Key Takeaways:
- Learn the meaning of change controls and quality issues
- Find out which change control and quality issue resolution metrics to track for success
- See examples of quality issue and change control improvement goals
- Learn how to find the best GxP compliant issue & change control management software
What are quality issues and change controls?
Issues and change controls are usually talked about simultaneously, often because good issue management requires good change management. But issue workflows and change control workflows aren’t always connected, so it’s important to understand the difference.
What is an Issue in Quality Management?
Quality issues are quality deficiencies, defects, or deviations from an expected outcome. Issues get classified based on their frequency and severity, typically into categories like Critical, Major, and Minor. But no matter their severity, all issues require a root cause analysis to get to the source of the problem, a risk assessment to determine the overall impact, and a CAPA to document how the issue was corrected and the steps you’re taking to prevent it in the future.
What is a Change Control in Quality Management?
A change control is the official process to request, approve, and document changes to your procedures, equipment, systems, etc.
For example, say you identify an issue with a piece of equipment no longer working the way it was intended. It turns out the equipment is outdated and out of warranty, and third-party maintenance is no longer cutting it. As a result, you find a new supplier and decide to replace your equipment with a new model.
In this instance, you’d launch a change control workflow which would document the need to replace the equipment, details on the new model selected, the procedures that would be impacted, the training needed, etc. – all with controlled signature approvals throughout.
What data should you track for quality issues and change controls?
The ultimate goal of quality issue management is simple: correct the issue and mitigate any risk of it happening again. For change controls, success means your change was applied as intended, was conducted in a timely manner, and ultimately, was effective.
But how do you prove the success of your issues and change controls?
It centers around tracking the right data. These are just a few examples of quality issue and change control metrics you should track:
Quality Health Metrics
These metrics help capture the overall health of quality management at your organization:
- Number of issues logged over time: You may think zero issues reported is a good thing, but in reality, issues will always appear. If you see zero new issues for a long stretch, it might signal a bigger problem (e.g. your employees don’t know how to log an issue, they aren’t getting logged correctly, etc.) On the other hand, if you see a surge of new issues in a short period of time, that’s also cause for high-alert.
- Severity level of issues: Track not only the number of issues, but also their severity in order to get a true picture of the health of quality management at your organization.
Completion Time Metrics
These metrics help determine your organization's ability to hit vital quality deadlines:
- Percentage of issues and change controls closed by the established deadline: Track how many issues and/or change controls you close on or before the target date in your SOP.
- Median days to complete: Determine how long, on average, it takes to complete an issue or change control.
- Completion time by stage: Track on-time completion percentage for each stage of any given issue and change control. Are there stages that are consistently delayed? Your issues or change control process probably needs refining.
Effectiveness Metrics
Successful issue and change control management isn't just about being timely. These metrics help determine if your workflows are actually effective:
- Recurrence of issues: Recurring problems mean the underlying cause was never truly fixed. Keep tabs on whether the same issues resurface.
- Root cause categories: Track and categorize root causes to identify patterns. If a particular root cause keeps showing up, you know exactly where to focus improvement efforts.
Examples of Quality Management Goals for Change Controls and Issues
Once you’ve set up a system for tracking the right quality management metrics (see the next section for the tools that help with this), it’s time to embrace the idea of continuous improvement. Here are some goals quality management leaders can set to help improve change control and issue management:
- Goal #1: Close X percent of issues by the established deadline.
- Goal #2: Reduce the recurrence rate of issues by X percent over the next year.
- Goal #3: Complete root cause analysis of critical issues within X days.
- Goal #4: Implement change controls within X days of approval.
- Goal #5: Have no more than X percent of over-due change controls.
- Goal #6: Complete post-implementation reviews of change controls within X days of completion to evaluate effectiveness.
How to find the right issues and change control software
An eQMS is the standard tool for managing issues and change controls, mainly because of its ability to connect all of your workflows, documents, training requirements, etc. You can document CAPAs, initiate change controls, retire an old SOP, assign training on a new SOP, and more without ever having to leave the system.
But keep in mind, if quality issue and change control management are priorities for your organization there are a couple of features your eQMS needs to have:
- True system configurability: The best issues and change control software will allow you to configure your categories and stages (this is especially important for life sciences organizations). This allows you to still use the vocabulary and procedures you’ve already established. A rigid eQMS won’t give you free rein to change the names, numbering systems, form components, signature requirements, etc., requiring you to adjust your process. Watch out for systems that say they’re configurable, but really mean they’re customizable for a cost. We explain the difference here.
- Robust data tracking and insights: You can’t set good goals without good data. Choose an eQMS that provides insights reports and real-time data dashboards so you can pull the issues and change control KPIs we mentioned above. See below for an example of the kind of metrics your eQMS should provide.
An example of the quality issues data captured in the ZenQMS Insights module which provides easy-to-read reports and dashboards.
There are a lot of pros to using an issue and change control management software within your organization. Not only does it make it easier on your quality management team (controlled workflows and automatic reminders are game changers), it also makes life easier for auditors – and we hear they appreciate that.