This piece on the impact of automation on QC and QA roles was co-authored by members of Clarkston’s Quality + Compliance Community. 

The traditional roles of both Quality Control (QC) and Quality Assurance (QA) within life sciences manufacturing have complimentary operational functions with the goal of ensuring product safety and quality; however, they do this through different approaches and focus.  

The QA role defines procedures and standards to reduce any defects in the manufacturing process, whereas the QC role identifies defects through testing samples through the production lifecycle to ensure the values fall within the respective specification limits. Both roles are critical to ensuring organizations consistently develop and manufacture safe, effective, and high-quality products.   

While in the past these roles have been reliant on manual, paper-based processes with large amounts of data, technological advances in systems and applications have introduced a great deal of automation. This piece explores the impact of automation on QC and QA functions, its benefits and challenges, and considerations for organizations looking to get started. 

Benefits of Automation 

In the QA and QC space, adding automation eases the burden of time-consuming tasks and increases data integrity. Whether simple or robust, the value and throughput gained is usually significant. Some examples:  

• Instrument interfacing eliminating the need for transcribing results  
• Electronic Laboratory Notebooks (ELNs) to remove the paper-based lab notebooks  
• Laboratory Information Management System (LIMS) to perform calculations automatically when results are entered  
• Review by Exception to allow for systematic release of data when specification criteria is met 
• Advanced Analytics for predicting potential quality issues  
• Robotics for routine tasks such as sample preparation  
• System integration for real time data transfer between systems 
• Automated reporting such as Certificate of Analysis (CoA) and email notifications of product release 

These examples have undeniable benefits for any organization by adding efficiency to these workstreams. Automating repeatable tasks allows time for personnel to focus on other areas such as drug discovery, product improvement, or process standardization. Predictive capabilities can stop issues before they happen resulting in reduced product loss. These benefits also enable resource optimization while decreasing the risk of waste. 

Risks of Automation 

Automation should be considered as an enhancement to the QA and QC functions, however, there are some challenges associated with automation. Process automation requires investment in current or new systems and technologies. Additionally, leadership buy-in is critical, and Return on Investment (ROI) should be carefully evaluated.  

System errors may occur, such as background rounding causing a false compliance; therefore, careful and robust validation efforts must be adhered to. And it’s important to have a detailed disaster recovery plan in the event of a system failure causing a return to manual processes. 

Considering Automation for QC and QA 

If your organization is considering automating processes for QC or QA, Clarkston Consulting can help throughout the project lifecycle from identifying inefficiencies, analyzing opportunities for process automation, and gathering requirements to implementation, validation, user adoption, and hyper-care. 

Contributions by Roderick Anderson, Anjali Chhamunya, Frank Kovach, Ayan Mohamud, Liz Mancio, Wayne Hurd, Olivia DeFrancesco, Charles Webb, Eric Borries, Nicole Sharp, Jonathan Benincosa, Josh Edwards, George Adams, Elizabeth Pegram