Implementation of Electronic Logbooks for the Utilities Area in a Pharmaceutical 
Manufacturing Facility
Elliot Ortiz Rivera
Advisor: Edgar Torres, Ph.D.
ABSTRACT OBJECTIVES RESULTS AND DISCUSSION RESULTS AND DISCUSSION
Technology is an ever evolving concept, that every year incorporates • Create a paperless environment with an integration among the Measure: In order to better understand the logbooks to be converted to Improve: During the improve phase all the validation activities started.
new terminology appropriate to technological advances and different business and other systems. electronic, as well as to identify opportunities for simplification and Validation of each electronic logbook developed was performed by
application domains. Industries are trying to leverage all of those new standardization, a Process review was performed. Once the process Utilities area operators, with the intent of integrating them and made
concepts to start to have major integration between their processes and • Eliminate data omission, documentation errors, second person review was completed, a Voice of the Customer (VOC) was used to them familiar with the solution. In parallel, al the SOPs that were being
their systems. One of the enablers to do this integration in the verification and maximize resources for their process. gather all the inputs and requirements from the customer (refer to Figure revised were send for review and approval, to ensure that documents can
pharmaceutical industry are the Manufacturing Execution Systems. 3). “The VOC analysis gathers the customers' needs and wants as a basis be effective in a timely manner.
Serving as the main point for capturing manufacturing data, the • Provide proactive management of situations to minimize deviations for establishing objectives” [2]
Manufacturing Executions Systems can help pharmaceutical industries as well as rapid access to current data for management to make Once all the validation activities were completed, the SOPs approved
detect inefficiencies and problems sooner, saving time and money and decisions with up to the minute information. and the training was delivered, coordination with the Utilities area was
support continuous business improvements. With the objective of performed to implement the electronic logbooks in the production
simplifying and standardizing processes, as well as to leverage the • Have all the data needed in a single place to enable future reporting environment and start Go Live activities.
infrastructure and systems already in place, this design project will focus capabilities for Environmental Agencies reports.
in the implementation of electronic logbooks for the Utilities area, Control/Support: Once the Go Live started, a stabilization period began.
including, but not limited to the creation of requirement and design An information technology resource was supporting the area on-site (24
documents, development of electronic logbooks, validation and METHODOLOGY hours, 7 days a week) for the first 2 weeks. Tier 1 support was covered by
production implementation. the previously identified Power Users. Power users are utilities operators
Lean thinking, as well as Six Sigma approach, will be used as part of the with additional trainings that are responsible in the identification and
INTRODUCTION methodology. In Six Sigma, one of the most effective process resolution of possible issues. Tier 2 support is performed by an
improvement technique is the DMAIC methodology (refer to Figure 2). Information Technology Analyst an it is typically performed on an on call
The main purpose to select DMAIC is that this technique is focused in basis.
With the objective of simplifying and standardizing processes, as well as
analyzing the process thoroughly before doing any kind of
to leverage the infrastructure and systems already in place, there is an
implementation. This approach is important in the conversion of paper In addition, the Project Team started to measure all the benefits that were
initiative to implement electronic logbooks for the Utilities area. This
logbooks to electronics due to all the simplification opportunities that established in the Analyze phase in order to compare in 6 months all the
area manages and assist with the electric system, air conditioning system,
can be identified such as data availability in other systems, activities that parameters and performance indicators, including deviations, resource
water supplies, nitrogen, condensate, cooling water as well as operate the
can be performed simultaneously, process improvements and resource management, documentation handling and execution time.
wastewater treatment facilities. This design project will focus in the
allocation.
implementation of a total of 10 electronic logbooks, using a Commercial
Off the Shelf Manufacturing Execution System (MES), for the Utilities
Analyze: In the Analyze phase, a detailed review of each paper logbook CONCLUSIONS
area. was performed, were several simplification opportunities were identified
such as: reduced documentation frequency, reduce parameters to Due to the highly regulated environment that controls Company X’s
BACKGROUND document due to information existing in other systems, reduce processes, having a process that standardizes, simplifies and facilitates
parameters due to no value added, standardize documentation methods, the documentation of process parameters is fundamental. An MES
Industry 4.0 re-organization of inspections routes and reduce amount of second system provides a mechanism to prevent documentation omissions or
Industry 4.0 is the so called fourth industrial revolution. In this new industrial person verification needed. errors, eliminate paper storage and archival, and guarantee a higher
revolution computers and automation will come together in an entirely new way. The degree of documentation integrity and availability.
initial goals in Industry 4.0 are automation, manufacturing process improvement and
Also in this phase, requirements for Environmental reporting were
production optimization. Applying Lean Six Sigma to this project helped identified opportunities
gathered, to ensure that data is collected in a meaningful manner to later to be more efficient and simplify the process such as:
Information Technology build reporting solutions for environmental purposes.
• Reduced documentation frequency
Information technology (IT) is the area in charge of supporting all other business area
in the leveraging of information management. The IT department is the one with the A summary of the benefits that were analyzed and that are expected as • Reduce parameters to document
expertise to work with computers, networking, infrastructure and processes to create, part of this project can be view in Figure 4. • Existing in other systems or no value added
process, store, secure and exchange all forms of electronic data. • Standardize documentation methods
Manufacturing Execution System • Reorganization of inspections routesRESULTS AND DISCUSSION • Reduce amount of second person verification needed.
A Manufacturing Execution System (MES) is an information system that “concerns the
activities that take place within manufacturing department. These include preparatory
Define: As part of this project it was defined that 10 logbooks would be
activities, such as detailed production scheduling and logbook management, but also
retrospective activities, such as data collection, reporting, and analysis. [1] converted to electronic as an initial phase. Project team was established
and it included a multifunctional team with representatives from FUTURE WORK
different areas. The main milestones were Project Kick-off, Utilities
Process Review, Electronic Logbook Application Training and Electronic Part of the next steps would be to fully convert all the other paper based
Logbooks Go Live. logbooks into electronic. In addition, once all the data resides into a
single source system, specific regulatory reports can be created to
facilitate Environmental agencies reporting.
Project  Team: Steering Team:
• IT Technical Lead • IT Technical Leader
PROBLEM • Utilities Team Leader • IT Manager REFERENCES
• Utilities Operation Representative • Utilities Manager
[1] B. Scholten, MES guide for executives. Research Triangle Park, NC: ISA,
The Plant Utilities area has more than 30 paper logbooks to document, • L&D Representative • L&D Manager
International Society of Automation, 2009.
resulting on thousands of paper records, manual data entries, calculations • Process Engineer
[2] J. Arthur, Lean Six Sigma demystified, 2nd ed. New York u.a.: McGrawHill, 2011
and verifications. Paper records does not prevent documentation • Electronic Logbook Configurator
omissions or errors and require storage, handling and procedures to • CSV/CSQ Representative
guarantee the documentation integrity and availability.