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Verification and Validation explanation

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

  1. Mark H

    Mark H Member

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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?

    Thanks!
     
  2. judegu

    judegu Active Member

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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

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    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).
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    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).
     
  5. BufferMess

    BufferMess Member

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    Hi. Your explanation was partially incorrect. The definition of "requirements" in QMS tells that customers needs, specifications, regulations and organization's internal requirements should be treated equally when planning the QMS. We are not allowed to choose between the requirements.

    The explanation could be like this:

    Validation - is an activity to proove that your final design is capable of meeting the defined requirements (customer, regulatory, corporative etc.)
    Verification - is to check and confirm whether your design activities is going as planned
     
  6. Artem

    Artem Member

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    Hi Mark

    Two news for the engineers. 1) Customer „need“ is not a customer requirement. Even if customer gave a spec it is not his need. The need is the intention for use.
    ISO 9001:2015 stipulates in 8.2.3.1. that in order to fulfill the requirememts you need also to take into account not stated requirements for your intended use
    I have drawn a small chart for you. Hope will help - sorry for a bad quality. Made on the laps so to say
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

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  7. judegu

    judegu Active Member

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    @Artem. A nice example in the attached files. However I got a question here. Based on the principle in your example, verification is easy to be conducted, because there are actual Specs. Whereas validation is a little tricky. How to define which extent can be deemed as "Low exhaust"? The customer has its need, but it only gave the specific requirement to the organization.
     
  8. Artem

    Artem Member

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    H
    Hi, in this particular case any kind of „simulation“ maybe a prototype building, would count. You can physically validate that the exhaust is low. Can you in your production environment make such a physical test?
     
  9. judegu

    judegu Active Member

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    We are making LED chips for lamps in the cars. In my case, the validation I can think of is to send the samples to the customers, let them to do the following. What`s more, we also do the reliability test which may be a way to simulate the working environment at the customer`s.
    Frankly speaking, in the development process of my company, we have two relevant phases(milestones), design verification review and product validation review. Because the ownership of these two belongs to oversea head quarter. Thus sadly I don`t know the details about what specific have been done. Put it into another way, I am not confident to say I can identify which activities I know belong to which phases.
    Maybe I can share more, when I know more about them.
     
  10. BufferMess

    BufferMess Member

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    To validate your product, you need to proove that your defined processes are capable of producing conforming LED chips. You have to model your processes and make necessary calculations.

    Testing the final product is an activity for verifying your process planning. Therefore, it is usually included in verification activities. You still need to validate your processes.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's PART of it. Validation of product - in this case LED chips - needs to be done in the manner a customer uses the product. Since it is for use in a car, cars tend to be used in cold/hot/dry/wet/dusty environments and, as such, the LEDs should be tested in these conditions, with defined parameters. It really doesn't matter if your processes can MAKE the product if, the first time it gets used in the rain, it fails...
     
  12. BufferMess

    BufferMess Member

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    Hi. Testing a sample of your product in adverse conditions do not validate your entire product line, it only validates your test sample. You still have to proove your process will be capable of producing LED chips conforming to the specifications of your control sample which passed the test. You have to validate your process capability.

    The validation you describe is not what ISO 9001 actually requires.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maybe in volume manufacture. If you only make one or two of anything what then? BTW - the requirement for validation only in DESIGN and, where it's appropriate for product which cannot be inspected/tested (so-called "special processes).

    I believe you may be reading too much into ISO 9001:215 requirements.
     
  14. BufferMess

    BufferMess Member

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    An other reason showing that testing a product is a verification activity.

    Basically, you must validate your process before launching the product line or after comissioning the plant.
     
  15. BufferMess

    BufferMess Member

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    If you design a special order, according to 8.3.4 d), you must validate the final product but that could take place after the validation of your design process since it is a "special process" and was not validated before. Therefore, you must first validate your design process, control and verify during the design phase and finally validate the resulting product.

    The hassle of making a "special process" makes the process quite hard to accomplish.
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    There is NO requirement, in ISO 9001:2015, with the exception of the need for validation/revalidation of some (special) types of process, to perform process validation.

    If some believe there is is, please quote, verbatim, the clause and text from the ISO 9001 requirements.
     
  17. BufferMess

    BufferMess Member

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    ... under the condition that you verify the resulting output at each process stage. Clause 8.5.1 f),

    but I do agree that the new validation requirements are less stringent than ISO 9001:2008.

    If we go back to the judegu's case where he needs to validate his LED chips production process, he has to outsource (clause 8.4) his validation process as it is carried out by the overseas headquarter (a parent company). He needs to establish controls over the validation / verification activities and preferably have these activities detailed in a contract.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Please quote directly from the standard.
     
  19. BufferMess

    BufferMess Member

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    Clause 8.5.1 f):
    "the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement"
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This applies ONLY to processes where the resulting product cannot be verified, as I've stated previously. I does NOT apply to ALL production processes.
     

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