Fmea Document Example: Fill & Download for Free

For the record, there have been numerous bugs in plane software and “rocket” software. Lookup what happened to 5 brand new F-22’s when they crossed the international date line for the first time (hint: they lost all systems and had to follow the tankers home). Or the Ariane 5 failed rocket launch. Or how about the priority inversion bug on Mars Pathfinder?That said, when developing mission critical software, we follow a very strict set of design controls. We have complete software specifications, which lead to detailed design specifications, which ultimately lead to source code. Every requirement is verified independently by the software verification team. The product is separately validated by the appropriate entities.I’ve got more than 20 years of mission critical software development. In my experience, we use methods and tools like:Design reviewsStatic analysis toolsDynamic analysis toolsMemory leak analysisCode coverage toolsUnit testingModule testingIntegration testingCoding standards and guidelinesMetrics which must be measured and met such as McCabe complexity, lines per method, max depth.Data hiding and encapsulation is properly usedCode reviewsFault injectionFMEAs and FMECAsTraceability matrices (requirements to design to code and back)Strict version control process. For example, when committing to trunk, commits must be reviewed and tested and documented prior to commit. Generally, there is a sandbox (mirror of trunk) which must be committed to first and pass all automated tests.Automated testingSimulationStress testing (high number of connections, low memory scenarios, high CPU loading, random mouse clicking, etc)Risk analysis and mitigation

It depends on the type of failure. Some failure is the result of abuse of the product, including using it outside its design limits.A bridge collapsing, or an aircraft crashing due to lack of maintenance is not the designer’s fault.Here is a good example of a poor design compounded by later changes that lead to disaster… Hyatt Regency walkway collapse - WikipediaThat said, very few failures are the result of a single engineer. Most designs are the result of a design team, with representatives from various departments and disciplines being represented.Any ISO certified company is required to have at least one part design review documented.In some companies, a design review will have all engineers invited, though in most cases its limited to the design team.The are also tools that came be used, such as a Failure Mode Effect Analysis (FMEA), to help eliminate design and process related risks.So, if a product fails, the best thing that can be done is to perform a thorough Root Cause Analysis to determine what went wrong, and why.Was it a design defectWas it a material issueWas it a manufacturing defect?Was it not used in a proper manner?Each one of these topics tie together at multiple levels (i.e., built in safety measures can take the user out of the equation, or eying components can prevent assembly errors).So the answer can be yes, the engineer can be at fault. But its usually not as simple as that.

Let’s add to Saulius Muliolis answer. I work in the medical device industry as a contract manufacturer. We build medical devices for OEMs.We are not responsible for deciding if the product is effective, as our customers are responsible that aspect. They would be, for example, performing the clinical trials.Once they “pass” they can obtain the 510k (pre-market notification).We provide the “design history” file to include part drawing, test data, any risk analysis (FMEA, control plan if required).The overall driving standard for medical devices is ISO 13485. It outlines requirements for design & development, and this is just one small area it covers. There is also ISO 14971 which is specific to risk management.https://www.iso.org/iso-13485-medical-devices.htmlISO 13485 - WikipediaRisk Management - Sterling Medical DevicesNote that my MS Word document version of our D&D procedure was 15 pages long, into we imported it into our enterprise software.On top of that, you have IEC 60601 that concerns electrical safety, will collateral standards that cover things likes EMC compliance.IEC 60601 - WikipediaMy particular company also uses EC-53 as a baseline for medical leadwires.ANSI/AAMI EC53:2013 (ANSI/AAMI EC 53:2013)And we have not touched on ISO 10993 for bio-compatible materials, or UL standards for flammability.We now have a person who only task is to make sure our materials are compliant to RoHS, Reach, Health Canada, Latex-free, DEHP, BPA, Prop 65 (and so on).It is quite daunting to be able to meet all of the above, in addition to all of the otherwise straight-forward engineering that goes into a new design.One could imagine how hard it would be for a medical startup, though there is a reason they often “outsource” the manufacture of their devices.~~~~Now for the second part of the question: to some degree the amount of regulation can seem excessive. That is true. It in fact poses a significant barrier to entry.But on the other hand, we all want safe medical devices. I am the last person who wants to hear that something I helped design has killed someone (not even considering the liability issue that come afterward!)So, yeah, regulations do act as a wet blanket. But sometimes that is necessary.The real issue is finding that sweet spot where economic consents, effectiveness and safety are all balanced.It really does not lend itself to soundbites or meme posters. I will make an exception for a Dilbert….