Implementing Lean Six Sigma in healthcare: issues from Italy

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Implementing Lean Six Sigma in healthcare: issuesfrom ItalyAndrea Chiarini & Enrico BracciPublished online: 01 Jul 2013.

To cite this article: Andrea Chiarini & Enrico Bracci (2013) Implementing Lean Six Sigma in healthcare: issues from Italy,Public Money & Management, 33:5, 361-368, DOI: 10.1080/09540962.2013.817126

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Inefficiency, waste and lack of quality areavoidable factors, which are partly responsiblefor the increasing costs of healthcare indeveloped countries. Inefficiency and lack ofquality can be measured, managed and changedthrough the introduction of continuousimprovement process and technologies (Koninget al., 2006).

Lean Six Sigma is a blend of Lean thinkingand Six Sigma. It is an approach to processimprovement that is currently popular inmanufacturing, as well as in some public servicessuch as public utilities, education and localgovernment (Radnor and Boaden, 2008).Brandão de Souza and Pidd (2011) highlightedthe implementation barriers to Leanimplementation in healthcare; and Proudloveet al. (2008) examined the lessons learned fromusing Six Sigma in the National Health Service(NHS) in the UK. However, despite recentprogress, the application of Lean Six Sigma inhealthcare still poses some challenges toresearchers and practitioners (Vest and Gamm,2009). For instance, it is not entirely clear howthe two systems, Lean and Six Sigma, can co-exist. This may explain the limited use of LeanSix Sigma in healthcare organizations.However, in Italy, there are a few examples ofsuccessful implementation of Lean Six Sigmain healthcare (Chiarini, 2013a).

The research reported in this paper wasaimed at understanding how, and in whatconditions, the Lean Six Sigma model might beadapted to the healthcare context, with a focuson the issues around people and process(Radnor and Boaden, 2008, p. 6). Empiricaldata in the paper are from two case studies ofItalian public sector healthcare organizationswhich carried out Lean Six Sigma projects.

Lean, Six Sigma and Lean Six Sigma:variations on a themePublic healthcare systems in developedcountries are being pushed to adopt systemsthat will improve efficiency and effectiveness.In addition, a growing pressure on the publicsector to reduce costs has led the adoption ofprivate management technologies (Fillingham,2007). Central and federal government(Radnor, 2010), and local government (Seddon,2005; Krings et al., 2006), have responded tothese pressures by implementing businessprocess improvement methodologies. Theseinclude Lean thinking and Six Sigma (see table1), as well as blended approaches such as LeanSix Sigma (Chiarini, 2012a).

The term ‘Lean thinking’ was coined byWomack and Jones (1998) after they studiedthe Toyota Production System (TPS). TaiichiOhno invented the TPS and identified seventypes of process waste: overproduction,inventory, extra processing steps, motion,defects, waiting, transportation (Ohno, 1988).Process waste increases production time andreduces the value added. Lean seeks to improveproduct flow and eliminate all forms of waste.According to Womack and Jones (1998), quickteams continually try to remove waste andmany small improvements foster thedevelopment of culture of improvement.

A peculiarity of these improvement projectsis their short duration (on average a week), andthe maximum involvement of people (Wickens,1993; Liker and Meier, 2007). Lean does notneed advanced statistical training, nor is itessential to have certified black and green belts.Lean specialists are team leaders who have tofacilitate Lean tools application for everyone.Lean inherits some basic problem-solving tools

Andrea Chiarini is avisiting professor atthe University ofFerrara, Italy.

Enrico Bracci isSenior Lecturer inBusiness Economics,University ofFerrara, Italy.

Implementing Lean Six Sigma inhealthcare: issues from ItalyAndrea Chiarini and Enrico Bracci

Lean Six Sigma is a method for strategic process improvement that aims toimprove operational uniformity and quality, and reduce variations and waste.Lean thinking and Six Sigma have traditionally been applied to manufacturing.This paper examines ways of using Lean Six Sigma in healthcare organizations.The authors discuss the implications of their research for practitioners (managersand physicians) and present an agenda for future research.Keywords: DMAIC, healthcare, Lean, Lean Six Sigma, Six Sigma, total quality management(TQM).

http://dx.doi.org/10.1080/09540962.2013.817126

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from total quality management (TQM) andproposes specific tools for speeding processflow. Examples are value stream mapping(VSM) for mapping flow and finding the waste;5S for organizing the workplace; and single-minute exchange of die (SMED) for quicklychanging from one product/service to another.In a recent literature review examining the useof business process improvementmethodologies in the public sector, it was foundthat 51% of publications focused on Lean and35% of theses were in the health sector (Radnor,2010).

Six Sigma was introduced by Motorola inthe 1990s and then improved by companiessuch as General Electric. It is characterized bya powerful project management pattern called‘DMAIC’ (define-measure-analyse-improve-control). Six Sigma can be defined as ‘anorganized and systematic method for strategicprocess improvements and new product andservice development that relies on statisticalmethods and the scientific method to makedramatic reductions in customer defined defectrates’ (Linderman et al., 2003; Senapati, 2004).Six Sigma focuses on problems, it uses numbersand statistics in order to reduce variations in allprocesses. Volland (2005) has clearlydemonstrated the value of using in Six Sigmatools in healthcare.

Six Sigma explicitly applies the five stagesof the DMAIC to the different levels of theorganization: business, operations, processes.In the define phase (D), a charter is draftedincluding a cost-benefit analysis. If the cost-benefit analysis meets the company’s thresholds,the charter will be accepted, and the project

will continue through the DMAIC process. Inthe subsequent measure phase (M), baselinedata are gathered, and diagnosing begins. Theproblem is then measured into quantifiableterms using critical-to-quality (CTQ)characteristics. The analysis phase (A) continuesthe diagnosis and involves an identification ofpossible cause-and-effect relationships betweeninputs and the CTQs. After the analysis hasbeen completed, the team proceeds bysuggesting potential solutions to the problemsand proposes improvement projects (I). Finally,in the control phase (C), control systems aredeveloped to ensure that improvements areachieved and maintained. The new improvedprocess can be handed over to the day-to-dayoperations staff. Each of the five DMAlC phasesinvolves detailed plans that help to guide teamleaders through the execution of the qualityimprovement project (De Koning and DeMast,2006). During the DMAIC path, team membersare supposed to implement all the toolsinherited from TQM (Chiarini, 2013b),including advanced statistical tools such asANOVA, regressions, design of experiments(DOE) and many others. Six Sigma practitionerscan certify as black belt or green belt, dependingon whether or not they are team leaders (Harryand Schroeder, 2000). To receive certification,they have to demonstrate a good knowledge ofstatistical improvement tools and dedicatedsoftware.

In the past decade or so, Six Sigma hasencountered Lean thinking, and shaped whatGeorge (2003) called ‘Lean Six Sigma’. One ofthe reasons for the fusion of these importantbusiness improvement systems is that Six Sigma

Table 1. Lean thinking and Six Sigma compared. (Adapted from Westwoo and Silvester, 2007.)

Lean thinking Six Sigma

Theory Improve flow and eliminate waste Eliminate defects and reduce variation

Focus Flow Problem

Assumptions Waste removal will improve System output improves if variation in allperformance. Many small processes is reduced. Figures and numbersimprovements help and develop are the way to identify problemsa culture of improvement

Primary effect Reduce flow time Uniform process output

Secondary effect Less variation Less wasteUniform output Fast throughputLess inventory Less inventoryNew accounting system Variation metricsFlow metrics Improved qualityImproved quality

Criticisms Less emphasis on statistical System interaction between processes is notanalysis and tools considered. Processes are improved independently.

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has some significant weaknesses (Koning et al.,2006):

•First, the complexity of Six Sigma, in the caseof simple problems with obvious and easy-to-implement solutions, may lead to aninefficient problem-solving process (George,2003).

•Second, unlike Lean, Six Sigma does not haveany standard solutions to common problems.

•Third, the danger of sub-optimizing a process,while failing to take into account the entirevalue chain, is ever present.

Nevertheless, Six Sigma offers a structured,analytic and logically sound approach toproblem-solving, as well as a strongorganizational framework. Six Sigma isproblem-focused, and it assumes that processvariation is waste because it generates defectsand costs of poor quality.

Lean thinking, by contrast, is focused onprocess flow and lead time. It views any activitythat does not add value as waste. Lean SixSigma combines the ‘speed’ introduced by Lean,the management of improvement projects, theSix Sigma DMAIC pattern and the Six Sigmacapability of reducing variation (Chiarini,2012a). On the other hand, Lean thinkingprovides a total systems approach, although itis less keen on analytical and statistical tools; asa consequence, merging the two approachesresults in a technique that is able to adapt tocomplex situations.

Lean Six Sigma seems to be a well-established model for improving processes inhealthcare organizations (Bahensky et al., 2005;De Koning et al., 2006; Caldwell et al., 2009;Vest and Gamm, 2009; Chiarini, 2012a). Someauthors have questioned the benefits of usingLean Six Sigma in healthcare (Bisgaard andFreiesleben, 2004; Bisgaard and DeMast, 2005).For example Proudlove et al. (2008) examinedthe lessons learned from using Six Sigma in theNHS and called for specific adaptations to thebasic model, whereas Radnor and Boaden(2008) stressed the need to focus on processesand people when introducing Lean Six Sigmamethods in healthcare.

However, there is limited evidence in theacademic literature of how to combine Leanand Six Sigma tools, and which situations shoulduse Lean tools rather than Six Sigma tools.

Case studies: combining Six Sigma andLean healthcareTo better understand how to combine SixSigma and Lean, research was conducted

through exploratory case studies in two Italianpublicly-owned healthcare organizations. Bothcases were public hospitals that hadexperimented with Lean Six Sigma for aboutfour years. Both hospitals were large: one with1750 beds and the other with over 2500 beds.Two medical managers, both doctors, for eachhospital, involved in the introduction ofexperimentation with Lean Six Sigma in theirorganizational units were interviewed. Theinterviews lasted about three hours each andwere conducted onsite. The answers were notedand key concepts to be analysed werehighlighted. The questions in the draft aide-mémoire were of the open type. Beforeinterviewing the doctors in the two hospitals,an interviewer guide was developed (seeAppendix 1). This guide contained some openquestions that explored the specific areas ofinterest, focusing on:

•The adaptation needed to the basic Lean SixSigma model in the context of a hospital.

•The extent to which Six Sigma and otherLean tools can be adopted in a hospital’sprocesses.

Organizational culture can influenceinterviewees’ responses, so responses werechecked through a focus group. Afterconducting an interview, leading a focus grouphelped the researcher to validate answers andbe able to define patterns of behaviour across awider audience. The focus group had sixmembers who were about to manage a newLean Six Sigma project. These people weredoctors and nurses who had carried out LeanSix Sigma projects in the past. In particular,one doctor had been a Six Sigma black belt orteam leader, and the others had led relevantprojects that had faced technical andorganizational problems. The researcher usedthe questionnaire shown in Appendix 2 as aguideline (the questionnaire used in the focusgroup was not filled out by the participants).

Institutional and cultural aspects of Lean Six Sigmain public healthcareThe interviews and the focus groupdemonstrated that Lean Six Sigma applied tohealthcare calls for interesting and distinctiveprinciples and tools. Peculiarities of Lean SixSigma principles in Italian healthcare can beconsidered at three different levels: strategic(or political), technical and process. Themanagers and focus group raised several issues.

First, targets should not always be linked toeconomic-financial savings. The doctors

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considered customer satisfaction to be a majortarget and, due also to ethical reasons, this canlead economic factors being neglected. Onedoctor stressed that ‘patient satisfactionsometimes is not a matter of money’. The otherdoctor underlined how patients are citizenswho pay huge taxes towards the Italianhealthcare system and consequently want thebest healthcare. So the doctors we interviewedthought that cost reduction should not be theonly driver for improvement projects. As in themanufacturing field, it is important to obtainsavings; nevertheless, savings may not be themain target. This was also the view of the focusgroup; they gave examples—for instance,providing an expensive drug will drive upcosts, but can improve a patient’s quality of life.In addition, a geriatric department in one ofthe hospitals added a new nurse—costsincreased, but patient satisfaction more thandoubled. So ethical considerations and patientsatisfaction may not correspond with the targetto obtain savings. Public healthcare expenditurein Europe (generally EU countries spendaround 10% of their GDP on health) is high,and most countries are dealing with budgetdeficits. To reach objectives such as patientsatisfaction, the reduction of waiting lists,infections and mortalities, public healthcareorganizations in countries such as Greece, Italy,Spain, Portugal and even France and the UK,can mean that a country has to spend morethan its income. It is important to note herethat, in the private sector, savings is one of themajor objectives behind the implementation ofLean Six Sigma (George, 2003; Chiarini, 2013c).

Second, in Italy, strategic targets oftendepend on local and national laws, and onpolitical choices and decisions. The doctorsexplained how local politicians can sometimesimpose strategic goals on a hospital and discussother ones with the senior managers. The firstdoctor, for instance, said that the one of theLean Six Sigma projects launched was aboutthe reduction of the waiting list for a specificservice. This was the result of a regional law.The second doctor told us that: ‘we are subjectedto many political issues. We cannot decide onour own what the Lean Six Sigma improvementsare’. So the targets in Lean Six Sigma projectsmight have nothing to do with an organization’sstrategic objectives but can be imposed by policy-makers.

Third, the characteristics of the processesinvolved are such that staff rarely use advancedstatistical tools. The processes tend to betransactional in nature. In transactionalprocesses, the number of variables (for example

patient arrival, patient conditions, patients’requests) that may affect the way the process iscarried out is high. Consequently, Lean toolsare preferable in order to analyse constraintsand value-added activities. Indeed, in thetransactional aspects of the processes, advancedstatistical tools are less useful than tools thatmake processes faster and simpler, such asthose derived from Lean thinking. For instance,the second doctor claimed: ‘we follow a typicalDMAIC pattern. However, inside this patternwe surely prefer Lean tools than statistical toolsderived from TQM or Six Sigma. Maybe thatcould be also related to our basic education’.The focus group was of the same view: all wereunaccustomed to advanced statistical tools.Nevertheless, statistical tools (for exampleANOVA and multiple regression) were beingused in projects where the factors that affect anoutput had to be investigated, such as infectionsor the quality of drugs. A nurse in the focusgroup said: ‘we are not engineers, butimplementing Lean Six Sigma we have to learnto act like them’.

The hospital found it difficult to find therelevant staff to be team members for the SixSigma project given their educationalbackground and lack of a statistical and/orengineering education. The roles and skills ofthe team members were frequently tied toorganizational structure and culture.Nevertheless, there was always a staff memberwith black or green belt certification on theproject team. However, the training coursestaff attended was more suitable formanufacturing industries. Apparently, thereare no specific training courses for healthcarein Europe. For instance, the first doctor said:‘Last year I attended a Lean Six Sigma coursebut the trainers were not very skilled inhealthcare processes. I looked up on the internetfor a specific Lean Six Sigma course dedicatedto healthcare, but I found just one in the USA’.Both the doctors interviewed wanted a coursedesigned for the field of healthcare.

We found cultural influences on theselection of the team members dedicated toLean Six Sigma projects. It emerged from afocus group that the black belt role was just fordoctors and not for nurses or paramedics. Onenurse said: ‘We nurses do not usually have amaster’s degree like the doctors, so ourorganization does not want to invest a cent inqualifying us as black belts’. Another nursesaid: ‘Our general manager prefers to havedoctors as team leaders. Consequently they arethe only ones that can achieve the black beltqualification’.

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Our interviews and focus group meetingsdemonstrated that Lean Six Sigma can beapplied to healthcare to meet targets that arenot necessarily economic or financial—political,legal and customer satisfaction targets can beachieved. In the large Italian hospitalsemploying Lean Six Sigma, advanced statisticaltools were rarely used but were not excluded—their use depended on the type of process.

Lean Six Sigma tools and healthcare processesFrom a technical point of view, a flexibleapproach is needed when applying Lean SixSigma to public sector healthcare. Differenttools inside the DMAIC path need to be useddepending on the characteristics of thehealthcare process involved. Table 2 showswhich kind of tools the Lean Six Sigma teamsused in different situations. If the process ishighly structured and has constraints, thenLean mapping tools are best used, rather thanthe advanced statistical methods in pure SixSigma projects. This point was emphasized bythe two doctors we interviewed. The first doctor,for instance, claimed: ‘Often we have to dealwith long patient-care processes. Therefore,first of all, we need to understand where wewaste time by carefully mapping the processesas a whole’. The second doctor explained that:‘Lean mapping tools such as VSM allow us tosee the overall picture. Statistical tools can beused on a second occasion, but only in case ofneed’.

Some focus group participants said thatuse of statistical tools depended on theparticularities of the staff, but also on thedifficulty of standardizing the process and theinput-output relations. They discussed theaccident and emergency department, wherethe variables that affect the process cannot befully considered. Mapping tools, such as VSMor Lean office tools, are particularly suitable incases in which there is no physical productinside the process, but a patient along with his/her medical record. By means of these mappingtools, doctors and nurses can track the patient,in terms of waiting times and the level ofdefectiveness during the process.

During the interviews, one of the doctors

discussed the classic Lean tools used inside aLean Six Sigma DMAIC pattern. He said: ‘Inthe manufacturing industry it is interesting tonote how managers tend to apply all the TPStools…But I’m not so sure whether we canapply all these tools in the same way’. Accordingto Ohno (1988), it is fundamental, after havingmapped the processes, to reduce lead time bymeans of tools such as SMED, Kanban, grouptechnology and many others. Althoughpractitioners in public healthcare haveintroduced these tools, they are better suited tomanufacturing (Vissers and Beech, 2005;Chiarini, 2012a, 2012b). Interestingly, oneparticipant in the focus group suggested that,in any case, after having applied a tool, it wasimportant to evaluate any patient risksintroduced as a result. This fundamental aspectwas also confirmed by the two doctors whowere concerned that this was too much takenfor granted in healthcare. Therefore, riskmanagement tools are more important in thehealthcare sector than in many manufacturingsectors; the same is true in nuclear,pharmaceutical and aerospace applications.

In cases in which the process is affected byseveral technical and physical factors, but wherestandardization of the process is possible, thenthe adoption of pure Six Sigma tools isappropriate and potentially fruitful. In theseinstances it is then feasible to apply statisticalanalysis to detect the causes of variations inquality standards. One of our doctors, forexample, explained: ‘So far we have used someadvanced statistical tools only for analysinghow to reduce causes of bacterial concentrationin the wards. We were forced to use suchdifficult tools because with other tools it is quiteimpossible to understand what the real rootcauses are’.

Overall, given the characteristics of thehealthcare organizations analysed, advancedstatistical tools are less important in healthcarethan in other industries, whereas riskmanagement tools are more important. Thisconsideration calls for a comprehensiveapproach to healthcare when dealing withquality improvement, in which the fullmethodological and technical arsenal available,

Table 2. Lean Six Sigma tools and healthcare processes.

Process highly transactional with constraints that Tools for value mapping derived from Lean thinkingslow down the flow (with a focus on risk management)

Process standardized and affected by technical- All Lean Six-Sigma tools (with focus on riskphysical factors management)

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from Lean and TQM tools to Six Sigma tools,is adopted.

Conclusions, implications and agenda forfuture researchIn light of our results we present someconcluding considerations and implications forpractice and research. There are three mainissues: institutional, cultural and technical.

From an institutional point of view, the useof the Lean Six Sigma model in public healthcarewill be influenced by the system’s regulationsand the incentives that the laws create. Pursuingcontinuous quality improvement, reducingwaiting lists and increasing operationalefficiency are strategic objectives that should bea political imperative. The role of thestakeholders (politicians, unionists, doctors,paramedics, managers and heads ofdepartments etc.) and their impact on the useof Lean Six Sigma in an organization is animportant issue to analyse. This issue isparticularly important in the Italian politicalsituation where local politicians are able todecide strategies in public healthcareorganizations.

The doctors we interviewed and theparticipants in our focus group agreed thatthere were important differences betweenimplementing Lean Six Sigma in publichealthcare organizations and implementing itin other entities. First of all, in the privatesector, Lean Six Sigma projects are driven bycost savings. It is impossible to launch a LeanSix Sigma project without filling in a costjustification chart measuring expected savings(Pyzdek, 2003). In contrast, public healthcareorganizations can be required to carry outimprovement projects that do not producesavings and might even add costs. Ultimately,profits and savings are not the only reasons forapplying Lean Six Sigma in healthcare. LeanSix Sigma teams in public healthcare have tofollow regulations and local political decisions,and take into account the demands of manydifferent stakeholders, such as patients’ rightsassociations and non-governmentalorganizations. In the private sector, the marketdrives Lean Six Sigma projects. As aconsequence, in the short term, Lean Six Sigmaimprovement projects in public healthcare neednot necessarily be linked to economical-financialresults. This issue probably can be generalizedto the entire European public healthcare sectorbecause its income is mainly from taxation(Alesina and Giavazzi, 2006) and patientsatisfaction is an important political concern.

Interesting cultural aspects emerged from

the two case studies. The interviewees agreedthat all Lean Six Sigma tools, including the SixSigma statistical ones, can be adopted inhealthcare. However, after a deeper analysis ofthe results, we found that doctors and nurseswere not particularly keen on using statisticaltools. They agreed that statistics are important,especially for problem-solving, but expressedconcern about the weak statistical backgroundof doctors and nurses. This could mean thatLean thinking projects will be used more widelyin healthcare organizations than Lean SixSigma. It would be interesting to explorewhether this is a worldwide phenomenon orpeculiar to Italy. Finally, in Italian publichealthcare there is an issue in that black belttraining appears to be available only to doctorsand not to nurses.

Of the classic Lean tools derived from theTPS, the most important in healthcare are themapping tools. Risk management tools werealways used along with the other Lean SixSigma tools. It was not so clear how, and howmany Lean tools were being used within theLean Six Sigma DMAIC pattern. Undoubtedly,there was a difference between our healthcareapplications of Lean Six Sigma and applicationsin the manufacturing sector or other privatesector organizations. Generally, we found that,in Italian public healthcare, there is less use ofstatistical tools and more use of basic TQM andLean tools. The doctors we interviewed andthe focus group participants suggested thatclassic Lean manufacturing tools should beapplied in a different way. This is an interestingissue for future research about Lean tools andtheir application in healthcare.

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Appendix 1: Draft aide-mémoire (interviewer’s guide)

1 Good morning doctor, you are being interviewed as an expert on Lean Six Sigma and Total QualityManagement. How long have you been dealing with Total Quality Management in the healthcaresector? (Try to understand if the person really is an expert on Six Sigma.)

2 Besides the project that we will discuss soon, have you managed other similar projects? (I am alwaystrying to understand his/her skills on the matter.)

3 How much time have you spent on the Six Sigma project and what role did you have in the project?(Try to understand if he/she has a deep knowledge of the project.)

4 Who sponsored the project? (This is the beginning of the technical part of the interview.)

5 Was the project linked to the strategic objectives of the business plan?

6 What kind of objectives?

7 How did you appoint the members of the Lean and Six Sigma team? (Try to understand if the teamwas really a team with TQM or Lean Six Sigma skills or something else.)

8 Did you train your team in any particular way? (For example black and green belt certification.)

9 How did you choose the team leader?

10 Did you structure the classic Six Sigma DMAIC path in other ways?

11 What kind of tools did you use during the path? (This is the core of the evaluation.)

12 What kind of statistical tools did you use?

13 When did you use advanced statistical tools?

14 When did you use Lean tools and TQM tools?

15 Do you believe that advanced statistical tools can affect the results of a Lean Six Sigma project?

16 What about the participants’ skills?

17 What about the awareness and behaviour of the team participants? (Very open question; pay attentionto doctor’s views about organization, how to involve the participants, their cultural background andso on.)

18 What about the language used by the team? Was it the same as used in the manufacturing field?

19 Could this kind of language change the meaning of the classic Lean Six Sigma vocabulary?

20 Were the results achieved by the whole team? Partially/totally?

21 Do you believe that only economic results are important in healthcare?

22 What other kinds of results are important?

Appendix 2. Focus group questionnaire: not given to participants but read to them.Answers were rated as follows: ‘Never before’; ‘Just a little’; ‘Yes’; ‘Yes, very well’.

1 Do the participants already know Lean Six Sigma?

2 Do the participants know any quality tools for improvements (i.e. Pareto, Fish-Bone etc.)

3 Have the participants ever implemented any of the quality tools?

4 Do the participants know any advanced statistical tools?

5 Have the participants ever managed an improving project?

6 Do the participants know some of the tools for certifying the results of the improving project?

7 Do the participants use tools taken from Lean Thinking inside the DMAIC pattern?

Debate with the participants. Notes: how to lead the DMAIC path, organizational aspects, when and whatLean Six Sigma tools were used etc.

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Documents

Implementing Lean Six Sigma in healthcare: issues from Italy