1. Common Industry Mistakes and How to Avoid Them Susan C. Reilly Reilly & Associates, LLC SReilly@ReillyandAssociates.com 617-899-2319 FDA Update December 2008 1

2. Reilly & Associates, LLC © 2008 Common Mistakes QMS links not recognized or identified Weak internal audit program CAPA poorly executed Lack of or poorly written procedure Inadequate training Competing resources Complex processes Timeliness Reliance on software Inconsistency across global companies 2

3. Reilly & Associates, LLC © 2008 QMS Links Clearly identify and understand process inputs and outputs  Process mapping  Allows QMS work as a system Cannot effectively function if each process remains an independent element 3

4. Reilly & Associates, LLC © 2008 Internal Audits Too many companies perform audits just because “they have to”?  Audits can, and need to be, value added 4

5. Reilly & Associates, LLC © 2008 CAPA CAPA links to all other QMS activities Consider what is relevant to your business  Product type and complexity  Manufacturing process and complexity  Volume of product manufactured Monitor data sources relative to the risks associated with failure 5

6. Reilly & Associates, LLC © 2008 Procedures Read the regulation… Write to the audience that will be using the document Less words, more process maps, tables, flow charts, pictures 6

7. Reilly & Associates, LLC © 2008 Training Employees at all levels require training against company specific systems Cannot always rely on “self training” Training effectiveness must be monitored for process improvements 7

8. Reilly & Associates, LLC © 2008 Records Records / files do not reflect the current status or level of work performed  Documentation rules: forward and backward traceability  It all needs to be there AS it is being done! 8

9. Reilly & Associates, LLC © 2008 Competing Resources More work - fewer resources  The quality system is not Quality’s job Conflicting or changing priorities Avoid competing for the same resources by aligning QMS goals with CAPA with business objectives 9

10. Reilly & Associates, LLC © 2008 Process Complexity Process complexity impedes ability to act appropriately  Unnecessary approvals and signatures  Software is driving the process  Poor use of committees  Multiple systems adding to complexity  Everything carries the same weight 10

11. Reilly & Associates, LLC © 2008 Timeliness What is timely? What is closed? What is pending?  Define criteria for closure, don’t bind yourself with unrealistic time frames  Build in means for management escalation 11

12. Reilly & Associates, LLC © 2008 Misuse of Software Automation is a tool …not a solution … Define your process first, then choose software that best works with your your process 12

13. Reilly & Associates, LLC © 2008 Global Companies Must overcome perceptions business, methods, terminology, cultures, etc. are different or unique Opportunities exist to consider similar issues across multiple facilities  Share product, process and quality system information from various locations, sister facilities, manufacturing plants, to emphasize both problems and solutions 13

14. Summary 14

15. Reilly & Associates, LLC © 2008 Questions 15

16. Reilly & Associates, LLC © 2008 Thank You! Feel free to call or email with any questions concerning the presentation Susan C. Reilly Reilly & Associates 50 Old Quarry Road Wrentham, MA 02093 617-899-2319 SReilly@ReillyandAssociates.com 16