Human Error is Not the Root Cause!

Strengthening Root Cause Analysis (RCA) in GDP

At a time when the Medicines and Healthcare products Regulatory Agency (MHRA) continues to highlight deficiencies in deviation investigations, one thing is clear… effective root cause analysis is essential for compliance with Good Distribution Practice (GDP) and for maintaining trust in the pharmaceutical supply chain.

Regulatory Framework for RCA

The requirement for effective deviation and complaint investigations is embedded in multiple regulatory frameworks:

EU GDP Guidelines:

Chapter 1 – Quality System:

1.2 (v) “Deviations from established procedures are documented and investigated.”

Chapter 6 – Complaints, Returns, Suspected Falsified Medicines and Medicinal Product Recalls:

6.2 “…any product distribution complaint should be thoroughly investigated to identify the origin of or reason for the complaint.”

MHRA Green Guide:

Deviation Management, corrective and preventative actions:

“… The greater the potential impact the more investigation into root causative effects is required to ensure a robust preventive action plan is created. A variety of tools can be used to ascertain potential root causes depending on the failure type…”

ICH Q10:

Chapter 3 – Continual Improvement of Process Performance and Product Quality:

3.2.2 Corrective Action, Preventive Action (CAPA);
“A structured approach to the investigation process should be used with the objective of determining the root cause. The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk…”

Across all three, the expectation is clear: True root causes must be identified and addressed. “Human error” on its own does not meet these standards.

The Problem with “Human Error”

Across the pharmaceutical sector, many organisations list the root cause of a deviation or complaint as human error. The problem with this is not that humans don’t make mistakes (they do), but that this conclusion is where the investigation ends. This results in weak CAPAs such as retraining, for example:

• A picker selects the wrong product.
• Investigation concludes human error
• Preventive action is to retrain the picker

By failing to dig deeper and ascertain why the error occurred in the first place, was the picker distracted? Was the picker appropriately trained and assessed competent? Was the lighting poor, meaning that the label could not be read properly? Was the product on the wrong shelf?

Without establishing the true cause, or mitigating factors of the human error, the CAPAs do little to prevent the issue from reoccurring in the future.

Why Root Cause Analysis Matters

MHRA inspectors frequently note:
“Investigations closed too quickly, with insufficient exploration of systemic contributors.”
Such findings suggest a weak Quality Management System (QMS), poor quality culture and expose companies to repeat findings in future inspections.

Root cause analysis (RCA) is more than a formality within the QMS. When performed well it:

• Safeguards product quality and integrity and ultimately protects patients.
• Reduces repeat deviations, complaints and costly inefficiencies.
• Demonstrates regulatory compliance with EU GDP Guidelines, Human Medicines Regulations 2012 (as amended) and MHRA expectations.
• Improves operational resilience and strengthens the quality culture of organisations.

MHRA inspectors consistently emphasise that robust deviation investigations are a cornerstone of GDP compliance. Superficial investigations lead to ineffective corrective and preventive actions (CAPAs) and ultimately to repeated findings during regulatory inspections. This puts your Wholesale Distribution Authorisation (WDA) and company reputation at risk.

Human Error is a Starting Point, not a Conclusion

Human error should never be conclusion to a deviation or complaint cause, it should be the starting point of a deeper investigation.

To move beyond human error, organisations need structured tools that encourage deeper analysis. Tools include:

• 5 Whys: Asking “why” repeatedly until systemic weaknesses are exposed.
• Fishbone/Ishikawa Diagram: Mapping the causes relating to people, processes, equipment, materials, environment and measurement.
• Failure Mode and Effects Analysis: Proactively identifying potential failures, their risks and controls.
• Fault Tree Analysis: Logical modelling of factors leading to rare failures.

Each method has its place within deviation and complaint investigations.

Further information and practical advise relating to RCA tools is contained within our Nonconformance and Deviation Management online training course.

Making RCA Engaging and Effective

Far too often, root cause analysis is seen as a compliance task for the Quality Department rather than an opportunity for improvement.
Effective RCA can lead to the uncovering of systematic failures across an organisation. To change this, teams from all areas of a deviation or complaint should be involved, for example (using the picking error example highlighted earlier in this blog), the RCA exercise should involve goods in, warehouse, picking and packing, maintenance, and leadership team personnel.

By including personnel from all areas involved in the activity that led to the error, it is more likely that all contributing factors will be uncovered thus improving the CAPAs and effectively preventing recurrence of the error.

N.B. Ensure your investigation is not a ‘witch hunt’ or to assign blame, as this can damage morale and encourage people to hide things.

Common Contributing Factors

Effective RCA recognises that most errors arise from multiple contributors. Common factors identified during audits by our GDP consultants include:

• Training: Insufficient, outdated, inadequate for new software/equipment, not competency assessed or overly theoretical training.
• Procedures: Ambiguous, overly complex or impractical procedures.
• Environment: Noise, distractions, inadequate storage conditions.
• Equipment: Poorly designed, inadequately maintained or not fit for purpose.
• Culture: Blame culture leading to staff reluctance to report issues. Or insufficient competent personnel for the workload.

When investigations fail to explore these mitigating factors, the risk of recurrence remains high.

From Compliance to Culture

Root cause analysis is one of the most powerful tools available to pharmaceutical wholesale distributors. Carried out poorly, it leaves organisations vulnerable to repeated deviations and critical MHRA findings. Done well, it protects patients, strengthens compliance and builds a culture of continuous improvement.

By moving beyond human error and using structured RCA methods, pharmaceutical distributors can:

• Reduce costly repeat issues
• Improve efficiency
• Build confidence with the regulators
• Protect public health
• Ensure the quality and integrity of medicinal products in their care

At its heart, effective RCA is about more than regulatory compliance, it is about creating a culture where deviations are not hidden or blamed on individuals but are seen as opportunities to strengthen the processes and reduce risk to medicinal products and patients.

Help and Support

Paradigm Shift Consulting have a comprehensive training platform, which includes a course specifically for the Management of Nonconformances and Deviations. The course is clearly laid out, covers all aspects of investigation and CAPAs, including the use of tools such as the 5 whys and fishbone diagram and is cost effective.

Our monthly GDP for RPs and Management webinar provides a comprehensive overview of GDP guidelines and National law. In addition, we have a wide range of GDP related courses to meet the needs of all personnel in your organisation. Successfully completing any of our courses will produce a certificate that is valid evidence of training, and presentable to inspectors, valid for 12 months.

We also provide bespoke training, and we are happy to discuss your needs with no obligation.

For further information on our products and services please contact us.