FMEA (Failure Mode and Effects Analysis) is a regular part of our development process (we call it "Hazard Analysis"), but I was unfamiliar with FRACAS (Failure Reporting, Analysis, and Corrective Action Systems) until I ran across this: 10/21/2007 FRACAS? – Never heard of it.
I'd also never heard of "software reliability growth". The model is described here, and there are also some other good links available from the Google search.
I'm a software developer, not a quality systems person. According to Jan, even medical device quality people are not that familiar with these methods. In addition to Jan's explanation for this, one reason I (or others) might not have heard of these is that my experience has been exclusively in Class II non-invasive diagnostic devices. The development of Class III life support and implantable devices is a whole different animal when in comes to quality control rigor.
CAPA's (Corrective and Preventive Action) are of course part of the standard FDA Quality System Regulations (§ 820.100). These procedures are primarily implemented to deal with quality problems after the product has been released to the field.
The concept of preventing recurrence of observed errors (FRACAS) during the development process is certainly an interesting one. The difference between CAPA and FRACAS is similar to the argument I made regarding Software Forensics -- these techniques should be used to ensure quality before the product is released.
[…] had a comment about my previous FRACAS post, which reminds me of something. In his comment, he refers to FDA […]
Hey, i liked your blog a lot. Discovered it from the Krouwer website. Keep up the good work.