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verification, and validation explanation.

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Mark H, Aug 8, 2018 at 10:19 PM.

  1. Mark H

    Mark H Member

    Feb 28, 2018
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    Hey guys!

    I gave my engineers a new Design Plan form.

    I added sections for a verification plan, and validation plan.

    I tried my best to describe the difference between verification, and validation, but they aren't understanding, and to be honest, I could use a little more understanding on the subject.

    I told them that Validation is making sure that the design meets the needs of the customer, and that verification is making sure that it complies with a regulation, requirement, specification. I got that explanation from these definition I found online.

    • "Validation. The assurance that a product, service, or system meets the needs of the customer and other identified stakeholders. It often involves acceptance and suitability with external customers. Contrast with verification."
    • "Verification. The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition. It is often an internal process. Contrast with validation."

    The way I look at it, You need to meet the specification, but you also need to make sure that the specification is correct. That is the difference.

    Clear as mud right? lol.

    So I explained this to my engineers, and they say something like "The needs of the customer is that it meets specifications... so it's the same thing"

    Can somebody help me understand this a little better?
    Give some examples?
    How do I Validate a design?
    How do I Verify it?
    How do I explain this to my engineers?

  2. judegu

    judegu Member

    Jul 11, 2018
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    Here is my idea, how I see them as two different processes.
    Verification: The organization itself runs some tests (Reliability test, pilot run) to see whether the newly-designed products meet the specification from the customer.
    Validation: Just send the samples to the customer. Let the customer to see whether the samples work well in the actual working environment in the customer`s end. (Or the organization can do itself by stimulating the actual working enviroment at the customer`s site?)
    The above is just my opinion. It may probably not be correct.

    "The way I look at it, You need to meet the specification, but you also need to make sure that the specification is correct. That is the difference"
    Is it necessary for us to check whether the specification is correct? I thought it was the customer`s job.
  3. tony s

    tony s Well-Known Member

    Sep 10, 2015
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    Laguna Philippines
    If you want to know whether the product design specifications are met, verification should be performed (e.g. inspections, measurements).
    If you want to know whether the product design intent are met, validation should be performed (e.g. tests, simulations).
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Jul 30, 2015
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    In the "Rust Belt"
    An org. that I worked for had a development process in which lab techs tested the product to specification, at various phases (this is verification). As the design was developed, they then created a test environment where it replicated the customers' typical use - by bringing in independent testers (like typical customer users) and also environmental testing to simulate the temp/humidity encountered (validation).

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