HUMAN ERRORS

PRESENTATION BY: G. S. ARUN KUMAR

What is a Human error?

For me, the Oxford Advanced Learners Dictionary got it right when it
defined human error simply as “a mistake made by a person rather than
by a machine”.

or

A slightly more extended definition of human error could be “a mistake

made by a person rather than by a machine that produces a result that
you did not want.”
Why Human Error is more focused
by Regulatory inspectors?

An inadequate work design may propitiate that a human error originates an

accident or promotes considerable economic looses on account of
equipment breaks, waste generation, delay in service deliveries,
indemnifications, loss of clients, and so on. That is why human errors must be
studied in every project for improve the quality of any process, understanding
human error as any human action or lack thereof that exceeds the tolerances
defined by the system with which the human interacts;
FDA 483’S/ WARNING’S
 Foreign matter was identified as a known process-related defect, yet
no specific root cause for the particulate 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.

 High percentage rate of invalidated OOS (77%)test results without

appropriate investigation was identified contributing mainly because
of human error, instrument/column error, and method error.

 Multiple LI investigations lacked scientific rationale for root cause

determination. Probable root cause were attributed to
contamination and analyst error.
WHO IS RESPONSIBLE FOR HUMAN
ERRORS?

Chemist, Operator, Analyst, Reviewer, In-charge, Manager,

HOD or Procedure (If so why) or Management etc……. Who is
responsible…
Regulatory Expectations on Human errors.
 How to investigate Human Errors?
 In one case, a batch had been packaged with the wrong patient information leaflet,
and in another case, the outer cartons of the product had been labeled with a non-
compliant label.

 When we looked into the incidents in question more closely, it was clear that multiple
groups, including production, quality control (QC), and quality assurance (QA) staff had
reviewed and approved the noncompliant packaging and labeling components for the
batches in question. However, in the related deviation reports, human error had been
attributed as the cause of the incidents in all cases, and operator retraining was identified
as a preventative measure in almost all of the cases.

 There would have been merit in considering whether a process or systems failure had
occurred before assigning human error as the cause. Yes, of course mistakes had
occurred, but these errors were clearly indicating the presence of an underlying problem
in the quality system in relation to packaging and label dispensing and checking
processes that had not been addressed.
Tools to use for Investigation of Human Errors
 5 Whys: The 5 Whys is arguably the simplest technique for root cause analysis. It can be
very effective when answers come from people who have hands-on experience in the
process being examined. It is remarkably simple: when a problem occurs, you drill down
to its root cause by asking “why?” five (or more) times. Then, when a countermeasure
becomes apparent, you follow it through to prevent the issue from recurring.

 Fishbone Diagram: Also called a “cause and effect” or “Ishikawa” diagram (among
others), a fishbone diagram is a visual tool for looking at cause and effect. A problem or
effect is displayed at the “head” or “mouth” of the fish and possible contributing factors
are listed on the “bones” under various cause categories. These models work best when
the “head” of the fish contains a very detailed problem statement. This helps eliminate
scope creep of the team’s discussions. What happened? When? Where? These can help
narrow the focus to solve the problem.
Investigation Example with 5 Why

 While reviewing of equipment requalification schedule, we observed that the

following equipment’s requalification not done as per schedule

S. No. Equipment ID No. Schedule date Due date

1 BI/SSR126 15/02/2022 16/05/2022

2 BIIIA/SSR308/01 21/02/2022 22/05/2022

3 BIIIA/SSR302/01 04/03/2022 02/06/2022

APPLIED 5 WHY
5 Why Analysis
Questions Answers
Why 1: Why Requalification not As per the schedule the concern engineering personnel has informed orally on date: XXXXX for the
done as per schedule for the respectiv e production in charges about the equipment requalification and asked for the
equipment’s BI/SSR126, clearance of equipment.
BIIIA/SSR308/01 and
BIIIA/SSR302/01. Later production has not given clearance after the intimation.

The concern production personal has informed the engineering the personnel that the
Why 2: Why production
campaign batches under execution. Hence will check the dates and handov er within the
personnel has not given the
Tolerance period of ±3 months of the scheduled date.
clearance for the equipment’s
Later production personnel has forgot to inform about the clearance and parallely the
to perform the requalification.
engineering personnel also forgot about the activity.

The respectiv e SOP equipment qualification was rev iewed and it doesn’t state about the
Why 3: Why did the both
individual departmental responsibilities and control for the requalification activities like
department personnel forgot
1) Engineering personnel has to inform to production personnel through a format and take the
and what is the control and
clearance date with sign & date.
tracking mechanism for this
2) Secondary control like reviewer/ Checked by for monitoring the requalification activity on
activity
monthly basis to avoid the skipping of the activity was not described in procedure.
Why 4: Why the details like
This could happen because for the Proficiency Gap at the time of the preparation of the SOP due
activity tracking and the
to lack of Awareness on How do they communicate and track the activ ities. Due to inadequate
responsibilities was not
knowledge on Practices routed through.
captured in the SOP.
As the human error is an inherent part of human nature, and is always unintentional
(if not it must be assumed as sabotage). So, potential sources for the human error
was identified i.e.

RCA: Based on further analysis of the

potential cause the exact cause
identified i.e. this abnormality was
happened inadvertently (Which is an
unintentional), lack of knowledge or
improper assessment of the proposed
Procedure and practices at the time
of preparation of SOP.
Human Errors
How to reduce Human Errors
 Low workforce morale
 High levels of emotional stress among staff
 Little or no intrinsic meaning in a task
 Unclear allocation of work and responsibilities
 Disruption of normal work-sleep cycles
 Prolonged inactivity or highly repetitious menial work tasks
 A poor or hostile workplace environment.
 Assign the task to the person based on competency and Capability.
 Provide the Effective training to the persons by an SME with approved
Modules.
 No hurries in execution of process, procedure, policies.
Suggested checklist for incorporating into deviation and complaint
investigation procedures for use when human error is suspected.
QUESTION YES NO
Can the manufacturing process or other work activity be considered to be robust, capable, and
stable?
Have the necessary process and other validation studies been executed and completed?

Is the necessary equipment (incl. instrumentation) in place for executing the work activity
correctly?
Have the necessary equipment qualification studies been executed and completed?
Is the manufacturing process or the concerned work activity formally proceduralised?
Are there up-to-date written procedures, guidance, or policies for the work activity in place and
do they provide sufficient detail so that this incident should not have occurred?

Are work instructions clearly written without ambiguity in what is required?

Is key terminology in procedures consistent? (The consistent use of terms across different
procedures helps ensure that staff take the same meaning from key terms.)
Are there documented materials for executing a work task available at the location in which the
activity occurs, where relevant?
If the answer is No to any of the above questions, the cause of the incident may not be human
error; it may be related to one or more of the areas above.
NOW A DAYS VALIDATION BECOME A KEY PART IN THE PHARMACEUTICAL
INDUSTRY THEY VALIDATE THE PROCESS, SYSTEMS, METHOD AND SO ON…

BUT SOON WE ALSO VALIDATE THE PROCEDURES (SOP’s) TO REDUCE THE HUMAN
ERRORS..
What is it true? Yes
Before implementing the procedure if we dive into the execution of the
procedure at shop floor then we understand applicability of the defined
procedure at the work place, feasibility, can avoid ambiguity and complexity
related concerns.

Avoid copying the Procedure from other sources, use them as reference and
ensure the applicability at organization.
 Culture:
 One of the best ways to immediately enhance quality throughout your organization is
to realize most of the problems being described as human errors are something else
entirely. Rather than using it as a convenient standing for thorough investigation, use
human error as an opportunity to improve your company’s problem-solving processes.
Fast closure rates of inaccurate deviations don’t demonstrate efficiency, just misguided
values on the problem solving process itself.

 Action Items:

 Conduct an objective assessment of your internal problem-solving processes (ideally

with the help of an experienced third party) and remediate accordingly.

 Replace metrics that establish problematic incentives with goals focused on long-term
trending.

 Explore ways to improve problem-solving within your QMS to reduce backlogs while
thoroughly investigating issues.
Politics
Problems caused by political dynamics can be particularly insidious and difficult to
address within an organization. While endless white papers could be written on the
effects of ego, power, and personalities, detecting their influence on your CAPA
program is often relatively simple: Are too many people touching it?

Overcommitting staff in the approval process in particular can be a clear signal that
problems may be getting swept under the rug—or conversely—the program is being
overused.

Politics are also usually at play when viable solutions get turned down for a myriad of
reasons. In general, the remedy is having the right people—and right number of
people—at each level. If one step feels bloated, it typically is.
by Brian Dense
Brian Dense brings over 25-years of industry experience, with more than 20-years
working directly in quality systems and assessing compliance with FDA 21 CFR Part
820, Parts 210 & 211, Part 58, ISO 13485 and ISO 9000.
References:

 THE GUIDE TO CAPA & ROOT CAUSE ANALYSIS IN FDA-REGULATED INDUSTRIES by FDA
group.
 Human Error and Retraining An Interview with Kevin O’Donnell, Ph.D., Irish Medicines
Board
 Human Error by IPA (Indian pharmaceutical alliance)
THANK YOU…..