Lean manufacturing tools for Mudas removal.
\r\n\t
",isbn:"978-1-83881-922-4",printIsbn:"978-1-83881-921-7",pdfIsbn:"978-1-83881-923-1",doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!1,hash:"dcfc52d92f694b0848977a3c11c13d00",bookSignature:"Dr. Fiaz Ahmad and Prof. Muhammad Sultan",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/10454.jpg",keywords:"Agricultural Engineering, Technologies, Application, Sustainable Agriculture, Information Technology in Agriculture, Food Security, Renewable Energies, Precision Farming, Smart Agriculture, Farm Mechanization, Robotics, Post Harvest Technologies",numberOfDownloads:null,numberOfWosCitations:0,numberOfCrossrefCitations:null,numberOfDimensionsCitations:null,numberOfTotalCitations:null,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"November 25th 2020",dateEndSecondStepPublish:"December 23rd 2020",dateEndThirdStepPublish:"February 21st 2021",dateEndFourthStepPublish:"May 12th 2021",dateEndFifthStepPublish:"July 11th 2021",remainingDaysToSecondStep:"2 months",secondStepPassed:!0,currentStepOfPublishingProcess:4,editedByType:null,kuFlag:!1,biosketch:"Dr. Ahmad is a researcher in the field of agricultural mechanization and agricultural equipment engineering, in-charge of Farm Machinery Design Laboratory at Bahauddin Zakariya University, with expertise in modeling and simulation. He applied for two patents at the national level.",coeditorOneBiosketch:"Renowned researcher with a focus on developing energy-efficient heat- and/or water-driven temperature and humidity control systems for agricultural storage, greenhouse, agricultural livestock and poultry applications including HVAC, desiccant air-conditioning, adsorption, Maisotsenko cycle (M-cycle), and adsorption desalination.",coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"338219",title:"Dr.",name:"Fiaz",middleName:null,surname:"Ahmad",slug:"fiaz-ahmad",fullName:"Fiaz Ahmad",profilePictureURL:"https://mts.intechopen.com/storage/users/338219/images/system/338219.jpg",biography:"Fiaz Ahmad obtained his Ph.D. (2015) from Nanjing Agriculture University China in the field of Agricultural Bioenvironmental and Energy Engineering and Postdoc (2020) from Jiangsu University China in the field of Plant protection Engineering. He got the Higher Education Commission, Pakistan Scholarship for Ph.D. studies, and Post-Doctoral Fellowship from Jiangsu Government, China. During postdoctoral studies, he worked on the application of unmanned aerial vehicle sprayers for agrochemical applications to control pests and weeds. He passed the B.S. and M.S. degrees in agricultural engineering from the University of Agriculture Faisalabad, Pakistan in 2007. From 2007 to 2008, he was a Lecturer in the Department of Agricultural Engineering, Bahauddin Zakariya University, Multan-Pakistan. Since 2009, he has been an Assistant Professor in the Department of Agricultural Engineering, BZ University Multan, Pakistan. He is the author of 33 journal articles. He also supervised 6 master students and is currently supervising 5 master and 2 Ph.D. students. In addition, Dr. Ahmad completed three university-funded projects. His research interests include the design of agricultural machinery, artificial intelligence, and plant protection environment.",institutionString:"Bahauddin Zakariya University",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"Bahauddin Zakariya University",institutionURL:null,country:{name:"Pakistan"}}}],coeditorOne:{id:"199381",title:"Prof.",name:"Muhammad",middleName:null,surname:"Sultan",slug:"muhammad-sultan",fullName:"Muhammad Sultan",profilePictureURL:"https://mts.intechopen.com/storage/users/199381/images/system/199381.jpeg",biography:"Muhammad Sultan completed his Ph.D. (2015) and Postdoc (2017) from Kyushu University (Japan) in the field of Energy and Environmental Engineering. He was an awardee of MEXT and JASSO fellowships (from the Japanese Government) during Ph.D. and Postdoc studies, respectively. In 2019, he did Postdoc as a Canadian Queen Elizabeth Advanced Scholar at Simon Fraser University (Canada) in the field of Mechatronic Systems Engineering. He received his Master\\'s in Environmental Engineering (2010) and Bachelor in Agricultural Engineering (2008) with distinctions, from the University of Agriculture, Faisalabad. He worked for Kyushu University International Institute for Carbon-Neutral Energy Research (WPI-I2CNER) for two years. Currently, he is working as an Assistant Professor at the Department of Agricultural Engineering, Bahauddin Zakariya University (Pakistan). He has supervised 10+ M.Eng./Ph.D. students so far and 10+ M.Eng./Ph.D. students are currently working under his supervision. He has published more than 70+ journal articles, 70+ conference articles, and a few magazine articles, with the addition of 2 book chapters and 2 edited/co-edited books. Dr. Sultan is serving as a Leading Guest Editor of a special issue in the Sustainability (MDPI) journal (IF 2.58). In addition, he is appointed as a Regional Editor for the Evergreen Journal of Kyushu University. His research is focused on developing energy-efficient heat- and/or water-driven temperature and humidity control systems for agricultural storage, greenhouse, livestock, and poultry applications. His research keywords include HVAC, desiccant air-conditioning, evaporative cooling, adsorption cooling, energy recovery ventilator, adsorption heat pump, Maisotsenko cycle (M-cycle), wastewater, energy recovery ventilators; adsorption desalination; and agricultural, poultry and livestock applications.",institutionString:"Bahauddin Zakariya University",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"2",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"Bahauddin Zakariya University",institutionURL:null,country:{name:"Pakistan"}}},coeditorTwo:null,coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"8",title:"Chemistry",slug:"chemistry"}],chapters:null,productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"},personalPublishingAssistant:{id:"252211",firstName:"Sara",lastName:"Debeuc",middleName:null,title:"Ms.",imageUrl:"https://mts.intechopen.com/storage/users/252211/images/7239_n.png",email:"sara.d@intechopen.com",biography:"As an Author Service Manager my responsibilities include monitoring and facilitating all publishing activities for authors and editors. From chapter submission and review, to approval and revision, copyediting and design, until final publication, I work closely with authors and editors to ensure a simple and easy publishing process. I maintain constant and effective communication with authors, editors and reviewers, which allows for a level of personal support that enables contributors to fully commit and concentrate on the chapters they are writing, editing, or reviewing. I assist authors in the preparation of their full chapter submissions and track important deadlines and ensure they are met. I help to coordinate internal processes such as linguistic review, and monitor the technical aspects of the process. As an ASM I am also involved in the acquisition of editors. 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To prevent rejection of SOT, the use of IS is essential. And with the continuous development of medical technology, individualized treatment has been paid much more attention. With the advent of new drugs, more choices of IS combination are available in present clinical practice, and the most widely used of which is a calcineurin inhibitor (CNI) + an antiproliferative agent + corticosteroid. Tacrolimus (Tac) and ciclosporin (CsA) are both CNI, and Tac has held most of the market in recent years. Mycophenolate (MMF) is the most widely used antiproliferative agent, which is a prodrug of mycophenolic acid (MPA) that has immunosuppressive activity [2]. There is also a monosodium salt of MPA that was developed to overcome the gastrointestinal side effects of MMF. Ahead of the “triple immunosuppressive therapy”, many maintenance regimens also have induction therapy, which consists of antibodies to lymphocytes. The mammalian target of rapamycin (mTOR) is a more recent IS, which includes sirolimus (SRL) and everolimus (EVE). They were first envisaged as a primary IS in regimens without CNI [1, 3, 4], while now, most of the time they are used at low doses in CNI-sparing regimens [5, 6].
To achieve the target blood concentration fast with less dose adjustment is clinically important, for the therapeutic window of these IS is narrow, which may lead to either acute rejection or over-immunosuppression [7, 8, 9]. There are also numerous drug-specific adverse effects, CNI has a closer relation to high blood pressure hypertension, nephrotoxicity, and new-onset diabetes after transplantation (NODAT) [10], steroids may also lead to NODAT [11], and the mTOR inhibitors are often associated with delayed wound healing and hyperlipidemia [8]. In the majority of cases, these adverse effects are associated with high drug concentrations in the blood, but this is by no means universal [12].
In consideration of inter-individual variation in PK of IS, monitoring the blood concentration has been essential. Therapeutic drug monitoring (TDM) has been widely used to ensure the blood concentration of CNI and SRL [13]. In daily clinical practice, the blood sample is taken and measured at a single time-point immediately before the next dose (called C0 or trough concentration). Although recent studies have suggested that, for measurement of CsA, 2 h after dosing (C2) correlates better with the area under the concentration-time curve (AUC) compared to C0 [9]. This may also apply for Tac, but the practice has not been adopted widely [12, 14, 15].
TDM is no doubt powerful and indispensable in the current management of IS, while many patients may still experience a significant delay in achieving target blood-concentrations, and drug dosage need to be adjusted repeatedly, which could significantly increase the risk of acute graft rejection [9, 16]. The narrow therapeutic window of the IS makes it impossible to use a higher initial dose for all patients, and here comes an unmet need for a strategy, which can lead to the fast achievement of IS target blood concentration in the period immediately following transplantation for all the patients. Fortunately, the investigation of GP combined with critical patient data and concomitant medications may help and thus potentially reduce the adverse events related to over- or under-exposure. In addition, studies may also possibly reveal the association between GP and IS PD, which may help clinicians to choose a better combination of IS for the specific group. A strategy based on GP is most likely to be effective when a single gene has a major influence on the absorption, disposition, elimination or tissue compartmentalization of a drug [12].
This chapter discusses the published genetic associations with IS PK and PD, and their potential use in clinical practice to guide drug dosing in SOT.
Tac is a 23-membered macrolide lactone isolated from Streptomyces tsukubaensis in 1987 for the first time [17], and in 1994, the US Food and Drug Administration firstly approved Tac for liver transplantation. Due to its excellent efficacy, Tac has been extended as a first-line regimen for kidney, heart, lung, intestinal and bone marrow transplantation. Genetic factors including CYP3A5*3, CYP3A4*1B, CYP3A4*22, ABCB1, and POR*28 have been reported frequently for their influence on Tac dose requirement, which reveals the importance of GP of Tac.
Reportedly, polymorphisms in the CYP3A5 gene may explain 40–50% of the variability in Tac dose requirement [18, 19]. The hottest SNP studied in CYP3A5 is CYP3A5*3, which is an A to G transition at position 6986 within intron 3 (rs776746) [20]. This mutation leads to alternative splicing, and truncation of the protein, which decreases the function of the CYP3A5 enzyme [21]. As a result, CYP3A5 expressers (CYP3A5*1/*1 or CYP3A5*1/*3 genotype) have significantly lower dose-adjusted C0 compared to CYP3A5 non-expressers (CYP3A5*3/*3 genotype), and the requirement of Tac dose is CYP3A5*1/*1 > *1/*3 > *3/*3 [20]. A large number of retrospective studies have shown that kidney graft recipients who are CYP3A5 expressers require an approximately 2-fold higher Tac dose compared with non-expressers [22, 23, 24]. In addition, no matter in adult or pediatric heart recipients [25, 26], in lung transplantation recipients [27], as well as in liver transplantation recipients [28], the same relationship has also been observed.
Other CYP3A5 SNPs include CYP3A5*6 (rs10264272) and CYP3A5*7 (rs41303343). CYP3A5*6 encodes a G to A transition at position 14,690, causing a splice variant mRNA and deletion of exon 7, resulting in nonfunctional CYP3A5 protein [21, 29]. CYP3A5*7 denotes a single base insertion at codon 346, causing a frame shift and resulting in a truncated mRNA and nonfunctional CYP3A5 [30].
As for the association between CYP3A5 and the early prediction of the risk of acute rejection, the results are quite inconsistent. Some studies involving Tac therapy did not find any significant association [23, 31, 32, 33, 34], while some other studies reported that CYP3A5 expressers had a higher risk of experiencing biopsy-proven acute rejection (BPAR) [35, 36].
As for other kidney transplantation outcomes involving Tac therapy, such as chronic allograft nephropathy or delayed graft function (DGF). Some studies reported that CYP3A5 expressers had a higher risk of experiencing biopsy-proven Tac-related nephrotoxicity [37, 38] and reduced renal function during the first year after transplantation [36], and CYP3A5 non-expressers were more likely to develop DGF [39] and early renal graft injury as assessed by the urine test [40].
As for CYP3A4 gene, two SNPs in relation to Tac PK have been investigated extensively: CYP3A4*1B SNP (rs2740574) and CYP3A4*22 SNP (rs35599367).
The CYP3A4*1B SNP involves an A to G transition at position −392 in the promoter region of CYP3A4 and is associated with an increase of CYP3A4 activity [41]. It showed that the C0/D ratio of Tac in patients with the *1B mutation was reduced by 35% compared with that of wild-type homozygotes [42]. However, there is a linkage disequilibrium (LD) between CYP3A4*1B and rs776746 of the CYP3A5 gene. It is possible that the effect of CYP3A4*1B on Tac PK and PD is caused by rs776746, which has been shown in several published studies [43, 44]. Therefore, the exact effect of CYP3A4*1B alone on Tac is still unclear.
The CYP3A4*22 SNP (rs35599367) contains a transition of C to T in intron 6 and is associated with reduced CYP3A4 mRNA expression and CYP3A4 enzyme activity in vitro [45]. In clinic observation of kidney transplantation, the CYP3A4*22 required less Tac dose to achieve the target exposure. What’s more, it was not influenced by the CYP3A5 genotype [46]. However, it should be noted that the frequency of CYP3A4*22 is relatively low. About 5% of the Caucasian population, 3% in the American population, and not found in Asians or Africans [47].
Other CYP3A4 SNPs such as CYP3A4*18 (rs28371759) may also have an impact on Tac PK. This SNP is located in intron 10, with a transition of T to C at position 878. This mutation may increase the activity of the CYP3A4 enzyme and thereby increase the Tac clearance rate and plasma drug concentration [48].
There is also a new and rare CYP3A4 variant, which is now designated as CYP3A4*26. This variant is an 802C>T transition and results in a premature stop codon at position 268 in exon 9 (R268*) [49]. The truncated CYP3A4 protein is non-functional.
When combining CYP3A4 and CYP3A5 genotypes, Elens et al. [50] were able to predict Tac dose requirements better compared with the CYP3A4 or CYP3A5 genotype alone. Based on these observations, it has been proposed to prescribe different Tac doses for ultrarapid (CYP3A5 expressers and CYP3A4 *1/*1), intermediate (CYP3A5 non-expressers and CYP3A4*1/*1) and poor (CYP3A5 non-expressers and CYP3A4*22 carriers) CYP3A metabolizers, respectively [51].
P-gp, also known as ABCB1 or MDR1 is a glycoprotein encoded by the human ABCB1 gene, which serves as drug transporter of Tac, and plays an important role in Tac PK. Recently, P-gp has been found to contain more than 50 SNPs. Among them, the ABCB1 3435C>T (rs1045642), 1236C>T (rs1128503) and 2677G>T/A (rs2032582; Ala893Ser/Thr) SNPs have drawn the most attention after intensive investigation [52, 53, 54].
The ABCB1 3435C>T (rs1045642) might be the hottest locus among all the ABCB1 gene SNPs. Reportedly, the frequency of this mutation in orientals is 37–49% [55]. The variation of rs1045642 locus might reduce the expression and function of P-gp in the duodenum, and thus potentially affect the bioavailability of Tac [56].
As for ABCB1 2677G>T/A SNP, wild-type patients required 40% higher Tac dose compared with homozygous carriers of 2677G>T/A SNP (P ≤ 0.05), while the concentration/dose ratio was 36% lower in the wild-type patients (P ≤ 0.02). The haplotype analysis further confirmed the results and suggested that 3435C>T and 2677G>T/A SNPs were associated with daily Tac dose requirements. In addition, the study of these three SNP haploids (1236C>T, 2677G>T/A and 3435C>T, which are in linkage disequilibrium) found that C-G-C (haplotype 1) and T-T/A-T (haplotype 2) accounted for 45.4 and 36.2% of the haplotypes, respectively; individuals with haplotype 1 required significantly higher daily doses of Tac than those with haplotype 2 [57].
Although there are many studies on the association of ABCB1 GP with Tac PK or PD, the results remain inconsistent. To further confirm the association, large-scale genotype-phenotype correlation trials are encouraged.
POR is essential for CYP-mediated drug oxidation as an electron donor [58]. POR*28 (rs1057868; A503V) is a coding variant in POR gene, which is believed to be effective in increasing the activity of POR and thus leads to the increasing activities of CYP3A4 and CYP3A5 [59, 60].
it has also been reported frequently that POR*28 carriers have lower adjusted Tac C0 and Tac C0/Tac dose in heart or kidney transplantation, no matter for the adult or the pediatric [61, 62, 63, 64]. Although the strength of this association seems weak and has a limited clinical impact on Tac dose requirements (15–20%), POR*28 may explain a part of Tac variability, and POR*28 carriers may experience faster Tac metabolism [61, 63, 65].
As for the association between POR*28 allele and BPAR after Tac or CsA therapy, no significant evidence was found [63]. As for other graft clinical outcomes, the POR*28 allele was not found to be associated with the higher risk of DGF after Tac therapy in patients with renal transplantation [63]. While it should be noted that one study in recipients with kidney transplantation demonstrated a higher risk of post-transplantation diabetes mellitus (PTDM) in patients carrying the POR*28 allele [60].
As a nuclear transcription, the human pregnane X receptor (PXR), which is encoded by NR1I2, regulates the expression of CYP3A and ABCB1. Polymorphisms of NR1I2 have been reported, but the results regarding their association with Tac dose requirement are conflicting [18, 66, 67].
The expression and activity of CYP3A are also related to the nuclear receptor peroxisome proliferator-activated receptor alpha (PPAR-α). Two sequence variants in the PPAR-α gene (PPARA), PPARA c.209-1003G>A and c.208+3819A>G, can reduce the PPAR-α expression and contribute to the intra- and inter-individual variability of CYP3A [68]. At present, PPARA c.208+3819A>G appears to have the strongest influence on Tac PK, though it still needs confirmation.
As for graft clinical outcome, one study in kidney transplant recipients demonstrated a higher risk of PTDM who carry the rs4253728 SNP [59].
The multidrug resistance-associated protein 2 (MRP2), which is encoded by the ABCC2, may also be associated with Tac metabolism [69].
The CYP2C8 enzyme, which is highly expressed in the liver, can also be found in extrahepatic tissues like kidney [70]. Reported by Suarez-Kurtz et al. [71], the CYP2C8*3 was associated with higher Tac C0/D, but only in CYP3A5 non-expressers. Furthermore, CYP2C8*3 and CYP2J2 -76G>T SNPs were reported to influence the renal function of the patients and the occurrence of adverse events during treatment with Tac and mycophenolate sodium [72].
Genetic polymorphisms in IL-18 (e.g., rs5744247) and IL-10 (e.g., −819 C/T and −592 C/A) can also affect Tac dose requirements [50, 62]. However, the exact mechanism by which they affect Tac dose requirements is unknown [73, 74].
Recently, it was also reported that IL-3 rs181781 and CTLA4 rs4553808 genetic polymorphisms probably influence the Tac dose requirements in Chinese kidney transplant recipients [75].
Both CsA and Tac are CNI. The GP that closely related to Tac as mentioned above could have more or less the effect on CsA, and as it should be, the effect is not exactly the same. In recent years, Tac gradually replaces the use of CsA, and here we will not make an in-depth introduction.
Reportedly, the influence of the CYP3A5*3 and CYP3A4*22 variants on the PK [19, 42, 50, 76, 77, 78, 79, 80] or PD [33, 81, 82, 83, 84] of CsA are controversial. The effect of CYP3A5*3 on the CsA PK appears to be weaker than observed for TAC, while the CYP3A4*22 allele appears to be stronger, which would decrease the clearance of CsA by 15%. As stated in [47], for the time being, no precise dose adjustment has been proposed based on these variants.
Both SRL and EVE are the mammalian target of rapamycin inhibitors (mTORi). SRL was not used as IS until the late 1990s. SRL can form a complex with the tacrolimus-binding protein (FKBP), which binds to mTOR. It inhibits the entry of cells from G1 phase to S phase and inhibits T lymphocyte activation (proliferation) [85, 86].
Despite the potential advantages of sirolimus, such as antitumor activity [87, 88, 89] and antiviral activity [90, 91, 92], there are also a number of side-effects that result in a limit use of mTORi in clinical trials and practice, including PTDM, hyperlipidemia, anemia, proteinuria, oral ulcers, diarrhea, impaired wound healing, interstitial pneumonitis and edema [93].
At least 2 studies found no association between the CYP3A5*3 allele and SRL trough levels (C0), dose requirement, C0/dose [94, 95]. On the contrary, several other studies described significant associations between SRL exposure and the CYP3A5*3 genotype [96, 97, 98, 99]. The difference between the two kinds of results may be caused by the co-treated use of CNI. The effect of CYP3A5*3 genotype on SRL may only be notable in the patients taking no CNI [100].
The CYP3A4*22 allele was found to be associated with a moderately lower SRL hepatic metabolism in vitro, which, is inconsistent with another study [101]. A 113 stable recipients post renal transplantation switched from a CNI to SRL and found no significant association between this allele and SRL PK.
As for CYP3A4*1B allele and SRL PK, a study including 149 recipients with renal transplantation confirmed a significant association between this allele and SRL C0/dose in the subgroup of 69 patients taking no CNI [96, 97], as the same case in CYP3A5*3. However, another study reported differently [97].
As for ABCB1 gene, two studies showed no significant association between the ABCB1 c.3435C>T SNP and the SRL C0/dose [96, 98]. In another study, no association was found between SRL C0/dose and any of the ABCB1 exon 12, exon 21, and exon 26 SNPs, nor with their haplotype [94].
On the other hand, some reported that ABCB1 haplotype combination has a significant influence on SRL PK [44]. According to the report, the mean SRL C0/dose was approximately 30% lower in Chinese renal transplantation recipients carrying ABCB1 CGC/CGC as than those carrying the CGC/TTT or TTT/TTT combinations (no effect of ABCB1 individual SNPs was found).
As for the POR*28 allele, the PPARA rs4253728 SNP, and CYP2C8*3, no significant association was found between these SNPs and SRL PK [60, 68, 102, 103, 104].
Reported data about the influence of P450 or ABCB1 gene variants on the PK/PD of SRL are inconsistent [96, 97, 101, 105, 106]. CYP3A5*3 genotyping might be potentially useful in kidney transplant recipients with no CNI because of the possible competition for CYP3A5 metabolism [100]. As was stated in [47], at the present time, data are insufficient to recommend any genotype test for this immunosuppressant.
EVE is the hydroxyethyl derivative of SRL, with a similar mechanism of action but much more predictable PK. Clinical trials using EVE followed, first in combination with CNI then in CNI-sparing regimens [100].
Again, the reported data about the association between SNP polymorphisms (including CYP3A5*3, CYP3A4*22, ABCB1 c.3435C>T, CYP2C8 and PXR) and the PK/PD of EVE are inconsistent [26, 104, 107, 108]. For more details, readers may refer to [100, 109], one of which was specifically devoted to EVE.
MMF is the most widely used antiproliferative agent [2], after administration, MMF is hydrolyzed to form MPA, which is in turn glucuronidated by several members of the uridine diphosphate-glucuronosyl transferase (UGT) family to form the main metabolite 7-O-MPA-glucuronide (MPAG). MPAG is excreted into bile by ABCC2 (or MRP2) and undergoes enterohepatic circulation [100]. Organic anion transporting polypeptides (OATPs, encoded by the SLCO genes), ABCB1 (P-glycoprotein, encoded by the ABCB1 gene), and cytochrome P450 (CYP) 2C8 and CYP3A4/5 are also involved in the PK of MPA [110].
As mentioned above, the UGT family plays an important role in the metabolic process MMF, of which, UGT1A9 is the most important family member that may affect the PK of MPA [110]. Reportedly, there a significant influence of the UGT1A9-2152C>T (rs17868320) and −275T>A (rs6714486) SNPs on MPA PK, while this conclusion seems to depend on the MPA dose, type of concomitant CNI (CsA or Tac), and time after transplantation [111, 112, 113, 114].
Another UGT1A9 SNP, −98T>C (or UGT1A9*3) has also been found to be associated with higher MPA exposure in healthy volunteers and kidney transplantation recipients [111, 113, 114, 115].
As for the association between MPA PK and genetic variants in UGT1A8 or UGT2B7, reported results remain conflicting. Further investigation is needed to reveal the associations between MPA PK and UGT genotype [110, 116].
ABCC2 is responsible for the biliary and renal excretion of MPAG and is inhibited by CsA [117]. According to the reports, the ABCC2 -24C>T has been studied most extensively among the SNPs that have been identified in the ABCC2 gene [110]. Some studies did find a significant relationship between various ABCC2 SNPs and MPA PK [118, 119], while many other studies have reported differently [110, 112, 113].
The OATPs 1B1 (SLCO1B1 gene) and 1B3 (SLCO1B3 gene), 2 uptake transporters located on the sinusoidal side of the hepatocytes, are involved in the uptake of circulating MPAG in hepatocytes [112], which contributes to MPA enterohepatic circulation.
Among the SNPs that have been described in SLCO1B1, the nonsynonymous 521T>C (Val174Ala) and 388A>G (Asn130Asp) SNPs are associated with altered transport activity. These 2 SNPs are in LD and form haplotypes designated as SLCO1B1*1A (388A-521T), SLCO1B1*1B (388G-521T), SLCO1B1*5 (388A-521C), and SLCO1B1*15 (388G-521C) [120]. In the studies of [112, 121], no significant association was found between the SLCO1B1 SNPs or haplotypes and MPA PK in renal transplantation recipients. In another study, SLCO1B1*15 allele carriers are found to be related to a lower level of MPAG than in noncarriers [122], suggesting a decreased hepatic uptake of the metabolite.
As for the various of SNPs in SLCO1B3, the most frequent are a T>G substitution at position 334 and a G>A substitution at position 699 (in complete LD), which result in 2 amino acid changes (Ser112Ala and Met233Ile). In a study of renal transplant recipients receiving MMF with no CsA immunosuppressive regimen, the SLCO1B3 334G allele was found to be associated with a significantly lower MPA dose-normalized exposure, Whereas in the group of MMF + CsA, no significant effect was observed [112].
The mechanism of action of MPA is the inhibition of the rate-limiting enzyme in de novo purine synthesis, inosine monophosphate dehydrogenase (IMPDH). Followed by the characterization of 2 isoforms in humans, IMPDH1 and IMPDH2 [123], many other genetic variants of both isoforms have been identified. Although a few of them seem to have an effect on the expression or the enzyme activity directly, most of the genetic variants are either rare or ineffective on enzyme activity [124, 125].
As for the potential influence of IMPDH variants on IMPDH activity, a study in a group of renal transplantation recipients on MPA demonstrated that the enzyme activity over 12 h was 49% higher in patients with the IMPDH2 variant rs11706052 than in patients with the wild-type. While in the group with no MPA, no difference was found [126]. In addition, for the IMPDH2 variant rs121434586, which has only been reported at a very low frequency, the enzyme activity is reduced to approximately 21% of wild-type activity, probably because of accelerated protein degradation. For the IMPDH1 variant only found in the Han Chinese-American group (rs72624960), the enzyme activity is as low as 10% compared with the wild type, also explained by accelerated degradation [124].
Tremendous efforts have been made in order to better understand the individual differences of IS. The genetics polymorphisms mentioned above are more or less related to the variability of IS PK/PD. To date, our knowledge of GP associated with IS in SOT is insufficient. It is still not sure whether genotype testing of these alleles would improve clinical outcome of SOT, this technique is definitely effective in depicting the PK parameters of IS, and has the potential to increase the chance of determining the best drug and the correct initial dose. A benefit of genotyping as a predictive test is that this is a fixed characteristic that will not change with pharmacological and physiological status [12]. Algorithms based on multiple genotypes may have a better performance in predicting the required dose, which helps recipients achieve target IS concentration faster with fewer dose adjustments. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has also published Tac dosing guidelines based on CYP3A5 genotype expression [127], which is inspiring that the transplant community devotes such great efforts to the PG research.
Whatever, based on the present literature, a study of initial tacrolimus dosing based on the CYP3A5 genotype would be logical. And according to [47], the French National Network of Pharmacogenetics (Réseau national de pharmacogénétique [RNPGx]) considered CYP3A4 (CYP3A4*22) genotyping would be potentially useful.
This work was supported by grants from the National Natural Science Foundation of China (no. 81771722) to YZ.M.
No conflict of interest.
Despite being in many fields, organizations continue to be the spearhead in the innovation process. In the competition to produce high quality, low cost products, industries want to be more agile and faster. The environment of modernity forces companies to compete in markets outside their national borders, it is itself part of globalization, which as we know has played a very important role in the development of international finance. Multinational companies have managed to position themselves as one of the engines of the economy, coexisting in complex and heterogeneous environments.
In the search for quality, there is a fierce competition of globalization; organizations have invested in the development of knowledge and technology, improving already established processes. However, progress has not been homogeneous in all areas.
Lean manufacturing implementation is more important in some areas, as different tools are used to benefit the company and its employees. Some of the benefits include: reduction in production costs, reduction of inventories, reduction of delivery time (lead time), better quality, less labor, greater equipment efficiency, reduction of waste, overproduction, time of waiting (delays), transportation, inventories, movements, poor quality, among others.
Lean Manufacturing has its roots in the Toyota Production System originated at Toyota Motor Company by Taiichi Ohno and Shigeo Shingo [1]. It focuses on developing high quality, low cost products using less time, less space, fewer workers, and fewer tools.
After the First World War, Henry Ford and Alfred Sloan (General Motors) changed artisan manufacturing –used for centuries and directed by European companies– for mass manufacturing. Largely as a result, the United States soon dominated the world economy [2].
In 1950 Eiji Toyoda visited Ford’s Rouge plant in Detroit for three months, an uncle had visited it in 1929. The Toyota Motor Company was founded in 1937. In 1950, after 13 years of work and effort they produced 2,685 automobiles, compared with the 7,000 they produced daily.
According to [3]. Toyota’s way of achieving a “lean” approach was to eliminate all waste, that is, activities that do not add value to the product from the customer’s point of view. This allows reducing costs and increasing productivity. However, waste disposal is not enough because it requires a context and a culture, known and understood by all stakeholders (senior management, collaborators and suppliers). The Toyota way in a model is in a pyramid representing Toyota culture from top to bottom. This is the 4P model: 1) a philosophy of long-term thinking; 2) continuous process improvement to eliminate waste; 3) People and partners respect, challenge and grow; 4) Problem solving through continuous improvement and learning.
To locate the origin of the word lean, it is necessary to name JP Womack, and Daniel Jones, two researchers from the United States and from England, respectively, who are referents in this matter, through their work entitled “Lean Thinking” managed to concentrate the fundamentals of thought ‘lean’ and the concept of waste (‘muda’). They also managed to perfect the concepts of value stream, flow, pull, among others.
Currently, a company that does not consider the implementation of this system is not in a position to compete in the world, since it will be absent from aspects such as the quality of products and services, reduction of operating costs and the subsequent increase in sales. However, to find the right tool it is necessary to carry out a detailed analysis of the company’s conditions.
It can be said that this system places a company as a world-class one, since it carries out procedures that guarantee productivity, efficiency and the quality of products and services. In addition, several previous works confirm the benefits of implementing this system.
In the study [4] many factories reported positive results with the implementation of lean manufacturing. Some of these benefits are improved quality, high inventory turnover, and productivity increases. All these benefits lead to greater customer satisfaction and loyalty, and higher profits, in addition [5] comments that one of the most important criteria of this system is to get rid of unnecessary issues in manufacturing that do not add value to the product.
We observe in [6] the current situation in the implementation of lean practices in manufacturing plants in India and its impact on operational performance. The study was conducted by applying a questionnaire to 79 plants in different regions from India. Lean manufacturing is a multidimensional construct, finding that 80% of the plants have implemented various dimensions of lean manufacturing; such as focus on the needs of the customer, pulled production systems, reduction of exchange time of molds (SMED), total productive maintenance (TPM), relationship with suppliers, statistical control of processes and inclusive problem solving. It was also found that productivity, quality at first intention, reduced delivery time and inventories, as well as occupied space, in summary, respondents stated that quality at first intention, reduction of time delivery and increased productivity are the top three drivers of lean adoption in that context.
Finally [2] finds that the constructs of lean, sustainable manufacturing and continuous improvement have a direct, relevant, positive and statistically significant impact on the dependent construct.
The fourth industrial revolution or revolution 4.0 is the product of the innovative efforts of the previous revolutions. Without a doubt, this phenomenon not only generated industrial improvements but also changes in the way of interacting with each other. Series production, electricity, transportation, are just a few examples of progress. In the current revolution, digital changes arise that cause ruptures in social, economic and political aspects, and in this sense, the administrative process is part of it.
In light of the technological developments associated with the revolution 4.0, the relationship between lean manufacturing and technology has once again become an area of research interest [7, 8].
The fourth industrial revolution promises to change the manufacturing landscape, and those who cannot take advantage of new technology-induced opportunities are destined to lag behind their competitors. An important area to investigate is the role that lean manufacturing will play in this new industrial age [7].
Lean manufacturing as a system is possible with various subsystems (tools), which are used to reduce and eliminate waste in companies. The right tools that help to eliminate all the waste and all the operations that do not add value to the product or to the processes, is the last aim of this system.
The challenges of lean manufacturing, especially in small and medium-sized companies have to influence the integration of the lean culture within their vision, develop leadership based on that culture. It is necessary to deploy that culture to everyone in the organization; involve the entire management team; have well-defined plans; know very well what processes contribute and which ones do not add value; and finally make this culture your day to day.
Below we give an account of the identification tools used in this system and we delve into the innovation of manufacturing, ending our analysis with the culture of quality.
The production systems related to a product or service must be analyzed under the approach of a value chain, which implies showing all the related activities to identify those activities that do not add value and that are classified as waste according to the manufacturing philosophy. Lean, which provides us with a series of tools that must be carefully selected to apply the most appropriate to eliminate waste and improve flow, as well as productivity in these production systems [9].
It is essential to know the types of waste that lean manufacturing proposes, also known as “Muda” due to its origin in Japan in the Toyota production system. Waste is anything that is not absolutely essential for production. Lean Manufacturing identifies the following seven types of waste that must be eliminated in a production system [10].
Overproduction. Process items earlier or in greater quantity than required by the customer.
Wait time. Products or goods that are not being transported or in the manufacturing process are on hold.
Transport. The handling and transfer of materials or documents that do not add value are considered wasteful.
Inventory. Excessive storage of raw material, product in process and finished product.
Over-Processing. It is about adding unnecessary steps in work activities and not required by the client.
Movement. Any movement that the operator makes apart from generating added value to the product or service.
Defects in the process. Repetition or correction of processes also includes rework on non-conforming products or products returned by the customer.
Once the activities of the process where some type of waste is being generated have been classified, it is necessary that all the employees of the organization participate by undertaking specific actions for the elimination, for which the managers must promote an environment that promotes the generation of ideas and the continuous elimination of waste. In addition, it is important to train in the different tools, techniques and methodologies that lean manufacturing relies on and to establish a deadline to verify the results.
It is necessary to note that the full identification and elimination of waste has become a pillar for companies, when deciding absolutely on the use, investment and management of their resources, which is essential to find opportunities for improvement in the organization and achieve greater process efficiency [11].
The lean manufacturing tools that are mostly used in the industrial sector to increase productivity are the following: [12].
5S is a tool focused on working with effectiveness, organization and standardization. It is used to improve work conditions, through the organization, classification, cleanliness and order in the workplace. It seeks to establish a pleasant and high-performance work environment that allows the correct performance of daily operations [13].
According to [14], Kaizen is a Japanese word that means continuous improvement and presents a methodology to improve any production process through the implementation of different techniques, tools and methods, in addition to promoting a cultural change, teamwork, skills development and initiative to identify root causes of problems.
Poka Yoke seeks to prevent the production of defects caused by humans when they make mistakes in their workplace, blocking or stopping the process in case of failure [15].
Andón is the signal system that allows showing the state in which the machine is (running, stopped, stuck, etc.) [15].
SMED Single-Minute Exchange of Dies Set of techniques that seek to reduce machine setup times, Standardization through the installation of new mechanisms, templates and functional anchors, eliminates downtime adjustments [15].
TPM Total Productive Maintenance Set of techniques aimed at eliminating breakdowns through the participation and motivation of all employees, maximizing effectiveness and lengthening the life of the equipment and preventing losses in operations [16].
Kanban is a tool that helps to improve the production flow in a line through “labels”, which serves as a “work order, informs in a timely manner what is going to be produced, in what quantity, by what means, and in what will be transported.
Jidoka Technique based on the incorporation of systems and devices that give machines the ability to detect failure in production.
Heijunka is key to achieving flow and leveling in production, the purpose is to level the production schedule by sequencing the orders according to a repetitive pattern that makes the average daily production similar between the different days of the week [16].
JIT Just in time. This system consists of getting the parts necessary for assembly to the line at the right time they are needed and in the right amount required.
VSM Value Stream Map is important to manage the entire value stream for each product, in order to understand where waste occurs, rather than looking at activities or processes in isolation. Therefore, a value flow map must be created where each of the actions required to design and manufacture a specific product is clearly identified.
Activities that create value from the customer’s point of view; as well as those activities that do not create value from the customer’s point of view, cannot be eliminated. They can be improved in order to reduce the time that they are given, and finally the activities that do not create value from the customer’s point of view, and that are unnecessary, and these can be eliminated immediately [17].
The implementation of quality tools in a lean production system is strongly linked to common sense, and that is why adequate preparation in the organizational culture must be required, where both managers and employees have the commitment to change their traditional ways of thinking and working [18].
If there is not clear identification of the different quality tools that are applicable for the elimination of the different wastes, then no efforts aimed at improving the production processes will have the expected impact. That is why as a contribution to this work, Table 1 shows the different changes and the lean tools that may be appropriate to solve these problems were identified.
MUDA type | Lean Manufacturing Tool |
---|---|
Overproduction |
|
Timeouts |
|
Transport |
|
Inventory |
|
Over-processing |
|
Unnecessary movements |
|
Defects |
|
Lean manufacturing tools for Mudas removal.
Tool | Basic purpose | Preliminary targeting | Method |
---|---|---|---|
Strategic tools | Strategic innovation tools are mechanisms that the company uses to analyze its internal resources and capabilities and external threats and opportunities. | Company strategy, useful for the entire organization. You get a SWOT of it. | A matrix is completed that gathers the characteristics of the organization and the behavior of the environment for the businesses developed. |
Creativity | They are mechanisms that the company uses to promote creativity and promote the flow of ideas. Creativity is used either for the search for creative solutions or for the design of new products. | All the company. | Carry out a creativity session through brainstorming. |
Technological surveillance | Know the main trends in the environment and technological leaders, in order to make decisions. | Company strategy, useful for the entire organization. | Databases or patents are analyzed and processed and in the end a technological map with different clusters is obtained. |
Organizational capabilities analysis | Know how the organization’s capacities are in innovation, external and internal, to take improvement measures. | Company strategy, useful for the entire organization. | Apply a questionnaire and in the end different graphs are obtained where the capacities are measured. |
Tools related to innovation.
According to [19] one of the industries with the greatest global impact is the manufacturing industry, in which there is high competition worldwide. Therefore, he recommends that companies become aware of the transformation they must have in three areas: Internet of things (IoT), Smart factory and Personnel management.
Within the manufacturing sector, identification devices such as RFID (Radio Frequency Identification) or RTLS (Real Time Location System) are key to optimizing and planning process automation [19].
More and more companies are interested in adopting digital approaches in their processes to optimize costs and times. One of the great transformers in the sector is business software that integrates processes, since they help improve the profit margin or reduce machine downtime. An example is ERPs (enterprise resource planning system), which benefit the generation of proactive analysis, the reduction of errors or the monitoring of payments and collections [19].
In Mexico, 5S’s application software was for MSMEs with the aim of being an engine of change towards continuous improvement [20]. Transforming the way of carrying out day-to-day operations in the MSME field is the innovative contribution that is intended to achieve it with the development of a 5S’s application software. An improvement to the software is considered by adding four more S’s, Shikari, Shitsukoku, Seishoo and Seido (Constancy, Commitment, Coordination and unification through standards); that is, implement up to 9S’s in companies. Likewise, the 5 W (5 why), poka yoke and visual control tools can be developed in the same software.
The implementation of the 5S tool in all SMEs, aims to eliminate waste and ensure a clean and orderly work environment. The results of the application of this lean tool in SMEs are immediate, the result is a great visual impact, avoiding customer complaints, improving staff participation and improving process efficiency [21, 22, 23].
The manufacturing industry is one of the most questioned when it comes to staff turnover. The sector must be more sensitive to the importance of retaining the best-qualified workers because their potential generates greater competitiveness. It invests in the training, promotion and well-being of workers. It also detects areas of opportunity and improvement in the functions they perform within the organization [19].
According to [24] successful innovation requires a strategic and tactical deployment in the organization, integrating the commitment, resources, capabilities, and joint efforts of the different dependencies of the company, from senior management to operators. This includes engineering, research and development (R&D), production, marketing, merchandising, finance, human resources, and other functions.
In the context of lean manufacturing and its multiple tools, continuous improvement is immersed. This is a key element in quality standards and processes. Currently in the quality culture of companies, the main standard is precisely continuous improvement, whose philosophy has permeated in various sectors around the world. A typical example is the Japanese companies, which lead the application of the tools of lean manufacturing, quality management and continuous improvement. This work methodology is about the Toyota Company, which is currently a model to follow in lean manufacturing since it achieved a balance in the combination of strategy design and operational excellence.
Some of the tools mostly used in companies, aimed at the operational area are 5 s (Seiri, Seiton, Seiso, Seiketsu, Shitsuke), which is applied in companies basically to avoid waste, improve performance and efficiency and thereby improve productivity in the workplace. SMED (Single Minute Exchange of Die), its usefulness in the processes is to reduce the change time and increase the reliability of the change process itself. TPM (Total Productive Maintenance), focuses on managing the maintenance of the company in order to maintain zero failures, here all personnel and all phases of the production process are involved. Kanban serves to identify the material requirements made in the production process [25].
JIT (Just In Time) tools, which originated with the purpose of eliminating inventory, are also widely used, in addition to other diagnostic and monitoring tools, automatic stops, takt time, level production etc. These tools originally created in the Japanese automotive industry, with a notable deployment to other sectors of the maquiladora industry, but especially in other areas and in small or medium-sized companies around the world.
In summary, lean manufacturing has triggered a series of steps that allow a true adherence to excellence, among these steps is continuous improvement, the objective of which is to achieve standards and good quality management. In this sense [26] mention that the starting point for companies is to have an organization focused on the client, understand current and future needs and try to satisfy them. Another essential aspect is having excellent leadership through which the staff is involved and thereby enhances the participation of different levels and areas of the company, which translates into a high level of commitment.
In the culture of quality, emphasis is on the focus on systematized processes directed towards quality management. These aspects result in a constant evolution towards quality and lead to efficient decision making that benefits both the forward processes, that is, with the client; as backwards, that is to say with the providers; thus achieving a convergence in all the processes involved.
Historically, there have been great companies and brands that have made revolutionary contributions to quality. Proof of this is undoubtedly Ford Motor Company, American Telephone & Telegraph and Western Electric, whose processes initiated the implementation of quality criteria in various areas, not only in production. On this same subject, the participation of Japanese companies has been more than relevant, since in addition to Toyota, “Company Wide Quality Control” was created, which involves all the resources and processes existing in the company, thus achieving what is called “total quality” [27].
On the other hand, in Europe there is the “European Foundation For Quality Management” that synthesizes its quality model in the satisfaction of customers and employees through leadership that promotes policies and strategies of the organization. Along with an adequate implementation of the resources and above all a perfect management of the most important processes in the organization to obtain excellence in results [28].
As for the Latin American region, there are also records of the implementation of lean manufacturing tools as a strategy for achieving quality. In the study [29] analyzed Mexican and Colombian companies, and applied an instrument where they were asked, among other things, how often they use tools for quality management. The responses showed a clear trend towards use in managerial positions and from middle to senior management onwards. What is interesting about this analysis is that it focused on small and medium-sized companies, which makes it clear that the culture of quality has permeated not only in various areas, but also in companies from different sectors.
In summary, lean manufacturing provides great benefits to companies by eliminating waste, processes that do not generate value and that make administration bureaucratic and expensive. The new projects seek to be born in the context of continuous improvement and quality culture, and on the other hand, existing companies make great efforts to incorporate these work methodologies, seeking as their main purpose the reduction of operating costs.
It is clear that the adoption of lean manufacturing is on the way towards efficiency in the processes of the main line of business of companies. It is evidently focused on permeating the organizational culture in order to transform the competitiveness of the company; and thus be more attractive to shareholders, employees, suppliers and customers. Every time of a demand of better conditions not only in the products, but also in the prices, response times of the company, the commitment that it shows on social responsibility and environmental responsibility; and in general in the image that is projected towards the market [30].
For companies to have the ability to respond to the new and increasingly demanding market requirements, the decision to adopt the culture of quality is necessary first. It corresponds to managers or owners of the companies, probably encouraged by the workers themselves who are in the operational area and know and experience the problems that carry out their work in a daily way.
A part of special importance in such a large organizational change is to establish, provide and promote the appropriate conditions for the development of this type of project. Carrying out an organizational transformation entails re-educating all the parties involved. From suppliers, at the time they are requested to implement computer systems that make deliveries just in time and without defects, through production that must focus on zero errors, zero waste and zero delays, encouraging real production cost calculations and exact, documentation, improvement and control of each of the processes, as well as efficient and effective management of resources. All the departments that together make up the company must also be involved, that is; continuous improvement and lean manufacturing must permeate the entire organization.
These business transformations must emerge from the organizational culture itself, it does not mean a change of personnel to generate new uses and customs, but an evolution in the way in which business processes are carried out, trying to reduce the maximum movements and the number of processes and transactions carried out to achieve production.
Among the main elements of the culture of quality, it is suggested to bear in mind that perfection does not exist; however, processes can work in a harmonious, uninterrupted way and with immediate error detection to avoid waste and rework. It is important to have an open mind that socializes the information openly, and above all to talk and share problems as well as opportunities for improvement, for example holding kaizen events where problems are analyzed to obtain holistic resolutions that involve the entire company.
Another essential aspect in the culture of continuous improvement is to instruct workers to maintain a dynamic based on learning, which is also systematized and is not linked especially to one person, but to the work team in general. This is important given that when a problem is studied and all parties participate, each department exposes its intervention in the analyzed process and the way in which they can intercede to improve and at the same time reduce the amount of processes, costs, and waste that were generated.
Once this open culture is established, the next level is to encourage accompaniment to support people in the development of their processes, and remain receptive to the emergence of new ways of doing things, accept, adopt and adapt changes that generate added value, lower costs and provide greater agility in deliveries. It should not be forgotten that in lean manufacturing there are four important parts that must be coordinated to achieve perfection in the systems. According to [31] the starting point is the design and engineering of the product, the supply chain, the demand and the customer.
The design is based on teamwork made up of members who come from different departments, with experienced leaders who encourage effective and respectful communication, where all participants must express acceptance of the decisions made, with the aim of that differences and conflicts are exposed at the beginning of the projects and not afterwards.
On the other hand, companies require excellent coordination in the supply chain to have access to good quality materials, with fair prices and in a timely manner. In the lean philosophy, functional levels are proposed and each of them has its own responsibilities. The first level is the integral part of the design and development of a new product. The second level is where the necessary parts are supplied. It should be borne in mind that lean manufacturing considers the customer first as the guiding principle of what to do. Therefore, companies must adapt to the market and the constant transformation of demand.
It is worth mentioning that every day the market and with it the demand, tastes and preferences of consumers continue to globalize. This fact has led small companies to incorporate lean manufacturing practices since to be part of the global value chains of the production systems of large companies (transnational, multinational, international and global), the main requirement is the management of quality demonstrated from production under standardization.
In this increasing integration, it is impossible to go back and regionalize production since supply chains are interconnected globally, which means that production is also global. In this sense, it is urgent, especially for micro, small and medium-sized companies, to join what has also been called the Toyota house, whose main objective is excellence in operations [32].
The key piece of this transformation is undoubtedly a human talent that enjoys commitment, academic training, professional experience, communication and leadership skills and with sufficient motivation to direct their efforts towards the realization of stable and standardized processes that result in a level production, always working under the motto of continuous improvement.
This chapter reviewed the application and integration of lean manufacturing tools in a current perspective, emphasizing the continuous improvement, detailed analysis of the current state of the process, and identification of a reliable starting point; in addition to the commitment of employees and management in the stages of planning, monitoring and taking actions.
Finally, it becomes clear that lean manufacturing increases quality and productivity in companies by reducing waste and therefore production costs; adapting favorably to the different innovation systems that are required today; and it enables the establishment of a continuous improvement work methodology that invites the constant review of processes and consequently the culture of change and quality within companies.
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