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Quality Plan (FDA) requirement

Discussion in 'Medical Devices (21 CFR Part 820)' started by Lee G., Aug 21, 2015.

  1. Lee G.

    Lee G. New Member

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    I am a lead quality auditor. Last year this time I issued a finding to the Medical Director for failure to develop and maintain a 2014 Quality Plan. After approval, the Quality Plan was only good for the remaining 4 months of the year. Management Responsibility is scheduled to be audited this month, I was asked by the Director to schedule the audit later in the month so that the Quality Plan could be developed for 2015. I audited Management Responsibility today and was shown a 2015 quality plan, but it was not approved. I'm disappointed that this was a finding last year and the same person was not prepared this year. How should I respond to this situation?
     
  2. Ronen E

    Ronen E Well-Known Member

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    In what capacity are you auditing? Are you an internal auditor? A third party auditor? A second party?

    I recommend you don't get emotionally involved. As an auditor, your role is to highlight shortcomings. You could also point out the right direction for compliance, but whether the audited party actually does anything about it is their sole responsibility.
     
    Gert Sørensen likes this.
  3. Lee G.

    Lee G. New Member

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    I am an internal auditor, this person is my manager.
     
  4. Candi1024

    Candi1024 Well-Known Member

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    Oh snap. Good luck with that.

    Could you lead the progress then? Take control of the situation, set up meetings, guide discussions, push approvals, so that this doesn't happen again.
     
    Nikki likes this.
  5. Lee G.

    Lee G. New Member

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    As the auditor, I'm not trying to give special treatment, I have already stated that this would be a write up. My question is, is this considered a true finding?
     
  6. RoxaneB

    RoxaneB Moderator Staff Member

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    If I were in your position, I would consider which finding would add more value to the system, the processes and the organization:

    FINDING 1
    "The Quality Plan for 2015 has not been approved, resulting in...(you say what the impacts are)."

    - OR -

    FINDING 2
    "The quality planning process is not initiated nor implemented in such a manner that allows for proper communication to the impacted organizational stakeholders, thus adversely impacting the ability of the organization to achieve results, engage employees and continually improve."

    Okay, FINDING 2 is a bit of a mouthful, but it is geared towards the process and the intent of quality planning, whereas FINDING 1 is a slap on the wrist to your boss, who, being your boss, will more than likely just shrug it off until next year.

    My recommendation is two-fold.

    1 - Word your finding in such a way that it is the process of quality planning that is put under review and possible modification.
    2 - If you feel strongly about this and believe that you have the ability to improve the process, request that you be given the opportunity to overhaul the quality planning process (everything from timing to reviewing to implementing and so on).
     
    Jim Hagenbaugh likes this.
  7. Lee G.

    Lee G. New Member

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    Thank you for your response, I did write the finding based on what you described in your Finding 2. I guess the word is getting out around here; the owner/CEO spoke with me about the matter and agreed that I should follow my procedures and do what I need to do. What a position to be in. Thanks again.
     
    Ronen E likes this.
  8. Marcelo Antunes

    Marcelo Antunes Active Member

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    And why exactly would a quality plan need to be developed yearly? At most, you would update your initial quality plan if needed, but not created one each year.
     
    Gert Sørensen and Somashekar like this.

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