See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/347512520
Error Risk Reduction: Concept and Case Study
Article · December 2020
CITATIONS
READS
0
805
1 author:
Tim Sandle
The University of Manchester
736 PUBLICATIONS 1,286 CITATIONS
SEE PROFILE
Some of the authors of this publication are also working on these related projects:
Laboratory Management View project
Pharmaceutical product recalls View project
All content following this page was uploaded by Tim Sandle on 21 December 2020.
The user has requested enhancement of the downloaded file.
Error Risk Reduction: Concept and Case Study
Tim Sandle
Introduction
This paper is concerned with human error and error risk reduction, centered on two case
studies. Human error has long been identified as a contributing factor to incident causation,
and pharmaceuticals and healthcare is no exception (1). Human error is a cause of substantial
variation across the sector, impacting upon quality. To a degree it can be prevented by
analyzing process for failure modes and implementing better training, clearer documentation
and by increasing automation. Hence, no root cause investigation should end by concluding
‘human error’.
With the first case study, during the filling of a batch of an aseptic liquid product a change of
the receptacle used for holding rubber stoppers (a ‘hopper’) was carried out within the aseptic
processing area. After unloading the stoppers, three clamps, three seals and a stainless steel
‘T’ piece were found to have been left inside the hopper. A deviation report was raised, and
an investigation performed in order to examine the reason why the error happened and with a
view to prevent the error from happening again.
The process followed falls within the general approach of error risk reduction. Error risk
reduction is associated foremost with human error and the ways to reduce the impact of
human error on procedures and processes. With this approach, it is important that the people
carrying out the assessment should understand the different types of failure and the factors
that make them more or less likely to occur.
The second case study looks at batch record errors, where the lesson to be learned is focused
at the design stage. Both case studies draw om the human factors approach, which is
discussed below.
In terms of what an error is, there are competing definitions and understanding of ‘error’. It
follows that the reason for errors occurring is a contested concept. In the context of this
article, errors will be considered as divergences of events from (expected) standards. This fits
in neatly with the GMP context.
One of the common mistakes is that there is ‘no such thing as human error’ or ‘regulators will
not accept human error’. This is not correct. It is possible for mistakes, errors, slips, or lapses
to occur, and these describe one immutable aspect of the human condition: to err is human.
However, the investigation process into an issue should not end here. It is necessary to find
the root cause for the error, the underlying issue, the factor, or the context that caused the
issue to arise in the first place.
What is error?
There are two schools of thought in relation to human error: the person and the system
approaches. These can be defined as (2):
•
The person approach focuses on the errors of individuals, blaming them for
forgetfulness, inattention, or moral weakness. This understanding of human error is
•
more generally connected with moral, cultural and religious perceptions of human
frailty.
The system approach concentrates on the conditions under which individuals work
and tries to build defenses to avert errors or mitigate their effects. This approach has
received considerable examination in terms of organizational theory and the sociology
of work. An example is with the human factors approach, which is discussed below.
There are different ways to classify an ‘error’ (3). One way of doing so is to divide error into
‘mistakes’ and ‘slips’ (and error itself is not the same as a deliberate act of not going
something that should be done, such as committing fraud). As to how these concepts of
‘mistakes’ and ‘slip’ might be distinguished, Norman explains: "The division occurs at the
level of the intention: A Person establishes an intention to act. If the intention is not
appropriate, this is a mistake. If the action is not what was intended, this is a slip (4)" The
author also identifies errors caused by an interface, as with a computer system; and scenario
errors, where the activity has a degree of artificiality about it.
Generally, as this article focuses on, mistakes can be addressed through revisions to
procedures and training. Slips, on the other hand, are the result of an influencing factor. Slips
can be described as: "most likely to occur (a) when we must deviate from a routine, and
automatic processes inappropriately override intentional, controlled processes; or (b) when
automatic processes are interrupted - usually as a result of external events or data, but
sometimes as a result of internal events, such as highly distracting thoughts (5)."
Human error and pharmaceuticals
Human error will occur in pharmaceutical production as much as it will occur in other
regulated sectors, although hopefully this will be at a rate lower than sectors where controls
and regulations are less exacting or where the impact of the error matters less. In fact,
regulations expect human error to occur, as with CFR 211.22 which states that: “[the quality
control unit has]…the authority to review Production records to assure that no errors have
occurred or, if errors have occurred, that they have been fully investigated.”
Similar phrasing is apparent in EU GMP. For example, in Chapter 14 (part xiv) it is stated:
“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…”
While these regulations acknowledge human error, it does not expect the process to end
simply with the acceptance of error. It is expected that the error is investigated, as the error
itself is rarely the root cause of the failure. Invariably some system or process is at fault,
leading to the error occurring (hence human error should be recognized as an outcome of
combined factors). This requires addressing through a correction and a preventative action,
aimed at seeking avoidance of the error in the future (6). The IVT Network have a useful
‘Voices In Validation’ featuring James Vesper, which takes an in-depth look into root cause
analysis (7).
Techniques like the iterative questioning approach – the 5-Whys – can help to unpick the
underlying reasons for employee errors and crystalize what needs to be done to correct the
triggers for errors. For example (8):
•
•
•
•
•
•
•
•
•
•
Human Error?
Accidental – why?
Application of a bad practice for the right reason- why?
Wrong tool/ equipment-why?
Improvisation in unfamiliar circumstances-why?
Omitting, forgetting or losing place-why?
Distracted at a critical point-why?
Incorrect assumption or perception-why?
Common practice not to follow procedure for that step-why?
Lack of appreciation on importance of following procedure-why?
This approach alone may lead to changes, or it might be that a more detailed error risk
reduction approach is required.
In terms of making changes, examples include:
•
•
•
•
•
•
Improved change management
Review of training
The inclusion of refresher training
Intruding employee mentoring systems
Ensuring procedures are in place to handle complex situations
Putting in place the supervision of key activities
Error risk reduction
Human error is a persistent challenge even for companies with successful continuous
improvement procedures. Even experienced people working with established processes can
make occasional errors, and such errors can be costly. Typical responses to human errors
include retraining; increasing the number of checks or sign offs required; or even the issuing
of warnings to staff. These generally produce disappointing results because they do not
address the underlying causes of the errors (9).
Time spent on error risk reduction allows an organization to (10):
•
•
•
Identify the causes of error in an organization’s operations,
Provide managers with the necessary tools for preparation and understanding of
outcomes,
Provide the organization with the tools necessary to implement and sustain continuous
error risk reduction improvements.
Most approaches to human error are qualitative; however, a quantifiable approach can be
used. Here this can take the form of (11):
Human error probability (HEP) = Number of times an error has occurred / Number of
opportunities for an error to occur
The case study in this paper is qualitative. With this, the approach is:
1. Identify the human failures that could be made in the task which might lead to an
incident and the performance influencing factors that make those failures more or less
likely to occur.
2. Identify appropriate control measures which prevent or mitigate the human failures
that have been identified.
3. Where possible aim to design out the potential for human failure and design in the
potential for recovery should human failure occur. This includes design of the plant,
system, environment and task, taking into account the needs and capabilities of users.
Reliance on procedures and training are unlikely to be sufficient. Change the
‘performance-shaping factors’ (PSFs).
4. Check the control measures work. Regularly review your risk assessment to see if any
further improvements can be made. The use ergonomics/ engineering judgment and
redesign is useful.
Such analysis can reveal subtleties like more errors occurring close to the end of a shift of at
the changeover of shifts. Improvement measures can include finding better ways to
communicate between staff leaving at the end of their shift and with new staff joining at the
start of a new shift. From a different standpoint, it could be that the analysis of operations
reveals that certain operations are best executed using two, and that using two operators in
place of one is necessary as an error prevention mechanism.
With procedures, improving procedures is an iterative process and there is a balance to be
struck between sufficient detail and straightforward, easy-to-follow instructions, and with the
linking procedures to effective training. According to Gallant, it is useful to ask (12):
•
•
•
•
•
Did the procedure specifically require the step to be performed?
Does the procedure reflect the actual process?
Can the process really be executed by the number of personnel described?
Did the procedure describe how the step should be performed?
Do the procedure and the way the operation is being performed match?
In considering the process or procedure, it is important to consider the environmental context.
Is the environment suitable for a person to concentrate in, or do special measures need to be
taken to enable a person to concentrate? Influencing factors here could be excessive noise, or
areas that are too hot or too cold. Everyday complex and stressful real-life situations can
overwhelm the human brain leading to distraction or a failure to able to accurately evaluate
the situation and persists in irrational actions or strategies.
Preventative actions need to be appropriate, based on some form of error classification. For
instance, training and competency can be an effective prevention and mitigation control for
mistakes made while planning an action (that is some form of knowledge-based or rule-based
mistake). Running simulations, as an example, can help to improve training and to reduce
error rates (13). However, this form of preventative measure is generally less effective for
skill-based errors of the type that occur during action execution (such as slips of action or
memory lapses).
To identify the relative risks of potential errors, some form of systematic approach is
required. One such approach is based on human factors.
Human factors approach
The approach taken to human factors in risk assessment should be proportionate to hazards
that the organization faces. For most industries a qualitative approach will be sufficient for
this type of analysis (14).
Human factors derives from the problems of designing equipment operable by humans during
World War II. The types of ‘human failures’ or ‘human factors’ that can lead to error include
(the list is not exhaustive):
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Impatience
Limited memory
Limited concentration
Changes in mood
The need for motivation
Prejudices
Fears
Misjudgment
Near-sightedness
Color-blindness
Distraction
The ability only to perform a limited number of concurrent tasks
Short-term memory, which works differently than long-term memory
Appreciating all users are all different
Thinking in terms of ideas composed of words, numbers, multimedia, and intuitions.
Fatigue
The need to both see and hear to fully understand
Avoiding presenting information in more than sets of threes
The need for complex information to be presented hierarchically
Requiring practice to become good at doing things
Resistance to change
Concern that a person could be physically harmed by some tasks
People often prefer to learn by doing than by explanation
Missing details when tasks are memorized and performed cursorily
Can be affected by socio/political climate.
Constrained by time
Require tasks to be modularized in order to work in groups
Associating unrelated things
Systems, process, procedures, training, environmental context and so on each need to be
considered to address those factors appropriate to a given situation and hence may be
connected to the chance of error. Of course, this is not inferring that some element of
personal discipline is not required (15).
Once steps 1 to 4 have been followed, the final task is to reassess the system risk level and
iterate until the risk is acceptable. This concerns ‘error risk reduction’.
Error risk reduction
Error risk reduction is sometimes used as part of a wider ‘human reliability assessment’,
which embraces:
•
•
•
Human error identification – to identify what errors can occur,
Human error quantification – to say how likely the errors are,
Human error reduction – to improve human reliability.
Underpinning error risk reduction is the presumption that human failure is normal and
predictable and hence it can be identified and managed. This means that the pharmaceutical
and healthcare sectors should tackle error reduction in a structured and proactive way. This
means identifying poorly designed activities might be prone to a combination of errors.
Perhaps the best way to do this is to involve workers in the design of tasks and procedures.
Whilst a proactive approach is best, there will also be circumstances where a reactive
approach is required to investigate an error and to identify the root cause so that a corrective
action can be set (16). Such incident investigations should seek to identify why individuals
have failed rather than stopping at ‘operator error’.
Making changes such as introducing labelling and color coding; ensuring any distractions are
removed so that the employee can undertake complex work tasks; and considering where an
automatic device can be used which makes it impossible for an error to occur, represent the
types of changes that can be implemented from error risk reduction exercises.
Human reliability assessment can be used to integrate ‘human factors’, like human error, into
risk assessments. The assessment of human factors differs slightly to classic approaches to
risk assessment, as shown in Table 1.
Human Factors Approach
Task analysis
Human error identification
Error representation
Human error quantification
Human error reduction
Risk Assessment
System analysis
Hazard identification
Risk modeling
Risk assessment
Risk reduction
Table 1: Differences between the human factors approach and the standard approach to risk
assessments.
What error risk reduction should avoid is concluding the following:
•
•
•
•
•
Treat operators as if they are superhuman.
Assume that an operator will always be present, be able to detect a problem and
immediately take appropriate action.
Rely on operators being well-trained, when it is not clear how the training provided
relates to prevention or control.
Rely on training to effectively tackle slips/lapses.
State that operators are highly motivated and thus not prone to unintentional failures
or deliberate violations.
•
•
•
Ignore the human component completely and failing to discuss human performance at
all in risk assessments.
Inappropriately apply techniques, such as detailing every task on site and therefore
losing sight of targeting resources where they will be most effective.
In quantitative risk assessment, provide precise probabilities of human failure (usually
indicating very low chance of failure) without documenting assumptions/data sources.
This is because such conclusions will not result in the error being addressed and the mistake
or slip could reoccur.
Building a focused workplace culture
The workplace culture and influence how well an organization operates and how a employee
is feeling. The totality of employee beliefs, values, unwritten rule, are influencing factors
upon employee behavior. When these factors are out of synchronicity, they can create
conditions whereby errors are more likely.
Central to the appropriate culture is strong communication. Often messages need to be
delivered in different forms and at different times. Moreover, there can be a benefit in
repeating and confirming instructions to create clarity and to avoid confusion.
Using human factors for preventative actions
Once analysis has taken place, the proactive approach is to identify different error types and
consider how they can be addressed. A genetic example is as per Table 2 (17):
Table 2: Classification of errors
Type of error Eliminate
/ Action
Mistake
Competency
assurance
Slip
Memory lapse
Prevent
Communication
conventions
Reduce
Software
interface
logic
and layout
Design for tactile Confirm action Error
differentiation
prompt
management
training
Checklist
Independent
Alert/Alarm
check
system
Mitigate
Automate
process
the
Automate
process
the
Automate
process
the
Case study #1
With this case study, of material found inside the device for holding, sterilizing and
transferring stoppers, the organization had six hopper devices. Following use, the hoppers are
sent for cleaning and preparation by personnel in the technical services department. For this,
the hopper is taken from an interlock area that separates technical services from the aseptic
filling area (a transfer from an ISO class 7 to an ISO class 8 cleanroom [operational states]).
Once in the technical services area two filters, stainless clamps, triclover seals, stainless ‘T’
piece and tray are removed from each hopper. The hopper and components are then
manually rinsed using Water for Injection Bulk (WFI). The components are placed in the
hopper and dried inside a drying oven. This is shown in figures 1 and 2.
Figure 1: After cleaning the components are left in the hopper during drying.
Figure 2: The hopper tray is washed and placed back into the hopper during drying.
The investigation into how the error occurred was subject to an analysis of Risk Influencing
Factors. Such an analysis is integral to the Error Risk Reduction Process. The exercise
identified the following:
Process Risk Influencing Factors
a) There was no formal process in place for the stripping of the hopper and for the
washing and drying of the components. This meant that an informal process was used.
Therefore, process reliability and consistency of application was not assured.
b) Individuals used their own sequence. This was shown to cause ambiguity, especially
if task is handed over between staff during shift change-overs.
c) The process was not standardized. Here individuals were adapting the basic method in
order to achieve the required outcome in their own way. The exact characteristics of
outcome and confidence in consistency were shown to depend upon who executes the
task.
d) There was also a danger of people working on ‘autopilot’ when the task became
‘second nature’. The consequence of this was that minimum monitoring fails to detect
something wrong unless it conflicts strongly with what is expected.
Information Risk Influencing Factors
a) It was discovered that there was an inappropriate level of detail in documentation.
This meant that too little information led to assumptions were being used to fill gaps.
b) The instruction was not visible in workplace, resulting in dependence on memory.
c) Which staff carry out which function was not specified meaning that some actions
were not taken by anyone.
The obvious corrections here were to add appropriate level of detail to the relevant batch
processing record and to the Standard Operating Procedure. Supervisors needed to ensure that
instructions were visible. Importantly, clear documented instructions decrease dependence
on memory.
Resource Risk Influencing Factors
a) It was noted that processes with differing requirements share a nearby workspace.
This was found to increase risk factors arising on one process to be imposed on
others. Distracting factors included noise and concentration. Sounds can lead to
interruption or distraction from task.
The correction here was to limit the number of different processes sharing the same
workspace and to organize individual tasks to limit the risk of one process being imposed on
another. Task segregation was used to achieve this.
Competence Risk Influencing Factors
a) It was found that staff training did not cover all aspects of processes, therefore,
increasing risk of error.
b) Competence on some tasks was assumed to extend to all others meaning that specific
competence deficits were not identified or addressed.
c) There was no specific training for individual tasks. Instead it was assumed that staff
only needed ‘common sense’.
d) There was also a degree of complacency among some personnel, with experienced
staff seeing the job as very routine with only a low perceived risk.
To address these, deficiencies in competence were assessed and specific training, for each
individual task, associated with the cleaning, preparation and autoclaving of the hopper was
implemented. Supervisors also re-enforced the need for a visual check of the hopper to
address specific competence deficit.
Good Practice Risk Influencing Factors
Upon review, some examples of best practice were found to be with the implementation of a
formal process to ensure that the hopper is checked before autoclaving. The previous practice
was that the checking of the hopper, to ensure it is empty, was not formalized. It was agreed
that it was necessary to reinforce the importance of a visual check. A revised procedure was
required to ensure that the process steps were consistent, including documented evidence of a
check taking place. This had the added benefit of preventing ambiguity if the task is handed
over.
Supervisors also undertook to ensure all team members are informed of the implications of
performing the task incorrectly.
Overall review
At the end of the error risk reduction exercise, the following measures were put into place:
1. A separate hopper tray and components from hopper prior to going into the oven were
put into practice. Designated drying ovens to dry the hopper tray and components
were used. This ensured that no hopper ‘parts’ were left in the hopper during the
drying process.
2. Stainless steel storage baskets were purchased to store hopper tray and components in.
These were labeled to identify the components from each individual hopper.
3. Permanently labeling the tray, clamps and T piece. These were labeled with the
hopper number. Therefore, assigning the parts to an individual hopper.
4. Adding an operator check on batch record. This included the requirement for a visual
check to ensure the hopper is empty of components prior to going into the autoclave.
5. An update the appropriate Standard Operating Procedure to inform the operator to
visually check the hopper before it enters the autoclave.
6. The retraining of all Personnel in the area to ensure the new procedure is followed.
Reinforce the importance of visually checking the hopper prior to sterilization.
With training, often a different approach needs to be taken as simply running the same
training may not be effective (on the basis of ‘why didn’t it work the first time?’). Drawing
on Gallant again, an effective review of training procedures should involve posting the
following questions:
•
•
•
•
•
Did the training reflect the procedure content – and are all operators performing the
task doing it the same way?
Was it the operator’s first time performing the task independently? Were they allowed
enough practice on the task, or was training rushed? Was training time used for
appropriate training activities?
Did the trainer verify the operator’s ability to perform each required element of the
task? Against what standard?
Is all the information the trainee needs to perform the task correctly accessible to
them?
Did the trainer teach them the correct way to do the task? Did the trainer have the
knowledge and skills required to teach it?
Case Study #2
The second case study considers pharmaceutical batch records. As a pharmaceutical product
is manufactured, information relating to the batch manufacturing activity needs to be
recorded. It is essential that everything is either written down or digitally captured, to enable
the person tasked with batch release to undertake their duties in a compliant manner. Batch
documentation needs to be reviewed at key steps to confirm, for example, compliance with
GMP, procedures, specifications and licenses. This can be carried out in conjunction with
Quality by design approaches, in relation to equipment and workspace optimization (18);
process can also be designed so they are more continuous and less error-prone (19). In
addition, space should be provided in the documentation to record any comments required to
be brought to the attention of the reviewing manager. When comments are necessary, this
should include information like:
•
•
•
•
The nature of the issue.
The reason it is or is not considered a concern.
Reference to any deviation report (which must describe corrective action taken).
Any preventive action taken or planned.
Each review stage should be signed by the reviewer and dated. If errors or omissions are
found, then the record must be completed and/or corrected by the relevant staff members. At
the end of the last process stage/test, or as soon as practically possible, a supervisor or
manager should review the record for at least the following:
•
•
•
•
•
•
•
Completion (that the process/test was satisfactorily completed and all required entries
present) and accuracy (batch numbers and dates, etc. are correct).
Compliance to procedure, specification and GMP.
That critical parameters have been met (e.g. sterilizer charts).
That any critical data such as weights or calculations are appropriately supported.
(e.g. checked by second operator).
Ensure any unexpected results, yields or reject material, any deviations, adverse
results investigation, reconciliations and any other notes must be put to file.
Review the record for any other entries and details as appropriate (e.g. expiry dates).
All relevant information has been commented on the relevant page of the batch
record.
The supervisor or manager should sign and date each record pertaining to separate process
stages. Where errors are recorded these should be trended and addressed. The reasons for
errors, especially human error, should form part of training program for personnel. Errorproofing ways of structuring and writing knowledge documents, procedures, batch records, as
well as practices for structuring, conducting, and documenting training to assure competence,
are each useful activities. It can be hopeful if organizations shift form the common 'training
for compliance' paradigm to a 'training for competence' paradigm, since training for
competence focus is more likely to achieve GMP compliance (20).
A focus on well-designed batch records as so to minimize errors and instigating regular
checks and ensuring that deviations and out-of-specification incidences have been carefully
examined, represent important steps for making the batch review process more robust and for
consequentially making recalls that could have been prevented due to issues with batch
release procedures less likely. Potentially a move away from traditional paper records to
electronic records allows pharmaceutical manufacturers to more easily review data and
provides a higher level of data security. Nonetheless, electronic data can also present
problems in terms of control, security and safety, and careful attention needs to be paid to the
design phase.
Summary
Human error is probably unavoidable; however, it can be reduced down to an acceptable
level and the impact of the error minimized. This can only be achieved through an analysis of
systems and work processes. Such an analysis can be (ideally) proactive or reactive (as in the
case studies presented). There are different approaches to error analysis, and these will have
their own merits and disadvantages. An approach based on human factors has been presented
here, but it is far from the only method.
This paper has explored how seemingly straightforward error risk reduction approaches can
help address human error related issues. This was through a general description of the
approach to error risk reduction and through a case study involving a stopper holding device.
The case study illustrates the dangers that can arise when people become complacent and
where operations are based on experience or head knowledge. The primary corrective action
was with producing clear instructions and in briefing staff.
Error risk reduction can be approached in different ways and it is very much situation
dependent, although the general approach outlined in this paper provides a useful framework
to adopt.
References
1. Taylor, J.T. (2015) Human Error in Process Plant Design and Operations: A
Practitioner’s Guide, CRC Press: Boca Raton, pp281–286
2. Reason, J. (2000) Human error: models and management, BMJ 320 doi:
https://doi.org/10.1136/bmj.320.7237.768
3. Hollnagel, E. (1993). Human reliability analysis: Context and control. Academic
Press, USA
4. Norman, D. (2013). The design of everyday things: Revised and expanded edition.
Basic books, USA
5. Cooke J.A., McMahon C.A., North M.R. (2003) Sources of Error in the Design
Process. In: Gogu G., Coutellier D., Chedmail P., Ray P. (eds) Recent Advances in
Integrated Design and Manufacturing in Mechanical Engineering. Springer,
Dordrecht
6. Khoja SS, Khoja S, Khoja FS, Khoja S, Pirani N (2017) Impact and management tool
for identification and reduction of human Errors in pharmaceuticals Industry;
PharmaTutor; 5(2); 7-13
7. Voices in Validation podcast (2020) Addressing the Root Cause, Not the Symptoms:
Root
Cause
Investigations
for
CAPA,
IVT
Network:
https://www.ivtnetwork.com/article/addressing-root-cause-not-symptoms-root-causeinvestigations-capa
8. Serrat, Olivier (2017). "The Five Whys Technique". Knowledge Solutions. pp. 307–
310. doi:10.1007/978-981-10-0983-9_32
9. David, B.A., Rodriguez, A. and Marks, S.W. (2008) Risk Reduction and Systematic
Error Management: Standardization of the Pediatric Chemotherapy Process. In
Henriksen K., Battles, J.B., Keyes, M.A., and Grady, M.L. (Eds.) Advances in Patient
Safety: New Directions and Alternative Approaches (Vol. 2: Culture and Redesign).
Rockville (MD): Agency for Healthcare Research and Quality (US), pp1-10
10. Kim G, Chen A, Arceci R, et al. (2006) Error reduction in pediatric chemotherapy.
Arch Pediatr Adolesc Med.;160: 495–498
11. Kirwan, B. (1996) The validation of three human reliability quantification techniques
- THERP, HEART, JHEDI: Part I -- technique descriptions and validation issues.
Applied Ergonomics. 27(6) 359-373
12. Gallant, J. (2014) Human Error Is The Leading Cause Of GMP Deviations – Or Is It?,
Pharmaceutical Online, at: https://www.pharmaceuticalonline.com/doc/human-erroris-the-leading-cause-of-gmp-deviations-or-is-it-0001
13. Mecugni Daniela, Turroni Elena Casadei, Doro Lucia, Franceschini Lorenza, Lusetti
Simona, Gradellini Cinzia, Amaducci Giovanna (2021) The Use of Simulation for
Teaching Therapy Management: An Observational Descriptive Study on 2nd and 3rd
Year Students of the Nursing Degree Course of Reggio Emilia, Methodologies and
Intelligent Systems for Technology Enhanced Learning, 10th International
Conference. Workshops, 10.1007/978-3-030-52287-2_13, (127-137)
14. Sanders, M. and McCormick, E. (1987) Human Factors In Engineering and Design
7th Edition, McGraw-Hill Education, USA
15. Marx D. (1997) Discipline: Why Process Is More Important than Outcome. Ground
Effects 2(5):2-6
16. Fantin, I. (2014). Applied Problem Solving: Method, Applications, Root Causes,
Countermeasures, Poka-Yoke and A3. Milan, Italy: Createspace, an Amazon
company
17. NOPSEMA (2020) Human error risk reduction to
ALARP
at:
https://www.nopsema.gov.au/assets/Information-papers/A424182.pdf
18. Djuris, J. and Djuric, Z. (2017) Modeling in the quality by design environment:
Regulatory requirements and recommendations for design space and control strategy
appointment, International Journal of Pharmaceutics, 10.1016/j.ijpharm.2017.05.070,
533, 2: 346-356
19. Capozzi, L. C., Trout, B. L. and Pisano, R. (2019) From Batch to Continuous: FreezeDrying of Suspended Vials for Pharmaceuticals in Unit-Doses. Industrial &
Engineering Chemistry Research, 58 (4): 1635-1649
20. Bodmann, K.; Reinhard, C.; Mödler, M.; Tinson, K.; and Johnson, M. (2016) Lonza
Error Prevention System (EPS) – Changing Human Performance in Pharmaceutical
Operations, CHIMIA International Journal for Chemistry, 70 (9): 610-615
View publication stats