HUMAN ERROR IN PHARMA INDUSTRY

CVMP
HUMAN ERROR Kiran Kota
Error can be defined as "An act which may produce unintendend results" and when a human is involved, it is Human error.

WHAT CAUSES EVENTS

TYPES OF
HUMAN
ERROR

ADVERTENT INADVERTENT

ADVERSE LACK OF
INTENTIONA WRONG NON- UNSKILLED
DELIBERATE INFLUENCED SHORTCUTS UNINTENTIONAL UNAWARNESS DIRECTION /
L ATTITUDE COMPLIANCE ATTEMPT
BEHAVIOR PROCEDURE

CAUSES OF HUMAN ERROR 2 TYPES OF ERRORS P-P-P CONCEPT IN ALL THE GXP RELATED ACTIVITIES
Action Errors Thinking Errors
Occur when a person Occurs when a person • Pre-requisites are to be defined
carries out an action
incorrectly. Such as when
the task is highly
correctly carries out the
wrong task because of
knowledge gapof unclear
Pre according to the standards /
requirements
Damage UNDERSTANDING repetitive
ATTENTION Deviations instructions
GAP GAP 1. Slips of action
CAUSES 3. Rule basedmistakes
Root cause: Temporary

Compliants
FOR
HUMAN
ERROR
fatigue, nervousness,
excitement, or
distraction
Root cause: Misusing a
good rule or correctly
using a bad rule
Pro • Pro controls are to be applied to have
effective / expected outcome

Incident
4. Knowledge based
SKILL GAP BEHAVIORAL 2. Lapses of memory mistakes
GAP Root cause: Forgetting Root cause: incomplete
• Post review & reporting system should
Recall to do something or
losing your
focusmidway through
a task
or inaccurate
understanding,
overconfidence, or
Post detect the errors occured during pre &
pro stages and If needed to re-work on
Pre-requisites
overstrain

PPP CONCEPT FOR ALL THE ACTIVITIES IN GXP AREA

Stage Phase Scope of Errors / Gaps RISK Action plan Case type Remarks
Programming (Design) Procedural gaps / Design Direct cause →
Pre High / Critical
phase gaps Common error precursors Visible errors
Open communication
High proove to Human are to be identified to
Post Performance phase Moderate Indirect causes → is required in all the
error detection prevent the errors
Invisible errors / Latent stages
Low Human error errors
Pro Presentation phase Low
detection
 HUMAN ERROR IN PHARMA INDUSTRY
CVMP
HUMAN ERROR Kiran Kota

MAPP THE ERROR HOW TO MAPP AN ERROR

M Monitoring of Review
When Where What How Reaction Who
comment
A Attributes related to
Review in
what is the
the error exactly has the error all wholistic
an error has consequenc
has happened has approach
P Personnel & been done -
happened - as an error - happened -
e due to has done
way to fix
describe this error - - this error
describe the - describe describe the CAPA to not
with details describe the
details the details details to recur
details
P Process again

HUMAN ERROR PREVENTION ATTRIBUTES

Data Integrity breach Digitilization

Multi factor risk detection mechanism
• Traditional training identification • Performance based rating
• System implementation /
is not appropriate to and work deployment
Governance of the
create adequate should be ensured to get
establishment system / Issue • Digitalize the procedure to
awareness on the • Risk assessment is a • Data Integrity (DI) breach effective output / desired
escalation mechanism is the not to have any scope for
activity to be mandatory tool prior detection force needs to output.
major / mandatory aspect in any Human intervention /
performed in a to implement any new be established and
GMP aspect errors while execution
compliance manner or formal modification identification of SMEs to
detect the latent / actual
errors in the problem /
flaw

TRAINING System monitoring & Performance

survivance mechanism management

Developing a system to minimize the risk of human error will help ensure that you
Human errors are inevitable, but you can minimize the risk of making them.
HUMAN ERROR don't repeat the same mistakes again.
PREVENTION
There are many ways to reduce human errors, including creating a system, MEASURES Recognizing that humans don't commit mistakes randomly helps to understand why
providing training, having regular audits, and encouraging open communication. they happen to better prevent them from occurring.
 HUMAN ERROR IN PHARMA INDUSTRY
CVMP
HUMAN ERROR Kiran Kota

HUMAN ERROR LIFE CYCLE

MAKING THE TREND ANALYSIS & IMPARTING THE

MISTAKES / FAULTS IN DESIRED OUTCOME IDENTIFICATION  FAILURE TO IDENTIFY THE
NECESSARY CONTROLS THROUGH CONCLUSION:
OF HUMAN ERROR HUMAN ERROR
 LAGGING INDICATORS Isolated Repetitive
 LATENT ERRORS
INVESTIGATION  INTRINSIC VARIATIONS
CAPA & ITS Lack of
SOP RELATED WORK FLOWS HUMAN OF CAUSE  ACTUAL ROOTCAUSE awareness Overconfidence
IMPLEMENTATION
WORK CULTURE ERROR IDENTIFICATION  CRITICAL ASPECTS OF THE
RISK ASSESSMENT REPORTS LIFE TASK
AVOIDING COMPLEX PROCEDURES CYCLE  ATTRIBUTABLE OR Procedure gap Intentional
CLEAR DELEGATION OF WORK CONTRIBUTABLE FACTORS
SYSTEM CONTROLS (HUMAN CONTROLS, AUTOMATED  COMPLETE PROCEDURES /
Unidentify gap Attitude problem
CONTROLS, MACHINE CONTROLS)
RIGHT RECRUITMENT REDUCTION
PROBLEM ESCALATION MECHANISM MECHANISM ANALYSIS OF
HUMAN ERROR Overload
PROPER PLANNING Unsuitable

TO REDUCE THE HUMAN ERRORS BELOW ARE THE THINGS TO ENSURE TO MEET THE COMPLIANCE

OPEN COMMUNICATION
PROCESS / PROCEDURE
SHOULD NOT HAVE

ACTIVITY DEMANDS
DISTRACTIONS
Managers: "Ask for what you RIGHT PERSON FOR PROPER INFRASTRUCTURE
EXECUTION

WORK AREA
need to hear, not for what you SHOULD BE SIMPLE SHOULD BE TRAINED WELL RESOURCES
CLEAR INSTRUCTIONS
want hear"

HUMAN
DIRECTIVE RIGHT ATTITUDE RIGHT EQUIPMENT /
RIGHT MANAGEMENT MACHINERY
FEESIBLE EXPERIMENT / OVERVIEW
RIGHT STANDARDS / CLEAN & HYGIENE
PRACTICLE CONTROLS PHYSICALLY / MENTALLY FIT
Subordinaters: "Tell your boss what PROBLEM SOLVING SKILLS PAPERLESS DOCUMENTS
ACHEIVABLE RIGHT REPRESENTATIVES
they need to hear, not what you ESCALATION MECHANISM VIDEO PRESENTATIONS
REPRODUCABLE OVER SEE MECHANISM /
SECONDARY CHECK ATTITUDE ON TIME SKILL DEMONSTRATION
UNDERSTANDABLE EXECUTIONS
RIGHT TOOLS SHOULD BE FREE FROM
SEQUENTIAL STRESS / WORK LOAD TOWN HALLS
PERIODICAL AUDITS /
REVIEW QUALITY FAILURE MEETS
PERIODICAL ERRORS REVIEW
MECHANISM