1.1 We expect appraisal costs are usually quite

1.1  Quality within NHS Production Units


quality and reducing costs are qualities the NHS has always strived for.  There has been increasing emphasis on
enhancing quality and decreasing costs; given the situation of unprecedented
financial constraint and the requirements of efficiency savings of £22 billion projected
by the NHS Five Year Forward Review (NHS
England, 2014; Alderwick et al., 2015). By purely concentrating on the monetary
value of the challenge faced by the NHS, we miss exploring a fundamental factor
of obtaining better value from the NHS budget. We aim to maximise outcomes
generated by NHS activities, whilst minimising costs (Bloor et al., 2000; Ham
& Murray, 2015).

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Production units, the costs associated with quality can include; appraisal
costs, external failures, internal failures and preventative costs.

costs aim to avoid problems with quality. These costs are built in during the
design, implementation and maintenance of the quality management system (QMS)
(Audit commission, 2006). 

costs include measuring and monitoring activities relating to quality. These
costs can include suppliers’ and customers’ assessment of purchased materials,
processes, and services to ensure specifications are met (Bevan & Hood,
2006). Appraisal costs also include auditing and inspection time. We expect appraisal costs are usually
quite high for pharmaceutical manufacturers due to the regulatory requirements
they have to adhere to.

Internal failure costs are
encountered when defects are discovered prior to product/service being
delivered to customer (Fillingham, 2007). These failure costs could include
waste (due to overwork or poor organisation), defective products and failure

External failure costs are
incurred to resolve issues discovered by customers. This occurs when products
or services that fail to reach design quality standards are not detected until the
customer receives the products (Hadley, Zuckerman and Lezzoni, 1996).


Three ideas will be
investigated; loss of stock due to expiry dates being exceeded, rejects and
failures of products, and generic labelling in tablet packaging (TP). The three
ideas have been highlighted as high-costing to Huddersfield Pharmacy Specials
(HPS); they will be investigated in order to determine whether costs associated
with these areas can be reduced.

By investigating and
highlighting areas that are of high-cost to HPS, we aim to suggest ways to
decrease the annual expenditure in these areas. Hopefully, we will then see a
financial decrease in expenditure for the unit during the 2017/2018 financial
year once the improvements have been implemented.



The fundamental principle of lean manufacture is eliminating
waste from the manufacturing process (Holweg & Matthias, 2007). Taiichi
Ohno was a Japanese industrial engineer and business man who used three
Japanese words to describe waste; Mura, Muri and
Muda. Mura is unevenness, Muri is overburden/unreasonable demands and Muda is
the non-value adding actions within processes (Liker, 2004).

customers want high quality products that are delivered on time and at the
right price. By eliminating waste in production processes, high-quality
products can be achieved (Krafcik, 1988).

Muri ultimately underlies Muda and Mura,
the causes of Muri can include:

insufficiently trained in certain processes

work spaces and organisation


or poor instructions

of proper tools and equipment/ unreliable equipment


processes and equipment


A company’s profit is calculated by the selling
price minus the costs associated with making the product. The selling price is
very much dictated by the market, if the company charges too much then
customers will seek the product elsewhere, and sometimes if you charge too
little there is potential to lose out on customers as they may perceive that
the product is of low standard (Ohno, 1988).

Therefore, we only improve profits by reducing
costs; this means the removal of waste from all processes.

Mura, Muri and Muda
‘wastes’ were categorised into seven areas; 

Overproduction; Over producing product beyond demand.
Inventory; work in progress (WIP), raw materials and finished
goods stocks.
Waiting; waiting for a machine to finish, for product
to arrive, etc.
Motion; the physical movement of a person or machine
during operations.
Transport; the movement of product between operations,
and locations.
Reworks/Defects; product rejects and rework within your processes.
Over-processing; conducting operations beyond those that customer

By using the
concepts of Lean manufacture, we were able to review and improve our systems of
work.  Within the NHS, we strive to:
improve health, provide the best care for patients, get the best value for
money for taxpayers and patients and aim to take pride and joy in our work.
Placing the patient first means developing a thinking workforce. The removal of
waste is not the ultimate goal but a means to improve benefits and services to
patients. At the core of lean is the process of prevention of waste, not just
elimination of waste. All processes, including healthcare processes, have a
large waste component: those steps in a process that do not create value as
perceived by the end user, the patient. By preventing waste, less time needs to
be spent on problem-solving, reworking processes and inspection. Steps in a
process which do not add value should be identified and eliminated; this is
enabled by using value stream analysis.

Over Production


Waste that occurs due
to overproduction usually results from making too much product or making a
product too early. Contributing factors to this waste include oversized
batches, long lead times, unreliable supplier, unreliable processes and working
to an inaccurate forecast, all of which leads to high inventory levels. The aim
would be to make only what is required, when it is required by the customer
which involves working to the principles of Just in Time (JIT).


Overproduction encounters capital tied up in stock
(i.e. in raw materials, WIP, finished good etc). By aiming to reduce batch
size, this would reduce stock amount which ultimately ends in improved flow
rates and reduced lead times (Rosenthal
& Frank, 2006).

By using value stream mapping, process
mapping, and other analytical tools we are able to make that value flow by
rearranging our work place. To tackle set up times on equipment which enables
the production of smaller batches, we can use the technique of Single Minute
Exchange of Die (SMED). Once this is utilised, we can use the JIT principles to
enable the production of product only when it is ordered.
In doing this we not only eliminate the overproduction in our processes, but we
begin to eliminate and highlight the causes of many other problems within our
processes that are hidden by this entire inventory.

Inventory costs are contained within raw materials, WIP, or
finished goods that have not yet been sold (Zuckerman, Hadley and Lezzoni,
1994). Whilst the money is tied up in stock, there is a cost involved with
storage, packaging and training involved with handling of the materials. There
is potential for the raw materials or product to be damaged during storage and
transport, therefore there is potential for loss of money.


High inventory and overproduction can also
be caused by poor layout and lack of balance in workflow causing inventory to
build up before or after different processes.


The waste of waiting disrupts work flow; we spend
money on the time waiting for people, machinery, documentation, approval all of
which comes directly out of profit. The cost of waiting could potentially then
be made up later during overtime at a premium rate which again affects profit.

Unbalanced processes, unreliable
processes, breakdowns, quality issues, transportation are all common causes of
waiting in work flow. Unclear or missing information regarding procedures and
processes can also cause waiting during work time.




Unnecessary motions made by operators or machines involve
excessive travel between work stations, poor station layout, machinery
movements are all examples of the waste of motion.



Within waste due to motion, we find a
reduction in work efficiency. A long-term risk with unnecessary motion for
operators that are constantly moving items could lead to muscle and back
strains increasing sickness absence from work which is a high cost for the NHS
(West & Patterson, 1999).

The simplest and most powerful lean
manufacturing tool used to eliminate the waste of motion is the 5S system. This
system utilises the implementation of seiri (sort), seiton (set in order),
seiso (shine), seiketsu (standardise) and shitsuke (sustain) shown in Figure 7.  The 5S
system challenges operators to review each and every step of the operation and
eliminate symptoms associated with the seven wastes.


The lean tool of SMED will also remove many
wasteful motions from your setup process, using similar principles to 5S, they
are applied to the setup process of your work and will often reduce setups from
hours to single minutes (Dillon & Shingo, 1985).

Reducing waste of motion, increases efficiency and
makes the work easier for operators.


transport category involves the movement of materials in the form of
deliveries, this acts as waste as it does not add any value to the product.

The waste of transport can be very costly, considerations
that need to be made include; paying for material handling equipment, staff to
operate equipment, safety training and precautions, extra space for movement of
material and waiting for deliveries due to delays (Severens, 2003). Excessive
transport also creates opportunities for handling damage and losses, which can
be of high value. The main contributor to the waste of transport includes the
waste of overproduction, which leads to the waste of inventory.

By improving layouts and utilising value
stream mapping and process mapping can lead to huge savings in time and money.

8. Image
detailing transportation (Earley,



Quality errors that
cause defects can be extremely costly. Every defective item requires rework or
replacement, which wastes resources, materials and it created paperwork and
loss of customers. Implementation of Pokayoke systems and autonomation can help
prevent defects from occurring.












defects are caused by incorrect method due to non-standard operations,
differences in the way that processes are undertaken by different operators on
different shifts. Also, errors are unknowingly built into our products by
failure to think about the best way items can be assembled (Pronovost &
Holzmueller, 2004).

a culture that empowers and makes our operators confident to highlight problems
and solve them means that there would be a reduced number of defects being
produced if operators are confident to highlight problems in manufacture and
packaging earlier on.

We aim to prevent waste before they occur, by
implementing standardised efficient procedures and high quality training to
ensure that the correct methods are undertaken and standards are achieved.


The waste of over
processing can occur due to use of inappropriate techniques, oversized
equipment, working to tight deadlines and tight tolerances and performing
processes that are not required by the customer.


The fundamental causes of over processing are due
to having unclear standards and specifications. It is very likely that
operators will not be aware of what parts in a process truly adds value to the
product or even the end use (Jimmerson et al, 2005).

Standardised working practices ensure that there
are no differences in methods. Design of procedures and processes also means
that potentially we are working to tighter tolerances which could be produced
by significantly less expensive methods.
Reviewing designs with techniques such as value engineering and value analysis
to identify opportunities to remove tolerances that are too tight would also
improve reducing over-processing.



Jidoka describes quality at source, or
‘built in quality’. Initially Jidoka began with the invention by Sakichi Toyoda
in 1896 of a simple device that could stop the shuttle on an automatic loom if
the thread broke. This meant that the machine was prevented from not only
creating defects but also alerted the operator to a problem which meant that
one operator could now operate several looms rather than have to stand there
watching just one in case something went wrong. This principle became known as

principle of Jidoka can be broken down into;

an abnormality
the immediate problem
and correct root cause

principle gives every individual the authority to stop a process should they
discover an abnormality. This way, defects and problems are highlighted and
actions are taken immediately. By removing problems from processes, within a
short period of time the numbers of problems occurring begin to reduce and
productivity begins to improve as root causes of problems are removed
(Rosenthal, 2002).  

Many machines produced today have
incorporated autonomation ideals in their design. However, operators cannot
rely solely on machines and must be trained in appropriate problem solving
skills in order to remove the root cause of problems when an issue is
highlighted. We then need to ensure that any process documentation is updated
to incorporate the changes and that we communicate those changes across similar
processes and products to spread the learning.


JIT is
a management philosophy that calls for the production of what the customer
wants, when they want it, in the quantities requested, where they want it,
without it being delayed in inventory. This means that instead of building
large stocks of presumptive orders, the company must stick to making exactly
what the customer asks for when they ask for it.

traditional manufacturing we try to predict what the customer will want and we
will create a forecast against which we will produce our products. We will also
try to produce those products in large batches as the belief is that will make
machines and processes more efficient, especially if those machines require a
long time to setup. This will typically result in long lead times through our
processes, huge amounts of WIP stocks and also large quantities of finished
goods stocks that have not yet been ordered by our customers.

If the
customer does order something that is not in our current stocks they will
either have to wait many weeks or even months for the product to be
manufactured or work will be hurried through the system by progress chasers
causing a huge amount of disruption to the production schedule (Ben-Tovim,

system on the other hand will seek to use simple visual tools known as Kanbans
to pull production through the processes according to what the customer
actually takes. It massively reduces the amount of stock held and will reduce
lead times by a significant amount, often from weeks to just a few hours or
days (Womack et al, 1990).


following are some of the many benefits that you could gain through the
implementation of just in time:

Figure 11. Image
illustrating the order-cash timeline (Reference)




Kanban is a visual method for
controlling production as part of JIT and Lean Manufacturing. As part of a pull
system it controls what is produced, in what quantity, and when. The system
ensures that you only produce what the customer is asking for and nothing more.
It is a system of signals that is used through the value stream to pull product
from customer demand back to raw materials (Hiroyuki & Furuya, 2006; Hopp,

It is important to maintain a
schedule for facilities and equipment. Regular equipment maintenance prevents
equipment breakdowns which can be costly. It also reduces the risk of product
contamination and maintains the validated state of the facility or equipment.
It is also a Good Manufacturing Practice (GMP) requirement to have a
maintenance schedule in place with the frequency determined by the criticality
of the equipment. GMP requires you to keep accurate records relating to
maintenance activities. We aim to design quality into the whole product lifecycle.
By performing regular audits, we are able to assess whether processes, people,
equipment and facilities maintain the quality we require. 


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