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The Application of ‘LEAN’ Methodologies in a Sterile Service
Department
Melanie Davies, Head of Medical Devices and Sterile Services,
Harrogate and District NHS Foundation Trust
An article recently published indicated that ‘Hospitals in England have run up a record deficit
of £2.45bn – the biggest overspend in its history – as it struggles to cope with a surge in
demand for care while suffering a major budget squeeze’. (The Guardian May 2016).
The official figures released by NHS improvement demonstrated that NHS Trusts ended the
2015-2016 financial year £461m worse off than what had been originally forecast. This major
overspend threatens already stretched hospitals further for this year’s financial planning. For
those of us that are budget holders, it requires us to be innovative and creative in making
further financial savings on our annual budgets to try to support the £700m gap.
Having spent many years working with suppliers to reduce costs in Sterile Services on
products by pooling resources and researching our field for different suppliers, we got to a
point whereby we felt if we changed anything else in our preferred suppliers and
manufacturing process we could potentially be at risk of compromising the quality of our
sterile products, which ultimately can affect patient safety – obviously this must be avoided.
A concern we reflected on at this juncture was: ‘when does quantity outweigh quality’ and
does this meet the ‘actual’ expectation of the patient? Reflecting on the NHS Constitution
(July 2015), the Care Quality Commissions (CQC) fundamental standards (November 2014)
and the Francis Report (February 2013) along with the NHS’s values which are integral to
‘creating a culture where patients come first in everything the NHS does’. It was important to
cogitate and deliberate as part of this LEAN implementation project; ‘Do we need to create a
LEAN quality culture or just quality champions in the NHS? Our perspective is we should be
encouraging both as an actual minimum to ensure our sterile and decontamination services
meet the expectations of both stakeholders and the patients whom we treat without
compromising quality but by being as process and financially efficient as we can be.
As part of a post graduate clinical leadership programme, I was introduced to the philosophy
of Taiichi Ohno, a Japanese industrial engineer and businessman (1912-1990), the Toyota
Production System (TPS) and the elimination of all waste by understanding the concept of
where you have variation you also have waste too (figure 1). The TPS is based on the Just-
In-Time (JIT) concept and the elimination of excessive inventory and extra processing steps.
Within the Sterile Services Department (SSD) at Harrogate and District NHS Foundation
Trust (HDFT) we refer to these as ‘technical touch points’. By reducing defective products
(corrective and preventative action) and ‘technical touch points’ in the production and
manufacturing environment, SSD is in essence a lean production facility as it does in
principle already follow an assembly line methodology akin to the decontamination life cycle.
(Figure 1 – History of the Toyota Production System)
TPS is described as a ‘pull’ method to meet recognised demands, ‘Kaizenworld’ describes a
true ‘pull system’ as ‘a system where we stop pushing orders through a system based on
inaccurate forecasts and instead couple the system to the customer and focus on the value
stream’.
By using creativity, data and innovative imagination we have been able to successfully apply
these theories, principles and concepts. ‘Data is of course important in manufacturing, but I
place the greatest emphasis on facts’ (Taiichi Ohno). They are now a fundamental part of
our whole departmental philosophy across the unabridged team within the SSD at HDFT
along with the integrated quality management systems (QMS), comprehensive work
instructions and technical file. These all have a very clear quality and LEAN focus on
continuous improvement, measuring and monitoring, standard working and risk
management.
We firmly believe it’s not about the quantity of devices manufactured to meet customer
demand, as more products that are ‘pushed’ the risk of mistakes being made increases
(Jidoka). When assessed, the actual risk profile, likelihood and consequence increases with
more problems in the manufacturing process, along with other wastes, such as technical and
human factor based risks which are all essentially wastes too. Eliminating these wastes
(Muda) can be achieved by introducing a true manufacturing ‘pull system’ that is production
levelled (Heijunka) against predetermined set objectives with our services users, supported
by comprehensive work instructions and a thorough QMS with a ‘quality over quantity’ mind-
set in the whole HDFT SSD team. We try to get it right the first time – every time.
‘Make your workplace into a showcase that can be understood by everyone at a glance. In
terms of quality, it means to make the defects immediately apparent. In terms of quantity, it
means that progress or delay, measured against the plan, and is made immediately
apparent. When this is done, problems can be discovered immediately, and everyone can
initiate improvement plans’ (Taiichi Ohno).
1913
First moving
assembly line
made by Ford
Motor Company
World's first automatic loom
with a non-stop shuttle-change
motion, the Type-G Toyoda
Automatic Loom developed by
Sakichi Toyoda. Jidoka –
automation with a human
touch – was conceived
1927
Introduction of a flow
production method using a
chain conveyor into the
assembly line of a textile plant
by Kiichiro Toyoda
1937
Flow production method using
a chain conveyor method into
the body production line
introduced at Toyota Motor
Co., Ltd.'s Koromo Plant by
Kiichiro Toyoda
1924 1950
Eiji Toyoda visited the US to
study Ford’s production
methods, which helped him
implement Just-in-Time
methods
1956
Taiichi Ohno visited US
auto plants and
supermarkets, where he
conceived KANBAN
1949
Taiichi Ohno experimented
with setting up equipment to
produce items in a timely
manner. After visits to the US,
he created Just-in-Time
framework
1978
Taiichi Ohno wrote the
book Toyota Production
System: Beyond Large
Scale Production
1987
John Krafick proposes that
‘Lean’ be used as the label
for the combination of
methods established at
Toyota
1988
Taiichi Ohno’s book
translated into English
Information found in Volume 5, Number 5 of iSixSigma Magazine
Having developed simple processes with reduced ‘technical touch points’ and minimising the
processing of excessive inventory, by only using the resources actually required for the safe
reprocessing of medical devices which only contribute to a value added quality process. We
are confident these value adding activities collectively convert all medical devices into a
quality product that meets the needs of our service user and the patient.
In 2012 we processed around 9,000 sterile medical devices in either tray or supplementary
peel packed format each month. When we became an integrated provider of additional
community services this increased to 24,000 each month. Restricted with the same footprint
and equipment, this is when we started to really embed the LEAN methodologies and think
differently and creatively. By following the philosophy of the TPS and Taiichi Ohno’s 7
wastes principle we were successful in this new service transition and increased the
manufacturing of sterile medical devices by 166%.
To date, by following the LEAN methodology and the Taiichi Ohno principle of ‘waste
reduction,’ coupled with the use of integrated paper light systems and internally designed,
bespoke data-capture programs, we find ourselves in a position by which we can analyse for
quality purposes and service improvements and developments, further promoting the LEAN
methodologies. We are confident that we continue to provide a first class and financially
efficient quality service. The department now processes approximately 2,259,336 individual
medical devices annually and on average 99.8% of these reach our patients ‘safe for their
intend use.’ Optimal patient value is at the centre of what we deliver and we are continually
striving through continuous improvement and our philosophy of achieving perfection.
When addressed, the concepts of the ‘LEAN Production House’ (figure 2) can be likened to
many aspects of the contents of the ISO13485 and ISO 9001 standards and can be
transacted. We found it useful to think of them as part of this philosophy and use our
enthusiasm to embed this thinking and approach into our department and for it to become
ingrained in the team culture on the Genba or Gemba – (‘The real place, the place where the
actual work is done’: Now adapted in management terminology to mean the ‘workplace’ or
the place where value is added). In manufacturing, it usually refers to the shop floor (The
official blog of Toyota GB). So in SSD, this would refer to the wash area, the inspection and
packing room, etc.
(Figure 2 - Adapted from Ohno 1988)
Taiichi Ohno was the creator of the ‘7 Wastes’ principle (figure 3) often acronymically refined
as TIMWOOD. Muda is the Japanese word meaning "futility; uselessness; wastefulness"
(Toyota Production System, 1988) and is a concept we addressed when reviewing the nine
stages of the decontamination life cycle. From start to finish we asked at each technical
touch point ‘what value does this add to the sterile and decontamination processes and the
end sterile product?’ We questioned if the service was picking up extra financial and storage
costs and was overproducing medical devices. Was increasing mistakes and machine
failures contributing to our Muda? Eliminating waste and inventory – a non-value added
process is one of the main principles of ‘Just in Time’ and ‘pull’ systems – it is so important in
fact, that it has its own pillar as part of the Lean Production House (figure 2). We also found
the simple but effective ‘5 whys’ processes helped to support the process. “Ask ‘why’ five
times about every matter” (Taiichi Ohno). If a process or ‘technical touch point’ was found to
have no critical added value to the end product then the process, resource or ‘technical
touch point’ was revaluated or removed.
Standardisation was then optimised by keeping things simple and by reducing several areas
of variation. Reducing wastes in SSDs seems simple but when interrogated closely the
results are shocking, even in a service that is already perceived as efficient. Reducing the
Muda seems simple but it is true and really worked for us.
(Figure 3 – 7 w astes: Tim Wood Acronym, Sterile Services HDFT)
1. Transporting: moving products that are not actually required to perform the
processing
2. Inventory: All components and raw materials that are work in progress of finished
goods does not have value added to the end product
3. Motion: people or equipment moving or walking more than is required to perform the
processing
4. Waiting: Whenever goods are not moving or being processed or waiting for the next
step, the waste of waiting occurs
5. Over Processing: resulting from poor tool or product design creating activity
therefore adding excess value
6. Over Production: to make too much, to produce sooner, faster or in greater
quantities than the customer demand
7. Defects: The effort involved in inspecting for and fixing defects
You could argue that there is an 8th
waste: the actual knowledge and skills to do the job in
hand. Respect in humanity and the knowledge of others is fundamental and investment and
time in training and assessing technical competence are paramount. The success in
individual roles is key; it’s our standard approach that technicians at HDFT are trained in all
areas to optimise and support the process flow and product levelling process. By having all
staff trained in all areas supports good ‘human jidoka’ and ‘standardised work’ which
ultimately supports a secure quality focus. Several of our technicians are trained Lean Six
Sigma green and yellow belts too.
As part of the decontamination lifecycle and our service we commenced mapping against
the cycle, highlighting which processes added value and which didn’t. We also used the
data we had been collating for several years to support this through effective use of that data
along with other metrics too.
Evidence already collated through the DMAIC, Define and Measure phases (100% Effective,
2013) already indicated that service users and staff were disgruntled by turnaround times
and availability of equipment to meet the capacity that is expected. Where possible, our aim
was for the best proactive levels of service and technical compliance at all echelons in SSD,
supported by the provision of real time quantitative data, a key aspect of the evaluation
process. This data was captured from routine information such as total productivity or
analysis at ‘critical test points of the process map’ (100% Effective, 2013).
Morgan and Brenig-Jones (2009) confirm that ‘managing by fact is one of the key Lean Six
Sigma Principles,’ therefore when transposed, any ‘Lean’ process owner, project lead or
Kaizen Officer should view data collection as a process that needs managing and continual
improvement to work in conjunction with the QMS. These statistics should be of variable
quality from varying sources and should capture both quantitative and qualitative data as
suggested by the NHS Institute for Innovation and Improvement (2007) when deciding what,
when and how to evaluate to meet the desired outcomes and improvement strategies.
So when we addressed our Muda in SSD whilst following the decontamination lifecycle and
process through from start to finish we were able to identify many areas of waste. Some
examples were:
 The use of soaker sheets, which once reviewed was discovered to be a historical
practice and upon testing were no longer required, so this did not only save time in
the manufacturing process and a reduction in several ‘technical touch points’, but on
ordering and stock control with added financial benefits too
 Reviewing the instruments in tray sets and rationalisation, including the removal of
unused suctions which held up processes in the wash area due to their cannulation.
We really pushed the concept of one piece flow through the stages of the
decontamination cycle – so reduced what was added or dealt with as part of the
sterile pack – this also included consumables
 We have removed all elements of manual cleaning – we have state of the art washer
disinfectors that should be doing this
 The continual unnecessary reprocessing of limited use medical devices such as
fingerswitch hand pieces, not used yet still deducted due to autoclaving. These have
since been removed and are now purchased as a single use medical device again
offering increased financial gain and reduction in technical touch points
 Adding consumable items to tray sets is a process we have removed, resulting in
‘true’ one piece flow
 We no longer add an autoclave batch label to sterile packs post sterilisation. It was
identified that the batch label added no value to the sterile pack other than an
additional indicator that it had been through a sterilisation process. The tray tracking
and processing data is retained through the medical device barcode and electronic
tracking and traceability system. The autoclave tape is a type 1 process indicator
(ISO11140-1:2005) which supports product release processes. However as part of
this process review we were able to change our current tray label to one that was
also a type 1 process indicator (ISO11140-1:2005) which added increased control to
the product release process. By reviewing this simple process and asking why (5
times), we considered: ‘why do we add a batch label? What does it tell us? How else
can that be delivered? What else is available?,’ we have not only saved financially
but the technical time taken to batch approximately 100,000 sterile medical devices
each year has since been reinvested elsewhere in our services
 We now peel pack small trays instead of wrapping them and still conform to
ISO11607. This had a financial impact and technical time saving. By working with our
service users - which can be challenging – the persistence did pay off
 We no longer add checklists to our community services standard podiatry trays. We
adapted the instrument tray label specifically for these sets which now serves the
same purpose
 We developed a ‘Just in Time’ stock room – whereby we reviewed annual usage
figures of raw materials and by working with our suppliers were able to set up weekly
or monthly standing orders and deliveries which meet the needs of our services. We
also developed an in house stock program/module (Kanban). Usually to buy systems
like this for this purpose can cost £1000s.
By strategically planning the SSD skill mix of the whole team to support my long term
strategy and vision over the years, we now have the skills in the department which support
us to develop our own databases - bespoke to our specific needs (figure 4).
(Figure 4 – Bespoke Stock Module, develop by SSD)
These are just some examples of the many opportunities we have come across when we
really interrogated our process. This culture remains to date; an ethos we work alongside
continually looking for improvements (Kaizen) which are also intrinsically linked to the
release of the new suite of Health Technical Memorandums (HTM) 01-01 (part a-e) by the
Department of Health (July 2016). It is noted that Sterile Services need to continuously
improve outcomes in terms of:
 patient safety
 clinical effectiveness
 patient experience
In addition, these HTMs put significant onus on best practice and that we should ‘aim to
further minimise risks to patients; deliver better patient outcomes; promote and encourage
innovation and choice; and achieve cost efficiencies.’
We then started to explore other areas not directly involved in the production process which
had little or no added value. A good example is our staff meetings. We sought staff opinion
(Nemawashi) on the effectiveness and value that staff got from the meetings in relation to
time lost off the shop floor (Genba). It became quite clear technicians were more concerned
about the build-up on the department and the strain this put on our services which did not
fully support a true ‘pull system’. We evaluated the data we had already been collecting
which included a calculation on how much it actually cost the service to have a staff meeting
and how much technical and management time this took away from our service and what
value this added. To summarise:
In 2015 we had 24 unit meetings. With office staff, attendance was 463 for the year, an
average of 19 attendees per meeting at an overall cost of £3,513.12. When this was
translated technically, overall 5599.93 hours of technical time was used up in unit meetings.
This was the equivalent of 335,995 community service trays (at a minute per tray) and
67,299 half-DIN trays (at 5 minutes each). This was Muda that had to be addressed. Team
communication is a fundamental prerequisite of effective team work and the last thing we
wanted was – if challenged - a member of our team saying ‘we don’t have team meetings,’
for example when responding to a staff survey or when being questioned by the CQC.
Because we had waste which needed to be addressed, we developed the ‘SSD Hub’ (figure
5) a program developed to support staff communication along with our communication
strategy, (figure 6) both internally and externally to the department.
(Figure 5 - Bespoke ‘Blog’, developed by SSD)
‘Costs do not exist to be calculated. Costs exist to be reduced’ (Taiichi Ohno)
(Figure 6 – SSD Communication Strategy)
The SSD Hub has since been exploited (obviously complying to the Data Protection Act
1998) to include information around sickness and attendance management, appraisal due
dates, staff personal details and a very comprehensive training matrix – again all supporting
LEAN and paper light processes.
We also developed DAD (figure 7) – a Decontamination Analysis Database, not only to
comply with ISO13485 but to record Jidoka and support Poka-Yoka (figure 10).
(Figure 7 – DAD, bespoke database, developed by SSD)
Kaizenworld describes Jidoka as ‘a device that will stop a process if an error (defective part)
occurs. It supports the principle of one-piece flow in that no faulty part is passed to the next
process and errors are resolved at source and in a timely manner. All evidence of the
creation of the fault is maintained so that it can be eliminated forever because the process is
evaluated and changed to remove the possibility of making the same mistake again,’ so
when likened to SSD this is a system that once fully developed supports this. We have since
developed a ‘Compliance Technician’ whose main role is the management of DAD. This
person is responsible for recording all service non-conformities and technical errors (such as
missing instruments). Other staff are expected to contribute to this (Hansei) in the form of a
Technical Information Notices (TIN) and the completion of action plans when the set
benchmark for nonconformity has been exceeded. The benchmark was established after
reviewing months of technical productivity and non-compliance data to devise a statistical
based figure.
To support Jidoka and Kaizen further we use these non-conformity figures to make
improvements to our service to prevent reoccurrence. Monthly RCA occurrence in
predetermined areas of risk and a monthly report is established and circulated not only to the
team but to all service users along with a summary of technical and service errors. We have
made every effort to be open, transparent and honest about our service and technical ability
and to also evidence the effort we make to support continual improvements for patient
safety.
All our data and team productivity is collated and managed through the ‘SSD Compliance
and Assurance’ dashboard (figure 8) used to communicate our service performance to
service users and directors within HDFT. This includes ‘heat maps’ around product non-
conformance (Jidoka) and ‘production levelling’ data mapped against actual capacity.
(Figure 8 – SSD Compliance and Assurance Dashboard)
As part of the application of LEAN and the reduction in waste, we are in the process of
reviewing technical output; the sample size below demonstrates the amount of medical
devices handled in the inspection and packing room (IAP). We decided to investigate the
data in this way as this addresses the variation as opposed to how many trays a technician
has produced and it avoids the “I always do the bigger complicated” scenario or ”I was doing
the wrapping”.
The critical test point below was taken over a 6 month period across 10 full time technicians
whom are all fully trained across all of the SSD to assess levels of production at one stage of
the process.
Technician Instruments
Handled
%
Deferential
1 78346 100%
2 42792 -45%
3 60256 -23%
4 68860 -12%
5 67337 -14%
6 48922 -37%
7 57309 -27%
8 64368 -18%
9 50237 -36%
10 41498 -47%
(Figure 9 – Critical test point)
What this sample data tells us is we have a technical inefficiency from technician 1 who has
handled the most medical devices (78,346) and technician 10, who has handled the least
(41,498) of -45% technical output therefore under rationalised capacity.
If we assume the average instruments actually handled was 57,993 then this is still a loss of
-28% of technical skills and production in the medical device assembly stage of the IAP
manufacturing process based on technician 10.
To summarise, this data translates to an overall loss of 26% in medical device assembly in
the IAP based on the maximum possible (78,346) achieved by all technicians mapped
against what we actually achieved (74%).
For the purpose of this quantifiable data capture ‘test point’ we factored in that we are
utilising tangible data from ‘value added’ activity (assembly of medical devices) only as there
are many variables to the working day and the role of a technician, such as; work in other
areas, troubleshooting, mandatory training, wrapping, unloading washers and training which
all have their own level of ‘value added’ criticality to the end product whilst following the QMS
and a true ‘pull system’.
If we factor in our average conformity performance of 99.8% of correct sterile medical
devices actually reaching the service user ‘safe for intended use’ we are able to demonstrate
waste reduction in the overall process. The 26% deferential in assembly needs addressing.
With this in mind we are in the process of developing an ‘SSD Technical Service Model.’
This will largely be a time based study where we will time and assess several ‘critical test
points’ across each section of the decontamination life cycle. Our vision is this service
model will demonstrate acceptable levels of service performance not only of technicians but
of equipment in the process too. It is hoped that this service model can be utilised to
address service capacity versus demand in the future and serve as an effective training tool.
The application of LEAN methodologies in SSD takes time and hard work and cannot be
reliant on just one process owner, as for the culture to change it needs full engagement from
the whole team and all service users who need to be aware of the fundamentals of following
these practices. Morgan and Brenig-Jones (2009) describe the ‘process owner as the
responsible person of the process, who needs to ensure that the process is designed and
managed to meet the ‘critical to quality’ so they must understand what the customer is
saying.’ This alone presents another evaluation stage because after the project has been
completed, questioning our customers, service users and patients not only keeps the
momentum and embeds further the constants with Experience Based Design (NHS Institute
for Innovation and Improvement, 2010) but also ensures we are capturing the right data that
is both quantitative and qualitative to improve our services.
(Figure 10 - Glossary of Lean Terminology and links to ISO Standards)
Effective communication techniques adapted by successful leaders make a difference when
implementing changes, improving collaborators and organisational performance. Bibby et al
(2009) suggests that ‘As improvement leaders we need to define goals in ways that connect
with people’s intrinsic motivation and values.’ Effective leadership communication and
consultations are the personification of any transformation formula for individuals and
change agents or as Bibby et al (2009) describes them as: ‘organisation radicals.’ They
explain that ‘activists join with others to create campaigners and movements,’ ‘To deliver
significant change in the NHS, many of these individuals will need to become organisational
radicals – activists are not satisfied with the status quo.’ I recognise that ‘activists’ need to
be given opportunities to exchange interpretations and opinion, discuss problems and
consider elaborations around the LEAN methodologies and the application of them. ‘Leaders
don’t get extraordinary things done all by themselves’ (Kouzes and Posner (2007)).
We have made savings, and in the 2015 – 2016 fiscal year we demonstrated an overall
saving of 6.4% (£62,000) as well as contributing to the additional 4% cost improvement
programme (CIP) for HDFT. I am confident that we provide the highest quality sterile medical
devices, with the lowest cost; with the shortest lead time (Takt time) we can to ensure our
service users and patients are contented.
Organisational intelligence and leading from the middle were and continue to be
fundamental to the successes of the application of the LEAN methodology and the
philosophy of Taiichi Ohno in SSD. I personally recognise leadership is not about rank, it’s
about having personal opinions, a sense of pride, values of what we all accomplish and are
achieving collectively. It requires a significant amount of ‘negotiating when handling
change,’ which when applied supported my leadership success in leading change in relation
to ‘Sharing the Vision’ and by garnering the potential intellectual capital from within. It has
added value to the organisation and supported us in our long term attitude of pursuing
perfection.
To conclude, I have spent many years strategically planning my overall vision of having a
LEAN, paper light SSD. I recognise that the right process will produce the right results in the
most cost effective way, and won’t compromise quality which in turn supports the safest
patient outcomes and the NHS values. This has incorporated me attaining and recruiting the
right staff with the skills, knowledge and expertise which I have been able to harvest
collectively to support our common goal and my vision. By having these skills and my
tenacity to achieve our goal - I am now fortunate enough to lead an exceptional department
with an exceptional technical and management team who continue to apply the LEAN
methodologies as an everyday occurrence. Kaizen is a massive part of what we do all day
every day whilst running alongside ISO13485.
I would urge any manager to get out, apply Genchi Genbutsu – and go see it for you. Think
of the last time a service turnaround time was not met and a member of staff replied when
challenged ‘we were short staffed’ or ‘the washer failed’ my response to that would be
‘really?’
‘If you are going to do TPS you must do it all the way. You also need to change the way you
think. You need to change how you look at things.’ (Taiichi Ohno).
References:
Bibby, J, Bevan, H, Carter, E, Professor Bate, P, Robert, G (2009). The Power of one, The
Power of Many. Coventry: NHS Institute of Innovations and Improvements
Care Quality Commission (2014). Fundamental Standards [online]. Available at
https://www.cqc.org.uk/content/publishing-new-fundamental-standards [accessed on 6th
July 2016].
Francis, R. (2013). The Mid Staffordshire NHS Foundation Trust Public Inquiry [online].
Available at http://www.midstaffspublicinquiry.com/report [accessed on 18th June 2016].
Kouzes, J and Posner, B (2007). The Leadership Challenge. 4th Ed. San Francisco: Jossey-
Bass.
Morgan, J. Brenig-Jones, M, (2009). Lean Six Sigma for Dummies. John Wiley and Sons
Ltd. West Sussex.
NHS Constitution, (July 2015). NHS Choices [online]. Available at [Accessed 10th June
2016].
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/474450/NHS_
Constitution_Handbook_v2.pdf
NHS Institute for Innovation and Improvement (2010). The Handbook of Quality and Service
Improvement Tools. Coventry.
NHS Institute for Innovation and Improvement Leaders Guides (various) (2007). Nottingham.
Taiichi Ohno, Toyota Production System, Beyond Large Scale Production (1988) CRC
Press, Taylor and Francis Group.
Kaizenworld, (2016) Glossary of Terms [online]. Available at
http://www.kaizenworld.com/kaizen-glossary.html [accessed 28th June 2016].
Toyota (2013). he official blog of Toyota GB [online]. Available at
http://blog.toyota.co.uk/genba-toyota-production-system [accessed 29th June 2016].
Acknowledgements:
Nick Burgoyne: Sterile Services Information and Data Analyst
Caitie Butler: Sterile Services Administrator

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IDSc Article - Lean Methodologies in SSD

  • 1. The Application of ‘LEAN’ Methodologies in a Sterile Service Department Melanie Davies, Head of Medical Devices and Sterile Services, Harrogate and District NHS Foundation Trust An article recently published indicated that ‘Hospitals in England have run up a record deficit of £2.45bn – the biggest overspend in its history – as it struggles to cope with a surge in demand for care while suffering a major budget squeeze’. (The Guardian May 2016). The official figures released by NHS improvement demonstrated that NHS Trusts ended the 2015-2016 financial year £461m worse off than what had been originally forecast. This major overspend threatens already stretched hospitals further for this year’s financial planning. For those of us that are budget holders, it requires us to be innovative and creative in making further financial savings on our annual budgets to try to support the £700m gap. Having spent many years working with suppliers to reduce costs in Sterile Services on products by pooling resources and researching our field for different suppliers, we got to a point whereby we felt if we changed anything else in our preferred suppliers and manufacturing process we could potentially be at risk of compromising the quality of our sterile products, which ultimately can affect patient safety – obviously this must be avoided. A concern we reflected on at this juncture was: ‘when does quantity outweigh quality’ and does this meet the ‘actual’ expectation of the patient? Reflecting on the NHS Constitution (July 2015), the Care Quality Commissions (CQC) fundamental standards (November 2014) and the Francis Report (February 2013) along with the NHS’s values which are integral to ‘creating a culture where patients come first in everything the NHS does’. It was important to cogitate and deliberate as part of this LEAN implementation project; ‘Do we need to create a LEAN quality culture or just quality champions in the NHS? Our perspective is we should be encouraging both as an actual minimum to ensure our sterile and decontamination services meet the expectations of both stakeholders and the patients whom we treat without compromising quality but by being as process and financially efficient as we can be. As part of a post graduate clinical leadership programme, I was introduced to the philosophy of Taiichi Ohno, a Japanese industrial engineer and businessman (1912-1990), the Toyota Production System (TPS) and the elimination of all waste by understanding the concept of where you have variation you also have waste too (figure 1). The TPS is based on the Just- In-Time (JIT) concept and the elimination of excessive inventory and extra processing steps. Within the Sterile Services Department (SSD) at Harrogate and District NHS Foundation
  • 2. Trust (HDFT) we refer to these as ‘technical touch points’. By reducing defective products (corrective and preventative action) and ‘technical touch points’ in the production and manufacturing environment, SSD is in essence a lean production facility as it does in principle already follow an assembly line methodology akin to the decontamination life cycle. (Figure 1 – History of the Toyota Production System) TPS is described as a ‘pull’ method to meet recognised demands, ‘Kaizenworld’ describes a true ‘pull system’ as ‘a system where we stop pushing orders through a system based on inaccurate forecasts and instead couple the system to the customer and focus on the value stream’. By using creativity, data and innovative imagination we have been able to successfully apply these theories, principles and concepts. ‘Data is of course important in manufacturing, but I place the greatest emphasis on facts’ (Taiichi Ohno). They are now a fundamental part of our whole departmental philosophy across the unabridged team within the SSD at HDFT along with the integrated quality management systems (QMS), comprehensive work instructions and technical file. These all have a very clear quality and LEAN focus on continuous improvement, measuring and monitoring, standard working and risk management. We firmly believe it’s not about the quantity of devices manufactured to meet customer demand, as more products that are ‘pushed’ the risk of mistakes being made increases (Jidoka). When assessed, the actual risk profile, likelihood and consequence increases with more problems in the manufacturing process, along with other wastes, such as technical and human factor based risks which are all essentially wastes too. Eliminating these wastes (Muda) can be achieved by introducing a true manufacturing ‘pull system’ that is production levelled (Heijunka) against predetermined set objectives with our services users, supported by comprehensive work instructions and a thorough QMS with a ‘quality over quantity’ mind- set in the whole HDFT SSD team. We try to get it right the first time – every time. ‘Make your workplace into a showcase that can be understood by everyone at a glance. In terms of quality, it means to make the defects immediately apparent. In terms of quantity, it means that progress or delay, measured against the plan, and is made immediately apparent. When this is done, problems can be discovered immediately, and everyone can initiate improvement plans’ (Taiichi Ohno). 1913 First moving assembly line made by Ford Motor Company World's first automatic loom with a non-stop shuttle-change motion, the Type-G Toyoda Automatic Loom developed by Sakichi Toyoda. Jidoka – automation with a human touch – was conceived 1927 Introduction of a flow production method using a chain conveyor into the assembly line of a textile plant by Kiichiro Toyoda 1937 Flow production method using a chain conveyor method into the body production line introduced at Toyota Motor Co., Ltd.'s Koromo Plant by Kiichiro Toyoda 1924 1950 Eiji Toyoda visited the US to study Ford’s production methods, which helped him implement Just-in-Time methods 1956 Taiichi Ohno visited US auto plants and supermarkets, where he conceived KANBAN 1949 Taiichi Ohno experimented with setting up equipment to produce items in a timely manner. After visits to the US, he created Just-in-Time framework 1978 Taiichi Ohno wrote the book Toyota Production System: Beyond Large Scale Production 1987 John Krafick proposes that ‘Lean’ be used as the label for the combination of methods established at Toyota 1988 Taiichi Ohno’s book translated into English Information found in Volume 5, Number 5 of iSixSigma Magazine
  • 3. Having developed simple processes with reduced ‘technical touch points’ and minimising the processing of excessive inventory, by only using the resources actually required for the safe reprocessing of medical devices which only contribute to a value added quality process. We are confident these value adding activities collectively convert all medical devices into a quality product that meets the needs of our service user and the patient. In 2012 we processed around 9,000 sterile medical devices in either tray or supplementary peel packed format each month. When we became an integrated provider of additional community services this increased to 24,000 each month. Restricted with the same footprint and equipment, this is when we started to really embed the LEAN methodologies and think differently and creatively. By following the philosophy of the TPS and Taiichi Ohno’s 7 wastes principle we were successful in this new service transition and increased the manufacturing of sterile medical devices by 166%. To date, by following the LEAN methodology and the Taiichi Ohno principle of ‘waste reduction,’ coupled with the use of integrated paper light systems and internally designed, bespoke data-capture programs, we find ourselves in a position by which we can analyse for quality purposes and service improvements and developments, further promoting the LEAN methodologies. We are confident that we continue to provide a first class and financially efficient quality service. The department now processes approximately 2,259,336 individual medical devices annually and on average 99.8% of these reach our patients ‘safe for their intend use.’ Optimal patient value is at the centre of what we deliver and we are continually striving through continuous improvement and our philosophy of achieving perfection. When addressed, the concepts of the ‘LEAN Production House’ (figure 2) can be likened to many aspects of the contents of the ISO13485 and ISO 9001 standards and can be transacted. We found it useful to think of them as part of this philosophy and use our enthusiasm to embed this thinking and approach into our department and for it to become ingrained in the team culture on the Genba or Gemba – (‘The real place, the place where the actual work is done’: Now adapted in management terminology to mean the ‘workplace’ or the place where value is added). In manufacturing, it usually refers to the shop floor (The official blog of Toyota GB). So in SSD, this would refer to the wash area, the inspection and packing room, etc.
  • 4. (Figure 2 - Adapted from Ohno 1988) Taiichi Ohno was the creator of the ‘7 Wastes’ principle (figure 3) often acronymically refined as TIMWOOD. Muda is the Japanese word meaning "futility; uselessness; wastefulness" (Toyota Production System, 1988) and is a concept we addressed when reviewing the nine stages of the decontamination life cycle. From start to finish we asked at each technical touch point ‘what value does this add to the sterile and decontamination processes and the end sterile product?’ We questioned if the service was picking up extra financial and storage costs and was overproducing medical devices. Was increasing mistakes and machine failures contributing to our Muda? Eliminating waste and inventory – a non-value added process is one of the main principles of ‘Just in Time’ and ‘pull’ systems – it is so important in fact, that it has its own pillar as part of the Lean Production House (figure 2). We also found the simple but effective ‘5 whys’ processes helped to support the process. “Ask ‘why’ five times about every matter” (Taiichi Ohno). If a process or ‘technical touch point’ was found to have no critical added value to the end product then the process, resource or ‘technical touch point’ was revaluated or removed. Standardisation was then optimised by keeping things simple and by reducing several areas of variation. Reducing wastes in SSDs seems simple but when interrogated closely the results are shocking, even in a service that is already perceived as efficient. Reducing the Muda seems simple but it is true and really worked for us.
  • 5. (Figure 3 – 7 w astes: Tim Wood Acronym, Sterile Services HDFT) 1. Transporting: moving products that are not actually required to perform the processing 2. Inventory: All components and raw materials that are work in progress of finished goods does not have value added to the end product 3. Motion: people or equipment moving or walking more than is required to perform the processing 4. Waiting: Whenever goods are not moving or being processed or waiting for the next step, the waste of waiting occurs 5. Over Processing: resulting from poor tool or product design creating activity therefore adding excess value 6. Over Production: to make too much, to produce sooner, faster or in greater quantities than the customer demand 7. Defects: The effort involved in inspecting for and fixing defects You could argue that there is an 8th waste: the actual knowledge and skills to do the job in hand. Respect in humanity and the knowledge of others is fundamental and investment and time in training and assessing technical competence are paramount. The success in individual roles is key; it’s our standard approach that technicians at HDFT are trained in all areas to optimise and support the process flow and product levelling process. By having all staff trained in all areas supports good ‘human jidoka’ and ‘standardised work’ which ultimately supports a secure quality focus. Several of our technicians are trained Lean Six Sigma green and yellow belts too. As part of the decontamination lifecycle and our service we commenced mapping against the cycle, highlighting which processes added value and which didn’t. We also used the data we had been collating for several years to support this through effective use of that data along with other metrics too. Evidence already collated through the DMAIC, Define and Measure phases (100% Effective, 2013) already indicated that service users and staff were disgruntled by turnaround times and availability of equipment to meet the capacity that is expected. Where possible, our aim was for the best proactive levels of service and technical compliance at all echelons in SSD, supported by the provision of real time quantitative data, a key aspect of the evaluation
  • 6. process. This data was captured from routine information such as total productivity or analysis at ‘critical test points of the process map’ (100% Effective, 2013). Morgan and Brenig-Jones (2009) confirm that ‘managing by fact is one of the key Lean Six Sigma Principles,’ therefore when transposed, any ‘Lean’ process owner, project lead or Kaizen Officer should view data collection as a process that needs managing and continual improvement to work in conjunction with the QMS. These statistics should be of variable quality from varying sources and should capture both quantitative and qualitative data as suggested by the NHS Institute for Innovation and Improvement (2007) when deciding what, when and how to evaluate to meet the desired outcomes and improvement strategies. So when we addressed our Muda in SSD whilst following the decontamination lifecycle and process through from start to finish we were able to identify many areas of waste. Some examples were:  The use of soaker sheets, which once reviewed was discovered to be a historical practice and upon testing were no longer required, so this did not only save time in the manufacturing process and a reduction in several ‘technical touch points’, but on ordering and stock control with added financial benefits too  Reviewing the instruments in tray sets and rationalisation, including the removal of unused suctions which held up processes in the wash area due to their cannulation. We really pushed the concept of one piece flow through the stages of the decontamination cycle – so reduced what was added or dealt with as part of the sterile pack – this also included consumables  We have removed all elements of manual cleaning – we have state of the art washer disinfectors that should be doing this  The continual unnecessary reprocessing of limited use medical devices such as fingerswitch hand pieces, not used yet still deducted due to autoclaving. These have since been removed and are now purchased as a single use medical device again offering increased financial gain and reduction in technical touch points  Adding consumable items to tray sets is a process we have removed, resulting in ‘true’ one piece flow  We no longer add an autoclave batch label to sterile packs post sterilisation. It was identified that the batch label added no value to the sterile pack other than an additional indicator that it had been through a sterilisation process. The tray tracking and processing data is retained through the medical device barcode and electronic tracking and traceability system. The autoclave tape is a type 1 process indicator (ISO11140-1:2005) which supports product release processes. However as part of this process review we were able to change our current tray label to one that was also a type 1 process indicator (ISO11140-1:2005) which added increased control to the product release process. By reviewing this simple process and asking why (5 times), we considered: ‘why do we add a batch label? What does it tell us? How else can that be delivered? What else is available?,’ we have not only saved financially but the technical time taken to batch approximately 100,000 sterile medical devices each year has since been reinvested elsewhere in our services  We now peel pack small trays instead of wrapping them and still conform to ISO11607. This had a financial impact and technical time saving. By working with our service users - which can be challenging – the persistence did pay off
  • 7.  We no longer add checklists to our community services standard podiatry trays. We adapted the instrument tray label specifically for these sets which now serves the same purpose  We developed a ‘Just in Time’ stock room – whereby we reviewed annual usage figures of raw materials and by working with our suppliers were able to set up weekly or monthly standing orders and deliveries which meet the needs of our services. We also developed an in house stock program/module (Kanban). Usually to buy systems like this for this purpose can cost £1000s. By strategically planning the SSD skill mix of the whole team to support my long term strategy and vision over the years, we now have the skills in the department which support us to develop our own databases - bespoke to our specific needs (figure 4).
  • 8. (Figure 4 – Bespoke Stock Module, develop by SSD) These are just some examples of the many opportunities we have come across when we really interrogated our process. This culture remains to date; an ethos we work alongside continually looking for improvements (Kaizen) which are also intrinsically linked to the release of the new suite of Health Technical Memorandums (HTM) 01-01 (part a-e) by the Department of Health (July 2016). It is noted that Sterile Services need to continuously improve outcomes in terms of:  patient safety  clinical effectiveness  patient experience
  • 9. In addition, these HTMs put significant onus on best practice and that we should ‘aim to further minimise risks to patients; deliver better patient outcomes; promote and encourage innovation and choice; and achieve cost efficiencies.’ We then started to explore other areas not directly involved in the production process which had little or no added value. A good example is our staff meetings. We sought staff opinion (Nemawashi) on the effectiveness and value that staff got from the meetings in relation to time lost off the shop floor (Genba). It became quite clear technicians were more concerned about the build-up on the department and the strain this put on our services which did not fully support a true ‘pull system’. We evaluated the data we had already been collecting which included a calculation on how much it actually cost the service to have a staff meeting and how much technical and management time this took away from our service and what value this added. To summarise: In 2015 we had 24 unit meetings. With office staff, attendance was 463 for the year, an average of 19 attendees per meeting at an overall cost of £3,513.12. When this was translated technically, overall 5599.93 hours of technical time was used up in unit meetings. This was the equivalent of 335,995 community service trays (at a minute per tray) and 67,299 half-DIN trays (at 5 minutes each). This was Muda that had to be addressed. Team communication is a fundamental prerequisite of effective team work and the last thing we wanted was – if challenged - a member of our team saying ‘we don’t have team meetings,’ for example when responding to a staff survey or when being questioned by the CQC. Because we had waste which needed to be addressed, we developed the ‘SSD Hub’ (figure 5) a program developed to support staff communication along with our communication strategy, (figure 6) both internally and externally to the department.
  • 10. (Figure 5 - Bespoke ‘Blog’, developed by SSD) ‘Costs do not exist to be calculated. Costs exist to be reduced’ (Taiichi Ohno)
  • 11. (Figure 6 – SSD Communication Strategy)
  • 12. The SSD Hub has since been exploited (obviously complying to the Data Protection Act 1998) to include information around sickness and attendance management, appraisal due dates, staff personal details and a very comprehensive training matrix – again all supporting LEAN and paper light processes. We also developed DAD (figure 7) – a Decontamination Analysis Database, not only to comply with ISO13485 but to record Jidoka and support Poka-Yoka (figure 10). (Figure 7 – DAD, bespoke database, developed by SSD) Kaizenworld describes Jidoka as ‘a device that will stop a process if an error (defective part) occurs. It supports the principle of one-piece flow in that no faulty part is passed to the next process and errors are resolved at source and in a timely manner. All evidence of the creation of the fault is maintained so that it can be eliminated forever because the process is evaluated and changed to remove the possibility of making the same mistake again,’ so when likened to SSD this is a system that once fully developed supports this. We have since developed a ‘Compliance Technician’ whose main role is the management of DAD. This person is responsible for recording all service non-conformities and technical errors (such as missing instruments). Other staff are expected to contribute to this (Hansei) in the form of a Technical Information Notices (TIN) and the completion of action plans when the set benchmark for nonconformity has been exceeded. The benchmark was established after reviewing months of technical productivity and non-compliance data to devise a statistical based figure. To support Jidoka and Kaizen further we use these non-conformity figures to make improvements to our service to prevent reoccurrence. Monthly RCA occurrence in predetermined areas of risk and a monthly report is established and circulated not only to the team but to all service users along with a summary of technical and service errors. We have
  • 13. made every effort to be open, transparent and honest about our service and technical ability and to also evidence the effort we make to support continual improvements for patient safety. All our data and team productivity is collated and managed through the ‘SSD Compliance and Assurance’ dashboard (figure 8) used to communicate our service performance to service users and directors within HDFT. This includes ‘heat maps’ around product non- conformance (Jidoka) and ‘production levelling’ data mapped against actual capacity. (Figure 8 – SSD Compliance and Assurance Dashboard) As part of the application of LEAN and the reduction in waste, we are in the process of reviewing technical output; the sample size below demonstrates the amount of medical devices handled in the inspection and packing room (IAP). We decided to investigate the data in this way as this addresses the variation as opposed to how many trays a technician has produced and it avoids the “I always do the bigger complicated” scenario or ”I was doing the wrapping”. The critical test point below was taken over a 6 month period across 10 full time technicians whom are all fully trained across all of the SSD to assess levels of production at one stage of the process. Technician Instruments Handled % Deferential 1 78346 100% 2 42792 -45% 3 60256 -23% 4 68860 -12% 5 67337 -14% 6 48922 -37% 7 57309 -27%
  • 14. 8 64368 -18% 9 50237 -36% 10 41498 -47% (Figure 9 – Critical test point) What this sample data tells us is we have a technical inefficiency from technician 1 who has handled the most medical devices (78,346) and technician 10, who has handled the least (41,498) of -45% technical output therefore under rationalised capacity. If we assume the average instruments actually handled was 57,993 then this is still a loss of -28% of technical skills and production in the medical device assembly stage of the IAP manufacturing process based on technician 10. To summarise, this data translates to an overall loss of 26% in medical device assembly in the IAP based on the maximum possible (78,346) achieved by all technicians mapped against what we actually achieved (74%). For the purpose of this quantifiable data capture ‘test point’ we factored in that we are utilising tangible data from ‘value added’ activity (assembly of medical devices) only as there are many variables to the working day and the role of a technician, such as; work in other areas, troubleshooting, mandatory training, wrapping, unloading washers and training which all have their own level of ‘value added’ criticality to the end product whilst following the QMS and a true ‘pull system’. If we factor in our average conformity performance of 99.8% of correct sterile medical devices actually reaching the service user ‘safe for intended use’ we are able to demonstrate waste reduction in the overall process. The 26% deferential in assembly needs addressing. With this in mind we are in the process of developing an ‘SSD Technical Service Model.’ This will largely be a time based study where we will time and assess several ‘critical test points’ across each section of the decontamination life cycle. Our vision is this service model will demonstrate acceptable levels of service performance not only of technicians but of equipment in the process too. It is hoped that this service model can be utilised to address service capacity versus demand in the future and serve as an effective training tool. The application of LEAN methodologies in SSD takes time and hard work and cannot be reliant on just one process owner, as for the culture to change it needs full engagement from the whole team and all service users who need to be aware of the fundamentals of following these practices. Morgan and Brenig-Jones (2009) describe the ‘process owner as the responsible person of the process, who needs to ensure that the process is designed and managed to meet the ‘critical to quality’ so they must understand what the customer is saying.’ This alone presents another evaluation stage because after the project has been completed, questioning our customers, service users and patients not only keeps the momentum and embeds further the constants with Experience Based Design (NHS Institute for Innovation and Improvement, 2010) but also ensures we are capturing the right data that is both quantitative and qualitative to improve our services.
  • 15.
  • 16. (Figure 10 - Glossary of Lean Terminology and links to ISO Standards)
  • 17. Effective communication techniques adapted by successful leaders make a difference when implementing changes, improving collaborators and organisational performance. Bibby et al (2009) suggests that ‘As improvement leaders we need to define goals in ways that connect with people’s intrinsic motivation and values.’ Effective leadership communication and consultations are the personification of any transformation formula for individuals and change agents or as Bibby et al (2009) describes them as: ‘organisation radicals.’ They explain that ‘activists join with others to create campaigners and movements,’ ‘To deliver significant change in the NHS, many of these individuals will need to become organisational radicals – activists are not satisfied with the status quo.’ I recognise that ‘activists’ need to be given opportunities to exchange interpretations and opinion, discuss problems and consider elaborations around the LEAN methodologies and the application of them. ‘Leaders don’t get extraordinary things done all by themselves’ (Kouzes and Posner (2007)). We have made savings, and in the 2015 – 2016 fiscal year we demonstrated an overall saving of 6.4% (£62,000) as well as contributing to the additional 4% cost improvement programme (CIP) for HDFT. I am confident that we provide the highest quality sterile medical devices, with the lowest cost; with the shortest lead time (Takt time) we can to ensure our service users and patients are contented. Organisational intelligence and leading from the middle were and continue to be fundamental to the successes of the application of the LEAN methodology and the philosophy of Taiichi Ohno in SSD. I personally recognise leadership is not about rank, it’s about having personal opinions, a sense of pride, values of what we all accomplish and are achieving collectively. It requires a significant amount of ‘negotiating when handling change,’ which when applied supported my leadership success in leading change in relation to ‘Sharing the Vision’ and by garnering the potential intellectual capital from within. It has added value to the organisation and supported us in our long term attitude of pursuing perfection. To conclude, I have spent many years strategically planning my overall vision of having a LEAN, paper light SSD. I recognise that the right process will produce the right results in the most cost effective way, and won’t compromise quality which in turn supports the safest patient outcomes and the NHS values. This has incorporated me attaining and recruiting the right staff with the skills, knowledge and expertise which I have been able to harvest collectively to support our common goal and my vision. By having these skills and my tenacity to achieve our goal - I am now fortunate enough to lead an exceptional department with an exceptional technical and management team who continue to apply the LEAN methodologies as an everyday occurrence. Kaizen is a massive part of what we do all day every day whilst running alongside ISO13485. I would urge any manager to get out, apply Genchi Genbutsu – and go see it for you. Think of the last time a service turnaround time was not met and a member of staff replied when challenged ‘we were short staffed’ or ‘the washer failed’ my response to that would be ‘really?’ ‘If you are going to do TPS you must do it all the way. You also need to change the way you think. You need to change how you look at things.’ (Taiichi Ohno).
  • 18. References: Bibby, J, Bevan, H, Carter, E, Professor Bate, P, Robert, G (2009). The Power of one, The Power of Many. Coventry: NHS Institute of Innovations and Improvements Care Quality Commission (2014). Fundamental Standards [online]. Available at https://www.cqc.org.uk/content/publishing-new-fundamental-standards [accessed on 6th July 2016]. Francis, R. (2013). The Mid Staffordshire NHS Foundation Trust Public Inquiry [online]. Available at http://www.midstaffspublicinquiry.com/report [accessed on 18th June 2016]. Kouzes, J and Posner, B (2007). The Leadership Challenge. 4th Ed. San Francisco: Jossey- Bass. Morgan, J. Brenig-Jones, M, (2009). Lean Six Sigma for Dummies. John Wiley and Sons Ltd. West Sussex. NHS Constitution, (July 2015). NHS Choices [online]. Available at [Accessed 10th June 2016]. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/474450/NHS_ Constitution_Handbook_v2.pdf NHS Institute for Innovation and Improvement (2010). The Handbook of Quality and Service Improvement Tools. Coventry. NHS Institute for Innovation and Improvement Leaders Guides (various) (2007). Nottingham. Taiichi Ohno, Toyota Production System, Beyond Large Scale Production (1988) CRC Press, Taylor and Francis Group. Kaizenworld, (2016) Glossary of Terms [online]. Available at http://www.kaizenworld.com/kaizen-glossary.html [accessed 28th June 2016]. Toyota (2013). he official blog of Toyota GB [online]. Available at http://blog.toyota.co.uk/genba-toyota-production-system [accessed 29th June 2016]. Acknowledgements: Nick Burgoyne: Sterile Services Information and Data Analyst Caitie Butler: Sterile Services Administrator