1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
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.

GDP - Having to give a reason to use N/A?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Nikki, Jun 18, 2018.

  1. Nikki

    Nikki Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    252
    Likes Received:
    136
    Trophy Points:
    42
    Location:
    Maine
    Hello All -

    Apparently, our company has not been following GDP as closely as it should.

    But we are putting the training in place now and hope it goes smoothly.

    While going on this training, it states that the person completely a form, much initial, date and provide a reason when documenting "N/A".

    We have a medical clean out which is completely for every product we produce. This does not mean a medical clean out is required for every product. It lists out all the steps of the medical clean out and at the bottom, there is a section for QC to approve the line clearance. Line clearance is required with every job.

    When a medical clean out is not needed, the operator put N/A next to all but a couple steps of the medical clean out.

    Does this mean he hates to write a reason for N/A next to every N/A?

    Thoughts?

    Thanks,
    Nikki
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    119
    Likes Received:
    56
    Trophy Points:
    27
    Good day @Nikki ;
    Can you please clarify what is meant by "...it states..."? (in other words, what/where is the "it" that you mention? Can you please share "it" with us here? Thank you.
     
  3. Nikki

    Nikki Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    252
    Likes Received:
    136
    Trophy Points:
    42
    Location:
    Maine
    Training slide show attached.
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

  4. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    592
    Likes Received:
    671
    Trophy Points:
    92
    Location:
    Ontario, Canada
    I think was John was asking was who determined this rule regarding the use of N/A? In which standard does it state that N/A must be explained? If this training material was developed by your or your organization, it's up to you or your organization to determine the rules regarding the use of N/A.
     
    John C. Abnet likes this.
  5. yodon

    yodon Active Member

    Joined:
    Aug 3, 2015
    Messages:
    83
    Likes Received:
    36
    Trophy Points:
    17
    RoxaneB is right (as usual) - there are no industry-wide rules for GDP and most of these things are driven from internal procedures. If it's obvious what the N/A means and why it was so then it would be unlikely you'd get called on it (unless it goes against your internal procedures). For example, if I had a box for comments and there were none, a simple N/A without explanation would be pretty obvious. On the other hand if I had a calculation result field and entered N/A in it, it would probably a require an explanation. Consider having a checkbox for N/A if that's typical.

    As a bit of aside note, the focus these days is as much or more on data integrity (see FDA Guidance: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf). The guidance outlines the 'ALCOA' principle (Attributable, Legible, Contemporaneous, Original, Accurate).
     
  6. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    119
    Likes Received:
    56
    Trophy Points:
    27
    Good day Nikki, @RoxaneB described it accurately.

    I am pasting here, the sections from your provided training materials, which I believe reflect the areas of concern...

    5. CLEAR – everyone who reads the document has the same understanding of what
    it means.

    > Looking at this document 5 years from now, would someone understand what I wrote?

    > Areas identified as N/A (not applicable) must have a documented reason, initials and date.


    7. COMPLETE – all information is included.

    > No blank spaces, pages or portion of a page.
    > N/A can only be used when it is very clear that a portion of a document, form, or record does not apply.

    > Provide an explanation with the N/A. (Example: record “N/A Job Complete” in unused process sheet parameter columns)

    These "requirements" are established only by your organization and not by the governing international standard. The terms "...must have..." and "Provide..." are equivalent to self imposed "shalls" . If these training materials are actually reflective of the determined/documented process, then the auditing process (internal and 3rd party) should hold your organization accountable to these self established requirements.

    The real questions are...
    1- are these self imposed requirements actually part of the corporate intent? (i.e. does senior leadership agree/require/want/need these requirements to be established?).

    ..or...

    2- are these self imposed requirements simply the result of some over zealous or careless instruction (documented process?) writing?

    First determine what is in the best interest and intent of your organization and then let's continue the conversation.

    Hope this helps.

    Be well.
     
  7. Nikki

    Nikki Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    252
    Likes Received:
    136
    Trophy Points:
    42
    Location:
    Maine
    Thanks everyone for your comments.

    The slide show is something I found online. I thought there were some actual RULES - because I got a finding for GDP during a customer audit. I had used continuation marks and was told that this was not allowed.
     
  8. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    119
    Likes Received:
    56
    Trophy Points:
    27
    Thanks for the clarification
    @Nikki .

    I would ask (require) to have your auditor state the exact requirement (the clause and verbiage) that he/she is claiming a non-conformance against. It would be unwise to “add” unnecessary work for your teams in response to a “nonconformance” that is based simply on the auditor’s opinion (which this sounds as it may be).

    Be well
     

Share This Page