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Commitment to a focused communication strategy brings numerous benefits:
- A barrier against errors by enabling real-time transmission of critical information, early detection of potential issues, and coordination of actions to prevent errors from compromising product quality.
- Identification of vulnerabilities and facilitating corrective actions among tiers such as quality control and validation processes, which reinforces overall system resilience.
- Making it harder for errors to propagate through all layers that can compromise product quality, regulatory compliance, and even patient safety.
Communication failures are costly
Current Good Manufacturing Practices (CGMP) are standards that cover several different processes and aspects of manufacturing procedures and can have profound consequences for pharmaceutical manufacturers’ ability to meet CGMP standards.
How much do pharmaceutical companies lose to poor communication? Looking across all industries, the 400 largest companies in the US and UK are estimated to lose an average of than $37 billion per year. Other studies show that as many as half of all reportable incidents in the process industry can be attributed, in part, to poor communication during shift handover.
Causes of communication breakdowns in pharmaceutical manufacturing
Pharmaceutical manufacturing involves complex and interdependent stages. Even a small miscommunication can lead to significant disruptions. Seamless collaboration provides accurate and timely information exchange, particularly when information-sharing must be coordinated among thousands of shift workers managing dozens of machines and processes across multiple locations.
Shift handover represents one of the biggest challenges for most pharmaceutical manufacturers. Many still rely on the traditional morning shift handover meeting for primary information exchange. Some even rely on information transfer via Excel spreadsheet, paper log, or in email exchanges. These ad-hoc communication methods can mean that important information slips through the cracks or fails to reach intended operators. Incomplete information transfer during shift changes can result in misunderstandings, errors, or oversights. Many reportable safety incidents in process manufacturing happen during or shortly after a shift handover.
Identifying communication problems
The lack of standardized procedures like poor or outdated shift handover processes is among the leading causes of communication breakdowns. Lack of training or clarity in communication protocols (who needs what and when), lack of dialog among teams or information overload, and a lack of feedback mechanisms for troubleshooting and correction, add to the disruptions in the information-sharing chain.
Five areas can be helpful in assessing communication glitches and are the foundation for a revamp of communication strategies.
- Day and night shifts: Missing handover logs, differing priorities between teams, night crews being surprised by existing problems, or a spike in safety or quality incidents right after shift changes all point to a misalignment between day and night shifts.
- Compliance issues: If routine compliance activities consistently lag, they may manifest as a noticeable accumulation of unfinished compliance checks, field observations that aren’t diligently logged or addressed, or vital paper logs buried under heaps of paperwork. You may notice discrepancies between the methods different shifts use to carry out the same compliance tasks.
- Missed production targets: If frontline operators seem out of the loop regarding production goals or if the rationale behind missing targets differs between teams, then poor communication might be a contributing factor. Communication problems may also result in an observable disconnect between frontline workers and management or repetitive unresolved production problems.
- Troubleshooting: If specific problems recur over several shifts, or if it takes too much time to address critical anomalies, then communication channels might need repair. Ineffective troubleshooting may occur when new shift teams are starting from scratch in diagnosing a problem rather than building on insights from previous shifts or historical data. Shift teams may also lack a clear action plan to follow during crisis scenarios.
- Breakdowns between departments and teams: If there are blame games following a mishap instead of collaborative problem-solving there are communication breakdowns, including silos where teams or departments seem to operate independently without mutual updates or discussions. There may even be a lack of camaraderie between different plant teams or departments. These are all signs of poor trust, low inter-departmental cohesion within the organization, and a sign of poor information sharing.
Communication challenges can be solved
Clear, timely, and accurate information sharing can help process manufacturers prevent avoidable accidents, reduce production delays, and product quality problems.
Digitalization of shift-to-shift handovers can go a long way toward addressing communication challenges between shifts and across teams and areas of responsibility:
- Shift handover: A digital shift handover system ensures that plant status is understood, critical information is not lost, and remains accessible to all.
- Standardized work execution: Standardized digital checklists ensure consistency and compliance. Inspection reports can be instantly uploaded to document observations and streamline the delivery of information between operators in the clean room or a control room, shift management, and maintenance departments.
- Tier collaboration: Tier 1, 2, and 3 meetings, are used in the pharmaceutical industry to ensure that communication and decision-making are shared within a hierarchical structure. Connecting the shift team and management with a digital platform helps to connect these meetings to manage information flow, resolve issues, and maintain efficiency.
- Dashboards: Easy-to-read charts and dashboards help teams assess progress, identify issues, and allocate resources efficiently.
- Manage organizational knowledge: A central digital platform continuously captures process knowledge by recording context during routine activities such as shift handovers or regular inspections, as well as during adverse events. This knowledge management repository for current and historical data is supercharged with an AI-powered search engine to for faster problem-solving and higher efficiency.
Digital Plant Process Management (PPM) systems, like shift-to-shift handover solutions, enhance communication, information sharing, and collaboration among teams across the organization. For process manufacturers, that translates to measurable gains in productivity and performance as well as safety and compliance. Better internal communication can improve organizational productivity by as much as 25%. Companies with fluid and accurate communication and a transparent corporate culture achieve revenue growth 4x higher than their peers.
When communication improves, every other facet of the organization does, too. Smart digital tools for communication and collaboration will help pharmaceutical manufacturers strengthen their competitive edge in a fast-moving and very competitive market.
Andreas Eschbach, CEO and founder of Eschbach.
Filed Under: Drug Discovery and Development, Industry 4.0, Regulatory affairs
