Difference between revisions of "Team:Grenoble-Alpes/femca"
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<h2><font color="#9e1212"> 1/ Definition of the system </font></h2> | <h2><font color="#9e1212"> 1/ Definition of the system </font></h2> | ||
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<p>This study will only address the failure modes coming from us (and the manipulations we made to build the prototype) and the environment (user, external aggressions…). We will consider that the parts we ordered are guaranteed to work under normal conditions (described in the datasheets of the components) and that their risks of failure are negligible.</p> | <p>This study will only address the failure modes coming from us (and the manipulations we made to build the prototype) and the environment (user, external aggressions…). We will consider that the parts we ordered are guaranteed to work under normal conditions (described in the datasheets of the components) and that their risks of failure are negligible.</p> | ||
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<h3><font color="#9e1212"> 1.1/ External analysis</font> </h3> | <h3><font color="#9e1212"> 1.1/ External analysis</font> </h3> | ||
| − | <p> | + | <p>The system is an entirely automatized system capable of identifying a pathogenic bacterium and a resistance marker and giving a choice of an alternative to antibiotics: a selection of bacteriophages effective against this pathogenic bacterium.</p><p> We assume that this machine is going to be used in hospitals and medical analysis laboratory by technicians who were formed to the utilization of our machine. They will have to interact with the machine by introducing a sample from the patient in a consumable containing reagents (phages, probes, competent bacteria...) and by introducing it inside of the machine. He will also have to power the machine and to read the useful information on a screen. A result will be given by the machine after 12 hours and no other interaction with the user will be needed.</p> |
| + | <h3><font color="#9e1212"> 1.2/ Internal analysis </font></h3> | ||
| + | <p>The machine is composed of 6 main modules: | ||
| + | <ul><li>A fluorescence module capable of detecting the fluorescence emitted by a sample</li> | ||
| + | <li>An extraction module capable of extracting the DNA of pathogenic bacteria</li> | ||
| + | <li>A temperature control module capable of heating and cooling the different samples for the biological steps</li> | ||
| + | <li>A pipetting module that dispenses liquids in the good tubes</li> | ||
| + | <li>A power supply module to power every part of the machine</li></ul> | ||
| + | <br> | ||
| + | <h2><font color="#9e1212"> 2/ Block diagram </font></h2> | ||
| + | <h3><font color="#9e1212"> 1.1/ External analysis </font></h3> | ||
| + | <center><img src="https://static.igem.org/mediawiki/2018/f/fb/T--Grenoble-Alpes--FMECAFig1.png" alt="Description of the FMECA process"><figcaption>Figure 1: Description of the FMECA process</figcaption></center> | ||
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| − | < | + | <h3><font color="#9e1212"> 1.2/ Internal analysis </font></h3> |
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| − | + | <div style="padding:3px; padding-left:6px; border:1px dotted #d0d0d0; border-left:4px solid #d0d0d0; margin-left:20px;"> | |
| − | < | + | <h3><font size="5">REFERENCES</font></h3> |
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<p style="font-size: 0.8em;"> | <p style="font-size: 0.8em;"> | ||
| − | <a href="http://www.dtic.mil/dtic/tr/fulltext/u2/a278508.pdf">Failure Mode, Effects and Criticality Analysis (FMECA), Concurrent engineering series, 1993,</a> MIL-STD-1629 | + | <a href="http://www.dtic.mil/dtic/tr/fulltext/u2/a278508.pdf">Failure Mode, Effects and Criticality Analysis (FMECA), Concurrent engineering series, 1993,</a> MIL-STD-1629 |
| − | + | Also thanks to Mr. Bruno COMMERE, working at TRIXELL as a R&D project manager who helped us to realize this FMECA study.</p> | |
| + | </div> | ||
</div> | </div> | ||
Revision as of 09:01, 17 October 2018
Template loop detected: Template:Grenoble-Alpes
FMECA
Because regulations on biomedical devices are so drastic, we decided very early in the process that this competition would not be just about producing a “proof of concept” but to go a step further in analysing beforehand the risks that would go with our prototype use and that wouldn’t need to be considered for an eventual industrial production.
The FMECA (Failure Mode, effects, and criticality analysis) was originally developed by the National Aeronautics and Space Administration (NASA) to improve and verify the reliability of space program hardware. This method is a reliability evaluation/design technique which examines the potential failure modes within a system and its equipment, in order to determine the effects on equipment and system performance and on the environment of the device. Each potential failure mode is classified according to its impact on mission success and personnel/equipment safety.
For our study, we based ourselves on a MIL-STD report (US Military standards on Environmental Engineering Considerations and Laboratory Tests) explaining the process of a FMECA.
Here is a description of the different steps of the process:
1/ Definition of the system
This study will only address the failure modes coming from us (and the manipulations we made to build the prototype) and the environment (user, external aggressions…). We will consider that the parts we ordered are guaranteed to work under normal conditions (described in the datasheets of the components) and that their risks of failure are negligible.
To carry out this study, we had to approaches:
- THE EXTERNAL ANALYSIS: We first considered the system as a whole and we listed undesirable events that could happen to it so that we could prevent them.
- THE INTERNAL ANALYSIS: Then we separated the system in sub-modules and we analysed their functions and the undesirable events that could occur.
1.1/ External analysis
The system is an entirely automatized system capable of identifying a pathogenic bacterium and a resistance marker and giving a choice of an alternative to antibiotics: a selection of bacteriophages effective against this pathogenic bacterium.
We assume that this machine is going to be used in hospitals and medical analysis laboratory by technicians who were formed to the utilization of our machine. They will have to interact with the machine by introducing a sample from the patient in a consumable containing reagents (phages, probes, competent bacteria...) and by introducing it inside of the machine. He will also have to power the machine and to read the useful information on a screen. A result will be given by the machine after 12 hours and no other interaction with the user will be needed.
1.2/ Internal analysis
The machine is composed of 6 main modules:
- A fluorescence module capable of detecting the fluorescence emitted by a sample
- An extraction module capable of extracting the DNA of pathogenic bacteria
- A temperature control module capable of heating and cooling the different samples for the biological steps
- A pipetting module that dispenses liquids in the good tubes
- A power supply module to power every part of the machine
2/ Block diagram
1.1/ External analysis
1.2/ Internal analysis
REFERENCES
Failure Mode, Effects and Criticality Analysis (FMECA), Concurrent engineering series, 1993, MIL-STD-1629 Also thanks to Mr. Bruno COMMERE, working at TRIXELL as a R&D project manager who helped us to realize this FMECA study.