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Program of requirements for quality internship

Discussion in 'Other Quality and Business Related Topics' started by Bastiaan, Mar 29, 2021.

  1. Bastiaan

    Bastiaan New Member

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    Hi, i'm new on the forum and I came here because I wanted some help with my internship.

    I am doing an internship in an injection moulding company where I am to set up a QMS. Right now there is barely any information about the production process we're running and it is done mostly on experience of our operator. My task as a mechanical engineering intern is to get insight into our production process. So think about making a dataset in which we can record weights, product numbers, process inputs and outputs etc. The idea is to structure all these kinds of data to eventually be able to find process improvement points and also to help get overall better insight in the processes within the company. The goal is to be able to prevent delivering non-conforming products to our customers and to better our own processes. I am working in line of ISO 9000, but my assignment is not to get the company a certificate.

    The problem I am encountering is actually with the report I need to write for my school. In the 'starting document' I need to write about the introduction of my assignment, the background, the purpose etc. One of the most important things of this document is setting up a program of requirements. I find it very difficult to write requirements for a QMS which are exact and can be tested to see if a requirement is met or not. This is the point on which I failed my first attempt of the report.
    To make the program of requirements I did some analysis in the company like a 5W2H, I analysed the purpose of the assignment and I set up a list of customer wishes for the QMS. Though those things did give me a lot of insight, I still can't really convert this info into actual requirements. I feel that the requirements are a bit vague and not really exact.

    I wondered if anyone here might have any tips on how to write actual requirements for a QMS which can be measured/checked at the end of my assignment. I would really appreciate some help :)
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome! The use of an ISO 9001-based QMS is frequently confused and conflated with the need for a certification, instead of the actual use to an organization - effective process controls!

    The use of a QMS can be "measured" in terms of the changes from the "as is" state of the organization - viewed through measurables such as process yield, timeliness etc and the after state. One organization of 6,000 people I am familiar with saw a 42% improvement in first time yield from their processes by simply writing down the instructions for building a product, across all 3 shifts.

    The clue is to base what you want to measure and the data derived should be based on the two foundational principles of "In Specification" and "On time" = "O.T.I.S" Specific goals can be established at critical core and support processes with the molding process which gives you good information about the process. That may be reduction of defects, such as cold welds, short shots, flash etc or mold-tool change over etc.
     
  3. Bastiaan

    Bastiaan New Member

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    Thank you for the quick reaction!

    Reading your reaction gives me a few thoughts. How can I set goals when I don't really know the as-is state of the organisation. Of course I can map the processes and such, but I have no information regarding the processes and their specifications in the past. At most I can find past invoices and machine settings which are not up to date and thus not fully correct.
    It is true though that in order to measure the effectiveness of a QMS you can measure/analyse things like process yield etc.

    An example of a vague customer wish which I find difficult to translate to something exact and measurable:

    The quality system is supposed to give insight into our production process.

    When I hear things like this I wonder: How do I measure insight? Can I even give an exact unit or goal to this? How can I translate this wish into one or several requirements which can be checked/measured?

    I am used to designing products, constructions, machines and parts and there it is a bit more straightforward to make requirements. I think that is why I find this change in field of work difficult.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You don't! The person who is responsible for a process - let's stick with moulding - should know what the process is yielding. Although not always so, each product from each machine should be capable of yielding so many good parts, (often for a known input of "X" amount of raw resin etc.) If the person responsible for production doesn't know this, then the process(es) should be studied. Once the actual yield is known, then targets can be set, recognizing that, on occasion, processes may not yield 100%, so something lower may be (financially) acceptable. It will be given that the "good" parts yielded will meet the agreed specification.
     
  5. TWhite

    TWhite Member

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    I would suggest that if the goal is to "prevent delivering non-conforming products to our customers and to better our own processes." then start with basic process tools such as an FMEA and Control Plan. The FMEA will identify pitfalls of the process and the control plan will identify specifications of the product (Product Drawing), targets and limits, what, when and how measure. This provides a framework for protecting the customer from receiving non-conforming product. Be sure to add visual work instructions so that the molding associates know exactly what they are looking at when they go to measure (training is important at this point). Always be consistent with the measurements as well as across all shifts. Also, add a product audit into your plan that way you can capture things like product traceability, identification and labeling.
    As you work through your assignment don't get caught up in trying to bite off to much. Just stick to manufacturing basics. Good manufacturing basics are making the product right the first time.