ASQ Vancouver 25th Anniversary Quality and Business Excellence Celebration “How to Manage Your Corrective & Preventative Action Process – An Introduction to Action Manager” Vanessa McCormick Copyright © 2012 BSI. All rights reserved. 2 Common Management Systems Issues – Globally! Over the last 3 years BSI has conducting over 250,000 audits, causing us to noticed a few trends in the CAPA process, & overall management of Actions. Top 5 include: • Inefficient overly manual CAPA processes • Scattered, Non-uniformed data and communications • Less visibility on CAPA activities • Deadlines are often missed • Inefficient processes (similar to #1) Copyright © 2012 BSI. All rights reserved. 5/7/2014 3 After 250,000 audits some common challenges arise Administration Processes Visibility Deadlines Copyright © 2012 BSI. All rights reserved. 5/7/2014 4 “Publicly available FDA data supports BSI’s internal analysis” QS Subsystem Total Citations % (1085 Total Citations) CAPA P&PC 342 331 32% 30% DES DOC MGMT 174 131 107 16% 12% 10% Direct & Indirect CAPA process effectiveness issues Copyright © 2012 BSI. All rights reserved. 5/7/2014 5 Action Manager & BSI Business Improvement Software Action Manager Copyright © 2012 BSI. All rights reserved. 5/7/2014 6 “Problems in manufacturing or service organizations cost time & money, and recurring problems or mistakes hurt morale,” Copyright © 2012 BSI. All rights reserved. 5/7/2014 7 Important Implications ISO / Compliance in jeopardy Contractual Penalties Damaged Company Reputation Reduction in Customer Satisfaction Costly Reworks & Recalls Copyright © 2012 BSI. All rights reserved. 5/7/2014 8 Some benefits More preventive, less corrective Save time – more important / less urgent Replace opinion with data Evidence to help satisfy multiple clauses Barometer for the health of the system Provide continuity & preserve ‘knowledge currency’ Copyright © 2012 BSI. All rights reserved. 5/7/2014 9 An effective corrective and preventive action process is Heartbeat the heart of your management system Copyright © 2012 BSI. All rights reserved. 5/7/2014 10 Corrective Actions – What Issues? ISSUES RAISED ACTION MANAGER Incidents  Complaints    Internal Audits / Inspections Observations Opportunities for Improvement   BSI Audits Copyright © 2012 BSI. All rights reserved. 5/7/2014 11 BSI Audits – Non Conformities Raised Continual Improvement BSI Accepts or Rejects Clients Actions BSI Audit Visibility Speed Traceability Client Receives Report & Loaded in to Action Manager Client Actions & Closes Out Copyright © 2012 BSI. All rights reserved. 5/7/2014 12 The Features BSI Non Conformities Form Customising Own Findings & NCRs Manage Actions Reports Create Action Plans Notifications Create Recurring Actions Copyright © 2012 BSI. All rights reserved. 5/7/2014 13 The Demo – Set Up Copyright © 2012 BSI. All rights reserved. 5/7/2014 14 The Demo - Introduction Copyright © 2012 BSI. All rights reserved. 5/7/2014 15 The Demo – BNC000011 Copyright © 2012 BSI. All rights reserved. 5/7/2014 16 The Demo – BNC000011 Copyright © 2012 BSI. All rights reserved. 5/7/2014 17 The Demo – CAC 000082 - Details Copyright © 2012 BSI. All rights reserved. 5/7/2014 18 The Demo – CAC 000082 – Details Cont…. Copyright © 2012 BSI. All rights reserved. 5/7/2014 19 Responsibility and system communication Copyright © 2012 BSI. All rights reserved. 5/7/2014 20 The Demo – Search Facility Copyright © 2012 BSI. All rights reserved. 5/7/2014 21 The Demo – The Reports Copyright © 2012 BSI. All rights reserved. 5/7/2014 22 The Demo – Conclusion (return to Dashboard) Copyright © 2012 BSI. All rights reserved. 5/7/2014 23 “How to Manage Your CAPA Process – An Intro to Action Manager” THANK-YOU! Questions? Want to chat? Vanessa McCormick, BSI Group Canada P: (604) 816-1657 vanessa.mccormick@bsigroup.com Twitter: @VL_McC