CASE REPORT
The Utilization of Quality KPIs in the Pharmaceutical Industry
Marianne Torkko & Nina Katajavuori & Anu Linna &
Anne Mari Juppo
# Springer Science+Business Media New York 2014
AbstractPurpose The overall aim of this study was to investigate thesignificance of quality key performance indicators (KPIs) andhow comprehensively they are used in the pharmaceuticalindustry. A specific aim was to find which KPIs were relevantto personnel from the perspective of their own work respon-sibilities. A further aim was to determine which factors moti-vate personnel enough to respond to improve KPIs.Methods Qualitative theme interviews of ten staff from onecase company were conducted to study the impact of KPIs.Interview data were analyzed using qualitative content analy-sis and reductive analysis.Results Personnel considered deviations in manufacturingand packaging to be the most important quality KPI whenthey considered their own work responsibilities. The qualityindicators data were utilized quite efficiently, for example, incomplaint and deviation handling processes, and they provid-ed useful information for corrective and preventive actions(CAPA)-reporting. The most important factors that motivatedsupervisors, managers, and experts regarding KPIs were those
that affected interviewees own particular work responsibili-ties, the cooperation within the operators own departments,and the cooperation between different departments. The inter-viewees opined that the production bonus was the most im-portant motivational factor for production operators to im-prove upon quality indicator performance.Conclusions Quality indicator feedback data were utilizedwidely by the case company and were considered to be auseful tool to guide personnel in ensuring or potentially im-proving the quality of operations.
Keywords Quality KPI . Quality indicator . Pharmaceuticalindustry . Lean practices
AbbreviationsKPI Key performance indicatorOPEX Operational excellenceTQM Total quality managementRFT Right first timeCAPA Corrective and preventive action
Introduction
Price pressure and stiff competition are driving the pharma-ceutical industry towards greater efficiencies, higher quality,and continuous improvement. It is crucial to do things rightthe first time (RFT)without a time delay and without incurringextra costs caused by losses and rejected batches. ICH guide-line Q10 highlights the importance of continuous improve-ment and urges the pharmaceutical industry towards everhigher quality standards [1]. Product quality and processperformance systems have to provide the tools for the mea-surement and analysis of quality and production parameters.The system should also include feedback from internal and
M. Torkko :A. M. JuppoDivision of Industrial Pharmacy, Faculty of Pharmacy, University ofHelsinki, P.O. Box 56, Viikinkaari 5E, Helsinki 00014, Finland
A. M. Juppoe-mail: [email protected]
M. Torkko (*)Orion Corporation, Tengströminkatu 8, P.O. Box 425, 20101 Turku,Finlande-mail: [email protected]
N. KatajavuoriFaculty of Pharmacy, University of Helsinki, P.O. Box 56,Viikinkaari 9, Helsinki 00014, Finlande-mail: [email protected]
A. LinnaOrion Corporation, Orionintie 1, P.O. Box 65, 02101 Espoo, Finland
J Pharm InnovDOI 10.1007/s12247-014-9184-3
external sources such as complaints, reports of deviations, andaudit findings.
The pharmaceutical industry can be considered as a specialcase because it is under strict regulatory control. However, themethods used in developing a supply chain in othermanufacturing industries, such as lean practices, have alsobeen implemented in the GMP environment [2–4]. The prin-ciples of lean practices involve the identification of value forthe customer, elimination of all types of waste, and the gener-ation of flow [5]. Any activity in the manufacturing processthat does not add value for the customer is considered a waste[6]. Lean practice also relies upon the continuous improve-ment principle.
Friedli et al. [7] investigated the implementation of OPEX(operational excellence) as a target state for lean manufactur-ing in the pharmaceutical industry. They also investigated theassociation of OPEX with key performance indicators (KPIs).OPEX includes four subsystems: total quality management(TQM), total productive maintenance, just-in-time, and effec-tive management system. Their study was based on a surveyof pharmaceutical production sites in 2004 and 2009. Theyfound that the pharmaceutical companies were able to im-prove the TQM significantly. The KPIs that most affectedTQM were complaint rate (customer), rejected batches, andthe complaint rate (supplier). The data from these KPIs werefound to be better in 2009 than in 2004 except for a slightincrease in the number of supplier complaints. Their studyshowed that pharmaceutical companies took steps towardsimproving OPEX over the 5-year period. However, there isstill a lot of work to do in this area in the pharmaceuticalindustry.
Companies must have the tools with which tomeasure theirperformance and quality dimensions. Bourne et al. [8] inves-tigated the major factors that impact upon the success orfailure of performance measurement systems. Those authorscarried out research on ten manufacturing companies. Theystudied the samemanagement process in all ten companies, sothat any differences between process-related factors theremight have been were excluded from their study. Semi-structured interviews with directors and managers of the com-panies were given. Their study found that the commitment ofthe top management and the perceived benefits from theperformance measurements were the two main factors thatdrove the implementation of performance measures. In anoth-er study, Antony and Banuelas [9] investigated the criticalsuccess factors that affect the implementation of quality im-provement initiatives by investigating the initiation of sixSigma projects in different companies. They found that thecommitment and involvement of the management were themost important factors in successfully attaining the implemen-tation of the quality improvement initiatives. Other criticalsuccess factors were the following: the understanding of thetools and techniques used for the initiatives, the linking of
quality initiatives with business strategies, linking of cus-tomers and suppliers, quality project selection, reviews andtracking, organizational infrastructure, cultural change in thecompany, quality project management skills, training, and thelinking of quality initiatives to human resources.
There is still a lot of work to do towards attaining higherquality and continuous improvement in the pharmaceuticalindustry. It is necessary, therefore, to have the appropriatetools to measure the quality of operations. It is also importantto know what the personnel think about ensuring and improv-ing quality and what they think about quality indicators interms of their value for the production process, because this isthe only way to influence attitudes and improve the quality ofoperations.
Torkko et al. used an e-mail survey to investigate the usageof quality KPIs in pharmaceutical and food companies inFinland [10]. The results of that survey showed that the qualityKPIs of the pharmaceutical and the food industries were quitesimilar to each other. However, the food industry was slightlymore advanced than the pharmaceutical industry in the utili-zation of the results of quality KPIs. The overall aim of thisinterview-based study was to investigate the utilization ofquality KPIs in depth in one case company. It is important toknow what those personnel, who are actively engaged inproduction, think about quality in general and quality indica-tors in particular. As far as we are aware, this type ofinterview-based study about the utilization of quality KPIs inthe pharmaceutical industry has not been previously pub-lished. The specific aim of this study was to investigate whichquality KPIs were considered essential to personnel in relationto their own work responsibilities. A second specific aim wasto investigate how comprehensively quality indicators wereused by personnel in this company. A third aim was to find outwhat factors motivate personnel enough for them to respondto and improve quality in response to KPI data reports.
Our hypothesis was that internal signals are more importantto personnel than external signals. In Fig. 1, quality indicatorsare arranged according to the internal and external signals, andaccording to their relative seriousness to the production pro-cess. The “Number of Deviations” and also “RFT”, keyperformance indicators are in the same group, because theyboth measure the same thing but in different ways.
Methods
One company was chosen for this study instead of multiplesof companies, in order to get a deeper understanding about theopinions of personnel within a single organization. Studyingthe data of only one company also excludes the between-company variation from studying two or more companies.The case company is a medium-sized pharmaceutical manu-facturer, which manufacture its own products and also carries
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out contract manufacturing. The company employs about2,800 staff and it has three manufacturing plants in Finland.This company was selected because the latest quality KPIswere implemented just before this study commenced and itwas a good opportunity to get important information about theutilization of quality KPIs from their inception. There were sixquality KPIs in use by the company during this study. Thesequality KPIs and their definitions are presented in Table 1.Some of these quality KPIs were implemented in 2008, but themost recent (“number of complaints,” “number of observa-tions in audits and inspections,” and “the number of recalls”)were implemented in August 2012. After implementing all ofthese quality indicators, the KPIs were presented to the rele-vant staff in various training sessions and meetings during theautumn of 2012. The background of these quality KPIs usedby this case company was known to the first author, and theperformance data of these quality KPIs weremade available tothe author for research purposes.
This study used a theme interview, which consisted ofseveral open-ended questions. The interview was chosen toobtain a deeper understanding of the attitudes and opinions ofthe personnel. An understanding of such opinions is seen asthe only way to influence the attitudes of involved staff andimprove the quality of the production operation. The open-ended questions provided the personnel with the opportunityto express their opinions about these quality KPIs and theimportance/relevance of these to their own particular workspecialties. The open-ended questions also provided the inter-viewees with the opportunity to describe their perceptions intheir own words. More questions were asked as and whenneeded for clarification purposes. The interview was designedto cover three themes: the operators’ knowledge of the qualityKPIs, the importance of the KPIs from the perspective of theinterviewees’ own work responsibilities including the utiliza-tion of quality KPIs data for improving the quality, and whichfactors motivated the personnel enough for them to respond tothe feedback data of the KPIs.
The contents of this interview were selected and arrangedbased on the literature. The coauthors then reviewed this draftof the interview and modified it according to the targets of theresearch. The modified interview was then piloted by oneexpert to check its suitability for the interviewees. There wereno subsequent changes made to the questions of the pilotinterview, which was adopted and used in this study.
The interview was given in September 2012. Intervieweeswere chosen from different departments of the company:production (n=6), quality assurance (n=3), and the technicaldepartment (n=1). Theywere also chosen from different stratawithin the organization, namely: operators, supervisors, andmanagers to get the widest variety of opinions of the companypersonnel. The number of interviewees was suitable, becausethe same themes were repeated in the interviews and a satu-ration point was achieved [11].
Recalls
Complaints
Observations in audits and inspections
Loss
Deviations: RFT, number of deviations
Seriousness and costs
External signal
Internal signal
Fig. 1 Hypothesis: Importanceof quality KPIs to personnelaccording to internal and externalsignals
Table 1 Case company’s quality KPIs
KPI Definition
Loss Loss incurred during manufacturing orpackaging process (%)
Deviations Number of deviations related to themanufacturing or packaging batch
Right first time (RFT) Manufacturing or packaging batcheswithout any deviations
Complaints Number of complaints/million packages
Observations made in auditsand in inspections
Number of observations/audit or inspectionday is presented as a rolling mean of12 months
Recalls The number of recalls is presented as arolling sum of the latest 12 months
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All the interviews were recorded on tape which was sub-sequently fully transcribed by the first author. Interviewslasted from 15 to 55 min. The transcribed texts of the inter-view varied in length from 5 to 13 pages. Each interview textwas first carefully read through, and the answers to the spe-cific study questions were ascertained. The data were groupedinto similar themes and ideas according to the qualitativecontent analysis method [12]. Different categories and subcat-egories were constructed. The interview responses werechecked again, and then the categories were combined andregrouped during the analytical phase of this study. Finally,the classification was checked by the coauthor, and the differ-ences between both researchers were discussed to achieve aconsensus. Furthermore, reductive analysis was used in ana-lyzing what the interviewees said about the case company’squality KPIs.
Results and Discussion
Three themes that arose from the interviews were knowledgeof the quality KPIs, utilization of quality KPIs, and the moti-vation of personnel that would be required to improve theoutcomes of quality KPIs. Each theme was further dividedinto subcategories. Some typical but informative quotationsfrom interviewees are presented in the results section to sup-port the analyzes of the results. Some numerical data are alsopresented to give a general description of interview materialanalyzed. The appropriateness of selected quality KPIs wasalso analyzed.
Knowledge of Quality KPIs
Interviewees had different opinions about quality in generaland about the specific quality indicators. The knowledge ofquality indicators was classified into three categories based onthe opinions expressed in the interview: “the importance of thequality indicators was well understood and internalized (class1),” “the importance of quality indicators was somewhatunderstood (class 2),” and “the importance of quality indica-tors was not understood at the time of the interview (class 3)”.This classification was based on how the interviewees de-scribed “quality” and “quality indicators” including express-ing opinions about how to attain quality improvements.
Representatives of class 1 fully understood and internalizedthe importance of quality and quality indicators. They pointedout that it is important to follow and when needed to respondto the performance data of the quality indicator reports. Theserepresentatives were knowledgeable about the quality KPIs,and they also had ideas about how to improve them. Those inclass 1 received information about the quality KPIs in differ-ent ways. They thought that they had the potential to improve
the quality KPI data. Four personnel were assigned to thisclass (class 1).
One representative of class 1 described the importance ofthe connection between quality and patient safety as follows:
“We manufacture medicine for people. They must besafe.” (Respondent 4, class 1)).
The representatives of class 2 knew about some of thequality indicators, but they were not familiar with them all.Class 2 representatives were also interested in quality and thequality indicators but their understanding was not as deep asthose individuals in class 1. They did not have any ideas abouthow to improve the quality KPIs. Half of the study inter-viewees (n=5) were in class 2.
The sole representative of class 3 did not understand theimportance of quality indicators at the time of the interview.This individual knew about some of the quality KPIs but wasnot as familiar with them as the representatives of either class1 or class 2. This individual did not follow the quality indica-tor reports as regularly as those individuals of class 1 and class2. Moreover, he had not participated in the quality KPIstraining sessions, which may have accounted for his lack ofunderstanding about the importance of quality KPIs.
There were also two individuals in class 1 who had notreceived formal quality KPIs training. However, these two hadreceived information about quality KPIs by other means, andthey were very familiar with quality topics in general. Thesingle individual in class 3 professed a wish to get moreinformation. Previous studies, suggest that training is a criticalfactor for the successful implementation of quality improve-ment initiatives [9]. However, one person in this studycommented that information can be obtained simply by seek-ing it.
If you are even a little bit interested you will get theinformation. (respondent 8, class 2)
Utilization of Quality KPIs
It emerged from the interviews that quality KPIs were beingutilized in two ways at the time of the study. The first was byadhering to the quality levels set by the company, and thesecond was by being involved in the development of a partic-ular operation for the company.
The quality KPIs provide information about the qualityof a company’s operations on two levels: they provideinformation about the quality of performance of an indi-vidual’s department and they provide more general infor-mation about quality of the plant and the company as awhole. Most of the interviewees followed the reporting ofquality indicators regularly, and eight of them scrutinizedquality indicator data at least once a month. Those, who
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did not follow quality indicator reports regularly,expressed the opinion that there was no indicator thatwas closely related to their own particular work special-ties. Some quality-related issues such as open deviationsand consequent corrective and preventative actions(CAPA) were followed weekly in the form of SAS-reports. An SAS-report is a quality KPI-related IT updatethat is available to personnel, which reports and follows-up open deviations and complaints. In SAS-reporting, it isalso possible to follow-up on what corresponding CAPA-actions were taken. The SAS-reports are updated everyday and were widely considered to be a useful tool. Theinformation being given in real-time was found to be veryimportant as described by one interviewee:
It is wonderful that I do not have to prepare presenta-tions beforehand because I will get the information inreal-time or in the middle of a meeting if it were needed.(respondent 3)
All interviewees thought that using different types ofmeetings in a broad approach is the best way to handleand respond to quality KPI reports. Alternative ways ofdisseminating information of KPIs mentioned by inter-viewees were email, intranet, and closed-circuit televisionmonitoring of the plant. An earlier study by Torkko andcolleagues [10] also showed that pharmaceutical and foodcompanies shared their information on quality-relatedKPIs in a variety of meetings and training sessions. Theinterviewees also mentioned that the results of quality KPIreporting should be very easy to understand. Support forthis view comes from two previous studies that suggestthat it is important that KPI reports must be simple tounderstand, if they are to be used properly [13, 14].
Interviewees also pointed out that it should be possible tomake more use of quality indicator reports when communi-cating with potential new partners, in audits or during inspec-tions. It was found that both pharmaceutical and food compa-nies shared their KPIs and their results with relevant partnersand authorities [10].
The interviews revealed that the results of direct qual-ity KPI reporting and KPI-related reporting such as SAS-reporting were utilized in the development of companyoperations. Interviewees also stated that the quality KPIdata were used in the CAPA-meetings of production de-partments, and in complaint and deviation handling pro-cesses. The quality KPIs were particularly useful in theCAPA-meetings during which they were used to evaluatethe quality of operations. For example, quality KPIs wereused in the analysis of trends of deviations and complaintsthat occurred over time and whether the correct CAPA-actions had been carried out. One interviewee commentedon the utilization of the data of quality indicators thus:
The complaints are perhaps the biggest item. There areclear reasons for them. If the reason was defectivematerial, the supplier has to be contacted. There areclear CAPA-actions to be taken to prevent the reoccur-rence of complaints.(respondent 2).
The interviewees considered SAS-reporting to be a veryuseful tool in the handling of deviations and complaints, and inthe follow-up CAPA-actions required. The SAS-report was alsoutilized in following up deviations and complaints. An earlierstudy found that the understanding of tools and techniques ofquality improvement was a critical factor for the successfulimplementation of quality improvement initiatives [9].
Most of interviewees (n=8) thought that the results ofcertain quality indicators were relevant and could be utilizedin fulfilling their own particular work responsibilities. Whenquality indicators were closely related to interviewees’ partic-ular work activities, the easier it was for them to utilize thisinformation. For example, operators who work in productioncan utilize production-related KPI data to a greater extent thanthose who work in the technical department. There were nodifferences in opinions between operators and supervisors ormanagers about the opportunities to utilize quality KPI results.At the time of this study, there was a development work beingundertaken by the company for the different departments toutilize more information-specific KPIs. For example, the com-pany has developed its own CAPA-meeting system to dealwith technical issues.
Some interviewees thought that quality indicators could bemore comprehensively utilized by analyzing more probablecauses for poor KPI data before taking corrective and preven-tative actions (CAPA). One interviewee commented about themost relevant CAPA thus:
Training sessions and learning ways to work, allowseveryone to have a clear idea of how to work withcertain machines and products.(respondent 2).
Motivation
The interview responses to the motivation theme were dividedinto four categories: the effect of motivation on one’s own workperformance in ensuring quality, the effect on one’s own profes-sional interest, on having greater cooperation with other opera-tives within the same department and with personnel of otherdepartments, and also receiving financial rewards (Table 2).
All interviewees were well motivated and interested inmaintaining or enhancing the quality of the products and inthe manufacturing of the products. Most of the interviewees(n=8) thought that they had the potential to improve thequality indicators. For example, identifying the causes ofdeviations and reducing the number of deviations were con-sidered important subjects for training as were how to improve
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upon existing working and manufacturing practices. Therewere no differences between the opinions of operators or thesupervisors or the managers. However, the reasons given toexplain why it was not possible to improve the outcomes ofsome quality indicators were that certain indicators were notclosely related enough to that particular person’s work spe-cialty thus he or she did not have the potential to influencethem, and also that the objectives of some of the quality KPIswere already set at unrealistically high levels. Furthermore,interviewees also opined that it is very important that man-agement set realistic objectives for quality KPIs.
In Table 2 factors that motivated personnel to improve theperformances of quality indicators are presented. Supervisors,managers, and experts held the opinion that the main reasonsthat motivated them to improve the data of quality KPIs werethe positive effect on their ownwork performance and to satisfytheir own professional interest. The effects on improving anindividual’s own work performance were divided into twosubcategories namely: the job became easier and the satisfac-tion of seeing the improved results from (higher qualityattained) one’s own efforts. For example, decreasing the num-ber of deviations reported by remedying the root causes of theproblemmadework easier. One interviewee alsomentioned theextra costs incurred as a result of having to deal with deviationswere a situation to be avoided. This indicates that some inter-viewees demonstrably understand that there are benefits fromutilizing the results of quality KPIs. Another study reported thatthe tangible benefits derived from implementing performancemeasurement were a major factor in the success ofimplementing that performance measurement [8].
One interviewee in our study commented on the satisfac-tion of seeing the improvements following the implementationof quality KPI data in her own work:
It positively motivates me when matters go in a betterdirection. It demonstrates that the right actions have
been taken and they give a good result. It is the biggestmotivator. At the same time, you know that the mattersare never perfect. The operation can always be improvedupon. So that is always the way and it is good. (respon-dent 10).
The ultimate aim of lean thinkers is perfection with a never-ending improvement cycle [6]. The above quoted intervieweehad understood and accepted this idea very well.
Interviewees pointed out that effective cooperation isalso a factor that motivates personnel to improve theperformance of quality indicators. Furthermore, the inter-viewees expressed the opinion that a production bonus isthe most important factor that motivates production oper-ators to improve the performance of quality indicators.Some quality indicators such as RFT and loss have adirect and a great impact on the operators’ productionbonuses. Therefore, if the KPI results are good, they willreceive more money. Two interviewees thought that theywere able to motivate others to improve the performanceof quality indicators by having the correct attitude formotivation. The motivation of operatives is important,because according to an earlier study cultural changewas a one critical success factor at the implementationof quality improvement initiatives [9].
Appropriateness of Selected KPIs
The hypothesis of this study was that internal signals aremore important to personnel than external signals (Fig. 1).Figure 2 presents the frequencies of most essential of the sixquality indicators in the opinions of the interviewees. Thenumber of deviations and also RFTs are both in the samegroup of quality indicators, because they both measure thesame thing but by using different dimensions. In the opin-ions of the interviewees, the internal signals for deviationsand RFTs were the two most essential quality indicatorsafter the external signal of complaints. Other external signals(observations made in audits and in inspections and alsorecalls) were not considered as essential from the point ofview of an individual operator’s particular work specialty asthe internal signals. This finding supports our hypothesis. Itis a positive finding that a less serious internal qualityperformance indicator such as deviations is considered mostimportant to the operator as it would already be too late foroperators to react to the most serious indicator of recalls.
The operator’s job description and responsibilities havea bearing on which quality KPIs are the most relevant tohis/her work. Well-planned quality KPI-reporting pro-vides the most direct information at the most appropriatetime and the most appropriate level for the operator [15].The statement below about the importance of quality KPI
Table 2 The factors that motivate personnel to improve the results ofquality KPI reports
Effect on own work activities-The job became easier:less work, real-time information-Satisfaction of seeing positive results of one’s own actions:higher quality
Own professional interest-Professional interest in the quality levels of one’s own department-Informative data: Professional interest in the general quality levels of the
plant
Cooperation-Cooperation within a department-Cooperation between different departments
Financial aspects-Performance bonus for operators
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from the perspective of that individual’s own job descrip-tion is apt.
They are the closest to the production work and I thinkthat they are the kind of quality indicator that I am mostlikely to respond to by my own actions”(respondent 9).
Each quality indicator discussed was considered to beessential and relevant from the work perspective by at leastone of interviewees, which is indicative that quality indicatorswere indeed useful for this company. Different types of qualityKPIs are important at the different levels of organization. Oneinterviewee commented on the importance of observationsmade as a result of audits and inspections as follows:
Audit observations are usually quite comprehensiveentities. They do exert effects at the grass root leveleven before one or more of the instructions has beenchanged or something (respondent 7)
A few of the interviewees (n=3) thought that the maximumnumber of quality indicators was already being used in thecompany. An earlier study by Gunasekaran and colleaguessuggested that it is better to have a few good indicators thantoo many less effective indicators [16]. One idea expressed inour study was that there could be a quality indicator implement-ed for the technical area to cover open deviations for machineryand plant, including the most appropriate follow-up CAPAmeasures that would be required for their solution. Other ideaswere for a quality indicator related to raw materials and for aquality indicator that comprehensively covered deviations. TwoKPIs for raw materials that have already been mentioned in theliterature are complaint rate (supplier) [7] and on-time-in-fulldelivery from suppliers [17]. Two interviewees also pointed outthat it is not possible to measure all things.
Limitations
One limitation of this study was that interviews werecarried out quite soon after the studied quality KPIs wereimplemented. Therefore, it would be interesting to repeatthese interviews after 1 or 2 years had elapsed to see howwell these KPIs were utilized in the longer term. Thesample size (n=10) was quite small. However, the samethemes were repeated in the interviews, and the saturationpoint was achieved. This study covered only one pharma-ceutical company, which may have affected the results. Itwould be interesting to compare these results with thoseof other pharmaceutical companies. However, this studydoes present important information about the hithertounder-reported utilization of quality KPIs in the opinionsof involved personnel in a pharmaceutical company.
Conclusions
The aim of this study was to obtain the opinions of personnelof one company about quality KPIs and their utilization. Eachquality indicator was considered to be essential and relevantby at least one of the interviewees from the perspective of thatindividual’s own work responsibilities. The general consensusof the interviewees was that quality indicators were useful.The performance data of quality indicator reports were utilizedquite efficiently, for example, in complaint and deviationhandling processes, and they provided useful information forCAPA-reporting, i.e., quality KPIs were actually used asintended. The factors that motivate personnel to improve theperformances of quality KPIs were also investigated. Themost important motivational factors for supervisors, man-agers, and experts to improve KPI outcomes were the im-provement in their own work activities, the satisfaction ofobtaining improvements, and the improvements in their coop-eration. The production bonus was considered to be the mostimportant motivational factor for production operators to im-prove the performance results of the quality indicators.
Further studies on the utilization of quality KPIs by otherpharmaceutical companies are required. However, this studypresents important new information about the little knowntopic of the utilization of quality indicators in the pharmaceu-tical industry. This information can also be utilized in theimplementation of other quality initiatives.
Ethical Standards Experiments comply with the current laws of thecountry in which they were performed.
Conflict of Interest The authors declare that they have no conflictof interest.
Recalls (1)Observations
in audits and inspections (2)
Loss (6)
Complaints (7)
Deviations: RFT (5), number of deviations (9)
Fig. 2 The most essential quality KPIs from the perspective of inter-viewees’ own work responsibilities
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References
1. ICH Guideline Q10: Pharmaceutical Quality System, TechnicalReport; 2008.
2. Chowdary BV, George D. Improvement of manufacturing operationsat a pharmaceutical company: a lean manufacturing approach. JManuf Technol Manag. 2011;23(1):56–75.
3. DeWit T. Lean techniques: the QC can reduce product lead times.Qual Assur J. 2011;14:72–5.
4. Sugiyama H, Sukowski L, Schmidt R. “Japan quality” in phar-maceutical operations part II: Building a blueprint for betterperformance in the Japanese market. Pharm Ind. 2011;73(5):912–8.
5. Womack JP, Jones DT. Lean thinking: Banish waste and createwealth in your corporation. New York: Simon & Schuster; 1996.
6. Melton T. The benefits of lean manufacturing; what lean thinking hasto offer the process industries. Chem Eng Res Des. 2005;83(6):662–73.
7. Friedli T, Goetzfried M, Basu P. Analysis of the implementation oftotal productive maintenance, total quality management, and just-in-time in pharmaceutical manufacturing. J Pharm Innov. 2010;5(4):181–92.
8. Bourne M, Neely A, Platts K, Mills J. The success and failure ofperformance measurement initiatives: Perceptions of participatingmanagers. Int J Oper Prod Manag. 2002;22(11):1288–310.
9. Antony J, Banuelas R. Key ingredients for the effective imple-mentation of six Sigma program. Meas Bus Excell. 2002;6(4):20–7.
10. Torkko M, Linna A, Katajavuori N, Juppo AM. Quality KPIs inpharmaceutical and food industry. J Pharm Innov. 2013;8(4):205–11.doi:10.1007/s12247-013-9159-9.
11. Mason J. Qualitative researching. 2nd ed. London: Sage Publications;2002.
12. Patton MQ. Qualitative evaluation and research methods. 2nd ed.Newbury Park: Sage Publications; 1990.
13. Blenkinsop S, Davis L. The road to continuous improvement. ORInsight. 1991;4(3):23–6.
14. Maskell B. Performance measurement for world class manufacturing.Manag Account. 1989; May:32–33.
15. Rose KH. A performance measurement model. Qual Progr.1995;28(2):63–6.
16. Gunasekaran A, Patel C, Tirtiroglu E. Performance measures andmetrics in a supply chain environment. Int J Oper Prod Manag.2001;21(1/2):71–87.
17. Ahmad M, Dhafr N. Establishing and improving manufacturing per-formance measures. Robot Comput Integr Manuf. 2002;18:171–6.
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