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Corretive & Preventive Action (CAPA) 101

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Corretive & Preventive Action (CAPA) 101

  1. 1. American Association of Tissue Banks Quality Assurance Workshop XI Westin La Paloma, Tucson November 11 th , 2009 CAPA 101 Corrective Action / Preventive Action John Cover, BS, CQA (ASQ), CTBS Quality Management Consultant Verus Quality Consulting, LLC Sylvain Cyr, BS, CMQ-OE (ASQ), CTBS Tissue Bank Quality Manager Lifesharing
  2. 2. <ul><li>“ Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” </li></ul>-William A. Foster CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  3. 3. Agenda <ul><li>Definitions </li></ul><ul><li>Corrective Action </li></ul><ul><ul><li>Discussion </li></ul></ul><ul><ul><li>Example </li></ul></ul><ul><li>Preventive Action </li></ul><ul><ul><li>Discussion </li></ul></ul><ul><ul><li>Example </li></ul></ul><ul><li>Case Studies – Workshop Format </li></ul><ul><li>Group Workshop & Reporting </li></ul><ul><li>Summary </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr 10 min 15 min 15 min 5 min 45 min
  4. 4. Definitions <ul><li>Quality: </li></ul><ul><li>Quality reflects the cumulative characteristics of a good or service that speaks directly to the voice of the customer. 1 </li></ul><ul><li>Quality should also reflect the cumulative characteristics of the environment that supports the production of goods and services that directly speaks to the voice of the customer. 1 </li></ul><ul><li>Quality should further reflect the empowerment of all stakeholders to constantly improve the environment that supports the production of those goods and services. 1 </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  5. 5. Definitions <ul><ul><li>Root Cause Analysis (RCA): </li></ul></ul><ul><ul><li>A quality tool used to distinguish the source of defects or problems. It is a structured approach that focuses on the decisive or original cause of a problem or condition. 2 </li></ul></ul><ul><ul><li>Corrective Action (CA): </li></ul></ul><ul><ul><li>Is the action to eliminate the cause of a detected nonconformity or other undesirable situation. 3 </li></ul></ul><ul><ul><li>Preventive Action (PA): </li></ul></ul><ul><ul><li>Is the action to eliminate the cause of a potential nonconformity or other potential situation. 3,4 </li></ul></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  6. 6. Definitions <ul><li>Voice Of the Customer (VOC): </li></ul><ul><li>Describes the spoken and unspoken true needs of the recipient of one’s goods or services. The customer can be both internal and external, and its voice cannot be overlooked. 1 </li></ul><ul><li>Effectiveness Check (EC): </li></ul><ul><li>Seeking evidence that the causes of the problem have been removed or reduced. 5 </li></ul><ul><li>Polka-Yoke: </li></ul><ul><li>An approach for mistake-proofing using automatic devices or methods to avoid simple human error. 6 </li></ul><ul><li>PDCA (PDSA) Cycle: </li></ul><ul><li>Is a flow diagram for learning and for improvement of a product or a process. 7 </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  7. 7. Corrective Action <ul><li>Corrective Action: </li></ul><ul><li>2 Phases </li></ul><ul><ul><ul><ul><li>Short Term Immediate Action </li></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Action taken to contain the problem or non-conformance. </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>The action taken is swift and limited in scope. </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>No long term thought involved. </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><li>Long Term Corrective Action </li></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Action taken to prevent problem or non-conformance re-occurrence. </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>The action taken is methodical, encompassing and deliberate. </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Process follows the Deming PDCA Cycle. </li></ul></ul></ul></ul></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  8. 8. Corrective Action Discussion Cont. <ul><li>Corrective Action: </li></ul><ul><li>Elimination of an undesirable situation or an actual non-conformity </li></ul><ul><li>Dovetails directly off of your Root Cause Analysis </li></ul><ul><li>Each RCA cause and contributing factor must be resolved with your CA. </li></ul><ul><li>Remember the definition of Quality. Your review of the RCA must include: </li></ul><ul><ul><li>Product or Service </li></ul></ul><ul><ul><li>Environment </li></ul></ul><ul><ul><li>Empowerment of Stakeholders </li></ul></ul><ul><li>Your CA Plan must include an Effectiveness Check to ensure that the CA was effective. </li></ul><ul><li>You must continue to review data from the process for trends. </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  9. 9. Corrective Action Examples CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr See Handout
  10. 10. Preventive Action Discussion <ul><li>Preventive Action: </li></ul><ul><li>Elimination of a potential situation or non-conformity </li></ul><ul><ul><li>Can dovetail directly off of your CA Plan. </li></ul></ul><ul><ul><li>Can be discovered in one area and applied to others. </li></ul></ul><ul><ul><li>Can be discovered as a natural course of process improvement. </li></ul></ul><ul><ul><ul><li>Quality Circles </li></ul></ul></ul><ul><ul><ul><li>Benchmarking </li></ul></ul></ul><ul><ul><ul><li>Internal Audits </li></ul></ul></ul><ul><ul><ul><li>Etc. </li></ul></ul></ul><ul><li>Application of PA </li></ul><ul><li>PA should have tangible goals and based on perceived risk. </li></ul><ul><li>PA should have limited scope due to its limitless applications. </li></ul><ul><li>You must continue to review data from the process for trends. </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  11. 11. Preventive Action Examples CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr See Handout
  12. 12. CA/PA Commonalities <ul><li>CA/PA share the following commonalities: </li></ul><ul><li>Both are measures of continuous improvement </li></ul><ul><li>Both can dovetail off of a CA Plan </li></ul><ul><li>Both should include polka-yoke (mistake-proofing) whenever possible </li></ul><ul><li>Both have the potential of helping and hurting your processes, so caution should be exercised. </li></ul><ul><li>Both should be well documented and should include: </li></ul><ul><ul><li>Problem or potential problem description </li></ul></ul><ul><ul><li>Formal Root Cause Analysis </li></ul></ul><ul><ul><li>CA or PA Plan and justification for each plan requirement. </li></ul></ul><ul><ul><li>Measure of scope and scale </li></ul></ul><ul><ul><li>Resources required </li></ul></ul><ul><ul><li>Implementation Plan </li></ul></ul><ul><ul><li>Effectiveness Check </li></ul></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  13. 13. <ul><li>Case Studies </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  14. 14. Case Studies - Group Workshop & Reporting <ul><li>Divide into groups to work on the Case Studies. </li></ul><ul><li>Each group will choose one of the CA and one of the PA case studies. </li></ul><ul><li>You have 20 minutes to complete the exercise. </li></ul><ul><li>Use the group’s flip charts to document your group’s progress. </li></ul><ul><li>Document your proposed CA/PA decisions and course of action on the blank CA forms that are given to each group. </li></ul><ul><li>Once the 20 minutes is up, each group will report their work to the rest of the groups. </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  15. 15. CA Case Studies <ul><li>CA 1: Questions on DRA unanswered. </li></ul><ul><li>You received a call from one of your processors and they notified you that 2 high risk behaviors questions were unanswered on the Donor Risk Assessment Questionnaire. </li></ul><ul><li>Your current procedure requires that all screening and recovery paperwork to be sent to processors immediately along with the tissues. </li></ul><ul><li>CA 2: Training Discrepancy </li></ul><ul><li>During your annual internal audit, you find out that one of your senior Recovery Tech. has no documentation of training for pericardium recovery. You looked at his training plan and this requirement is missing. You observe that all recovery techs’ training plans are inconsistent. </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  16. 16. PA Case Studies <ul><li>PA 1: Recovery Pack Problem </li></ul><ul><li>You performed a supplier qualification on your new recovery pack manufacturer. When reviewing the supplier’s complaints files you observed several complaints coming from other tissue banks having an issue with the plastic jar lid leaking. This plastic jar is currently in your approved recovery pack and you already have 50 packs in your inventory ready to be used as soon as the supplier is approved. </li></ul><ul><li>PA 2: New problematic electronic feature </li></ul><ul><li>You are the Quality Manager of an OPO responsible for organ and tissue procurement. Both departments are using the same electronic charting system for all donor records but only the organ department is using the electronic signature feature. You are in the process of activating this feature on the tissue module. After reviewing some data, you realize that most of the deviations reported on the charting software last year were related to missing electronic signatures on forms. </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  17. 17. Summary <ul><li>Corrective Actions eliminate and undesirable situation and are reactive in nature. </li></ul><ul><li>Corrective Actions fall into two groups: immediate and long term. </li></ul><ul><li>Preventive Actions eliminate a potential situation and are proactive in nature. </li></ul><ul><li>Corrective and Preventive Actions are critical to every aspect of your organization, your donors, your customers and the community your organization serves. </li></ul><ul><li>All actions must be documented, rationale must be provided and must be based off of your root cause analysis. </li></ul><ul><li>Ensure that the three distinct parts of the definition of Quality have been factored into the CA/PA process. </li></ul><ul><li>Verify CA/PA effectiveness with an Effectiveness Check. </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  18. 18. References <ul><li>Cover, John. The Importance of Quality. American Association of Tissue Banks Annual Meeting – 2007. Boston, MA. </li></ul><ul><li>Wescott, Russel. The Certified Manager of Quality/Organizational Excellence Handbook. Milwaukee, WI. ASQ Quality Press, 2006. </li></ul><ul><li>Cianfrani, Charles, Tsiakals, Jospeh, West, John, The ASQ ISO 9001:2000 Handbook. Milwaukee, WI. ASQ Quality Press, 2002. </li></ul><ul><li>Russell, J.P., The ASQ Auditing Handbook. Milwaukee, WI. ASQ Quality Press, 2005. </li></ul><ul><li>Cochran, G., Verifying The Effectiveness of Corrective Action, Quality Digest, Obtained from: http://www.qualitydigest.com/inside/fda-compliance-article/verifying-effectiveness-corrective-action.html on October 28, 2009. </li></ul><ul><li>Evans, J., Lindsay, W., Managing for Quality and Performance Excellence 7 th Ed. Mason, OH. Thompson South-Western, 2008. </li></ul><ul><li>Deming, W.E., The New Economics, Cambridge, MA. MIT Press, 1994. </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr
  19. 19. <ul><li>Thank you! </li></ul>CAPA 101 AATB Quality Assurance Workshop XI - 2009 John Cover & Sylvain Cyr John Cover, BS, CQA (ASQ), CTBS Quality Management Consultant Verus Quality Consulting, LLC [email_address] www.verusqualityconsulting.com Sylvain Cyr, BS, CMQ-OE (ASQ), CTBS Tissue Bank Quality Manager Lifesharing Sycyr@ucsd.edu www.lifesharing.org

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