Lean Bundles and Performance Outcomes in the Pharmaceutical Industry : Benchmarking a Jordanian Company and Operational Excellence International Project

This study benchmarks the implementation levels and performance outcomes of lean bundles of a Jordanian pharmaceutical manufacturing company with the results of the Operational Excellence (OPEX) model. The OPEX model is an ongoing international research pro ject in the pharmaceutica l industry. The results of the OPEX pro ject were obtained, along with permission to use them in the present study. The same question items used in the OPEX pro ject were used to prepare a questionnaire to collect data from the Jordanian pharmaceutical company. Fifteen managers from the Jordanian company with responsibilities related to lean management completed the questionnaire. The results demonstrated that the implementation levels of lean practices and the lean performance outcomes of the Jordanian pharmaceutical company varied in comparison to the OPEX project. The overall assessment showed that the Jordanian company is excellent in the total quality management bundle (at or above the levels of the benchmarked data), good in the human resource bundle (al most at the levels of the benchmarked data), acceptable in the just-in-time bundle (below the levels of the benchmarked data), and weak in the total preventive maintenance bundle (considerably below the levels of the benchmarked data). There are few benchmarking studies in the pharmaceutical industry in the area of lean management. In part icular, this area is under-investigated in the developing world. The current study provides insights into the value of benchmarking key lean metrics against leading companies. Th is approach is expected to support pharmaceutical industry managers in the developing world to evaluate their current lean state, estimate the desired state based on the benchmarking results, and set appropriate strategies to promote lean management and operational excellence in their companies.


Introduction
The pharmaceutical industry in the developing world faces many challenges, such as the pressures of rising costs coupled with low pricing policies fro m the authorities, along with strong competition in the markets.All these factors create the need to imp lement a system that can imp rove the co mpany's performance and increase pro fits.In this context, lean management is seen as a key strategic option that can considerably improve the efficiency and effectiveness of pharmaceutical co mpanies' operational processes, thus enhancing their co mpetitiveness in today's globally co mpetitive markets (Abdallah and Matsui, 2007;Phan et al., 2010;Al-Zu'bi et al., 2015;Shokri, 2017).
The pharmaceutical industry in Jordan started in the early 1960s.The industry concentrated on the production of generic drugs (patent-free med icines) and building quality into its products to have the potential for export.The industry was unable to attract foreign partnerships in its early stage due to the small size o f the companies and the Jordanian population in comparison with Egypt, Syria, and Morocco (Global Research, 2007).
Today, there are 14 pharmaceutical manufacturing co mpanies in Jordan that are act ive in the production of pharmaceuticals (JAPM , 2017).The pharmaceutical industry is considered to be a pioneer among the exporting sectors in Jordan; 81% of production capacity is designated for export to more than 60 countries (JAPM, 2017).
Per the Jordan Pharmaceutical Country Profile, published by Jordan's Ministry of Health in co llaboration with the World Health Organization (WHO) in 2011, Jordanian pharmaceutical production capabilities are categorized into research and development for discovering new active substances, production of pharmaceutical starting materials (APIs), production of formu lations from pharmaceutical starting material, and repackaging of fin ished dosage forms (W HO, 2011).The report further revealed that in 2008, do mestic manufacturers held 33% of the market share according to the produced value.
Although lean management is widely imp lemented by manufacturing co mpanies (Abu Nimeh et al., 2018;Abdallah et al., 2017;Abdallah and Matsui, 2009), it has been missed by many pharmaceutical co mpanies in developing countries including Jordan (Shehadeh et al., 2016;Awad et al., 2016;Ayoub et al., 2017).Most of the pharmaceutical co mpanies in the Middle East and North Africa (M ENA) region focus on compliance with Current Good Manufacturing Practices (cGMP) guidelines while the operational performance of the manufacturing p lants is overlooked.These companies mainly use financial perfo rmance measures, while operational measures are rarely used.Due to the scarcity of research on lean management and performance in the pharmaceutical industry in developing countries, it was necessary to initiate such research to address these shortcomings.
The driving force behind this study is the need to shed light on the concept of lean management in pharmaceutical co mpanies in developing countries, especially in the MENA region, in order to provide the industry with a new tool to imp rove operations.These companies usually face problems of underutilization of capacity, low levels of technology, high scrap rates, insufficient product quality, and others (Bello -Pintado and Merino-Dí az-de-Cerio, 2013).In part icular, the purpose of this study is to evaluate the levels of lean bundles and lean performance of a Jordanian pharmaceutical co mpany.Next, the collected data is benchmarked with the results of the Operational Excellence (OPEX) model.The OPEX model is an ongoing international research project in the pharmaceutical industry in the area of lean management and operational performance, adopted fro m St. Gallen Un iversity, Swit zerland, with permission to use its data and results.Finally, conclusions and recommendations will be derived based on the findings.
The remainder of this paper is structured as follows: section 2 presents the literature review.Section 3 presents research methodology.Section 4 presents results and discussion.Finally, section 5 presents conclusions, recommendations, and research limitations.

Lean Management
The term lean production was first used by Krafc ik in 1988, as part of his study of the Toyota Production System (TPS) aimed at the elimination of waste (Krafcik, 1988).The holistic consideration of lean thinking and its principles have been successfully described by Womack et al. (1990) in the book Th e Machine that Changed the World.Later, a second book was published, entitled Lean Thin king, by Wo mack and Jones (1996).In this book, the authors defined the central practices which lead to lean management and provide recommendations for applying these practices in any organization.
The main princip les of lean management are the identification of value for the customer, the elimination of waste, and the optimu m generation of flow (Melton, 2005;Abdallah and Matsui, 2009;Saleh et al., 2017).Value definit ion refers to the idea that any manufacturing process is a way to deliver value to the customer, and any activity that does not add value to the customer is a waste (Womack and Jones, 1996).Waste is defined as "any human activity which absorbs resources but creates no value" (Ohno, 1988).Lean management strives to eliminate types of waste that include overproduction, wait ing, transport, unnecessary motion, over-processing, defects, excessive inventory, and unused employee creativity (Liker, 2003).The opti mu m generation of flow refers to the idea that the production flow should be continuous, with no variat ion.The production line should not be stopped for machine breakdown, delay, or any other problem (Besterfield, 2014).Such lean principles might not be imp lemented, however, due to t ime constraints and concerns about the impact of such principles on regulatory compliance (Womack and Jones, 1996).
The literature dealing with lean practices indicates that different authors have different approaches to lean group concepts.For example, Wo mack et al. (1990) focused on the influence of specific aspects of lean management on manufacturing performance figures.Shah and Ward (2003) postulated four "bundles" of interrelated and internally consistent practices; they proposed just-in-time (JIT), total quality management (TQM ), total preventive maintenance (TPM), and human resource management (HRM ).Gebauer et al. (2009) concluded that JIT/continuous flow production, preventive maintenance, pull system/kanban, quick ch angeover techniques, cross-functional workforce, and continuous improvement programs are the most frequently included lean practices.Azevedo et al. (2012) used the following lean practices in their study: supplier partnership, JIT, pull flo w, quality management, and customer relationships.So and Sun (2010) measured lean management in terms of supplier selection, pull production, information technology, process focus, and employee empowerment.Tortorella et al. (2017) emp irically validated four bundles of lean practices, namely, elimination of waste and continuous improvement, logistics management, top management co mmit ment, and customer-supplier relationship management.Eriksson (2010) determined the following lean practices: waste reduction, process focus, continuous improvement, customer focus, systems perspective, and cooperative relationships.
This study adopts the approach proposed by Shah and Ward (2003).Accordingly, lean management is measured using four bundles: JIT, TQM, TPM, and HRM.These four b undles were selected to benchmark lean implementation of the Jordanian pharmaceutical co mpany with the ongoing benchmarking project at St. Gallen University, which used this approach to measure lean management in the pharmaceutical industry.

Lean Operational Performance
Operational performance is defined as "the output or result achieved due to unique operational capabilities" (Tan et al., 2007).It usually refers to measurable outcomes of organizational processes, such as cycle time, inventory turns, and delivery (Neely et al., 1995).In this vein, operational performance is regarded as internal or process performance (Manikas and Terry, 2009).Flynn et al. (2010) pointed out that operational performance is related to internal imp rovements in a firm's response to a dynamic environ ment with regard to its competitors and customers.Lean operational perfo rmance refers to performance outcomes achieved as a result of applying lean principles.An organizat ion that is operationally excellent through lean implementation leads its competitors by providing the lowest cost and the highest quality to its customers.It does this by performing the right tasks, at the right time, in the most efficient manner (Abdallah et al., 2009;Sharafat et al., 2016;Al-Sa'di et al., 2017).
Chen (2008) suggested that it is necessary to choose an appropriate range of performance measures, and these measures must be balanced to ensure that one performance or set of performance d imensions is not stressed to the detriment of others.Meanwhile, Gieskes et al. (1999) suggested that performance areas must be operationalized in a way that allows performance to be adequately measured against relevant performance indicators.It is necessary to find a co mprehensive tool that can measure the overall lean operational performance of pharmaceutical co mpanies.Benchmarking data are also important, especially with regard to limited published data about developing countries.Upon literature rev iew, this study identified only a limited nu mber o f publishe d works on lean pract ices and associated operational outcomes at pharmaceutical co mpanies in the developing world.Shabaninejad et al. (2014) investigated the development of an integrated performance measurement model for the pharmaceutical industry in the Iranian market.They identified 25 key perfo rmance indicators; however, their suggested indicators were not presented as a comprehensive system to measure the overall lean performance of the company.Friedli et al. (2013) adopted an operational performan ce model with their research group at the Institute of Technology Management at St. Gallen University.Their model had two distinctive elements: a technical sub-system and a social system.The technical sub-system consisted of the outputs of three lean bundles: TPM, TQM, and JIT.The social system included the outputs of an HRM bundle.Likewise, Bellm (2015) investigated lean operational performance in the pharmaceutical industry in emerg ing markets.The study used the quantitative data from the ongoing benchmarking project at St. Gallen University.
As the objective of this study is to benchmark lean bundles and lean operational performance of one Jordanian pharmaceutical co mpany with the ongoing benchmarking project at St. Gallen University, lean operationa l performance indicators were adopted fro m the model proposed by St. Gallen University and its benchmark data.These lean operational performance indicators included items related to JIT performance, TQM performance, TPM performance, and HRM performance.

Benchmarking Model Selection
The OPEX model was selected as a benchmarking model for this study.The model was adopted from an international research project in the pharmaceutical industry in the area of lean management and opera tional performance.The pro ject was begun in 2004 at the Institute of Technology Management at the University of St. Gallen, Swit zerland, and the Transfer Center for Technology Management at the University of St. Gallen, Switzerland (Fried li et al., 2013).The pro ject provides participating firms the opportunity to position their p lants against a broad range of pharmaceutical plants, to identify possibilities for improving lean operational performance (Gütter, 2014).Since 2008, pharmaceutical firms have been permitted to enter the continuous benchmarking process at any time.The OPEX database includes more than 280 pharmaceutical plants fro m small and medium-sized companies (Bellm, 2015).
The OPEX benchmarking model includes lean enablers and outcomes.Enab lers include lean bundles of JIT, TQM, TPM, and HRM.The outcomes reflect lean operational performance indicators related to JIT performance, TQM performance, TPM performance, and HRM performance (Gütter, 2014;Bellm, 2015).

Measures
The survey items were adopted from the OPEX research project.In part icular, the items were adopted from Bellm (2015) and Friedli et al. (2013).In the OPEX pro ject, each lean bundle consists of several widely cited practices in the literature.Each practice was measured using several question items.The number of items to measure each practice ranged fro m 3 to 10.The JIT bundle included the practices of setup time reduction , pull production, layout optimization, and planning adherence.The TQM bundle included the practices of process management, cross-functional product development, customer integration, and supplier quality management.The TPM bundle included the practices of preventive maintenance, technology assessment and usage, and housekeeping.The HRM bundle included direction setting, management commit ment and company culture, employee involvement and continuous improvement, and functional integration and qualificatio n.
Respondents were asked to indicate the degree to which the provided statements apply to their plants, using a Likert scale of 1-5 where 1 indicated not at all and 5 indicated completely.
Lean operational performance was measured using key operational p erformance indicators adopted from the OPEX project.The indicators are related to JIT performance, TQM performance, TPM performance, and HRM performance.Tab le I summarizes lean operational performance indicators of each lean bundle and their respective definitions, as adopted from Bellm (2015), and the measurement unit of each indicator.

Data Collection
The data were collected fro m one Jordanian pharmaceutical co mpany and were verified by site visits and observations at the manufacturing site.A questionnaire was prepared with constructs reflect ing lean bundles and lean operational performance.The same question items used in the OPEX model were adopted for this study.The questionnaire was completed by fifteen managers, principal persons, and supervisors from various departments.In addition, interviews were conducted with the respondents to ensure that all the question items were understood and carefully answered.Respondents were encouraged to refer to the company's enterprise resource planning (ERP) system and various company units to ensure the accura cy of their responses whenever it was appropriate.The average response of the fifteen respondents was calculated for each question item and used later for benchmarking purposes.
The company selected for the survey is a local manufacturer and distributor o f a broad range of pharmaceutical products.The manufacturing site has three main production plants, one for general products and the other two for cephalosporin and penicillin.The major production line at the company is solids, which represent 65.46% of the product portfolio, followed by semisolids at 26.54%, liquids at 6.16%, and sterile vials at 1.83%.
The company has a large production staff of more than 400 full-t ime emp loyees working in eight-hour day shifts.The company has many export markets in the Middle East and some European countries.The company is referred to as Jordanian Pharmaceutical Company (JPC) throughout the paper.

Treatment of Data
As the results of the OPEX benchmark data are reported in percentages, the data collected fro m the JPC was also converted to percentages.For lean constructs, the implementation level was calculated as a percentage of each practice by taking the average value of the set fro m the 5-point Likert scale, div iding it by 5, and mult iply ing by 100.Most performance indicators were reported in percentages.In order to convert the remaining performance values into a percentage, each value was divided by its corresponding complete value in %; for examp le, to convert absenteeism (in days) into a percentage, the valu e was div ided by 365 days and mu ltip lied by 100 to generate a percentage.
The OPEX benchmark data regarding the imp lementation levels of the practices of lean bundles were split into four categories for comparison purposes with JPC: top 10 refers to the top ten companies from the advanced sample; advanced refers to co mpanies in Eu rope, USA, Canada, and Japan; offshore refers to mu ltinational companies operating in emerging markets; and domestic refers to local companies from developing countries.
With regard to lean operational performance indicators, an average value fo r the entire OPEX data set was calculated and labeled average industry, which was compared to JPC results.

Benchmarking JPC's Implementation Levels of Lean Practices with OPEX Data
Table 2 shows the comparison of the imp lementation levels of lean practices between JPC and other sites.JPC implementation levels varied among practices.Pract ices at JPC were higher than the top-10 samp le in preventive maintenance, customer integration, and pull p roduction; in supplier quality management, employee involvement, and functional integration, JPC was at the level of the advanced sites.JPC was lo wer than the benchma rk data in the implementation of technology assessment, housekeeping, process management, cross -functional development, setup time reduction, layout optimization, and management commitment.

Benchmarking JPC's JIT Performance with Industry Average
The results in Figure 1 show that cycle time at JPC fro m weighting to packaging is 22.5 days, wh ich is similar to the industry average of 22.7 days.This indicates well-optimized processes with the supply chain.However, JPC's perfo rmance in the aspects related to working cap ital was not as expected.In raw materials turns, JPC was only 2.4 wh ile the OPEX average was about 8.In addition, the finished goods turns value at JPC was 3.9 turns per year compared to an average of about 16 for the industry.JPC's performance at the service level (order fulfillment on time) was 9 7%, which was higher than the OPEX average value of 95%.Th is high service performance can be attributed to JPC's effect ive use of pull production; JPC's value was 68%, as shown in Table 2, wh ich was higher than all the other sites.Interviews with managers at JPC revealed that the company adopts both a pull system and a push system simultaneously.They use the push system for the local market, while the pull system is used for the export markets.The company's policy in the local market is to maintain a sufficient stock of products; production for export is upon request from customers.However, the usage of both pull and push systems simultaneously seems to have an effect on raw materials and fin ished goods turns.In addition, JPC showed the worst result regarding set-up time reduction, as shown in Table II; this might also have had an effect on raw materials and finished goods turns.

Benchmarking JPC's TQM Performance with Industry Average
The results fro m JPC indicate high internal performance with regard to rejected batches; it was 0 at JPC, while it was about 1% for the OPEX industry average.The scrap rate at JPC o f 3.5% was a bit h igher than the OPEX average of 2.5%.Zero rejected batches at JPC can be attributed to the well -implemented cGMP requirements.JPC uses well-known cGMP systems, such as annual product quality review and trend analysis, to monitor all quality-related issues.Site v isits at JPC revealed that the use of measurement methods, such as statistical process control, are poorly imp lemented.This may exp lain the high scrap rate compared to the OPEX average.Th is is supported by the extent to which the TQM practice of process management is imp lemented; process management includes the documentation, measurement, and improvement of pro cesses.It was 7% lower at JPC compared to the top 10 sites, as shown in Table 2.

Figure 1. JIT implementation and performance at JPC compared to industry average
As for the indicators of external TQM performance, JPC showed similar high performance as the OPEX average, with regard to customer co mplaints (< 1%).In addit ion, supplier comp laints were only slightly h igher at JPC, with 4%, as compared to the OPEX average.The high external TQM performance results at JPC can be attributed to the extensive implementation of the TQM practices of supplier quality management and customer integration; the JPC levels of imp lementation are very close to top -10 co mpanies, as shown in Table 2. Interviews with supply chain managers at JPC revealed that the company has 180 active suppliers (35% fro m India, 25% fro m Europe, 15% fro m the Middle East, 7% fro m China, and 18% fro m the rest of the world).The company applies a vendor qualification system, according to cGMP requirements.For example, to approve a supplier of act ive pharmaceutical ingredients (API), they require a GMP certificate for the manufacturer site and a drug master file (DMF) for the API; in addition, they perform the audit at the site.

Benchmarking JPC's HRM Performance with Industry Average
The performance indicators of the lean HRM bundle are shown in Figure 3. Absenteeism and fluctuation are used as measures of emp loyee satisfaction (Bellm, 2015).Absenteeism, at 2.1%, was lo wer at JPC than the industry average value of 3.3%.In fact, the low absenteeism rate at JPC might be traced to strict ro les in the pharmaceutical industry in Jordan, where absenteeism may lead to loss of employ ment.Fluctuation, however, was higher at JPC, at 13%, co mpared to the industry average of 7.5%.Fluctuation seems to have a greater negative effect on the company, since knowledge can be lost when workers leave the co mpany.In the Middle East reg ion, there is a tendency for experienced workers to go work in the Gu lf countries, where the salaries are much higher for the same position compared to Jordan.The generic pharmaceutical industry in that region is developing quickly, wh ich is very attractive to Jordanian workers.Another reason fo r high fluctuation at JPC could be the lack of empowerment and qualification programs.Transferring authority fro m supervisors to line staff is not a common practice on the shop floor, as was observed from the site visits.Emp loyees have limited authority to act on the problems they face during production, where a wrong decision could cost an employee his job.In fact, the degree of cross -trained employees was not high at JPC.It seems that the management at the company was not previously aware of the importance of job rotation and qualification programs; a newly implemented policy at the co mpany is aimed at improving th is weak point by providing mo re train ing and rotation.
Staff qualification, represented by the portion of unskilled emp loyees as a percentag e of the total number of emp loyees, was similar to the OPEX industry average.However, the number of training days at JPC was 2.4 days, compared to the industry average of almost 17 days.This could be attributed to company culture at JPC. Site v isits revealed that executive management believes there is no place for indiv idual involvement in any changes that are not within the regulations, so they consider following rules and regulat ions more important than giving suggestions or employee involvement in improvement.They feel that giving the emp loyees freedom to implement change would negatively affect comp liance with regulations.It is therefore obvious that the direction of development, orders, decisions, and new projects flow fro m top management to emp loye es without feedback from shop floor employees.
Figure 3. HRM implementation and performance at JPC compared to industry average

Benchmarking JPC's TPM Performance with Industry Average
The backbone of a manufacturing site is its production lines, wh ich are dependent on machines.Thus, the main concern is to keep the machines running at full capacity during production time.Machine failu re, lo wer production capacity, and low product quality are issues that have been addressed in depth in the literature as the results of poor production maintenance (Ahuja and Khamba, 2008;Abdallah, 2013).
Figure 4 shows the benchmarking results of TPM implementation practices and TPM performance at JPC compared with the industry average.The overall equip ment effectiveness (OEE) level at JPC was 36%, which is less than the industry average of 51%.In addition, unplanned maintenance work at JPC represented 70% of its overall maintenance time.The percentage seems to be very high compared to 33% for the OPEX bench mark dat a. JPC v isits and interviews with managers revealed that the co mpany suffered fro m a lack of real preventive maintenance programs.This issue is currently undergoing improvement; the imp lementation level at JPC, at 81%, is higher than the top-10 sites (Tab le 2).Engineering management is serious about implementation of preventive maintenance programs and has already started train ing programs for production and maintenance staff, in addition to the performance of fu ll maintenance programs for the machines.T hey are also working on autonomous maintenance by empowering shop floor emp loyees and mach ine operators.The new policy at the company is to shift fro m reactive to proactive maintenance.JPC is still lagging in the issues of utilizat ion of equipment and minimizing downtime.The issue of OEE was still new to the company when they implemented a new program to measure it for all machines.
Dedicated equip ment at JPC is only about 1%, wh ile it represents about 36% of the OPEX benchmark data.The dedication of equipment to certain products reduces the need for changeovers and lowers the need for full cleaning validation between different batches after line clearance.This is evident from the TPM performance indicator of set up and cleaning, which represents 25% o f schedule time at JPC as co mpared to the OPEX average of 15%.JPC's low percentage of dedicated equipment is explained by its large product portfolio, which comprises more than 200 formu lat ions in 1554 d ifferent stock keeping units (SKUs).The level o f ded icated equipment is closely linked to the type of pharmaceutical industry; in Jordan, it is mainly a generic industry.

Conclusion
In this study, the extent to wh ich lean practices have been imp lemented at one Jordanian pharmaceutical company were benchmarked with the results of the international research project in the pharmaceutical industry (OPEX).The adopted operational excellence (OPEX) benchmarking model provides a comprehensive methodology to evaluate the overall lean levels and performance of pharmaceutical manufacturing co mpanies.The proposed model can assist pharmaceutical co mpanies in emerging markets to evaluate their perfo rmance and develop appropriate imp lementation procedures for imp roving and enhancing operational effect iveness and efficiency.The model includes four lean bundles: JIT, TQM, TPM , and HRM.Each bundle was benchmarked in terms of the implementation levels of its main practices and the performance of the lean bundle.
The criteria shown in Table 3 were adopted in order to assess the implementation and performance levels at JPC compared to the benchmarked data.
The proposed criteria co mbine the implementation and performance levels of each lean bundle in order to make an overall assessment and rating of each bundle relative to the benchmarking data.The overall assessments are based on the results of JPC regarding the practices and performance indicators of each bundle compared with the benchmarking data reported in the previous sections.In addition, site v isits to JPC by the authors and interviews with managers were taken into consideration to avoid misleading conclusions.The implementation and performance levels of the lean bundle at JPC are at or above the levels of the benchmarked data.

Good
The implementation and performance levels of the lean bundle at JPC are almost at the levels of the benchmarked data.

Acceptable
The implementation and performance levels of the lean bundle at JPC are below the levels of the benchmarked data.

Weak
The implementation and performance levels of the lean bundle at JPC are considerably below the levels of the benchmarked data.
A carefu l assessment reveals a rating for JPC that is close to excellent for the TQM bundle.The imp lementation of TQM pract ices at JPC was excellent with regard to customer integration and supplier quality management.Process management and cross -functional product development showed levels ranging between good and acceptable.Likewise, the TQM performance was excellent, especially g iven the 0% of rejected batches and customer co mp laint rate.In addit ion, good performance results were shown with regard to scrap rate and supplier complaint rate.
The overall assessment of the HRM bundle reveals a rating close to good.The imp lementation level of the HRM practice of functional integration was excellent.Emp loyee involvement showed a good implementation level.The practices of direction setting and management commit ment showed acceptable imp lementation levels.HRM performance indicators showed excellent ratings regarding three indicators: unskilled emp loyees, absenteeism, and fluctuation.However, JPC showed a weak rating regarding training days.
The overall rat ing of the JIT bundle is close to acceptable.The imp lementation levels of the JIT practices of pull production and planning adherence at JPC were excellent.However, the two other practices, setup time reduction and layout optimization, showed acceptable implementation levels.As for JIT performance, JPC showed excellent performance concerning delivery service level and good performance concerning cycle time.Nevertheless, JPC showed weak performance with regard to finished goods turns and raw materials turns.
Regarding the TPM bundle, the overall assessment of JPC tended to be weak.A lthough the implementation level of TPM pract ice of p reventive maintenance was excellent, the levels of technology assessment and housekeeping were weak and acceptable, respectively.TPM performance showed an excellent rating regarding setup and cleaning.However, performance indicators of dedicated equip ment, unplanned maintenance, and OEE showed weak ratings at JPC. Figure 5 summarizes the overall rating of each lean bundle.
Figure 5. Overall rating of implementation levels and performance of lean bund les at JPC

Recommendations
With regard to TQM, it is reco mmended that JPC management maintain customer co mplaints at a low level while keeping rejected batches to zero.In addition, imp rovement p lans are needed to reduce supplier co mp laints and scrap rates.With regard to JIT, it is reco mmended that JPC continue working on reducing cycle and setup times.In addition, considerable imp rovements are needed to imp rove performance metrics on raw material and fin ished product turns.With regard to HRM, JPC management should make an effort to diffuse the strategic direction co mpany-wide, to positively influence the organizational culture and reflect management's commit ment to lean philosophy.Training represents one major weakness at JPC; it should be given p riority, as it promotes cross-functional teams and provides the basis for real imp rovements.Likewise, emphasis should be TQM JIT HRM TPM Excellent Good Acceptable Weak given to reducing fluctuation and increasing employee involvement.With regard to TPM , there is plenty of roo m for improvement by enhancing preventive maintenance programs while in itiating OEE monitoring, reducing unplanned maintenance, improving housekeeping, and increasing the qualification of the maintenance staff through training.

Managerial Implications
The pharmaceutical indus try, like other industries, faces challenges associated with severe global competit ion and pressure to improve quality while reducing cost.This situation is even more ev ident in developing countries, where many co mpanies struggle to sustain their market s hares and improve the efficiency and effectiveness of their operations.While lean management has grown in popularity in the pharmaceutical industry in developed countries, it is still a new concept in developing countries.Managers must consider lean mana gement as an effective competit ive strategy for achieving operational excellence.Benchmarking the levels and performance outcomes of lean bundles with lead ing international co mpanies enables co mpanies in the developing world to assess their success and determine areas that should be targeted for improvement.The current benchmarking study of the pharmaceutical manufacturing co mpany in Jordan prov ides insights regarding the usefulness of comparing key lean met rics against leading companies.This new approac h to the pharmaceutical industry in developing countries can support senior management in adopting appropriate strategic plans to promote lean management and operational excellence in their co mpanies.In addit ion, the data presented in this study represent essential information in this field that can be utilized by companies to imp lement a lean program and steer themselves toward operational excellence, regardless of the region in which the manufacturing site is located.

Limitations
This study was applied to only a single pharmaceutical co mpany in Jordan.This was due to the familiarity of this company with lean management; in addition, other companies declined to participate.Future studies are needed in developing countries with an appropriate sample size of pharmaceutical co mpanies to obtain more generalizable results regarding lean management and enable investigation of causal relat ionships.Finally, only fifteen responses were received fro m JPC.Th is small nu mber is inappropriate for performing validity and reliability analysis of the constructs.Future studies with an appropriate sample size will avoid this limitation.

"
The time spend for setup and cleaning as a percentage of the scheduled time".% Unplanned maintenance "Proportion of unplanned maintenance work as a percentage of the overall time spend for maintenance works".OEE) availability x (OEE) performance x (OEE) quality (OEE) availability = (Scheduled time -Downtime) / Scheduled time (OEE) Performance = (A mount produced x Lead cycle t ime) / Available time (OEE) Quality = (Inputs -Defects) / Inputs".%

Figure 2 .
Figure 2. TQM implementation and performance at JPC compared to in dustry average

Figure 4 .
Figure 4. TPM implementation and performance at JPC compared to industry average

Table 1 .
Performance indicators of lean bundles

Table 2 .
Implementation levels of lean practices Source of Table with major data except JPC data were obtained from St. Gallen University with Permission.

Table 3 .
Proposed criteria for rating JPC's results compared with the benchmarked data