Medical devices represent one of the most demanding manufacturing disciplines with perhaps the smallest margin for error of any industry. This is particularly true on the production side of a medical device manufacturing operation, which starts with raw materials and components and flows through to the production of a validated, finished product.

Adding to the pressure, quality demands on medical device manufacturing continue to grow even as the availability of expert supervision and labor is shrinking. This is putting a premium on automated processes. However, with today’s tight labor market and a shortage of experienced technicians and supervisors, adding more skilled people to directly manage these processes is often impractical and sometimes impossible.

To close the process management gap, more medical device manufacturers are adopting a “management by exception” strategy to address the issues of quality and skilled employee shortages at the same time. Let’s start by defining management by exception and then review three common ways that this strategy is applied to medical device manufacturing.

Defining Management by Exception

Management by exception is a management style that focuses on identifying and resolving situations that deviate from normal or expected outcomes. It is a conscious decision to move away from rote supervision and to instead emphasize trust in teams and systems to alert management to issues that require attention.

In medical device manufacturing, the four objectives of managing by exception are straight forward:

In adopting management by exception, manufacturers need to go beyond physical automation (i.e., assembly lines, robotics) and process automation (i.e., accounts payable, procurement) and step into an area that can best be described as management automation. For this reason, management by exception in a manufacturing environment is typically implemented by using enterprise resource planning (ERP) and manufacturing execution system (MES) software as the eyes and ears of the operation. These systems of operation are overlaid with mechanisms of workflows, alerts, and intelligence that guide actions and monitor information streams and production processes. In effect, automated queries are continuously running in the background probing for the next steps and identifying situations that require management intervention.

Many manufacturers have the technology in place to implement management by exception, since alerts and workflows are standard features of modern MES and manufacturing ERP platforms. At their core, they provide configurable systems of rules and routings that management establishes to guide the workflows of the business and trigger alerts when bottlenecks, missed steps or issues arise.  Most management teams start with a simple set of workflows and alerts. Then, as their confidence and proficiency in the practice grows, they build upon these initial rules until they have comprehensive rule-based management by exception program in place.

Common Medical Device Manufacturing Scenarios

There are countless ways that management by exception can be applied to medical device manufacturing operations. To get started however, manufacturers may want to focus on three typical scenarios for managing by exception: in-line quality inspection, certification of raw materials, and production process validation.

In-line Quality Inspection

In this example of in-line quality inspection, a precision stamping machine is making medical device contacts at the rate of 200 pieces per hour. The operator needs to inspect two pieces every 10 minutes to ensure that contact pressure is between 7 and 10 pounds, as measured by a test fixture, and then record the results of the test. If the results are recorded manually, there are many possible avenues for error. The operator might skip several cycles and then record partial results, be distracted from taking accurate measurements, or not even realize they need to make the measurements. Really anything is possible. The typical oversight in these situations is to have a supervisor or quality control team member check on the operator periodically to make sure the tests are being performed as specified.

By contrast, with a workflow set up in the MES, the operator is notified of the need to take the periodic measurements when logging on to the job. Additionally, the workstation operator screen (a human-machine interface) provides a tool to input the test results, and it time-stamps the entries. Meanwhile, the rules engine knows to alert supervision if the measurements are not occurring or are they outside specified limits. As a result, a correctly run job requires no intermediate supervision to ensure the correct tests have been performed, and if there is an issue with the testing, it is identified immediately. In this way, all four of the goals of management by exception are accomplished.

Certification of Raw Materials

Another very common medical device manufacturing workflow is the certification of raw materials. Here, raw materials are received, held in an inspection quarantine, inspected, and then released to production. Some materials require inspection; others don’t. So, the manufacturer needs a skilled worker with the proper knowledge to route the newly received materials to the correct location. The materials in quarantine then have to be validated, typically by a quality technician, before they are released to production. 

In an operation managed by exception, materials requiring inspection are flagged as such in the ERP system and are automatically routed to the quarantine area. As the flagged materials are received, inspectors are notified (alerted) that they need to complete the inspection. Then, after the inspections are recorded in the ERP system, the goods are automatically marked as available for production. If the inspection is not completed in the time period allocated by the workflow rules, the supervisor is notified, and the inspection is escalated so downstream production can proceed on time. In this way, workflow rules and alerts minimize the amount of skilled supervision necessary to complete a business process when everything goes according to plan, and conversely, immediately alert management to an issue when a process breaks down.

Production Process Validation

Moving up to a higher level in the organization, let’s consider the situation where a key regulatory supervisor has unexpectedly gone out on medical leave. In a traditional operation managed by direct supervision and institutional knowledge, the general manager is suddenly faced with a number of essential validation steps that may or may not happen. The situation will be disruptive at best and could become chaotic and delay important deliveries.

If the organization has adopted a management by exception strategy, the general manager is in an entirely better situation for two key reasons. First, the validation steps that are not being performed will trigger alerts that, albeit in a reactive mode, that will at least alert the general manager to take remedial action and ensure that nothing is forgotten. Second, because the business has taken the time to codify the production processes and assign responsibility for each step, the general manager can proactively see exactly what tasks the absent supervisor was responsible for and automatically re-assign those tasks to different individuals. Not only will the tasks be re-assigned, but the workers responsible will be automatically advised of the when, where, and what of all these new tasks.

Conclusion

Rarely do management strategies need to change overnight. But over the last few years, it has become increasingly necessary for businesses to move forward from a high dependency on continuous oversight and tribal knowledge to management systems based on ordered processes that are recorded, institutionalized, and implemented by automated systems. Management by exception is a strategy that builds sustainability, resilience, and cost reduction into a business. As the scenarios reviewed here show, it is both a thorough process and a philosophy that can be practically implemented by taking advantage of the automated management features of modern ERP and MES solutions.