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What exactly are the FDA’s requirements for CAPA? A compliant CAPA process should include: ●?????Data collection and trend analysis ●?????Investigation the cause of the non-conformities ●?????Actions needed to correct and prevent recurrence ●?????Ensuring information is shared with the right stakeholders ●?????Submitting relevant information for management review ●?????Assessing and prioritising issues based on risk ●?????Documenting all the above activities But, it’s not just your own internal non-conformances that your CAPA process should be addressing. The FDA requires you to develop procedures for handling CAPAs related to supplier quality issues, too. These should include how you communicate with suppliers, track their corrective actions, and verify their effectiveness. A supplier management process is essential. Feel free to save the diagram below to help you identify the internal and external inputs for initiating your CAPA process:

What exactly are the FDA’s requirements for CAPA? A compliant CAPA process should include: ●?????Data collection and trend analysis ●?????Investigation the cause of the non-conformities ●?????Actions needed to correct and prevent recurrence ●?????Ensuring information is shared with the right stakeholders ●?????Submitting relevant information for management review ●?????Assessing and prioritising issues based on risk ●?????Documenting all the above activities But, it’s not just your own internal non-conformances that your CAPA process should be addressing. The FDA requires you to develop procedures for handling CAPAs related to supplier quality issues, too. These should include how you communicate with suppliers, track their corrective actions, and verify their effectiveness. A supplier management process is essential. Feel free to save the diagram below to help you identify the internal and external inputs for initiating your CAPA process:

Dare to be different (or same)! Lab quality is more similar than we realize. The essentials to a good Corrective/Preventive Action process is the same regardless of compliance...... FDA, EPA, DOD, CDC, ______ (write in). Whichever agency you must comply with, step outside of the box and see what can be learned from other analytical disciplines. I can almost guarantee that everyone has tips that others can use. Networking for best practices is always beneficial! #Pacelabs #Environmental #Health #Quality

Work in a Regulated Industry? This Event Is for You. ?? Outdated audits risk compliance, efficiency, and success. On February 7 in Indianapolis, learn how to modernize your audits, prepare for FDA inspections, and make an impact where it matters most. Learn more and reserve your spot: https://lnkd.in/ebNiWMmR

Quality Compliance Need help ensuring your root cause analysis for OOS batches pass muster with the Agency? Or why your Quality Program is getting repeat observations despite internal oversight? Give KTK a call and have one of our industry experts previously employed by the FDA and industry operations help you get your Quality program back in compliance!

The #1 issue FDA finds with CAPA procedures. In 2023, FDA issued 252 inspection observations related to establishing procedures for corrective and preventive action. ?? This was the most common finding, just like it is every year. Let's break it down a bit more. Of all the requirements in 820.100, two main things showed up the most in warning letters last year. One of those is analyzing sources of quality data to identify quality problems. So, how can you make sure this doesn't happen to you? During your planning, you should do the following: ?? Identify important sources of data (complaints, suppliers, service, etc.). ?? Provide enough resources, including personnel, infrastructure, or training. ???? Set up clear roles and responsibilities for those people. ? Define what's needed for each data source, including limits, acceptance criteria, escalation criteria, and ways to report issues. ?? Analyze the data from these sources. By doing this, you can make sure your quality processes connect to measurement/analysis/improvement, and avoid getting an observation of your own! (I'll touch on the second biggest CAPA procedure FDA finds in another post!) P.S. If you liked this post you'll enjoy my newsletter. Every week I share tips and insights for getting your QMS ready for FDA and notified bodies. Join hundreds of subscribers here: https://QARAsolutions.com/

?Corrective and preventive action (CAPA) isn't just a part of quality management, it IS quality management! ? CAPA is about excellence. It's about identifying risks at their roots, crafting solutions, and improving your processes to prevent those pesky non-conformities from creeping back in. As an organization, your aim should always be to uphold the highest standards of quality. And to do that, you need CAPA in your corner. ?? Our toolkit is here to revolutionize the way you manage CAPA. With in-depth guides and resources, we're handing you the keys to an integrated approach. ??? Access now ?? #CAPA #qualitymanagement #CAPAmanagement

?? PCN Dossier Quality: Is Your Data Up to Standard? ???? Submitting your PCN dossiers is just the beginning—but is your data truly compliant and of sufficient quality? ?? Poor-quality data can lead to compliance issues, product delays, or even fines. Don’t let your company fall into the trap of thinking submission alone is enough. ?? In our latest article, we explain what you need to know about data quality in PCN dossiers and how to ensure your submissions meet the required standards. ?? Read the full article HERE >> https://lnkd.in/dJsXkzRy #PCNDossier #Compliance #DataQuality #SafetyDataSheet #Chemius #RegulatoryCompliance #ChemicalSafety #PCN

“Death by CAPA” refers to the overwhelming burden of an inefficient or excessively complicated Corrective and Preventive Action (CAPA) process. This often results in unresolved issues, reduced effectiveness, and a drain on resources. To avoid this scenario, it’s crucial to streamline and optimize the CAPA process to address issues efficiently and improve overall quality management. Read more here: https://lnkd.in/dn_WvqXZ

Nonconformances in your processes, suppliers or product can have far reaching consequences. If managed improperly, a company can face challenges in loss of product reputation, long recall processes, or even patient harm. SmartSolve Nonconformance Management, along with our CAPA Management, helps you properly manage all your NCs and ensures every process is followed to completion based on the level of risk associated with each defect. Check out this fact sheet to learn more. #medicaldevices #medtech #qualityassurance #compliance