Q: To what extent must an engineering firm, specializing in railway infrastructure and transportation, have its AutoCAD software “calibrated” or verified?
Also, what about software designed to calculate earthwork quantities for railway alignments laid out on topographic mapping for all levels of studies – pre-feasibility through preliminary engineering (not for final design, operation simulation and design dynamic system models)? This type of software is utilized by competent draft persons and engineers, but it is not verified prior to use or periodically calibrated.
We don’t confirm “the ability of computer software to satisfy the intended application…”
Your assistance or reference is appreciated
A: AutoCAD is considered “Commercial -Off-The-Shelf” (COTS) software. It is purchased without modification and cannot be modified by the end-user. A similar example would be Excel spreadsheet software. The COTS software by itself should be considered validated and used as is provided it is configured per the software manufacturer’s instructions.
The functionality of the software (distance, volume, formulae and other functions) is fit to be used as intended. If an application is created using COTS software (Excel Templates, AutoCAD applications), then it must be validated and records of validation must be kept.
It should also be noted that definitions of verification and validation are not clearly understood. So, I am repeating them here:
ISO/IEC Guide 99:2007—International vocabulary of metrology—Basic and general concepts and associated terms, defines these terms as:
Verification: provision of objective evidence that a given item fulfills specified requirements
Validation: verification, where the specified requirements are adequate for an intended use
Validation is a quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.
It is sometimes said that validation can be expressed by the query “Are you building the right product?” and verification by “Are you building it right?”
“Building the right thing” refers back to the user’s needs, while “Are we building the product right?” checks that the specifications are correctly implemented by the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.
Dilip A Shah
ASQ CQE, CQA, CCT
President, E = mc3 Solutions
Chair, ASQ Measurement Quality Division (2012-2013)
Secretary and Member of the A2LA Board of Directors (2006-2014)