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Rhonda Goss
How are we going to expand knowledge of the Audit Division when only members can access this site?
Rhonda Goss Jun '19
Hi Rhonda,
Thanks for your question.  At this time it is true that only Audit Division Member may access the Audit ...
Betty Leonhard
I'm looking for a few real-world examples of how companies meet this 8.5.6 requirement. What changes would this ...
Betty Leonhard Apr '21
Hi Betty,
At my last job where I worked for a company that designed and built jet engine test systems, we would have 3 ...
That sounds great for 8.3.6 which is design changes.

I'm curious about 8.5.6 which is for production changes.
Good Afternoon Betty,

"The organization shall review and control changes for production or service provision, ...
    Betty,

    The way I approach Change control - be it process of document related, I established a Change Control Form ...
    Matthew Miller
    Good morning, I have been performing internal audits for our company for about 4 years now. Every time I think I know ...
    Matthew Miller Dec '20
    Oh well, I was hoping a membership with ASQ would help me as our auditor from SAI Global suggested, but I guess not.
    Hi Matt, 
    First, what did you answer when the auditor asked you why you hadn't audited sub-processes?  I thought ...
    Duke Okes Duke Okes Jan '21
    Use a risk-based approach to decide what sub-processes to audit and how frequently.

    1. Sit down with the process ...
    I'm four months in at my current co. And I'm trying to audit every process this year. I've got a list of about 60 of ...

    Matthew, your pose a good question. I dislike the feedback from your auditor a lot. For several reasons. If we go to ...

    Sheronda Jeffries
      Recently I conducted a webinar for the ASQ Audit Division titled “Valid or NOT? – Verifying Management System ...
    Richard Tanner
    I am looking for some participation in a Project I am currently developing. I hope this request is appropriate for ...
    Richard Tanner Sep '19
    I would be willing to help out. Send me the details.
    I have now receive all the assistance needed. 

    Though it strange how I received more response on the Quality ...
    Beat Schlumpf
    In Switzerland,   companies conducting audits use the same auditors for years in the same companies. It is a ...
    Beat Schlumpf Jun '19
    Hi Beat Schlumpf, 

    Subject: Batch Record Review, Deviations and Change Control, CAPA Corrective and ...
    Thank you Saima for your request.
    Unfortunately I have no additional information.

    Beste regards
    Beat

     
    Hi Beat,

    In response to your question, I offer the following:

    "ISO makes standards and does not get involved in the ...
    Thank you very much John for your reply.

    Beat
     
    You are right, but I would like to point out that the standard that specifies the rules for the work of certifying ...

    Beat Schlumpf :
    In Switzerland,   companies conducting audits use the same auditors for years in the same ...

    Elizabeth Nichols
    Is the Audit Division planning a conference for 2021, be it in-person or virtual? Just trying to plan my training ...
    Unfortunately, at this time we are not planning an event for 2021, but stay tuned for October 2022. More updates ...
    Brian Frye
    Our organization is looking for Quality Management Software with Internal and External Auditing ...
    Brian Frye Jan '21
    Kim K Burson
    I am trying to determine if audits are required for non-GMP clinical sites in the USA that will perform ...
    Kim K Burson Apr '20
    Jeremiah Genest
    A big thank you to the Audit Division leadership team and conference committee for the great 2019 conference in ...
    Jeremiah Genest Oct '19

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