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SOP/Work Instructions

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by KyleG, Nov 29, 2018.

  1. KyleG

    KyleG Active Member

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    Im wondering if i can use 2 sop's to cover my work instructions, i have 2 separate production lines and each "produce" we'll say 45 different products, am i allowed to make a flow chart that is a general SOP or do i have to actually create a SOP for each set of work instructions. it seems repetitive as i would just have 45 ish "flow" documents. maybe im missing something with what a "SOP" is. any advice is appreciated.
     
  2. Stanley

    Stanley New Member

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    I worked for a company that referenced their SOPs in the Quality manual as Non-controlled (General Instructions). I was an internal auditor with that company and this was never Questioned by an External auditor.
    So I guess you could reference the SOP in a work instruction. Include that the SOP is Not controlled. Make sure the SOP does not have a document/form number and I think you'd be good. If the SOP is not retainable Quality record, is does not need control.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome!
    This is NOT justification for making the decision on controlled documents! The standard is very clear and always has been. Documents which form part of the QMS MUST be controlled. Relying on an external auditor is totally wrong. They often know less than you do about what the actual standard says, or have dreamed up some bizarre interpretation.
    Yes, because no documents have to have either. They still have to be controlled.
     
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  4. Golfman25

    Golfman25 Well-Known Member

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    You might be overthinking it. How do your people know how to make each of those 45 products?
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Typically, SOP means "Standard Operating Procedures". It's an "old school" terms which has its roots in the military/regulatory QA world. When you say "Im wondering if i can use 2 sop's to cover my work instructions," what do you mean?

    Procedures usually describe how a process is performed - in fact it's a standard definition which (was) in ISO 9000. It's in congruent to use procedures to describe activities which are usually in work instructions.
     
  6. KyleG

    KyleG Active Member

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    For example, normally a work process will go through a b c d process i am defining the SOP as these are the standard set of work instructions and then linking my work instructions into the SOP. I can email you an example Andy, if im not making sense
     
  7. KyleG

    KyleG Active Member

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    Through work instructions, the products change and very small details change in each of the work instructions, PSI for sand blasters. Most items go through a specific flow through out the shop but some skip "side steps" i don't have to wash all of the parts that go through my shop but 20% of them i do before i can begin the SOP
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Typically, in manufacturing, the overall process flow the product takes, is defined in a (planning) document called a "Router", 'Job Ticket" or similar. It is a list of the various operations that a component or assembly would logically follow. It may include items like "Op 10 - saw to length" and would provide a cost center, duration etc so that work can be costed. Any detailed activity like an assembly operation, inspection or test is often referenced to a work instruction. Does this help?
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yeah, why not. Send it to anicholsqa@gmail.com
     
  10. KyleG

    KyleG Active Member

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    with using a router (currently we call them travelers) that can be an SOP? saying for this particular item it moves through our manufacturing process this way.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not if you want to align with commonly used terminology or the definitions of ISO 9000. A traveler is the plan of how an organization will "realize" the product (to use old ISO terms). It's NOT how a process is carried out because it often lists many, many processes and even indicates when a process is out-sourced. It's a plan, pure and simple.

    Frankly, you can call it what you like, but beware that many other people will be confused by your "new" terminology.
     
  12. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @KyleG ;
    1- In regards to "am I allowed to make a flow chart", the answer is YES, absolutely. The current (2015) version of ISO 9001 no longer requires procedurs (although they are certainly helpful in many cases), and ISO 9001 certainly does not dictate what type of document formatting you use. Remember to act selfishly on the behalf of your organization...(i.e. do all things for the good of the organization and NOT for the auditor).
    2- In regards to your comment "it seems repetitive". I would council that you definitely should not repeat information in multiple documents. You can "point" to another document, but if you actually repeat the information you will create a document control monster (i.e. how to locate and change ALL redundant locations of repeated information?).

    If you are going to create documents (i.e. procedures, instructions, etc...), then consider this:
    "Procedure"
    In my professional experience, a "procedure" (or whatever you want to call them) can be helpful when you are wanting to ensure sustainability (i.e. when people come an go from the organization). A "procedure" in this example is a very macro level and simply identifies WHO- does WHAT- and WHEN. This will help to ensure that WHO-WHAT-WHEN is maintained if/when people come and go. In this example the documentation/verbiage would be VERY brief and would avoid detail on HOW to do something

    "Work Instructions"
    In my professional experience , a "work instructions" (or whatever you want to call them), can be helpful when you are needing to define HOW something is done.

    Here is a somewhat silly but poignant example:
    It is important to the organization that COFFEE is made every morning. In order to ensure this, COFFEE making is identified as a role of the Quality Manager (since everything else seems to land in his/her lap).

    The procedure, therefore, may look like this...
    Purpose: To ensure we ALWAYS have coffee
    Scope: This procedure applies to caffeinated coffee. (This procedure does not include tea, cocoa, or [heaven forbid] DECAFFEINATED coffee)
    Responsibility: Proper implementation, use, and maintenance of this procedure is the responsibility of the Quality Manager
    Procedure:
    1- Each working day, prior to the start of normal business hours
    (WHEN), the Quality Manager (WHO) will make a full pot of coffee (WHAT).

    In this example, you would probably conclude that a work instruction (HOW) is not needed. However, replace the term "make a full pot of coffee", with "start the reactor", then indeed, a work instruction may be needed.

    Hope this helps.


     
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  13. Golfman25

    Golfman25 Well-Known Member

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    Why do you need anything more than what you have? You have instructions, travelers, whatever, for each part. Of what value is a separate "sop?"
     
  14. KyleG

    KyleG Active Member

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    i came to this conclusion about 2 hours ago and talked it over with my production manager that wanted the "SOP" so were washing our hands of using an SOP.
     
    Last edited by a moderator: Nov 30, 2018
  15. Neo113016

    Neo113016 Member

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    @KyleG Keep it simple. Always keep in mind to question "Why?" you need to document a SOP or work instruction.
     

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