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Risk Assessment - Saline Solution

Discussion in 'Supplier Quality, Audits & Other Supplier Issues' started by Olufsen, May 9, 2024.

  1. Olufsen

    Olufsen New Member

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    Hi

    Can anyone advise as to how I would go about carrying a risk assessment, if I want to change from one supplier to another for a Saline solution.


    Not sure what what I should be looking for or what such a risk assessment should look like,


    Thank you
     
    Andy Nichols likes this.
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome, Olufsen!
    For clarification, can I ask for some background on why a risk assessment is needed?
     
  3. Bev D

    Bev D Moderator Staff Member

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    What is the saline solution used for? There are many uses, some of which might require a change validation (intravenous use or eye drops) and some that might not. The basic ‘problem’ to look for is contamination and perhaps salt concentration.
    Is this an off-the-shelf part that would certify conformance to certain specifications or is it a custom order?