Clinical OMICs - Volume 3, Issue 9 - 31
ful collective outcome of the design
control process.
So, LDTs equal design control and
lab certification equals systematic
testing conformance. When combined, the approach adds up to a
well-managed operation with prolific
(robust) orientation with a risk-based
approach. Without critical thinking
processes in use, the "chemistry" of
design control in LDT development
would be a design for disaster.
Moving Forward
Figure 2. A bow-tie risk analysis for events identified in the IQCP.
ture and conformance of the laboratory, in essence, he was saying our
test methods are bulletproof. They
may be, but they do not account for
human factors.
Virtually every R&D department
holds this same belief-that their
design group should be set up as a
skunkworks project and must not
come under the scrutiny of conformance or compliance. (For those
not familiar with the term, a skunk
works project is a project developed
by a small, loosely structured group
of people primarily for the sake of
radical innovation. It originated with
Lockheed Corporation's World War II
Skunk Works project.)
This misconception could not be
further from the truth based on the
glaring premise that you simply cannot have this plurality where quality/
compliance is built in after the fact.
Ironically, the product could survive
www.clinicalomics.com
such a premise, if it had to, by "pulling out" the bad stuff. However, with
testing you just do not do this, nor
do you retest until the results are
good by some supporting concession about the test. Where are the
control plans for such testing (IQCP),
and was it designed for such causal
factors to characterize what influence they have on the risk of test
performance?
As shown in Figure 2, risk-based
event/incident assessment is the
function of phased design review
planning for control measures and
mitigation measures based on root
cause evaluation of causal factors
that are unique in of themselves
or a combination of them (materials, methods, equipment, facility,
people, and measurement). However, without the context of which
design phase a team is performing,
a review is essential to the success-
In conclusion, it is important to recognize the GMP/GLP orientation to
developed testing is a design control approach. This includes the
technical transfer phasing of design
control in GMP. The risk consideration is the IQCP orientation of GLP
and CLIA conformance. While the
CLIA ranks worry about the professionalism in testing, the FDA worries
about how it translates to patient
safety. Both are right, and both have
oversight based on systematic
application. Can it be done at the
same time? Absolutely. Is there risk
in not taking such an approach?
Absolutely. Should teams attempt
groupthink without processes for
risk and critical thinking? Absolutely
not! We live in a world where quality-by-design is the mantra and the
expectation based on how we deal
with risk.
WALT MURRAY
is CEO of ARC Experts and a
MasterControl Quality & Compliance
Consulting Partner.
September 2016 Clinical OMICs
31
http://www.clinicalomics.com
Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9
Contents
Clinical OMICs - Volume 3, Issue 9 - Cover1
Clinical OMICs - Volume 3, Issue 9 - Cover2
Clinical OMICs - Volume 3, Issue 9 - Contents
Clinical OMICs - Volume 3, Issue 9 - 4
Clinical OMICs - Volume 3, Issue 9 - 5
Clinical OMICs - Volume 3, Issue 9 - 6
Clinical OMICs - Volume 3, Issue 9 - 7
Clinical OMICs - Volume 3, Issue 9 - 8
Clinical OMICs - Volume 3, Issue 9 - 9
Clinical OMICs - Volume 3, Issue 9 - 10
Clinical OMICs - Volume 3, Issue 9 - 11
Clinical OMICs - Volume 3, Issue 9 - 12
Clinical OMICs - Volume 3, Issue 9 - 13
Clinical OMICs - Volume 3, Issue 9 - 14
Clinical OMICs - Volume 3, Issue 9 - 15
Clinical OMICs - Volume 3, Issue 9 - 16
Clinical OMICs - Volume 3, Issue 9 - 17
Clinical OMICs - Volume 3, Issue 9 - 18
Clinical OMICs - Volume 3, Issue 9 - 19
Clinical OMICs - Volume 3, Issue 9 - 20
Clinical OMICs - Volume 3, Issue 9 - 21
Clinical OMICs - Volume 3, Issue 9 - 22
Clinical OMICs - Volume 3, Issue 9 - 23
Clinical OMICs - Volume 3, Issue 9 - 24
Clinical OMICs - Volume 3, Issue 9 - 25
Clinical OMICs - Volume 3, Issue 9 - 26
Clinical OMICs - Volume 3, Issue 9 - 27
Clinical OMICs - Volume 3, Issue 9 - 28
Clinical OMICs - Volume 3, Issue 9 - 29
Clinical OMICs - Volume 3, Issue 9 - 30
Clinical OMICs - Volume 3, Issue 9 - 31
Clinical OMICs - Volume 3, Issue 9 - 32
Clinical OMICs - Volume 3, Issue 9 - 33
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