human error in pharmaceutical...
TRANSCRIPT
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your partner in compliance
Human Error in Pharmaceutical
Manufacturing
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Overview
Human Error frequently occurs in
pharmaceutical manufacturing, even when
the organisation considers that they have
done everything to prevent its occurrence.
Documentation appears accurate,
personnel are fully trained and equipment
operates as designed; but errors continue
to be made. In many organisations,
‘Human Error’ is assigned as the root
cause of the event with reasons assigned
such as ‘lack of attention to detail’ or ‘failure
to follow procedure’. Corrective action will
involve re-training or disciplinary action.
Such approaches do not seek to
understand why the error(s) occurred and
they certainly cannot be expected to
prevent re-occurrence.
In this article we look at the common
causes of Human Error in pharmaceutical
manufacturing. We outline an approach to
reduce these errors with an objective to
offer you an insight into the common
causes of Human Error in the area of
pharmaceutical manufacturing and to
provide you with a defined approach to
investigating risk influencing factors and
root cause, reducing Human Error and
sustaining error reduction within your own
company.
Human Error
So what is Human Error and why is its
impact so important for pharmaceutical
manufacture?
An ‘error' is a deviation from accuracy or
correctness.
Human Error...
“A mistake made by a person rather
than a machine”.
Oxford English Dictionary
According to Dr. Kevin O’Donnell, Senior
GMP Inspector and Market Compliance
Manager with the Irish Medicines Board
(IMB), “Human Error is frequently cited as
a primary cause of Quality Defect issues
that have led to batch recalls” 1.
Indeed, as highlighted by Dr. O’Donnell at
the Pharmachem Skillsnet &
PharmaChemical Ireland Conference in
Cork on 02 December, 2009 the IMB has
reported that 25% of all Quality Defects
such as deviations, laboratory errors,
complaints, and inspection issues are
attributed to Human Error, for example:
Failing to follow procedures
correctly
Using technical dossiers to support
batch release that do not correctly
reflect the contents of the Marketing
Authorisation (MA)
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Poor line clearance resulting in
rogues being left on a processing
line
Failing to implement Variations
following their approval by the
Competent Authority
In the same presentation, Dr. O’Donnell
outlined that the IMB has also reported that
90% of recalls relating to packaging and
labelling are attributed to Human Error and
that quality defects are often attributed to
Human Error without scientific evidence.
John Evans, Managing Director of HEB,
and leading expert on Human Error,
identifies two main types of Risk
Influencing Factors (RIF’s) for Human
Error. These are Stressor RIF’s (pressure
causing a feeling of stress) and Structural
RIF’s (inherent weakness in activity). RIF’s
can be grouped into ‘families’ of issues that
might affect the risk of Human Error; for
example, Process, Information, Resource,
Competence, Organisation, Stressors
(PIRCOS).
Stressor RIF’s increase the probability of
Human Error. They are often temporary
but may re-occur, i.e., if they are caused by
fatigue or very tight work deadlines and;
therefore, are subjective as they depend on
the person within the team making an error.
They do; however, also expose structural
vulnerability of activity which will need
further investigation.
Structural RIF’s are relatively persistent in
nature but are not often immediately
obvious unless triggered by stressors.
Structural RIF’s occur across a company
and can be caused in any one of a number
of areas, for example: processes where
several concurrent activities are competing
for attention; information giving (poor layout
of Batch Manufacturing record); resource
characteristics such as environmental
conditions causing distraction;
organisational planning, including when
shift arrangements undermine vigilance. It
is important that realistic demands are
placed on employees as work
overload/concurrent conduct of tasks lead
to mistakes. Other factors to take into
consideration when identifying RIF’s
include an individual’s physical and mental
capacity and the effect of sleep deprivation,
stress or emotional upset.
Leadership & Team Work
To ensure a true understanding of Human
Error and its contributory factors, a
strategic approach should be taken. It is
extremely important to create awareness
and understanding of risks in your
organisation by analysing your processes
and understanding your Human Error risks.
To do this, we recommend you apply a
Quality Risk Management (QRM) approach
(Risk Assessment, Risk Control, Risk,
Review, and Risk Communication) that
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includes routine tracking, evaluation and
analysis of Human Error metrics.
While it is advisable to proactively assess
potential risks, situations occur where
retrospective analysis is necessary. We
outline below key activities that should be
undertaken in each situation:
For prospective Risk Identification you will
need to identify How & Where in the
process ‘Human Error’ is likely to occur
through the use of a Scientific Approach:
Review process flow and information
flow
Identify the RIF’s
Identify the issues with which RIF’s
are commonly associated (PIRCOS)
Plan your processes to minimise and
control these risks
For retrospective analysis, you will need to
capture the event in real time, taking note
of environmental and other factors that may
be relevant to a thorough evaluation of the
issue. You will also need to consider the
level of the RIF effect:
1. Individual – affects a single individual
2. Local – within a limited physical area,
relevant to a specific activity, affects
a finite number of people
3. Generic – Can be common or
independent. Common risks are
those shared across numerous
instances of a common problem; for
example, misreading a table in a
document that is used widely in the
organisation. Independent risks are
those present in different parts of the
organisation; for example,
misreading a typeface that is used in
numerous documents
Then you should analyse whether your
non-compliances associated with Human
Error can provide further insight (for
example, from QMS, Deviations and
Complaints Management System, CAPA).
There are a number of Root Cause
Analysis (RCA) tools and techniques that
can be used such as Brainstorming;
Fishbone Diagrams; 5 Whys and Fault
Tree Analysis.
Conditions to sustain error
reduction and enhancing
human reliability
In order to design and manage your
operations with Human Error in mind, an
open communication environment is
essential. It is important to include the
following key factors to support all of the
team to achieve a reduction in Human
Error:
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• Don’t assume the cause of a
Quality Defect is Human Error!
• Shift from a retrospective and
superficial evaluation of Human
Error to a prospective risk-based
evaluation of your critical processes
and procedures
• Investigate and identify true
contributory causes:
o Use a Team-Based
Approach
o Use a Science-Based
Approach
• Motivate your people to embrace
Human Error identification through
recognition and support:
o Be aware of limitations – risk
factors can be outside of
conscious control
• Create an atmosphere of
accountability by displacement of
blame
• Give and take feedback
• Empower personnel to address
their own RIF’s
• Continuous improvement process:
o Involve staff at all levels
o Introduce a core risk-
reduction team who
develop the organisation’s
body of knowledge
• Support innovation and
understanding
In summary, be clear as to what constitutes
Human Error. Use a risk-based approach
to identify the RIF’s for your critical
processes and design to minimise Human
Error potential. Apply a QRM approach to
sustaining low levels of Human Error and to
promoting a working environment that
supports a proactive approach to
minimising the potential for Human Error.
The Author
Ann has over 30 years’
experience divided
between industry, as a
Regulator with the Irish
Medicines Board, as CEO
and Registrar of the Pharmaceutical
Society of Ireland and as owner and
Principal Consultant of McGee Pharma
International, a pharmaceutical
consultancy. Ann’s wealth of expertise
includes Facility Design, Quality Risk
Management in accordance with ICH Q9
and Human Error reduction.
References
1. Human Error & Re-training – Issues to
consider during deviation and complaint
investigations
Kevin O’Donnell Ph.D., Market
Compliance Manager, Irish Medicines
Board (December 2009)
2. Human Error Seminar
By Ann McGee and John Evans (May
2010)
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