MARIJO VOLAREVIĆ*, DUBRAVKA SMOJVER** e-KNOWLEDGE MANAGEMENT AS A QUALITY TOOL * PLIVA Pharmaceuticals, IT dept. Prilaz B. Filipovića 25, HR-10000 Zagreb, CROATIA ** PLIVA Pharmaceuticals, QA dept. Prilaz B. Filipovića 25, HR-10000 Zagreb, CROATIA marijo.volarevic@pliva.hr, dubravka.smojver@pliva.hr ABSTRACT: Modern market environment and customer oriented business, a s well as constantly increasing amount of information exchanged and processed have resulted in shrinking response times, as well as reduced time-to-decision. In the same time, higher quality standards and regulatory requirements are putting additional pressure on day-to-day business. Advanced web-based Content Management technologies can provide us with a powerful tool for managing content across enterprise. That technology, incorporating and adopting some well known knowledge management tools and policies, makes knowledge management operative and widely used for the first time, thereby enabling us to sustain high quality decision making as well as high quality of our business processes and products. In this article some key techniques and constraints will be pointed out, and presented some high-end Content Management products available on the market. Own experience from pharmaceutical industry will be used as an example. KEYWORDS: knowledge management, electronic document management, web content management Introduction In a modern market, technology and globalization have caused intensive exchange of information, simultaneously shrinking time-to-market, thereby time-to-decision, within very short time periods. Information is now considered mission-critical. At the same time, quality standards, environmental and other regulatory requirements are so high that they are causing production of billions of documents. In Pharmaceutical industry, in particular, every procedure must be in details described and approved by Quality Assurance, every piece of data or results stored for possible future audits. For example, Drug master file for Bayer’s drug Cerivastatinâ consisted of 2.057.596 documents, and weighted 10 tons in paper version. Managing that quantity of paper effectively is practically impossible. Another problem is the share of knowledge within company. Knowledge is the most important competitive advantage in the modern market, but it is stored in heads, office desks, or files on personal computers [7]. Thereby it is a private, not the company asset as it should be. Demand for sharing knowledge, together with regulatory environment, legal suits and audits (financial or regulatory), are pushing toward transferring to an electronic document management system and the use of new technologies, such as Internet. These new Internet-based systems are widely known as Web Content Management (WCM) systems.

Knowledge management-just another buzzword? Increasing number of X-management words creates a fuzzy picture and arises suspicion, specially when it seems that there is no clear definition of the expression itself. Is there a lot of hype in KM, or is there reality behind, that can really transform the business? Recent multiclient study from Gartner Group found that 90% of larger companies were aware of KM and had some activity under way. The main question is not , however, how many companies are thinking about KM, but when and how KM is right for our company. Many are still confusing KM with data warehousing, data mining, business intelligence and other knowledge intensive processes. Despite of that, Regina Casonato, vice president and most prominent KM expert of the GartnerGroup in her recent KM scenario study [1], believes that vision for and definition of KM is clear: KM is a business process for the management of the enterprise s intellectual assets. It requires five critical success factors: · KM must be linked to the enterprises strategic direction · KM requires an organisational culture and discipline that promotes and supports knowledge sharing, collaboration accross and among employees/business units, and a drive toward innovation; · KM must be enabled by robust business and human processes; · KM depends on a compelling technology environment to automate the processes and support collaboration and the KM discipline; · KM requires an extra-enterprise scale and scope of the processes, people and content. Companies will require a KM discipline at individual, team, enterprise end extended-enterprise level to compete in an environment of e-business, shrinking response times, hyperoutsorcing, and shortages of expert resources. Key employee competencies, business data and market data are now considered mission critical, and competitive advantage is achieved when these knowledge assets are enriched with the insight of employees and applied within the context of enterprise business principles, past experience and strategic directions. KM challenge is to draw out the tacit knowledge of people, but it goes much further than capturing and making accessible. The aim of KM is for enterprises to become more competitive through the ability of their people to apply insight to mission-critical knowledge, and be more responsive and innovative. K-workers Increasing number of jobholders are being classified as knowledge-workers (k-workers). Their jobs entails doing work for which there is no finitely determined process. Tasks are not prescribed in advance, but are determined just-in-time in responses to issues, opportunities and problems as they arise. In the emerging definition K-worker is not only manager or expert of some sort, but a person who understands the domain of his/her responsibilities, understands the information and people who are potential resources in the domain, and has the skills and the authority to act within the domain. Support of K-workers requires a unifying interface to processes, access to people and content, and enabling infrastructure. Enterprises are applying KM to drive innovation-they extend their explicit knowledge base by codifying experience, insight or judgement into a form that can be

reused for others. KM users than begin to internalise new or shared explicit knowledge and are stimulated to broaden, extend and rethink their own tacit knowledge. Framework for KM process includes: · Creation-activities that result in new knowledge or new assemblies of existing knowledge · Capture-activities that make tacit knowledge explicit, i.e. that move knowledge from individual to enterprise · Organise- activities that classify and categorise knowledge for navigation, storage and retrieval (this process include knowledge maintenance as well · Access-activities that disseminate knowledge to users · Use-activities that apply knowledge to business decisions and opportunities. From an employee perspective, this represents investments in three ways: -In contributing knowledge, employees sacrifice some of their personal power -Knowledge is the source of value in the resource market, and sharing knowledge and capturing it in explicit form dilutes or diminishes employee s value -Employees give up some of their creative freedom. Using the ideas of others negates the need to create new solutions and lowers the reuser’s level of contribution The cultural dimensions of KM can therefore overshadow technology. These problems can emerge and become a main obstacle for efficient KM systemApart from tacit knowledge, stored in people’s heads, that needs to be converted into explicit form and distributed to the potential users, there is a lot of other structured and unstructured information within the company. This information, already in explicit form, can be treated as ( and it really is) knowledge as well. It includes, for example, standard operating procedures (SOP’s) in production, QA, and many other departments, as well as procedures for contract processing, building top-down or bottomup company plans (education, BSC), request for holidays, personal files etc. Mainly stored in local documents or databases, these information are also valuable company asset and should be managed, distributed, changed etc. on a company level as well. These issues of information flow and knowledge flow across company are strongly cross related, and should be considered together. Internet and content management technology will make breakthrough in this area, making solutions realisable, and easy-to-use. Most of the problems addressed or related to collecting and distributing knowledge, from ancient libraries to modern data warehouses can nowdays be efficiently resolved for the first time. A perspective Since it is impossible to build expert system that can replace human judgement within a fitting amount of time, money and energy [2], KM system should be something else, a system that : · -enables knowledge sharing, · -links people,

路 路

-links processes -links cultures and values of a organisation as a whole.

It is therefore far more useful concept than an expert system from a business point of view. A knowledge management system (as a top element of overall information processing within the company) can be broken into several sub-components:

LIBRARY

OTHER CONSULTING

INTERNET TACIT KNOWLEDGE

IN-HOUSE

EXPLICIT INFO & KNOWLEDGE ERP RDBMS Local databases

STRUCTURED (transaction data)

UNSTRUCTURED

PAPER DOCUMENTS FILE SERVERS PERSONAL DISCS E-MAIL

Fig 1: Enterprise knowledge scheme The repositories hold explicit formal and informal knowledge and rules associated with them for accumulating, refining, managing, validating, maintaining, annotating and distributing content. Specially in pharmaceutical industry these rules ( when it comes to procedures associated with product quality in any way) are very rigid, and often controlled by different regulatory organisations (FDA). Collaborative platforms support distributed work and incorporate pointers, skills databases, expert locators, and informal communication channels. Networks support communications and conversation. Finally, culture will determine it the knowledge is shared and can freely flow. Explicit knowledge: In order to enable sharing knowledge, it must become explicit, i.e. transferred to documents, multimedia files, reports etc. Explicit knowledge can come from outside, originate from internal sources or already be available in another system. To manage new internal content within the organisation, a content management system is needed [2]. To enable searching and browsing, all inputs must be indexed, classified, enriched with keywords and attributes etc. There is also

always a matter of security policy, when distribution is automatically made to different levels of employees. The difficult part is to get the right documents to the right people. An efficient knowledge management system will try to impose as little intrusion on the user’s working environment as possible. If users have to change their working habits, experience teaches us that KM projects fail unless users are forced to comply by the highest ranks in management. Forcing users will result in systems that contain much noise—never forget we’re dealing with unstructured information here that is likely to be sabotaged if groups within the organization oppose to it. Forcing users into unusual working habits does not yield the best results, so the only alternative is to automate as many processes as possible in the knowledge management arena. This can be done by using powerful content management tools, that will automate processes of document (content) management, and hide them from the end-user behind user-friendly and familiar WEB interface. Tacit knowledge Tacit knowledge resides inside human heads-says definition. In order to manage it, and to transfer it from a personal to a company asset, it must be converted to explicit. The only problem is, again, culture. How we can make experts to write every step they take? How do we make sure that they are feeding system with write information? Employees, that are usually employed because of their unique knowledge, personality or service will hate to store and distribute their knowledge to be reused by the others, which significantly lessens the value they have for the company. Even if they would have time to do that. This problem can be resolved by alternate means: Yellow guide system should make it easy to find experts in certain area within company. This guide will contain each person’s details and description of his/her education, expertise and experience in various fields. Storing multimedia files, presentations, minutes, reports, seminars, with attributes attached to these information, so they become searchable. This will keep most valuable tacit knowledge even when the person leaves the firm. This way employees will continue to work as they used to do, and other can reuse and benefit from their knowledge. External sources Content from external sources should be treated the same as internal, transferred to explicit electronic form (for example by scanning if on paper), indexed, enriched with attributes and added to the repository. It can be only note about some book, or summary of the article, or link to a database with summary of the articles. Internet is an enormous source of information, often unmanageable. Therefore, some additional tools apart from standard WEB browsers (Yahoo, AltaVista etc) can be used, such as semantic search (for example: find answers to: “ contains azythromicine”). These tools can be very useful (unfortunately, available so far only in world languages) and can be used on internal information systems as well, if enabled with appropriate technology. Basically, they use some advanced filtering on the results of the standard search programs results, and perform repaginating and reindexing of these results. Main problem is, that key business information are secured, and are not in public domain.

Solution An organised integral KM/Info management system could be like one on the picture, based on powerful features of Documentum 4i, a leading web content-management system:

PERSONALIZED WEB PORTAL

INTERNET/ INTRANET

4i

TACIT KNOWLEDGE Yellow guides, presentation, notes DOCUMENT CREATION

CONTENT MANAGEMENT SYSTEM

In any standard format EXTERNAL DOCUMENTS Scanning, import, copy / paste

SAP R/3 RDBMS

DATABASES Reports, material documents

Fig 2: Integral KM/Info WCM system This concept will result in a personalised WEB portal, which will enable each user (workers in labs, production line or k-workers) to: · receive tasks in his/her inbox within WCM system, if his business role is in workflow for some document creation or as a recipient of the approved/issued document · store own documents, created in standard Office (and other) applications · receive documents he need to receive (SOPs, contracts, SAP reports, etc) updated without need for repeating retrieval after creator changes the original document, or when new document from that area is created. · keep documents in a CONTROLLED environment, one document in only one place, with versions, rendition, electronic (biometric) signatures [6], reports, automated distribution, workflow, to be read & understood notification etc. · powerful search capabilities (queries, smart tagging, smart cathegorisation – find what is relevan, not just what matches) · full-text search engine (searching for any word or phrase in WHOLE content of ALL documents within very short time · utilize all these features through well known, simple and easy-to-use Internet GUI

As a result, information and/or knowledge, stored within various types of documents, will be available within seconds, in an easy-to-use, personalised and familiar WEB environment. This way, that knowledge will be transferred from private assets (people heads, papers on desks or personal computers) to company asset, as they should be. Documentation production will be speded up as well as information flow and availability. However, this should not be confused with, or treated as alternative to extended use of ERP systems, and valuable transactional data. Evaluation of large ERP systems, such as SAP R/3, is moving toward advanced interpretation of business data, forecasting, trend analysis etc., which is more or less already KM area. SEM - Strategic Enterprise Management System KM - Knowledge Management BW - Business Warehouse

KM On-Line Analytical Processing

Enterprise Analytical Processing

Consolidation & Reporting

Enterprise Profitability

R/3 Reporting

Sales Information System (SIS)

Operational Effectiveness

Enterprise Consolidation

Mega Account Consolidation

Financial Consolidation

Cross Territory Consolidation

Logistics Information System (LIS)

S D

Financial Information System (FIS)

Profitability Analysis (PA)

FI

R /3

Q M P M H R

Bolt-on

A M

SA P

PP

BW

External Data

C O

M M

Transaction Processing

SEM

Balanced ScoreCard

Cross Functional Consolidation Sales & Marketing

Focused Analysis & Reporting

B2B

R/3

P S W F IS

Legacy Systems

Fig 3: Advanced use of ERP systems Reporting based on actual data has another advantage: even on a very high-level, it is always possible to use “slice & ice” techniques, i.e. to dig deep into data and to find out what was the real reason for some deviations on high-level reports. These systems are also incorporating some document management features, and are generally open for interfacing with other Content Management Systems. They are also moving to WEB as a new platform. Through integration of ERP (Supply Data Chain) & WCM (Knowledge chain) systems, daily operations are supplied with required non-transactional information (SOP’s, plans,

specifications..), and KM area & K-workers are getting valuable on-line information about trends and performance of the business process, without the need to be a user of ERP system. Conclusion: Technology, and applications, that can provide robust and flexible Content Management System are already here. Time is the resource that is running out. Sustaining high quality, together with high performance and production, requires the new factor: a new tool: e-Technology is the answer. The advantage is knowingÔ. References 1. Knowledge management scenario according to Regina Casonato, Vice president GartnerGroup, 15-16 march 2000, Paris, France 2. Knowledge management: A view by Erik Vlietinck, based on interviews and analyst’s reports from 1998 to 2000 –www.documentum.com 3. Bielawski, L., Boyle, J. (1997), Electronic Document Management Systems, Prentice Hall Press, USA 4. Brown & Root (1997), “EDMS cost/benefit analysis”, International Data Corporation 5. Documentum, Inc. (1999), Sharing product knowledge across corporate Intranet to improve business performance, PLATINUM technology company profile, Pleasanton 6. FDA (1997), “FDA final rule on electronic signatures”, Fed. Reg., 21CFR, part 11, USA 7. Kroenke, D. (1992), Management Information Systems, McGraw-Hill, San Francisco 8. Wiig, K.M. (1999), “What future knowledge management user can expect”, Journal of the Knowledge Management, July 9. KMWorld ranks Documentum #1 in Knowledge management-january 1998 10. Management of information systems, D. Kroenke, Mc-Graw Hill Watsonville, CA 1992 11. Information systems concepts for management, H.Lucas Jr., Mc Graw Hill, San Francisco-CA, 1994 12. A Philosophy of the electronic document management, M.Volarevic, E.Paćelat, V.Strasberger, proceedings of the Information Iechnology Interfaces conference, ITI 2000, Pula, july 2000,