To begin our “5Ms” Blog Series, we will discuss the importance of digital transformation as it relates to the workforce (“Man”) in Medical Device and Diagnostic manufacturing.  As a reminder, this is a fundamental truth in manufacturing: the efficient delivery of quality products means controlling the 5Ms – man, material, machine, method, and measure. Understanding these five factors is key in strengthening the production process, ensuring efficiency, and securing an economic and regulatory foundation.

If you are operating with paper-based processes, knowing whether the 5Ms are in control is nearly impossible in this environment of constant change and increased complexity. Manufacturing errors, lack of visibility, inefficiency, inability to make data-driven decisions, and increased waste are potentially damaging your bottom line, your reputation, and your desire to impact the Life Sciences industry. The good news is that, while the need to control the 5Ms hasn’t changed, the ability to control them has.

“Ultimately, it’s not going to be about man vs. machine. It’s going to be about man with machine.”

Satya Nadella

Empowerment.  Engagement.  Efficiency.  All buzzwords or phrases that populate current literature written about the modern-day workforce.  We, as humans, want to do good work.  We want to work well, and we want to feel impactful and contribute to the mission and vision of our workplace.  When this is absent, workplace efficiency and effectiveness suffer.

In medical device and diagnostics manufacturing, how does this translate to our teams who work directly with the products they are helping to produce?  How does the manufacturing associate, production team member, or shop floor staff experience success of a “job well done?”  And – for the sake of this article – how does the implementation of a digital solution impact the effectiveness and importance of the people in our facilities?

There are multiple issues related to the first M: MAN (manpower) that can have significant impact on the efficiency and effectiveness of your manufacturing processes.  However, implementation of a digital solution can reduce any negative impact and increase production effectiveness. With that being understood, let’s take a look at three of these issues below – and how implementation of digital solutions (specifically a Manufacturing Execution System – MES) supports the relationship between man and machine. 

  1. Product and Process Traceability

Implementation of digital solutions such as a Manufacturing Execution System can easily solve many staff training and development issues simply by improving product and process traceability.  For example, with Siemens Opcenter Execution for Medical Device and Diagnostics®, manufacturers can trace any product, lot or unit and its processes across the supply chain, a factory, multiple factories, or the entire enterprise. Traceability data includes

  • forwards and backwards genealogy of materials consumed,
  • processes and equipment utilized,
  • parametric and quality data collected,
  • exceptions,
  • rework,
  • dates and times, and
  • electronic signatures.

This increased traceability leads to a significant reduction in worker error and significantly increases efficiency.  Additionally, Siemens Opcenter Execution enforces GMP (Good Manufacturing Practices) and regulatory compliance, error-proofs manufacturing processes, and includes operator training certification.

2. Productivity

Implementation of a digital solution such as Siemens Opcenter Execution eliminates or reduces non-value-added activities, allowing staff to focus more fully on the important tasks of their role.  Also, inherent with this solution is the creation of an Electronic Device History Record (eDHR) or Electronic Batch Record (eBR), supporting activities related to data collection, calculations, and documentation review – and enabling operators to focus time on making product rather than completing paperwork.

Lastly, increased productivity is supported due to the intuitive user interface of this solution, which includes interactive reporting and dash-boarding, as well as electronic signatures.  These advantages, as well as real-time granular visibility into manufacturing and (Work in Progress) WIP, allows for better process enforcements and “right first-time” production.

3. Accountability/ System Checks

Increased product yield is a natural result of a digital solution such as Siemens Opcenter Execution, reducing scrap and rework.  By eliminating human error and oversight, manufacturers can improve first pass yield through systematic product/process enforcements of accurate data collections, usage of only authorized materials, utilization of the right procedures and equipment, certification of operators, and more.  Manufacturers utilizing Opcenter have also experienced a decrease in ramp time and an improvement in line balance.  This, combined with the electronic signatures and interactive reporting and dashboarding mentioned above, allow for increased accountability and the creation of a “right first time” culture.

In today’s highly technical workplace, the modern manufacturing workforce must be properly educated and prepared to interact with the technology on the floor.  Manpower – the operational and/or functional labor of people engaged in delivery of a product and/or service – is usually a rare cause of process disfunction, but it can certainly lead to other manufacturing and process issues.  In Medical Device and Diagnostics Manufacturing, there is still great dependency on people for the production of these products.  As such, people management and support is vital to the success of the industry.  As “M #1” of the “5Ms of Manufacturing,” it is important that manufacturers not overlook their prized resource – people. 

Through increased digitalization and implementation of solutions such as Siemens Opcenter Execution for Medical Device and Diagnostics, smart manufacturers are seeing that these advancements aid the success of their workforce, and support of lean manufacturing doesn’t mean the elimination of people.  A fully digitalized process supports a well-trained, efficient workforce, which leads to greater productivity, increased employee satisfaction, and increased company revenue. 

Stay tuned for the next “M”: Material.  Look for the next blog coming soon!