Dr. Ginette M. Collazo

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1 Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations Dr. Ginette M. Collazo

2 Regulation Subpart B_Organization and Personnel Sec 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.

3 What s coming?

4 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.

5 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.

6 What is happening? The 5 Errors Investigate technical problem not HE Real Root Cause is not identified IA/CA/PA Ineffective HE HE Human Error as a Root Cause Wrong problem is addressed We don t ask why. Root cause analysis for human error events is usually inexistent.

7 What can be done? THE METHOD

8 Diagnosis 12 Month Categorize & Code HE Rate Baseline Pulse Check Training Investigators Management Supervision and Operational Monitor/Trend Implement System Changes 80 Culture Change Process 20

9 Move away from human error creation. Break the Blame Cycle PPI, 2009

10 Will answer What How When Where Who Why? And then correct, prevent, predict and control.

11 Human error: but where? Strategic End User/Client Tactical Operational 11

12 Let s understand the 80% and the 20% System Problem Administrative Management Systems Human Error Human Performance Problem Operation Controls (factors) Individuals Work environment (external) Cognitive Overload (internal)

13 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

14 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

15 Root Cause Wrong/Incomplete 33% 9% 14% 10% Typographical Sequence Facts wrong Wrong revision 12% 22% Inconsistency between requirements Incomplete

16 Individual Performance 1. Slip 2. Mistake 3. Violation Cognitive Load

17 Cognitive Load Available Time Stress Complexity and task design Experience/Trng. Instructions Human Machine Interphase Fitness for duty Work process/supervision Environment Communication

18 Tools

19 Cognitive Load Tool Software

20 Cognitive Load Tool- Graphic Results

21 CA-PA Effectiveness CA- Corrective PA- Preventive # of repeated events # of recurring root causes

22 Root Cause Determination Tool (RCDT)

23 Procedures Human Factors Engineering

24 RCDT SaaS

25 Root Cause

26 Results Baseline 4.7% Result 1.9% 60% Reduction in less than 10 months!!! 26

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