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. Can one of the experts help explain these terms? Thank you.
A: This is a great question and I hope I’ll be able to help you.
To begin, I refer you to ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. 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.
In 9000:2005, under clause 3.8 Terms relating to examination, we find:
Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
NOTE 1 The term “verified” is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as
– performing alternative calculations,
– comparing a new design specification with a similar proven design specification,
– undertaking tests and demonstrations, and
– reviewing documents prior to issue.
Confirmation, through the provision of objective evidence, that the specified requirements for a specific intended use or application have been fulfilled
NOTE 1 The term “validated” is used to designate the corresponding status.
NOTE 2 The use conditions for validation can be real or simulated.
3.8.6 qualification process
Process to demonstrate the ability fulfill specified requirements
NOTE 1 The term “qualified” is used to designate the corresponding status.
NOTE 2 Qualification can concern person, products, processes or systems.
EXAMPLE Auditor qualification process, material qualification process.
I’ll try to expand on these definitions in hopes of making things a bit more clear. 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.
Validation is an act, process, or instance to support or collaborate something on a sound authoritative basis.
Verification is the act or process of establishing the truth or reality of something.
Qualification is an act or process to assure something complies with some condition, standard, or specific requirements.
A design verification verifies that a frozen (static) design meets top level product specifications.
A 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.
An installation qualification qualifies that equipment was installed correctly and are a subset of a process validation (or possibly a test method validation).
• Design validation, sterilization validation, test method validation, software validation, and process validation.
• Design verification and process verification.
• Installation qualification, operational qualification, process performance qualification, product performance qualification, and supplied material qualification.
After reading all of this, I am confident you would be able to explain qualification. 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?
ASQ Senior Member, CQT, CQI