the utilization of quality kpis in the pharmaceutical industry

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  • 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: anne.juppo@helsinki.fi

    M. Torkko (*)Orion Corporation, Tengstrminkatu 8, P.O. Box 425, 20101 Turku,Finlande-mail: marianne.torkko@orion.fi

    N. KatajavuoriFaculty of Pharmacy, University of Helsinki, P.O. Box 56,Viikinkaari 9, Helsinki 00014, Finlande-mail: nina.katajavuori@helsinki.fi

    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 [24]. 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

    J Pharm Innov

  • 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 i