A Case for Mixed Model Line Design in Complex, High Mix, Electronics Manufacturing

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Manufacturing facility design is like puzzle-solving, where managing space and operational efficiencies can pose a challenge – especially during periods of growth.

Do we carve out more manufacturing space within our existing facility? Do we acquire more manufacturing space? Or do we continue to find new ways to optimize existing product flow?

At Creation, the manufacturing model as we know it is largely based on triggers to build right-sized batches that are built on dedicated and segregated lines. We often get requests from our Production Team Leaders for more floor space and workbenches when we partner with a new customer or launch additional programs. At first glance, this expansion can seem necessary to avoid mixing products on the same workstations.

So why is it that auto manufacturers can build a seemingly infinite number of different products all on the same production line, sometimes concurrently, and ramp up and down (within reason) without having to expand?

In my role as Continuous Improvement Coach in our Vancouver manufacturing facility, I’m continually looking for solutions that make our production processes flexible and scalable while factoring in existing space constraints.

Luckily, this is also a hot manufacturing industry topic and there are many good ideas being shared, like at the Mixed Model Line Design workshop I and some other process minded team members attended, hosted by Toyota and facilitated by the Leonardo Group.

At a high level, Mixed Model Line Design is a Lean manufacturing methodology to optimizing the value streams of multiple, similar products with mostly the same workstations and equipment, at the highest possible productivity level, without compromising quality.

The specific focus of the Toyota-Leonardo Group workshop was optimizing product flow to scale with customer demand, accelerating the production process with more predictability.

Here are a few takeaways that resonated with us as transferable to Creation’s manufacturing environment of complex electronic devices and programs.

 

Design Thinking: Get Granular

In Creation’s Lean Manufacturing environment, we are always thorough and intentional in designing our work cells and manufacturing lines to achieve maximum efficiency.

This process involves Product, Process, Test and Quality Engineering, our Production Team, and often our customers. We break down our processes, balance all work elements, and design flow and workstations for optimal floor space usage. But we can get even more granular.

For example, our supply chain team procures materials from our suppliers based on a Plan for Every Part (PFEP) strategy. Once materials reach Creation, we’ve optimized the process by which they are delivered and replenished to our manufacturing cells at line-side stock.  We can take it a step even further to optimize the process by which those materials are delivered to each operator in the cell at their point of use.

Similarly, we can design in more specifics around how product moves along the production line. Today we consider quality and inspection criteria, ergonomics and sequence, but we could also specify how many pieces at a time, or whether they’re on a tray or in a box at the point of transfer.

We can also design flow based on a multitude of factors that affect a line’s ability to meet takt time (the maximum amount of time in which a product needs to be produced to meet the pace of customer demand).

I think you get the picture.

 

Lean Thinking in Action

Our test case Production Team was apprehensive about trying something new, but after trialing Mixed Model Line Design in one cell with one product family to assess its effectiveness, they are excited about the promising results seen so far.

  • The team has increased capacity by 100% on the target product family. Increases have also been noted for other products, even before a focused effort to optimize.
  • Footprint has been reduced by 570 sq. feet or 10% of previously occupied space.

Who knows? All of our Production Team Leaders may soon be asking for Mixed Model Line Design in their own areas instead of more floor space and benches.

Stay tuned for a follow-up post on our progress and results.

 

 

10 Things You Need to Know about Manufacturing FDA-Approved Medical Devices

Manufacturing FDA-Approved Medical Devices
There are many critical elements to quality manufacturing of FDA-Approved medical devices

The purpose of the Food and Drug Administration (FDA) is to safeguard the health of the American public through the regulation of certain products, including medical devices and food-processing equipment. Health Canada has a similar mandate.

The FDA and Health Canada have full federal authority to ban and recall any products deemed dangerous.

They can also suspend or revoke registration or licensing of an establishment, effectively shutting down manufacturing facilities. Investigations can lead as far as criminal prosecution.

As outlined in a Business Case for Quality at a recent Pharmaceutical Quality System Conference, there are many costs of non-compliance, including:

  • Direct costs (e.g. scrapped materials, production time)
  • Remediation costs (issue identification, correction and reporting)
  • Regulatory action costs (legal, logistical)
  • Market share costs (lost opportunities)
  • Reputational costs (loss of goodwill)

According to FDA regulations, “the finished device manufacturer”, or the OEM, “bears overall responsibility for the safety and effectiveness of the finished device and must control all contractors under 21 CFR 820.”

It’s obvious that a government-issued, publicly visible ‘stop-production’ order can be catastrophic to a customer base, a brand, and a bottom-line.

So how do OEMs evaluate their processes and supply chains when commercializing a new medical device?

And how can OEMs looking for a manufacturing partner for a medical device assess whether the EMS provider is compliant with the Quality System Requirements and Current Good Manufacturing Practices critical to passing an FDA audit?

We can offer some tips based on our own experience manufacturing FDA-approved medical devices and other products in highly regulated industries.

 

3 Things You Need to Know about
Manufacturing FDA-Approved Medical Devices

    1. A Gap Analysis Will Protect Your Investment

      Knowing the right way forward begins with understanding your current state.

      A Gap Analysis will require you to have an intimate understanding of the regulation and identify where you have procedural inadequacies.

      A good manufacturing partner will ultimately help you address some of these gaps.

        • Go through each step of the regulation.

       

        • Identify and size up the gaps in your documentation system first, then look at the implementation gaps.

       

      • Find an expert resource for advice, don’t reinvent the wheel. Consultants and other resources are available to help you address a particularly weak area.

 

    1. Get Your Team On Board

      Similar to many practices that stem from technical initiatives, it’s not enough if it’s only the management team that understands the implications of the regulations. We can’t stress this enough!

      Everyone with their hands on FDA-approved product needs to understand the consequences of deviating from procedure.

      For example, a production associate may not realize the full significance of a Line Clearance Procedure…until a process deviation results in product mix-up, which results in a product recall. Or maybe until two similar labels get confused, which results in a patient receiving incorrect care.

      Waiting until the “until” is not acceptable!

        • Roll out comprehensive communications programs to connect the product with the end customer.

       

      • Ensure everyone involved in building FDA-approved medical devices understands the impact of their work!

 

Good team communications and documentation are essential elements
Good team communications and documentation are essential elements
  1. Build a Robust Training Program and Keep Complete Training Records

    There’s perhaps nothing more critical than traceability to the process of manufacturing regulated products like medical devices.

    Because of product significance and legal liability, a document trail is essential.

    More importantly, should an adverse event take place, visibility of the processes and parties involved can help save lives.

      • Ensure that you have properly defined which documents constitute your Device Master Record (DMR) and Design History File (DHF) to avoid iteration.
        (Hint: if you aren’t familiar with the DMR and DHR, go back to your Gap Analysis. Alternatively, contact our Creation Design Services team who can walk you through the development process).
      • Construct a solid system for conducting and controlling training that accounts for all people that touch your product as it’s being manufactured.

     

    • Once training is completed, make sure that your training records are well-defined and available for review by an auditor or other party.

    If you need additional resources in constructing your training program, today there are many good courses available. We recommend AAMI (Association for the Advancement of Medical Instrumentation) for a variety of programs that are taught by experienced regulatory professionals and endorsed by the FDA.

Manufacturing top-quality medical devices takes a great deal of preparation, expertise and commitment. At Creation, we know that the investment is worth it.

We are very proud to partner with medical device OEMs who do so much to employ technology to improve the lives of people around the world.

Our first blog post dedicated to this important theme outlines the first three things you should consider when deciding how to manufacture your FDA-approved medical devices. Stay tuned for the next installment!

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