Ever since the FDA first formalized the drive for continuous improvement (CI) in 2004, our industry has adopted and embedded the philosophy to apply better business practices and more streamlined approaches that reduce loss and do better at identifying and realizing opportunities.

In the whitepaper, “Innovation and Continuous Improvement in Pharmaceutical Manufacturing”[1], the FDA suggested what would be required next to ‘achieve the desired state of pharmaceutical manufacturing’:

  • CI to replace corrective actions
  • Development of a deep understanding of the processes and systems
  • Effective and efficient design of the manufacturing processes
  • Critical sources of variability in the manufacturing process to be identified and explained, these variabilities then to be controlled in the manufacturing processes to ensure the quality of products can be reliably predictable
  • Continuous real-time measurements
  • Statistical process control

CI has become vital to process excellence and is a key tenet to lean approaches which are often misconstrued as flexibility in operational capacity in the pharma industry. True agility for pharma contract service providers is about shifting the mindset and culture of an organization so it can leverage its capabilities to deliver the best outcomes for its partners.  

Processes are not static or ‘one-and-done’, they are constantly improved upon as operators and engineers push the boundaries of a process, exploring new approaches that create value, save time and eliminate unnecessary, low-value tasks.

Here John McCullough, Continuous Improvement Engineer at Sharp, discusses how companies can empower employees to think about the way they work and be part of improvement efforts.

Embracing continuous improvement

What commonly happens within teams dedicated to continuous improvement is an internalization of principles and jargon as they focus on securing organizational buy-in to the actions and behaviors required to deliver continuous improvement. For example, in addition to running a kaizen event or coordinating Gemba Walks, CI is encouraged at the most fundamental level by asking operators, engineers, frontline support functions, and team leaders to review performance and discuss issues at daily stand-up meetings. The focus then turns to identifying a root cause followed by determining a solution. Finally, considering the return on investment (ROI) and securing support for implementation are crucial to success. The emphasis should be on thinking about how everyone across an organization works and how, if changes were made, these improvements would make their jobs easier.

Adversely, it can be off-putting to a colleague who is not familiar with CI to be overly exposed to the principles involved because they may not have a point of reference and may be afraid to ask. Engagement and organizational acceptance is vital, so focusing on the actions and projects that deliver results and then relating them to general principles is preferred to esoteric discussions around lean theory.

The essence of continuous improvement is recognizing that there is always a better way to do things, and importantly, organizations and the people leading them should encourage positive change that comes from doing things differently. Being open and flexible to change can lead to huge improvements to efficiency, quality and safety.

Leadership commitment

Cross-organizational representation and engagement, which includes communicating and sharing challenges, presenting projects and celebrating accomplishments is key to the successful incorporation of CI into a business’ culture.

Champions within a company’s leadership team are also essential.

A common and successful approach is to create a steering committee comprised of a subsection of a company’s leadership team. The committee must meet periodically to discuss culture, the direction of the business and review a portfolio of CI projects, identifying where additional resources are required or reprioritizing them according to business needs.

Importantly, the committee will also direct which strategic projects are taken on by the CI team. As alluded to above, it is essential that every person across the business is observing challenges and communicating these at daily stand-up meetings and up to leadership. This is a very simple but powerful tool. Sometimes, there are broader items identified that need to be escalated to senior leadership who sponsor projects to support transformation.

Prioritizing projects

Establishing clear criteria for a project to be prioritized by the committee is another key component. Projects need to be fully scoped, clearly outlining the opportunity and the business case for modification. ROI and enhancements to client processes are often the significant items that determine whether a project will be sponsored or not, and where it will sit on the list of priorities. Quality improvements and increasing efficiency are also key drivers.

A vital element of scoping is clearly defining the challenge. A quote often attributed (wrongly or rightly) to Einstein goes: “If I had an hour to solve a problem, I’d spend 55 minutes thinking about the problem and 5 minutes thinking about solutions.” The message is clear – time planning is time saved.

In ratifying a CI project at a company in the pharma and biotech industry, this approach is a must for 3 reasons. First, the regulations that govern the sector are stringent and quality, which ties in with patient safety, is always critical. Any project must adhere to guidelines and a significant amount of planning is required to ensure that any solution implemented is right first time.

Second, there are always limits to what the business can reasonably invest in terms of financial and staff resource. In short, there may not be a strong enough business case to justify a project, but this can only be understood through careful scoping.

Finally, where the proposed project originates from a client initiative, there can be a misalignment between their request, the actual challenge and the outcome desired. The CI team’s role here is to collect and analyze data and define the challenge as accurately as possible and communicate this to the client – this often leads to a more collaborative approach and repositioning of the requirement.

Use case – reducing overcommunication and creating efficiency in warehousing  

Sharp is currently delivering a CI project that will further improve warehouse operations. Both Sharp and the company’s clients have item numbers, but they are not the same. Sharp’s warehouse receiving teams may get a product that only has a client item number, so they are not necessarily aware of what it is and how it needs to be received and stored as the number does not correlate with any identifying data in Sharp’s systems. This created a lot of time-consuming overcommunication with clients and Sharp receiving teams trying to identify products. 

Sharp’s CI team established a process to connect client item numbers to Sharp item numbers to allow the receiving team to scan either organization’s identifying number and receive the product automatically. The overall impact is time saved for both clients and Sharp personnel and more efficient warehousing operations.

CI’s increasing importance

There is enormous opportunity around rare and orphan disease therapies and development pipelines are increasingly focused on those spaces. Invariably, the patient populations are incredibly small, which demands the flexibility to manufacture at low volumes and an incredibly robust supply chain to handle very high-value, critical products. Relative to blockbuster drugs, an enormous amount of resource can go into developing and manufacturing a single product.

Contract packaging companies are often the last critical step in the supply chain from a manufacturing and production standpoint and anything they can do to safeguard and maximize yield has a huge impact on clients and patients who rely on the drug product. Existing operations need to be flexible to the requirements of these products and a continuous improvement culture by its nature allows companies to adapt quickly and effectively to these needs.

Managing the time and cost pressures for companies getting their product to market is also an area of ongoing focus. It is vital for pharma and biotech companies to get regulatory approval to the market as quickly as possible.  With a continuous improvement mindset, contract partners can constantly improve their efficiency which means they can get products to market quicker for their partners and respond more effectively to fluctuations in demand.


Sharp has adopted a continuous improvement culture to ensure it constantly explores ways to further improve operations and deliver flexible, scalable and efficient clinical services and commercial packaging solutions.