Maintenance Strategies and Innovative Approaches in the ...

ARTICLE International Journal of Engineering Business Management Special Issue: Innovations in Pharmaceutical Industry

Maintenance Strategies and Innovative Approaches in the Pharmaceutical Industry: An Integrated Management System (IMS) Regular Paper

Fabio De Felice1, Antonella Petrillo2,* and Claudio Autorino2 1 University of Cassino and Southern Lazio, Department of Civil and Mechanical Engineering, Italy 2 University of Naples "Parthenope", Department of Engineering, Italy * Corresponding author E-mail: [email protected] Received 29 Jun 2014; Accepted 29 Aug 2014 DOI: 10.5772/59023 © 2014 The Author(s). Licensee InTech. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract Pharmaceutical industries are continuously seeking out new strategies to improve their operations and gain a competitive advantage. Maintenance tends to be a key management issue for many pharmaceutical companies. Proper maintenance management requires information about maintenance performance for the planning and controlling of maintenance processes. However, it is generally difficult to reconcile production and maintenance goals. This work presents an integrated management system that can help in finding optimal maintenance strategies via a multi-object approach. The availability of an integrated system allows for detecting potential management problems and optimizing costs. Furthermore, the proposed method offers significant additional input data that can be useful to analysts for improving maintenance management. Keywords Management, Efficiency, Maintenance, Pharmaceutical

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Productivity,

1. Introduction The pharmaceutical industry can be defined as a collection of complex processes, operations and organizations. In the pharmaceutical industry, authorities are raising the standards of good manufacturing practice (GMP) requirements in order for companies to introduce the concept of "continuous improvement", as affirmed by Liker (2003) in his work "The Toyota Way" [1]. The importance of continuous improvement is also noted in Sugiyama and Schmidt [2]. In many industries, there is the strong perception that bad maintenance is a major cause of organizational problems; therefore, it is necessary to invest in maintenance improvement [3].

Fabio De Felice, Antonella Petrillo and Claudio Autorino: Maintenance Strategies and Innovative Int J Eng Bus Manag, 2014, 6:29 | doi: 10.5772/59023 Approaches in the Pharmaceutical Industry: An Integrated Management System (IMS)

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The maintenance function is important for an organization to maintain its competitiveness [6]. We have gained experience from various optimization projects and believe that pharmaceutical companies still require a business process model for realizing a manufacturing culture [7]. Recent surveys [8] have indicated that 33 cents of every dollar spent on maintenance costs is wasted in the US manufacturing industry as the result of unnecessary and improperly carried out maintenance. An effective maintenance programme ensures a satisfactory level of system reliability and reduces operating costs. Information flow between production and maintenance is very important in order to define a proper "maintenance organization" [9]. The aim of the present research was to study the relationship between the complexity of the production environment and the use of maintenance practices in the Pharmaceutical Industry in order to define proper maintenance strategies and innovative approaches. This study employed qualitative research and includes a literature review and a case study. Specifically, in this work we present an integrated system that is useful for defining an optimal maintenance strategy and a proper policy for continuously monitored degrading systems. Section 2 in this paper presents a literature review on maintenance strategies in the pharmaceutical industry. In section 3, the theoretical approach of the research is discussed. Section 4 provides details about the proposed research framework. Section 5 reports the results of the analysis and provides a discussion of the results. 2. Literature review: maintenance strategies in the Pharmaceutical Industry In the past two decades, changes in the production environment have rendered maintenance tasks increasingly complex. As a result, industries are being forced to consider systematic approaches for optimizing their maintenance policies [10]. The overall objective of the maintenance process is to optimize the total life cycle of **** without compromising safety or environmental issues [11]; [12]. In fact, unexpected failures usually have adverse effects and may result in major accidents. Studies by Khan and Haddara have illustrated the close relationship between maintenance practices and the occurrence of major accidents [13]. The aim of the present study was to identify best practices for maintenance management systems from the literature review and to establish the key concepts adapted for the pharmaceutical industry.

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Int J Eng Bus Manag, 2014, 6:29 | doi: 10.5772/59023

The following considerations were suggested from the extant literature on maintenance strategies in the pharmaceutical industry. Studies conducted by Rafols [14] using a variety of sources and perspectives revealed that the pharmaceutical industry faces a productivity crisis and is undergoing substantial transformation. As pointed out by Shah [15], the pharmaceutical industry relies on several drivers, but likely the single most important driver is the time-to-market. From this point of view, for pharmaceutical industries, it is vital to recoup their investments in developing new products as soon as possible [16]. Swanson [17] emphasized that without well-maintained equipment, a plant is at a disadvantage in a market that requires low-cost products of high quality to be delivered quickly. Competitive pressures on manufacturing organizations have forced them to consider all improvement possibilities, for example, as stated by Hipkin and Cock [18], the consideration of management tools integration like total quality management (TQM) and business process reengineering (BPR). In particular, two maintenance interventions have seen significant industrial application over the past decade: reliabilitycentred maintenance (RCM) and total productive maintenance (TPM). According to Kister & Hawkins [19], one of the fundamental measures of performance used in total productive maintenance (TPM) is overall equipment effectiveness (OEE), which measures in percentage points three important concepts from the point of view of manufacturing: the availability, efficiency and quality rate of a plant. Though OEE is a well-known performance measurement [20], on its own, it is not sufficient for "monitoring" organizational maintenance management. As pointed out by Gulati [21] a company must also understand that achieving a high level of computational accuracy is a critical factor for the success of maintenance management. Without computer-assisted prompts, operators carry out unnecessary preventative action routines or leave them until too late [22]. Computational facilities offer effectiveness and efficiency. Maintenance is one area in which computing can be applied with great results. A computerized maintenance management system can offer support on a variety of levels within the organizational hierarchy [23]; [24]. The literature review indicated that, in general, studies were focused on a particular type of maintenance policy. In our opinion, there is a need for a more generalized methodology that can be applied to all contexts. Thus, we believe that according to the literature review, the critical

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factor for en nsuring a pro oper maintenaance managem ment system is to invest in i systematiic and effective maintenance by employin ng a good maanagerial deciision support tooll. Therefore, it is necessarry to analysee the maintenance management process glo obally, that is,, the system shou uld be looked d at holisticallly by taking into account maaintenance levels, l work k planning and scheduling, maintenance m a analysing, spaares managem ment, the computeerized mainteenance manag gement system m in place and thee staffing requ uired.

S). Following the preliminaary study, it iss necessary to o (IMS inveest research in n three main feeatures: 1) thee maintenancee man nagement process, which caan be considered as having g six phases; 2) the mainten nance/plant organizational o l angements, th hat is, the ability to build b properr arra maintenancee orga anizational structuress; 3) thee maintenance imp provement procedures, wh hich representt the best practicces to implem ment into th he integrated d man nagement systtem, as illustraated below in Figure 1. The main featuress of each stagee are defined below. b

m 3. Research methodology This section addresses a hodology thro ough the research meth the analysis of o the proposeed research ap pproach. Theree is a continuing n need to review w the maintenaance procedurres of nt to pharmaceuticcal industriees. Thus, it is importan improve maaintenance fun nctions for seeveral reason ns: to increase com mpetitiveness, reduce costss, increase hiigher availability and a reliability y in the context of plants and equipment, improve i safetty and eliminaate environmeental disasters attrributable to eq quipment failu ure [25]; [26]. ove reasons, the first step toward fo ormal For the abo of a maintainabiliity managem ment is the formulation f rigorous meethodological approach divided d into four procedural sttages. Our pro oposal is show wn in Figure 1.. n to perform p a preeliminary stud dy in Firstly, it is necessary order to ideentify the main maintenaance managem ment system probllems. After gaaining a basic understandin ng of maintainabiliity and its impact on the project it is necessary to o build an in ntegrated man nagement system

AGE 1: "Mainttenance Prelim minaries" conssisting of two o STA partts: − Data collectiion, where thee collection of primary dataa is conducted d; − Data analyssis, where qu uantitative an nd qualitativee analysis of primary p data o occurs. AGE 2: "Mainteenance/plant o organizational STA arra angements", where w a group of individualss with age issues vary ying levels of eexpertise is deefined to mana related to mainten nance program mmes. We deffined group a consisting of: o "a" as − Plant Managger, person reesponsible forr determining g who should work and theeir duties; − Operations Manager, person with personal p and d professionall skills deriveed from experrience able to o manage seveeral problemss; − Engineering Manager, peerson with basic formall n engineering; education in − Maintenancee Manager, perrson with appropriate skillss in maintenan nce practices.

Figure 1. The proposed p researrch approach

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Fabio De Felice, Antonella Petrillo and Claudio Autorino: Maintenance Strategies and Innovative Approaches in the Pharmaceutical Industry: An Integrated Management System (IMS)

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STAGE 3: "M Maintenance Management M P Process" consissting of six phases: − Work identification, where infformation about a perform mance indicato ors such as m mean time betw ween failuress (MTBF), mean time to reepair (MTTR) and overall equipment efffectiveness (O OEE) is defined d; − Work planning, p thatt is, the ideentification off all required d resources; − Work sccheduling, wh here opportun nistic mainten nance tasks sy ynchronized with w productio on are develop ped; − Work exxecution, wheere an effectiv ve control off the mainten nance work ex xecution function through clear accounttability for eacch type of dem mand placed upon u the orgaanization is deefined; − Mainten nance history recording, which w consistts of evaluating and analy ysing the curreent programm me in o direct necesssary refinemen nts; order to − Mainten nance analysingg, which conssists of identiffying and in nvestigating potential p system (producct or processs) weaknesses.. STAGE 4: "M Maintenance Im mprovement Procedures" P w where an integrated d model aimin ng to improvee the mainten nance process is dev veloped. ment System 4. An Integraated Maintenaance Managem within the Ph harmaceuticall Industry o study waas to construcct an approach h for The aim of our managemeent the improving maintenance within he above stagees. A pharmaceuticcal industry acccording to th typical pharrmaceutical in ndustry was considered and pictures relatiing to the prod duction site aree shown in Figu ure 2.

We asked thee individuall responsiblee of every y uestions such h as: "In yourr unitt/department to answer qu opin nion what are the t main probleems, if any, in trying to havee prod duction machin nes/equipment available for maintenance?"; m ; or "In " your opinioon what are thhe problems, iff any, with thee engiineering staff regarding tthe engineerin ng structures,, comp petency and traaining?". y Table 1 is an exaample of the results of thee preliminary dy; 15 question nnaires were ccompleted. stud #

Main Prob blem

1

Lack of maintenance and producction planning iintegration. Predictive maintenancce is not being b practiced. No clear process p of wheen change con ntrols and deviattions are need ded. No value-adding main ntenance ana alysis d on maintenaance data. performed Lack of traaining of Eng g Staff in the latest l technology y

2 3 4 5

% 85 75 50 65 70

Tablle 1. Primary maintenance man nagement system m problems

F 3, Pareeto analysis sshows the ex xamination off In Figure losses for each unit/departme u ent. The analy ysis indicated d oth in terms off unitts nine and 10 to be the mosst relevant, bo num mber and of tim me spent on reepairs.

Figu ure 3. Pareto anaalysis of losses ffor each unit/deepartment

S 2: Mainteenance/plant orrganizational arrrangements 4.2 Stage

Figure 2. Production site: a description off different stag ges is w reported below

M preeliminaries 4.1 Stage 1: Maintenance A preliminarry study, performed using questionnairees for data collectiion and dataa analysis, was w conducted d to identify the problems in current prim mary mainten nance managementt. 4


To guarantee a formal main ntainability process, p it iss neceessary to dev velop maintaiinability awa areness at thee corp porate level.. Thus, in the presentt stage, wee exam mined three different p profiles (P1, P2 and P3)) rela ated to plan nt manager;; engineerin ng manager,, maiintenance manager m and d operation ns manager,, acco ording to the following crriteria: problem m solving, softt skillls, hard skillss, leadership, decision-makiing and team m grou up. For each h profile, wee selected th he best onee acco ording to the charts below w (Figure 4, 5, 5 6 and 7). A scorre from 1 to 10 was assigneed.

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n: in an indu ustry context, data analysiss Worrk identification geneerally starts att the system leevel in order to t identify thee systtem contributiing the most tto plant down ntime. During g this phase, mean n time to reepair (MTTR)), mean timee ween failurees (MTBF) and overalll equipmentt betw effectiveness were defined, acccording to Equ uations (1), (2)) a typical p performance indicators i forr and (3). These are conttinuously operated plants. ∞

M MTTR =  t g(t)dt g = 0

Figure 4. Plantt manager profile

1

(1))

μ

wheere: g(t):: probability density d of repaair at time t µ(t): repair rate att time t t

(2)

MTBF =  t • f (t )dt 0

wheere f(t) is the probability p of ffailure. E = (equipmen nt availability)) x (performan nce efficiency)) OEE x (ra ate of quality) (3) These are robustt, easily comp puted statisticcs that can bee applied at the plaant, system or equipment lev vel [27].

Figure 5. Engin neering manageer profile

In Figures F 8, 9 and 10, analysis for MTTR (minutes), MTBF F (min nutes) and OEE E (%) is shown n for a period of o 10 weeks.

MTT TR 150,0 1 100,0 1 50,0 0,0

Figure 6. Main ntenance manag ger profile

1

2

3

4

5

6

7

8

9

10

Figu ure 8. MTTR anaalysis – 10 week ks (from 40 to 50 0)

MTB BF 150,00 1 100,00 1 50,00 Figure 7. Operrations managerr profile

0,00

M Maanagement Proccess 4.3 Stage 3: Maintenance

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The aim of th his stage was to offer a sysstematic apprroach for managing g the mainten nance processs. Below is a brief description fo or each phase. www.intechopen.com

2

3

4

5

6

7

8

9 10 11

Figu ure 9. MTBF anaalysis – 10 week ks (from 40 to 50 0)


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Worrk scheduling: the t aim of thiss phase was to o organize thee diffeerent types of maintenaance over tim me for each h unitt/department. An exam mple of sch heduling forr maintenance prog grammes is sh hown in Table 3.

O OEE 80,00 60,00 40,00 20,00 0,00

Unit/Dept. U

1

2

3

4

5

6

7

8

9 10 11

Figure 10: OEE E analysis – 10 weeks w (from 40 to 50)

ng: the aim off this phase was w to identiffy all Work plannin required reso ources. In ord der to achievee this goal it was necessary to analyse all ty ypes of faults and map them in order to identify the reso ources (manp power, equipm ment, materials) neeeded to reso olve failures. The type of fault and causes aare shown in Table T 2. A parrticular colourr was associated with each one: − Orange indicates imp proper maintenance; − Yellow for incorrect design; d − Green for f failure to maintain ns; m operaating condition − Blue forr failure to maaintain basic co onditions. #

U7

Belt faailure

2

Tempeerature too hig gh

3

Pressu ure too low

4 5

Comprressor overheated Electriicity outage

Weekly Mon nthly

1

Ordinary

2

Cy yclic

x

3 4 5

Cy yclic Prreventive Ordinary

x x

Six Monthly

x

x

Tablle 3. Scheduling g for maintenan nce programmess

Worrk executioon: for establishing g effectivee plan nning/schedulling, it is esssential to defiine the work k scheeduling, i.e., the t "maintenaance organizattion" in orderr to define d who dooes what. In our case, wee applied thee follo owing procedure (Figure 122), which syncchronized thee task ks of the main ntenance man nager, operatiions managerr and engineering manager. m

Cause

T Type of fault

1

Date e

Type of Maintenance

Faults

Impro oper mainttenance Failurre to mainttain basic conditions Failurre to mainttain basic conditions Incorrrect design Failurre to mainttain operaating condition ns

Table 2. Type of fault and its causes c

A map of fau ults is shown in n Figure 11.

Figu ure 12. Maintenaance organizatio on

Haalt prod duction n 10 1 5

Figure 11. Exam mple of a map of o faults

Maintenance history h recordin ng: the aim off this phase was to analyse any anomalies a during the production such as the halting of pro oduction (num mber), as show wn in Figure 133. 6


0 1

2

3

4

5

6

7

8

9 10 11

Figu ure 13. Halt prod duction – 10 weeeks (from 40 to 50)

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Figure 14. Exam mple of FMECA A

Maintenance analysis: a the aiim of this phaase was to identify critical poin nts in the maaintenance prrocess. Theree are several tools that can be ussed here, but in i our opinion n, the best of thesee is the failurre mode, effeects and criticcality analyses (F FMECA). Th his method consists of o a methodology y for examin ning all the ways w in which a system failu ure can occur, the potentiaal effects of then ystem perform mance and safeety, as well ass the failure on sy seriousness of o these effectts. Figure 14 shows s an exam mple of the FMECA A approach. Computerized an nd standardizedd 4.4 Stage 4: C a improvement actions The definitio on of perform mance indicato ors for each lin ne is rather compllex, especially y from a man nagement poin nt of view. Therefore, we hav ve developed d a synchron nized model based d on Visual Baasic logic for the collection n and implementation of the data with regards to both a maintenan nce. In Figuress 15, 16, 17 and 18, production and some IMS maasks are illustrrated.

Figure 15. IMS S homepage

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uterized modeel (Figure 15),, On the homepagee of the compu ons: mask forr therre are the folllowing seven main functio prod duction; mask ks for personn nel managem ment activities;; massk for mainten nance; mask ffor the additio on of workerss massk for the ad ddition of a p production line; mask forr add ding a maintain ner; closing ap pplication. We used a speciffic script for the constructiion of masks.. Belo ow is an exam mple of the production mask k.

Priv vate Sub Form m_Open(Canccel As Integer)) OPE EN.Visible = False F CLO OSE.Visible = True Form m_Mask_PRO ODUCTION..AllowDeletioons = False Form m_Mask_PRO ODUCTION..AllowEdits = False Form m_Mask_PRO ODUCTION..AllowAdditioons = False Refrresh End d Sub

Figu ure 16. IMS perssonnel mask


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Dec 2014

nov-14

Oct 2014

Sept 2014

Aug 2014

July 2014

June 2014

March…

apr-14

Febr 2014

150 1 1 100 50 0 Jan 2014

ntenance massk (Figure 177), there are the In the main following primary p funcctions: mach hine; compon nent; duration of the t fault; desccription of faiilure (in minu utes); description of o the fault.

M MTTR - Unit 1

Dec 2013

In personnell mask (Figurre 16), there are the follow wing primary funcctions: overtim me; training; hours of abssence (for reasons not n specified above). a

Figu ure 19. MTTR – Unit U 1

c wee can summarize the prim mary results off In conclusion, this study as follo ows: − Reduced MT TTR 55% M 47% − Increased MTBF − Increased OEE 26% − Zero machin ne breakdown ns ntenance 15% − Increased prreventive main C an nd discussion 5. Conclusions

Figure 17. IMS S Maintenance mask m

duction mask k (Figure 188), there are the In the prod following prrimary functiions: data (daay, month, year); y breakdown; net time of production; shifts; s numbeer of pieces produ uced.

Figure 18. IMS S production maask

6. References R

An importan nt feature of th he IMS is the automatic a creaation of performan nce indicatorss such as MTT TR and MTBF F for each line and d month. For example, e the MTTR M for Uniit 1 is shown in Fig gure 19.

[1] Liker J (20033) The Toyotaa Way. McGra aw-Hill, New w York. [2] Sugiyama H,, Schmidt R (22012) Realizin ng Continuouss Improvemen nt in Ph harmaceutical Technicall Operations – Business P Process Modeel in Roche'ss Parenterals Production P K Kaiseraugst. Prroceedings off the 22nd Eurropean Sympo osium on Com mputer Aided d Process Engin neering, 17 to 20 June 2012, London.

S constant mo onitoring, peaak performancce of With an IMS the entire plaant is possible.

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The presence of a well-organ nized mainten nance system m ps an organizzation to incrrease machinee availability,, help redu uce productio on downtimee, production n losses and d overrtime costs. Th he information n flow betweeen production n and maintenancee is very imp portant. It is necessary to o defiine a specific and method dical approach h in order to o perfform producction and maintenance tasks. Thee prop posed model incorporates i eelements from m the literaturee stud dy concernin ng best prractices in maintenancee man nagement systtems, as well aas the main prroblems of thee maintenance man nagement sysstem identified d in our casee stud dy. The resultts of our approach are verry interesting,, beca ause it is sho own that it is possible to achieve a betterr proccess control. Moreover, tthe research methodology y proccess allows fo or a broader v view of the work w done by y both h the producction and maaintenance teeams. Furtherr reseearch will be performed b by applying the t proposed d mod del in other ph harmaceuticall companies. It I is clear thatt the proposed integrated m maintenance managementt systtem model can n be implemented within different d typess of co ompanies.


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[3] Di Dio M, Iannone R, Miranda S, Riemma S (2013) A Framework for the choice of the Opportunistic Maintenance Policy in Industrial Contexts. Proceedings of the 2013 IEEE International Conference on Industrial Engineering and Engineering Management Bangkok 10-13 December 2013 Tritos Laosirihongthong, Thammasat University, Thailand - Roger Jiao, Georgia Institute of Technology, USA Pag.1-6. [4] De Carlo F, Arleo MA (2013) Maintenance cost optimization in condition based maintenance: a case study for critical facilities. International Journal of Engineering and Technology, vol. 5, pp. 4296-4302, ISSN:1793-8244. [5] Gaspar D (2004) The information in maintenance management in a pharmaceutical factory. Second World Conference on POM, Cancun, Mexico, 30 April to 3 May, 2004 [6] De Felice F, Petrillo A (2012) Productivity analysis through simulation technique to optimize an automated assembly line. Proceedings of the IASTED International Conference, June 25 to 27, 2012 Napoli, Italy. Applied Simulation and Modelling (ASM 2012) DOI: 10.2316/P.2012.776-048 – pp. 35-42. [7] De Felice F, Petrillo A (2013) Key success factors for organizational innovation in the fashion industry. International Journal of Engineering Business Management. Volume 5, pp. 47-57, 2013. [8] Liu X, Li J, Al-Khalifa KN, Hamouda AS, Coit DW, Elsayed EA (2013) Condition-based maintenance for continuously monitored degrading systems with multiple failure modes. IIE Transactions (2013) 45, 422-435. [9] De Carlo F, Tucci M, Borgia O (2013) Conception of a prototype to validate a maintenance expert system. International Journal of Engineering and Technology, vol. 5, pp. 4273-4282, ISSN: 1793-8244. [10] Peng Y, Dong M, Zuo MJ (2010) Current status of machine prognostics in condition-based maintenance: a review. International Journal of Advanced Manufacturing Technology, 50, 297-313. [11] Hirst I L, Carter DA (2000) A "Worst Case" methodology for risk assessment of major accident installations. Process Safety Progress, 19(2), 78-82. [12] Laggoune R, Chateauneuf A, Aissani D (2009) Opportunistic policy for optimal preventive maintenance of a multi-component system in continuous operating units. Computers and Chemical Engineering, 33(9), 1499-1510. [13] Khan FI, Haddara MM (2003) Risk-based maintenance (RBM): a quantitative approach for maintenance/inspection scheduling and planning. Journal of Loss Prevention in the Process Industries 16 (2003) 561–573.

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[14] Rafols I, Hopkins MM, Hoekman J, Siepel J, O'Hare A, Perianes-Rodríguez A, Nightingale P (2014) Big Pharma, little science? A bibliometric perspective on Big Pharma's R&D decline. Technological Forecasting & Social Change 81 (2014) 22-38. [15] Shah S (2004) Pharmaceutical supply chains: key issues and strategies for optimisation. Computers and Chemical Engineering 28 (2004) 929-941. [16] Levis AA, Papageorgiou LG (2004) A hierarchical solution approach for multi-site capacity planning under uncertainty in the pharmaceutical industry. Computers and Chemical Engineering 28 (2004) 707725. [17] Swanson L (2003) An information-processing model of maintenance management. International Journal of Production Economics 83 (2003) 45-64. [18] Hipkin IB, De Cock C (2000) TQM and BPR: lessons for maintenance management. Omega 28 (2000) 277±292. [19] Kister, TC, Hawkins B (2006) Maintenance planning and scheduling handbook. United Kingdom: Elsevier Inc. [20] Muchiri P, Pintelon L (2008) Performance measurement using overall equipment effectiveness (OEE): literature review and practical application discussion. International Journal of Production Research, 46(13): 3517-3535. [21] Gulati R (2009) Maintenance and reliability best practices. New York: Industrial Press, Inc. [22] Cato WW, Mobley RK (2002) Computer-managed maintenance systems: a step-by-step guide to effective management of maintenance, labour and inventory. 2nd edition, Butterworth-Heinemann, Woburn MA. [23] Labib, AW (2004) A decision analysis model for maintenance policy selection using a CMMS. Journal of Quality in Maintenance Engineering, 10(3): 191202. [24] Aleem H, Zhao Y, Lord S, McCarthy T, Sharratt, P (2003). Pharmaceutical process validation: An overview. Journal of Process Mechanical Engineering, Part E (217): 141. [25] Ferdows K (2006) Transfer of changing production know-how. Production and Operations Management 15, 1-9. [26] Graya JV, Roth AV, Leiblein MJ (2011) Quality risk in offshore manufacturing: Evidence from the pharmaceutical industry. Journal of Operations Management 29 (2011) 737-752 [27] Andrews J, Moss T (2000) Reliability and Risk Assessment. 2nd edition, Professional Engineering Publishing.


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