When you're dealing with quality issues in a manufacturing plant, keeping up with all the data is a struggle.
In fact, depending on the size of your operations, manually tracking and analyzing all the data manually can cause delays in responding. A lack of prompt handling often results in repeated quality issues and minor product problems escalating into bigger ones.
Compliance is another headache. Keeping up with the changing regulations and putting new documentation in place manually is time consuming and mistakes are easy to make. Inconsistent documentation becomes a serious problem when audit time comes around.
What you need is a system to handle these processes in the most efficient way possible and Corrective And Preventive Action (CAPA) system software does just that.
CAPA stands for Corrective and Preventive Action. A good CAPA system helps you to quickly find and fix problems with products or processes, making sure they don't happen again. The software keeps an eye on everything quality related, identifies any potential problems, flags issues, helps you identify the cause of the problem, and guides you through how to fix them.
Let's consider a chemicals manufacturer that learns that one of their products has unexpected impurities affecting its quality. Here's how they might handle it with CAPA software:
Now you know what a CAPA system is and what it does, let's explore the top nine features to look out for when choosing the right software for you.
Ideally, you want to make sure that your CAPA system software communicates smoothly with other software systems, such as ERP or quality management software. You want to avoid data getting isolated in one system and not shared where it's needed, known as a data silo.
In other words, you need to make sure that all your systems talk nicely to each other. This allows you to see the big picture without any gaps and make decisions faster. It also helps you to improve risk management and put together action plans.
Root cause analysis helps you find the true reasons behind quality issues, rather than just focusing on the obvious symptoms. Finding the source of the problem in this way means you can put measures in to stop it from happening again, rather than patching them up with a temporary fix. This reduces the risk of non-compliance, fines, or reputational damage.
Common root cause analysis tools include 5 Whys or fishbone diagrams (also known as ishikawa diagrams).
Having real-time access to the latest data means that if something goes wrong, or there's even a hint of a quality issue, you can react quickly and decide how to address it. This approach effectively mitigates the escalation of minor problems into more significant ones.
Sticking with the chemical manufacturer example, let's say you're producing a batch of chemicals and you need to keep the temperature low during a reaction process. Using sensors connected to your CAPA software, you can get alerted if the temperature exceeds the upper threshold. There's no need for end-of-day reports, you can see it straight away and rectify the issue quickly.
To avoid fines and penalties, look for software that has compliance features. For instance, you can get CAPA management software that automatically aligns your data capture with FDA guidelines, ISO standards, and any other regulatory frameworks you need to follow
You can also use your CAPA system to manage risk assessments, to make sure you're in compliance with health and safety legislation, which will make your compliance manager happy when it comes to completing internal audits.
Every company is different. You have unique processes, specific challenges, and particular ways of doing things. So, having an effective CAPA system that adapts to your specific needs makes it much more effective.
For example, you might need to modify the way reports are generated or adjust escalation workflows. Customization features let you tweak elements to fit better with your existing operations.
Good customization options makes it far easier for everyone on the team to adopt and use the system and reduce resistance.
Data security is a non-negotiable CAPA software feature for most businesses. Maybe you want to keep your proprietary formulas or personal data well-protected. Data security features act like a high-security vault, stopping unauthorized access or breaches. For best security, use encryption for data in transit and at rest, strict access controls, and regularly check for security issues.
As your company grows, your processes and data volumes grow too. You need a system that can handle this, without needing a new system every few years. Scalability usually means expanding capabilities, managing more data, or adding new features.
For example, let's say you start managing the quality of a few hundred products, but then expand your line to thousands, the CAPA software should be able to handle it.
If you run into a snag or something unexpected happens with your CAPA software, ideally you want experts on call to sort it out quickly. Any downtime or malfunction disrupts operations and could lead to bigger issues.
Training is important too. When the software gets updated or new team members come on board, you should have training resources showing people how to use the system effectively.
CAPA software audit trails keep track of all changes in the system. This includes new entries and edits, The trails also show who made the changes and when they were made. This gives you a clear, chronological log of everything that happens for accountability and transparency.
For example, if a change is made to a corrective action plan or if new data is added about an issue, the audit trail ensures there's a record of who did it and the exact time it was done.
AlisQI is a robust quality management system (QMS) and CAPA software solution that improves quality processes and compliance management. AlisQI not only addresses current issues but also preemptively mitigates future risks and helps achieve continuous improvement. With all the features you need to ensure compliance and customizable options, AlisQI equips you with software to improve quality across your organization.
Check out AlisQI today - book a demo here.