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A few questions about ISO 9001:2015 8.5.6 and 7.5.3

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Devin A, Oct 16, 2018.

  1. Devin A

    Devin A New Member

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    Hello, I pretty much got thrown in the deep end here. I took over the quality department in our machine shop when our quality tech left for another job and our quality manager got laid off. I had no previous experience in quality and now we have an ISO 9001:2015 surveillance audit coming up. I'm struggling to wrap my head around a few of the requirements and I would love some direction from those of you more experienced and knowledgeable than I am in this so I can hopefully salvage this situation.

    8.5.6 Control of changes:
    Does this apply to all changes to all controlled documents? If no, what does it apply to? If it is not all controlled documents then my interpretation would be anything directly related to the process like work instructions. Is any documentation required for the change outside of a log with the specifics mentioned in the clause? For example, do we need a "document change request form" to be filed and kept? Or just a log of the results?

    7.5.3 Control of documented information
    Specifically the retention part. Do we need a document retention log of sorts to show what documents we're retaining and for how long?

    I would really appreciate any input. Trying to learn this stuff on the fly on such a short time frame is frying my brain
     
  2. BufferMess

    BufferMess Member

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    Hello.

    8.5.6. refers to changes to the operations related to production or service provision.

    'Document Change Request Form' is related to '7.5.2 Creating and Updating'. It is used to review and approve an application for revising a documented information before updating it. If the document is related to your operations, then you should consider change management before the update takes effect.

    Change Request ----> Document Change Request ----> Review/Approval ----> Updating the Document ----> Communicating the Change ----> Releasing the Revised Document ----> Controlling the Change ----> Evaluating the Results

    As for the 'document retention log', you should determine types of records you're going to retain and duration of retention for each record.
     
  3. judegu

    judegu Active Member

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    @Devin A

    Hi, welcome to the quality world. Quite curious what postion you got (quality manager?).

    Here is my opinion regarding the questions you have raised.

    Firstly, 8.5.6 Control of changes
    Let`s begin with what the BOOK has told us. "The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements." Here "to the extent necessary" means you can make the decision regarding what kind of changes should be reviewed and controled. Of course, it is my understanding.
    However in my real life, if there is any word, even a typo, has been changed(corrected in the typo case) in the controled documents, the change will go through review process. We have a change managment matrix to tell which kind of control is needed on each type of the changes even for changes to correct typos. The document change request form you mentioned is highly recommended. Just a log seems to be not enough.

    Secondly, 7.5.3 Control of documented information
    The documented information which is being retained is basically the record to demonstrate what you have done to conform to the QMS, to show the confidence that the requirements of the QMS are indeed met. If there is no requirement ON PAPER to determine which kind of information should be retained and how long we should retain it, how can we do the retain thing correctly? In my company, what we should retains and how long we should keep it is always determined in the corresponding documented quality procedures.

    The above is my answer to your questions. Hope it wil be helpful. ;)
     
  4. Devin A

    Devin A New Member

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    I really appreciate your reply. As for the position I got, I believe my official title is "Quality Technician" or something along those lines? I'm filling the role of Quality Manager though. It's been an interesting ride.
    I got about a week of training with the old quality tech before he left for his new job. I was an operator out on the floor beforehand, about a year of experience.
    Shortly after that they laid off the quality manager without warning and had me fill her position with zero training on that side of things.
    Been winging it the best I can haha. It's gone quite well so far, as it's mostly been communicating with customers when there's a problem, and letting people on the floor know when they're making garbage and how to fix it!
    Unfortunately with this audit coming up, I'm now WAY out of my depth. Trying to get us through it, even if just by the skin on our teeth. Thankfully the Vice President of the company is heavily helping out. We just might make it!:eek:
     
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  5. Artem

    Artem Member

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    Hi Davin,
    I have drafted a small explanation of the changes process (attached). Please note that 8.5.6 is not a documentation changes clause. Documents can relate to it but not only them

    As for the retention - it is a Common and good practice to have a log of documentation stating the review date, place of storage and for how long it is stored. By the way it’s a good example to illustrate the 8.5.6 in the context of documentation: let’s say you have a new customer who required you to store retained documents for each and every production operation including product release - and this shall be stored for 8 years! Depending on the turnover and documentation complexity you may need terrabytes of memory. Are you ready for such a change - which risks/impact it will have on physical space, personnel, investments. Just an example

    Best regards
    Artem
     

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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm sorry, but I can't agree with either of these assertions. Firstly, you have not been clear on what TYPE of documents you are suggesting are retained. Are you saying ALL types of documents or simply records? The retention part has always been about records - and not plans, procedures, instructions, manuals etc. I've never seen in 30+ years in the UK and USA, anyone keeping a log of documents with review date/place of storage and length of storage. In many cases, this information is either IN the procedure/instruction which generates the record or in a Records Control Procedure. Of course, we don't know your location, however I'd recommend caution about what is suggested as any kind of "best practice" on a few observations.
     
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  7. Artem

    Artem Member

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    Who gave „best“ practice?! I gave a „good“ only. Why you never read my posts with attention Andy? ;)
    For medical products you need to preserve procedures too (iso 13485:2016 clause 4.2.4). Even though Devin‘s company may not be a certified medical company it may be supplier to it. Which will force the medical client to make sure their suppliers are keeping all the documents as per p.7.4.2.
    And even despite all that - have you never in 30+ years experienced a non conformity because some procedure was retained more than necessary and used where not necessary ?)
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Never found that to be an issue in running a QMS. If it's not flowed down, why would you put such a system in place? Like creating a monster and feeding it.
    Never! Retaining procedures? Used where not necessary? I can't imagine even the worse ISO 9001 auditors creating an NC based on that. They'd be laughed off the client site...
     
  9. Artem

    Artem Member

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    Non conformity per se is not only audit topic, but ok...
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm willing to learn: How else would such a non-conformity exist, without an audit?
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You missed my point in total. It's NOT as you claim - in certain countries and markets. I'm guessing your experience isn't in the UK & USA, which are 2 markets which lead ISO implementation by about 10 - 15 years. Plus, unless you are a consultant or auditor and see many, many, many implementations, the vast majority of individuals get to experience one, two, three implementations - maybe four or five in extreme situations. Therefore, to discuss what's "common" or "good" practice is drawn from a very small sample. When - as in my case - all but 9 years since 1987 have NOT been involved in both auditing and consulting across a significant number of industries and markets, I feel reasonably experienced in providing some feedback for our readers on what might be considered "common" and also "good" practice.
     
  12. judegu

    judegu Active Member

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    Yes, that is right. The change management is not just the control of the documentation. If a change relevant to product or service provision, as long as you deem it important in terms of ensuring continuing conformity with requirements, no matter there is a document for it or not, you should put it into change review process.
     
    Last edited: Oct 18, 2018
  13. Artem

    Artem Member

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    Wow... „since 1987“, „one or two experiences“. I thought we are talking about quality here, not quantity.
    P.S. good that you draw a perfectly reasonable statistically trustable qualitative conclusion (i.e. „I guess“) about my position, location and number of experience years :)
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This has been taken off the rails. Please let's get back to a discussion about the OP's question. It's not about what's "good" and "common" practice. It's about an effective system.
     
  15. tony s

    tony s Well-Known Member

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    Not really. 8.5.6 applies to changes during production or service provision. Changes at this stage can occur due to various factors (e.g. variation order by customer, quality issues, critical equipment failure, labor issues, force majeure, etc.). Since the intention of this clause is "to ensure continuing conformity with requirements", the organization should have controls in place when factors that could lead to changes happen.
    Most, if not all, organizations do this. However, this requirement applies to documented information that we "retain". On the previous version of ISO 9001, these are called "records" (see A.6 of ISO 9001:2015). Retention periods could be a customer, statutory/regulatory, or contractual requirement or as determined by the organization.
     

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