#11
Review - review of requirements, whether the requirements are properly developed or not.
Verification - Testing of requirements is verification.
In software V&V means Verification of Verification not Verification and Validation.

Question:
What is the meaning of validation in software development process? In hardware development process we can validate the product through flight testing.
 

Jim Wynne

Super Moderator
#12
Review - review of requirements, whether the requirements are properly developed or not.
Verification - Testing of requirements is verification.
In software V&V means Verification of Verification not Verification and Validation.

Question:
What is the meaning of validation in software development process? In hardware development process we can validate the product through flight testing.
"V & V" does stand for "verification and validation" in software development. I don't know where your definitions came from. In software development. "verification" is a process step, with the idea being to verify that the development process is proceeding as planned and required. "Validation," on the other hand, is testing to assure that the software performs in accordance with design intent.
 
#13
previously, we were certified to 2008 version and with design& development clause as exclusion. the reason for exclusion is that our management information system was an outsourced process. we are now applying for the new certification under 2015 version and our organization acquired the MIS developed by the external provider. can we state that only 8.3.6 design and development changes be applicable to our QMS since we are now doing only changes in the hospital MIS developed by former external provider?
 

DinuStan

Senior Design Engineer
#14
hi,

it doesn't matter whether the product is prototype or customer product. if it is a new product, all the design development activities are important. and it shall be properly documented. each and every document is very important for maintaining the quality system. so all the activites are properly recorded and maintain also have to retain for some applicable period.

Review - the checking of the entire process whether it is going in the right direction or not. it can be done at any in between D&D process. it can be done by the process owner along with the complete team from other departments like manufacturing, QC etc. the purpose of the other function involvement is getting their suggestion to improve the development process. so review can be done at any stage like planning, input or output.

Verification - it is nothing but to ensure the outputs that meets the original inputs. which means process of the examine the results of DD output. it can be done based on the methods for the following.
  1. accuracy of the Design results - Any other alternate calculation or FEA results
  2. output results verification by historical experiences/ previous proven design / comparing the design with other similar design.
Verification shall be done by the person or persons who not involved the entire D&D processes. So you can appoint a person from you design team itself. because if you take the person from your parent company or some other persons who is not from your company , the process will be considered as a outsourced process, then you should have cleared defined the outsourced process in your D&D procedures.

Validation - it is nothing but the validate the product by doing some acceptance tests. the tests can be prototype tests, Functional or operational tests, test specified by the specific standards related to the product, field performance test and reviewing of MTCs for material analysis etc. it can be done by the D&D assembly or Quality Team.

Part of documentation,

have to follow the all the stages documents;
For example i have given the link which i created index topics for your reference. i could not post a link on here. so please make copy and past and add www before.

scribd.com/document/394139408/Design-File-Index?secret_password=U9lL25qC2ktpcsJJz5rJ

if you have more doubts on package creation please contact me haidinu@hotmail.com. i will surely help on this.... because my interested subject is more about system implementation on design and development process areas.

Thanks
Dinesh
 
#15
You have a basic problem. You cannot exclude something that you outsource. you should have never been permitted to exclude design if you outsource it.
 

DinuStan

Senior Design Engineer
#16
You have a basic problem. You cannot exclude something that you outsource. you should have never been permitted to exclude design if you outsource it.
yeah!! if we are doing any outsourcing that we should have clear procedures as well should have to clearly specify the outsourced activities.
 

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