Common Industry Mistakes and How to Avoid Them

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

2. 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 Common Mistakes

3. 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

4. Internal Audits • Too many companies perform audits just because “they have to”? • Audits can, and need to be, value added

5. 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

6. Procedures • Read the regulation… • Write to the audience that will be using the document • Less words, more process maps, tables, flow charts, pictures

7. 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

8. 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!

9. 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

10. 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

11. 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

12. Misuse of Software • Automation is a tool …not a solution … • Define your process first, then choose software that best works with your your process

13. 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

14. Summary

15. Questions

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