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Quality systems v3

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Quality systems v3

  1. 1. Quality Systems 101 orThe Most Boring Topic in the World Made Fun and Easy Ravi Pamnani BioE 141 Biodesign Capstone 2012 Feb 23
  2. 2. Who am I and what am I doing here? Background • Guidant → Boston Scientific → Maquet Cardiovascular • Eberhard Grube Fellow, 2010-2011 • ExploraMed, Transcend Medical • By no means an expert – more of a discussion facilitator Goals • Not put you to sleep • “Why” as opposed to “What” • Hands-onR. Pamnani Quality Systems v3.pptx 2
  3. 3. Overview • What is a Quality System? Why should you care? • Components of a Quality System • Start-ups – What do I really need to do? • Pop Quiz 3R. Pamnani Quality Systems v3.pptx
  4. 4. Quality Systems, in a nutshell Manufacturers establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Link to 21 CFR 820Federal Register Vol 61 No 195 Oct 7 1996 Rules and Regulations 4R. Pamnani Quality Systems v3.pptx
  5. 5. A short of history of Quality 1200s European craftsmen formed guilds and developed strict product quality rules 1800s The birth of the factory and the standardization of product inspections 1906 President Roosevelt signs Food and Drugs Act 1920s Shewhart, “processes”, and statistical quality control 1937 Elixir of Sulfanilamide incident 1938 Federal Food, Drug, and Cosmetic Act is passed – first regulation of medical devices 1940s WWII 1950s Deming, Juran, and Japan 1953 The Factory Inspection Amendment 1961 Thalidomide Incident 1962 Kefauver-Harris Amendments – Good Mfg Practices (GMPs) for drugs 1976 Medical Device Amendments – establishment of pre-market registration, cGMPS for devices 1984 Congressional committee investigates deaths related to design of cardiac pacemaker leads 1989 FDA publishes a study on device recalls – 44% attributed to design issues 1990 Safe Medical Devices Act – better reporting, design controls 1997 FDA Modernization Act – the birth of the QSR as we know it todayhttp://www.gmp-quality.com/FDA_history.htmlhttp://asq.org/learn-about-quality/history-of-quality/overview/overview.htmlhttp://www.mdiconsultants.com/Publishing/article12.htmhttp://www.mddionline.com/article/ba-brief-history-fda-good-manufacturing-practicesbR. Pamnani Quality Systems v3.pptx 5
  6. 6. Why does it matter? • FDA can order a recall • FDA can shut you down • DOJ can charge you with criminal violations • If done wrong, can slowly suck the life out of your company – or worse, hurt someone • If done right, can improve product safety and efficacyhttp://biomed.brown.edu/Courses/BI108/BI108_2007_Groups/group05/pages/guidant_stent.htmlR. Pamnani Quality Systems v3.pptx 6
  7. 7. Components of a Quality System CFR Title 21 Part 820 • Management responsibility • Process validation • Quality audit • Acceptance activities • Personnel • Nonconforming product • Design controls • Corrective and preventive • Document controls action • Purchasing controls • Labeling and packaging • Identification and traceability • Handling • Production and process , Storage, Distribution, and controls Installation • Inspection, measuring, and test equipment • Records • ServicingR. Pamnani • Statistical Techniques Quality Systems v3.pptx 7
  8. 8. Management responsibility • Establish quality policy • Commit – Organization – Authority – Resources • Management rep • Quality system procedures • Ultimate responsibilityR. Pamnani Quality Systems v3.pptx 8
  9. 9. Quality audit • Not only will FDA audit you – you have to audit yourself • Someone unbiased to the subject matter – Someone not on your project – Often a specialized role, if a large company – Consultants • You decide when and how often (FDA will decide if you’re being reasonable when they audit you)R. Pamnani Quality Systems v3.pptx 9
  10. 10. Personnel • Sufficient, smart people (this is actually in the law) • TrainingR. Pamnani Quality Systems v3.pptx 10
  11. 11. Design Controls • Affects Class II and III (and a few Class I) devices • “… ensure specified design requirements are met.” • A framework manufacturers MUST USE when designing new medical devices • A lot of flexibility, some best practices • People usually screw themselves overR. Pamnani Quality Systems v3.pptx 11
  12. 12. Waterfall ProcessR. Pamnani Quality Systems v3.pptx 12
  13. 13. Design Control Example • User need – Catheter guidewire for stroke treatment needs to be able to enter the lenticulostriate arteries from the middle cerebral artery (MCA). • Design input – Can you quantify this? What “engineering” requirements would you consider to meet the user need? • Design process – The actual physical, iterative process of design • Design output and design verification – How do we check if your design meets your design input? • Medical device and design validation? – How do we check if the device meets the user need?R. Pamnani Quality Systems v3.pptx 13
  14. 14. Document controls • Document approval and distribution Signature requirements for a • Document changes change to a part, pre-launch • A great opportunity to: • R&D Eng, Quality Eng, Project – Hold projects hostage Mgr., Buyer/Ops – Stonewall – Delay something you don’t Signature requirements for a understand – Use as a substitute for good change to a part, post-launch communication • R&D Eng, Quality Eng, Supplier • Really though: Quality Eng, Mfg Eng, – Hold people accountable Buyer/Ops, Finance, R&D Mgr, – Make sure you don’t do something stupid Quality Mgr, Dir. of Ops, Project Mgr,R. Pamnani Quality Systems v3.pptx 14
  15. 15. Purchasing controls • Evaluate your suppliers – How will you control the quality of your supply chain? – More audits • Purchasing data – Quality requirements for suppliersR. Pamnani Quality Systems v3.pptx 15
  16. 16. Identification and traceability Identification • Prevent mixups Traceability • In case something goes wrong • Know: – which components – which suppliers – which manufacturing lots – which days – which operators – which processingR. Pamnani Quality Systems v3.pptx 16
  17. 17. Production and process controls She is building an implantable device. What’s wrong with this picture?R. Pamnani Quality Systems v3.pptx 17
  18. 18. Inspection, measuring, and testequipmentR. Pamnani Quality Systems v3.pptx 18
  19. 19. Process validation Electrical resistance of Strength of spot weld assembled circuit vs.R. Pamnani Quality Systems v3.pptx 19
  20. 20. Acceptance activities and non-conforming product Acceptance Activities Non-conforming product • Receiving • Control • In-process • Review and disposition • Finished device acceptance • … • Records!R. Pamnani Quality Systems v3.pptx 20
  21. 21. Corrective and preventive action • What you do with all of those audit findings • Can also come from anywhere – Product complaints • Gives you a little bit of breathing room if you accidentally broke the rules, but you pay later…R. Pamnani Quality Systems v3.pptx 21
  22. 22. Labeling • Labeling includes: – Indication statement – Intended use – Instructions for use – Warnings & Precautions – Storage & Handling – Traceability info – Shelf life • Changes must be cleared with FDAR. Pamnani Quality Systems v3.pptx 22
  23. 23. Packaging • Make sure device can safely get from A to B • The #1 Project Delayer, in my experienceR. Pamnani Quality Systems v3.pptx 23
  24. 24. Handling , Storage, Distribution, andInstallation • Mixups, damage, deterio ration, contamination, o r other adverse effectsR. Pamnani Quality Systems v3.pptx 24
  25. 25. Records • Keep records of EVERYTHING – As long as the device is being sold – Device Master Record (DMR) – Device History Record (DHR) – Quality system records (SOPs, Training records, everything) • Complaint files – Very specific requirements – Must report the really bad ones to FDAR. Pamnani Quality Systems v3.pptx 25
  26. 26. Servicing • For capital equipment, document servicing procedures • Servicing is a selling point, and often a revenue driver Intuitive Surgical’s remote monitoring and servicing of the da Vinci http://www.intuitivesurgical.com/support/onsite.htmlR. Pamnani Quality Systems v3.pptx 26
  27. 27. Statistical techniques • Statistical rationales for test sample sizes • Often based on risk level • Up to you to determine and justify what is appropriate… just like everything elseR. Pamnani Quality Systems v3.pptx 27
  28. 28. Start-ups: What do you do? Entire quality system at a local start-upR. Pamnani Quality Systems v3.pptx 28
  29. 29. When do the QSRs apply? QSR starts “RESEARCH” here “ENGINEERING”R. Pamnani Quality Systems v3.pptx 29
  30. 30. Clinical / Regulatory implications • Are you preparing for a clinical trial? • Are you preparing for investigational device exemption application? • Are you preparing for GLP animal studies that will eventually be part of a regulatory submission? • Are you developing the device design that will eventually be used above? • Are you doing an animal study as a proof-of- concept / feasibility test? • Are you cobbling together things you bought from Walgreen’s to test on each other?R. Pamnani Quality Systems v3.pptx 30
  31. 31. Planning ahead • Where will you make devices that will be for human use? • You can use contract manufacturing facilities for early growth – but you are still the finished good manufacturer, according to FDA! • The laws are flexible – but justify any decisions or exemptions you make for yourself • What kind of equipment are you using to build, measure, test devices? Why didn’t you calibrate that ruler? • Risky devices will need larger investment up front • Non-significant risk devices can find simpler ways to show safetyR. Pamnani Quality Systems v3.pptx 31
  33. 33. Pop quiz • Ancure device, used for abdominal aortic aneurysms (AAA)R. Pamnani Quality Systems v3.pptx 33
  34. 34. Pop quiz • Guidant received approval for Ancure device and began selling it • Implanted device designd well • Catheter, on the other hand, not so much • Catheter would become lodged and could not be removed by conventional means – Extensive surgery would be required to remove the device • Guidant still sold it; advised “handle-breaking technique” to remove catheter • Of 7,632 devices shipped, there were close to 3,000 injuries, including 12 deaths and 57 conversions to traditional open surgical repair – 34% failure rate – Mortality rate of 0.2% (interestingly, compare with surgical mortality rate of 3.5% at the time) • Guidant submitted only 172 reports to FDA during this period • Did Guidant break the law?http://biomed.brown.edu/Courses/BI108/BI108_2007_Groups/group05/pages/guidant_stent.htmlR. Pamnani Quality Systems v3.pptx 34
  35. 35. Pop quiz "Guidants EVT division violated the fundamental trust that exists between the medical device industry, doctors, patients, and the public at large. Because of the companys conduct, thousands of patients underwent surgeries without knowing the risks they faced, and their doctors - through no fault of their own - were unprepared to deal with those risks. These actions were criminal, and I am happy to say that today, for the first time in more than three years, the public will be able to learn the truth."R. Pamnani Quality Systems v3.pptx 35
  36. 36. Recall ExerciseR. Pamnani Quality Systems v3.pptx 36
  37. 37. Recall Exercise CFR Title 21 Part 820 • Management responsibility • Process validation • Quality audit • Acceptance activities • Personnel • Nonconforming product • Design controls • Corrective and preventive • Document controls action • Purchasing controls • Labeling and packaging • Identification and traceability • Handling • Production and process , Storage, Distribution, and controls Installation • Inspection, measuring, and test equipment • Records • ServicingR. Pamnani • Statistical Techniques Quality Systems v3.pptx 37