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