How to create an audit ready philosophy and culture

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 What kinds of audits are happening at your company? • Internal customers • External customers • Certification bodies • Regulatory bodies • Etc.

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

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)***

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***

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***

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 • Don’t drop items on others (the spouse list) • Assist in making goals a reality • Suggest vs. demand

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***

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)

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***

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 SOP’s • Policies and procedures to control forms • Create unbroken audit trails

12. Inspect What You Expect Pre-Audit Inspections (When Possible) • Walk-through of critical areas • Warn staff likely to be involved ***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

14. ISO17025 Reference Sheet

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? ***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.

17. Be Proactive Create Programs that TEACH! • 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.

19. Be Proactive Follow-Through • Ensure actions were taken • Ensure actions were effective • Look at other areas to implement actions ***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. ***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)

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

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

24. Final Thoughts People can’t change what they don’t 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

25. Questions/Comments Email: Jake Walton jwalton@nelsonlabs.com