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On-site Supplier Audit Checklist

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Lindy, Jan 31, 2018.

  1. Lindy

    Lindy Member

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    I'm revamping my company's audit program and documents. Does anyone have any suggestions on creating an audit checklist for on-site supplier audits?

    My company is ISO 13485 and ISO 9001 certified, but we have various suppliers that aren't ISO approved and are in various types of industries. I need to create a supplier audit checklist that is general enough to use across these industries and qualifications, while still hitting all of the major categories. My other issue is that sometimes I need to do a narrow scoped audit, focusing on a specific process, while other times I'll just need to perform a general audit of the overall quality system. Should I create two different types of supplier checklists?

    Thank you for any suggestions you have!
     
  2. RoxaneB

    RoxaneB Moderator Staff Member

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    You could create two checklists with an audit report cover page indicating which combination of the two checklists was used.

    Regarding the details of the checklist(s), why not create one that is based on your purchasing requirements? That way, you're assessing if they meet your own standards. I'm presuming it's the general stuff like p.o., inspection before delivery, how they know what your requirements are, etc.
     
  3. Lindy

    Lindy Member

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    That's a good idea Roxane - and it would easily link with our purchasing process. Thank you for your input!
     
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  4. RoxaneB

    RoxaneB Moderator Staff Member

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    My pleasure!
     
  5. Jose Ramon Salazar

    Jose Ramon Salazar Member

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    I am used to perform different kind of audits to our suppliers (deepening of the reason) So we handled audits for assessment, product and process together, quality systems etc. and most of the checklist were handled as a "doctor case" where the main cover of the document is the "case" and the different kind of audits are the "instruments",this way we carry on our "case" only what we need depending of what king of audit we were going to perform. And as a controlled document it has only one number assigned to this master checklist that have no more than around 8 pages where the 1st was the cover and the rest the different kind of checklist we used, it was very useful and easy to control. Due to the large rotation of suppliers for the short term contract we had with customers.
     
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  6. Joe Wojniak

    Joe Wojniak New Member

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    Hi- I like Jose's suggestion because flexibility is built in. There are common elements in any of the audits your describing, however the devil's in the details and having a single checklist to cover all situations gets very cumbersome- I've worked for several companies that tried this and it became very inefficient.

    If we recognize that auditing is a process itself, supporting it with at least a work instruction, checklist(s), and an audit report template then tailoring the checklist can be part of audit preparation.

    -Joe W.

     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can you help me understand why work instructions and checklists are necessary?
     
  8. RoxaneB

    RoxaneB Moderator Staff Member

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    Because we're not all as amazing as you. ;););)

    But, presuming there is some sort of checkbox and/or comment field with said checklist/work instruction, I'm guessing it's to help demonstrate all the "appropriate" stuff has been audited. I mean, gee, you don't expect folks to simply trust the auditors to do their job in a competent manner, do you? :rolleyes:
     
    Andy Nichols likes this.

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