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PFMEA in low volume medical device manufacturing

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Renaz, Oct 20, 2018.

  1. Renaz

    Renaz New Member

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    Hi ,
    I wonder if a PFMEA method is appropriate to use as a risk management plan in manufacturing process of a low volume medical device company.
    I used to use it in automotive industry but not sure it works in medical industry.
    Has anyone has this experience in developing or implementing it? Any strengths and weaknesses?
    Thanks,
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    PFMEA isn't volume dependent.
     
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Renaz and welcome to the site;
    As mentioned by @andynichols, volume has no bearing on the use/effectiveness of a PFMEA. For example, of my favorite "PFMEA" applications is actually specific to workplace safety and the controls that mitigate accidents specific to governed (USA- OSHA) functions...i.e. stairways, mezzanines, overhead cranes, confined space, etc..etc..etc...

    Specific to your questions...
    Strengths: A simple, understood, disseminated, beneficial, utilized, dynamic, and sustainable tool to identify and prioritize (severity), potential failures and the controls implemented to mitigate the occurrences.
    Weakness: A busy stack of "documents" that are understood and held by only one or a few individuals, stuck in a proverbial "drawer" with no understanding of how to incorporate into process development and review, destined to die with the term life of the individual(s) that created them....(i.e. no sustainability or benefit to the organization).

    Hope this helps.
    Be well.
     
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