changing the performance paradigm in pharmabiotech - integrating human performance in global...

10.5731/pdajpst.2015.01088Access the most recent version at doi: 658-66569, 2015 PDA J Pharm Sci and Tech

Amy Wilson, Michael Moedler and Gerry McAuley Integrating Human Performance in Global OrganizationsChanging the Performance Paradigm in Pharma/Biotech:

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EDITORIAL

Changing the Performance Paradigm in Pharma/Biotech:Integrating Human Performance in Global OrganizationsAMY WILSON (Director, Performance Development, Global Mfg Operations, Biogen)MICHAEL MOEDLER (Head, Error Prevention System, Lonza) andGERRY MCAULEY (Facilitator, BioPhorum Operations Group)

1. Introduction

Errors are a part of life. In a pharmaceutical context,though, errors affect safety and quality and can lead toissues with supply. Direct financial impact from lostbatches, investigations, and remediation activities—aswell as compliance issues, higher inventory due to latebatch releases, or even lost market share—all have tobe considered when thinking about total cost of errors.With existing deviations attributed to human errorestimated at 50% within the biopharma industry [in-ternal BioPhorum Operations Group (BPOG) membersurvey], the vital importance and real-world value ofintegrating human performance (HuP) principles isobvious.

Despite the high error rate, resistance to the kind ofcultural change needed to improve HuP is rooted inpast attitudes and paradigms. For example, it is gen-erally accepted as inevitable that more batches meanmore deviations, that higher turnover means moredeviations, and that new product introductions meanmore deviations. Overall, we deliver products thatmeet rigorous compliance requirements to our patientsand have a positive impact on their lives. So why doanything differently?

We can do better. We want to reduce losses so that ourpatients receive every volume of product we make. Wewant to reduce production costs so that we can domore to reinvest in our pipelines of new therapies. Wewant to continue to reliably deliver to market in achanging and dynamic environment. We want to ex-ceed the expectations of our regulators.

So what do we do to overcome a plateau of goodperformance and achieve enviable levels of opera-tional performance? In researching our historical de-viations, we discover an entry point. Industry datashows 50% of deviations are attributable to humanerror. We have found internally that despite our bestefforts the human error rate has been constant overseveral years. Comparing ourselves to other high-riskindustries with unparalleled levels of reliability, suchas nuclear power and aviation, we see that we havechanges to make. And those changes are all tied to theintegration of HuP into our operations.

This article utilizes the experience of two large, globalbiotech companies to illustrate pathways to integrateHuP and the benefits realized. It is important to rec-ognize that integration of these principles do notmerely address human error, but rather have an overallpositive benefit to quality, safety, compliance, andon-time delivery—the critical measures that will makeor break a biotech company’s performance.

2. What Performance Is—and Is Not

There is no such thing as productivity versus quality.Those two major subjects—productivity and quality—cannot be separated but are intrinsic. Everyone in-volved has to understand that there is no productivitywithout the best quality. This includes the need toimprove operational performance in general, includinga culture change towards HuP principles.

The integration of HuP is not about overlaying aprogram on top of what you already do. It is aboutchange—about breaking long-held paradigms andways of thinking, and this means the following:

Changing the Way the Organization Deals withHuman Errors

Human error is a part of the human condition: peopleare fallible (1). Reliance on the old view of humanerror—that punishment, retraining, and firmer disci-

Corresponding Author: Gerry McAuley, Facilitator,BioPhorum Operations Group (BPOG), 5 WestbrookCourt, Sharrow Vale Road, Sheffield, S11 8YZ,United Kingdom, [email protected]

doi: 10.5731/pdajpst.2015.01088

BPOG SPECIAL SECTION: The following article is a special editorial contribution from the BioPhorum Operations Group(BPOG). Please note that it did not go through the PDA Journal and Pharmaceutical Science and Technology regular peerreview process.

658 PDA Journal of Pharmaceutical Science and Technology

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pline will have an impact— has been proven to notdrive improvement (2). Organizationally, we need torecognize that performance is not that simple. Oursystems and environment are dynamic and complex.Rather than focus on the person, we need to explorethe task, tools, and operating environment. This meansthat human error becomes a starting point for investi-gation, not the root cause.

Ensuring the Organization Has an Open ReportingCulture

Within good manufacturing practice (GMP) regula-tions we are accustomed to reporting deviations. Whenan activity does not go according to expectations orprocedure, if we can point to a document or instructionthat was violated, we report and investigate a devia-tion. What we are not necessarily so good at doing isreporting all of the issues that create challenges inoperations. What about the time a hose was almostmisconnected? What about the time we selected thedrain valve to be opened but caught it before we lostproduct? What about the time we took a chance onautomation and batch record instructions that didn’tmatch, and were lucky to get it right? We want toknow about those potential error traps—and have ourpersonnel feel open and encouraged to report them.This is foundational to being able to be proactiveabout addressing system issues before they becomedeviations, or major events.

Ensuring the Organization Has a Learning Culture

In a learning culture, an organization is focused ongathering as much information as possible in order toidentify how it can adjust its systems and processes toachieve higher levels of performance. Based on ourhistorical responses to human error and variable levelsof management engagement on the shop floor, we aremissing out on opportunities to learn. Data gatheredthrough open reporting processes will provide awealth of learning. Similarly, implementation of front-line observation and coaching programs create oppor-tunities to gather information about potential breakpoints in operations. The organization needs to takethis information and do something about it.

3. Human Performance (HuP)—how To GetStarted

This section focuses on how two global organizations,Lonza and Biogen, have made significant progress

towards HuP integration. Their paths are similar.Where there are differences, these will be highlightedand discussed to help others shape what integratingHuP may mean for them.

Both organizations started by learning from others.Both conducted benchmarking and learned from highreliability organizations, such as nuclear power andaviation. They also learned from industry peersthrough BPOG. Drawing upon BPOG resources andexamples, learnings were consolidated into a HuPassessment tool. This tool evaluates organizationalHuP maturity, and it provides a blueprint for imple-mentation.

HuP is designed to encourage behavioral changes thatwill lead to dealing differently with human errors andpreventing them—for the individual, the leaders, and theorganization. Such a HuP effort has to offer positiveexamples to employees—through a series of differentworkshops and lessons—of both the kinds of behaviorsthat exemplify HuP as well as tools and techniques theycan use to execute key principles of HuP (Institute ofNuclear Power Operations Handbook—Principles for aStrong Nuclear Safety Culture):

● Managers are responsible for, and everyone ispersonally involved in, HuP.

● Leaders demonstrate commitment to HuP.

● Trust permeates the organization.

● Decision-making reflects error prevention first.

● A questioning attitude is cultivated.

● Organizational learning is embraced.

● Error prevention undergoes constant examination.

Let us make it clear: Even if a company makes HuP amust-do throughout the organization, the implementa-tion cannot be accomplished in one year. This is amulti-year, phased-in process.

The Biogen Story

Biogen’s journey towards improved HuP began at itsCambridge manufacturing site. Following initialbenchmarking and BPOG activities, the Cambridgeteam brought a consultant in to perform a current-state

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assessment of their operating culture. This assessmentanswered the question, where are opportunities to im-prove in order to better manage operational risk? Thisassessment, though performed at one location, becamea catalyst for the company’s other manufacturing sites.The ideas and recommendations were shared globallywithin the organization, and in early 2014, it wasdecided that integration of HuP would be a globalstrategic effort for all of the company’s internal man-ufacturing sites.

Figure 1 describes Biogen’s implementation roadmapto create a culture aligned to HuP principles. Biogenbranded their HuP efforts “Hu”, which is reflected inthis figure. Details supporting each component of thetransition are described in the sections that follow. Thedesired future state for Biogen once HuP is fullyintegrated includes

● System weaknesses are identified and effectivelyaddressed before they have impact

● Documents, software, and hardware are designedfor optimal human cognition—significantly reduc-ing error likelihood

● Value is placed on technical training for all per-sonnel so they are better positioned to identify andmanage risk

● Workers apply technical understanding when exe-cuting work and utilize HuP tools consistently

Leadership and Governance

Each Biogen site was in a different starting place.Cambridge had started to implement some new toolsand was initiating people leader training in early 2014.At the time HuP was declared a global effort, the othermanufacturing sites needed to be enrolled. Biogen’sapproach is to enable site autonomy and ownershipwhile ensuring common philosophies and frameworksat a global level. Therefore, the organization took a

Figure 1

Biogen’s implementation roadmap to create a culture aligned to human performance (HuP) principles.




site-oriented approach to initiating HuP throughout itsmanufacturing network. To support HuP, conceptswere introduced at each site through its site leadershipteams. Each site was asked to identify a site HuP lead,and that lead then assembled a team with cross-func-tional representation. Site teams establish site imple-mentation plans, and site general managers are theexecutive owners of HuP for their sites.

Like many companies, Biogen has functions that areled globally, such as manufacturing, quality assurance,quality control, and engineering. Though these orga-nizations were engaged on site teams, focus and at-tention also needed to be given to global functionalleadership to ensure aligned support. Today Biogenhas a cross-site/matrix function team that overseesHuP globally. This team includes all of the site HuPleads, and a global HuP lead for each global function.

HuP Integration—Biogen’s First Steps and ContinuingEfforts

Building HuP Knowledge within the Organization:Awareness sessions, lunch-and-learns, and generaltraining sessions have been performed at all of Bio-gen’s sites. Training is done top-down, starting withsite leadership teams, then people leaders, then asso-ciates. The training includes overviews of HuP con-cepts with focus on how the organization and ways ofworking need to change.

Implementing New Operational Tools To Identifyand Manage Risk: A concept introduced throughBiogen’s learning was that of critical steps (3). Thefirst new HuP tool Biogen implemented is pre-jobbriefs. These were implemented for each unit opera-tion containing critical steps. Pre-job briefs are astructured dialog performed prior to performance of anactivity to ensure all involved are clear about what isto be done, roles and responsibilities, what past expe-riences need to be remembered, and what will be doneif something goes wrong.

Implementing New Approach to Task Instructions:Biogen had initiated improvements to its proceduresprior to HuP. The organization’s strategic focus onHuP elevated the importance of this work and alsoexpanded it beyond procedures to include all toolsutilized during task performance, such as batch re-cords and automation prompts. Applying human fac-tors to all of these elements of the tools used to

perform work, and approaching it in a holistic way, areyielding good results (see Early Results section).

Eliminating “Human Error” as a Root Cause: Bio-gen is currently implementing a global project to im-prove its deviation and investigation process. Part ofthis project is implementing new root cause choices.These new choices do not include “human error” as anoption. This ensures appropriate focus on systems andbehaviors that drive overall performance. Success cri-teria for implementation of these new selections in-clude conducting investigations with a systems per-spective, uncovering all contributing factors to events,gathering information without hindsight bias and withapplication of local rationality (2), and most impor-tantly, identifying corrective and preventive actionsthat improve resilience to errors and enhance systemrobustness. Implementation is targeted for late 2015.

Including Error Prevention in Equipment and Pro-cess Design: To fully realize the benefits from HuP, itis not sufficient to stop with new behaviors and doinga better job with root cause analysis. Biogen is em-bracing the need to modify its approaches to equip-ment and process design so that HuP considerationsare built in from the start. Biogen is integrating HuPconcepts into its projects that affect how associatesinterface with production system elements by includ-ing deliberate success measures and/or check pointsfor human factors in project plans.

Focusing on Learning—Not Just When Things GoWrong: One of the next steps in Biogen’s journey isfocus on leader observation and providing mecha-nisms for open reporting. Observation and coachinghave started to be implemented as a formal programwith associated metrics to reinforce it as a new expec-tation. Open reporting is a process Biogen plans to usein order to gather information about not just devia-tions, but when obstacles or unexpected conditionswere encountered. For Biogen, this is an importantaspect of transitioning to a learning culture and a vitalstep in being able to proactively address issues.

The Lonza Story

Lonza built its global HuP program on the back of itsoperational excellence program and BPOG immersionmeetings at nuclear facilities, applying lessons learnedin building high reliability and preventing human er-rors. BPOG provided a good overview of what’s al-ready in the industry without consultants and helped to




avoid many pitfalls and perhaps saved Lonza 1–2years on its HuP journey.

The overriding theme at Lonza is creating an environ-ment where everyone is involved in identifying pit-falls, habits, and situations that will likely cause errorsand then taking actions needed to ”prevent” thoseerrors from happening. The essence of HuP at Lonza isa fundamental cultural change program with five be-liefs behind it (Figure 3):

● It starts with the understanding that we all makeerrors, even the best of us—it’s simply a part ofbeing human;

● Second, we acknowledge that error-likely situationsare predictable, manageable, and preventable;

● Third, we have to positively influence the behaviorof our employees through the right processes andapproaches;

● Fourth, the way we encourage and give feedbackto our employees has a high influence on theirindividual contributions to the company and theirrole in safety and quality;

● Finally, we have to learn from past mistakes andtake into account ways to avoid them from hap-pening in the future.

Similar to production systems in the automotive industry,Lonza branded its HuP program as the error preventionsystem (EPS) globally across all pharmaceutical sites,making it instantly recognizable to all employees and a

part of their daily working life. Rolling it out did not justfocus on training (though all of Lonza’s pharma & bio-tech operations staff went through a full-day on sourcesof errors, and how behavior influences errors) (Figure 2),but the HuP program was based on the broad approachesthat proved successful in the nuclear industry and thatwere adapted for a biopharma setting.

Leadership and Governance

In designing EPS, Lonza recognized that a simpletop-down approach wasn’t the best fit. From the be-ginning it was easy to convince top management andget buy-in, and from an operator level there was strongsupport for a structured approach to dealing with is-sues and to discussing before things are done. Therewas a passiveness in middle management, though,who saw EPS as “just another initiative”. Lonza’sinternal set-up, however, made this easier to over-come. Engagement, communications, and most impor-tantly good results were shared across the network.The clarity that EPS is non-negotiable, and buildingmandatory observation walks into daily practice formanagers, removed the resistance.

For successful implementation, the Lonza ExecutiveCommittee has the ultimate responsibility to ensure thatmanagement puts the right organizational systems inplace as well as proper control mechanisms. Conse-quently, EPS is embedded as a key element in the globalquality strategy. EPS experts, site leaders, quality assur-ance, and operations people are working jointly to setpriorities for what needs to be done and to ensure everyemployee understands and puts the right emphasis oncontinuous improvement of HuP. The responsibility forcreating the EPS culture does not rest only with theindividual front-line worker. The area and functionalleaders are role models for Lonza EPS and have to makesure the EPS elements are followed, and that they meetthe needs of their employees and their own operations sothey can achieve their goals.

This cultural change is driven by establishing a system toactively coach employees on expected behaviors by reg-ular “Leader Observation Walks” using cards with errortraps and behavioral countermeasures (Figure 4). Thesefrequent interactions are trended for defined traps andmeasures to identify areas for HuP-related root causeinvestigation as well as corrective and preventative ac-tions. Also a financial reward system for site people andteams who fulfill milestones along their journey, includ-ing awards to honor the areas with the most exemplary

Figure 2

Elements of Lonza’s error prevention system (EPS).




performance, has been established. Early results havebeen encouraging (see Early Results section).

In June 2014, the Lonza EPS team met to begin workon the Phase 2 ”Excellence in Documentation andLearning” Planning Workshop. The team reviewedexternal best practices in the areas of documentationand learning from across the industry as well as inter-

nal best practices from several Lonza sites. Guidelinesand templates were designed for master batch records,work instructions, and knowledge documents in orderto make our documents more logical for users and toreduce error traps:

● Master Batch Records provide process specific in-structions and are used to record process data.

● Work Instructions provide simplified instructions forthe operator, with minimized error opportunities.

● Knowledge Documents contain background infor-mation and context for the process or procedure.

To build the link between theory and practice, a com-prehensive learning package concept was outlined.Effective learning is the foundation for consistentknowledge and empowers every employee to antici-pate, manage and prevent errors. Proof of concept waspiloted at GMP and ISO sites, and demonstrated re-duction of errors by 20 – 40% in pilot areas aroundfilling in batch records as well as errors categorized asomissions, inconsistent execution, or failing to followinstructions. Lessons learned are being used for finaladjustment of roll-out plans for EPS Phase 2 in 2015.

Figure 3

The four phases of Lonza’s error prevention system (EPS).

Figure 4

Leader observation walks reinforce and encourageproactive behavior.




4. Early Results

Biogen Case Study

The benefits of integrating HuP are illustrated by acase study performed on the pre-use cleaning steps ofan ultrafiltration operation at one of Biogen’s manu-facturing sites. A project was initiated to analyze thisprocess with a systems perspective in order to reducethe potential for misinterpretation of instruction, pro-duce consistent results, and address human interactionwith the process.

Process mapping was conducted of the process, asso-ciated documents, and automation steps. This analysisuncovered significant opportunities to improve in-struction clarity and reduce automation prompt re-quirements. Positive results included reduced processtime, increased reliability, and decreased error rate.Changes that were made as a result of this analysis,though taken from a HuP perspective, had a broad

impact. Following the analysis, a pump was no longerrequired to be reset prior to starting the automation,which reduced automation calls and associated down-time. By modifying how the operation was performed,the need for cassettes to dry out after blow-down wasalso completely eliminated. Summarized results areprovided in Table I.

Lonza’s Results

In February 2014, the first phase towards deploying HuPtools and principles was launched. By the end of 2014,over 4700 employees participated in 1 day EPS intro-ductory training, more than 3,000 observational fieldwalks by leaders are executed every month, and dailyengagement of front-line operators in identifying errortraps and opportunities for improvement was practiced.This played a major role in reducing human error–relatedquality deviations and non-conformities by over 40%(Figure 5) and resulted in an overall reduction in devia-tions by 30% within the first year for all pharma sites.

Figure 5

Correlation of human error–related deviations and EPS deployment.

TABLE ISummarized Results of the Process Mapping Analysis Implementing HuP for UF Cleaning Operation

Before After % Reduction

Total signature points 47 24 49%

Automation prompts 13 2 85%

Average idle time (h) 44 18 59%




That reduction is a remarkable and early achievement! Itunderscores why a HuP program is not just a passing“management flavor-of-the-month” fad. To the contrary,HuP is a cultural change initiative that comes completewith a full set of powerful, continuous improvementtools—from observational walks to new, simplified, im-proved ways of writing and formatting work Instructions,batch records, and standard operating procedures. Ulti-mately, Lonza’s aim is to make it harder for an employeeto do something wrong than right.

Non-Quantifiable Benefits

At both organizations, positive feedback has beenreceived regarding employee engagement and empow-erment to improve how employees work. IntegratingHuP helps make jobs easier—the early results fromboth Lonza and Biogen demonstrate this clearly.

Conclusion

Integration of HuP is starting to make measurableresults in biotech. The stories from Lonza and Bio-

gen provide insight for other organizations who arewilling to take a step forward to this new opera-tional paradigm. Both companies use the same ele-ments by looking at document and process improve-ments, observations, focused tools, equipment, andprocess design. Even as HuP implementation plansare different, the results are similar. What next stepswill you take?

References

1. Reason, J. Managing the Risks of OrganizationalAccidents; Ashgate: Farnham, England, 1997.

2. Dekker, S. Field Guide to Understanding ‘Hu-man Error’, 3rd ed.; Ashgate: Farnham, England,2014.

3. Muschara, T. Critical steps: how to identify andmanage the most important human performancerisks in operations. Performance Improvement2014, 53 (9), 11–21.




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