1. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 1 of 30 Bioburden Failure Analysis An E. coli strain being plated for identification.

2. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 2 of 30 Presentation Outline Important environmental monitoring data to collect and analyze Most common reasons for exceeding validated bioburden limits Containment & corrections Corrective actions & preventive actions Conducting a supplier audit of environmental monitoring Training & quality objectives

3. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 3 of 30 What data should you collect? Important environmental monitoring data to collect and analyze

4. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 4 of 30 Most Common Causes People not following gowning procedures Inadequate gowning procedures Inappropriate storage conditions for components Failure to remove secondary packaging or clean primary packaging outside controlled environment Failure to following cleaning schedule Inadequate cleaning and preventive maintenance

5. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 5 of 30 Containment Which lots? If specific cause is unknown, there should be statistical rationale for the bracketing based upon sampling and trend analysis of bioburden. Identify product and/or raw materials as nonconforming (i.e., initiate an NCR) Don’t contaminate your “good” product

6. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 6 of 30 Corrections Re-sterilization of product (if you do not have this validated, evaluate the adverse effects of re- sterilization) Conducting a recall Scrapping product Cleaning product (rework procedures with an evaluation of the adverse effects of rework) Cleaning—a lot!

7. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 7 of 30 Corrective Actions Changes to supplier environmental controls Changes to raw material storage Retraining Changes to gowning procedures Increasing the frequency of cleaning Changing the disinfection solution & creating a rotating schedule More frequent replacement of HEPA filters Where should hairnets be removed?

8. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 8 of 30 Where should hairnets be removed?

9. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 9 of 30 Preventive Actions Most companies struggle to identify purely preventive actions Bioburden trend analysis is an excellent source Don’t wait until you have an excursion. Examples of Preventive Actions: – Monitoring raw material bioburden – Improved gowning procedures – Increasing the frequency of cleaning – Rotating disinfecting solutions – Preventive maintenance of HEPA filters

10. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 10 of 30 Supplier Audits Supplier qualification audits should be conducted on-site—not remotely Types of suppliers that should include a review of environmental monitoring, gowning and cleanroom cleaning procedures – Contract manufacturers of finished devices – Contract packagers – Component suppliers for sterile devices

11. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 11 of 30 When NOT to Audit Remotely Onsite visits facilitate the building of supplier-customer relationships. Touring facilities and watching demonstration of processes improves understanding of a supplier’s processes better than reading documents and records can. Cleanliness and capabilities of suppliers are best evaluated onsite, where camera angles can be used to crop out important details Sometimes suppliers misrepresent their capabilities by showing photographs on their website of other companies.

12. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 12 of 30 “Witch Hunts” Supplier Audits “For Cause”

13. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 13 of 30 SCAR Effectiveness Check http://www.medicaldeviceacademy.com/supplier-auditing-tool-kit

14. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 14 of 30 If supplier delays SCAR… How do you monitor production processes? Step 7 Output is the DHR for each production lot. Input is the production work order or job order. Step 2Step 3 Step 5 Step 6 Sample calibration records. Sample maintenance records. Sample validation & re-validation records. Sample environmental monitoring and cleaning records. Step 4 Step 1: Describe the process for controlling production processes. Reference supplier’s procedures and forms, including revisions of documents. Sample training records for person(s) performing manufacturing. Look for effectiveness of training and competency.

15. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 15 of 30 Remote Auditing “Any time you can audit in a conference room, you could probably do the audit remotely.” http://medicaldeviceacademy.com/4-ways-make-best-use-remote-audits/

16. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 16 of 30 Training

17. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 17 of 30 Quality Objectives Quality objectives

18. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 18 of 30 Q&A

19. Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Slide 19 of 30 Need help? Contact me. Rob Packard rob@13485cert.com +1.802.281.4381 rob13485