Effective Personnel Drive Operational Integrity

by | Sep 20, 2021 | Digital Transformation, Life Sciences & Medical, Operational Excellence

Michalle Adkins

Director, Life Sciences Consulting

As consumers of medicinal products of various kinds (vaccines, immunotherapies, tablets, capsules, cell therapies, etc.), we know that although product quality is important, reliable supply is also critical. A reliable supplier of therapeutic goods requires the facilities within its manufacturing supply chain to also be reliable suppliers of their intermediates and products.

An important part of being a reliable supplier is preserving the integrity of the manufacturing facility. Yes, it is important to manage production readiness, equipment reliability, and facility efficiency; yet another important part of operational integrity is personnel effectiveness.

There are some sources of production problems that can be detected and addressed directly by operators; however, sometimes lack of experience or the right training result in ineffective responses or even cause a more significant problem. Differences in production performance may even vary shift to shift with the most experienced operators yielding the best results or with some specialized knowledge that exists on a particular shift. Often, operators do not have actionable, easily accessible information to quickly address potential problems. Think about the significance of these statements for your facility:

  • Lack of skills, experience, and access to interact with equipment and controls, along with poorly designed or underutilized automation tools can drive exceptions, inconsistent equipment performance, delays in production, and material/product losses.
  • Lack of real-time measurements or actionable data, difficulties in accessing and viewing key performance metrics, and silos of information result in operators making poor decisions or failing to take appropriate, timely actions when needed.
  • Insufficient or ineffective overall training, such as limited training environment exposure to appropriate responses for abnormal situations, causes deviations and inconsistent production performance.
  • Difficulties accessing current instruction manuals and SOPs, and problems with paper records that require signatures, dates, or values result in inconsistent operations and maintenance practices, which leads to more equipment breakdowns, delays in production, and material losses.
  • Inconsistent operator performance across shifts, slow or incorrect response to upset situations, variability in recipe execution, and recording errors can drive inconsistent production performance and delays in review and release.

There are many different training tools and technologies that we can use to enable our operators to be well prepared to perform their responsibilities effectively. Let’s consider some of the digital plant capabilities that enable effective operator performance:

  • Identify and resolve exceptions in near real-time based on quality triggers such as alarms or specific events or workflow deviations. Track and escalate resolution of exceptions in a collaborative environment.
  • Train operators in a real-world simulated environment on both automated and manual processes using a combination of augmented reality tools, process models, responses to operator actions, and various training scenarios that can include infrequent but important events.
  • Use workflow to enforce proper use of equipment, correct material additions, right-first-time calculations, proper batch record completion, and more.
  • Provide operators with analytical tools to predict equipment and process problems and provide possible failure modes and correction steps to prevent as many problems as possible.
  • Know in real-time how an issue such as a delay of a process step will affect the current batch schedule as well as subsequent batches. Use this knowledge to ensure that equipment will be in the right state, materials are held appropriately, and for other general scheduling needs such as overtime scheduling or quick repairs that can be completed prior to the next batch.

There are certainly many opportunities for errors in a manufacturing facility; however, when we can arm our production personnel with effective tools and training to recognize problems and prevent errors, we are more likely to be able to deliver quality goods on time.

Technologies such as digital twins powered by Emerson’s Mimic Simulation Software™ can help operators effectively train for both normal and abnormal conditions without risk to production. And tools such as Syncade’s electronic batch records help deliver right the first time production while leveraging paperless workflows to improve the accuracy and consistency of documentation. Technologies like Plantweb Optics Analytics enable operators to see what is happening, diagnose why it is happening, predict what is likely to happen, and give advice on what should be done. Additionally, Bio-G RTMS can be used to view real-time schedules, optimize production resources, identify process bottlenecks, adjust schedules automatically, and make efficient use of schedule changes.

To learn more about these and other digital plant solutions to increase operator effectiveness, please visit Emerson’s Life Sciences page. And feel free to comment below on the strategies you have used to improve the effectiveness of personnel at your facility.

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The opinions expressed here are the personal opinions of the authors. Content published here is not read or approved by Emerson before it is posted and does not necessarily represent the views and opinions of Emerson.