role related to CAPA, accurate information is of utmost importance for both identification of the problem as well as the correct solution  Creator of data  Reviewer/decision maker  Potential product end user Importance of a Fix not a Band-Aid Approach
  29. 29. ©2016 Maetrics. All Rights Reserved. 29 What to Do When Your CAPA System Needs a CAPA  Purpose of remediation effort  Scope of work  Remediation process  Gap analysis  Timelines and reporting  Ownership and accountability  Management and quality oversight  Success criteria and closure Establish a Remediation Plan

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