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Best practice in tracking changes in Records

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Jimqa, Nov 15, 2021.

  1. Jimqa

    Jimqa New Member

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    Dear all,
    I have a few months in a new job, and I am a quality person in a company that is going to be 13485 certified.

    I have a question regarding controlled documents and changes recording

    Each form has a changes recording table along with a version number. Each time the form changes, the changes are recorded and the version is changed by 0.1
    So far so good.

    Now let's talk about records. We have two types of records:
    A) Records that originate from a form, and
    B) Records that do not originate from a form

    A former collegue of mine, that has now left the company, had told me that I should only keep changes log in type B records and not in type A.
    Of course I always state clearly the version of the form the record is originating from as well as the version of the record.

    This is somewhat confusing and I think it is prone to error.

    Is there any advice on keeping track of changes in records, type A or type B or in all types? What is the best practice?

    At last since I don't have much experience and I haven't understood basic notions (like the above) what would you recommend for training and becoming a better quality person?
    Online seminars? Books? Any suggestion?

    Thank you
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hello Jimqa and welcome:

    First of all, we should be clear that records should not be changed (usually). They are (should be) records of fact (data) and not should not be edited in any way, after the data has been recorded.

    Recording changes made to documents isn't the same thing, of course and although it's common to make a record of changes actually in the document, usually in some kind of table at the end of the document, it's not a good way to do it and there are better ways. But that's a topic for another thread.
     
    Last edited: Nov 15, 2021
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  3. yodon

    yodon Well-Known Member

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    I have come across many cases where (data recorded in) records do need to be changed, for the right reasons. Changes need to follow good documentation practices (ALCOA / ALCOA+). Whether a record originates from a form is irrelevant. It's all data.

    Now if you're changing the (controlled) form (e.g., deleting a field or adding a field), that's a different story.
     
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  4. Jimqa

    Jimqa New Member

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    Thank you @Andy Nichols for the warm welcome and for the prompt response to my question!
    I don't quite understand this notion of record should not be changed. For example the Instructions For Use for a product is a controlled document, a record. Today based on some changes in the design of the product, I need to ammend something or delete or correct something. As far as I understand this would result into having the old one and the new one, both records, but with distinct version number and date. Is that bad practice? How else can I do it?

    @yodon thank you for your reply. I didn't know about ALCOA principle, but I will surely adopt it into my daily routine. Thank you
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Jimqa, we're happy to have you here and help.

    In my experience, something like "Instructions for Use" is "maintained documented information" (as the ISO 9001 requirements refer to it) and not "retained documented information" (a record"). It is merely a document which specified instructions for use, like a plan, more than anything. A record might be a document which is completed for an activity which needed to be checked and recorded/reported when carrying out the instructions. Does this help?
     
    Last edited: Nov 18, 2021
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  6. Jimqa

    Jimqa New Member

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    I didn't have in mind at all the difference between those types of documents! I thought that they are all records.
    I understand now the notion of recording information and creating a record and yes, I agree, that these should never be changed e.g. the daily temperature log of a storage location.

    One thing is for sure. I lack training on basic quality notions and definitions.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Don't worry! It's not uncommon for people to be somewhat confused. The last version of ISO 9001 attempted to clarify (the ISO 13485) terminology of various documents and records but IMHO just muddied the waters even further. It's possibly easier to think of types of documents as "planning" and "results" documents. Policies, procedures, instructions etc are all what an organization plans to happen. Records are usually the results of the plans in action.
     
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