Precise communication is critical to success in any field, and the pharmaceutical industry is no exception.
A shift supervisor working in a pharma plant typically needs to manage a team of engineers and work collaboratively with cross-functional stakeholders such as technical development, manufacturing, regulatory and quality, to ensure all technical aspects of production are successfully executed. The top valued skills among pharma manufacturing teams usually involve critical thinking, problem-solving, data analysis and collaboration — but none of these skills can be consistently and effectively leveraged without good communication. It helps guard against errors and ensures equipment effectiveness, product quality and patient safety.
The pharma industry continues to face increasing pressure to deliver healthy returns to its investors by innovating new therapies. So how do companies build operational resilience and keep innovating? Dependable, automated communication is the answer. It remains a key focus because it enables teams to not only share important information but also to build trust and relationships with colleagues. Developing such relationships creates a more effective and productive work environment.
Making cancer vaccines
Take the experience of a second shift supervisor, who is responsible for process implementation, technical support and person-in-plant coverage to ensure robust end-to-end production of a new FDA-approved cancer vaccine, as an example. In this complex and highly technical environment, communication is key.
For starters, the supervisor oversees a team of process engineers with expertise in bioprocessing unit operations and CGMP manufacturing. She is also responsible for technical support, change control, safety observations, manufacturing investigations and person-in-plant coverage for the cancer vaccine process. This means that as part of her role as a shift supervisor, responsibilities include:
- Supporting process training for CGMP operations and development of process understanding and expertise
- Training and assistance to the manufacturing team in operational excellence projects driven by 5S, Lean Six Sigma, Kaizen and similar programs
- Leading cross-functional technical process support and investigation teams
- Partnering with technical development, manufacturing and quality to enable and sustain CGMP processes; Serving as the technical lead supporting CGMP manufacturing activities
- Acting as the subject matter expert for plasmid, drug substance and lipid nanoparticle processes for the cancer vaccine process; This includes troubleshooting process and equipment issues
- Authoring deviation/investigation reports, technical reports and managing technical CAPA/change controls
- Establishing and maintaining process performance trending/metrics using digital information and statistical analysis tools
- Providing weekend coverage for maintaining manufacturing operations, working at least a weekend day on a rotational basis
So, how does a second shift supervisor with this many responsibilities effectively manage? She relies on software and its automated checks and balances for all of her responsibilities. Using an interactive dashboard, communication gaps that often occur between shifts, including the protective multilayers involved in pharma manufacturing are practically eliminated.
Communication is key
Communication is the number 1 priority across shifts, teams and all of areas of a shift supervisor’s responsibility because it mitigates nonconformities, product quality issues, expensive recalls, regulatory penalties, and safety incidents. Additionally, with Industry 5.0 now available, data, technology, equipment and humans are now more connected than ever before. Utilizing a tiered collaboration approach increases transparency across all levels of the enterprise while at the same time improving communication, making it quicker to see critical KPIs and key information for faster decision-making.
Like an onion, there are many layers when delving into the intricacies of pharma manufacturing processes. Dependable communication practices can help prevent errors or deviations throughout the multi-layered operations, from raw material handling to product packaging. Gaps in communications from one process to the next can cause vulnerabilities and this is where communication plays a crucial role in helping teams to be as productive as possible.
Effective Communication:
- Mitigates risks from errors occurring and often provides early detection of potential issues, enabling the proper coordination to prevent process deviations from compromising product quality
- Intertwines with multiple process layers, (e.g. quality control, validation, safety) as well as automates real-time communication, identifies vulnerabilities, facilitates corrective actions and ensures all multi-tiered processes are synchronized
- Enables regulatory compliance in a highly regulated industry and ensures all staff involved in the various processes are aware of, and compliant with, necessary regulations
What can result from communication failures
Following CGMP standards helps make sure products released are of the best quality and safe. Poor communication often causes:
- Manufacturing deviations: Errors in drug formulation, packaging, or labeling can result in wastage or recalls
- Problematic batches: If important information is not provided or the team that takes the next shift has been given the wrong priorities, mistakes happen that result in a delayed or lost batch
- R&D delays: Miscommunication in pilot plants can delay drug discovery and development, resulting in loss of patent exclusivity or being the first on the market
- Increased operational costs: Cuts into profitability can delay new opportunities
Process manufacturing often involves complex and interdependent stages, where a small miscommunication can lead to significant disruptions. Departments must collaborate seamlessly, accurately and exchange information in a timely manner. A large pharma manufacturer may need to coordinate thousands of shift workers managing dozens of machines and processes across multiple locations, in addition to suppliers, service providers and clients.
In addition, many process manufacturing plants operate 24/7. Shift handovers and continuous workflows augment the need for precise, dependable communication. Shift handover continues to be a huge challenge in pharma manufacturing. While morning huddles are important, they are no longer the primary activity for critical information exchange.
No longer are the uses of Excel spreadsheets, paper logs or in-email exchanges and other ad-hoc communication methods key ways to share information. Too often important information slips through the cracks or doesn’t reach all intended parties. Incomplete or inaccurate information exchange during shift changes cause misunderstandings, mistakes or oversights. This is the main reason that many safety incidents in process manufacturing are reported during or shortly after a shift handover.
When it's all said and done
Evaluate your current procedures and existing systems to see if there are areas where potential communication breakdowns could occur or perhaps have occurred. If there is a lack of standardized procedures or platforms for communicating critical information or poor or outdated shift handover processes, eradicating issues in these areas will be immensely helpful.
Often it can be a simple as providing training or clarity in communication protocols (i.e., people are not sure who needs to know certain information or how to report it). Make sure there is an open dialogue between teams as well as across different levels of the organization. Too often information overload occurs where, for example, employees are bombarded with information that doesn’t pertain to them. This is where feedback mechanisms for troubleshooting and making the appropriate corrections should be automatic, such as what occurs when using customized digitalization solutions.
Keeping communication a focal point while following CGMP standards will help guide pharma companies to ensure that their finished products are safe for human consumption.
Pharmal manufacturers would be wise to evaluate current procedures and existing systems to see if there are areas where potential communication breakdowns could occur or perhaps have occurred. If there is a lack of standardized procedures for communicating critical information or poor/outdated shift handover processes, eradicating issues in these areas will be immensely helpful. Often it can be a simple as providing training or clarity in communication protocols (i.e., people are not sure who needs to know certain information or how to report it).
Make sure there is an open dialogue between teams as well as across different levels of the organization. Too often information overload occurs where, for example, employees are bombarded with information that doesn’t pertain to them. This is where feedback mechanisms for troubleshooting and making the appropriate corrections should be automatic, such as what occurs when using customized digitalization solutions.
Keeping communication centralized while following CGMP standards will help guide pharma companies to ensure that their finished products are safe for human consumption.
