Just like your own health thrives on proactive habits and regular check-ups, your QMS requires a similar approach. With evolving regulations, shifting team dynamics, and changing systems, “set it and forget it” should be a forbidden phrase for your quality team. In fact, the most effective quality teams spot potential issues and mitigating risks long before they lead to a tricky diagnosis.
In the spirit of fresh starts, now is the perfect time to do a pulse check on your QMS to make sure it’s as healthy – and effective – as possible. Before diving into a new year of quality, follow these 4 steps to assess, adjust, and continuously improve your quality management processes:
Step One: Determine the focus of your tests
Before you can judge the strength of your QMS, you have to know what metrics you’re measuring it against. Start by examining your problem log. What patterns or consistent issues do you see? These could be things like:
- A specific action (like a signature or approval) is frequently delayed
- Access controls are incorrect
- Documents are missing or taking too long to find during an audit
- The wrong documents are being uploaded
- …Or a host of other problems.
Pay special attention to processes within your QMS that have a high risk of human error, as well as practices that haven’t scaled or adapted as your company’s products, teams, and procedures have changed.
Once you know what’s happening, then you can set up tests and metrics to determine how often these problems occur and what factors within your QMS may be causing them. Not only does it help you set up an effective action plan, it gives you a great benchmark against which to compare your continuous improvement goals next year.
Pro Tip: This is where an eQMS can really come in handy. Instead of tracking issues across several different spreadsheets, an eQMS keeps records of issues as they occur, helping QA teams identify patterns or consistent issues. It’s much easier to spot trends in signature delays or consistent deviations – which means it’s easier for QA teams to fix them.
And if you don’t have an eQMS, a closer examination of your problem log may show signs it’s time to get one.
No matter how smoothly your QMS functions, if your processes aren’t aligning with official regulations or your GxP standards (GMP, GLP, GCP, etc.), you can’t call it “healthy.” When you’re evaluating your QMS, this is your starting point.
It may seem obvious, but keeping up with regulatory changes can be a challenge. Regulatory bodies like the FDA don’t typically drop surprise changes; they spend time discussing, gathering feedback, and providing guidance on potential regulation updates long before they go into effect. But they don’t come knocking on your door with this information. Staying on top of changes is a proactive endeavor. Use the new year to assess how your team is staying informed. Are you active in quality communities? Subscribing to newsletters? Attending quality webinars? (Take a look at some upcoming quality events here).
Some auditors will even ask you how you monitor for regulatory and GxP changes, so make sure it’s baked into your plan for the year!
Step Three: Set up an internal audit and periodic review plan
While the new year is a great time to take a closer look at your QMS, it’s not the only time you should be doing a pulse check on your processes. When you’re defining goals and projects for the year ahead, establish a comprehensive internal audit plan.
As you do, decide on the frequency of your audits. Annual audits that check everything at once are common, and usually take about a month to conduct. However, more frequent checks, like quarterly or monthly, can be beneficial, especially for dynamic organizations. These might break down the audits by department or process, like development, manufacturing, IT, and more. In effect, they keep your teams audit-ready or in a constant state of control.
Once your audit plan is in place, don’t skip setting up a periodic review schedule too. How do periodic reviews differ from audits? They typically monitor something very specific and happen more frequently than standard internal audits.
Here are some examples where periodic reviews can ensure your QMS is at peak health:
- Intrusion Detection Monitoring: Life sciences companies often deal with sensitive data, so maintaining data integrity through intrusion detection systems is common. Though your team likely assess alerts in real time, a deeper, weekly review of all system logs can ensure no anomalies or threats slipped through the cracks or were miscategorized, which would signal a need to adapt your processes.
- Work Form Verification: For CROs, lab work and documentation are critical, so a quality team may want to set periodic reviews to verify work instruction forms were contemporaneously signed and contain all necessary batch IDs.
- Periodic Competency Checks: Let’s say you work in a lab. A helpful periodic review might involve overseeing staff as they conduct an experiment, verifying that their steps adhere to protocols, and confirming the outcomes fall within expected parameters. This makes sure SOPs and training procedures are functioning properly within your QMS.
Step Four: Remove any unnecessary monitoring
If you never had a history of high blood pressure, you probably wouldn’t go out of your way to check it beyond your yearly wellness appointments, right? The same principle applies to your QMS.
Take time to remove any “bloated” monitoring processes from your QMS. Some signs it may not be needed in your future health checks include:
- It’s not giving you any new or actionable information. Avoid monitoring just to “check a box.” If you can't draw any useful conclusions from a particular evaluation, it’s time to either adapt it or ditch it from your health test.
- It’s monitoring a function that has consistently been error- and issue-free. For example, let’s say you want SOPs approved within 4 days of creation. Your monitoring reveals that in the past 2 years, it has never taken longer than 2 days for approval. Do you still need to devote time and resources to monitoring this process? Probably not.
Quality teams are frequently short on time and resources, so you’ll want to zone in on the most high-risk components of your QMS.
Remember, evaluating the health of your quality management system is a cycle. You monitor, analyze, make an action plan, monitor again, make changes, check the effectiveness of your changes, and so on and so on. But more than a routine exercise, it's a strategic move to ensure your QMS remains robust, compliant, and capable of supporting your organization’s quality objectives for the year to come.