Reducing human error in pharmaceutical manufacturing

Few experts would dispute that human error is the cause of most pharmaceutical manufacturing failures.Some estimate it to be as high as 80 percent! 

The traditional approach has been to pass as much of the operation as possible on to machines and computers, which tend to be more reliable. New advances in workflow software, however, now make human actions more reliable by guiding them in implementing standard procedures. This combines machine-like efficiency and accuracy with the flexibility of human operation.

Workflow software ensures that, in response to a designated event, operators have at hand all information necessary to perform time-critical interventions that might be necessary to carry out stored maintenance sequences, error correction protocols or other standardized procedures. For any given problem, workflow assures that the right people, have the right information, at the right time.

In addition, this new generation of software will notify the designated stake holders simultaneously, which covers collaboration and reporting requirements. Users will capture manual and automated processes, using a single application that extracts data from different systems and integrates data for traceability, quality control and other critical processes. This reduces error, waste, and delay and enables operations teams to manage by exception, orchestrate production, and achieve event-based, data-driven results.

Going with the flow…

A process engineer configuring a pump from an engineering software package, for example, might want to trigger a specific workflow when a critical alarm is received. They would configure the alarm event and then either associate it with an existing workflow or create a new workflow around it. Linking to an established (or soon to be established) workflow not only saves time, it assures that everyone in the company follows the same procedure for handling the alarms. Likewise, creating a new workflow provides a template for future standardization.

Another example, an end-user configuring quality-hold reason codes within an MES application might want to kick off a specific workflow to resolve the issue. To do so, they would create a reason code and link it to a new or existing workflow.

While there are many types of workflow software available, those which allow embedded workflow design are the most effective. These enable seamless integration of document, industrial process, human activity, and operations management workflow via a single user interface. Having to leave one application and open one or more others to resolve any situation, jeopardizes productivity and timeliness, it also makes the process more susceptible to error.

Contact the expert

Martin Boisvert

Sales Executive for Regulatory Compliance and Validation

Sales Executive on the Life Sciences Compliance Consulting team with a comprehensive background in manufacturing, industrial automation and supply chain operations during my 14+ years career. Passionate about my goal to help people understand how to embrace compliance as a vector that can solve persistent regulatory compliance challenges in their organization.

Whatever your question feel free to reach out, I am here to help.

Connect with me: LinkedIn | Email