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  1. TWhite
    Post

    Infallibility of QA department?

    Malius: In a utopia everyone would follow the rules/procedures and there would be no need for a non-conformance. However, I have never worked in...
    Post by: TWhite, Nov 22, 2021 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  2. TWhite
    Post

    Program of requirements for quality internship

    I would suggest that if the goal is to "prevent delivering non-conforming products to our customers and to better our own processes." then start...
    Post by: TWhite, Mar 31, 2021 in forum: Other Quality and Business Related Topics
  3. TWhite
    Post

    Error caused to produce bad product, once in 5 years, Root cause?

    In the scenario stated by Qualmx the employee had not made this defect in 5 years. I would consider that a robust process. However, due to...
    Post by: TWhite, Mar 23, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  4. TWhite
    Post

    What does "Opportunity" mean in ISO 9001's "Risk and Opportunity"?

    Although I don't have an ISO text book answer I am going to take a stab at defining the intent of "Opportunity." At a quick glance opportunity is...
    Post by: TWhite, Mar 23, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  5. TWhite
    Post

    Error caused to produce bad product, once in 5 years, Root cause?

    Don't dismiss the Human Error factor to quickly. Fatigue is something we are all susceptible to. The more fatigued we become the worse we are...
    Post by: TWhite, Mar 22, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  6. TWhite
    Post

    Internal Audit

    I agree with Andy's comment about "80% of accomplishing any task is planning" Abraham Lincoln was quoted as saying “Give me six hours to chop...
    Post by: TWhite, Mar 22, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  7. TWhite
    Post

    IATF Internal Auditing

    Located in north central Indiana.
    Post by: TWhite, Jan 12, 2021 in forum: IATF 16949:2016 - Automotive Quality Systems
  8. TWhite
    Post

    IATF Internal Auditing

    I'm just looking for things that will help me better train/inform our internal auditors. They only audit a couple of times a year and therefore,...
    Post by: TWhite, Jan 12, 2021 in forum: IATF 16949:2016 - Automotive Quality Systems
  9. TWhite
    Post

    IATF Internal Auditing

    I read your article on How Football Can Help With Auditing a Process Based QMS. I think I understand how to use the Football diagram but could...
    Post by: TWhite, Jan 12, 2021 in forum: IATF 16949:2016 - Automotive Quality Systems
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