CAPA Posts

Risk-based CAPA and the Drive for Continuous Improvement

Risk-based CAPA and the Drive for Continuous Improvement

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

No matter the industry, if you are a member of a Quality Affairs team, you know that a Corrective and Preventive Action (CAPA) system provides a wealth of information regarding the quality of your organization’s products and processes. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.

For instance, it is commonplace for a CAPA to be initiated for each nonconformance or deviation, or product quality-related complaint or audit finding, regardless of scope or severity. Despite intense regulatory pressures, though, not every one of these circumstances should necessarily trigger a CAPA. The “everything is a CAPA” syndrome is both costly and time consuming. (more…)

Pharmaceutical Organizations: Are You Ready for the Unexpected?

Pharmaceutical Organizations: Are You Ready for the Unexpected?

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Unforeseen, unanticipated, unpredicted, unexpected. These are frightening words to pharmaceutical quality and compliance professionals because an unexpected event often indicates a costly, risky problem; it means that something is not completely under control.

This, of course, has regulatory implications. One familiar regulatory example is 21 CFR 211.192: “Any unexplained discrepancy…shall be thoroughly investigated…The investigation shall extend to other batches…that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”
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Better Together: How Integrated Nonconformance and CAPA Management Help You Avoid FDA 483s

Better Together: How Integrated Nonconformance and CAPA Management Help You Avoid FDA 483s

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

It’s an often cited statistic. Inadequate corrective and preventive action (CAPA) processes are still the number one reason for Life Sciences FDA 483s. Every day, the FDA issues three to four CAPA-related citations. If you’re trying to avoid FDA 483s and warning letters, your first step is to develop a CAPA process that is consistent and under control. Let’s explore some ways to make your CAPA process better by teaming up key quality processes and tools for maximum impact. (more…)

5 Steps to a Compliant CAPA Process

5 Steps to a Compliant CAPA Process

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

The Corrective and Preventive Action (CAPA) process is a requirement for compliance as well as a trigger for continuous improvement activities throughout your quality system. Complying with CAPA requirements and maintaining a reliable CAPA process is a challenge for many Life Sciences organizations. Let’s focus on 5 improvements that will help your organization create a reliable and compliant CAPA process. (more…)

How to Get Started with Quality Analytics

How to Get Started with Quality Analytics

Matthew Littlefield, President & Principal Analyst, LNS Research

There is a lot of hype when it comes to Industrial Internet of Things (IIoT) and Big Data Analytics. Many executives today see the mainstream media marketing campaigns being run by companies like IBM with Watson winning Jeopardy and are instantly interested in seeing how such a tool might be able to solve their business problems.

Although there is undisputed business value in using Big Data Analytics to enable predictive and prescriptive analytics, LNS Research sees most industrial companies are just at the earliest stages of adopting these technologies as part of IIoT pilot projects. For most companies, there is still much work to be done in gaining insights from the data already locked up in their enterprise systems.

In this post we will examine how quality executives can start getting value from the data they already have with an eye to the future, making sure the investments made today will pay dividends in a fully mature IIoT world. (more…)

The Do’s and Don’ts of Successful Root Cause Analysis

The Do’s and Don’ts of Successful Root Cause Analysis

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

We often hear that the CAPA process is the “heartbeat” of the quality system. The changes that emerge from the CAPA process are critical to correcting defects, improving business processes, and meeting customer expectations. When you think more about CAPA, you realize that an effective CAPA process hinges on your team’s ability to understand the true cause of each problem you encounter. With that in mind, here are some tips to help refine your root cause analysis process and keep risky problems from reoccurring. (more…)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

The Corrective and Preventive Action (CAPA) process is at the heart of your quality and compliance system. When properly implemented, CAPA resolves and prevents critical problems and also keeps you in compliance with FDA regulations. But year after year, lack of CAPA procedures and documentation make the list of top FDA 483 observations. The FDA closely monitors the CAPA process, which is why you need to have a handle on it as well. (more…)

3 Ideas for Reducing Quality Risks

3 Ideas for Reducing Quality Risks

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Sometimes small changes make a big difference. You’re already doing the difficult work of managing your quality system to stay in compliance and keep product quality high. But there may be some areas where you can focus to further reduce quality risk. Here are 3 areas to examine if you’d like to make some quick gains toward risk reduction and continuous improvement. (more…)

Quality is Everyone’s Job

Quality is Everyone’s Job

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Vision, values, goals and strategy are the guiding principles of a corporation and culture culminates from them. Quality culture refers to the complete awareness, commitment, attitude, and behavior of the organization with respect to quality.  Corporate leadership must effectively communicate and more importantly demonstrate quality as an inherent value of the organization. (more…)

CAPA Risk Management and ROI

CAPA Risk Management and ROI

Konyika Nealy, Director of Quality Assurance, Pilgrim Quality Solutions

CAPA systems provide a wealth of information regarding the quality of a product or process.  However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line. For instance, it is commonplace for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records, of varying degrees of severity, which are often vetted by issuance order rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process? (more…)