From mboxrd@z Thu Jan 1 00:00:00 1970 X-Spam-Checker-Version: SpamAssassin 3.4.4 (2020-01-24) on polar.synack.me X-Spam-Level: X-Spam-Status: No, score=0.6 required=5.0 tests=BAYES_20,INVALID_MSGID autolearn=no autolearn_force=no version=3.4.4 X-Google-Language: ENGLISH,ASCII-7-bit X-Google-Thread: 103376,640402846afb9f3a X-Google-Attributes: gid103376,public From: George Romanski Subject: Re: Off the Shelf Software Date: 1996/10/03 Message-ID: <32544C29.56D2@east.thomsoft.com>#1/1 X-Deja-AN: 187062710 sender: news@thomsoft.com references: <2.2.32.19961002170112.006f8994@mail.cts.com> content-type: text/plain; charset=us-ascii organization: Thomson Software Products mime-version: 1.0 newsgroups: comp.lang.ada x-mailer: Mozilla 2.0 (Win95; I) Date: 1996-10-03T00:00:00+00:00 List-Id: Robert C. Leif, Ph.D. wrote: > > From: Bob Leif > Vice President Ada_Med > > As has been obvious from postings to Comp.Lang.Ada and other Ada > distribution lists, the Department of Defense (DoD) is favoring the use of > commercial off the shelf software. Very recently the US Food and Drug > Administration (FDA) has addressed this subject. Please see below. I have > also include the comments on Open systems. For the last few years, I have > been arguing that the FDA could learn much from the DoD. I believe in this > case the FDA can provide good advice to the DoD. The US DoD has addressed this subject in MIL-STD-882C. (19 Jan 1993) System Safety Program Requirements The words are different - 882C uses Non Developmental Items (NDI). Section 60.5 System Safety for nondevelopmental items Section 60.5.1 Market investigation Section 60.5.2 Hazard assessment Depending on the hazard analysis the NDI will need to be analysed to the same standards as the rest of the application. The problem I notice is that the Program Manager has some discretion on how rigorously subjective material is reviewed. Companies will to accomplish the least they can get away with, and people are rewarded for cost saving, not for risk reduction. George Romanski