How digital helps pharma manufacturers drive operational excellence

As the industry continues to evolve, pharma manufacturing leaders need to leverage a new approach to performance improvement.

In brief

• From supply chain inefficiencies to siloed functions and more, today’s pharma manufacturers have many opportunities to enhance operational performance. 
• Features such as real-time data monitoring, cloud solutions and process integration comprise a digital operational excellence approach that adds value. 
• Successful deployment of these and other digital solutions requires cross-functional collaboration across the full lifecycle of the project.

Given today’s rapidly changing pharmaceutical market, pharma manufacturing companies must leverage the latest industry trends to keep pace with competition. These trends include shifting from generic to personalized drugs, expanding biosimilar markets and managing smaller commercial batch sizes. Below are several key considerations around supply chain and manufacturing transformation that enables operational resiliency and unlocks value.

Background

Major pharmaceutical manufacturing networks traditionally have been segmented by business unit and global region. As such, customary local practices frequently became the norm, creating siloed operations that could not leverage the power of a global manufacturing network to drive success. 

In recent years, however, pharma companies have sought to standardize their supply chain processes across the various value streams of their network of sites through an operational excellence framework. Typically, they begin by determining a standard set of business practices, including structured meeting cadences, reporting strategies, operator care and ways of working. Once defined, companies implement these standard processes across their network to build consistent culture and value throughout the organization. 

Benefits of digitalization

Establishing a modern, fit-for-purpose operational excellence framework to address today’s supply chain and manufacturing challenges requires a more strategic approach — one that can deliver improved manufacturing reliability, reduced costs, and increased productivity. Achieving long-term operational resiliency today also involves a digital commitment, including investing in the right digital tools; storing, managing and analyzing large amounts of data; navigating global labor shortages; and developing new strategic operating models for both today and the future. 

By digitalizing this framework early, pharma manufacturers can achieve cross-functional collaboration for their sites and supply chains to drive efficiencies and enhance revenue. Other benefits of the digital framework include real-time feedback, cloud solutions, maturity progression monitoring, improved accessibility to the value chain, streamlined communication, process integration, the ability to leverage large volumes of data with a connected worker platform and predictive analytics. Digitalization also enables plants and shop floors to be more proactive in solving problems and optimizing operations. 

In addition, by adopting a digital manufacturing operational excellence approach, pharmaceutical companies can significantly accelerate their performance improvement efforts. This approach can enable enhanced productivity; fewer product recalls; less waste; reduced labor, maintenance, and energy and water costs; and several other operational benefits.

Using a smart management and coaching application enables consistent and phased improvement of leading practices and processes, capability development and maturity progression monitoring across a distributed network of factories. As such, the application builds and sustains capability while also helping to empower people. For pharmaceutical manufacturers, these features are essential to enable an effective digital supply chain transformation that creates a more connected, predictive plant network.

Moreover, networks that utilize real-time data monitoring are better suited to handle disruption. For example, advanced schedulers allow for scenario planning. This equips the organization to mitigate unplanned activities. In addition, available and comprehensive data drives predictive analytics. This allows the company’s system to guide its teams on where to focus their cybersecurity and consumer engagement efforts.

Design

To support process transformation and drive value realization, the following elements are crucial:

• A focus on business objectives and results: Predicated on a zero-loss mentality and 100% total employee ownership, leaders leverage the full capability of the organization and a facilitate a fundamental shift to operator technical mastery.
• Leadership as a critical driver of the journey: All levels of leadership act as servant leaders and are highly engaged through coaching and development of their people, creating a culture of excellence.
• Reliability engineering to prioritize losses based on the largest potential gain: A simple and proven set of analytics can help the organization derive value, identify top losses, and validate sustained improvements.
• Daily management system to transition from reactive to predictable: Line teams set the plan for the day by developing a 24-hour plan using line event data, operator input and line observations to minimize stops and losses.
• Empowered employees with full accountability to drive results: Operators are transformed and serve as equipment owners who are responsible for standards and results within their individual operating area.

Develop

In selecting digital solutions to complement their operational excellence structure, pharma companies should consider two key approaches:

1. Internally build a connected worker platform
2. Externally source a digital solution through a reputable vendor

Whether built internally or sourced externally, digital operational excellence modules provide leading practices and journey maps that are customized down to the line level. These tools support the operational excellence journey and enable the organization to advance along the digital maturity curve. Key features of digital operational excellence modules include the following:

• Assessor:  Determine practice capability and performance gaps in a collaborative manner.
• Planner:  Leverage operational excellence improvement journey maps that acknowledge gains already made and schedule the work bundles needed to close capability gaps.
• Improvement actions:  Focus on logically ordered, step-by-step actions that lead to performance improvements.
• Capability building:  Utilize operational excellence skill development workshop material that is linked to each improvement action and downloadable from the platform for internal trainers’ just-in-time usage.
• Performance improvement reporting:  Track manufacturing excellence capability improvement instead of production metrics improvement.

Both internal and external options bring their own advantages and trade-offs. On one hand, many pharma leaders choose external sourcing because fewer company resources are needed to stand up the solution. However, as this approach also requires more upfront investment, it may not be feasible for emerging organizations. On the other hand, an internally built tool may be a better fit for the company’s unique processes, but it will also require a more long-term investment to keep the tool current.

Deploy

The implementation of digital solutions involves a structured process, and it is best to organize a deployment team to implement them across the company’s sites. There are two distinct options to deploy a digital operational excellence solution:

1. Two-phased approach: First deploy the operational excellence production system, and then deploy the digital application to support the process.
2. Direct to digital: Deploy the production system in parallel with the digital application.

With either approach, the deployment team should engage with the site stakeholders during the full lifecycle of the project. This includes solution scoping, master data setup, end-user training and hypercare support. The right structured approach will provide systematic and disciplined line-level deployment methods, which rapidly improves manufacturing reliability by focusing on three key areas:

1. Accelerating deployments
2. Driving tangible benefits
3. Building capacity

Developing a structured deployment guide is another leading practice, often leveraged through a smart operational excellence deployment console. By integrating improvement methodologies with maturity-based roadmaps, organizations can establish a full digital “plan, do, check and act” process cycle that does the following:

• Conducts performance gap analysis
• Executes 90-day sprint action planning
• Supports teams’ ownership of the improvement journey
• Achieves rapid, scaled deployment of leading practices and methods
• Enables real-time knowledge sharing across networks

After the solution has been deployed, the team should focus on optimizing the site’s solution use and value realization, driven by usage adoption metrics. The deployment team would work with sites to determine value levers against which success is measured. Once these value levers have been determined, value measurements should be taken at the time of deployment, and at a set time after deployment (typically a few months later).

The author would like to thank Ernst & Young LLP Consulting Senior Peter J. Bruns for his contributions to this article.