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Procedure Deviations

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Lindy, Feb 1, 2019.

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  1. Lindy

    Lindy Member

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    Hi everyone -
    My company currently allows deviations for Engineering controlled documents such as production methods that are product specific, drawings, etc. The deviations may be in response to an issue that was discovered, requiring quick action in response to the issue. Revising the Engineering document may take longer to do, which is why deviations are allowed.

    A few people at my company have asked about creating a deviation for my company's operation procedures and quality forms, which we currently do not allow. I feel that allowing deviations to these documents may create problems and open us up for possible issues.

    I wanted to get other opinions on allowing deviations to procedures and forms to see if it has worked for other companies, or if my hesitation to allow this is justifiable.

    Thank you!
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Lindy:
    In Quality Systems, I always make a place for deviations. There are 2 fundamental principles that they address nicely"

    Not all documentation fits all situations all of the time and when making improvements, it's best to trial the change before locking-in that change. Of course, that's if you believe, in the first place, that the documents you've got are really that good...
     
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  3. Lindy

    Lindy Member

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    Thank you Andy! Yeah, I'm on the border about allowing deviations to procedures because an instance may occur requiring a quick adjustment. Part of me wants to allow that flexibility, whereas the other part of me is getting nervous about employees continuing to perform the deviated process after the deviation expires, or an adjusted form to be used during the deviation timeframe continues to be used afterwards. It's those instances that I worry will cause employees to become confused, leading to the process being completed incorrectly. On the other hand, if we wanted to try out a new way of performing an operation on a trial basis to see how the company adapts to it, that could help our company evolve and improve.

    I'm having an internal battle between the two trains of thought...
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You have the safety net of internal audits, don't forget... Instead of simply doing internal audits to some 12 month calendar, consider that your audit program can also look at changes like this at both points, to see what's going on.
     
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