Defining Qualification, Verification, and Validation


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:

3.8.4 verification
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.

3.8.5 validation
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.

For example:

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).

Validation Examples:
•         Design validation, sterilization validation, test method validation, software validation, and process validation.

Verification Examples:
•         Design verification and process verification.

Qualification Examples:
•         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?

Bud Salsbury
ASQ Senior Member, CQT, CQI

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12 Responses to Defining Qualification, Verification, and Validation

  1. ramaqwer45 says:

    ADB Consulting differs from its competition in that we provide experts to provide expertise in desired fields, project managers to oversee and ensure conformance to expectations and ensure delivery of products that meet performance, efficiency, and quality standards utilizing state-of-the art technology centered at the forefront of advancement.

    automateandvalidate

  2. Here is my long-winded take on these terms as applied to computerized systems validation in the Life Sciences industry.

    http://riganati.blogspot.com/2012/06/tower-of-babel-validation-verification.html

  3. As to resume the three conceptos:
    Instruments are calibrated.
    Equipments are qualified.
    Processes are validated.
    Néstor Aversa CQE

  4. Steve Whatley says:

    Validation is only possible once the plant has been built to verify it actually works. Verification is asking “if we build this, will it work”. You can do this using experience, calculations, etc. There is also design review where you compare the output of design & development with the input. So, ask yourself do these drawings include all requirements that have been provided.

  5. John Dalrymple says:

    This may be a case of, ”You can’t get there from here”! But here is my understanding.

    All product shipped has two characteristics, i.e. Qualification and Acceptance. Validation (contract requirements) and Verification (design requirements) are tools used to produce objective evidence in support of one or both of these product characteristics.

    A. Validation (contract requirements)
    Defined as objective evidence that the product will satisfy the contract requirements, i.e. intended use.

    B. Verification (design requirements)
    Defined as objective evidence that the product will satisfy the as-designed requirements, i.e. Engineering documentation.

    C. Qualification tasks are performed on a representative sample of the product to produce objective evidence that the product will satisfy the end use requirements, including product safety.

    D. Acceptance tasks are performed on all units shipped to produce objective evidence that the manufacturing process resulted in ‘Qualified’ product. Typically ESS testing is included.

    E. Certificate of Conformance is objective evidence provided to the procuring activity that the product is both ‘Qualified’, and ‘Accepted’.

    John Dalrymple, CQE
    NGC NSD

  6. GM Samaras says:

    Here is a much simpler explanation, I think.
    Qualification refers to someone’s or something’s “being fit for its intended purpose”. For manufacturing equipment, we have 3 types of qualification: installation qualification (IQ), operational qualification (OQ), and process qualification (PQ). All that means is that you installed it right, it works right, and it produces the right thing, the right way.
    Verification and validation are a different matter. For design, there is only one type of engineering validation, but five (5) types of engineering verification – 3 from systems engineering and 2 from risk management. Take a look at Figure 2 in my recent article in Medical Electronics Design (“Medical Device Mechatronics Maturity”) on V&V processes. Engineering validation is about experimentally proving that you met your stakeholder’s expectations (you built “the right thing”). The five engineering verifications are internal error-correcting processes in the systems engineering and risk management process; they are about demonstrating that you are “doing things right”.
    GM Samaras Pueblo CO

  7. Jesse G.Gentile says:

    I try to keep it simple as it seems the definitions vary within each organization. Most companies have their own “defined” definition in their Quality manual or other Procedures which may or may not fall within the formal definitions above. The key for me is to ensure that I understand the intended definition as received and meet that intent regardless of formality. If I am not sure I clarify and then execute per my customer’s expectations.

    From a simplistic view – I try to keep it in my mind as such:

    Verification – Confirms an assumption – Is everything included – Evidence
    Validation – To substantiate – Is it valid? Official confirmation that will meet the intent?
    Qualified – Demonstrated success – an accomplishment

    Jesse Gentile, CQI, CQT, CCT
    Quality Manager
    Automotive Supplier

  8. Lawrence Lagman, CQM-OE, CQA says:

    I agree with your answer, however, I would like to point out that in some standards (ISO/IEC 17025 (2005), the term “Qualification” is not used except in the area determining the fitness of either personnel to perform a task through training or proficiency or instruments/equipment to meet the specifications for performing an intended task. I like to think that Qualification is the “Fitness for Use” element of an ISO quality system and it meets the criteria of the customer and organization performing the work.

    Lawrence Lagman, CQM-OE, CQA
    Quality Manager
    Arkansas Regional Laboratory

  9. Vivian Ngan-Winward says:

    Thanks, Bud! I will surely use this explanation when teaching my students.

  10. This really doesn’t answer the question. For example, I am auditing hundreds of drawings for constructing a power plant. Just how should those drawings be; validated and verified.
    A second opinion is worthless; a P.E. signoff means little. He probably prepared them.
    The only V and V is the constructed item and if it doesn’t work, it is too late. Point being; there are some instances wherein V and V is impossible and the standard should recognize this.
    Patrick Hughes
    QCMS, LLC

    • GM Samaras says:

      AS you say, you are AUDITING the drawings! The drawings are design outputs (one or more engineers workproduct) and so it is impossible to validate them (validation requires design inputs). What you can do with those design outputs is verifiy them against the design inputs to make sure there is a 1:1 (or 1:many) relationship between design inputs and design outputs. Then, as subassemblies are being constructed, you can (a) verify each subassembly against the corresponding design output drawing(s) and (b) validate each subassembly against the corresponding design inputs (that you identified above). Finally, have integrated all the validated subassemblies, you will need to validate the complete system. Hope that helps.
      GM Samaras Pueblo CO

    • Steve Whatley says:

      Validation is only possible once the plant has been built to verify it actually works. Verification is asking “if we build this, will it work”. You can do this using experience, calculations, etc. There is also design review where you compare the output of design & development with the input. So, ask yourself do these drawings include all requirements that have been provided.

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