1. HOW TO CREATE AN AUDIT READY PHILOSOPHY AND CULTURE By: Jake Walton Regulatory Auditor, Nelson Laboratories, Inc. 21 June 2011

2. What is Audit Readiness? Being audit ready means that your systems are ALWAYS ready to be audited, regardless of who is looking Internal customers External customers Certification bodies Regulatory bodies Etc. 2 What kinds of audits are happening at your company?

3. Assess Your Foundation 3 Are there cracks? Are past repairs holding? What needs to be repaired? Lets breathe

4. Fix The Cracks What is Your Objective? Set a SMART Goal Specific Measurable Attainable Realistic Timely ***Start small, prove the concept, and apply it again in a bigger format (creating a snowball effect)*** 4

5. Getting To Your Goal A goal without a plan, is just a wish – Larry Elder Formulate a Plan of Attack When/where are you going to start? Who will be involved? What resources do you need? What are my biggest obstacles? Etc. ***Process map it out*** 5

6. Communicate the Objective Inform Department Top Management Company Sell Your Objective Money (waste, cost of quality, grow business, etc.) Productivity Process improvements (future ease) ***Sell To Your Audience*** 6

7. Change the Culture Teach Rather Than Police Teach (explain the whys) Share understanding (two-way street) Respect processes/ideas Involve Audits Investigations Help People Achieve Assist in making goals a reality Dont drop items on others (the spouse list) Suggest vs. demand 7

8. Change the Culture Celebrate Achievements/Improvements Good times (no findings) Embrace Audits How can you make yourself better? Free consulting (external audits) Who is the REAL enemy? ***Quality cannot be achieved with a closed mind*** 8

9. Tools For Success Risk, Risk, Risk Perfect quality vs. acceptable practice Pick your battles Make risk based decisions Walk The Walk Improve yourself or your department Allow change in your process Be approachable Know Your Audience When completing/creating documentation Write, re-write, re-write (avoid red flags) 9

10. Tools For Success Pre-Audit Tools (For External Audits) What is going to be audited? Review past audits Is everything fixed from the last audit? Schedule subject matter experts (SME) and audit team Pull documents ahead of time Map out (flow chart) difficult processes ***Run a first class audit*** 10

11. Tools For Success Other Critical Items Good internal audit program (EA and IA – go together) Strong CAPA and Complaint programs Top 5 483 items pertain to these systems Effective, efficient, and well written SOPs Policies and procedures to control forms Create unbroken audit trails 11

12. Inspect What You Expect Pre-Audit Inspections (When Possible) Walk-through of critical areas Warn staff likely to be involved 12 ***Perform walkthroughs with area managers, teaching as you go. Overtime, they will be able to perform the walkthroughs on their own***

13. Inspect What You Expect Internal Audits First and best line of defense Create a program that audits against standards (GMP/ISO/ASTM/AAMI/ETC) Create a standard vs procedure reference (next slide) Audit full processes (not just segments) Pay special attention to areas that auditors audit: Training Labeling Validations Calibrations 13

14. ISO17025 Reference Sheet 4.8 Complaints The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory. SOPXXXX establishes our policy on how we handle and resolve customer complaints. Records are maintained in Regulatory Affairs, and include the following: complaint initiation, complaint coordinator assignment, investigation, correction, and preventive action (if needed), and complaint closure evidence. 14

15. Inspect What You Expect Daily Duties Train your entire staff to ask themselves, what would a customer or auditor think about this? Can it stand alone? Who is our audience? 15 ***Teach best practices and reward good behavior***

16. Be Proactive Trend All Audit Findings (See Further Slides) Non-Conformities Observations Recommendations Take Corrective and Preventative Actions Consider recommendations to be free consulting and take action where you see patterns or benefit. 16

17. Be Proactive Create Programs that TEACH! 17 Quality 360

18. Be Proactive Collaborate Hold meetings with areas of higher criticality, or repeat findings, and collaboratively work with personnel to find optimal solutions. Simply making decisions and pushing agendas on outside areas WILL NOT WORK. 18

19. Be Proactive Follow-Through Ensure actions were taken Ensure actions were effective Look at other areas to implement actions 19 ***Repeat observations will take you down. Formulate a system to ensure that all audit observations are taken care of***

20. Be Proactive Risk Based Justification If several auditors have raised the same question, and you have keep defending that process, have a risk- based written justification ready. 20 ***Well written justifications can save an audit***

21. Measure the Results SMART Goals = Meaningful/Measurable Results >95% On-time audit responses (External) >10% Decrease in Non-Conformities year to year (External and Internal) >50% Audits requiring no formal response (External) 21

22. Measure the Results Keep Metrics Looking at cumulative data tells you where your weaknesses and strengths are Number of audits and whether 1 st time or repeat Turn-around time of response Number and criticality of findings Responsible area of finding Procedure finding is governed by 22 ***Keep your metrics current and audit ready***

23. Measure the Results Compare Data to Find Holes External Internal Complaints CAPA Etc 23

24. Final Thoughts People cant change what they dont know If you are willing to teach, you will succeed Explain, explain, explain Be the change that you want to see (Gandhi) Changing habits/minds/processes takes time 24

25. Questions/Comments Email: Jake Waltonjwalton@nelsonlabs.comjwalton@nelsonlabs.com 25