NQA-1 in use software testing REQ 11

By Mikeqc1 (****)

Date 09-13-2011 19:03

Is this only required if you design software?
Thats what it seems to me.
Any opinions?

By js55

Date 09-14-2011 12:48

If you utilize computer programs for design or operational control activities (see Req 11 para 400) you have to have procedures in place to verify that the program is doing what you are expecting it to. This section was of course greatly expanded in the 2008 Edition.
What I did in my Manual (since we do maintain an N Stamp though we sub Design) was just state that we don't utilize programs for design or operational control to address Req 11 para 400. We verify our subs have the procedures.

By Mikeqc1 (****)

Date 09-14-2011 15:07 Edited 09-14-2011 21:43

where are the references to REQ 11? in design control?
http://www.swri.org/4org/d30/pqpnuclear.pdf

note for self....
4.3.2 Control of Software
Software design controls (NQA-1, Requirement 3, Paragraph 800) are
not implemented in this program. SwRI does not design software for its
nuclear industry customers. Software controls are implemented by
SwRI, but are limited to the software used for testing purposes as
described in the QSM, Section 7.6, and the applicable division
procedures.

By js55

Date 09-14-2011 18:15

I did it in both my testing and design sections to make it easier for the teams (and customers) to find. I don't state Requirement 11 specifically, but I do have para headings that segregate the subject. I just address the subcontract program control verification and in other locations when the context is applicable I address compliance with NQA-1 in general. In my testing secito I emphasize we do't do design or manufacturing computer control, and in my deisgn section I emphasize that its subcontracted.

By Mikeqc1 (****)

Date 09-14-2011 21:18

not so sure there is a need to in-use testing if software is not being designed.