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When manufacturing medical devices, errors and defects are a non-starter. Not only can a defect result in massive fines, it can also be a literal life or death situation. What’s the key to mistake-proofing medical device assembly? Rigorous, universal adherence to standardized work.
Video-based standardized work
Developing standardized work instructions is a classic part of lean manufacturing. Standardized work provides a base, a standard, “golden” way, to systematically debug and solve problems in order to execute a continuous improvement approach. Standardized work is collaboratively defined by the team — the line associates, the team leader and the industrial engineer — as the current best practice for performing a process.
Today, this approach is employed around the world and in a wide range of industries. For example, McDonald’s (or, Starbucks, if your palate so desires) is well-known for ensuring that the customer experience is the same, at every restaurant, every time. These companies do this by completing the same process in exactly the same way so that the product — whether a hamburger, french fries or a tall mocha latte with no whip — looks and tastes the same, every single time. That is the epitome and goal of standardized work.
Creating a video-based record takes this idea to the next level. There are enormous benefits to having video-based standardized work instructions, including:
It is linguistically and culturally agnostic
It appeals to millennials, who are the largest share of the workforce
It ensures each viewer gets the same information, in a common and easy-to-comprehend format
It is interactive, increasing engagement and “stickiness”
With video, you can easily share best practices on how the work needs to be done
Nuances in assembly are more visible and easily described
It gives supervisors visibility into opportunities for upskilling line associates
As manufacturing has entered Industry 4.0, technologies have matured, introducing advanced ways of developing new models that make it easier than ever to create and test standardized work.
Standardized work only works when it’s followed
So you’ve developed video-based standardized work instructions, but you still need to ensure your workers follow the training they’ve received. Here’s where video comes back into play, particularly when it’s backed by AI like Drishti. Typically, a line supervisor monitors an associate’s cycles and tries to spot deviations as they happen. It’s no surprise that this is a poor methodology, for a number of reasons:
Line supervisors get distracted — there’s a lot happening on the factory floor.
It can be tough to see exactly what’s happening at a station, particularly with small devices that are assembled under a microscope.
Particularly in a lean shop, the vast majority of cycles follow standardized work. The chances of a supervisor seeing the one or two in 100 that deviate are slim.
Even the most alert supervisor can only watch so many cycles. She has other responsibilities, multiple other line associates to monitor and only so many hours in a day. Also, is watching each cycle the best use of her time?
With technology like Drishti, each station’s cycles are captured and assigned data points that show if a step was completed out of order in real time. Before a devices makes it to the end of the assembly line, it can be flagged and either reworked, or taken out of the assembly process so more time isn’t spent on a nonconforming unit.
When standardized work adherence ensured, end-of-line inspection becomes less important, scrap rates go down, rework drops and quality costs plummet. There’s a reason standardized work is considered the “golden way” to do assembly tasks, and Drishti elevates standardized work to a platinum level.
