You Have a Problem Statement, Now What?
Turning Analysis into Action
In our previous post, we explored the evolution of a problem statement. Now it’s time to put it into action. If a problem well stated is a problem half solved, what happens next?
This final post in the “A Problem Well Stated” series will show how to use your problem statement to drive meaningful improvements in your laboratory.
A problem statement is more than a description—it’s a guide, a communication tool, and a historical record. It helps you:
- Respond to major issues with clarity.
- Justify resources and corrective actions to leadership.
- Document the journey from detection to resolution.
For accredited labs, this is critical: make sure your problem statements live in your nonconformance or corrective action records per ISO/IEC 17025:2017 requirements.
Finalizing the Problem Statement
Before moving forward, ensure your problem statement is clear, validated, and documented:
Validation
Confirm the statement reflects verified facts and scope. Remove outdated assumptions or irrelevant details.Alignment
Get agreement from all stakeholders. Without alignment, corrective actions will lack buy-in.Documentation
Once validated, formalize the statement. Attach it to your nonconformance or corrective action record, or store it in your lab’s knowledge base.
Planning Corrective Actions
With your problem statement in hand, you now have a roadmap for what needs fixing. For complex issues, you may face multiple contributing factors. Prioritization is key.
A simple approach:
- Root Cause Analysis: Review investigation notes and identify major contributing factors.
- Action Plan: Translate findings into structured tasks with timelines and responsibilities.
- Implementation: Assign ownership and monitor progress.
Helpful resource: ASQ Root Cause Analysis Guide
Case Study: How a Missing Sheet of Paper Caused a Big Problem
A client asked the lab to retest samples after their confirmation lab reported different results. The retest revealed a dilution error. At first, it seemed like a simple math mistake, but the impact was severe—the client had already shipped product based on the incorrect data. The corrected results showed the product did not meet specifications, costing the client about $1 million.
The lab launched a full investigation. The root cause? A missing paper bench sheet. The samples had been prepared with a 10X dilution, but the analyst didn’t know that because the sheet was lost during handoff. The samples were analyzed as if they were undiluted, and the error went unnoticed.
After a lengthy investigation and a revised problem statement, the lab had a strong case for implementing an electronic laboratory notebook (ELN). This event became the catalyst for a project that significantly improved record-keeping and information sharing.
Lessons Learned
- Paper-based systems create risk – Critical information can be lost during handoffs.
- A clear problem statement matters – It helps justify major improvements like ELN implementation.
- Investigations should focus on facts, not blame – Open conversations and fresh perspectives uncover the real issues.
- Big problems often start small – What looks like a simple error can reveal deeper process weaknesses
Measuring Success
- Metrics: Define measurable indicators (e.g., error rates, turnaround times).
- Monitoring: Track progress and impact over time.
- Review: Schedule follow-ups to confirm sustained improvement.
Your Turn!
Ready to put this into practice? Download our Problem Statement & Corrective Action Template to get started: