Human Error Reduction

Mr. D. B. Sridhar Ms. Nilanjana Basu

Sr. Vice President, M.S.&T. Sr. GM, Technical Training
Zydus Lifesciences Lupin Limited
 Agenda

Understanding the Human Reliability

Human Error Investigation Techniques

Human Error Prevention tools /techniques

Best Practices of Human Error Reduction- Case Studies

Conclusion - Change our views on Human error

 Preamble

Human Error

Increased Investigation
Workload efforts

Vicious Cycle
Holding of
Re-work efforts activity/Missed
Commitment
 Preamble

What’s the Problem?

Why are capable, conscientious people not always reliable?

What more can organisations do to improve human reliability?

 Understanding the Human Reliability

Error Error Risk Reduction

The Error reduction process designed to…
Error can be defined as… ’An • Identify the areas where human error may occur
act which may produce • Identify adverse influences that increase the
chance of error
unintended results’ and
• Reduce risk by addressing those adverse
when a human is involved, it influences
is Human Error • Systematically increase human reliability across
the organization

Human Relaibility Human Errors

 Understanding the Human Reliability

Human Reliability : Human reliability refers to the likelihood of successful human performance within specified timeframes and
environmental conditions. It is critical to overall system reliability and is one factor that contributes to, or prevents, unwanted
events occurring

• Focuses on ‘Everyday Errors’ such as..

• Unintended/occasional, incorrect
execution of familiar tasks
• Forgetting to act when required
• Failing to notice something needing
attention

• Focuses on activities and their operational

context rather than individuals

• Aims at reducing overall burden of risks

rather than preventing occurrence or
recurrence of specific errors.
 Understanding the Human Reliability

Human Learning – The Brain Factor

Fore-brain:
• The Cerebrum (Cerebral Cortex): associated with higher
brain function such as thought and action.
• Cerebrum Is divided into two halves, Left and Right
Hemispheres
• Left Hemisphere: Logical Side
• Right Hemisphere: Creative Side
Limbic System: (Emotional Brain / Childish Brain)
• Plays a role in emotionally laden memories
• It is particularly important in forming new memories,
and connecting emotions and senses, such as smell and
sound, to memories.
 Understanding the Human Reliability

Human brain – hemispheres (Left brain vs Right brain Theory)

Left Hemisphere Right Hemisphere

Words
Language
Logic symbols
54387
2/3 = 5
ABC, 123

Different type of info

processed differently
 Understanding the Human Reliability

How the brain learns?

1. When we learn, links formed

2. Learning = forming links Remembering = activating links

Learning = Neural Pathways = Links

3. Cannot learn new unless can link to known!

4. If wrong links formed or links not formed - high chances of errors

During Learning Links needs to be created

 Understanding the Human Reliability

Reticular Activating System

1.Decides ..let in ? Keep out ? Reticular activating

system

2.Works to keep things out-if thinks it already knows

filters info
3.Adult learns if need – “unconscious incompetent”?
Need LOs or quiz to activate RAS

During Learning Links needs to be created

Understanding the Human Reliability

Video
 Human Error Investigation Techniques

Investigation of Human Error – An overview

Training
Drill Down Analysis Spaghetti diagram Root cause analysis Complacency
/Knowledge deficit
• To look at or • A visual • A systematic • A feeling of being • Qualification for
examine representation method of satisfied with how respective task
something in using a understanding things are and not • SOP awareness
depth. continuous flow root causes wanting to try to • Training on
• An interactive line tracing the contributing to make them current procedure
way to explore path of an item or human error better. Major
• Technical know-
data points and activity through a contributor to
how
view row-level process. errors!
data in the grid
without changing
the underlying
query.
 Human Error Investigation Techniques

Investigation of Human Error – Understanding the Causes Task Demands: Individual Capabilities:
•Time Pressure (in a hurry) •Unfamiliarity with task
•High Workload (memory •Lack of
 Human Failure: Refers to any deviation occurred requirements)
knowledge/proficiency/experience
•Lack of effective communication
•Simultaneous, multiple tasks
due to human error. •Repetitive/ monotonous actions
•Inadequate problem-solving skills
•Lenient attitude for critical task
•Correct Interpretation (of
•Illness / Fatigue
 Human Violation: Refers to a deviation that is instructions and situations)

made deliberately.

 Human Factor: Any factor that influences human

behavior at work in a way that can affect the output Work Environment Human Nature
of the process. •Distractions / Interruptions •Stress (limits attention)
•Changes / Departures from routine •Habit patterns
•Assumptions (inaccurate mental
•Confusing displays or controls
picture)
•Culture of accepting workarounds •Complacency / Overconfidence
• There are three primary elements viz. task •Unaddressed personality conflicts •Mindset (“tuned” to see)
•Inaccurate risk perception
complexity, behavioural characteristics and (Pollyanna)
•Limited memory
error prone situations that are potential triggers to
human errors

• In addition, there are multiple Human Error

Precursors that too contribute to occurrence of Human Error Precursors
 Human Error Investigation Techniques

Risk Review of Human Error – Check for Error Producing Conditions

Was the infrastructural support for job

Clarity of instructions in procedure Could fatigue play a role in this failure?
delivery adequate, e.g., hardware design?

• Is there an approved SOP in place for the task? • Person is working for long hours more frequently • Layout of the work area not matched to process or
• Does the existing SOPs provide all encompassing • Not enough breaks from work /no tasks rotation natural sequence of activities
elaboration? • Shiftwork rotation… • Working surfaces overcrowded, where location is
• Does the SOP mention handling deviations, if any, • Staff shortage important
in the task/activity • People pressured to work (to cover staff shortage) • Several similar containers (bins, folders, etc.) used to
• Approved procedure is available but not used • Extremes of physical environment keep items separated
often/always • Background color of working surface provides poor
Was training adequate?
• No startup checklist, for beginning of day/shift work. contrast
Reliance on memory (and not procedure) for Was supervision adequate? • Screens, equipment displays, labels and documents
identifying areas that need attention/check. etc. too far away to see easily
• No unambiguous visual indication of point
Was the relevant person experienced?
• Things that need to be handled or adjusted are too
reached in work sequence. far away to reach easily.
Was there any sign of negligence?
 Human Error Investigation Techniques

Human Error Categorization

Do not know
Learning (lack skill or knowledge, or insufficient understanding of consequences)

Knows, but does not remember

Memory (unable to use skill or knowledge at time/situation required)

Knows, but variability in method/standard

Inconsistency (inconsistent performance/results)

Knows, but applied incorrect action/info

Application (slips, wrong outcomes, transcription errors)

Knows, but missed a step/ action

Omission (missing info/step, used wrong item)

Wrong decision given situation/info

Decision (inappropriate decisions&/or behavior)

Take Picture of the area when error Happens, it helps to understand

Human Error Investigation Flow

Further drill down analysis

can be done using specific
checklists for respective
type of error
 Remediation of Human Error

Derivation of good practices : Concept

Hierarchy of Actions: five main error management strategies:
 Error Prevention:
Aims at avoiding the occurrences of errors.
 Error Reduction:
Aims at minimizing both the likelihood and magnitude of error.
 Error Detection:
Aims at making errors apparent as quickly and as clearly as
possible and therefore enabling recovery. An error can be:
- Detected by the person that committed the error (self-monitoring).
- Detected by another person.
- Detected by system e.g., an alarm.
 Error Recovery:
Aims at making it easy to rapidly recover the system to its safe
state after the error has been committed.
 Error Tolerance:
Aims at making the system as robust as possible towards error.
 Human Error Prevention
tools/techniques
Mistake proofing model (Poka-Yoke)
Example : Blend sampling in the form of slug instead of powder
Five principles or methods of mistake
Slug sampling in powder form may lead to sampling bias i.e. Segregation during sampling or sample handling,
proofing: Sample in sample etc. To avoid the issue of sampling bias, blend sampling is performed in the form of slug using
compaction machine. The quantity of slug formation is kept as quantity required for QC testing that avoids
1. Elimination: To eliminate an error- probability of error due to sample in sample.
prone process step by redesigning the
product or process.
2. Replacement: To substitute for
more reliable process step to improve
repeatability.
3. Simplification: To redesign the
process so that it become easier for
execution.
4. Detection: To identify a mistake
before further processing in order to
correct the defect.
5. Mitigation: To minimize the
effects/mistake or to reduce the
impact of an error or defect.
 Human Error Prevention
tools/techniques
Mistake proofing in day-to-day analytical activities:

Action Application
To avoid solution
Usage of single row test
interchange in profile
tube stand
dissolution test
Different colour rings To avoid interchange of
inserted to the volumetric volumetric flasks in profile
flask of different time point dissolution test.

Partition affixed on the desk To avoid interchange of

of analyst glassware / solution

Storage facility with

To avoid interchange or
segregation of cleaned
wrong selection of pipette
pipettes

Affixing printed labels on To improve label legibility &

volumetric glass wares longevity.
 Best Practices of Human Error Reduction- Case
Studies

1 Sampling Error 2 Visual Inspection Error

Inadequate swab sampling from equipment surface. Performing visual inspection of equipment surface
Error Description Cleaning Validation protocol was devoid of the clause Error Description
cleanliness without inspector qualification.
to perform zig-zag swabbing

Error Category Inconsistency Error Learning Gap (as the inspector wasn’t trained and
qualified on inspection of equipment surface for its
Additional
Enhancement of CV protocol to include clause for zig- cleanliness) and procedural inconsistency for
Information
zag swab sampling in equipment surface along with allowing personnel to inspect without prior
pictorial depiction (Error Prevention Model) qualification.

Error Category Learning Error

Recommendations

Inspector qualification procedure was prepared, and

SOP was revised to incorporate a clause to perform
Recommendations
inspector qualification prior to deployment for
visual inspection activity (Error Prevention Model).
 Best Practices of Human Error Reduction- Case
Studies

3 Forgot to check the parameters 4 Wrong Result Reported

Operator forgets to check the environmental Wrong interpretation of chromatograms due to

Error Description conditions of the manufacturing suite prior to Error Description
absence of reference chromatograms in STP.
commencement of the unit operation.

Error Category Memory Error Error Category Inconsistency Error

Usage of attention activator and a note was added

“Record temperature and %RH prior to
commencement of operation” in Batch Reference chromatograms attached to the STPs and
Manufacturing Record. (Error Prevention Model) Recommendations training imparted to analyst.
Recommendations
OR
(Error Prevention Model)
Implement BMS for online data monitoring (Error
Proofing Model)
 Best Practices of Human Error Reduction- Case
Studies

5 Missing Second Check 6 Analyst Error

Response ratio was not achieved as per specified

"Verified By" sign missing in cleaning checklist of
Error Description Error Description criteria i.e., obtained similarity factor 0.97 against
Pressure vessel
limit 0.98 to 1.02.

Operator who was responsible to verify the activity

Additional inadvertently missed to sign in the "Verified By" Additional The incident occurred because the analyst had not
Information column of cleaning checklist as he was engaged to Information dipped the inlet filter in rinse bottle properly.
help the other operator in cleaning activity

Error Category Omission Error Error Category Omission Error

Implementation of digital platform for cleaning

execution (Error Proofing) OR HPLC verification checklist appended to ensure all
Redesigning of checklist in HER (Human Error the lines are dipped properly in the Mobile
Reduction) Format with Gray background for non- Phase/Rinse line/ fill wash with their respective
Recommendations Recommendations
executable instructions and White blanks for solution and the pictorial representations of
recording observations during execution. (Error precautionary measures have been fixed in work
Prevention) with consent from site/company benches as a job aid. (Error Prevention Model).
management
 Best Practices of Human Error Reduction- Case
Studies

Investigation of Human Error – Process of Error Risk Reduction

Blue Red Yellow Green Purple

Make clear Toolbox error Continuous

Understand
what Risk Review reduction reliability
causes
happens improvement

Making Elimination or Continuous

Identification Identification of
activities and reduction of improvement in
and assessment risk influencing
their context risk influencing human
of risk of errors factors
explicit factors reliability
 Best Practices of Human Error Reduction- Case
Studies
Blue Red
Problem Identification Detailed understanding the process – workflow
• Total 37% Invalid failure was reported in a Process steps – Dilution & Potential Risk Areas
year at one of the Mfg. site
Sample collection and Selection of STP / TDS
Diluent addition as per STP

• Brainstorming exercise done for

identification of causes for higher Collection of Glassware / chemical /water
Diluent Preparation as per STP
Volumetric flasks shifting to sonication/Shaking
area
OOS/OOT/Deviation
Selection of sonicator and check the water level
Collect Mortar pestle and Volumetric flask , calibration status & temperature
• Identified that 28 and 22 failure are due
to Dilution and Transcriptional error Calculate Avg. weight and Crush sample in Volumetric flask place in sonicator
mortar pestle.
respectively which is approximate 13 % of
total number of failure reported in a year E-Logbook entry for weighing balance & Weigh
Sonication start
sample as per STP
111111111 Intermittent shaking & addition of diluent as per
22 31
2 STP
4 Transfer the sample to dry volumetric flask with
22
2 identification & e-logbook /TDS entry
3
4 Again Sonication with intermittent shaking
28 7
Volumetric flask shifted to work place
8
8
15 10
Error Producing Conditions
 Best Practices of Human Error Reduction- Case
Studies
Yellow
Potential Risk Identified

Wrong
Wrong volumetric
Pipette Used flask used Wrong
meniscus
Use of setting
Broken PLC
Vial Septa
Due to
Bumping
Practices
Wrong
pipetting Dilution Error
practices
Wrong
wiping
practices
Inappropriate
stopper used Improper
Filter
Delay in
Use of selection
dilution of
syringe with /Saturation
Degradable
Rubber
product
plunger
 Best Practices of Human Error Reduction- Case
Studies
Green
Elimination of Error Producing Condition – Good Practices implementation
Error Working surfaces overcrowded, where location is important, (for Error
Producing example various grades of items in separate piles). Producing Qualitative descriptions used where precision is needed, e.g.
Conditions Information must be remembered whilst other tasks are carried Conditions soon/warm
out, before being used.

Concerns in During Analysis due to insufficient space to keep STP at working Concerns in STP has mentioned freshly prepared sample to be injected .
Lab place , analyst refers and keeps STP on top shelf during analysis. Lab Some time analyst is unaware about how soon the second
There is restricted issuance of STP in order to have a control on dilution is to be made . Delay in second dilution results in
traceability. As a result, one STP gets referred by 3 analysts at a degradation of solution.
time and execution largely depends on Short Term memory which
fails at times.

Evidences Evidences
Good practices: Good practices:
second
- SDMS(Soft data management dilution
second
system:Omnidocs) done with
dilution - Standard testing procedure included
done after
implemented for storage of in 30 sec. 1 hr and
and kept note of risk indicating parameter
kept for 6 hr
specification/STP for 6 hr
- 2 Computers provided in each regarding Freshly prepared sample .
QC Lab , analyst/reviewer can - Special Precaution note shall be issued
refer STP any time from Online
system in case of highly sensitive product.
- List of Total Specification/STP
with Reviewed date shall be
maintained
 Best Practices of Human Error Reduction- Case
Studies
Green
Elimination of Error Producing Condition – Good Practices implementation
Error Producing
Conditions Similar Appearance - e.g. same color/style/shape of packaging, clear, colorless liquids, white powders, etc.

Concerns in Lab 1. Wrong Volumetric flask (VF)/Pipette may be selected due to same appearance e.g. 5 mL pipet instead of 4 mL pipet and vice versa, 200mL VF
instead of 250 mL VF, 75 mL VF instead of 100mL VF etc.
2. Methanol and Acetonitrile are being used in large volume in QC for mobile phase preparation and both bottles are having same shape /colour
label , analyst gets confused and may use wrong solvent .
3. Pipette used with broken/damaged ends/tips may vary amount delivered in pipetting, may result in lower/higher results. Similarly uses of
broken/inappropriate stoppers may leads to spillage of mother solution and may change the concentration of stock solution.

Evidences

Good practices:

- Glassware marked with ring. Different shape for

look alike glassware procured
- For Acetonitrile and Methanol solvents bottle
supplier informed to differentiate the labeling
- Both solvents procured from different make for
easy identification
- Glassware are coated with thin film that prevent
breakage of Pipette at tip .Special treatment at
Tip Coating.
 Best Practices of Human Error Reduction- Case
Studies
Purple
Continuous Reliability Improvement – A snapshot of project outcome

Error reduction methodology applied for Human Error Investigation

Project taken up at 4 major manufacturing sites
Target taken to reduce invalid OOS by 50%
Clear shift of baseline
Target achieved and is sustained
 Sustenance of Human Reliability

Approach for continual improvement of human reliability

Once an area attains accepted level of human errors, multiple measures can be taken to sustain the human reliability

Conducting periodic survey to gather information about perception of

stakeholders on error reduction initiatives along with contemporary
challenges. This will also throw light on emerging vulnerable area.

Before and after comparison of error reduction to see if the failure rates
are reduced/maintained.

Area to area comparison on error reduction initiatives/metrics in

governance forum.
 Conclusion - Change in views on Human
error

To achieve continued success in reducing risk of human error, a well-designed strategy that includes the following kinds of

processes amongst others

 Visibility: Managers to have meaningful and comprehensive understanding of error risk and their potential consequence

 Awareness: The workforce understands how to identify and address risk of error

 Measurement: Measurement of cause and consequences of error to be factored in driving new improvement projects

 Handling: Assessment on whether handling of failures help in long term error reduction through review of identified metrics

 Empowerment: Provision of time and resources needed to address error and empowerment of workforce to apply them

 Deployment: Knowledge based development and proactive application of well-founded know how
 Conclusion - Change in views on Human
error
Successful application of these approach in an organization, may lead to a transformational change happening and
Improvement in human reliability

Reactive Approach Proactive Approach

Focus on Individuals Focus on activities

Toolbox fix System improvement

Error avoidance Reliability Enhancement

“85% of the reasons for failure to meet customer requirements are related to deficiencies in systems and processes rather
than the employee. The role of management is to change the process rather than badgering individuals to do better”
Mr. Edward Deming
 Acknowledgements
• Dr. Ranjana Pathak (Mentor) = Dr. Reddy’s Lab.
• D. B. Sridhar (Sub Group Head) : Zydus Life sciences Ltd.
• Nilanjana Basu
• Manoj Gera - Zydus Lifesciences Ltd.
• Narendra Deshpande - Lupin Ltd.
• V Sneha Shree - Dr. Reddy’s Lab.
• Yogita Bhanwaria - Dr. Reddy’s Lab.
• Raju Tukra - Sun Pharma Ind. Ltd.
• Vaibhav Swaroop - Sun Pharma Ind. Ltd.
• Sanjay Ghare - Cipla Ltd.
• Ankit Pandey - Cipla Ltd.
• Sweety Shah - Torrent Pharmaceuticals Ltd.