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.

Better Together: Nonconformance + CAPA Management

Integrated nonconformance and CAPA management solutions can help keep your CAPA process compliant. A strong process starts when a defect is found and includes steps to:

  • Record problems and assess their risk
  • Contain and disposition defective products
  • Document investigation methods and results, including root cause
  • Implement corrective and preventive actions to resolve the problem
  • Verify the effectiveness of the corrective and preventive action plans
  • Analyze failure modes, root cause, and effectiveness trends

During the analysis phase, trend analysis can help you measure the effectiveness of the CAPA process, and the data can provide insight into future CAPAs. For example, through analysis, you may discover that reaching a certain failure mode threshold may be the trigger for the CAPA process to begin.

Better Together:

Avoid FDA 483s with Integrated Nonconformance and CAPA Management

Download our 5-minute overview video to learn more.

NC & CAPA Management Video


Better Together: Nonconformance Management + Risk Assessment

You’ve probably heard the saying, “Not every defect should result in a CAPA.” While we all realize the truth of that statement, it can be difficult to put into practice. Sometimes it is easier to create and investigate the CAPA than to decide whether a CAPA needs to be created. That’s where risk comes in.

Risk assessment early in the process gives your team a consistent way to determine whether a CAPA needs to be created for a defect, and to document the results of that decision. This allows you to create CAPAs for high-risk problems and make sure they’re investigated quickly. Conversely, you can give low-risk defects less priority by dispositioning them and monitoring for future reoccurrence.

Creating the right CAPAs at the right time quickly makes an impact. By eliminating time spent on unnecessary investigations, your process becomes more efficient. Even more importantly, you’re focusing your efforts on the highest-risk problems, reducing the likelihood that a serious defect will affect your customers.

Better Together: CAPA Plans + Effectiveness Review

CAPA effectiveness is a key quality metric and a measure of the health of your CAPA process. This step is often overlooked or forgotten, but consistent effectiveness reviews are necessary to ensure that CAPA plans successfully resolve the root cause of systemic issues and drive improvement over time.

The concept of effectiveness can extend beyond individual CAPAs and serve as a metric for monitoring the entire CAPA process. Here are some questions to ask yourself as you examine the health of your process as a whole:

  • How long does each step in the CAPA process take for your organization?
  • How often do your initial and final risk assessments match?
  • How effectively are you able to identify root cause?
  • How often do problems reoccur?
  • Do CAPAs occur more often for a specific site, department, or group? What can the larger organization learn from this?

Better Together: An Effective CAPA Process + Reporting and Trend Analysis

Many organizations have realized that in order for a CAPA process to be effective, it needs to be automated. This allows CAPA data to be captured quickly and consistently, and also enables detailed reporting and trend analysis. Trend analysis is an important aspect of improving the CAPA process. Your process and results will improve if you’re able to monitor failure modes, recurring root causes, and CAPA effectiveness metrics. Monitoring aging and workflow status provides further insight into where high-impact improvements can be made.

Business intelligence raises the bar on CAPA reporting, giving you the flexibility to “slice and dice” data by site, department, product, process, and more. This can lead to insights and improvements that wouldn’t be possible with a manual system.

Better Together: CAPA Management + The Cloud

If you’re deploying an automated CAPA solution, a cloud-based deployment can have you up and running quickly and securely. Plus, a cloud deployment will help your CAPA management process scale and remain harmonized as new teams or sites are added to your organization. This is especially helpful in light of the frequent mergers and acquisitions within the Life Sciences.

A cloud deployment also relieves you of the need to administer the more technical aspects of the system such as hardware upgrades, software maintenance, and even some aspects of validation. This enables you to focus on maintaining and improving your key business processes.

Finally, when done right, a cloud deployment can be more secure than deploying a solution within your own organization. A good cloud vendor will monitor the hardware, network, and firewall for your system in a SOC 2 Type II-compliant environment. This includes handling security at the network, server, and application layers to safeguard your data. Examine these areas closely when looking for a cloud-based CAPA solution.


FY 2015 Inspectional Observation Summaries

Roxane Napoli

Senior Marketing Manager, Pilgrim Quality Solutions

No Comments

Leave a Comment

Your email address will not be published. Please fill out all required fields.

This site uses Akismet to reduce spam. Learn how your comment data is processed.