CAPA, or Corrective and Preventive Actions, are critical activities of pinpointing, addressing, and preventing issues in manufacturing facilities. While the Corrective Action is designed to correct immediate problems, the Preventive Action aims to prevent it from recurring. Here, we’ll take a closer look at the importance of CAPA management, and how software can support a seamless CAPA process.
Unlike the previous industrial revolutions that involved replacing existing technologies and assets with modern ones, Industry 4.0 is about mastering the hurdles and opportunities presented by disruptive technologies like big data, machine learning, and AI, which continue to blur the lines between the digital and physical worlds.
Put an end to Corrective and Preventive Action (CAPA) plans that get lost in the back of a filing cabinet or on someone’s desk. By choosing a solution to modernize the process, you can easily track, schedule, and follow through on all investigations. This step-by-step guide will help you understand the SafetyChain tools available to efficiently perform CAPA when necessary to ensure that your facility can quickly meet requirements and resolve issues.
Poor quality can waste a considerable portion of an organization’s operating budget. Alarmingly, some manufacturers even have the cost of poor quality factored into their budget, meaning these companies are willing to allow it to persist in plain sight and hinder their overall performance.
While there will always be some factors that affect quality to a certain degree, identifying and addressing the factors contributing to poor quality is critical. This ensures competitiveness, supports ongoing improvement efforts, and minimizes waste. Here’s a closer look at the unexpected costs related to poor quality, as well as how to measure and address them with a cost of quality analysis.
When I enter a manufacturing plant, the first thing I look for is paper — clipboards, paper forms, folders, envelopes, binders, etc. The presence of these items on the plant floor is a telling indicator of the plant's maturity and operations.
Don't get me wrong, I love paper, and it has many uses. As a technology, few alternatives are faster, more flexible, and cheaper to implement than paper. Paper itself is not the problem, but it is a crucial symptom pointing to deeper challenges in the factory. My goal in helping Operations improve their efficiency, effectiveness, and profitability is not "to eliminate paper," however that is the inevitable result.
There was a time during the 1940s when working in the food industry was considered a “war job.” It was said that food was the mightiest weapon of them all. Eight decades later, that phrasing still holds. Yet, while it once referred to the power of keeping troops fed, the message is reversed: Food can also be the mightiest weapon of them all when used against us. The intention of the Food Safety Modernization Act (FSMA) Intentional Adulteration Rule from the FDA is to prevent the mass harm that can be caused by contaminating the U.S. food supply.
While many process manufacturers understand the potential benefits of digital transformation, often, their vision is clouded by past failed projects. Just 30% of digital transformation initiatives are successful and because they require both time and financial investment.
Fortunately, we can learn from past mistakes. With a little extra planning and preparation, you can pursue a foolproof digital transformation that supports positive change throughout your facility and sets you up for continuous improvement. Avoid the frustration of attempting a digital transformation and failing by adopting a data-first approach.
Most process improvements start with plenty of momentum, but their changes don’t always stick. In fact, just 54% of major change initiatives stick long-term—a concerning statistic, considering the number of dedicated resources to these types of projects.
Whether you are a beginner to making digital process manufacturing improvements or a seasoned veteran, to enact change that lasts, we must identify why operational improvements don’t stick in the first place. Often, it’s not the tools used but the psychology behind the improvements that come up short. Improvement requires change, and to support that; we must accept that we aren’t perfect and recognize a need for change. Here, we’ll take a closer look at some of the barriers to change as well as ways to dismantle them.
At its core, manufacturing success is all about quality. Consistently adhering to quality standards ultimately delights your customers and takes you far beyond the benefits of brand loyalty. Determining the cost of quality (COQ) is a complex but essential endeavor; there’s the cost of poor quality to consider and the cost of good quality or preventing issues from happening in the first place. In plants producing hundreds of separate items, tracking the many variables that influence quality can feel like a massive undertaking. And of course, it’s not just tracking this information that facilitates change; the goal is to derive meaningful insights from the data to inform future decisions.
With the Food Safety Modernization Act (FSMA) in place for more than a decade, the FDA has focused more heavily on regulation rather than education for FSMA rules. One rule in particular, which generated more than 550 Form 483s (issued when FDA inspectors observe violations) in 2020, is the Foreign Supplier Verification Programs (FSVP) Rule.
Here, we'll provide a refresher of the FSVP Rule and review some of the main reasons for receiving a 483 so that you maintain compliance and stay audit-ready.