1. Griffin Jones Congruent Compliance LLC 1March 2012 Test Strategy and Design #602 Surviving an FDA Audit: The Heuristics for Exploratory Testing Griffin Jones, Consultant, Congruent Compliance

2. The Heuristics for Exploratory Testing 2Griffin Jones Congruent Compliance LLCMarch 2012 3. Preliminaries Who is in the room? My goal: Stimulate your interest to study the subject more Leave with a heuristic to help you organize and present with confidence your ET results to regulatory auditors Have a conversation and try to meet your needs Quick Preview The context The heuristic and how to apply it Some of the traps about ET in a regulated industry Griffin Jones Congruent Compliance LLC 3 4. Assumptions and Terms More reference information here than I will present Follow the for the key points Much of this can be adapted to other contexts i.e., not FDA regulated, Exploratory Testing Schools of Testing by Bret Pettichord Analytic , Standard, Quality, Context-Driven, Agile Exploratory Testing Simultaneous learning, test design and test execution Agile Testing Story completion, test automation: Test Driven Dev., etc. 4Griffin Jones Congruent Compliance LLC 5. Terms Congruence Being balanced between inner feelings & outer actions Smells Symptom that possibly indicates a deeper problem 5 Whys Questions-asking method to investigate root causes Mary had a little lamb heuristic Emphasize each of the individual words in a statement Checking: confirming existing beliefs; versus: Testing - finding new information (Michael Bolton) Griffin Jones Congruent Compliance LLC 5 6. The Problem Lets assume that you are FDA regulated and trying to do compliant context-driven or Agile, Exploratory Testing You likely have these concerns about passing an audit: Evidence is not sufficient Documentation is not sufficient Process control is not sufficient Cant clearly explain what you do and why Auditors value different things than you, and speak a different language Griffin Jones Congruent Compliance LLC 6 7. Fast Takeaway The regulator is not your business partner The regulator has police powers Pick your battles Sometimes, Let the Wookie win Render unto Caesar, that which is Caesars Auditors are likely of the Quality (gatekeepers) or Routine (traceability matrix) testing school model You are a different testing school. Deal with it. Auditors think testing is demonstration and checking Dont try and convert them. Deal with it. 7Griffin Jones Congruent Compliance LLC 8. Spoiler The regulations are not the problem How you are coping with the regulations is the problem Give the Auditors what they want: Clear traceable requirements and description of risks Description and demonstration of control Clear objective evidence The ability to understand their concerns, speak their language, and explain how you are compliant Abundant, quality evidence mitigates your other problems 8Griffin Jones Congruent Compliance LLC 9. Not going to talk about The Fear, Uncertainly, and Doubt swirling in the field Vendor/Experts: You should be scared, but I have Silver Bullets and Big Magic so trust me and just buy my wares. By the way, .. Persistent Myths IMO the regulators frown on ET ( I dont sell it). The Typical Regulatory Affairs Presentation 9Griffin Jones Congruent Compliance LLC 10. Regulatory Overview Regulations For the public good - because people died Regulators FDA regulates >25% of the Gross Domestic Product Regulatory Auditors Police Powers Industry Auditors Assessors and valued advisors to management Audits 10 Details Griffin Jones Congruent Compliance LLC 11. Audit Survival Heuristics CHCMWCE Chocolate Mousse Congruent Honest Competent Model (Appropriate) Willing Control Evidence 16 Model Competent Honest Evidence Control Willing Congruent Griffin Jones Congruent Compliance LLC 12. Lets take a journey 17 Practice Congruent Theory Less Stressful Audits Griffin Jones Congruent Compliance LLC 13. The Congruence Triad Congruence is when you are balanced between inner feelings and outer actions The Congruence Triad Self, Other, Context Being congruent is a process A way of communicating with yourself and others Incongruence is when part of the triad is missing Placating, Blaming, Super-rational, or Irrelevant? What is missing and fill it in: Self, Others, Context 18 Other Context Self Details Griffin Jones Congruent Compliance LLC 14. Congruence is like a Sailboat Because: It is a vessel or container, like a basket It requires preparation and maintenance You dont drive it, and requires skills of crew members Subject to weather Is vulnerable to sinking 20Griffin Jones Congruent Compliance LLC Tools 15. The Theory Mountains Dishonest Incompetent Inadequate 22 Honest Competent Appropriate Model Self-Incriminating Experts and Heroes Over-Constrained Griffin Jones Congruent Compliance LLC 16. Honest Integrity, Truthful, Trust, Sincerity in: You and your organization Words, actions, and documents Smells Dishonest Self-incrimination Dont create even the appearance of a problem Tests How do you and the organization react to criticism? Are you a learning organization? (5 Why) 23Griffin Jones Congruent Compliance LLC 17. Competent Are you and your organization: Capable, credible, understands context, speaks the language; trained in the industry, technology, and regulatory obligations Smells Incompetent Experts and heroes Tests Do you believe you are capable of doing good work? (5 Why) 24Griffin Jones Congruent Compliance LLC 18. Appropriate Model Is the process model: Complete, reasonable, practical, logical, explainable Smells Inadequate model Over-constrained model Test: What problem is this model solving? How will it Fail? What is required in this model? Missing? Do you believe this model is sufficient? (5 Why) 25Griffin Jones Congruent Compliance LLC 19. The Practice Mountains Unwilling Out-of-Control No Evidence 26 Excessive or Wasteful Micro-Management Obsessive-Compulsive Willing Under Control Evidence Griffin Jones Congruent Compliance LLC 20. Willing Motivated, focused, prioritized, committed, resourced, staffed, supported, given attention, nurtured Smells Unwilling Excessive or Wasteful Test Do people care? (5 Why) Is there sufficient resources for the work and expectations? (5 Why) 27Griffin Jones Congruent Compliance LLC 21. Under Control Explain what you are doing and why. Are you living it? Coherently explain your: configuration control and authorization traceability and accountable organization, preparation, planning, independent review, prevention, correction, checking and testing Smells Out-of control Micro-managed Tests Is the type and level of controls appropriate? (5 Why) 28Griffin Jones Congruent Compliance LLC 22. Evidence Auditable evidence: Clear, objective, retrieval, human readable, attributable, contemporary evidence that a third party can review or reconstruct (with minimal outside help); and quickly reach the same results and conclusions. Smells No-evidence Obsessive-compulsive evidence Tests Explain why the specific evidence meets the criteria. (5 Why) 29Griffin Jones Congruent Compliance LLC 23. How do you apply this? Application is as simple as: 30 Remembering to ask the questions. Follow the energy of the answers. Fix the base, first. Griffin Jones Congruent Compliance LLC 24. During an Audit Choosing a regulatory posture Manageable issues (within reason) Evidence Controls Willingness (resources and priority) Unmanageable issues Broken process model Lack of competence Broken trust Incongruence 31Griffin Jones Congruent Compliance LLC 25. More Fast Takeaways The FDA is open to agile processes and realizes that the current approach to software validation is not working At the same time, companies are more concerned about: the business risk that the FDA would not accept the agile process, than the product or project risk that is associated with waterfall type development Find the middle option for your context 32Griffin Jones Congruent Compliance LLC 26. Natural Evidence Periodically , take the observer point-of-view and ask: Is what I see and hear, about the theory and practice of what we do: acceptable from both a product qualification and regulatory compliance point of view? If yes, what is the most natural, efficient, and strongest evidence we could collect? Why not a video/audio recordings w/ paper summary? Is it being collected? If no, why not? (5 Why) organizational problem? 33Griffin Jones Congruent Compliance LLC 27. Organizational Smells Going Tilt Traps 34Griffin Jones Congruent Compliance LLC 28. Smells that lead to Stop Shaking the Snow Globe Hyper-change alongside brittle/heavy formal processes The Best Practice Cargo Cult We dont really understand the details of what we do, why we do it, or how what we do works. But have faith. Testing Death Spiral Regulator does not care about testing and management might only care about regulatory compliance. Spiral. The Titanic The gigantic engineered process is perfect people are the source of problems, not solutions 35Griffin Jones Congruent Compliance LLC 29. Organizational Disasters Pathetic Compliance Following a regulatory compliant procedure in a way that does not solve the testing problem for which it was designed. Utopian Shelf-ware Procedures No one reads them. They are not reality. Close Enough I dont have to do it exactly. I know better. No one will notice or care. Read My Mind Because that is the only place where the evidence is. 36Griffin Jones Congruent Compliance LLC 30. Is the Auditor on Tilt? 37 Maybe it is something we said or did, or are doing? History That you are unaware of, and it might be complicated Notches on the gun May be making a name for themselves Making an example of you May be constructing an example to deter others Griffin Jones Congruent Compliance LLC 31. Classic Agile Traps Mixing informal and formal processes Start informal - clearly switch to formal when ready Emphasizing change; light documents = poke the bear Stokes anxiety: control, process model, and competence Mistaking team conversation and understanding For objective documented evidence Speaking Crazy Agile Moon Language Give the auditor what they want, in their language Shows empathy and industry competence 38Griffin Jones Congruent Compliance LLC Pass Fail 32. Classic ET Traps Implementation details identified as requirements Tighten and simplify your requirements Documentation lacks detail to support traceability Require less mind reading Control is vague or assumed Summarize and document what control is for you 39Griffin Jones Congruent Compliance LLC 33. The BIG Trap Weak Evidence Clear, objective, retrieval, human readable, attributable, contemporary evidence that a third party can review or reconstruct (with minimal outside help); and quickly reach the same results and conclusions. Check it via Mary had a little lamb Collect it naturally Weak evidence is likely a symptom of other deeper issues Abundant, quality evidence mitigates your other problems 40Griffin Jones Congruent Compliance LLC 34. Audits can be Useful Candor can result in free consulting and insight Should you take the risk? Provides motivation management cares Provides actionable data The jiggle that is needed by the organization A counter-measure to low expectations & poor practices 41 If you cant be a good example, you are going to be a stern warning. Griffin Jones Congruent Compliance LLC 35. Recap of the Spoiler The regulations are not the problem. How you are coping with the regulations is the problem. Give the Auditors what they want: Clear traceable requirements and description of risks Description and demonstration of control Clear objective evidence The ability to understand their concerns, speak their language, and explain how you are compliant Abundant and quality evidence mitigates your other problems. 42Griffin Jones Congruent Compliance LLC 36. The Big Take Away Understand your regulatory context Work on your congruence Work each level of the model, ask the questions Document how you are under control Improve your evidence, collect it naturally Avoid the smells, disasters, and traps Summarize your regulatory story, practice explaining it Apply what you learn during the audit 43 1 2 3 Griffin Jones Congruent Compliance LLC 37. Questions? 44 Model Competent Honest Evidence Control Willing Congruent Griffin Jones Congruent Compliance LLC 38. Further Study - A FDA presentations and resources: Webinar with FDA's John Murray on Software Validation in the Field of Medical Devices Presentation: Preparing for an FDA Medical Device Sponsor Inspection Quality System Inspection Technique Inspection Guide General Principles of Software Validation; Final Guidance for Industry and FDA Staff 45Griffin Jones Congruent Compliance LLC 39. Further Study - B Regulatory Compliance The Art of Compliance: Turning Compliance into Sustainable Business Advantage by Robert Rhoades of Quintiles FDA inspections: How to Host an FDA Inspection by SGS Life Science Services Preparation for FDA Inspection by NEMA/ADVAMED/PHILIPS FDA Sponsor Inspections: How to Prepare and Survive by Medtronic, Inc 46Griffin Jones Congruent Compliance LLC 40. Further Study - C Audits The ASQ Auditing Handbook by J. P. Russell Congruence Beyond Blaming by Jean McLendon and Gerald M. Weinberg The Satir Model: Family Therapy and Beyond by Virginia M. Satir More Secrets of Consulting: The Consultant's Tool Kit by Gerald M. Weinberg Testers and Auditors Testers are like auditors by James Christie Evidence 21 CFR Part 11 Electronic Records by the FDA 47Griffin Jones Congruent Compliance LLC 41. Further Study - D Agile and the FDA Business Risk (from the FDA) versus Product Risk http://blogs.construx.com/forums/t/432.aspx What is Exploratory Testing? And How it Differs from Scripted Testing by James Bach Coping With Complexity: Lessons From a Medical Device Project by Yaron Kottler Introduction into IEC 62304 Software life cycle for medical devices by Christoph Gerber http://www.spiq.com/abs/JF200809IEC62304%20SPIQ%20 Rev004.pdf Who says ET is good for Medical Devices? The FDA! by James Bach http://www.satisfice.com/blog/archives/602 48Griffin Jones Congruent Compliance LLC 42. Further Study - E Agile and the FDA http://rdn-consulting.com/blog/2007/07/25/update- agile-development-in-a-fda-regulated-setting/ http://www.agilejournal.com/articles/columns/column- articles/3463-four-reasons-medical-device-companies- need-agile-development http://rdn-consulting.com/blog/wp- content/uploads/2007/07/060703ResMed.pdf http://scalingsoftwareagility.wordpress.com/2010/11/23/ an-iterative-and-incremental-process-model-for-agile- development-in-regulated-environments/ http://scalingsoftwareagility.wordpress.com/category/hi gh-assurance-and-regulated-environments/ 49Griffin Jones Congruent Compliance LLC 43. Griffin Jones Congruent Compliance Griffin.Jones@CongruentCompliance.com Thank you for attending this session. Please fill out the evaluation form. 50Griffin Jones Congruent Compliance LLC