1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
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.

Control of Records

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jamescrockford, Dec 7, 2018.

  1. jamescrockford

    jamescrockford Active Member

    Joined:
    Aug 1, 2017
    Messages:
    69
    Likes Received:
    18
    Trophy Points:
    7
    Hi guys,

    I am in the process of writing a new procedure for control of records and just wanted to ask for any best practice advice around identification, storage, protection, retrieval, change control, disposal etc.

    Thanks.
     
    jamescrockford, Dec 7, 2018
    #1
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,227
    Likes Received:
    2,613
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Tough call, James. "Best practice"? What medium are you speaking of? Paper? Digital?
     
    Andy Nichols, Dec 7, 2018
    #2
  3. jamescrockford

    jamescrockford Active Member

    Joined:
    Aug 1, 2017
    Messages:
    69
    Likes Received:
    18
    Trophy Points:
    7
    Hi Andy, its digital medium.

    I've written a document that outlines the following;

    Identification (but this section is very general i.e. records should be adequately and appropriately identified and described e.g. title, date, author, reference number etc.)
    Storage
    Protection (against loss, confidentiality, improper use and unintended changes)
    Retention (by type e.g. customer data, H&S, Quality etc.)
    Disposal
    Review

    I don't have anything in there about control of changes i.e. going back into a record and updating it
     
    jamescrockford, Dec 7, 2018
    #3
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,227
    Likes Received:
    2,613
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Identification - to me this is file naming convention. I'm not certain all those things you list apply.
    Storage - this is where you can find the above mentioned files.
    Protection - who can access, read/write etc.
    Retention - how long do we keep them in active files on the general (server) storage? Any archival/back up considerations? Disaster recovery? See protection above.
    Disposition - who decides what/when to archive etc.

    Records should NEVER be changed, esp. digital records.
     
    Andy Nichols, Dec 7, 2018
    #4
    tony s likes this.
  5. jamescrockford

    jamescrockford Active Member

    Joined:
    Aug 1, 2017
    Messages:
    69
    Likes Received:
    18
    Trophy Points:
    7
    Thanks Andy. My procedure reflects the vast majority of your comments which is good to know.

    Understood re identification - a naming convention is what I was alluding to but I haven't specifically stated it as at the moment a naming convention hasn't been decided other than for our procedures and forms. I am trying to say that records should be clearly identified in a way that makes retrieval straightforward. Do you think this even needs to be included in the procedure?
     
    jamescrockford, Dec 7, 2018
    #5
    Andy Nichols likes this.
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,227
    Likes Received:
    2,613
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Well, if you want everyone (Process Owners) to be responsible for their own records, then yes. If you make a Process Owner for records, then not so much.
     
    Andy Nichols, Dec 7, 2018
    #6
    jamescrockford likes this.
  7. jamescrockford

    jamescrockford Active Member

    Joined:
    Aug 1, 2017
    Messages:
    69
    Likes Received:
    18
    Trophy Points:
    7
    Also, I have already written and published a document for the "Creation, Issue and Control of Procedures" but also need to write one for Document Control in general i.e. how we control all types of documents other than procedures. Any advice on this would also be welcomed.
     
    jamescrockford, Dec 7, 2018
    #7
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,227
    Likes Received:
    2,613
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Yes, you already have a procedure, just rename it because document control is document control, regardless of the category of document.
     
    Andy Nichols, Dec 7, 2018
    #8
  9. jamescrockford

    jamescrockford Active Member

    Joined:
    Aug 1, 2017
    Messages:
    69
    Likes Received:
    18
    Trophy Points:
    7
    Understood but there are some differences...the way I have written this procedure is very specific to the process of writing, issuing and controlling procedures (e.g. references a master procedure index, reviewed by Quality Manager prior to approval by senior manager, training on new/amended procedures, annual procedure review by managers etc). This would not be applicable to some other documents.
     
    jamescrockford, Dec 7, 2018
    #9
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,227
    Likes Received:
    2,613
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    So, build in the alternatives. don't make a bureaucracy for the (small) differences.
     
    Andy Nichols, Dec 7, 2018
    #10
  11. jamescrockford

    jamescrockford Active Member

    Joined:
    Aug 1, 2017
    Messages:
    69
    Likes Received:
    18
    Trophy Points:
    7
    Absolutely agree...thanks.
     
    jamescrockford, Dec 7, 2018
    #11
    Andy Nichols likes this.
  12. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,353
    Likes Received:
    1,059
    Trophy Points:
    112
    Location:
    Laguna Philippines
    I believe the same procedure can be used for other types of documents like manuals, policies, work instructions, flowcharts, control plans, drawings, even forms.
     
    tony s, Dec 23, 2018
    #12