Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Approaching a Customer Audit

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Rachael3000, Jan 7, 2020.

  1. Rachael3000

    Rachael3000 New Member

    Joined:
    Jan 7, 2020
    Messages:
    2
    Likes Received:
    0
    Trophy Points:
    1
    Hi,

    So I’ve been away from QA for a while and I’m getting back into it. I’m required to audit customer studies in a biotechnology company. I need some advice? I’m not sure if this is the place to post but any help would be great. Thank you all.

    Rachael
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,606
    Likes Received:
    1,817
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Welcome, Rachael!

    It's as good a place as any. What do you need?
     
  3. Rachael3000

    Rachael3000 New Member

    Joined:
    Jan 7, 2020
    Messages:
    2
    Likes Received:
    0
    Trophy Points:
    1
    Hi Andy,

    Thanks for the welcome!

    I’m just not sure how I’d start really. I’m presenting how I’d approach an audit of a customer study. I know I’d review the work done by the scientists and operators, check the contract to ensure the work carried out was actually what was agreed upon with the client and ourselves, and basically checking the study data complies to all quality standards. And if there’s any CAPAs and deviations raised, that they’re closed out as a result. But I’m not sure how to talk about it in detail.

    I’m just coming back from month off and I’m just looking for a nudge in the right direction.

    Thanks in advance!

    Rachael
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,606
    Likes Received:
    1,817
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    So some basics to start. Is this audit at the request of management? I'm guessing the organization has an audit program of some type and audits have been done before this one? Do you know the "scope" (boundaries) of the audit? Is there something which defines the audit criteria? Like a particular process?

    If these things aren't in place, you may need to do a bit of leg work on those. As far as YOUR preparation:

    Get access to any documentation which defines the process(es) for how a customer study is carried out. Also, take a look at any contractual commitments made (service agreement) so that you understand what your organization undertook. Choose an agreement which was either recent and/or problematic. Create some kind of guide to help you with the key parts of the process (like a word search) which will help you to a) reference as people tell you their version of the process and b) will help you to ask specific questions about the process and, finally, c) be a reference to know if the process wasn't followed and you can identify if there's a non-conformity. Some people will call this a "checklist". You can, if comfortable, taking a highlighter to the documentation and highlighting those keywords and then using that (it makes note-taking a bit of a nightmare). I prefer to think of it like a shopping list.

    Prepare using any audit documentation that your own audit procedure(s) tell you to. (I'm guessing they aren't much use, since you're here asking for help!)
     
    Last edited: Jan 7, 2020
    tony s and John C. Abnet like this.

Share This Page