Purpose: We would like you to gain practice (1) searching for known problems, (2) conducting a risk analysis, and (3) incorporating your known problems analysis findings into your risk analysis.

Step 1. Identify an existing product on which you would like to focus

Choose a product that you are interested in. This could be related to any industry (e.g., cooking               veterinary, medical, aviation, …). The only requirement is that you are able to complete this assignment with a focus on that product (as described below, you will need to identify 20 known problems and        develop a 20-line risk analysis for the product).

Step 2. Conduct your search

Next, find known problems related to your product. You can use one of the following databases that we discussed in class, or another database of a similar nature:

•    Aviation Safety Reporting System (ASRS):

https://akama.arc.nasa.gov/ASRSDBOnline/QueryWizard_Filter.aspx

•    National Transportation Safety Board (NTSB) database:

https://www.ntsb.gov/_layouts/ntsb.aviation/index.aspx

•    Manufacturer and User Facility Device Experience (MAUDE) database:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

o Note: If you decide to use the MAUDE database, identify one type of product you want  to search for, use the Product Code Database to identify that device’s product code, and

filter your MAUDE search by that product code. The product code database is here:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

If you are focusing on a product that is not from a regulated industry – and accordingly, might not have a dedicated database such as the ones above – you can also search for known problems online in articles,  blog posts, product reviews, etc. As you know from class, anything can be a known problem if it is             related to use (i.e., someone made an error while using the product).

During your search, identify at least 20 unique known problems that are related to use. Be sure to keep track of where you find your known problems. In the final Excel file (described in step 4), we would like links to the known problems so we can read the source material if we have any questions.

Step 3. Summarize known problems

Summarize each known problem in a 1-2 sentence description that would be easy for anyone to             understand. These summaries will ultimately be included in the final Excel file (described in step 4). For example:

User assigned tracker ID to incorrect airplane, and did not notice the error until the plane had already traveled 100 miles. Notably, no collisions were reported.

User did not complete Before Takeoff Checklist, and consequently did not extend the flaps before take-off. The plane could not achieve the intended altitude and crashed into nearby mountains.