1.1  Quality within NHS Production Units Improvingquality and reducing costs are qualities the NHS has always strived for.  There has been increasing emphasis onenhancing quality and decreasing costs; given the situation of unprecedentedfinancial constraint and the requirements of efficiency savings of £22 billion projectedby the NHS Five Year Forward Review (NHSEngland, 2014; Alderwick et al., 2015). By purely concentrating on the monetaryvalue of the challenge faced by the NHS, we miss exploring a fundamental factorof obtaining better value from the NHS budget. We aim to maximise outcomesgenerated by NHS activities, whilst minimising costs (Bloor et al., 2000; Ham& Murray, 2015).

 WithinProduction units, the costs associated with quality can include; appraisalcosts, external failures, internal failures and preventative costs. Preventativecosts aim to avoid problems with quality. These costs are built in during thedesign, implementation and maintenance of the quality management system (QMS)(Audit commission, 2006).  Appraisalcosts include measuring and monitoring activities relating to quality. Thesecosts 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 usuallyquite high for pharmaceutical manufacturers due to the regulatory requirementsthey have to adhere to. Internal failure costs areencountered when defects are discovered prior to product/service beingdelivered to customer (Fillingham, 2007). These failure costs could includewaste (due to overwork or poor organisation), defective products and failureanalysis.

External failure costs areincurred to resolve issues discovered by customers. This occurs when productsor services that fail to reach design quality standards are not detected until thecustomer receives the products (Hadley, Zuckerman and Lezzoni, 1996).  Three ideas will beinvestigated; loss of stock due to expiry dates being exceeded, rejects andfailures of products, and generic labelling in tablet packaging (TP).

The threeideas have been highlighted as high-costing to Huddersfield Pharmacy Specials(HPS); they will be investigated in order to determine whether costs associatedwith these areas can be reduced. By investigating andhighlighting areas that are of high-cost to HPS, we aim to suggest ways todecrease the annual expenditure in these areas. Hopefully, we will then see afinancial decrease in expenditure for the unit during the 2017/2018 financialyear once the improvements have been implemented.  The fundamental principle of lean manufacture is eliminatingwaste from the manufacturing process (Holweg & Matthias, 2007). TaiichiOhno was a Japanese industrial engineer and business man who used threeJapanese words to describe waste; Mura, Muri andMuda.

Mura is unevenness, Muri is overburden/unreasonable demands and Muda isthe non-value adding actions within processes (Liker, 2004). Ultimately,customers want high quality products that are delivered on time and at theright price. By eliminating waste in production processes, high-qualityproducts can be achieved (Krafcik, 1988). Muri ultimately underlies Muda and Mura,the causes of Muri can include:·       Peopleinsufficiently trained in certain processes·       Inefficientwork spaces and organisation·       Clutteredworkplaces·       Complicatedor poor instructions·       Lackof proper tools and equipment/ unreliable equipment·       Fluctuatingdemand ·       Unreliableprocesses and equipment ·       PoorcommunicationA company’s profit is calculated by the sellingprice minus the costs associated with making the product. The selling price isvery much dictated by the market, if the company charges too much thencustomers will seek the product elsewhere, and sometimes if you charge toolittle there is potential to lose out on customers as they may perceive thatthe product is of low standard (Ohno, 1988).Therefore, we only improve profits by reducingcosts; 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 requires.By using theconcepts of Lean manufacture, we were able to review and improve our systems ofwork.  Within the NHS, we strive to:improve health, provide the best care for patients, get the best value formoney 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 ofwaste is not the ultimate goal but a means to improve benefits and services topatients. At the core of lean is the process of prevention of waste, not justelimination of waste.

All processes, including healthcare processes, have alarge waste component: those steps in a process that do not create value asperceived by the end user, the patient. By preventing waste, less time needs tobe spent on problem-solving, reworking processes and inspection. Steps in aprocess which do not add value should be identified and eliminated; this isenabled by using value stream analysis. 1.

2.2 Over Production     Waste that occurs dueto overproduction usually results from making too much product or making aproduct too early. Contributing factors to this waste include oversizedbatches, long lead times, unreliable supplier, unreliable processes and workingto an inaccurate forecast, all of which leads to high inventory levels. The aimwould be to make only what is required, when it is required by the customerwhich 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 batchsize, this would reduce stock amount which ultimately ends in improved flowrates and reduced lead times (Rosenthal& Frank, 2006). By using value stream mapping, processmapping, and other analytical tools we are able to make that value flow byrearranging our work place. To tackle set up times on equipment which enablesthe production of smaller batches, we can use the technique of Single MinuteExchange of Die (SMED). Once this is utilised, we can use the JIT principles toenable the production of product only when it is ordered. In doing this we not only eliminate the overproduction in our processes, but webegin to eliminate and highlight the causes of many other problems within ourprocesses that are hidden by this entire inventory.

Inventory costs are contained within raw materials, WIP, orfinished 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 withstorage, packaging and training involved with handling of the materials. Thereis potential for the raw materials or product to be damaged during storage andtransport, therefore there is potential for loss of money. High inventory and overproduction can alsobe caused by poor layout and lack of balance in workflow causing inventory tobuild up before or after different processes.  The waste of waiting disrupts work flow; we spendmoney on the time waiting for people, machinery, documentation, approval all ofwhich comes directly out of profit. The cost of waiting could potentially thenbe made up later during overtime at a premium rate which again affects profit. Unbalanced processes, unreliableprocesses, breakdowns, quality issues, transportation are all common causes ofwaiting in work flow.

Unclear or missing information regarding procedures andprocesses can also cause waiting during work time.    Unnecessary motions made by operators or machines involveexcessive travel between work stations, poor station layout, machinerymovements are all examples of the waste of motion.   Within waste due to motion, we find areduction in work efficiency.

A long-term risk with unnecessary motion foroperators that are constantly moving items could lead to muscle and backstrains increasing sickness absence from work which is a high cost for the NHS(West & Patterson, 1999). The simplest and most powerful leanmanufacturing tool used to eliminate the waste of motion is the 5S system. Thissystem utilises the implementation of seiri (sort), seiton (set in order),seiso (shine), seiketsu (standardise) and shitsuke (sustain) shown in Figure 7.  The 5Ssystem challenges operators to review each and every step of the operation andeliminate symptoms associated with the seven wastes.

 The lean tool of SMED will also remove manywasteful motions from your setup process, using similar principles to 5S, theyare applied to the setup process of your work and will often reduce setups fromhours to single minutes (Dillon & Shingo, 1985).Reducing waste of motion, increases efficiency andmakes the work easier for operators.  Thetransport category involves the movement of materials in the form ofdeliveries, this acts as waste as it does not add any value to the product. The waste of transport can be very costly, considerationsthat need to be made include; paying for material handling equipment, staff tooperate equipment, safety training and precautions, extra space for movement ofmaterial and waiting for deliveries due to delays (Severens, 2003).

Excessivetransport also creates opportunities for handling damage and losses, which canbe of high value. The main contributor to the waste of transport includes thewaste of overproduction, which leads to the waste of inventory. By improving layouts and utilising valuestream mapping and process mapping can lead to huge savings in time and money. Figure 8. Image detailing transportation (Earley, 2017).

     Quality errors thatcause defects can be extremely costly. Every defective item requires rework orreplacement, which wastes resources, materials and it created paperwork andloss of customers. Implementation of Pokayoke systems and autonomation can helpprevent defects from occurring.

           Manydefects are caused by incorrect method due to non-standard operations,differences in the way that processes are undertaken by different operators ondifferent shifts. Also, errors are unknowingly built into our products byfailure to think about the best way items can be assembled (Pronovost , 2004).Leadinga culture that empowers and makes our operators confident to highlight problemsand solve them means that there would be a reduced number of defects beingproduced if operators are confident to highlight problems in manufacture andpackaging earlier on. We aim to prevent waste before they occur, byimplementing standardised efficient procedures and high quality training toensure that the correct methods are undertaken and standards are achieved.  The waste of overprocessing can occur due to use of inappropriate techniques, oversizedequipment, working to tight deadlines and tight tolerances and performingprocesses that are not required by the customer.

 The fundamental causes of over processing are dueto having unclear standards and specifications. It is very likely thatoperators will not be aware of what parts in a process truly adds value to theproduct or even the end use (Jimmerson et al, 2005). Standardised working practices ensure that thereare no differences in methods. Design of procedures and processes also meansthat potentially we are working to tighter tolerances which could be producedby significantly less expensive methods. Reviewing designs with techniques such as value engineering and value analysisto identify opportunities to remove tolerances that are too tight would alsoimprove reducing over-processing.

  Jidoka describes quality at source, or’built in quality’. Initially Jidoka began with the invention by Sakichi Toyodain 1896 of a simple device that could stop the shuttle on an automatic loom ifthe thread broke. This meant that the machine was prevented from not onlycreating defects but also alerted the operator to a problem which meant thatone operator could now operate several looms rather than have to stand therewatching just one in case something went wrong. This principle became known asautonomation.Theprinciple of Jidoka can be broken down into; Discover an abnormality STOP Fix the immediate problem Investigate and correct root causeJidokaprinciple gives every individual the authority to stop a process should theydiscover an abnormality. This way, defects and problems are highlighted andactions are taken immediately.

By removing problems from processes, within ashort period of time the numbers of problems occurring begin to reduce andproductivity begins to improve as root causes of problems are removed(Rosenthal, 2002).  Many machines produced today haveincorporated autonomation ideals in their design. However, operators cannotrely solely on machines and must be trained in appropriate problem solvingskills in order to remove the root cause of problems when an issue ishighlighted. We then need to ensure that any process documentation is updatedto incorporate the changes and that we communicate those changes across similarprocesses and products to spread the learning.  JIT isa management philosophy that calls for the production of what the customerwants, when they want it, in the quantities requested, where they want it,without it being delayed in inventory. This means that instead of buildinglarge stocks of presumptive orders, the company must stick to making exactlywhat the customer asks for when they ask for it. Intraditional manufacturing we try to predict what the customer will want and wewill create a forecast against which we will produce our products. We will alsotry to produce those products in large batches as the belief is that will makemachines and processes more efficient, especially if those machines require along time to setup.

This will typically result in long lead times through ourprocesses, huge amounts of WIP stocks and also large quantities of finishedgoods stocks that have not yet been ordered by our customers. If thecustomer does order something that is not in our current stocks they willeither have to wait many weeks or even months for the product to bemanufactured or work will be hurried through the system by progress chaserscausing a huge amount of disruption to the production schedule (Ben-Tovim,2007)..A JITsystem on the other hand will seek to use simple visual tools known as Kanbansto pull production through the processes according to what the customeractually takes. It massively reduces the amount of stock held and will reducelead times by a significant amount, often from weeks to just a few hours ordays (Womack et al, 1990).

 Thefollowing are some of the many benefits that you could gain through theimplementation of just in time: Figure 11. Image illustrating the order-cash timeline (Reference)        Kanban is a visual method forcontrolling production as part of JIT and Lean Manufacturing. As part of a pullsystem it controls what is produced, in what quantity, and when.

The systemensures 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 productfrom customer demand back to raw materials (Hiroyuki & Furuya, 2006; Hopp,2004). It is important to maintain aschedule for facilities and equipment. Regular equipment maintenance preventsequipment breakdowns which can be costly. It also reduces the risk of productcontamination and maintains the validated state of the facility or equipment.It is also a Good Manufacturing Practice (GMP) requirement to have amaintenance schedule in place with the frequency determined by the criticalityof the equipment.

GMP requires you to keep accurate records relating tomaintenance 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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