Root cause analysis vs blame culture - the real path to quality

Every time a deviation is blamed on “human error,” an opportunity for real improvement is lost. In high-stakes industries like medical device development, where safety, compliance, and cost pressures collide - we can’t afford shallow root causes. It’s time to move beyond blame.

The problem with blaming people

In the world of quality management, “human error” is too often the default explanation when something goes wrong. But it’s rarely the true root cause.

Labelling an incident as “human error” may seem simple, but it prematurely ends the investigation. It shuts down learning, diverts attention from systemic vulnerabilities, and ensures that the issue is likely to recur.

To build resilient systems - especially in regulated industries like medical devices, pharmaceuticals, and life sciences - we must go deeper. True quality improvement begins when we replace blame with investigation, and adopt structured root cause analysis methods to understand how and why the error occurred.

What industry voices are saying

When I raised this point in my LinkedIn channel a little while ago (you can follow me here)  I hit a nerve - and not just in the life-science sector.

Hundreds of you responded with your own experiences and views about the state of root cause investigation in the companies you’ve worked with:  

"Non-conformity reporting should be easy. Encourage a culture of error and improvement without blame or punishment.” 

Quality Systems Leader

"Problems often go unresolved because we fail at identifying the real problem in the first place.” 

Quality Manager, FMCG

“Make the workplace visual. Simplify standards. Audit regularly. Most people don’t make mistakes on purpose—they just don’t know or see the standard.” 

Lean Six Sigma Coach

The message was clear: many quality management systems are poorly equipped to trigger meaningful non-conformance investigations  - or support quality behaviours from the ground up, so you can stop them arising in the first place!

How to break the cycle: six practical approaches

When we strip away blame and start asking better questions, quality begins to improve - systematically and sustainably. That was the clear message that came from my Linkedin interactions. 

But, to achieve this we need better tools, not stiffer targets or scapegoaring.

So, how do we build that kind of system?

Here are six ways to strengthen your approach to non-conformance reporting and CAPAs

1. Establish a no-blame Culture

Ask “how did the system allow this to happen?” rather than “who messed up?” Psychological safety is critical for reporting and resolving issues openly. 

Has your company got a culture of continual improvement in place that stresses shared responsibility, rather than scapegoating? 

Do you encourage proactive reporting of ideas to improve quality (‘opportunities for improvement’) as well as the rooting out of non-conformities when they arise?

2. Improve problem-identification tools (RCA methods)

Jumping to corrective action without properly diagnosing the problem can be costly and ineffective. That’s where structured root cause analysis methods come in.

Some of the most effective root cause analysis tools include:

• 5 Whys – A simple, iterative method to dig down to the root of a symptom.
• Fishbone Diagram (Ishikawa) – A visual technique to explore multiple potential causes (People, Processes, Equipment, etc.).
• Fault Tree Analysis (FTA) – A top-down approach ideal for identifying error propagation in complex systems.
• Design Failure Mode and Effects Analysis (DFMEA) – A forward-looking method especially useful during product development, helping teams anticipate and prevent potential design risks.

Selecting the right root cause analysis method depends on the stage of the product lifecycle, the complexity of the issue, and the data available. In regulated industries, aligning these methods with standards like ISO 13485 and ISO 14971 is crucial.

2. Strengthen training and context

Procedures alone aren’t enough. Combine real-world examples, visual SOPs, interactive refreshers, and ongoing feedback to ensure understanding.

3. Engage All Stakeholders

Cross-functional collaboration is essential. Operators, engineers, quality professionals, and supervisors all bring vital context to the investigation.

4. Redesign the process, not the people

If it’s possible for someone to make a mistake, someone eventually will. Error-proof your systems. Implement poka-yoke, improve interface design, and clarify standards to make errors harder to commit.

5. Measure the learning process

CAPA effectiveness isn’t just about solving this incident - it’s about making sure the learning spreads. Share internal case studies, update documentation, and monitor process metrics.

6. Make accountability about systems

True accountability means owning the system improvement - not punishing individuals. Reward those who raise concerns, participate in investigations, and help build better processes.

The real cost of blaming human error

The fact is, when human error is treated as the conclusion rather than the starting point:

• Root causes remain hidden
• Problems are repeated
• Employee trust deteriorates
• Regulatory risk increases

Each non-conformance is a message from your system. So, are you listening - or pointing fingers?

Why smarter CAPA management matters

“Corrective and preventive actions shall be appropriate to the effects of the nonconformities encountered.”

— ISO 13485:2016, Clause 8.5.3

In high-risk, highly regulated environments, managing non-conformances with rigour and precision isn’t optional -  it’s foundational. That’s why your root cause analysis methods must be supported by systems that make investigation and improvement not just possible, but practical.

Every organisation has its own way of detecting and resolving non-conformities. But even the best-designed CAPA process will fail if:

• Reporting mechanisms don’t work,
• Investigative steps are inconsistently followed, or
• Corrective actions aren’t implemented as a result

Creating investigative procedures that are too lengthy and complex to follow through properly - can end up with them being ignored. 

When lack of process fuels blame culture

But not having the right digital tools in place to monitor and control CAPA procedures can mean serious non-conformities end up slipping through the net.

Where end-to-end  NRC and CAPA processes can be side-stepped, the temptation to leap to conclusions about human error and tell stories about other people’s failures can be great.

This article in the BMJ makes a great point about how investigations that focus on telling the story of how specific mistakes happen - can just miss the wider context in which mistakes occur.

What’s needed now?

We need a leaner, more configurable approach to CAPA - one that fits growing companies and empowers them to act quickly, trace decisions, and continually improve the way they work.

Cognidox: Designed to support the way you work

That's where solutions like Cognidox come in.  Cognidox is a modern electronic Quality Management System (eQMS) purpose-built for the evolving needs of medical device and life science organisations.

Unlike rigid, one-size-fits-all platforms, Cognidox is designed to adapt to you — not the other way around. It enables teams to build CAPA workflows that reflect the real structure, size, and complexity of your business.

With Cognidox, you can:

✅ Automate and streamline CAPA workflows that align with your internal processes
✅ Assign ownership, set due dates, and track escalation paths with full transparency
✅ Link CAPAs directly to design controls, risk registers, SOPs, and audit trails
✅ Track effectiveness and identify systemic trends to support continuous improvement

By embedding traceability, accountability, and real learning directly into your quality operations, Cognidox helps you go beyond reactive fixes and build a culture of investigation, improvement, and compliance-readiness.

It’s about systems — not stories

When we blame people, we punish.
When we examine systems, we learn.
And when we learn, we improve.

So the next time a non-conformance is flagged, resist the urge to stop at “human error.”

Ask more. Dig deeper. Fix smarter.