![Page 1: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/1.jpg)
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
![Page 2: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/2.jpg)
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.
![Page 3: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/3.jpg)
What’s coming?
![Page 4: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/4.jpg)
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.
![Page 5: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/5.jpg)
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.
![Page 6: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/6.jpg)
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.
![Page 7: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/7.jpg)
THE METHOD What can be done?
![Page 8: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/8.jpg)
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
![Page 9: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/9.jpg)
Move away from human error creation. Break the Blame Cycle
PPI, 2009
![Page 10: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/10.jpg)
Will answer… • What • How • When • Where • Who
And then correct, prevent, predict and control.
Why?
![Page 11: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/11.jpg)
Human error:… but where?
11
Strategic
Tactical
Operational
End User/Client
![Page 12: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/12.jpg)
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)
![Page 13: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/13.jpg)
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
![Page 14: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/14.jpg)
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
![Page 15: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/15.jpg)
Root Cause
9%
14%
10%
22%12%
33%
Wrong/Incomplete
Typographical
Sequence
Facts wrong
Wrong revision
Inconsistency betweenrequirementsIncomplete
![Page 16: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/16.jpg)
Individual Performance
1. Slip 2. Mistake 3. Violation
Cognitive Load
![Page 17: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/17.jpg)
Cognitive Load
• Available Time • Stress • Complexity and task design • Experience/Trng. • Instructions
• Human Machine Interphase • Fitness for duty • Work process/Supervision • Environment • Communication
![Page 18: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/18.jpg)
Tools
![Page 19: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/19.jpg)
Cognitive Load Tool Software
![Page 20: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/20.jpg)
Cognitive Load Tool- Graphic Results
![Page 21: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/21.jpg)
CA-PA Effectiveness
• CA- Corrective • PA- Preventive
• # of repeated events • # of recurring root causes
![Page 22: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/22.jpg)
Root Cause Determination Tool (RCDT)
![Page 23: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/23.jpg)
Procedures Human Factors Engineering
![Page 24: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/24.jpg)
RCDT SaaS
![Page 25: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/25.jpg)
Root Cause
![Page 26: Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations](https://reader033.vdocuments.net/reader033/viewer/2022052212/58758a3a1a28ab901c8b585f/html5/thumbnails/26.jpg)
60% Reduction in less than 10 months!!!
Result 1.9%
Baseline 4.7%
Results
26