Human Error–––

#Slide 4

Human error is an unintentional act or omission that results in a mistake or

unintended consequence. It can be caused by a number of factors, including human
nature, inadequate training, and flawed equipment or processes. (Presented)

What causes defects?

“The great majority of reported defective medicinal products has resulted from human error
or carelessness, not from failures in technology” MHRA , Orange Guide 2002

Human error is a generic term that involves all those instances where a planned activity fails
to achieve its intended outcome.

A human error is an action or decision which was not intended.

Human errors are inevitable, but can minimize the risk of making them.

Human errors can be either active or latent.

#Slide 5

Active failures are direct and immediate causes of accidents or deviations. They are usually
made by front-line staff, such as operators.

There are three types of active human error:

Slips and Lapses – made inadvertently by experienced operators during routine tasks.

Slips are errors that occur during routine activities that do not require thought. These activities
are so repetitive that we often think of them as things that we could do with our eyes closed.

Mistakes – decisions subsequently found to be wrong, though believed to be correct at the

time.

Mistakes are errors that occur during activities that require thought. They may be activities that
have some familiarity with or new activities that we have not performed before, but both require
us to engage our brain and think through the situation and our actions.

Violations – deliberate deviations from rules for safe operation of equipment.

Latent failures are those aspects of an organization that influence human behaviour and
potentially lead to active failures.

Contributing factors include, but are not limited to,

 lack of time,
 lack of knowledge,
 inadequate procedures and manufacturing processes,
 wrong labeling,
 fatigue,
 work pressure,
  inadequate retraining as well as
 poor equipment design or workplace layout.

#Slide 6

Human Error

 As technology advances, human error in manufacturing becomes more and more

visible every day. Human error is responsible for more than 80% of failures and
defects.
 “The great majority of reported defective medicinal products has resulted from human
error or carelessness, not from failures in technology” – MHRA Orange guide 2002.
 Falsified sterility data, manipulated media fill data, invalidated failing result,
incompletely investigated deviation/ OOS results are the glaring example of human
errors.
 Sadly, little is known about the nature of these events mainly because the quest for
answers ends where human error investigations should begin.
 Tendency for doing mistake is viral, unless prevented at right time!

Slide No. 6, Change the bullet  to  (May be Slide 7 it is done the same)

#Slide 7

Types / Examples of Human Error:

 A slip while performing the task Eg. spillage.

 A memory lapse E.g. missing a step or inadvertently repeating a step.
 Lack of knowledge, skill, or ability on how to perform the task.

Examples of Human Error

 A person who has been hired for a particular job but does not have the required skills or
experience may perform poorly in that position. ...
 An employee may make an honest mistake while performing his duties. ...
 An employee may deliberately falsify data on a report or other document.

Some of the typical causes of human error -

 poor training,
 poor management,
 poorly written operating procedures, and
 improper work tools.

#Slide 8

There are three general types - skill-based, rule-based, and knowledge-based errors.

#Slide 7

.Ways to reduce human errors -

 creating a system,
  providing training,
 having regular audits, and
 encouraging open communication

Developing a system to minimize the risk of human error will help ensure that you don't
repeat the same mistakes again.

Slide No7, bullet the last point i.e encouraging…….. (Included)

# Slide 9

Example of human limitations …..

• Attention – may be limited in duration or focus, especially if attention must be spread

 Perception- Work environments often challenge human perception systems and

information can be misinterpreted.

• Memory – working memory is limited, especially when active processing of information is

required

• Situation awareness – refers to a person’s perception of what’s happening around them

• Automaticity – consistent, over-learned responses may become automatic and completed

without conscious thought

 Stress - Occurs when there is a mismatch between what people are expected to do
or cope with and the resources available to them

• Fatigue - Caused by too much or too little to do, sustained activity, physical / emotional
exertion, amount / quality of sleep, time of day.

# Slide 10

Action not as Slip of action

planned (Error)
Attention gap Lapse of memory
Unintended Actions
Rule-based mistake
Human errors Action as planned Understanding Gap
(Mistake) Knowledge-based
mistake Skill gap
Routine -
Intended Actions
Situational -
(Behavioral Gap)
Exceptional -
 #Slide 11

Human Errors
Attention Gap Understanding Proficiency Gap Behavioral Gap
Examples Gap Examples Examples
Examples
1.Memory gap / 1. Learning gap 1. Inadequate 1. Work
forgetfulness 2. Decision error knowledge environment
2. Lazy 3. Procedural / SOP 2. Skill / Analytical
3. Attention toward 4. Complex system ability 2. Attitude
work 5. Communication 3. Concept
4. Omission of gap application error 3. Culture
action 6. Judgement error
5. Absent- 4. Physical / Mental
mindedness limitation

5. Intentional errors

Probable causes Probable causes Probable causes Probable causes

• Clear Job • Training • Lack of • Incorrect R&R,
responsibilities • SOP / Instructions knowledge • Collaboration
• Infrastructure • Communication • Decision error • Leadership focus
• Fatigue mechanism • Suitability for the • Metrics
• Work • Overconfident role • Habitual
pressure/overload • Complex
• Work allocation systems /
procedure
#Slide 12
FACTORS INFLUENCING HUMAN ERRORS
• Job Factors

 Illogical design of equipment and instruments

 Constant disturbances and interruptions
 Missing and unclear instructions
 Poorly maintained equipment
 High workload
 Noisy and unpleasant working conditions
 # Slide 13
Organization and Management Factors:
Such factors are often overlooked during the design of jobs but have a significant influence
on individual and group behavior.

 Poor work plan, leading to high work pressure

 Poor SOP/ lacking clarity in subject
 Lack of safety systems and barriers
 Inadequate responses to previous incident
 Improper root cause identification
 Irrelevant remedial, not preventing same error
 Management based on one way communications
 Deficient co-ordination and responsibility
 Poor management of health and safety
 P-D-C-A cycle not followed
 # Slide 14
Interlink – Individual, Job and Organization & Management factors
 # Slide 15
Mutual influence – Individual, Job and Organization & Management factors

# Slide 3

Human error is an inherent part of human nature, and is always unintentional (if not it must
be assumed as sabotage). It can be reduced but more investigation needs to be done on
understanding the root cause of it. They are more often than not forced by the circumstances
of the situation.
 #Slide 16

Contributing factors to Human Errors and Accidents

Human Errors Can Usually Indicate

 Potential deficiencies in the process (robustness)

 Potential deficiencies in the procedures (complexity)
 Potential deficiencies in the training (effectiveness/frequency)
 Potential deficiencies of the equipment (ergonomics)
 Potential resource bottleneck (stress, lack of time)

#Slide 17

Categories of Human Error

Un-intentional errors are the “actions that were not as planned”

• omissions like forgetting to do something particularly during repair, calibration,

maintenance, testing, etc.
• Forget fullness
• Carelessness
• Overconfidence
• Hereditary
• Improper grooming
• Body language, artificial barrier

Intentional errors are the violations like;

• Routine violation – a behavior in opposition to the rule, procedure, instruction, etc.

• Exceptional violation – are rare, planned and happen only in unusual and particular
circumstances
 • Situational violation – occurs as a result of factors dictated by the Doer’s immediate
workplace
• Act of sabotage – self-explanatory, although the causes are complex, ranging from
vandalism by the demotivated employee to terrorism.

#Slide 18

Human error investigation starts when it is known or suspected that it was a human action or lack
of action that caused the quality defect or deviation from the process to occur (non-conformance,
failure).

Where human error is suspected or identified as the cause, this should be justified,
having taken care to ensure that process, procedural or system-based errors or problems
have not been overlooked, if present. …Chapter 1 of the European GMPs 1.4 (xv)

Most problems that appear to be caused by human error especially those that occur multiple
times are actually rooted in processes or systems that when left unchanged, will keep producing
the problem.

When human error is identified more frequently than it should be expected to happen, it signals
to investigators that problems are not being internally investigated thoroughly enough which
quickly shift the investigator into problem-hunting mode and open quality management system up
to even greater scrutiny.

It is helpful to arm with a model for analyzing what might appear to be human errors in order to
determine whether actions (or inactions) were deliberate or inadvertent.

Slide 8
Slide 19

Human error tree diagram

#Slide 20

Skill,Rules knowledge (SRK)/Generic Error Modelling System (GEMS)

“Failure is an event, never a person” ~William D. Brown

The model identifies that human failures present either as someone intentionally (deliberate)
or unintentionally (inadvertent) doing the wrong thing.

The inadvertent errors are considered to be human errors, which fall into one of three
categories:

 skill-based,
 rule- based, or
 knowledge-based mistakes.

Skill-based mistakes can be further broken down into slips or lapses, both of which occur
due to a lack of attention to the task at hand.

Following this model errors that are shown to be “inadvertent” can be considered genuinely
“human,” which then fall into one of four categories:

 Learning,
 Omission,
 Application, or
 Inconsistency

#Slide 21
When errors are revealed “deliberate” upon closer examination, need to check how the type of
work in question is actually being done.

This may lead to discover the problem may be more serious and widespread, particularly in one
of two areas i.e. documentation and culture.

#Slide 22

Slide No.22, remove the bullet from the last line i.e. the real problems may……..
(Removed)

Documentation

If human error is found, check whether:

 change processes are long and cumbersome

 Staff are working with out-of-date or obsolete SOPs
 SOPs are readily accessible and employees easily navigate to them and understand the
information they need

The real problems may lie in processes for creating, maintaining, and distributing the
documentation that drives the quality system.

#Slide 23

Culture

To enhance quality throughout the organization, need to realize most of the problems being
described as human errors are something else entirely.

Rather than using it as a convenient stand-in for thorough investigation, human error to be used
as an opportunity to improve company’s problem-solving processes.

Fast closure rates of inaccurate deviations do not demonstrate efficiency, just misguided values
in the problem-solving process itself.

This metric to be replaced with a trending reduction in total deviations over time.

The size of backlog and closure times is functions of each other and should be handled
accordingly.
Lack of a backlog may lead investigators to look at closure trends. If deviation backlog is reduced
abruptly, investigators might know that methods were rushed rather than being a natural
component of QMS.

#Slide 24

Slide No 24, change the title as Investigating Human Error or Investigation of Human
Error (Done)

Investigating Human Error

Important points for human error investigations

• Pre-defined Interview checklist.

• Photographic evidence
• Approved hypothesis plan (Wherever required)
• Spot verification
• Data analysis based on system, person, area, process etc

Conduct interviews shortly after the incidence occurs, otherwise important information may
be forgotten or it becomes too biased.
#Slide 25

Example of an Investigation - Failure to follow procedure.

“Why wasn’t the procedure followed?”

• The procedure was inadequate, not able to be followed: assess the procedure for:

- Did the procedure specifically require the step to be performed?

- Did the procedure describe how the step should be performed?

- Do the procedure and the way the operation is being performed match?

#Slide 26

• The training is inadequate to perform the task: check the following:

- Did the training reflect the procedure content – and are all operators

performing the task as per the procedure?

- Was it the operator’s first time performing the task independently?

- Were they allowed practice on the task, or was training rushed?

- Did the trainer verify the operator’s ability to perform each required element

of the task?

- Is all the information for the trainee to perform the task correctly accessible
to them?

- Did the trainer train them the correct way to do the task? Did the trainer
have the knowledge and skills required to train?

#Slide 28

• The process isn’t designed to prevent errors: Ask the process design questions:

- Did the procedure reflect the current process?

- Is this process prone to errors? Why?

- Can one person realistically perform the process, or does it demand multiple

people (complexity, multiple tasks performed at once, etc.)?

- Is the procedure available to the Doer while performing the task, or he did

It out of memory?

#Slide 27

• The environment in which they were asked to perform wasn’t conducive to proper
performance:

- Were the operators assigned too many work tasks at once?

 - Was the operator rushing? Would structuring the person’s time or task list

Differently would have avoided the error?

- Did the operator ask for assistance and not got it?

- Were required resources (like reviewers or witnesses) available when

needed?

- Did the manager clearly set expectations that included performing the task

as per the procedure, and the procedure was available at the work place?

• If the answer of all the above questions are ‘YES’, the case “Why wasn’t the
procedure followed?” can be concluded as human error.

#Slide 31

ANALYSIS OF HUMAN ERROR

Accidental pathway:

• Accidents are caused by active failures or latent conditions which can lead to human
error or violations.

• Active failures are the acts or conditions precipitating the incident situation. They usually
involve the front-line staff, the consequences are immediate and can often be prevented
by design, training or operating systems.

• In a situation where there is no room for error these active failures have an immediate
impact on health and safety.
#Slide 32

Latent conditions are the managerial influences and social pressures that make up the
culture, influence the design of equipment or systems & define supervisory inadequacies.

They tend to be hidden until triggered by an event likely to have serious consequences.
Latent conditions can lead to latent failures: may occur when several latent conditions
combine in an unforeseen way.

Latent failures are typically failures in health and safety management systems. Examples:

- Poor design of plant and equipment;

- Uncertainties in roles & responsibilities

- Inadequate supervision;

- Ineffective training;

- Inadequate resources (people/ equipment);

- Ineffective communications;

#Slide 33

#Slide 34

Human reliability analysis (HRA):

• Human reliability is the probability of humans conducting specific tasks with satisfactory
performance. Tasks may be related to equipment repair, equipment or system operation,
safety actions, analysis, and other kinds of human actions that influence system
performance.

• Human error is contrary to human reliability and basically the human error probability
(P(HE)) is described as:

• P(HE) = Numbers of errors/ Numbers of error opportunities.

 • Third generation HRA method;

#Slide 35

Bayesian Network - Assess failure in task or action sequence and is applied in maintenance,
operational, or incident analysis. The methods regard human factors performance dependency.

Human reliability analysis (HRA): (Repeated content same is available in slide 34)

• Human reliability is the probability of humans conducting specific tasks with satisfactory
performance. Tasks may be related to equipment repair, equipment or system operation,
safety actions, analysis, and other kinds of human actions that influence system
performance.

• Human error is contrary to human reliability and basically the human error probability
(P(HE)) is described as:

P(HE) = Numbers of errors/ Numbers of error opportunities.

• Third generation HRA method;

Bayesian Network - Assess failure in task or action sequence and is applied in maintenance,
operational, or incident analysis. The methods regard human factors performance dependency.

#Slide 36

• The following flow diagram shows the human reliability analysis factors that influence
human error.
#Slide 37
Cognitive and behavioral Heuristics:

• A heuristic behavior is a mental shortcut that allows an individual to make a decision,

pass judgment, or solve a problem quickly and with minimal mental effort.

• A cognitive behavior is a systematic error in thinking that occurs when people are
processing and interpreting information in the world around them, affects the decisions &
judgments that they make.

• Nobel economist and cognitive psychologist Herbert Simon introduced the concept of
heuristics. Humans were limited in their ability to make rational decisions. Rational
decisions would involve weighing all alternatives such as potential costs against possible
benefits.

• Psychologists Amos Tversky and Daniel Kahneman presented their research

on cognitive biases. They proposed that these biases influence how people think and
the judgments people make. The study revealed that people rely on to simplify the
decision-making process.

• While heuristics can help us solve problems and speed up our decision-making process,
they can introduce errors. It can also contribute to things such as stereotypes and
prejudice.

#Slide 38
Cognitive and behavioral Heuristics biases:

 Anchoring (pay too attention to the 1st piece of info received)

 Attentional (buy a car model, notice everyone drives the same car
 Choice-supportive (vote just pros values to one decision, not cons
 Conservatism (tend to put previous beliefs ahead of new)
 Confirmation (consider the info supporting own hypothesis only
 Hindsight (Inclination to perceive an event as obvious)
 Illusory (improving Facebook profile gives us more "likes"
 Negativity (hindrance as a result of precedence of first decision
 Ostrich effect (ignore dangerous/ -ve information, even feedback
 Outcome (Judge a decision based on the outcome, not on means)
 Overconfidence (trusts more decisions or judgements)
 Stereotyping (only housewives are only interested in cleaning)
 Zero-risk (prefer the complete elimination of a risk)
#Slide 39

Management of Human Factors

• Human factor engineering is the science of designing systems to fit Human capabilities
and limitations

 Perception,

 Cognition

 Physical performance

• Poka-Yoke is a Japanese term that means "mistake-proofing" or “inadvertent

error prevention”. It is a method that prevents people from making mistake.

 Understanding human errors – physiology and psychology

 Causes of errors and incidents

 Where do Errors occur, identifying the potential causes

 Implementing new interventions – approaches and tools to reduce errors

 How the system can be fixed

 Prevention through Design

#Slide 40

#Slide 41

Prevention type:

In this type of poka-yoke system, a process is designed so that the defect or mistakes is
impossible to occur. Human error can be prevented to occur by:

• Elimination
  Prevention

 Replacement

 Facilitation

Detection type:

In this type of poka-yoke system, mistakes or errors are easily detected and corrected at the
source. In simple words, detection poka-yoke allows the mistake to occur but provide some
means of detecting, alerting, and correcting it. Effects can be minimized after occurrence by:

• Detection
• Correcting or Mitigating.

Whenever the text is continued on next slide show as Contd…… next to the heading
(Included)

#Slide 42, 43

Steps for improvement

Conduct an objective assessment of 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 QMS to reduce backlogs while thoroughly
investigating issues.

Create an open-minded atmosphere for the interview, so no finger pointing and try to avoid
quick judgements.

Ask open-ended questions to encourage people to provide a full, meaningful answer in their
own words coming from their knowledge and feelings about the situation.

During the interview, make sure to write down all the details even if it does not seem
important for later analysis. This is to make sure you don't miss any key information.

Remember! Most root causes are multifactorial.

Analyze the information with the interviewed colleagues.

Let the interviewed colleagues draw the conclusions and to define CAPAs. It will be a
smoother process to except the new system if they have created it themselves, and if they
come to the conclusion it creates an atmosphere of accountability and promotes greater
learning.

Put together consequent CAPA follow-ups including effectiveness checks to avoid

recurrence of the issue.
 Once the root cause is established and a new effective procedure is in place, communicate
the successful investigations and CAPAs!

#Slide 44

MANAGEMENT OF HUMAN FACTORS

Implementing
Understanding Where do Prevention
new
Human errors errors occur through Design
interventions

LEARNING CRONOLOGY OF HUMAN ERROR

#Slide 45

Prevention of Human Errors

 Good and accurate administrative management systems that controls clear accurate
procedures, instructions, and other aids that are crucial for human error prevention,
 Good human factors,
 Engineering of control systems,
 Appropriate processes and work environment,
 Job-relevant training and practice,
 Appropriate supervision,
 Good communications,
 And individual’s personnel performance.

#Slide 46

Continuously monitor the P-D-C-A cycles for targeted improvement

 PLAN

ACT MONITOR DO

CHECK

Slide No.45 – remove the bullet before A Systems Approach for Human Error
Reduction (Removed)

#Slide 47

A Systems Approach for Human Error Reduction

If the root cause for Human Error is assigned as ‘Lack of Attention to detail’ or ‘Failure to
follow procedure, corrective action will involve re-training or discipline.

Such approaches do not typically get to the true root cause as to why errors occur, and
generally will not prevent a re-occurrence of the issue.

Simply “cataloguing” and “assigning cause” to a defect or error is not compliance.

Cross Functional Team shall be established

Team should understand human error by adopting a more systematic structured approach.

#Slide 48

Following methodology can be employed

 ‘Cause and Effect’ analysis and

 ‘Gap Analysis.’
In addition, an internal training program shall be developed to provide a greater theoretical
understanding of human behaviour and system design.

#Slide 49

Step 1

Brainstorm all possible reasons for human error.

#Slide 50

Step 2
Generate a cause and effect diagram with all potential reasons for error identified.

#Slide 51

Slide 49, one picture of Gap Analysis can be deleted. (Deleted)

Step 3

Generate a gap analysis study. Critically evaluate each individual error category.
#Slide 52

Slide No. 50 - Can it be recreated by deleting TEVA? (Done)

Can we change the heading as Human Error - A Systems Approach? (Done)

#Slide 53

Personnel
  Ineffective Training
 Focus, motivation and application
 Suitability for role
 Shift handover and communication between breaks
 Repetitive Tasks
 Work load and multitasking

Methods/Procedures

 Lacking detailed instruction

 Inconsistent format
 No visual images in documentation
 Poorly written procedures
 Test method variability
 Procedures too detailed and difficult to follow

Machinery

 Reliability of equipment
 Preventative Maintenance
 Multiple Settings
 Equipment Change Control
 Suitability for task being performed

Materials

 Staging and Issuing Process

 Material Flow
 Identification & Segregation
 Labelling

Environment

 Layout of work area

 Insufficient space
 Noise and distractions
 Temperature/Humidity conditions
 Lighting
 Ergonomics
#Slide 54

Slide No. 52 - Can it be recreated by deleting TEVA? (Done)

#Slide 55

Human Error Factors

 Physiological Factors
 Psychological Factors
 Environmental Factors
 Material Flow
 Segregation and Identification
 Documentation Design
 Robustness of Test Methods
 Multi-tasking & Resourcing
  Maintaining employee motivation and engagement
 Communication & Shift Handover
 Effective system of Training
 Reporting of errors

Human error is an inherent part of human nature and most of the time is unintentional (if not it
must be assumed as falsification. It can be reduced but more investigation needs to be done on
understanding the root cause of it. They are more often than not forced by the circumstances of
the situation.

#Slide 56

Slide No 54, remove (refer picture below): as picture is in the next slide (Removed)

The Rightness Behind Human Errors - What are the brain processes that play a role in
human performance?

The brain is made up of two hemispheres, the right and the left, and they are very similar in their
anatomy and their physiology. Yet, a striking number of differences in how the two hemispheres
function - ranging from differences in the processing of basic sensory features to differences in
emotion, language, and problem solving.

This disparity between the general neural similarity of the two hemispheres and the
distinctiveness of their functions highlights the limits of our current understanding of the mapping
between neural and functional properties (refer picture below):

#Slide 57

Human brain- Hemispheres process different information types differently

“Human Error occurs because we are human beings.”

 Mind’s fatigue, wander and lose concentration;

 Have varying strength and stamina;
 Numerous other human factors;
  Variability of human performance is complex;
 Hemispheres process different information types differently.

Change Human Error occurs because we are human beings.” As “Human Error
occurs because we are human beings.” (Done)

#Slide 58

Strategies to reduce human error

Identify areas prone to Human Error

By conducting thorough employee training sessions and regular audits.

It's also beneficial to understand which areas require the most attention in terms of
minimizing human errors.

Implement a System to Minimize the Risk of Human Error

Once the areas prone to making mistakes are identified, processes should be established to
limit the possibility of those mistakes happening again. E.g.if inputting the data is manual -
automating this activity can be considered.

Use Checklists to Reduce the Chance of Mistakes

Check lists provide step-by-step instructions on how to complete various tasks. They also
serve as reminders of things which might be forgotten and helpful with repetitive tasks.

#Slide 59

Ensure that all employees are aware of their Roles and Responsibilities

Every employee should be made to understand their roles and responsibilities.

Plan Regular Audits

Regular audits are effective way to reduce human error. This helps to understand where
mistakes are being committed, and also helps to know how to improve.

Ensure that everyone has access to Information

When everyone has access to information, they'll be able to communicate effectively and
work together more efficiently. They'll have less opportunity to commit mistakes.

Provide Training on how to avoid Making Errors

Another effective way to minimize human error is to train employees on how to avoid making
mistakes.

#Slide 60

Create a Culture where people feel comfortable reporting any Issues or Concerns
 Encourage open communication within the company. If someone sees something wrong or
thinks they've made a mistake, they should feel comfortable reporting it to management.

Eliminate or Simplify Complex Tasks

If human error needs to be eliminated from the workplace, simplify complex tasks which will
help prevent people from spending too much time figuring out how to perform them. they can
rely on pre-established guidelines.

Take Corrective Actions

Once the areas where there is a possibility of committing human errors is identified,
corrective actions should be taken to avoid similar mistakes in future.

#Slide 61

Human error tree diagram

#Slide 62

Some examples of human error:

 Deleting important files on a computer hard drive accidentally

 A person who has been hired for a particular job but does not have the required skills or
experience may perform poorly in that position. This results in low productivity and quality.
 A worker may use unsafe equipment.
 Falsifying data on a report or other document deliberately.
 Incorrectly reading an instruction
 Using the wrong tool, or using it incorrectly.
 Performing a process or activity incorrectly.
 Improperly measuring something.
 Failing to maintain safety procedures.
 Taking an incorrect action or making an incorrect decision.
 Transcriptional error (lab) which occurs when data is recorded or written down incorrectly
and estimation error.

#Slide 63
 Experimental error:
 systematic,
 random, and
 blunders.

Systematic errors are errors of precision as all measurements will be off due to things such
as mis-calibration or background interference.

 Instrumental - When an instrument itself is flawed and provides inaccurate readings.

Example
A thermometer that registered 102 (instead of 100) in boiling water bring results that
was too high.

 Observational - When the observer incorrectly reads a measurement.

Example
A person, standing at an angle (rather than straight on) while reading the weight on a
scale. As a result, he consistently reads the scale in a way that reflects that angle.

 Environmental - When problems in the lab’s surroundings lead to inaccurate results.

Example
An experiment involving organic material may be affected if changes in humidity in
the lab are not controlled.

#Slide 64

Random errors occur due to fluctuations in temperature or pH.

 are caused by unknown or unpredictable changes in the environment

 lead to random fluctuations in measurement (about one-half of the measurements
will be too high and one-half too low)
 do not always have sources that are identifiable
 can often be quantified by statistical analysis

Observational
When the judgment of an observer leads to random (rather than consistent) inaccuracies.
Example
A person reading the weight on a scale records measurement to the smallest division.
Random error suggests that, over time, the person’s judgment is inconsistent. The individual
will record some measurements that are too low and some that are too high.

Environmental
When there are unpredictable changes in environmental conditions, such as temperature,
mechanical vibrations, etc.
Example
A piece of electrical equipment may have unpredictable noise that affects the results.
#Slide 65

Blunders are considered as human error which happens due to mistakes made by the
person performing the experiment, such as adding the wrong chemical or using the wrong
media.
In science, a blunder is an outright mistake. An individual might record a wrong number, or
add a digit while reading a scale, for instance.
Although the types of mistakes are similar to systematic and random errors, blunders can be
identified because the mistakes are usually not consistent. They also are usually not
frequent enough to be random errors.
Blunders should stick out as one-time mistakes by a person, and so cannot be analyzed in
the way that other scientific errors can.
However, if the blunder had a significant impact on the experiment, it should be mentioned in
the report.

Slide No 63, However, if the blunder had a significant impact on the experiment, it should be
mentioned in the report. To be corrected as
However, if the blunder had a significant impact on the experiment, it should be mentioned in
the report. (No change observed in PPT hence remained same)

#Slide 66

Types of human failure

#Slide 67

Unintentional actions can be due to the following:

 A slip while performing the task, for instance, spillage
  A memory lapse, like missing a step or inadvertently repeating a step
 Lack of knowledge, skill, or ability on how to perform the task
 Poor decision making while dealing with a non-routine situation
example,
when the analyst fails to report that the sample has an unusual colour

Intentional actions can be:

 Failure to conduct the task as described

 Failure to complete the task, for example, due to lack of time
 Exceptional situations when something has gone wrong, and an attempt is made to
rectify the situation rather than following proper procedure.

#Slide 68

Most common human errors in Pharma Industry

Manufacturing

 Documentation
 Labelling
 Line clearance
 Missing Schedule
 Incorrectly reading an instruction.
 Using the wrong tool, or using it incorrectly.
 Performing a process or activity incorrectly.
 Improperly measuring something.
 Failing to maintain safety procedures.
 Taking an incorrect action or making an incorrect decision.

#Slide 69
#Slide 70

Improper line clearance is human error

Quality Assurance

Document review

Usage of correction fluid, multiple cross-outs or marker pen to obscure the original record

Retain sample review

Laboratory / OOS

Solution preparation
Dilution
Weighing
Documentation

#Slide 71

Data Integrity
Engineering

Missing schedule –

Preventive Maintenance

Calibration
Documentation

#Slide 72

Common Compliance Issues due to Human Error

Lack of Clearly Defined Procedures and SOPs - Clear steps are not outlined for
carrying out specific tasks in the workplace in Standard Operating Procedure (SOP)

Inadequate Maintenance Facilities – Lack of clearly outlined methods for cleaning

and maintaining hygienic conditions in the facility e.g.

 Providing clear instructions for cleaning.

 Indicating who is responsible.
 Planning cleaning schedule.
 Providing the guidelines / procedures for maintaining the equipment properly.
 Ensuring regular inspections and protective measures for equipment.
Not properly utilizing data – Non availability of access to Real-time to data

#Slide 73

Inadequate laboratory control - Improper monitoring and maintaining the

laboratory controls to maintain the laboratory data.

Lack of communication and collaboration – Approved SOPs without clarified roles

and responsibilities. Employee is better able to perform their duties and remain
compliant with standards if they correctly understand what is expected of them
through SOPs / Instructions and by providing compliance training at regular intervals.

Participation among departments is low – SOPs must be updated to keep it current.

To ensure that the SOPs remain relevant, departments that use them need to
collaborate and update them as required. Encourage feedback, suggestions for
improvements from employees which will help to maintain a culture of quality and
continuous improvement.

#Slide 74

Faulty Product Review Records

To avoid omissions, the review and investigation processes must be clearly defined.
Non availability of standard operating procedures for batch record review

Examples of noncompliance with cGMP

Review maintenance records beyond review date

Using an older copy of the SOP by lab employees if the updated document is lost.

Quality management systems not reviewed periodically.

Inadequate Investigation of Deviation

#Slide 75

Categorization: Human Factor

Physical

Physical Capability

Vision / Hearing / Sensory

Disabilities
Restricted body movements
Difficult body positions

Physical Condition
Injury
Illness
Insufficient Rest
Oxygen deficiency

Mental

Mental State
Memory
Reaction time
Medication
Mental Stress
Frustration
Conflicting communications
Too many problems

Behavior

Shortcuts
Improper reward
Avoids discomfort
Relaxing attitude

Skills

Wrong skills
Insufficient training / OJT
Improper assessment

#Slide 76

Knowledge Transfer

Clear and concise operating instructions –

Improper risk assessments and controls

Engineering Design

Design of area / equipment / system

 Standards
 Ergonomics
  Change management of engg changes

Work Planning

 Work allocation
 Output orientation (e.g. In-sufficient PM)

Policies

 Induction
 R&R
 Risk assessments: Acceptable risk ratings

Management / Supervision

 Assignment of roles
 Delegation
 Standard work
 Performance dialogues

Communications

 No clear communication
 Focus on speed

#Slide 77

Controlling / Reducing human error

The most effective way to control human error is to implement adequate systems. Systems
take care of human factors (any aspect of the workplace or job implementation that makes it
more likely for the worker to make an error) and external factors.

 Providing clear, accurate procedures, instructions, and other job aids.

 Implementing good human factors engineering for control systems, processes,
equipment, and work environments.
 Provide relevant training and practice.
 Provide appropriate supervision.
 Assure good communications.
 Make sure the personnel have all the capabilities needed to succeed in the
assigned task.

#Slide 78

Case study 1 is too elaborated. Can we retain only 2 & 3? (Ma’am Please confirm)
Case Study 1 - A Situation That May Be A True Human Error:

An Analyst performs a task that requires manually calculating and then mentally rounding a
value and recording it in a Analytical worksheet. He performs the calculation, mentally
rounds the result, and has in his head what he needs to write down. A co-worker arrives,
interrupting him and diverting his attention from what he’s doing. He then writes other value
rather than a rounded value.
The analyst then asks another analyst to verify the step. He hands the documentation to the
verifier but continues talking to him, which distracts the verifier and causes him to miss the
rounding error. Processing continues, using the incorrect result. Later, QA identifies the
rounding error in the worksheet (Raw Data), which alters every calculation from that point
forward. In this instance, the impact on the batch was minimal — no limits or specifications
were exceeded.
Upon investigation, the supervisor identified no gaps or issues in the process — the
calculation is clearly and correctly defined in the procedure. He verified both people had
successfully completed training on the rounding procedure and had training on the current
version of the process procedure. Additionally, both successfully completed and checked
this calculation many times in the past with no errors. The supervisor addressed the error
with each individual, and both said they hadn’t been paying full attention to the task and did
not realize an error had occurred

#Slide 79

In this example, we have what may be a true human error — a one-time event where
trained personnel executing a well-defined process had their attention diverted from the task,
resulting in a mistake due to inattention.
If we can justify this as the situation, having identified that no other process/system issues
existed, then why not call it a slip or lapse, as appropriate? Again, it can happen. It just
shouldn’t happen frequently. However, even if it is a true human error, we shouldn’t
necessarily assume that only the involved personnel are at fault. When rule- or knowledge-
based errors occur, we should also look at other processes — training and oversight, in
particular — to identify factors that may have contributed to the mistake.

#Slide 80

For example, a rule-based mistake occurs: A new Analyst misapplies a rounding rule and
rounds all values instead of just the final value, which generates an out-of- specification
(OOS) result. When this error is addressed, we should also question why the person wasn’t
appropriately prepared for the task. Did the training not provide them enough practice? Did
practice examples reflect the operational situations the person would face? Does the
procedure specify that only the final value should be rounded? With knowledge-based
mistakes, cognitive strain errors can occur when a person is multitasking — it may require
more focus than they can provide to mentally manage the information required to accomplish
multiple tasks at once. In this situation, we should identify why the person was multitasking.
Were they assigned to perform too many tasks at once? Is the department under-resourced?
Was the supervisor aware that the person is multitasking and is unable to function at the
required level?
These are only two examples of how other processes should be considered when
investigating human errors. Others may require addressing difficult procedure formats, non-
user-friendly equipment, and other issues that may indicate problems in other areas.

#Slide 81

#Does every deviation/Non Compliance require investigation and corrective action —

even the lowrisk ones?

Addressing the CAPA part of the question first: Would a CAPA be necessary in the rounding
error example? May be not. A risk assessment may classify it as a low-risk situation
because:
Severity is low: The error had no batch impact, and future, similar rounding errors likely
would not have a significant batch impact either. Detectability is high: The calculations are
checked at least twice — by the verifier and QA and the checks caught the error that
occurred.
Frequency is low: Both operators had correctly performed the task several times before
with no errors.
We could use this to justify requiring no action beyond the supervisor pointing out the error
to the involved analyst . For individuals who simply had an off day, a discussion with their
supervisor may be enough to set things right. If further action is deemed necessary,
requiring follow-up checks monitoring the operator and verifier to ensure a similar error isn’t
made may be appropriate.

#Slide 82

However, from a different perspective this error shows that, while this process is often
correctly executed, it has possible failure points: Both the operator and the verifier missed
the rounding error. Manual calculations or other manual operations can, and on occasion
will, fail. So a CAPA could be identified to protect against the failure occurring again in the
future. Automating the performance of the calculations and rounding would reduce the
possibility of future errors.
We also don’t know whether other analyst /verifiers have made the same mistake. The
example only discusses the two operators involved in this specific situation. Looking at a
broader data set may identify several similar errors in manual calculations. In this case a
CAPA should be considered, because it’s a broader failure than initially identified.
To loop back to the first half of the question and tie all of this together, I do believe that every
deviation/NC requires some level of investigation, root cause analysis (RCA), and corrective
action. Risk analysis shows that some deviations/NCs pose higher risks than others. And
those that pose product quality or patient safety risks require thorough investigation, RCA,
and CAPAs.

#Slide 83

However, minor/low-risk situations still resulted from a process issue/problem, and they
should not be ignored or excluded from the process simply because they didn’t pose a
significant/high-risk impact to the process this time. Disregarding minor/low-risk situations
allows the problem to continue, which will likely create a larger problem the next time it
occurs. May be the better way to state it is that for low-risk situations, a less formal approach
to investigation, RCA, and CAPA is appropriate.
Consider our “low-risk” rounding error example. It went through a simple investigation, RCA,
and CAPA process. When the error was identified, it was assessed to determine batch
impact. The supervisor investigated whether the involved operators were trained, how the
error occurred, and whether their prior performance was acceptable. This led to identifying
human error as the root cause. The supervisor took corrective action by addressing the error
with the involved personnel, which hopefully leads to a behaviour adjustment. So all
three elements were, in fact, done, but in a less formal manner that befitted the situation.

#Slide 84

What are some first steps to begin using human performance improvement tools and
Processes?
Use these tools and processes where you have existing human errors/performance issues to
correct, or to help identify ways to continuously improve performance. In the case of
identified human errors/performance issues, these are the gaps that would be identified in
the Gap Analysis step on the Human Performance Technology (HPT) Model (Figure: 2).
From there, specifically define how Actual Performance differs from Desired Performance,
and investigate to understand the existing situation (Environmental Analysis) and identify
possible causes that could be contributing to the errors/issues that are occurring (Cause
Analysis). -GAP Analysis

#Slide 85

Case Study 2: Inadequate Deviation Investigations for Depyrogenation Tunnel

One investigation reviewed by the agency was related to the depyrogenation tunnel for
vials. The firm manufactured a lyophilized sterile injectable drug product in glass vials and
various batches of the lyophilized drug product were found to contain black particles over a
period of several months.

The company investigation found that the particles were metal shavings that were falling
from the upper surfaces of the tunnel into the empty vials that were subsequently filled with
the drug product. Various repairs were conducted on the tunnel but the problem continued
intermittently.

Rejection of batches of injectable drug product took place due to vials that contained black
particles upon visual inspection. The investigation did not extend to other batches
manufactured with the same equipment during the same time frame.

They were only rejecting vials where they could see contamination on the outside of
the cake. However, particles embedded within the cake would not be detected upon
visual inspection.”

#Slide 86

Case Study 3: Inadequate Deviation Investigations for Malfunctioning Autoclave

In the second scenario at the same facility, another injectable drug product was filled in
syringes and terminally sterilized in an autoclave. At the time of the inspection, the terminal
sterilization cycle for the injectable drug product was exceeding the validated autoclave
parameters as the ramping time to achieve the set parameters was increasing. It was taking
longer to achieve the set parameters for the autoclave. This resulted in various batches of
the product being rejected because the sterilization cycle was taking longer and was not
meeting its validated parameters.

Different investigations identified different root causes for the malfunctioning of the
equipment. Various repairs were performed but nothing seemed to resolve the issue
completely. The investigations did not extend to all batches that may have been potentially
impacted that were sterilized using the same equipment.

#Slide 87

At the time of the FDA inspection, the requalification of the autoclave had failed in that the
bioindicators had shown positive growth. Even after the requalification failure, the
equipment was still being used for commercial manufacturing. The firm was certain that the
requalification failure was due to using improper bioindicators with the wrong D value and
not due to the malfunctioning of the autoclave.

However, this investigation was still open at the time of the inspection, which occurred about
a month into the investigation, and the equipment continued to be used.

#Slide 88

Slides 86 – 89 is not part of Case study 3, to be corrected based on the headings in

particular pics (Made changes)
#Slide 29

#Slide 30

Performance Improvement / Human Performance Technology Mode

During the investigation -

 talk to the involved analyst (Person Involved) about the error/issue, and
 ask how/why it happened,
 how the error could be avoided or eliminated,
 what is needed to enable correct performance, and
 whether they understand the expectations for the task.

Observe the task(s) and identify where distractions or multitasking occur, verify personnel
are performing as expected, and verify that the procedures have enough information to
guide task performance.

Slides 87 and 88 can be moved after Investigation of Human Error (Moved to slide 29
& 30)

#Slide 89

Human negligence is said to have caused the accident at the Sainor Life Sciences
Private Limited at the Jawaharlal Nehru Pharma City (JNPC) at Parawada.
Two employees were killed and four other employees hospitalised when hydrogen
sulphide vapours leaked from a hosepipe connected to one of the reactors at the
pharmaceutical company on June 29 at around 11.30 p.m.

#Slide 90

Warning Letter / FDA 483

 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 as 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

 CAPAs have often been limited to retraining analysts. Improvements in analytical

methods and equipment were not generally implemented to enhance the robustness
and prevent error

#Slide 91

Inadequate Investigations and Equipment

Maintenance
#Slide 92