- #Clarify vs verify verification#
- #Clarify vs verify software#
- #Clarify vs verify iso#
#Clarify vs verify verification#
Validation (contract requirements) and Verification (design requirements) are tools used to produce objective evidence in support of one or both of these product characteristics.ĭefined as objective evidence that the product will satisfy the contract requirements, i.e.
This may be a case of, ”You can’t get there from here”! But here is my understanding.Īll product shipped has two characteristics, i.e. An old and trusty phrase to help summarize the other two is: Validation – Are we producing the right product? Verification – Are we producing the product right?
Installation qualification, operational qualification, process performance qualification, product performance qualification, and supplied material qualification.Īfter reading all of this, I am confident you would be able to explain qualification. Design verification and process verification. #Clarify vs verify software#
Design validation, sterilization validation, test method validation, software validation, and process validation. Qualification is an act or process to assure something complies with some condition, standard, or specific requirements.Ī design verification verifies that a frozen (static) design meets top level product specifications.Ī process validation validates that the on-going (dynamic) manufacturing process produces product that meets product/print specifications and consist of installation qualifications, operational qualifications, process performance qualifications, a product performance qualification and perhaps process verifications.Īn installation qualification qualifies that equipment was installed correctly and are a subset of a process validation (or possibly a test method validation). Verification is the act or process of establishing the truth or reality of something. Validation is an act, process, or instance to support or collaborate something on a sound authoritative basis. Keep in mind that qualification, verification, and validation are individual processes, but the explanations below (from Boston Scientific) should help you recognize their individuality as well as their interdependence. I’ll try to expand on these definitions in hopes of making things a bit more clear. NOTE 2 Qualification can concern person, products, processes or systems.ĮXAMPLE Auditor qualification process, material qualification process. NOTE 1 The term “qualified” is used to designate the corresponding status. Process to demonstrate the ability fulfill specified requirements NOTE 2 The use conditions for validation can be real or simulated. 
NOTE 1 The term “validated” is used to designate the corresponding status. – undertaking tests and demonstrations, andĬonfirmation, through the provision of objective evidence, that the specified requirements for a specific intended use or application have been fulfilled – comparing a new design specification with a similar proven design specification, NOTE 2 Confirmation can comprise activities such as NOTE 1 The term “verified” is used to designate the corresponding status. In 9000:2005, under clause 3.8 Terms relating to examination, we find:Ĭonfirmation, through the provision of objective evidence, that specified requirements have been fulfilled
#Clarify vs verify iso#
As you may already know, this document is used to define/describe many terms used in the ISO 9000 series, including the three words you question. To begin, I refer you to ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. Can one of the experts help explain these terms? Thank you.Ī: This is a great question and I hope I’ll be able to help you. Q: I understand the hierarchy, but I would be hard pressed, if asked, to give a clear definition of the terms: qualification, verification, and validation.
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