Quality Progress - May 2017 - 13

commonly known as the Medical Device Directive (MDD).
Annex ZA describes the
changes in the form of what
are called content deviations.
Briefly, the new or clarified
requirements of EN ISO
14971:2012 are:
+ Each individual residual
risk and the overall residual
risk must be reduced "as
far as possible" (AFAP)-
even risks identified as
negligible.
+ Risk-benefit analysis must
be conducted for each
individual risk, as well as for
the overall risk (weighing all
risks combined against the
benefit).
+ If "as low as reasonably
practicable" (ALARP)
terminology is used in the
risk management file, economic considerations must
not be used to justify risk
acceptability.
+ All the control options must
be applied and not stopped
if the first or second control
option has reduced the risk
to an acceptable level.
+ No additional risk reduction
may be attributed to information given to the users.
To address the changes,
organizations have implemented any or all of the
following fixes, although there
are many different approaches
with respect to specific
details that may demonstrate
compliance:
+ Eliminate ALARP terminology. Document the
reduction of all risks AFAP

Differences of opinion

If an organization
proactively and
comprehensively
documents device
benefits as well
as risks in the risk
management file,
post-market decisions
that affect product
availability can be
more objective and
fact based, and less
judgment based.

in individual risk analyses
and the risk management
report.
+ Document risk-benefit
analyses for each individual
risk (that is, line item) in the
risk analysis. Document the
overall risk-benefit analysis
in the risk management
report.
+ State in the governing
internal standard operating
procedure and in the risk
management report that
all the control options have
been applied and no risk
reduction credit was given
for residual risk disclosure,
such as warnings and
precautions.
Ultimately, in a global
organization, it is desirable
to create and maintain risk
management files to comply with EN ISO 14971:2012
because the requirements
generally include those of ISO
14971:2007.

Revisiting the people side of
the job, all of these implementation details provide
opportunities for differences
of opinion to develop. For
example, a risk-benefit analysis
on an individual risk may be:
+ A general, repeated statement on each line of a risk
analysis.
+ A comprehensive statement
specific to each particular
risk.
+ A reference to where the
risk-benefit statement
can be found, such as in a
clinical evaluation or risk
management report.
To work through the inevitable differences of opinion
regarding exactly how to
implement the details of any
standard, two questions must
be asked:
1. "Do we want to
standardize?"
2. "Is there consensus
regarding best practice to
standardize on?"
Depending on the answers
to these questions, details
regarding next steps have
been previously introduced in
a 2 x 2 matrix called a consensus chart.⁴
While ISO 14971 is the
foundation for medical device

risk management, several
related guidance documents,
reports and standards build
on the concepts. In the United
States, current hot subjects
include the application of ISO
14971 to usability and human
factors, cybersecurity and
risk-benefit determination.
Last December, the U.S.
Food and Drug Administration
(FDA) guidance document
"Factors to Consider Regarding Benefit-Risk in Medical
Device Product Availability,
Compliance and Enforcement
Decisions" was issued. If there
was any doubt the FDA does
not recognize the EN version,
appendix A clearly states "ISO
14971 is an FDA-recognized
standard ..."5
While this guidance was
written for post-market nonconforming or noncompliant
product issues, the principles
can be applied proactively in
developing an EN ISO 14971
risk management file. While
it is simple to systematically
document risks in a hazard
analysis performed early in
product design, benefits can
be less clear at that time.
As a potential mind-jogging tool, the FDA guidance
describes the following factors
that may be considered to

Do you have a suggestion on a topic or industry that
Field Notes should focus on? Let us know your thoughts
by sending us a note at editor@asq.org.

qualityprogress.com ❘ May 2017

QP 13


http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - May 2017

Seen and Heard
Expert Answers
Progress Report
Mr. Pareto Head
Field Notes
Mind the Gaps
Solid Footing
Are These the Same?
New Tricks for an Old Tool
Innovation Imperative
Experience More
Career Coach
Statistics Spotlight
Standard Issues
Marketplace
Footnotes
Back to Basics
Quality Progress - May 2017 - intro
Quality Progress - May 2017 - cover1
Quality Progress - May 2017 - cover2
Quality Progress - May 2017 - 1
Quality Progress - May 2017 - 2
Quality Progress - May 2017 - 3
Quality Progress - May 2017 - 4
Quality Progress - May 2017 - 5
Quality Progress - May 2017 - Seen and Heard
Quality Progress - May 2017 - Expert Answers
Quality Progress - May 2017 - Progress Report
Quality Progress - May 2017 - Mr. Pareto Head
Quality Progress - May 2017 - 10
Quality Progress - May 2017 - 11
Quality Progress - May 2017 - Field Notes
Quality Progress - May 2017 - 13
Quality Progress - May 2017 - 14
Quality Progress - May 2017 - 15
Quality Progress - May 2017 - Mind the Gaps
Quality Progress - May 2017 - 17
Quality Progress - May 2017 - 18
Quality Progress - May 2017 - 19
Quality Progress - May 2017 - 20
Quality Progress - May 2017 - 21
Quality Progress - May 2017 - 22
Quality Progress - May 2017 - 23
Quality Progress - May 2017 - Solid Footing
Quality Progress - May 2017 - 25
Quality Progress - May 2017 - 26
Quality Progress - May 2017 - 27
Quality Progress - May 2017 - 28
Quality Progress - May 2017 - 29
Quality Progress - May 2017 - Are These the Same?
Quality Progress - May 2017 - 31
Quality Progress - May 2017 - 32
Quality Progress - May 2017 - 33
Quality Progress - May 2017 - 34
Quality Progress - May 2017 - 35
Quality Progress - May 2017 - New Tricks for an Old Tool
Quality Progress - May 2017 - 37
Quality Progress - May 2017 - 38
Quality Progress - May 2017 - 39
Quality Progress - May 2017 - 40
Quality Progress - May 2017 - 41
Quality Progress - May 2017 - 42
Quality Progress - May 2017 - 43
Quality Progress - May 2017 - Innovation Imperative
Quality Progress - May 2017 - 45
Quality Progress - May 2017 - 46
Quality Progress - May 2017 - Career Coach
Quality Progress - May 2017 - 48
Quality Progress - May 2017 - 49
Quality Progress - May 2017 - Statistics Spotlight
Quality Progress - May 2017 - 51
Quality Progress - May 2017 - 52
Quality Progress - May 2017 - 53
Quality Progress - May 2017 - Standard Issues
Quality Progress - May 2017 - 55
Quality Progress - May 2017 - 56
Quality Progress - May 2017 - 57
Quality Progress - May 2017 - Marketplace
Quality Progress - May 2017 - 59
Quality Progress - May 2017 - Footnotes
Quality Progress - May 2017 - 61
Quality Progress - May 2017 - 62
Quality Progress - May 2017 - 63
Quality Progress - May 2017 - Back to Basics
Quality Progress - May 2017 - cover3
Quality Progress - May 2017 - cover4
http://www.nxtbook.com/naylor/ASQM/ASQM0719
http://www.nxtbook.com/naylor/ASQM/ASQM0619
http://www.nxtbook.com/naylor/ASQM/ASQM0519
http://www.nxtbook.com/naylor/ASQM/ASQM0419
http://www.nxtbook.com/naylor/ASQM/ASQM0319
http://www.nxtbook.com/naylor/ASQM/ASQM0219
http://www.nxtbook.com/naylor/ASQM/ASQM0119
http://www.nxtbook.com/naylor/ASQM/ASQM1218
http://www.nxtbook.com/naylor/ASQM/ASQM1118
http://www.nxtbook.com/naylor/ASQM/ASQM1018
http://www.nxtbook.com/naylor/ASQM/ASQM0918
http://www.nxtbook.com/naylor/ASQM/ASQM0818
http://www.nxtbook.com/naylor/ASQM/ASQM0718
http://www.nxtbook.com/naylor/ASQM/ASQM0618
http://www.nxtbook.com/naylor/ASQM/ASQM0518
http://www.nxtbook.com/naylor/ASQM/ASQM0418
http://www.nxtbook.com/naylor/ASQM/ASQM0318
http://www.nxtbook.com/naylor/ASQM/ASQM0218
http://www.nxtbook.com/naylor/ASQM/ASQM0118
http://www.nxtbook.com/naylor/ASQM/ASQM1217
http://www.nxtbook.com/naylor/ASQM/ASQM1117
http://www.nxtbook.com/naylor/ASQM/ASQM1017
http://www.nxtbook.com/naylor/ASQM/ASQM0917
http://www.nxtbook.com/naylor/ASQM/ASQM0817
http://www.nxtbook.com/naylor/ASQM/ASQM0717
http://www.nxtbook.com/naylor/ASQM/ASQM0617
http://www.nxtbook.com/naylor/ASQM/ASQM0517
http://www.nxtbook.com/naylor/ASQM/ASQM0417
http://www.nxtbook.com/naylor/ASQM/ASQC12518
http://www.nxtbook.com/naylor/ASQM/ASQM0317
http://www.nxtbook.com/naylor/ASQM/ASQM0217
http://www.nxtbook.com/naylor/ASQM/ASQM0117
http://www.nxtbook.com/naylor/ASQM/ASQM1216
http://www.nxtbook.com/naylor/ASQM/ASQM1116
http://www.nxtbook.com/naylor/ASQM/ASQM1016
http://www.nxtbook.com/naylor/ASQM/ASAC0016
http://www.nxtbook.com/naylor/ASQM/ASQM0916
http://www.nxtbook.com/naylor/ASQM/ASQA0016
http://www.nxtbook.com/naylor/ASQM/ASQM0816
http://www.nxtbook.com/naylor/ASQM/ASQM0716
http://www.nxtbook.com/naylor/ASQM/ASQM0616
http://www.nxtbook.com/naylor/ASQM/ASQM0516
http://www.nxtbook.com/naylor/ASQM/ASQM0416
http://www.nxtbook.com/naylor/ASQM/ASQM0316
http://www.nxtbook.com/naylor/ASQM/ASQM0216
http://www.nxtbook.com/naylor/ASQM/ASQM0116
http://www.nxtbook.com/naylor/ASQM/ASQM1215
http://www.nxtbook.com/naylor/ASQM/ASQM1115
http://www.nxtbook.com/naylor/ASQM/ASQM1015
http://www.nxtbook.com/naylor/ASQM/ASQM0915
http://www.nxtbook.com/naylor/ASQM/ASQM0815
http://www.nxtbook.com/naylor/ASQM/ASQM0715
http://www.nxtbook.com/naylor/ASQM/ASQM0615
http://www.nxtbook.com/naylor/ASQM/ASQM0515
http://www.nxtbook.com/naylor/ASQM/ASQM0315
http://www.nxtbook.com/naylor/ASQM/ASQM0215
http://www.nxtbook.com/naylor/ASQM/ASQM0115
http://www.nxtbook.com/naylor/ASQM/ASQM1214
http://www.nxtbook.com/naylor/ASQM/ASQM1114
http://www.nxtbook.com/naylor/ASQM/ASQM1014
http://www.nxtbook.com/naylor/ASQM/ASQM0914
http://www.nxtbook.com/naylor/ASQM/ASQM0814
http://www.nxtbook.com/naylor/ASQM/ASQM0714
http://www.nxtbook.com/naylor/ASQM/ASQM0614
http://www.nxtbook.com/naylor/ASQM/ASQM0514
http://www.nxtbook.com/naylor/ASQM/ASQM0414
http://www.nxtbook.com/naylor/ASQM/ASQM0314
http://www.nxtbook.com/naylor/ASQM/ASQM0214
http://www.nxtbook.com/naylor/ASQM/ASQM0114
http://www.nxtbook.com/naylor/ASQM/ASQM1213
http://www.nxtbook.com/naylor/ASQM/ASQM1113
http://www.nxtbook.com/naylor/ASQM/ASQM1013
http://www.nxtbook.com/naylor/ASQM/ASQM0913
http://www.nxtbook.com/naylor/ASQM/ASQM0813
http://www.nxtbook.com/naylor/ASQM/ASQM0713
http://www.nxtbook.com/naylor/ASQM/ASQM0613
http://www.nxtbook.com/naylor/ASQM/ASQM0513
http://www.nxtbook.com/naylor/ASQM/ASQM0413
http://www.nxtbook.com/naylor/ASQM/ASQM0313
http://www.nxtbook.com/nxtbooks/naylor/ASQM0213
http://www.nxtbook.com/nxtbooks/naylor/ASQM0113
http://www.nxtbook.com/nxtbooks/naylor/ASQM1212
http://www.nxtbook.com/nxtbooks/naylor/ASQM1112
http://www.nxtbook.com/nxtbooks/naylor/ASQM1012
http://www.nxtbook.com/nxtbooks/naylor/ASQM0912
http://www.nxtbookMEDIA.com