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Verification of containment activities

Discussion in '5S, 5Why, 8D, TRIZ, SIPOC, RCA, Shainin Methods...' started by MonsterEnergy22, Feb 12, 2024.

  1. MonsterEnergy22

    MonsterEnergy22 Member

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    Good Morning all, I hope you had a nice week end.

    Something I think I'm struggling with, that is the verification of containment activities.

    My organisation's Non-conformance process specifies that containment actions taken against a reported Non-conformance shall be verified.

    First of all, the definition of verification as per ISO 9000:2015:

    Confirmation, through the provision of objective evidence, that the specified requirements have been fulfilled.


    Now, using an example, My organisation has produced a non-conforming product, the usual containment activities that I would personally initiate are the following:

    1. 100% inspection of any inventory stock
    2. Communicating the issue to internal process-owners, to be wary of the issue and to introduce heightened inspections of those producing the same product. (Issue of a "Quality Alert", directly issued to specific production cells involved).
    3. Isolating any in-process manufacturing applicable to the product.
    4. Possible deviation to the manufacturing process.
    5. communication to any customers that may have recently received the product & its outcome.

    Now my question is, how do I verify that these actions taken have been successful? It's easy enough to complete the above listed actions, but how do I truly verify that I have indeed stopped their unintended use or delivery?

    I'm unsure as to if I'm over thinking this.

    I look forward to any input or guidance.

    Thank you & have a nice day.
     
  2. Bev D

    Bev D Moderator Staff Member

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    One critical thing I don’t see you articulating is an inspection to catch the NC so it doesn’t shipped. You do state that you issue a ‘quality alert’ but in your example, the NC was missed so how do you know that a ‘quality alert’ is effective? Usually exhortations to pay better attention don’t work - especially if the reason for the original escape was a poor inspection/testing/measurement system. Typically a targeted MSA is performed to ensure that inspection system is effective. THAT is your primary verification of containment. Monitoring customer complaints or field performance also is a verification of containment actions.

    Basically you have to answer a really simple question: how do you know that the action worked? (Not opinion, not belief, not hope. Knowledge is based on data and facts.)
    How do you know that the inventory screen got all of the NC parts? Do you know when the NC started? Did you inspect all material manufactured since then? Do you know that your inspection itself is effective (MSA?) Did any of the suspect material get shipped? Etc.
     
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  3. MonsterEnergy22

    MonsterEnergy22 Member

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    Thank you for your reply Bev, yes your observations regarding a previously poor inspection process are true. Unfortunately I'm not familiar with MSA, I've had a quick google for the term definition though it's something I shall have to research.

    I've taken note of monitoring customer complaints & field performance though.

    I think this is the one I'm struggling with the most, I simply don't, I've no way to verify than others saying "it's been done". Though I suspect I'm over simplifying that a bit.

    Thank you for your reply.
     
  4. Bev D

    Bev D Moderator Staff Member

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  5. MonsterEnergy22

    MonsterEnergy22 Member

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    Morning Bev,

    Thanks for the response, I had a look though unfortunately it's far beyond my current knowledge & understanding.

    Do you have any recommendation for some one who an absolute extreme beginner in this field?
     
  6. Bev D

    Bev D Moderator Staff Member

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    Try reading this focusing on continuous data first and plotting the data. Don’t worry about the math yet.

    Do you know how to make a scatter diagram?
    Take 20-30 parts. Number them 1-20/30 and Measure each one twice. Plot on a scatter diagram and post the plot and data here
     
  7. Bev D

    Bev D Moderator Staff Member

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    Attached is a list of QE references for yoru study. Most are free…
     

    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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  8. Miner

    Miner Moderator Staff Member

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    @Bev D FYI, some of the links in your document are dead.
     
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  9. Bev D

    Bev D Moderator Staff Member

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    Please see the MSA presentation at Elsmar Cove
    I guess I’ll have to go thru it…thanks Miner