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Verification and Validation explanation

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

  1. tony s

    tony s Well-Known Member

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    Clause 8.5.1f is intended for "special processes". Such process is defined in ISO 9000:2015 Section 3.4.1 Note 5 where it specified: "A process where the conformity of the resulting output cannot be readily or economically validated is frequently referred to as a "special process".
     
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  2. BufferMess

    BufferMess Member

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    This is the reason I suggested judegu to validate his processes. Verification is not an easy task for the PCB assembly industry. He needs a well-equipped lab and a group of skilled technicians (working in shifts) to verify every stage of his assembly line. Therefore, I suggested him to validate his production line and revalidate periodically at certain circumstances.
     
  3. Miner

    Miner Moderator Staff Member

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    I use the following example. I owned two cars that used the exact same engine. GM's Quad 4 engine was used in both the Pontiac Sunfire as well as the Grand Am. The Quad 4 engine had all sorts of performance requirements associated with it. Verification is testing the engine to ensure it meets all of those requirements. Validation involves putting the engine into each of the intended vehicles (Sunfire and Grand Am) and testing whether the resulting vehicle performance meets the intended requirements. I can tell you that the acceleration and mileage was quite different between the two vehicles.
     
  4. BufferMess

    BufferMess Member

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    Hi Tony. Glad to see you again.

    By "special processes", the standard means the processes where the final product is verified after the delivery. If you cannot verify the final product at your organization's control, or this is a customer requirement, you must validate your production processes. But this is certainly not the case with the LED production. judegu is able to verify his final product as there are numerous industry recognized testing practices for the electronic products. An industry experienced auditor will not accept the justification for "special processes" since there is nothing "special" with the production of LED.

    While I do suggest that judegu still needs to validate his primary process, organizing verification activities at every production stage is an other option. Only this way he will be able to avoid process validation.

    All I explained were case specific. I was not arguing the theory behind 8.5.1 f.
     
  5. BufferMess

    BufferMess Member

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    Hi. Note that the purpose of your testing activities is to verify if the engine meets the requirements. In both cases you actually verify the engine.

    Validation in this case should involve load calculations if the engine components are capable of delivering performance requirements.
     
  6. judegu

    judegu Well-Known Member

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    @BufferMess

    Hi Our product supplier chain is as below:LED Chip (our product) -> Lamp Assembly -> OEM. Something like that, I am not 100% sure.
    And the product/process design is made in the oversea corporate HQ. Basically, my company just does the massive production test.(Here I avoid using the words, verification and validation since I don`t know exactly what they refer to anymore :confused:)
    In the massive production test, we do the following: 1) pilot run to see how production line perform during the massive prodcution 2) reliability test 3) make some samples to send to the customer.

    If verification means computer-aided simulation, the R&D does do this simulation in the development stage. And they also make some samples to see whether the process/product design work and get some samples to do the reliability test and send to the customer.

    So what is your opinion to validate the product and process design?:)
     
  7. BufferMess

    BufferMess Member

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    Hi judegu.

    You actually validate the capability of your processes with 1) and 2) but you have to document it in a proper manner. Ask your engineers to model your pilot run (mathematically) and make necessary calculations for process capability. Document them according to your QMS.

    3) do not qualify for the process validation. The reason is that the customer is not a LED chip manufacturer, therefore, they do not have necessary knowledge and capability to validate your product. What you are doing is simply testing your sample not your entire production line. This type of testing is typically considered with the verification activities though involving a customer (or consumer) in testing an electronic product is not a preferred way of verification, considering that you have a legal obligation for the electric safety. You have to verify your product in your lab or in a outsourced lab at reasonably short intervals.

    I suggest to everybody willing to validate the production process to document the information under these subjects:
    • description of the process
    • technical parameters
    • intended control (your target tolerances)
    • scientific literature and test procedure
    • mathematical models of the process and pilot tests
    • evaluation of the test data
    • verification of the validity (continue collecting data for future revalidation studies)
    Computer-aided simulation could be used at the design and development phase. It typically focuses on product validation. But designing a product and manufacturing it are completely different stories. You could be able to design a product conforming to requirements but that doesn't ensure your process performance or its capability to continually provide the required outcome.

    Finally, because your overseas parent company does the design task, you should exclude "8.3 Design and development of products and services". Outsource the design and R&D service from your parent company. Include your design specifications, verification and validation requirements in a contract signed with the parent company and forget about it for the next 10 years.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm sorry, but this is NOT correct! Validation is to show that the verification (which is also calculations) is accurate. Verification can be done in a lab etc and give all kinds of results, but VALIDATION should be close as possible to the actual user experience. Load calculations don't do that at all!. Speaking of cars and their components, a significant part of any new car development is actual "ride and drive". This is REAL user experience. I know because I live and work IN the NA auto industry and see this daily validation and verification. In my lab days, the validation was actual end user testing, not calculations.
     
  9. judegu

    judegu Well-Known Member

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    @BufferMess

    A real detailed answer. Thanks for your opinion.

    First, regarding the process, 1) and 2) can be considered as process validation, then there is the question, Which can be considered as process verification. One colleague of mine who is actually maintaining IATF 16949 also holds the similar opinion that 1) is the valdation of the process design. Still, I wonder which kind of activities can be considered as the process verification. Maybe the process verification is part of the process validation? They can not be clearly seperated?

    PS: We do have a fine process to do the 1) and 2) in a proper manner. :)

    Second, in my original idea, sending the samples made during massive production was part of the product validation.:oops: With regard to the legal obligation for the electric safety, I also ask my colleague about it. Sadly, I got nothing. It belongs to the HQ. Or maybe there is no specific safety requirements towards LED chip (quite a wild idea:D). Is there any chance that In-line product test can be seen as product verification?;)

    At last, I don`t agree with you on this one. Computer-aided simulation must be kind of verification.

    Again, thanks for your valuable input.:D
     
  10. judegu

    judegu Well-Known Member

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    Hi Andy. My company is far away from OEMs in the supplier chain. Here, for us, it is not realistic to do the end user testing. Sending samples to the customer is my best bet.
    And regarding the reliability test, what does it belongs to? product validation? process validation?
     
  11. BufferMess

    BufferMess Member

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    Sorry, but I have to disagree. How are you going to validate a safety measure of a car with an end user? Are you going to suggest a crash test with the user behind the steering wheel? Or are you going to wait for the user to have a real accident?

    How many end users are aware of the many hidden or undisclosed functions a final product incorporates?

    I can count hundreds of components and measures in a car where your real user experience will never encounter during the life of the car.

    Quite often, a verification activity involves calculations too but that does not mean similarity with the validation. Purpose is different.
     
    Last edited: Sep 28, 2018
  12. BufferMess

    BufferMess Member

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    You didn't detail what you meant for the 2) reliability test. If it is meant for the finished product, it is a verification activity (although reliability is not the only parameter to focus on). On the contrary, if you are testing your production process for reliability, then you are actually validating it.

    For verification of a process, you need to measure certain characteristics of the product at defined intervals during the production. You have to measure characteristics of the finished product too. This is usually done by establishing a lab and employing inspection technicians. It shouldn't be confused with the monitoring activities which is an operator's job. In a factory, verification is a continuing activity. This is the most distinguishing property of verification vs. validation.

    Process verification is not a part of the process validation because with process verification you actually measure characteristics of the processed product to detect on time if anything goes wrong. It is something to do with the production planning. Process verification usually gives you the most valuable data for analysis, evaluation and validation.

    What you do in computer-aided simulation is modelling your product in a simulated environment and optimizing the outcome. So you are trying to find an optimum model for your intented product, right? Is there anything to do with the verification? :)
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You've never seen "crash test dummies"?
     
  14. tony s

    tony s Well-Known Member

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    In addition with the examples given here, let me quote the vocabulary:

    upload_2018-9-29_13-9-34.png


    upload_2018-9-29_13-10-1.png
     
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  15. judegu

    judegu Well-Known Member

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    Maybe I should read the standard again. However in the standard there is rarely a detailed example. Always one term to another term.
     
  16. BufferMess

    BufferMess Member

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    That is not a real life experience. Crash test dummies are good source of the crash data. They are not used to validate a new model, but to verify (usually by government bodies) manufacturer's specifications. This is a typical verification procedure.

    I agree that live experience can provide useful data for marketing purposes, improvement of comfort and cabin materials, functional improvements of equipment like radio, head unit, heater, instrument cluster, bluetooth etc. But a real life user cannot validate an automobile and its components.