Taking quality assurance to new heights

Oct. 1, 2021
More companies are implementing MES to improve quality at every step – and get products to patients faster

In the pharma industry, quality is everything. But batch record review is a painstaking process if your company relies on exhaustive paper records or even a combination of paper and electronic records.

Large quality teams must comb through batch records to confirm good documentation practices (GDP). And when deviations are uncovered, the teams must initiate incident investigations, a time-intensive process that requires you to spend a lot in labor costs and records storage.

Additionally, because a myriad of issues can impact quality throughout production, following the paper trail to reach a resolution can take weeks. Meanwhile, quarantined product waits for release, delaying availability of crucial medications to patients and posing risk of waste.

Today, there’s a better way to manage quality with manufacturing execution systems (MES). A growing number of companies are using this technology to reduce quality issues and accelerate resolutions – and improve overall operations.

Getting started

We all know that following standard operating procedures (SOPs) is critical to maintaining product quality. But especially with manual operations, deviations from paper-based SOPs can easily occur due to human error or clerical confusion, despite the best intentions.

What happens when an operator misreads a barcode during a material addition step, enters an incorrect temperature setpoint or inadvertently uses uncalibrated equipment?

In some cases, the answer could be that you lose an entire batch.

An MES leverages the power of its electronic batch record (EBR) to add electronic guardrails that keep procedures on track. It also records and validates every step in the process, from the goods received to the finished and packed product. And it shows your operators exactly where they are in the process – and only allows them to proceed per recipe design.

This automated assistance can result in significantly fewer entry mistakes and investigations, thanks to MES guidance.

For example, the MES can require barcode scans to electronically verify material additions and incorporate input limits to prevent inaccurate manual entries. And to enforce the use of the right equipment, the system could utilize barcode scans and access data from other systems to obtain maintenance, calibration and hygienic state data. Then, it can record the use in the electronic equipment logbook and EBR without the risk of manual data entry errors or omissions.

Enhancing quality by going paperless

One Chinese pharmaceutical provider used an MES to help increase efficiencies and manage compliance for the production of an antibiotic that was on the FDA’s drug-shortage list.

First, the company eliminated 100% of paper records from its operations. It used an MES to completely digitalize the facility’s documentation process in accordance with U.S. and European regulations.

The MES was fully integrated into the provider’s network architecture, connecting everything from enterprise resource planning (ERP) to the facility’s programmable logic controllers (PLCs).

The system pulled production orders from business systems and identified the necessary materials. It then guided operators through each step of production, verifying that tasks were completed according to recipe.

Throughout these processes, real-time monitoring and exception handling alerted operators to abnormal situations and helped make sure issues were immediately addressed and reviews handled efficiently.

The automated data recording helped the company save 5% to 10% on its labor costs. The company also estimated that automated data management and more efficient batch-review processes helped it achieve a 46% to 75% reduction in batch product review cycle time and a 50% reduction in management-review cycle time.

Accelerating issue resolution

While an MES provides important guardrails to minimize errors, issues can still occur. The cause might be as simple as an operator adding the incorrect amount of a substance during a manual addition, or as complex as raw material variability reported by a supplier.

An MES can’t completely erase these issues. But a robust digital system helps you resolve these issues faster and more effectively in two important ways.

First, the system enables “review by exception.”An EBR eliminates the time-intensive line-by-line confirmation of manual data entries, allowing quality reviewers to focus their efforts on critical process exceptions – like an out-of-specification production reading that may directly affect the quality of the product.

The MES can identify these exceptions as they occur and report them to the right people via a dashboard to enable real-time correction and optimization. This can help you dramatically decrease review cycle times for batch documentation.

Review-by-exception capabilities can also reduce the time and effort you spend on researching process deviations to optimize the total cost of your deployments.

Second, an MES delivers complete process genealogy and traceability.

When a deviation does occur, the MES allows you to quickly identify all batches, lots and raw materials that were impacted by the mistake. Root cause analysis investigation time can be reduced because the system tracks each step in the process — and all production-relevant resources including material, equipment and personnel.

This data collection and real-time exception review also results in less product sitting in the warehouse waiting for release — transforming faster turnover into reduced inventory costs for you.

By continuously reducing the likelihood of errors and decreasing product waiting time, an MES also reduces wasted stock — not only on the production side, but also by minimizing the likelihood of expensive product recalls.

The power of insights 

 A holistic MES is designed to help you run and monitor your operations in real time. And it also provides richly contextualized data that’s ripe for analysis.

Because the system provides so much context around a specific batch, including the product, materials and equipment used, even a manual analysis can quickly uncover valuable insights into your process.

For example, MES data can show you how many deviations occurred within a specific time frame and which step of the process had the highest occurrence. This can help you identify actions to take that can reduce impacts to quality, such as by adding electronic verification for a manual step or updating operator training. 

Analytics tools can also help you correlate your data with information from other systems. For example, adding data, such as temperature, humidity, or particle counts from your building management system can help determine if environmental factors had an impact on production — and guide you to the root cause of the issue.

This analytics framework also provides the basis for machine learning to leverage information from systems to continuously optimize outcomes prescriptively. The analytics tool compiles information recorded by an EBR across multiple devices and systems to connect data in dashboards and reports customized for you and your business.

Accelerating time to market

By accelerating issue resolution and providing optimization insights, an MES can help you improve your time-to-market in several ways.

The system can instantaneously retrieve batch protocols and eliminate the need to pass records physically between stations. This can help you shorten the time required to produce and ship products, optimizing your cycle times.

To achieve shorter deployment times, an MES can offer a library of pre-validated recipe building blocks that can be re-used. This can reduce time-consuming programming and validation.

Combined with your insights for optimization, these time-saving tools mean that products are ready for approval much faster than with manual processes.

Risk management in action

By delivering individualized, context-specific instructions to production operators and enforcing processes and procedures, an MES makes compliance seamless. Complex regulations are made easy to understand with steps like requiring sign-offs for compliance measures throughout the manufacturing process.

The system can restrict production activities to authorized personnel using advanced security features, such as role-based access. In doing so, an MES lowers your overall risk for security breaches and errors.

FDA protocols dictate that facility inspections occur based on risk potential. By automating processes and requiring checkpoints along the way, the system can negate the need for frequent inspections and ease concerns from regulatory bodies.

It can also work in tandem with other tools, building on the benefits of an EBR within your MES. One of these tools is a serialization system for combatting the threat of counterfeits.

Deploying a serialization system within an MES can simplify compliance by centralizing data onto a single platform – making it easy to meet data-collection and data-management requirements for emerging anti-counterfeit laws, such as DQSA, and eliminate the burden of maintaining multiple stand-alone systems.

Not only will this common data thread improve your serialization strategy, but it can also offer other benefits in areas like consumer authentication and the ability to conduct more accurate recalls when necessary.

Extending and maintaining impact

With an MES, you can significantly improve operations in one production facility, and you can extend those gains throughout your company by applying a common MES across your manufacturing footprint.

Oftentimes, a company’s production facilities have evolved over time – each in their own unique way. Some were established decades ago. Others are the product of growth and development.

An enterprise MES delivers a holistic view across all your production sites, leading to larger datasets, more robust insights – and more ways to make improvements. Because procedures and recipes can be shared, improvements identified at one site can be applied companywide.

By standardizing operations across your company with an MES, efficiencies multiply. Abnormalities at one location can be completely prevented at another facility due to data sharing and machine learning.

Furthermore, operator training is unified and efficiencies can be gained when employees have a step-by-step framework available to follow throughout the manufacturing process.

And when you choose an MES that takes an “evergreen” approach to system upgrades, you can cost-effectively maintain your continuous improvement momentum.

An evergreen MES allows you to incrementally upgrade the core functionality of your system, while preserving the master data and batch records of your sites. As a result, your system stays up to date without the cost of additional customization and new recipe validation.

About the Author

By Doan Chau | Global Industry Technical Consultant