A Robust Manufacturing Software Solution Reduces the Frequency and Impact of Deviations

Deviations are an inevitable part of manufacturing, but the ability to detect and deal with deviations in real time, reduce the occurrence of avoidable manufacturing deviations, and limit their impact is made more difficult than it need be with paper or disconnected systems.

Relying on manual, paper-based systems to manage the deviation process in manufacturing hinders manufacturers’ ability to track manufacturing changes, identify quality events, and take corrective action in real time. In turn, this reliance on paper increases the acceptable level of risk in production and practically ensures the occurrence of bottlenecks and downtime.

“Deviation or nonconformance management is a critical topic for companies today because unaddressed issues can lead to product recalls and reputational damage,” according to McKinsey & Company research.¹ “More often, deviations or nonconformances can affect a company’s product-release process, capacity, and lead times.”

Manufacturers can save themselves a lot of pain by leveraging manufacturing software with robust digital tools to increase operational visibility and stay on top of deviations so that they don’t turn into corrective/preventive actions (CAPAs), or worse. This requires closing the offline data gap caused by paper on the shop floor.

Paper or Disconnected Manufacturing Systems Create Offline Data Gaps

You may have an automation control system that is collecting data on machinery and is probably even telling you when a lot starts and ends – but will it tell you about all the actions in between? If not, that means you have missing data. Similarly, if working with other types of disconnected systems, then you either rely on paper or end up manually tracking and transcribing data from one system to another – also an inefficient and risky process.

When so much data is trapped in paper and disparate systems, this offline or disconnected data gap makes it difficult to track quality events and nearly impossible to make informed decisions. The lack of deviation awareness and control causes delays in corrective actions and quality review and increases the risk of quality events turning into major or critical issues.

Digital Connectivity With Manufacturing Software Improves Data

An integrated, digital manufacturing solution like MasterControl Manufacturing Excellence can help companies better manage the deviation process in manufacturing. Managing quality events efficiently is good, but even better is mitigating quality events: fewer deviations, fewer quality events to manage.

MasterControl’s integrated manufacturing software solutioncan help reduce the number of planned deviations and unplanned deviations by allowing you to open up the “black box” created by paper to quickly detect and deal with quality events before they become severe.

A fully connected, digital solution can provide real-time work-in-progress visibility and traceability into the status of production lines, batches, lots, and operator performance. Then you can dive deeper into specific production runs to determine who is working on a specific lot, what processes are taking place and how far along they are. You can even access data being entered in real time and, with Review By Exception, easily group the data you care about in one place.

A fully connected digital solution also allows you to integrate the recording, assessment, and approval of all deviations throughout the manufacturing process with real-time deviation-tracking tools. You can connect deviations and other processes with electronic batch records (EBR) or device history records (eDHR) and launch deviations and CAPAs directly from the record. A fully integrated manufacturing software solutionallows for in-process deviations to be displayed to the right users at the right time, bringing this data directly to the people who need it when they need it.

Better Data Access Means Better Managed Manufacturing Quality Events

With improved access to shop floor data, process engineers can make quicker, more informed decisions about deviations, CAPAs, nonconformances, and other quality events. Data from the EBR or eDHR can be used to glean real-time insights, identify bottlenecks, and reduce the frequency and impact of deviations.

One pharmaceutical company estimates that optimizing manufacturing production processes with MasterControl’s manufacturing software solution reduces total deviations related to data integrity by upwards of 30%. Another manufacturer says 20% of deviations were caused by human error before digitizing, and by reducing data input errors that create data integrity issues by more than 90%, MasterControl allows better data to drive fewer deviations.

Ultimately, effectively handling the deviation process in manufacturing and keeping up with quality checks means:

• Fewer deviations and CAPAs to manage.
• Deviations are planned rather than unplanned.
• Deviations are managed in the master record.
• Less time spent chasing marked-up paper after the production run.

By enabling real-time work-in-progress visibility and traceability along with integrated deviation management, a fully connected, digital solution allows manufacturers to streamline production processes, reduce unplanned downtime, and enforce quality controls without slowing production.

Resource:

1. “Making Quality Assurance Smart,” Tacy Foster, Evgeniya Makarova, and Vanya Telpis, McKinsey & Company, January 2021.