1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
  2. 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.

4.2.3 Control of documents

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by wywy2020, Oct 9, 2015.

  1. wywy2020

    wywy2020 Member

    Joined:
    Sep 23, 2015
    Messages:
    13
    Likes Received:
    2
    Trophy Points:
    2
    is it a must to performa a procedure review within a certain period? e.g. every 5 years a review must be done to determine it is still valid and with up revision if there is a necessary changes.

    Noticed that some company put a rules that a validity preriod of 5 years. It is their internal requirement on their documentation precedure?
    i did not see a clear requirement on ISO9001 on the document validity.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,685
    Likes Received:
    860
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Nope! It is common - in certain industries to do this, I've learned. Some consultants who have worked in those industries seem to think it's a good idea, but in 40 years of being in quality management in all capacities, I've never found a compelling reason to waste time doing this...
     
  3. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    As Andy says it is not a requirement, but it is common place to have a review period.

    The main reason I have come across for this is the standard problem of a procedure being written and never looked at again and over time the actual process slowly changing from what has been documented. In having a review period, this ensures that this shouldn't happen.
    From my experience there are several key aspects to consider when having a review period
    1. Make sure the review is carried out by the document owner and not by QA.
    2. Don't have all documents requiring review at the same time, stagger the initial review times. If you give them all 5 years when they are first issued in 5 years time you have a lot of work.
    3. Make the review period work for you to get ownership of the system by all.
    4. Have in place a way of tracking the review periods, nothing is worse than setting a review period than not doing it.
    5. In your tracking system have an early warning process so that people no well before (possibly 6 months) that a document requires review.
     
    Jennifer Kirley likes this.
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,685
    Likes Received:
    860
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    If this happens, what are the internal auditors doing? Shouldn't they be detecting this? Adding an extra (boring) review instead of making the internal audit do what it's supposed to do, is, IMHO, silly.
     
  5. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    I agree that is what should be identified at internal audits, but doesn't mean that this doesn't occur. I have found in several companies where out of date documents is an indication of a bigger problem.

    What I have found is getting the document owners to review their documents brings them in to owning them and therefore nothing to find at internal audit as they want them to be current.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,685
    Likes Received:
    860
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Well yes. But why not address the internal audit programme to them as a way to provide feedback to them on the state of their documents - instead of hoping to make them own something through a review which could be 11 months and 28 days (too) late?

    Please don't lose sight of the fact that often the documents were created without these people's ownership, plus the documents were often created as a bureaucracy and changing them isn't a simple process. THEN you force them into an annual review? IMHO there's something fundamentally wrong with the QMS "as designed" and as a result we force the users to do these meaningless (in their eyes) tasks...

    Give them a break, and use the internal audit programme to head off the issue.
     
  7. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    The key issue was lack of ownership of the quality system. It was seen as being the responsibility of QA and the would maintain the system. The action taken involved trying internal auditors, raising actions against the departments responsible for the. documents that hadn't been reviewed, then working with them to resolve the issue. It took time but it was understood that the QA system was everyone's responsibility.

    The big question was how this issue had not previously been raised at certification audits.

    As you point out the internal audit should be used to head off the issue but if this is broken as well you need to start somewhere
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,685
    Likes Received:
    860
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    I'm not sure it's a "big question". People live with mass murderers and apparently never know. Expecting an auditor who spends a few hours a year to pick up on "ownership" is a tough call to make on someone.

    Making someone read a document once a year doesn't promote ownership. Fix that and also fix your internal audits so that you reinforce the ownership...
     
  9. Nikki

    Nikki Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    237
    Likes Received:
    134
    Trophy Points:
    42
    Location:
    Maine
    Wow... I'm not sure why I never caught onto that. Our system has us reviewing all of our procedures annually!!! :oops::eek::mad:
     
    Andy Nichols likes this.
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,685
    Likes Received:
    860
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    It's OK Nikki! We used to send 8 year olds into mines to work. We learned to do things better...
     
    Nikki likes this.
  11. Pancho

    Pancho Active Member

    Joined:
    Jul 30, 2015
    Messages:
    73
    Likes Received:
    80
    Trophy Points:
    17
    Location:
    Cypress, Texas, USA
    There is no need for periodic review by process owners if procedures are actually being used.

    Every time someone uses a procedure, it is being reviewed. Make such reviews count by empowering users to update procedures. Then they will really feel ownership and the docs will remain fresh.
     
  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    598
    Likes Received:
    432
    Trophy Points:
    62
    Location:
    USA
    Internal auditors should absolutely be looking at this, but may not be able to review the entire documents. When I was internal auditor, some of the process instructions were over 100 pages and very technical.

    An additional question is: do you want process documents to wait until a regularly scheduled audit before they get reconciled to practice? The standard asks that definitions of process are in place, which I take it means in between audits as well as a result of audits. Ideally the documents would get updated at the time of changes, but a periodic review could be done to see if that's happened.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,685
    Likes Received:
    860
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    I'd suggest that 100 pager work instructions are fairly rare. If you schedule audits to some artificial 12 month based calendar (which is neither required nor effective) you will be tempted into doing similarly artificial reviews. As I said, with anything done once a year, why would someone want to discover 11 months and 28 days days later, something was amiss?
     
  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    598
    Likes Received:
    432
    Trophy Points:
    62
    Location:
    USA
    That is why process owners absolutely should change their documents at the time the changes happen. In most cases I agree a 1-year period is too often for a scheduled review. I also agree that many of them are ineffective, as I've observed document owners don't tend to notice errors in their own work.
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,685
    Likes Received:
    860
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Actually, the more I think about it, it shows that the "Quality Planning" requirement isn't robust, if documents and practice diverge (when changes are made), that document control isn't well linked to the planning requirement (how many organizations have a "pilot" process to try out a change) and that the new standard should tighten up on this, with the process change control requirement.
     
  16. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    598
    Likes Received:
    432
    Trophy Points:
    62
    Location:
    USA
    I believe the next version is trying to do that by referring to managing change.
     
  17. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    I agree with all the comments about annually review and ownership and pressure on auditors.

    I was explaining some of the issues that I have encountered with document ownership and review. The worst case I have come across is documents that were over 5 years old and not been reviewed. This was a result of a lack of ownership and the view it was QA's responsibility. By putting in a review period and asking for the documents to be reviewed it started the QMS ownership being taken on board across all areas and not just QA's

    This was just part of the whole process of getting the QMS ownership in the right place.

    I still have a review periods on documents, but as we have a fully operational QMS none reach these dates.
     
  18. Rich008

    Rich008 Member

    Joined:
    Sep 13, 2015
    Messages:
    23
    Likes Received:
    16
    Trophy Points:
    2
    Location:
    North West - UK
    My take on this is as follows:

    Question: why check them?
    Answer: to ensure they are correct, because things may have changed.

    So I think, documents should be reviewed when:
    • a process changes - review relevant documents
    • changes to the business KPI(s) - does the current systems address the changes
    • new equipment introduced
    • management changes
    • new business IT systems introduced
    • changes to international standards
    • after customer complaints and/or 8D reports - process flow - FMEA - Control plans - SOP etc
    • site moves - new site locations
    • work force changes - reduction and increases
    • new products introduced
    Hope you are on my wavelength... if not, be nice ;)
     
    Andy Nichols likes this.
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    1,685
    Likes Received:
    860
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Interestingly enough, ISO 9001:2015 now requires AUDITS when changes are made, so the need for document review in isolation is even less needed. All the above are also Quality Planning topics, so documentation should have been dragged out and used to review as a means to control the changes...
     
    Rich008 likes this.
  20. Pancho

    Pancho Active Member

    Joined:
    Jul 30, 2015
    Messages:
    73
    Likes Received:
    80
    Trophy Points:
    17
    Location:
    Cypress, Texas, USA
    What clause requires audits when changes are made, Andy?
     
    Sidney Vianna likes this.

Share This Page