How to build a quality management report [a 4-step guide]

Quality teams sit on a lot of data. Metrics like average document approval time, company training status, CAPA closure time, recurring deviations (and a whole lot more) can paint a pretty clear picture of your organization’s overall health.

For example, with the right tracking, you can see how a delay in an SOP revision might correlate with a spike in production issues, or how a new training course cuts down on deviations weeks later. 

But having the data is one thing; translating this mountain of information into a clear story that leadership can understand and act on is another. 

That’s where this guide comes in. We’ll walk through how to plan and build a quality management report that highlights your team’s value, shares data in a way leadership can understand, and sets the stage for continuous improvement. 

Step 1: Define your audience and report objective

The data you share, the level of detail you provide, and the frequency at which you provide it will change based on who’s reading the final report. For example, here’s how it could vary with these three audiences: 

QA Internal Reports:

These reports will likely happen more often and get more granular than others. Maybe this is where you closely track your progress against internal department goals, monitor QC trends, keep an eye on CAPA closure times, and log the general activity of your Quality team (e.g. number of QRAs, issues, documents created, etc.).

• Goal: Spot concerning trends, make sure you’re staying on track, and understand what’s working and what’s not.

Leadership Reports:

Your leadership reports may be less frequent, but they can shape critical decisions. This is the time to share the trends that require action. For example, maybe you saw a 15% increase in logged quality events for 3 months in a row, a trend that signals you need more headcount in H2 to maintain resolution times.

• Goal: Inform strategic business decisions based on risk, resources, and opportunities.

Client/Sponsor Reports: Clients and sponsors need proof that you’re a reliable partner. These reports are where you provide it. Refer back to the commitments and promises you made at the beginning of your partnership and showcase how you’re performing against them.

• Goal: Build trust, provide transparency, and demonstrate the health and stability of your QMS.

Pro Tip: You may not need a separate report for your internal team & leadership. A single, full report could start with an executive summary and the most important insights/action items, and then lead into detailed charts and metrics in the later sections for your team (or for leadership if they feel moved to dig deeper). 

Step 2: Define the metrics to include in your quality report

If you included every data point your team has access to in one report, it might explode.

Instead, think about the value of the metric. What information is it really giving you? Is it going to help you make improvements?

To choose the metrics that matter and cut out the noise, follow this framework:

Start with Your Commitments:

The most relevant data points are tied to promises you've already made.

• Client Commitments: Think about the procedures and timelines you’ve agreed upon with your clients or sponsors.
• Internal Commitments: Your own SOPs are a source of truth. If your procedure says an issue investigation must be concluded within 20 days, you need to be tracking and reporting on that data.

Use QC Data as a Leading Indicator:

Quality Control trends can be an early warning system. Here’s a real-world example:

An organization noticed a sudden trend of failing positive controls in their lab. After investigation, they found it was due to a technician’s failure to follow set Work Instructions. Because the Quality Management team was tracking relevant QC data, they uncovered a training gap that, once fixed, eliminated the issue.

Focus on Organizational Decisions:

Your report should provide the data that helps leadership decide if you have the right resources, tools, people, and infrastructure. An 25% increase in deviations for the third quarter in a row might mean it's time to invest in more QA support, more training resources, or a tool that automates parts of the investigation process.

Uncover Risk

Choose metrics that act as a diagnostic tool to expose compliance gaps and help you get to the source of problems (e.g. frequency of specific root cause categories, issue types, etc.)

Analyze Your Audit Performance:

ISO 9001 requires you to report on your audit activity. This goes beyond simply how many you hosted, covering everything from number of critical observations, how you’re responding, how fast you’re responding, and where you currently are in the improvement plan. 

Step 3: Build the structure

A quality management report is more than just a data dump. No matter which metrics you feature, your report should include: 

• Executive Summary: Put one slide at the very beginning that tells the whole story. What are the most important takeaways from this period? What decisions need to be made? What actions should be taken? 
• The Wins & Accomplishments: What went well? What did your Quality team deliver? Quality Management teams add a lot of value – now is that time to show it.
• Areas for Improvement & Analysis: This is the core of the report. What are the challenges the organization faces? What trends in deviations, compliance, delivery times, etc. are you seeing? Use data to show where processes are struggling and, most importantly, provide your analysis of why it's happening.
• External Factors: Look outside your own four walls. How are external events impacting quality and compliance? Are there new regulations, market trends affecting your supply chain, or updated client requirements? 
• Opportunities, Recommendations, and Resource Needs: Based on all the data and analysis, what do you propose moving forward? New initiatives? Changes to the QMS? New resources or better tools? 

Step 4: Turn data into a compelling story

Raw numbers will make your reader’s eyes glaze over. To hold their attention, try this: 

• Visualize Everything. Use charts and dashboards. A trend line is more powerful than a number in a spreadsheet. Visuals make complex data easy to understand at a glance.
• Add Context and Analysis. Don't just show a chart; explain what it means. This is your chance to provide the "so what?" behind the data. 
• Focus on Trends Over Time. A single data point is a number. A trend is a story. Compare this quarter to last quarter, or this year to last year. This is the essence of continuous improvement.
• Connect Data to "Interested Parties." Always tie your analysis back to its impact on your clients, regulators, vendors, patients, etc. How do the trends you're seeing affect them? This helps you prioritize improvements.
  
  

The Complete QMS Software Validation Guide

What are UAT and URS requirements? When is it time to revalidate? How can you make software validation simpler? Find out in our complete guide!

The best tool to track and report on quality and compliance data 

If you don’t have an eQMS, you’re in trouble when it comes to reporting.

Remember all those data examples mentioned above? You’ll have to find them across random files, pieces of paper, and emails, and then type them all into a spreadsheet, and then build formulas to generate trends and charts.

With an eQMS, your quality activity is at least all in one place. But if your eQMS doesn’t have an Insights module, you’ll be left manually transferring data into a separate spreadsheet and building calculations to translate it into charts.

To put it simply, an eQMS with Insight capabilities means a quality report might take you 2 hours. Without an Insights tool, your quality report could easily take a full day or more.

For example, here’s just a snapshot of the data and charts available within the ZenQMS Insights Module: 

With the Insights Module, you get:

• A Single Source of Truth: All your quality data is in one place, so you know the numbers are accurate and up-to-date.
• Real-Time, Automated Dashboards: Instead of building charts from scratch, the system generates them for you. You can also export them to PDFs for easy sharing.
• Drill-Down Capabilities: Want to dig deeper into a specific data point? You can filter by date range, department, document type, and more with a few clicks.

Need more support building your quality reports? Our team can help!