Transcript HFES2016-1 Foundations of Risk and Risk Managementx

Risk Management Workshop for the
HF & E Practitioner with
Healthcare-related Case Studies
G E O R G E M . S A M A R A S , P H D, D S C , P E , C P E , C Q E , C B A
& L I B BY A . S A M A R A S , D N P, M S N , C P E , R N , N P, H E M
S A M A R A S & A S S O C I AT E S , I N C . , P U E B LO, C O U S A
Session 1: Foundations of and Rationale
for Risk Management
Objectives Session 1:
Participants will be introduced to why risk management is important to HF &E practitioners in
the healthcare arena.
Participants will be able to:
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Describe why risk management (RM) is a critical engineering activity and relevant to HF &E practice;
Articulate the historical roots of risk and relevant milestones in its development;
Define fundamental concepts such as hazard, harm, risk, etc.
Differentiate between system use and individual use errors
Why do we care about good risk
management?
It is the Standard of Care
Manufacturer, not user, responsible for safe and effective product; system use
errors from:
◦ design, including labeling & training
◦ construction, and
◦ distribution
Inadequate risk management (RM) result in manufacturer ignorance
RM is all about knowledge & awareness
Ignorance (lack of knowledge & awareness) falls below the Standard of Care,
can result in harm and liability
Part 1:Evolution of Risk Concept
What is Risk?
The boundary between modern
times and the past is the
mastery of risk:
the notion that the future is
more than a whim of the gods
and that men and women are
not passive before nature.”
-P. L. Bernstein,
AGAINST THE GODS:
The Remarkable Story of Risk,
Wiley, 1998
The evolution of our modern
concept of RISK and the
accompanying mathematics
of probability and statistics
were driven first by interest
in gambling and then by the
realization of risk
management’s value in
decision-making
Numbers were Fundamental
 Absent numbers, there can be no knowledge of odds or
probabilities.
 “Without odds and probabilities, the only way to deal with risk
is to appeal to the gods and the fates” Bernstein, Loc 543
 Before the adoption of Arabic numbers, Greek and Roman
numbering made calculation extremely cumbersome, if not
practically impossible.
Probability & Statistics
 Risk is a choice, not a fate, unless you are uninformed
 Probability tries to look into the future (forecasting), but is
hobbled by its reliance on the past
 Statistics is a tool for trying to make sense of observations
(samples) from the past, in an attempt to forecast the future
 Over the past half millennium, we have made progress; we
continue to do so now
Historical Perspective
1550
1654
 Gerolamo Cardan manuscript
 Blaise Pascal & Pierre de Fermat
addressed probability of certain
worked on a gambling problem set by
outcomes in rolls of dice, the problem
(non-nobleman) Antoine
of points, and presented a crude
Gombaud, Chevalier de Méré.
definition of probability.
 Title was an affectation
 Manuscript lost until 1576 and printed
 Pascal and Fermat laid the basic
in 1663.
ground work for the theory of chance
 He would have been known as father
and probability
of probability theory, except …
Historical Perspective (continued)
1713
 Jacob Bernoulli, uncle of Daniel Bernoulli of
fluid dynamics fame
1730
 Abraham de Moivre
 First statement of “normal curve” –
 Publishes Law of Large Numbers (LLN) and
binomial successes approximate normal
methods of statistical sampling
distribution for large number of trials
 LLN implies that the empirical results of a large
(special case of Central Limit theorem)
number of repeated (independent) trials will
tend toward the expected value
 It basically says that the effects of noise and
other disturbances will average out
 Concept of standard deviation and how
ignorance of sample size affects statistical
variation
Historical Perspective (continued)
1812
 Laplace publishes modern formulation of
Bayes notion of conditional probability
 Relates current (posterior) probability to prior
probability (distribution)
 P(A|B) ≡ P(B|A) x P(A)/P(B)
 A, B = Events: set of outcomes of an
experimental trial
 Probabilities here not frequency or
propensity, but beliefs (objective or
subjective) regarding outcomes
1875
 Francis Galton (Darwin’s cousin) &
Regression Fallacy
 Ascribes cause where NONE exists
 Also known as Regression Towards
The Mean
 NON-Random Resampling yields
results that move toward or away
from the true mean
Understanding RISK
The word “risk” derives from the early Italian “risicare” – “to
dare”. From this perspective, RISK is a choice, rather than a fate
- Bernstein, Loc. 262-3
BUT, never forget that choices cannot be made in ignorance!
Basic Definitions
 HAZARD (al zahr, Arabic for dice):
 Potential source of harm
 HARM:
 Physical injury or damage to the health of persons, property, or
environment
 RISK:
 Future uncertainty of the deviation from an expected outcome
 PRACTICAL MEASURE OF RISK:
 Combination of probability of occurrence of harm and severity of that
harm
Risk
 RISK (R) has TWO Components
 Probability of a Hazard Occurring [P]
 Probability of Exposure to Hazardous Situation
 Probability of Harm Actually Occurring
 Severity of Consequences of Hazard Occurring [S]
 Practical Measure of Risk
R = S x P … actually, just a relative risk index
 not mathematically sound (do the dimensional analysis)
 Detection or Detectability [D]
 NEVER, EVER a part of RISK: D is a risk CONTROL (and a poor one, at that!)
Risk Perspectives
 Slice & Dice risk a wide variety of ways:
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

Internal versus External
Strategic versus Tactical (Operational)
Financial versus non-Financial
Technological versus Socio-Economic
Political/Regulatory versus Environmental
Product versus Process
Design versus Manufacturing
What is Modern Risk
Management?
The fundamental elements of managing risk are basic to decision-making.
“Risk management guides us over a vast
range of decision-making,
from allocating wealth to safe guarding
public health,
from waging war to planning a family,
from paying insurance premiums to
wearing a seatbelt,
from planting corn to marketing
cornflakes.”
- Bernstein, Loc. 141
Benefit versus Cost
 Major driver in risk management is benefit versus cost
 But the word “we” means us collectively, NOT just “us” locally!
 Need to consider ALL costs
 Most tabulate all benefits, but tend to ignore or forget many
costs
 We cannot eliminate risk; we must MANAGE it!
Lifecycle Process
International Consensus Standards
(some examples relevant to medical devices)
 ISO 9001:2015
 All Products Quality Management System
 New version is highly risk-based
 ISO 15288: 2008 § 6.3.4
 Systems & Software Engineering
 Specifically defines risk management process
 ISO 13485:2003 §7.1 Note 3
 Medical Device Quality Management Systems
 Specifically calls out ISO 14971
 ISO 14971:2007 (:2012 is EU-harmonized version)
 US Medical Device Risk Management
Setting Boundaries
 Just not possible to engineer products for all infinite
possibilities (no matter how awesome we claim to be)
 Must set boundaries: intended use, intended users, and
intended use environment
 Must recognize: expected use, novel use, misuse, and abuse.
 Must discriminate System Use errors from Individual User
errors
SYSTEM USE vs INDIVIDUAL USER TAXONOMY
OF ERROR
Individual USER Errors
Some System USE Errors