HUMAN ERROR &

ITS REDUCTION

Kiran Kota
VP - Quality
What is an Error Types of an Errors

ERROR FULL FORM ???

Active Error
EVENTS REPORTED /
RECURR WITH SOME
ROOTCAUSE WHICH
ORGINATES FROM A
REALISTIC (FACTUAL) ACT

Latent Error
 Regulatory Observations
Ref. Warning Letter and FDA 483
1. Foreign matter was identified as a known process-related defect, yet no specific root
cause was identified. And the most likely root cause of failure to identify the critical / major
defects during 100% visual inspection was identified as Human Error.

2. High percentage rate of invalidated OOS test results without appropriate investigation
was identified contributing mainly because of human error, instrument / column error and
method error.
Introduction
Human failures are not commonly investigated to find the root cause, the organization ends

up in providing retraining to the concerned employee.

On a similar note, USFDA draft guideline on Quality Metrics makes the following observation on

retraining: "FDA has observed that less robust quality systems due to recurrence of the same

errors and by providing the re-training & re-re-training and so on which in-turn triggers to

re-design the system.“

This re-design and re-development of process / system can only happen when there is a sound

human error investigation with some methodologies / tools defined in this presentation.
Types of Human Error
Why & how a Human Error become latent in nature:

WHAT CAUSES EVENTS

Managers: "Ask for what
you need to hear, not for
what you want hear"

Sub-ordinates: "Tell your

boss what they need to
hear, not what you think
they want to hear"
Most Common Human errors in Pharma
Laboratory
Errors / OOS

Manufacturing
Calibration / Errors – Practice
Maintenance errors
error
Human
Errors in
Pharma
Document
Warehousing errors
Error

Labelling
Error
 HE – Categorization w.r.t system factor as probable cause
01 Knowledge Transfer 04 Policies
• OJT • Induction
• Clear & concise operating instructions • Risk Assessments
• Inadequate assessment & controls • Acceptable risk ratings

Probable Causes
02 Engineering Design 05 Management / Supervision
• Design of Area / Equipment /
system for Human • Improper Assigning of roles

Errors
• Standards • Improper Delegation of work
• Ergonomics • No Performance dialogues
• Engineering Changes • Lack of Clear directions

03 Work Planning
06 Communications
• Work allocation
• Output orientation • No Clear Communication
(eg: inefficient PM) • Focus on Speed
Advantages of Human error reduction
Regulatory compliance
Proper Maintenance of
Equipment
Avoid manual
errors & Good ROI

Reduce the lapses &

Document Compliance
gaps in the system
Human
Error -
reduction
Advantages
Contemporaneous recording of
Customer satisfaction
data
with right Quality
Product

Auditable ready documents Can Automate QMS with no

with 21 CFR compliance Alerts and Easy lapses
Notifications retrieval
Human Error Investigation & its goals & benefits
Investigation Tools Goal of Investigation Benefits

Gemba Walks – Spot Checks Compliance in the System Improve Regulatory

Compliance & Adherence to
High level of Data Integrity through ALCOA+
thorough RCA & CAPA
Brain Storming – CFT discussions
Improve Productivity
Drill down Analysis – data points Productivity
review Efficient equipment management
Achieve Right First Time &
Accelerated batch release times Reduce Waste
Spaghetti Diagram – Visual
representation with sequential flow Quality Accelerate Batch Release
Achieve right first time times
Cause & Effect Diagram / Ishikawa
Eliminate gaps with vigorous checks
Reduce cost of critical quality issues
diagram or Fishbone diagram Improve man power Resource
Management & Efficiencies
Flexibility
Quickly adapt to changes (market,
5why’s regulatory bodies) Gateway to Data Analytics
Seamless integration with supply chain
optimization
Investigation of Human Errors with the available tools

01 Pre-defined interview checklist

02 Photographic evidence

03 Approved Hypothesis Plan

(wherever it is required)

04 Gemba Walk (Spot verification )

Data Analysis based on System /

05 Person / Area / Process etc.,
Human Errors……
• Errors are basically the symptoms of a cause or causes, which needs to be understood and addressed
Human error should be viewed as the effect, rather than the cause.
• Introduction of technology viz., automation/artificial intelligence, etc., could prevent human error
however, such technologies are in the early stages of evolution in the pharma industry and to
facilitate those in our routine for effective use, Human should equip to the current requirements
• In the meantime, it is crucial to understand that the majority of the processes are still manual, i.e.
these require human intervention and thus the occurrence of errors remain unpredictable to a large
extent.
• There are three primary elements that are potential triggers of human errors, viz. task complexity,
behavioral characteristics and error-prone situations.
• In addition, there are multiple precursors to human error that contribute to the occurrence of errors.
Human Error Reduction approach

Define • Clearly defined scope of work

• Leverage standardized Procedure
• Fit-Gap Analysis to understand Procedure Vs. practice

Standardize • Implement Industry standard best practices & re-engineer the

process / procedure wherever needed
• Embrace the change in a phased manner

Human
• Risk assessment to be performed before implementation
Error
Execute
• Shop floor readiness through effective training &
Reduction awareness creation

Approach Measure • Monitoring & measuring & controlling on periodical basis

• Efforts to be kept on realistic approach than paper based
conclusions

• Key User Training & Change management sessions

Adapt • Harmonized operational SOPs across sites
• Accelerated in-house design for quick migration from traditional to modern
systems to reduce errors
Human Error Handling Hierarchy

REDUNDANCY
Human Error Handling Hierarchy with examples
ERROR
HANDLING EFFECTIVENESS DESCRIPTION EXAMPLES
MODEL
 RMG cannot be operated if lid isopen.
Error Proofing
Design processes or systems in such away  Electronic data transmission toolssuch as bar code readers.
(Mistake Proofing
High that possibility of human errors is minimal.  Card reader checks to ensure training before admitting
/ Poka-yoke)
operator into specific area.

 Use of attention activators like

 Sound.
 Motion, change in pattern.
Change in colour.
Utilize attention activators within the

Error Change in shape (e.g., use of boxes for text, symbols
documentation to prevent errors from 
Prevention High-Medium using different colour).
occurring.
 Change in text formats (bold, italic, size, etc.).
 Use of colour in quality documentsshall align with emotional
associations (for example, green = go, red = stop). It is also
easier to detect changes or omissions in patterns.

Resilience Provide the option to “undo” the error,

 In-process testing that allows adjustments like pH of a batch.
often utilizing additional attention
(Detect and Medium-Low  Inclusion of a command (Yes/No) to recheck the record before
activators or an undo or confirmation
Recover) finally submitting.
option when using electronic systems.

 Double checking and observation of any activity by a second

Implementation of doer and checker person.
Redundancy Low
principle / repetition of efforts.  Retraining the same way as before (using same
methodology/SOP/ learning assessment).
Human Error Handling Hierarchy with examples
If the above process is successfully applied in the organization, we may expect a transformational change

happening leading to improved human reliability.

The nature of transformation is indicated below:

Tag line statement for Human error investigation
Human Errors - Summary:
• Human Errors do happen.

• Categorize it as Human Error after all possible causes have been negated.

• Some of the deviations will be yielded from human errors.

• Investigation should be thorough to ensure that cause for the error is identified & controlled.

• Eliminate any possible process, environment, procedural or system based issues.

• Take appropriate actions based on the causes identified from the errors.

• Look for error proofing instead of blame, duplication etc.

Thank you for your attention