Why Getting Process Owners to put Pen to Paper Helps the QA Representative

Posted: May 13, 2013 in Advisor, Auditor, ISO 9001, Quality, Quality System, Uncategorized
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Nowadays people tend to be comfortable with the idea of electronic signatures, not so much a password controlled image that is but just a name added usually to the footer of the document. It more often than not is the person who has written it which, in order to get the job done, is the QA person.

Personally, I am not convinced this works on two levels. The need to demonstrate documents have been reviewed before issue and the perhaps more nebulous one of instilling ownership with the process owner with a view to making it an effective process.

It is for both these reasons that I recommend that you adopt a double wet signature approach. First off, the process owner ‘authorises’ the procedure in that he or she accepts that it reflects how the process works in their department. Then the QA Representative ‘approves’ it in that it complies with the document control procedure and would stand up to audit.

If it get’s left to the QA person how do you know the head of department is happy with what has been written. They may not have even seen it!

Nothing beats signing off a document to get ownership, so I would always recommend that you consider this approach. Do you agree?

Comments
  1. I fully agree. The Process Knowing Person (preferably owner) needs to ensure the the procedure is ‘adequate” and does ‘ fairly reasonably’ reflects the actual set of activities and its interface with linked procedures,as well the currently applicable and accepted tools for monitoring the process. Whetting by Quality or The Standards person lends objectivity. That also enables review of adequacy w.r.t. to the requirements of the quality system /standard.

    Like

  2. Jason says:

    I totally agree, really useful blog, thanks.

    Like

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