Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA

Effectiveness Measurement for Human Performance Related Deviations

Dr. Ginette M. Collazo www.humanerror.com

Regulation 211.22 • Subpart B_Organization and Personnel Sec. 211.22 Responsibilities

of quality control unit. • (a) There shall be a quality control unit that shall have the

responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

What’s coming?

High Reliable Organizations

• A High Reliability Organization (HRO) • Succeeded in avoiding catastrophes in an

environment where normal accidents can be expected due to risk factors and complexity – Chemical – Nuclear – Financial – Aerospace

We have learned what works and what does not.

How is Human Error controlled?

– 80% by using human factors in SYSTEMS (any aspect of the workplace or job implementation that makes it more likely for the worker to make an error)

• Management Systems – 20% by managing acquired behaviors- PEOPLE

We focus on systems… and then people. We believe people make mistakes because they can. Our systems allow it.

What is happening? The 5 Errors

Investigate technical

problem not HE

Human Error as a

“Root Cause”

Real Root Cause is not

identified

Wrong problem is addressed

IA/CA/PA Ineffective

HE HE

We don’t ask why. Root cause analysis for human error events is usually inexistent.

THE METHOD What can be done?

Diagnosis •12 Month •Categorize & Code •HE Rate •Baseline

Training •Investigators •Management •Supervision and Operational

Implement System Changes 80

Culture Change Process 20

Monitor/Trend

Pulse Check

Move away from human error creation. Break the Blame Cycle

PPI, 2009

Will answer… • What • How • When • Where • Who

And then correct, prevent, predict and control.

Why?

Human error:… but where?

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Strategic

Tactical

Operational

End User/Client

Let’s understand the 80%… and the 20%

Human Error

System Problem Administrative Management

Systems

Human Performance

Problem

Operation Controls (factors)

Work environment (external)

Individuals Cognitive Overload

(internal)

Administrative Management Systems

1. Policies & Administrative Controls – 12 Root Causes 2. Quality and Risk Review- 5 Root Causes 3. Problem Identification, Investigation and Control- 4 Root

Causes 4. Product/Material Control- 9 Root Causes 5. Procurement Control- 6 Root Causes 6. Documentation and Configuration Control- 7 Root Causes 7. Process/Validation/Project Planning- 9 Root Causes 8. Facilities/Maintenance- 5 Root Causes

Operation Controls

1. Procedures- 3 NRC= 22 RC 2. Human Factors Engineering- 4 NRC= 19 RC 3. Training- 3 NRC= 16 RC 4. Immediate Supervision- 2 NRC= 10 RC 5. Communication- 3 NRC=12 RC

Root Cause

9%

14%

10%

22%12%

33%

Wrong/Incomplete

Typographical

Sequence

Facts wrong

Wrong revision

Inconsistency betweenrequirementsIncomplete

Individual Performance

1. Slip 2. Mistake 3. Violation

Cognitive Load

Cognitive Load

• Available Time • Stress • Complexity and task design • Experience/Trng. • Instructions

• Human Machine Interphase • Fitness for duty • Work process/Supervision • Environment • Communication

Tools

Cognitive Load Tool Software

Cognitive Load Tool- Graphic Results

CA-PA Effectiveness

• CA- Corrective • PA- Preventive

• # of repeated events • # of recurring root causes

Root Cause Determination Tool (RCDT)

Procedures Human Factors Engineering

RCDT SaaS

Root Cause

60% Reduction in less than 10 months!!!

Result 1.9%

Baseline 4.7%

Results

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