Information Governance in MEMS / NEMS process development Ortloff, Dirk; Popp, Jens 1
Process Relations GmbH Emil-Figge-Str. 76-80 44227 Dortmund Germany Tel: +49 231 9742 5970 Fax: +49 231 9742 5972 Em:
[email protected]
Reprint from the Proceedings of Main subject addressed: Micro-Nano Manufacturing and Tools
Abstract Information governance is becoming a more and more important topic for organizations to consider, especially if supplying products into regulated markets like medical devices, aviation and so forth. Because of the multidisciplinary nature of MEMS / NEMS device developments and the cross-cutting nature of Information Governance aspects, an interesting mix of requirements and constraints emerges. This paper will introduce a systematic software driven approach to organize, track and govern the data and information gathered during the research phase of process development efforts. It will introduce how the four pillars of Information Governance (retention, security, lifecycle management and discovery) can be mastered by various tools of a consistent tool suite. The introduced approach and tools allow organizations to minimize the risks, comply with regulatory requirements, and foster reuse and collaborative learning. Furthermore they allow engineers to take good decisions and work more efficiently. Therefore complying with Information Governance aspects becomes an efficiency gainer rather than a burden. Introduction Before going into the details, let’s ask the question: What is meant by Information Governance? IBM defines it as: “The people, processes, policies, and technologies used to formally manage and protect structured and unstructured data assets to guarantee commonly understood, correct, complete, trusted, secure and findable information throughout the enterprise.” [1]. According to IDC [2], Information Governance is the vehicle to manage risks, foster reuse, protect organization reputation, take good decisions
and collaborative learning partly implied by compliance and governance regulations. The major pillars for complying with Information Governance principles are:
Information retention for regulatory compliance Security / Access control providing the right information at the right time to the right people Information reuse and lifecycle management E-Discovery for collaborative learning as well as for audit requests
Today the situation in many MNT development organizations does not live up to these expectations. Data and information is oftentimes crudely managed in an ad hoc fashion. In many organizations every engineer has his/her own way of storing information implying that various office and freeware software tools are used to create documentation. In many cases lab books are only useful to the people who wrote them (One customer example: “Our main development engineer wrote his lab book in Kanji. After he had left the organization, the last project he was working on broke down.”). Even if computer files are available on servers or groupware solutions, they are often distributed on several servers or are hidden in some place (desktop / laptop) and they are only sorted by a predefined set of, oftentimes only one dimensional criterion. Searching from another perspective is almost impossible. Additionally more and more metrology capabilities imply more and more digital data being generated requiring proper archival, management and information governance. This crude and ad hoc management of digital data and information implies that engineers are spending a significant portion (20% – 35%) of their time just administering this data rather than evaluating it. In a recent event Prof. Richard De Veaux from Williams College, Williamstown MA, presented that 60% to 95% of the time for a Figure 1: Knowledge pyramide with time spending in statistical data analysis is spent for data traditional environments preparation. Therefore engineers are spending valuable resources at the bottom of the knowledge pyramid, as indicated in Figure 1, rather than preforming knowledge and creative work. Oracle [1] reports that “80% of the digitized information in a typical company is in the form of unstructured data such as documents, e-mail, and images.” Furthermore this report states “The amount of unstructured content in a typical business grows by 50 percent every year.” These two facts together demonstrate the importance of the issue. Not having tools tailored to support process development activities and not managing the resulting data, information and knowledge slows down the development and adds risks to not comply with regulations and to the organizations reputation. Definitions Data: symbols Data is raw. It simply exists and has no significance beyond its existence (in and
of itself). It can exist in any form, usable or not. It does not have meaning of itself. In computer parlance, a spreadsheet generally starts out by holding data.
Information: data that are processed to be useful; provides answers to "who", "what", "where", and "when" questions. Information is Data that has been given meaning by way of relational connection.
Knowledge: application of Data and Information; answers "how" questions. Knowledge is the appropriate collection of information, such that it's intent is to be useful.
Solution overview After outlining the challenges MNT development organizations regularly face, a brief overview about approaches addressing the four major tenants of Information Governance should be given. Information retention for regulatory compliance (Pillar 1) As motivated by the introduction, the current practice in MNT developments concerning information retention suffer from numerous deficiencies. Between them are
Untraceable and undiscoverable R&D results
Limited formalized data available
Incomplete documentation
R&D data not interlinked
Figure 2: Management of experiment data in its full context
All in all this unmanaged data results in higher risks and increased development costs. To improve the situation a centralized, platform independent, structured and comprehensive data repository for structured & unstructured data is required. Key aspects of such a centralized system are the preparation for audits and compliance fulfillment in keeping a version history and being able to automatically build and maintain the repository. For the later it is essential that schedulable importing capabilities exist, automatically importing data from diverse sources (e.g., Excel, File repositories, SQL databases) and being able to (re)create the context of the data pieces. The context is the precondition to form information from the data being the precondition for generating knowledge. All this is important to allow for a low effort documentation approach to relieve engineers from tedious tasks. Platforms providing for these requirements are typically called Process
Development Execution Systems (PDES), such as XperiDesk, or can be partly realized by Product Lifecycle Management systems, e.g. from SimaticIT. Security / Access control providing the right information at the right time (Pillar 2) In the realm of security and access control the traditional data organization pose further challenges. Some of which are
Lack of access to results and timeline of former projects
Documentation on file servers, Excel, on local desktops/laptops …
Access and transfer protection difficult
These facet’s require a repository of former and current R&D and manufacturing data including a detailed timeline as motived in the first pillar of Information Governance. But such a repository needs to be enhanced with access protection on a per-item level. The latter is typically difficult to achieve with the traditional data organization schemes and requires specialized approaches where security and IPR protection is part of the foundation of the software system. What is required is that the system is multi-tenant able to be able to shield different users / groups /roles from each other on a fine grained control scheme. Furthermore easy access and multi-dimensional retrieval possibilities are essentials. Today’s MNT development environment is so rich in data with a high growth rate, that new approaches to visualize and access the repository are essential. Data and Information is not valuable if it cannot be found with a few button clicks. Multi-dimensional access to the same data piece to allow access from diverse perspectives (domain expertise) and elaborated searching capabilities are a must. Additional graphical representations of the context of a data piece (e.g., presented in Figure 2) as well as a graphical flowchart of the development timelines are required. Information reuse and lifecycle management (Pillar 3) The third pillar of Information Governance of establishing information reuse and lifecycle management is based on the first pillar. Without introducing proper information retention and a compliant management of that, information reuse becomes impossible. Today, next to the deficiencies mentioned for pillar one, the following major points can be recognized in MNT development organizations.
Know-how no longer available due to employee fluctuation
Process knowledge lost due to improper archiving / inappropriate context
Documentation not useable due to not established and enforced documentation rules
Sometimes usage of old / retired data due to improper lifecycle management.
Based on pillar one most of the above listed deficiencies can be mitigated. Establishing a comprehensive, automatized information capturing and management system like a PDES allows collective learning and prepares for employee fluctuation. The automatized collection into a secured and regularly backed-up environment prevents losing the data,
information and knowledge and thoroughly using the automatized importing capabilities (re)establishes the context of development data. The controlled and structured documentation capabilities of a PDES enforce certain documentation artefacts to be present. Additionally it provides them in the intended structure. Therefore a way to document the development work can be predefined. All these three together therefore establish the baseline for reuse. Another important requirement is the audit trail creation and history building, especially for developing products for regulated markets like medical devices. To prepare for this the development data management approach needs to incorporate the capability to record the full timeline of the changing development flow. It is essential to record every change to data, information and knowledge with time and author to be able to comply with the regulatory requirements. In this context the lifecycle management adds another important dimension to the collection and management requirements. The development management system / approach needs to incorporate clear mechanisms to deprecate or retire historical data without deleting it. Only this way it can be ensured that only current data, information and knowledge is used to perform new development work. This lifecycle management needs to be enabled for every item. E-Discovery for collaborative learning as well as for audit requests (Pillar 4) As established in the previous section regulatory compliant data acquisition, management and retirement is essential for certain application areas of developed MNT products. Anyway and as previously mentioned, the following deficiencies can be still encountered in MNT development organizations:
Documentation on file servers, Excel, paper notebooks, …
Untraceable and undiscoverable R&D results
Limited formalized data available
R&D data not interlinked
To mitigate risks for the development organization a centralized, platform independent, structured and comprehensive data repository for structure & unstructured data like a PDES needs to be established. To fully establish information governance in an MNT development organization the following additional requirements need to be fulfilled.
Multi-dimensional access possibilities
Sophisticated searching capabilities
The multi-dimensional access possibilities ensure to encompass and cater for multidisciplined working environments as regularly present in the MNT field. These feature allow, e.g., to find the same material from diverse perspective for example Silicon Dioxide as an Insulator Materials as well as a Sacrificial Material. Depending on the discipline a user is coming from, they might approach the material search from different perspectives. Furthermore graphical navigation through historical data aids for retrievability.
Another important requirements to allow for e-discovery are sophisticated searching capabilities. These need to allow searching in structured as well as in unstructured data such as documents. While text based unstructured data / files can be searched relatively easily using advanced index services, the structured data management needs to be equipped with physical awareness. This means that searching for a Temperature only really searches Temperature parameters and additionally digs through all possible units to comprehensively retrieve the information. Therefore a development management system needs to be unit aware and unit compliant to provide for a much more insightful retrieval. Furthermore the search needs to cater for using the context of an item for the searching, e.g., “Give me all wafers manufactured with a deposition step using a temperature in this interval where SEM images were taken from.” To provide for such sophisticated retrieval, the baseline of the system needs to be robust, physically aware and use sematic web approaches to store and retrieve information.
Figure 3: Graphically definable searching queries
Conclusions Information governance is becoming a more and more important topic for MNT development organizations. This is not only true for organizations developing for regulated markets but basically for any organization. But although enforced by legislation Information Governance does not need to be a burden. It can be considered a chance to establish a more controlled and efficient development path. Using the right tools, made specifically for the purpose of driving and tracking MNT developments high gains in development efficiency can be achieved. This paves the ground for more and faster innovation to become or remain more competitive. Acknowledgements A just finished research project (CORONA) funded by the European Commission under the 7th Framework has supported the improvement of these holistic Product Engineering concepts and systems.
References [1] IBM White Paper: Succeeding with Information Governance Using IBM Technologies,
[2] [3]
http://docs.media.bitpipe.com/io_25x/io_25153/item_384162/Succeeding%20with %20Information%20Governance.pdf, 2010. IDC: Inforamtion Governance and EMC SourceOne, http://www.youtube.com/watch?v=r3aLQpIRgmw&feature=related, 2010. Oracle: Information Management – Get control of your Information
