For life sciences manufacturers and those operating in regulated industries, balancing quality and efficiency is often like walking a tightrope.

On the one hand, businesses must comply with Good Manufacturing Practices, ensuring quality standards are met and SOPs are followed. On the other hand, compliance efforts often slow the production process, preventing product batches from being released and causing inventory to sit in storage.

Faced with rising costs and shorter product lifecycles, life sciences manufacturers continue to look for ways to reduce inventory and accelerate time to market.

One way to achieve this is to reduce the time required to identify, review, and resolve process exceptions.

In this post, we’ll discuss review by exception and how manufacturers are leveraging digital tools to more effectively identify quality issues and deviations, and streamline the review process.

What is review by exception?

Review by exception is a modern way of executing quality assurance and control measures to ensure that the final product contains no flaws prior to being released. Instead of reviewing every detail outlined in the associated quality report, many manufacturers leverage review by exception to only highlight deviations, speeding up the process significantly.

For pharmaceutical products, deviations can include quality defects as well as aberration from the established standard operating procedures.

In more traditional manufacturing environments, operators, supervisors, and quality control personnel utilize paper-based methods to record production processes and quality events. These paper reports are forwarded to the quality reviewer to scrutinize the various exceptions.

However, reviewing these production and control record documents can be considerably time-consuming and demanding.

The quality assurance team combs through these multi-page documents to identify and manually clear each exception to the set quality parameters, limits, and tolerances. As a result, this review process holds up product batches, delaying their transition to the release and delivery stage.

Given the rise of digitization across the pharmaceutical manufacturing industry in recent years, manufacturers are increasingly digitizing the review process. This digital approach points out the exceptions automatically, saving the QA team from manually combing through paper documents.

Implementing review by exception in operator workflows

Regulator bodies including the Food and Drug Administration require manufacturers to follow good manufacturing practices to ensure the products being developed are safe for human consumption. As such, manufacturers must outline specific production processes and develop strict quality parameters for their products and ensure that each production batch aligns with those specifications.

But as discussed earlier, the traditional paper-based method of identifying quality exceptions leads to a significantly increased time-to-delivery. Not only does this disappoint customers, but it also increases inventory costs due to the lengthy review process.

Because of this, modern manufacturers leverage digitization to implement quality reviews during the production process instead of at the end. Consequently, workers can focus on analyzing and handling issues in real-time, as soon as the system flags them.

For effective and efficient review by exception, manufacturers benefit from digitizing the entire production process. By implementing a digital solution across every step of production, manufacturers are able to collect comprehensive production data, enabling seamless integration between operations and quality control processes.

Additionally, digital review by exception tools log and record all necessary quality event details, often furnishing the record with severity levels and associated resolution processes. The system makes this easier with interactive work instructions and automated reports.

Benefits of digitizing the review by exception process

Taking a digital approach to quality assurance provides pharmaceutical manufacturers with a number of significant benefits, including:

Eliminating human errors in production: Manual, paper-based document management presents several opportunities for human error. These errors interfere with the quality assurance and control process because teams are then forced to work with faulty, inaccurate data. As a result, it can be challenging to pinpoint the origin of the errors, making review and resolution more time-consuming and difficult to drill down.

Using an integrated, digital platform enables businesses to leverage data collected from digital work instructions, machines, and IoT devices to eliminate the need for manual data entry and prevent human error from clouding the quality report.

Quicker and easier review of exceptions: Using a digital solution for review by exception helps to identify non-conforming parameters and devations in real-time. This allows quality teams to respond to issues more quickly, ensuring that the production run isn’t affected by these quality events down the line.

Additionally, the system can help supervisors understand each exception’s severity, allowing timely intervention during production.

Faster time to market: Reviewing exceptions using paper-based methods creates a bottleneck at the end of the production run, increasing time-to-market. As a result, order fulfillment is delayed, negatively impacting the business’s revenue.

Digitizing review by exception allows manufacturers to catch issues before they progress. Timely intervention ensures that operators can focus on production processes, ensuring quicker time-to-market, and more reliable product fulfillment.

Using Tulip to digitize your review by exception

Currently, 7 of the top 10 life science companies are leveraging Tulip’s platform in some capacity to help digitize their production processes.

Using Tulip, pharmaceutical manufacturers are able to digitize their standard operating procedures, guiding workers through every step of the production process. As a result, businesses can ensure that the batch was produced in accordance with the established SOPs.

Additionally, Tulip enables operators to conduct in-line quality checks, ensuring that products meet the necessary specifications and are produced under the right conditions.

Should any deviation or quality events occur, they are immediately logged and can be responded to in real-time.

If you’re interested in seeing how Tulip’s operations platform can help you streamline review by exception processes, reach out to a member of our team today!

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