Novartis Investigation Certification

Key Points - NJodule 4: Preventing human error

Novartis Investigation Certification

Key Points - Module 4: Preventing human error

Objectives:
• Understand that human error is inevitable, but realize that with our patients and
customers in mind we should strive for an error-free workplace nonetheless.

• Correctly identify the contributing factors which cause us to make errors, whilst
maintaining a blame-free environment

• Feel more confident in working with your colleagues to prevent (through our
processes and procedures) and investigate (identifying root causes and implementing
effective CAPAs) human error to make safer, more cost-effective products.

Topic 1: Human error is human nature

• Human error is inevitable; it’s human nature! However with our patients and
customers in mind we should strive for an error-free workplace nonetheless.

• Human error is much more likely to occur when a process or procedure is badly
designed, poorly written or difficult to use. This is why it’s important to perform
a deeper analysis of human error in order to improve.

• We work together to reduce the probability of errors occurring by:

identifying high risk opportunities for human error to occur and
mitigating these in our processes, procedures and daily routine
improving investigations to identify true root cause or contributing
factors leading to human error.
implementing effective CAPAs to prevent recurrent problems.

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Key Points - NJodule 4: Preventing human error

Topic 2: Basics of human error

• Simply defined, human error is the inappropriate action or response by a person,
resulting in an undesired outcome.

• Intentional human error is when an employee purposefully and knowingly

takes an inappropriate action or response. This can also be called intentional
misconduct. unintentional human error on the other hand can be broken down
into three sub-categories in order to better understand how and why human error
occurs: skill based errors, rule based errors, and knowledge based errors.

• A skill based error occurs when a person makes the right decision but executes
it incorrectly. Their actions are different from their intentions.

• A rule based error occurs when a person does what they intended to do, but
made the wrong decision because knowledge (a known rule) was incorrectly
applied, or a situation was misinterpreted or appears in an unfamiliar situation and
the wrong knowledge was chosen.

• A knowledge based error occurs when a person makes the wrong decisions
and/or executes it incorrectly because they did not have the proper knowledge.
These kinds of errors happen in new, rare or difficult situations requiring a
conscious usage of know-how and skills.

• We design our processes to minimize the risk for human error and implement
controls such as automated calculations and double verification steps to catch
errors when they occur. Steps such as these act as layers of defence, working
together to identify and prevent potential errors before they have a negative
consequence.

• We need to either reduce the risk of human error through the design of our
systems and processes or implement proper controls. Prevention of human error
after all, is better than fixing an error once it has occurred.

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Key Points - NJodule 4: Preventing human error

Topic 3: Human error - contributing factors

• Human error really is just the tip of the iceberg — there’s a lot more going on
beneath the surface. Human error should be viewed as the effect, rather
than the cause.

• Sometimes what we consider to be human error may only be a piece in the puzzle,
or a link in a chain of events leading to a negative outcome.

• We may see human error ‘on the surface’ as evidence of an issue. All too often we
stop here and blame the individual(s) involved, but we should investigate further to
understand what contributing factors could be have led to the human error.

• Being able to identify and understand what contributing factors lead to a human
error will help us to proactively remove the probability of human error through
process design or controls, as well as help us to implement effective CAPAs,
which address the true root cause of a problem.

• The following categories have been developed to assist with identifying

contributing factors to human errors: organization, tools, governance and
metrics, procedures, processes and products, people, physical environment.

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Topic 4: Roles in preventing human error

• No matter where you operate in the organization, understanding each role’s
responsibility in preventing human error is critical — we must work together
to truly make an impact.

• However, don’t fall in to the trap of just identifying a problem; instead, take the
time to think of ways to solve it. It’s important to be solution-orientated. -How
can we ‘design’ human error out of our processes?

• Let’s face it, factors such as stress, fatigue, lack of focus and automatism can have
an effect on your work. There are times that we all experience these factors; it’s a
part of life. However, recognizing these factors and being aware of their impact on
your work can help mitigate the risk of an error.

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Topic 5: Investigating human error

• We must stop human error from recurring. We can do this through better
investigation, unearthing true root cause and contributing factors, and ultimately
implementing effective CAPAs to prevent issues from recurring.

• Investigating human error follows the same general investigation process as

used in other types of investigations: detection, investigation, corrective and
preventative actions and follow-up.

• We should always first verify that the root cause is human error: don’t just
assume it.

• The most useful investigation techniques are the Five Whys’, ‘Cause and Effect
Diagrams (Fish bone)’ and interviews. These techniques not only support digging
deeper into an issue and detecting the root cause, but are helpful in visualizing
the contributing factors which enabled the event to occur.

• (Re)training of an associate should generally only be used if the contributing

factor to the human error is a knowledge gap. If an associate has completed
such training, but still has a knowledge gap, the training method or training itself
needs to be revaluated.

• Follow up is important: it should not only check new deviations related to the
case, but include interviews and inquiries, too. This will enable us to check if
there have been ‘close calls’ again.

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Topic 6: Error free workplace

• Supervisors, managers and leaders have a critical role in fostering a culture which
supports an error free workplace.

• Nlanagers should be honest with employees and take the time to listen to ways of
improving processes.

• The best way to encourage employees to speak up is to action their suggestions,

properly investigate troublesome procedures and implement effective CAPA
resolutions.

• Evaluate what behaviour your priorities, objectives and metrics are driving.

• Time spent in the short term will save money and time in the long term, as well
as making your team feel valued.

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Notes
Use this space to write any notes and/or new ideas which you have had since
completing Module 4: Preventing human error.

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