This article was originally published by SeerPharma's business partner MasterControl and is republished here with their permission.
Digital transformation continues to be a central part of our lives. It wasn’t too long ago that we would use paper maps to find the best route on a road trip, but not anymore. Today maps are digital, and so is your path to quality manufacturing. To help guide you in eliminating paper from the manufacturing process, MasterControl recently hosted a webinar titled "Manufacturing Excellence: Fully Digitize Your Production Environment to Drive Smart Manufacturing". Key points to consider along the journey to transforming operations are highlighted below.
Avoid Detours Caused by Paper
Using a paper-based production record system takes you down a road leading away from your destination – getting quality product to market quickly. Mistakes are inherent to the pen and paper method, which is a problem when you’re tracking manufacturing data vital to operations.
Risks of a manual process, as pointed out by Adam Sybrowsky, general business manager at MasterControl, include inefficient processes, inaccurate information, poor data tracking, and disconnected systems. The consequences are product recalls, warning letters, consent decrees, and costly shipping delays.
Relying on paper leads to mistakes in critical areas, which creates a ripple effect making for a choppy ride through the entire production process. For example, an operator or technician writes the wrong figure on a form, and this has the potential to create paperwork issues, increase deviations/nonconformances, holds, and downtime. The result is slower time to market and lost revenue.
Paper on the shop floor is an expensive detour no company can afford to make if they want to remain competitive. In their “2019 Global Life Sciences Outlook,” Deloitte reiterates this point by stating, “Investment in digital technologies and the organization transformation is critical not only for success, but for survival.”(1)
Bridge Digital Gaps on the Shop Floor
Connectivity is key to remaining competitive because it bridges quality to the shop floor, allowing for visibility into operations that are an essential part of U.S. Food and Drug Administration (FDA) compliance. This includes being able to explain why something happened, when it happened, who did it, and why they did it. A solution like MasterControl’s Manufacturing Excellence helps streamline operations and avoid common pitfalls in good manufacturing practices (GMP).
In “FDA’s Top GMP Inspection Findings for 2019,” it was reported the second most frequent GMP lapse is failure to thoroughly review unexplained discrepancies or batch/component failures to meet specifications, which moved up from third place. (2) These preventable issues are often caused by using paper-based records that are disconnected from core operating systems.
A connected, digitized solution transforms operations by stopping the ripple effect before it even starts, and through which valuable insights are no longer buried in piles of paper. Mistakes are avoided by using configurable templates that allow data limits to be built in so an entry that falls outside a pre-specified limit is rejected or the system operator is alerted. Operators and technicians have a tablet in-hand allowing them to enforce rules, limits, and ranges during in-line execution.
Additional advantages include ensuring operators have access to current standard operating procedures (SOPs) and work instructions. If a technician is not up-to-date on training, they’re unable to enter data into a production record until necessary training is completed. The digital solution allows for efficiency that simply isn’t possible in a manual process, and mistakes like writing down the wrong number in an incorrect field are avoided entirely. Simple errors can no longer slow the rest of the production process.
Once manufacturing is completed and the production record goes to review by the quality department, a fully digital solution makes all the difference. With a paper-based solution, personnel must sift through hundreds of paper records to find and correct data entry errors. Meanwhile, a product sits ready to ship and can’t go out the door for days and sometimes weeks. With digitized production records, it’s possible to review by exception or achieve right-first-time (RFT) production. These abilities are game-changers and can save hours or even weeks of your time.
Real-time insights into corrections, quality events, failure rates, and related attachments can create a seamless review process where data entry errors are virtually eliminated.
Direct Quality and Manufacturing to the Same Path
Along the way to streamlined production, the disconnect between quality and manufacturing is a common roadblock. With a paper-based system, manufacturing operations and quality departments appear to have conflicting priorities. While quality focuses on complete paperwork, adherence to quality control processes and up-to-date training, manufacturing works to minimize downtime and accelerate time to market. In actuality, these are all steps along the same path toward a common goal.
The departments are not the problem; the conflict is created by disconnected systems and cumbersome, error-prone processes. Using paper on the manufacturing floor is akin to unnecessarily taking separate, more difficult routes to get to the same destination. Going paperless with full digitization throughout all systems finally gets quality and manufacturing on the same path. For example, connecting training with the production system means quality can ensure operator training is always tracked, enforced and verified. Up-to-date operator training on the shop floor leads to increased, more effective production. Both departments have visibility into key information and work together on rapidly delivering a quality product to market.
Arrive at Results that Drive Revenue
Switching from a paper-based approach to an electronic one delivers measurable results with a significant impact on the bottom line.
After implementing Manufacturing Excellence, Wellington Foods cut production errors which led to improved RFT by more than 90%. They not only reduced the risk of inaccurate data but decreased the time of their review period by more than 75%. Prior to adopting a digital solution, it could take them several weeks to complete their review process and release a product, and now those same reviews only take hours.
Legacy Pharmaceutical Packaging adopted a digital solution and improved data integrity, which reduced their total deviations by up to 25%.
Both companies improved quality and saw efficiency gains by reducing the amount of overhead spent on managing a paper-based process. The elimination of errors and improved data integrity, made possible by a digital solution, can put a company in the fast lane for time to market and increased revenue.
The bottom line is if your company still relies on paper, it’s time to digitize production records and go “the last mile” by extending connectivity to the shop floor. This allows you to correct mistakes as they happen, thus errors never have an opportunity to trickle through your production process and slow the process enough to result in expensive delays. Connectivity provides a holistic view of your production data while helping you achieve a paperless production environment that improves quality and accelerates time to market.
(1) “2019 Global life sciences outlook,” Deloitte, 2019.
(2) “FDA’s Top Ten GMP Inspection Findings for FY 2019,” FDAnews, September 2019
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