Maintenance Strategies and Innovative Approaches in The Pharmaceutical Industry: An Integrated Management System (IMS)
Maintenance Strategies and Innovative Approaches in The Pharmaceutical Industry: An Integrated Management System (IMS)
Maintenance Strategies and Innovative Approaches in The Pharmaceutical Industry: An Integrated Management System (IMS)
Maintenance Strategies
and Innovative Approaches
in the Pharmaceutical Industry:
An Integrated Management System (IMS)
Regular Paper
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.
The aim of the present research was to study the Competitive pressures on manufacturing organizations
relationship between the complexity of the production have forced them to consider all improvement
environment and the use of maintenance practices in the possibilities, for example, as stated by Hipkin and Cock
Pharmaceutical Industry in order to define proper [18], the consideration of management tools integration
maintenance strategies and innovative approaches. This like total quality management (TQM) and business
study employed qualitative research and includes a process reengineering (BPR). In particular, two
literature review and a case study. maintenance interventions have seen significant
industrial application over the past decade: reliability-
Specifically, in this work we present an integrated system centred maintenance (RCM) and total productive
that is useful for defining an optimal maintenance maintenance (TPM).
strategy and a proper policy for continuously monitored
degrading systems. Section 2 in this paper presents a According to Kister & Hawkins [19], one of the
literature review on maintenance strategies in the fundamental measures of performance used in total
pharmaceutical industry. In section 3, the theoretical productive maintenance (TPM) is overall equipment
approach of the research is discussed. Section 4 provides effectiveness (OEE), which measures in percentage points
details about the proposed research framework. Section 5 three important concepts from the point of view of
reports the results of the analysis and provides a manufacturing: the availability, efficiency and quality
discussion of the results. rate of a plant. Though OEE is a well-known performance
measurement [20], on its own, it is not sufficient for
2. Literature review: maintenance strategies in the "monitoring" organizational maintenance management.
Pharmaceutical Industry
As pointed out by Gulati [21] a company must also
In the past two decades, changes in the production understand that achieving a high level of computational
environment have rendered maintenance tasks accuracy is a critical factor for the success of maintenance
increasingly complex. As a result, industries are being management. Without computer-assisted prompts,
forced to consider systematic approaches for optimizing operators carry out unnecessary preventative action
their maintenance policies [10]. The overall objective of routines or leave them until too late [22]. Computational
the maintenance process is to optimize the total life cycle facilities offer effectiveness and efficiency. Maintenance is
of **** without compromising safety or environmental one area in which computing can be applied with great
issues [11]; [12]. In fact, unexpected failures usually have results. A computerized maintenance management
adverse effects and may result in major accidents. Studies system can offer support on a variety of levels within the
by Khan and Haddara have illustrated the close organizational hierarchy [23]; [24].
relationship between maintenance practices and the
occurrence of major accidents [13]. The aim of the present The literature review indicated that, in general, studies
study was to identify best practices for maintenance were focused on a particular type of maintenance policy.
management systems from the literature review and to In our opinion, there is a need for a more generalized
establish the key concepts adapted for the pharmaceutical methodology that can be applied to all contexts. Thus, we
industry. believe that according to the literature review, the critical
www.intechopen.com Fabio De Felice, Antonella Petrillo and Claudio Autorino: Maintenance Strategies and Innovative 3
Approaches in the Pharmaceutical Industry: An Integrated Management System (IMS)
STAGE 3: "M Maintenance Management
M P
Process" consissting We asked thee individuall responsiblee of every y
of six phases: unitt/department to answer qu uestions such h as: "In yourr
− Work identification, where infformation about a opin
nion what are the
t main probleems, if any, in trying to havee
performmance indicato ors such as m
mean time betw ween prod
duction machin nes/equipment available for maintenance?";
m ;
failuress (MTBF), mean time to reepair (MTTR) and or "In
" your opinioon what are thhe problems, iff any, with thee
overall equipment efffectiveness (O OEE) is definedd; engiineering staff regarding tthe engineerin ng structures,,
− Work planning,
p thatt is, the ideentification off all comp petency and traaining?".
required d resources;
− Work sccheduling, wh here opportun nistic maintennance Table 1 is an exaample of the results of thee preliminary
y
tasks syynchronized with
w productio on are developped; dy; 15 question
stud nnaires were ccompleted.
− Work exxecution, wheere an effectiv ve control off the
mainten nance work ex xecution function through clear # Main Prob
blem %
accounttability for eacch type of dem
mand placed upon
u
1 Lack of maintenance and producction 85
the orgaanization is deefined;
planning iintegration.
− Mainten nance history recording, which
w consistts of
2 Predictive maintenancce is not being b 75
evaluating and analy ysing the curreent programm me in
practiced.
order too direct necesssary refinemennts;
3 No clear process
p of wheen change conntrols 50
− Mainten nance analysingg, which conssists of identiffying
and deviattions are need
ded.
and in nvestigating potential
p system (producct or
4 No value-adding main ntenance ana alysis 65
processs) weaknesses..
performedd on maintenaance data.
5 Lack of traaining of Eng
g Staff in the latest
l 70
STAGE 4: "M Maintenance Im
mprovement Procedures"
P w
where
technology y
an integrated
d model aiminng to improvee the mainten
nance
process is dev
veloped. Tablle 1. Primary maintenance man
nagement system
m problems
Figu
ure 3. Pareto anaalysis of losses ffor each unit/deepartment
4.2 Stage
S 2: Mainteenance/plant orrganizational arrrangements
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
Figure 6. Main
ntenance manag
ger profile 0,0
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
4.3 Stage 3: Maintenance
M Maanagement Proccess 1 2 3 4 5 6 7 8 9 10 11
www.intechopen.com Fabio De Felice, Antonella Petrillo and Claudio Autorino: Maintenance Strategies and Innovative 5
Approaches in the Pharmaceutical Industry: An Integrated Management System (IMS)
Worrk scheduling: the
t aim of thiss phase was to
o organize thee
O
OEE diffeerent types of maintenaance over tim
unitt/department. An exam mple of sch
me for each
heduling forr
h
# T
Type of fault Cause
1 Belt faailure Improoper
mainttenance
2 Tempeerature too hig
gh Failurre to mainttain
basic conditions
3 Pressu
ure too low Failurre to mainttain
basic conditions
4 Comprressor overheated Incorrrect design
5 Electriicity outage 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
0
Figure 11. Exam
mple of a map of
o faults
1 2 3 4 5 6 7 8 9 10 11
Maintenance history
h recordin
ng: the aim off this phase was to
analyse any anomalies
a during the production such as the Figu
ure 13. Halt prod
duction – 10 weeeks (from 40 to 50)
halting of pro
oduction (nummber), as showwn in Figure 133.
Maintenance analysis:
a the aiim of this phaase was to identify On the homepagee of the compu uterized modeel (Figure 15),,
critical poin
nts in the maaintenance prrocess. Theree are therre are the folllowing seven main functio ons: mask forr
several tools that can be ussed here, but in
i our opinionn, the prodduction; mask ks for personnnel managem ment activities;;
best of thesee is the failurre mode, effeects and criticcality massk for mainten nance; mask ffor the additio
on of workerss
analyses (F FMECA). Th his method consists of o a massk for the ad ddition of a p production line; mask forr
methodology y for examin ning all the ways
w in which a add
ding a maintain ner; closing ap
pplication.
system failuure can occur, the potentiaal effects of then
ystem perform
failure on sy mance and safeety, as well ass the We used a speciffic script for the constructiion of masks..
seriousness of
o these effectts. Figure 14 shows
s an exammple Belo
ow is an exam
mple of the production mask k.
of the FMECA A approach.
Priv
vate Sub Formm_Open(Canccel As Integer))
Computerized an
4.4 Stage 4: C nd standardizedd OPE EN.Visible = False
F
improvement actions
a
CLOOSE.Visible = True
The definitioon of performmance indicato ors for each linne is
Formm_Mask_PRO ODUCTION..AllowDeletioons = False
rather compllex, especiallyy from a man nagement poin nt of
view. Therefore, we hav ve developed d a synchron nized Formm_Mask_PRO ODUCTION..AllowEdits = False
model based d on Visual Baasic logic for the collectionn and Formm_Mask_PRO ODUCTION..AllowAdditioons = False
implementation of the data with regards to both Refrresh
production and
a maintenan nce. In Figuress 15, 16, 17 and 18, Endd Sub
some IMS maasks are illustrrated.
www.intechopen.com Fabio De Felice, Antonella Petrillo and Claudio Autorino: Maintenance Strategies and Innovative 7
Approaches in the Pharmaceutical Industry: An Integrated Management System (IMS)
In personnell mask (Figurre 16), there are the follow
wing
primary funcctions: overtim
(for reasons not
me; training; hours of abssence
n specified above).
a
M
MTTR - Unit 1
150
1
In the main ntenance massk (Figure 177), there are the 1
100
following primary
p funcctions: machhine; compon nent; 50
duration of the
t fault; desccription of faiilure (in minu
utes); 0
March…
description of
o the fault.
Dec 2013
apr-14
Dec 2014
Febr 2014
June 2014
July 2014
Aug 2014
nov-14
Sept 2014
Jan 2014
Oct 2014
Figu
ure 19. MTTR – Unit
U 1
In conclusion,
c wee can summarize the prim
mary results off
this study as follo
ows:
− Reduced MT TTR 55%
− Increased MTBF
M 47%
− Increased OEE 26%
− Zero machin ne breakdown
ns
− Increased prreventive mainntenance 15%
5. Conclusions
C an
nd discussion
An importan nt feature of th
he IMS is the automatic
a creaation [1] Liker J (20033) The Toyotaa Way. McGra aw-Hill, New
w
of performannce indicatorss such as MTT TR and MTBF F for York.
each line and
d month. For example,
e the MTTR
M for Uniit 1 is [2] Sugiyama H,, Schmidt R (22012) Realizin ng Continuouss
shown in Figgure 19. Improvemen nt in Phharmaceutical Technicall
Operations – Business P Process Modeel in Roche'ss
With an IMS S constant mo onitoring, peaak performancce of Parenterals Production
P K
Kaiseraugst. Prroceedings off
the entire plaant is possible. the 22nd Eurropean Sympo osium on Com mputer Aidedd
Process Engin neering, 17 to 20 June 2012, London.
www.intechopen.com Fabio De Felice, Antonella Petrillo and Claudio Autorino: Maintenance Strategies and Innovative 9
Approaches in the Pharmaceutical Industry: An Integrated Management System (IMS)