Its What You Dont Know That Can Hurt You...                  Ray Garrison
Who am I? Ray Garrison   Director of Quality Assurance   Stryker Orthopaedics – Alameda CA -Over 24 years in Manufacturing...
Framing the discussion In the time we have together today, we will explore: - Probabilities and Rationalizations -KKnown a...
Framing the discussion Undesirable, unknown, unplanned for events can    l     df       t and do happen. What you don’t kn...
Undesirable, unknown,   unplanned for events can and do              happen.Brooksley Born the Cassandra of the Derivative...
Undesirable, unknown,     unplanned for events can and do                happen.                hFukushima tsunami safety ...
Undesirable, unknown,unplanned for events can and do           happen.Tue Jan 24, 2012 4:21pm EST  Johnson & Johnson (JNJ....
Undesirable, unknown,unplanned for events can and do           happen.     The pharmaceutical giant Pfizer agreed     to p...
Undesirable, unknown,     unplanned for events can and do                happen.      4/11/12 – Johnson & Jo so       / / ...
Undesirable, unknown,unplanned for events can and do           happen.4/18/12 – St. Jude Medical / 8/       S J   Earlier ...
Undesirable, unknown,unplanned for events can   l     df       tand do happen.What you don’t know is farmore relevant than...
How do Unknown/Improbable EventsOccur?            Undesirable, unknown,            unplanned for events            Conflue...
Probabilities    Probability: “a strong likelihood or chance of    something” For Statistics: “the relative frequency     ...
Probabilities  Odds of being killed by lightening - 1 in 2 million.  Odds of being killed in a car crash - 1 in 5,000.  Od...
The Difficulty of Prediction             y You are using the past to predict the future – Not always a good indictor. What...
Randomness    Physicist Leonard Mlodinow of the California    Institute of Technology – “our brains never    evolved a pro...
Examples of Items that Hamper   Evaluation/Assessment Incomplete and overlapping information from multiple units can cause...
We Always Try To Rationalize:Why?   ? We try to make sense of the world around use. We try to simplify to understand      ...
Undesirable, unknown,unplanned for events can   l     df       tand do happen.What you don’t know is farmore relevant than...
Conscious versus Unconscious          IncompetenceCognitivedesignsolutions.com                               Ray Garrison
Conscious Incompetence You’re out of your league               y       g You’re in way over your head Ego Says – I can han...
Unconscious IncompetenceYou don’t know what you don’tknowDon’t have a clueCompletely taken by surpriseAssumptions of capab...
Sources of Indicator Data to Help Identify the UnknownTraditional indicators: Complaints,NCR’s, CAPA’sYour People are y   ...
Sources of Indicator Data to   Help Identify the Unknown              fAllow Time to think about the following:   Focused,...
Sources of Indicator Data to Help Identify the Unknown            fInternal Audits: How robust are your internal audit pro...
Sources of Indicator Data to Help Identify the Unknown            fHow Can You Identify the Unpredictable?                ...
Preparing for the Unknown in Our         Personal LivesWe prepare for unknown (p   p p                 (potentially       ...
Can You Prepare for the      Unpredictable?                   ?An Event (any event) Occurs                     Occurs.What...
How Can You Mitigate? A Response Plan  Knowing your processes intimately  Knowing where the control points are A Rapid Res...
Risk Management Standards &Tools ISO 14971: Medical Devices – Application of Risk Management to Medical D i M            t...
Additional Topics of Study that       can be beneficial                   f Complex Systems Thinking  Because complex syst...
Undesirable,unknown, unplanned         , pfor events can and dohappen.What you don t know          don’tis far more releva...
So What Are YOU Going ToDo?  ? Engage and Embrace the Unknown Acknowledge missing and undefined variables in our neat litt...
QUESTIONS?    Ray Garrison
THANK YOUFor Your Time!      Ray Garrison
Upcoming SlideShare
Loading in …5
×

Mitigating Risk, Looking for the Unpredictable: It’s What You Don’t Know That Can Hurt You… - Raymond Garrison, Stryker Orthopaedics

537 views

Published on

Raymond Garrison, Stryker Orthopaedics - Speaker at the marcus evans Medical Device Manfufacturing Summit Spring 2012, held in Las Vegas, NV, delivered his presentation entitled Mitigating Risk, Looking for the Unpredictable: It’s What You Don’t Know That Can Hurt You…

Published in: Business, Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
537
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
3
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Mitigating Risk, Looking for the Unpredictable: It’s What You Don’t Know That Can Hurt You… - Raymond Garrison, Stryker Orthopaedics

  1. 1. Its What You Dont Know That Can Hurt You... Ray Garrison
  2. 2. Who am I? Ray Garrison Director of Quality Assurance Stryker Orthopaedics – Alameda CA -Over 24 years in Manufacturing, Quality and R d Regulatory C l Compliance li -MBA –University of Florida -Six Sigma Black Belt -Held leadership positions at Biomet and Johnson & J h J h JohnsonThe views expressed in this p p presentation are my own and do not reflect the views yof my employer or other organizations with which I am or have been affiliated.All cited trademarks are the property of their respective owners. Ray Garrison
  3. 3. Framing the discussion In the time we have together today, we will explore: - Probabilities and Rationalizations -KKnown and U k d Unknown I Incompetence t - Identifying more of the Unknown - How to quickly assess and respond to events Ray Garrison
  4. 4. Framing the discussion Undesirable, unknown, unplanned for events can l df t and do happen. What you don’t know is far more relevant than what you d know. do k Think about this for a moment…. Ray Garrison
  5. 5. Undesirable, unknown, unplanned for events can and do happen.Brooksley Born the Cassandra of the Derivatives Crisis Born, Tuesday, May 26, 2009 A little more than a decade ago, Born foresaw a financial cataclysm, accurately predicting that exotic investments known as over-the-counter derivatives could play a crucial role in a crisis much like the one now convulsing America. Her efforts to stop that from happening ran afoul of some of the most influential men in Washington, men with names like Greenspan and Levitt and Rubin and Summers -- the same Larry Summers who is now a key economic adviser to President Obama. She was the head of a tiny government agency who wanted to regulate the derivatives They were the derivatives. men who stopped her. The same class of derivatives that preoccupied Born -- including the now- infamous "credit-default swaps" -- have been blamed for accelerating last falls financial implosion. But from 1996 to 1999, when Born was the chairman p , of the Commodity Futures Trading Commission, the U.S. economy was roaring and she was getting nowhere with predictions of doom.* *Washington Post Ray Garrison
  6. 6. Undesirable, unknown, unplanned for events can and do happen. hFukushima tsunami safety plan: a single page memo raises questions, sparks outrage over Japanese nuke sites disaster readiness TOKYO — Japanese nuclear regulators trusted that the reactors at Fukushima Dai-ichi were safe from the worst waves an earthquake could muster based on a single-page memo from the plant operator nearly a decade ago. In the Dec. 19, 2001 document — one double-sized page obtained by The Associated Press under Japans public records law — Tokyo Electric Power Co. rules out the possibility of a tsunami large enough to knock the plant offline and gives scant details to justify this conclusion, which proved to be wildly optimistic*The document wasn’t updated once innine years, even as earthquake scienceadvanced – and last year, when TEPCOtook another look at safety preparation, itwas the same conclusion: The plant wouldstay dry no matter what.***MSNBC.com**AP Ray Garrison
  7. 7. Undesirable, unknown,unplanned for events can and do happen.Tue Jan 24, 2012 4:21pm EST Johnson & Johnson (JNJ.N) took ( ) quarterly charges of more than $3 billion largely related to the recall of its defective artificial hips and gave a 2012 earnings forecast below analysts estimates.* ti t ** Reuters Ray Garrison
  8. 8. Undesirable, unknown,unplanned for events can and do happen. The pharmaceutical giant Pfizer agreed to pay $2 3 billion to settle civil and $2.3 criminal allegations that it had illegally marketed its painkiller Bextra, which has p , been withdrawn. It was the largest health care fraud settlement and the largest criminal fine of any kind ever.** New York Times Ray Garrison
  9. 9. Undesirable, unknown, unplanned for events can and do happen. 4/11/12 – Johnson & Jo so / / Jo so Johnson A state judge in Arkansas ordered Johnson & Johnson to pay a $1.1 billion fine after a jury found the company had minimized the risks of its p y antipsychotic drug Risperdal. The Arkansas jurys decision and the judges p penalty are j y just the latest legal setbacks for g Risperdal. A South Carolina judge upheld a $ $327 million penalty against J&J and its Janssen unit late last year. Earlier this E li thi year, th company agreed t pay $158 the d to million to settle charges it improperly marketed Risperdal in Texas and caused the states Medicaid program to spend too much on the medicine.**Bloomberg News Ray Garrison
  10. 10. Undesirable, unknown,unplanned for events can and do happen.4/18/12 – St. Jude Medical / 8/ S J Earlier this month, St Jude halted sales of its QuickSite and QuickFlex leads, wires that carry electricity from defibrillators to the heart, due to concerns the insulation could wear away and expose the wires. Around the same time, HeartRhythm, a prominent medical j y p journal, published an article by Dr. Robert Hauser of the Minneapolis Heart Institute that took a critical look at St Judes Riata lead line that was recalled i 2011 The piece concluded th t th ll d in 2011. Th i l d d that the St Jude product failed at a higher rate than Medtronic Incs (MDT.N) lead, prompting St Jude to ask for a retraction of the article article, drawing even more attention to the issue. Ray Garrison
  11. 11. Undesirable, unknown,unplanned for events can l df tand do happen.What you don’t know is farmore relevant than whatyou d know. do k Ray Garrison
  12. 12. How do Unknown/Improbable EventsOccur? Undesirable, unknown, unplanned for events Confluence of known and/or unknown inputs Known and unknown indicators Probabilities, planning, monitoring metrics
  13. 13. Probabilities Probability: “a strong likelihood or chance of something” For Statistics: “the relative frequency thi ” F St ti ti “th l ti f with which an event occurs or is likely to occur”* Before you go out tonight, Las Vegas: “Each game you play at a casino has a statistical probability against you winning. Every single time.” “The slot machine odds are some of the worst, “ f ranging from a one in 5,000 to a one in about 34 million chance of winning the top prize when using the maximum coin play ”** play.*Dictionary.com**Investopedia.com – Casino Stats, Why Gamblers Rarely Win. Ray Garrison
  14. 14. Probabilities Odds of being killed by lightening - 1 in 2 million. Odds of being killed in a car crash - 1 in 5,000. Odds of being killed in a tornado - 1 in 2 million. Odds of being killed in a plane crash -1 in 25 million.The thing about probabilities is that no one thinks g p it will happen to them….. Ray Garrison
  15. 15. The Difficulty of Prediction y You are using the past to predict the future – Not always a good indictor. What do the mutual fund commercials say? Past performance is not a predictor of future performance. performance We are not fortune tellers Technology, interconnections, Technology interconnections interdependencies, complexities exist that make predictions difficult diffi l Ray Garrison
  16. 16. Randomness Physicist Leonard Mlodinow of the California Institute of Technology – “our brains never evolved a probability network and thus our network, folk intuitions are ill equipped to deal with many aspects of the modern world. Our intuitions are misleading when it comes to probabilistic problems.”* Extraordinary events do not always require extraordinary causes. Given enough time, they can happen by chance. Knowing this, we can learn to judge decisions by the spectrum j g y p of potential outcomes they might have produced rather than by the particular result that actually occurred.** Scientific American: How RandomnessRules Our World and Why We Cannot See It Ray Garrison
  17. 17. Examples of Items that Hamper Evaluation/Assessment Incomplete and overlapping information from multiple units can cause executives/regulators to underestimate i / l d i risk and leverage. Interconnected dependencies that we are aware of or unaware of Insufficient grasp of systemic risk Ray Garrison
  18. 18. We Always Try To Rationalize:Why? ? We try to make sense of the world around use. We try to simplify to understand understand. We extrapolate and make conclusions using insufficient or incorrect data. We are uncomfortable with the unknown, uncertainty. Ray Garrison
  19. 19. Undesirable, unknown,unplanned for events can l df tand do happen.What you don’t know is farmore relevant than whatyou d know. do k Ray Garrison
  20. 20. Conscious versus Unconscious IncompetenceCognitivedesignsolutions.com Ray Garrison
  21. 21. Conscious Incompetence You’re out of your league y g You’re in way over your head Ego Says – I can handle this g y Worried about how you look, what you will say How are knowledge/skill gaps communicated, evaluated, mitigated? Ignoring gaps hoping you will have what’s what s needed before you have to deal with the g p gap. Ray Garrison
  22. 22. Unconscious IncompetenceYou don’t know what you don’tknowDon’t have a clueCompletely taken by surpriseAssumptions of capability, control, p p y, ,and detection are incorrectDenying relevance / usefulness ofindicators or dataThe dim light at the end of thetunnel is a Train coming right atyou and You Don’t See ItPerception is out of line with reality fGAPS HAMPER RESPONSE! Ray Garrison
  23. 23. Sources of Indicator Data to Help Identify the UnknownTraditional indicators: Complaints,NCR’s, CAPA’sYour People are y p your ggreatest resource.Ask what they see, hear, experience.Debriefing / Learning from Near MissesFault Seed TestingMonitoring Regulatory AgenciesLiterature ReviewsProfessional Organizations/Groups g p Ray Garrison
  24. 24. Sources of Indicator Data to Help Identify the Unknown fAllow Time to think about the following: Focused, regular discussions on what could happen and how the organization pp g would react. Emergency / Contingency Planning g y g y g Data Analysis: Creating new ways of looking at current data Creating/Capturing new data Transposing data matrices p g Ray Garrison
  25. 25. Sources of Indicator Data to Help Identify the Unknown fInternal Audits: How robust are your internal audit programs? Are you challenging the audit teams to dig deep? Audit Team Training Audit Team / Organization Mindset Trends and Trending Ray Garrison
  26. 26. Sources of Indicator Data to Help Identify the Unknown fHow Can You Identify the Unpredictable? y p Active Thought Activities Process Mapping Brainstorming internal/external unpredictable events Framing the event context ○ What ○ Where ○ When ○ To What Extent Ray Garrison
  27. 27. Preparing for the Unknown in Our Personal LivesWe prepare for unknown (p p p (potentially y damaging) events in our personal lives Emergency Funds Insurance: Life/Home/Car/Disability Documents: Wills/Trusts/POA’s Ray Garrison
  28. 28. Can You Prepare for the Unpredictable? ?An Event (any event) Occurs Occurs.What do you do?What process is there?Who is involved?Who today in your organizationmanages the gray, the big problems, theemergencies? i ?How do they do it? Ray Garrison
  29. 29. How Can You Mitigate? A Response Plan Knowing your processes intimately Knowing where the control points are A Rapid Response Team – The key here is “Rapid”! Analysis Paralysis will kill Rapid ! you!!! Always focused on the customer in decision making (For Med Device / Pharma - Patient / Doctor) Ray Garrison
  30. 30. Risk Management Standards &Tools ISO 14971: Medical Devices – Application of Risk Management to Medical D i M t t M di l Devices ISO 16085: Systems and Software Engineering – Life Cycle Processes – Risk Management ISO 31000 Risk Management – P i i l and Ri k M t Principles d Guidelines Failure M d Eff t Analysis: ISO 60812 F il Mode Effects A l i Preliminary Hazard Analysis (PHA) Fault Tree Analysis (FTA): IEC 61025 Event Tree Analysis (ETA): IEC 62502 Assurance Case Analysis: ISO 15026-2 Ray Garrison
  31. 31. Additional Topics of Study that can be beneficial f Complex Systems Thinking Because complex systems are inherently non-linear, small events can suddenly produce large and unexpected effects This is a key point in systems effects. theory. Statistics Truly understanding what data is used, how data is used, what analysis was completed, what the results are indicating. g ○ Incorrect/inappropriate data may be used. ○ Incorrect/inappropriate Statistic Tools may be used. Ray Garrison
  32. 32. Undesirable,unknown, unplanned , pfor events can and dohappen.What you don t know don’tis far more relevantthan what you do yknow. Ray Garrison
  33. 33. So What Are YOU Going ToDo? ? Engage and Embrace the Unknown Acknowledge missing and undefined variables in our neat little equations Allow Yourself and Your Teams time to critically think about these topics Ray Garrison
  34. 34. QUESTIONS? Ray Garrison
  35. 35. THANK YOUFor Your Time! Ray Garrison

×