Win at Medical Device On-Time Delivery Performance: Control Processes

This is the first in a three-part series on how to improve medical device on-time delivery performance.

Proper control processes improve medical device on-time delivery performanceOn-time delivery (OTD) is one KPI used to measure manufacturing performance.

Medical device manufacturers should always look for ways to improve on-time delivery performance, whether manufacturing their own medical equipment or a partner’s.  Control processes, supply chain management and customer forecasting are three areas to focus on to speed on-time delivery.

Implementing the right control processes is the first OTD-domination method that we’ll discuss in the series.

Driving on-time delivery through control processes

Establish organizational control processes that include time-saving manufacturing methods, such as lean manufacturing and a robust Manufacturing Execution System (MES).

Trim delivery time with lean manufacturing

Ramp up on-time delivery performance by implementing lean manufacturing, which eliminates wasteful steps and adds control, throughout the entire medical manufacturing process.

The Houston Chronicle article Typical Lean Manufacturing Measurements by Luanne Kelchner states:

As cycle times are reduced in a lean business, the company improves its on-time delivery. A business using lean manufacturing techniques builds products only when a customer places an order. This allows the company to be responsive to the needs of its customers and decrease the time it takes to deliver an order.

This kanban manufacturing method limits the amount of inventory based on demand to ensure quicker, just-in-time delivery.

Kanban checkpoints in the manufacturing process create a feedback loop directly from the manufacturing floor to the supplier, regulating inventory turns with floor-level management.

KMC uses a two-bin kanban system for parts. When one parts bin is empty, the assembler replaces that bin with a full one from the kanban shelf and scans the kanban card, which automatically emails a parts-fulfillment request to the supplier.

Point-of-use is another key lean manufacturing process, as described here by KMC's Assembly Manager, Dave Burns:

Burns says that, “By utilizing this type of medical device lean manufacturing system, we save about an hour and a half of assembly time per unit. … We don’t overproduce or under-produce. We build what’s needed when it’s needed.”

Your medical devices are high-performing - is your MES?

Your medical device manufacturing process is only as strong as your manufacturing execution system. A
robust MES alongside lean practices makes for optimal efficiency.

For instance, complex quality assurance processes aren’t an on-time-delivery drag with the right MES.

With a powerful MES, when quality adjustments need to be introduced during the manufacturing process, you have the “ability to cut in engineering changes with minimal interruption to workflow, and the ability to quickly recognize and react to internal or supplier quality issues,” Gail Wiegand, KMC’s Director of Quality Assurance and Regulatory Compliance, said.

KMC’s MES houses more than 900 interacting databases that control, share and store information. That information includes manufacturing, quality-system, engineering-support and training-management databases – and more – all with FDA compliance baked in.

That’s right, built-in FDA compliance. For example, if someone who hasn’t had the proper training tries to log into a project, the managers are notified and must approve training completion in order for that person to have access. A robust MES has much more FDA-compliance functionality, but we’ll keep it at that for this post.

KMC Principal Quality Engineer Cheryl Caron, M.T. (ASCP), says, “KMC’s MES provides real-time, readily accessible information that allows us to very quickly respond to changes, whether they are planned (e.g. ECO cut-ins) or unplanned (e.g. quality issues, customer scheduling changes).  We have developed an information connection between the ERP and the MES that keeps it all working together and helps our teams stay on top of what needs to happen and when it needs to happen.”

KMC Senior Software Systems Engineer Doug Finner expands on this, saying the MES “helps make sure that right people on the floor have access to the right processes at the correct time. The use of electronic assembly/test procedures decreases problems associated with failure to remove all of the 'old' rev processes during an update and users building to the wrong version of a process.  It also means that updates can be pushed out in real time allowing production additional levels of flexibility.”

Control processes in your medical supply chain

Maybe your internal-control processes rock, but when using suppliers, make sure they have the proper processes in place.

KMC’s Senior Supplier Quality Engineer Christine Long shares her process:

  1. I look to see if they have adequate control processes documented in the Quality Manual/ Procedures.
  2. When I perform an on-site audit, I randomly verify that they are performing in compliance with their documented procedures.

For more on maintaining quality in your supply chain, check out this other post.

BOTTOM LINE: Your customers will love you

The more thorough control processes you have in place, the more control you have with on-time delivery performance.

As a supplier to large medical OEMs, “Our customers love our MES because we provide them with the capability to view manufacturing data from a web interface so they are aware of how we build their product, their build status, quality issues, and pending changes,” Caron says.

Your customers get full visibility of their medical project while confidentiality remains intact.

Time- and money-saving lean medical manufacturing methods combined with a top-notch MES produce the on-time delivery results that you strive for and that your customers demand.

And happy customers are what it’s all about!

How have control processes improved your medical device manufacturing on-time delivery performance?

Stay tuned for the second in our series on how supply chain management improves medical device on-time delivery performance.

Topics: medical device lean manufacturing, lean medical device manufacturing, medical device on-time delivery performance, OTD, medical MES, medical control processes, medical supply chain