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PILOT:Suite
Functional Overview
Content
Felten Group – PILOT:Suite V1.0 Page I of II
Content
1 General Information ...................................................................................................... 1
1.1 Felten Group ........................................................................................................................1
2 Product Portfolio ........................................................................................................... 2
2.1 PILOT:Suite ..........................................................................................................................3
2.2 PILOT Multifunctional Terminal ............................................................................................4
2.2.1 Multifunctional Terminal Features ........................................................................5
2.2.2 Multifunctional Terminal Benefits ..........................................................................6
2.3 PILOT:MES Manufacturing Execution System ....................................................................7
2.3.1 PILOT: MES Features ..........................................................................................8
2.3.2 PILOT : MES Benefits ..........................................................................................8
2.3.3 PILOT: MES Add Ons ..........................................................................................9
2.3.4 PILOT: EBR Electronic Batch Recording .............................................................9
2.4 PILOT: WDS Weighing and Dosing System ..................................................................... 10
2.4.1 PILOT: WDS Features ....................................................................................... 11
2.4.2 PILOT : WDS Benefits ....................................................................................... 11
2.5 PILOT:APM Advanced Performance Management .......................................................... 12
2.5.1 PILOT: APM Features ....................................................................................... 13
2.5.2 PILOT: APM Benefits ........................................................................................ 13
2.5.3 PILOT: APM Add Ons ....................................................................................... 13
2.6 PILOT:APS Advanced Planning & Scheduling ................................................................. 14
2.6.1 PILOT: APS Features ........................................................................................ 15
2.6.2 PILOT: APS Benefits ......................................................................................... 15
2.7 PILOT: Shift - Management .............................................................................................. 15
2.8 PILOT:WMS Warehouse Management System ............................................................... 16
2.8.1 PILOT: WMS Features ...................................................................................... 17
2.8.2 PILOT: WMS Benefits ....................................................................................... 17
2.9 PILOT:LES Logistic Execution System ............................................................................. 18
2.9.1 PILOT: LES Features ........................................................................................ 18
2.9.2 PILOT: LES Benefits ......................................................................................... 19
2.10 PILOT:QMS Quality Management .................................................................................... 20
2.10.1 PILOT: QMS Features ....................................................................................... 21
2.10.2 PILOT: QMS Benefits ........................................................................................ 21
2.11 PILOT:CPO Control Plan Organizer ................................................................................. 22
2.11.1 PILOT: CPO Features ....................................................................................... 23
2.12 PILOT:Maintain ................................................................................................................. 24
Content
Felten Group – PILOT:Suite V1.0 Page II of II
2.12.1 PILOT: Maintain Features ................................................................................. 25
2.12.2 PILOT: Maintain Benefits ................................................................................... 25
2.13 PILOT:EMS Energy Management System ....................................................................... 26
2.13.1 PILOT: EMS Features ....................................................................................... 27
2.13.2 PILOT: EMS Benefits ........................................................................................ 27
2.14 PILOT:ERP-Connector ..................................................................................................... 27
2.15 PILOT:IO-Connector ......................................................................................................... 27
3 Project Implementation Strategies............................................................................. 28
3.1 IT-System Structure .......................................................................................................... 29
3.2 Data Collection .................................................................................................................. 30
3.3 Project Team ..................................................................................................................... 31
3.4 Support .............................................................................................................................. 32
3.4.1 Support Features ............................................................................................... 32
3.5 Project Management ......................................................................................................... 33
3.6 Implementation Management ........................................................................................... 34
3.7 Validation Strategy ............................................................................................................ 35
General Information
Felten Group – PILOT:Suite V1.0 Page 1 of 36
1 General Information
1.1 Felten Group
As a Software and Consultant Company, FELTEN Group has been focusing on
the development of software and solutions for the pharmaceutical, food, flavor,
cosmetics and paper industry from 1990.
With 6 locations in Germany, Luxembourg (location of production management),
Poland and the United Kingdom, We developed 50 software solutions with high
added value and having in consideration innovating thinking, excellent
competencies and many years of experience.
The PILOT: Suite of Felten Group has been successfully introduced into production
management in more than 36 countries worldwide. As a result Felten has many
years of know-how and experience with the introduction of specific IT systems.
(E.g. MES, QMS, APS, MDE, BDE, OEE, MAINTAIN, Production controlling, etc.).
Our customers include: Boehringer Ingelheim Pharma GmbH & Co. KG, Bio-Rad
AG, Fagron BV, Henkel AG & Co. KGaA, Symrise AG, Beiersdorf AG, Paper mill
Adolf Jass.
Image 1: Felten Group - References
Product Portfolio
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2 Product Portfolio
To implement your requirements, PILOT:Suite provides the following modules.
Image 2: Pilot Suite: Portfolio
Product Portfolio
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2.1 PILOT:Suite
PILOT: Suite is a Software-Platform that includes various modules for the planning
and control of your companies and production processes.
Modules can be implemented in their standard configuration or adapt specifically
to the customer’s environment and requirements.
The web-based PILOT: Suite is compatible with all popular browsers. Data is
stored in a relational database. The acquisition and display of data is possible by
mobile data acquisition devices (E.g. PDA, tablet, etc.) and terminals connected to
the system. Also it is possible printing labels and the execution of reports in
different file formats. E.g. Adobe PDF, MS Excel, etc.
PILOT: Suite offers the possibility of a hierarchical representation of a company.
Different levels of authorization for individual organizational units, the system has
rights and roles management, requirements for login and logout, password
assignment and multilingual options. Also enables logging and traceability of all
processes in the system.
Image 3: Pilot Suite: Connectivity
Product Portfolio
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2.2 PILOT Multifunctional Terminal
A typical everyday life for an employee is carrying out their tasks on different
devices or in many cases using paper forms. However FELTEN multifunctional
terminal provides all the necessary information a user could need for his work area
in one place and on a user-optimized surface. All papers and documentation are
completely digitalized.
Real time data from the shop floor as well as ERP master data are communicated
bidirectional via PILOT: Suite and are available to the user via the most modern
web technology. Employees can be inform in an accurate manner and safely
guided through the process, either stationary on the multifunctional terminal or on
mobile terminals.
Image 4: Multifunctional Terminal User Interface
The design and the content in the system has been arrange flexibly in order to
provide the staff with the exact amount of important information they need to
prepare the next work steps efficiently. The current order and shift performance
displays the production target/actual comparison and motivates then to achieve
the set goals.
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Image 5: Terminal Structure, Examples
2.2.1 Multifunctional Terminal Features
Capable of controlling over one to more Production Facilities at the same
time.
Manages visual and graphical components with different information from
the modules related with the production cycle. E.g. Production Orders,
Downtimes, Maintenance events, etc.
Provides internal knowledge of the effectiveness and efficiency of
production operations using the most relevant KPI’s for each production
facility or a total KPI related with production process.
Collect and show information as a Trend, so the staff in charge can analyze
this graphical information.
Offers the possibility to show some value documentation for the staff on
charge of a line or production facility. E.g. Machine manuals, System
manuals, etc.
Displays all the previous information using graphical and statistical
graphical components that can show the customer the real status of the
production process.
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2.2.2 Multifunctional Terminal Benefits
Better organization of the production process.
Gives to the customer a general and specific view of what is really
happening in the production process.
Allows the customer to acknowledge, analyze and compare previous and
present information for a better decision making process.
Helps the company to increase production performance based on previous
miscalculations or configuration errors.
Control over the production process without involving paperwork.
Easy customization related to the User interface using graphical, visual,
statistical components.
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2.3 PILOT:MES Manufacturing Execution System
PILOT: MES is the central instance and data hub of production management. This
solution creates a network of the information and accelerates the production
process between planning and execution. It also ensures more efficient use and
performance of production facilities.
Functionalities of PILOT: MES will become indispensable during the time of a
comprehensive digital networking in production. For that, the solution is at the
same time a crucial bridge to the industrial world, where horizontal integration is
fundamental for connecting all functions and data across the value chains.
Because Industry 4.0-Scenario requires decentralized real-time data to be
provided at production times, use of machines, human resources, material and
energy consumption and more, no future model can function without an MES
infrastructure with ERP integration. Because of that, the introduction of modern
MES landscape is an investment-safe issue that would also generate a high
economic benefit and thereby effectively supports the lean endeavors.
Image 6: Pilot Suite: Vertical Integration
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2.3.1 PILOT: MES Features
Flexible production-planning (MES Scheduler).
Automatic process-control and monitoring.
User and master data management.
Equipment & resource management and order management.
In process control & LIMS functionalities.
Warehouse management, KANBAM, material scheduling and dispatch.
Maintenance.
Operating and machine data acquisition.
Report management.
Document management.
ERP Interface.
Track & Tracing.
2.3.2 PILOT : MES Benefits
A unique technology with the approach for more intelligent production
processes.
Future-proofed through the Industry 4.0-oriented systems concept.
Creates more flexible process models
Reduces production costs sustainably, significantly increases capacity and
produces higher quality.
Hidden potential efficiencies are located and easily exploited.
Guarantees a fast ROI and high investment security.
Product Portfolio
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2.3.3 PILOT: MES Add Ons
PILOT: Working Plan: This add on is designed to combine different
production orders with the same material components and to weigh the
materials simultaneously. All events and consumption will still be allocated
to the individual orders, and documented.
PILOT: API Calculation: Assists with the calculation of the pharmaceutical
active- and binding-ingredients for batch-related weighing (API
concentration).
PILOT: Production Order: This allows the automatic translation of existing
customer orders into executable part-orders. PILOT: MES calculates the
part-orders based on available recipes and equipment (container capacity,
measurement ranges, etc.).
PILOT: Filling Order: Was developed to convert customer or production
orders automatically into orders for filling and packaging (for example,
several customer orders for the same product, etc.). All events and
consumption are also assigned to individual customer or production orders,
and documented.
PILOT: Inline printing: Delivers a high level of automation in the printing
and labeling of products, intermediate products or packaging with fast
location changes and customizations, also can be made in the course of
the production process.
2.3.4 PILOT: EBR Electronic Batch Recording
PILOT: EBR: for Electronic Batch Record Management takes
pharmaceutical companies a long way towards full production digitization.
It provides a consistent electronic and GMP-compliant process for recipe
creation, through weighing and validation of production data, to complete
documentation, including batch records. In this it takes all regulatory rules
and requirements, such as FDA, EMA, AMG, cGxP etc., into account.
The master batch record (MBR) with the creation and management of
recipes (according to ISA-95/ISA-88 standards) forms the basis of the
manufacturing instructions. These include for example the definition of
workflows, general conditions, the equipment and the quality requirements.
This information is transmitted to the following operational processes:
weighing, dosing, production data validation and the collection of additional
data. PILOT:EBR then documents all production steps based on the MBR.
Among the many user benefits are simplified batch testing and release. In
addition, LIMS, central building control systems, process control and other
systems can be integrated, via the appropriate interfaces.
PILOT: Recipe Management: Allows product manufacturing to be
described and documented easily as the individual process steps and
materials required. Recipes can be created directly from an existing
production order, or equally can be produced independently of an order.
Production with different systems and machines is also possible.
Additionally PILOT: Recipe Management responds flexibly to changes in
raw material, by recalculating the recipe quantities.
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2.4 PILOT: WDS Weighing and Dosing System
Weighing and dosing operations are anything but trivial: firstly, to be efficient these
procedures must be integrated into the production processes, producing efficiency
and other benefits, and secondly the product requirements demand a high level of
precision and documentation. The whole process should ideally be digital, for
efficiency and additional benefits. For these reasons the PILOT:WDS solution
stands out. The system can be used with all popular weighing-scales and terminals
and easily integrated into existing systems such as MES, PPS or ERP/SAP.
The modularly-structured FELTEN solution has a range of other benefits. The
system is 21 CFR Part 11-compliant and hence has an easily-used backwards-
tracking capability thanks to electronic batch recording (EBR). In addition, the
labelling of sub-batches or intermediate products using the bar code system
ensures simpler, more secure identification during subsequent processing.
Image 7: Pilot WDS: Terminal Menus
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2.4.1 PILOT: WDS Features
Order- or material-related weighing
Fully-automated weighing including taring
Part-weighing for container or LOT-number changes
Validity checks to assist users in weighing and dosing operations
Simplification of control operations by supporting barcodes for all activities
Weighing dialogue with minimal manual input
Functions for active ingredients calculation, material identification, PDA and
bar-code label printing
2.4.2 PILOT : WDS Benefits
Clear increase in efficiency and cost optimization throughout the entire
workflow
Helpful transparency through analysis and reporting
Direct conversion of production orders into weighing tasks
Automatic documentation and feedback of actual material usage (EWC)
Tracking and tracing of all process, weighing and container data
Error reduction through barcode / transponder support
Hardware independence for both terminals and weigh-scales
Guaranteed quality through FDA / GMP compliance
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2.5 PILOT:APM Advanced Performance Management
Production companies are subject to a constant cost pressure due to changing
market requirements. In order to increase the profitability of the company, the staff
must be deployed efficiently, the plants operated optimally, the maintenance
management should be aligned as best as possible, and the resources
consumption should be minimized.
However, this can only be achieved if there is a high degree of transparency in all
relevant performance factors: Potential for optimization must be identified
continuously and risks already identified by means of key figures. And this is
important in terms of cost, effectiveness, productivity, quality, service and
sustainability. In addition, this information must be available in real-time, for
example, production disturbances can be identified immediately and can be
rectified immediately.
PILOT: APM was developed precisely for this requirement of production control.
This solution for advanced performance management includes components for
data collection, analysis, evaluation and communication. And by selecting and
preparing the key figures for all levels, they offer active support for targeted
optimizations to the employees or responsible persons in the respective task
functions.
The special advantage: for all controlling requirements, key figures are pre-defined,
available at the touch of a button and can be used immediately.
Image 8: PILOT: APM Terminal
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2.5.1 PILOT: APM Features
freely-definable measurements
ability to call up current or historical process values or states
individual trend displays
numerous chart types and freely-configurable report systems for display
and documentation of the recorded data and results
configuration of groups and process lines
capture of malfunction causes
recording of downtime and changes in status
shift-, order-, batch- and line-related analyses of the machine data
KPIs and OEE calculations, using the formula-editor
Add ons for the management and analysis of employee usage in production
and line visualization on large-screen display
2.5.2 PILOT: APM Benefits
the causes of production disruptions can be identified directly and can
usually be cleared immediately
the level of production downtime will be substantially reduced
the system and process resources can be exploited systematically
better quality means higher yield, a lower complaint rate and more satisfied
customers the system actively supports company cost-reduction
strategies
Best Practices speed up systems implementation and support a minimal-
administration operation
it will pave the way to Production Intelligence
sustainability is guaranteed by in-house systems
accelerates RoI
2.5.3 PILOT: APM Add Ons
PILOT: Personnel Management: This add on is designed to manage and
analyze personnel use during production. You can record the operating
times for each process station, and the operator times and numbers per
employee. A parallel recording system for different cost centers is also
possible, including feedback to your ERP system (the ERP Connector must
be used).
PILOT:External Display: offers templates for a line visualization within
current production as a large-screen display. Potential displays are order
data, production line status, machine status, target and actual performance
data, etc. The display contents are fully configurable.
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2.6 PILOT:APS Advanced Planning & Scheduling
The more precise planning is, the more effective and cost-effective the production.
Therefore, no production can work without planning using an Advanced Planning
and Scheduling System (APS). PILOT: APS with the holistic planning of all
production steps is the ideal solution for this. It helps to configure, control and plan
the supply chain. A variety of different parameters are considered in the areas of
resources, processes, order processing, raw material and quality. Also a simulation
of the production processes including the secondary processes like cleaning or
similar. Is possible according to various criteria, for example, the effects of the
failure of a machine can be recognized and can be re-scheduled accordingly in
seconds.
This tool gives the managers a comprehensive overview of the current status of
the production and at the same time an outlook on the future status. And as the
entire production process can be visualized, potential bottlenecks can also be
calculated. PILOT: APS ensures significantly shorter through times, reduces
inventories and leads to significant savings in both fixed and variable costs.
Intelligent planning logic also offers significant advantages in the synchronization
of the entire production processes. In addition, the production process is
accelerated because numerous best practice parameters are stored. And last but
not least, the solution can be easily integrated into SAP and other ERP systems
via the PILOT: ERP connector.
Image 9: PILOT: APS System
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2.6.1 PILOT: APS Features
Intelligent Scheduling logic
Integrated production planning for all production steps including service
departments (e.g. maintenance).
Takes resources into account (e.g. equipment and operating stuff) in
planning.
Full presentation of production in both, as the current state and as a
forecast.
Production sequences can be prioritized by customer, resource, product,
etc.
Integrated data transfer and communication with:
o The scheduled job start forwarded to the MES/OEE system.
o Update all operator terminals and the connected systems.
o Feedback and data exchange with ERP system.
o Confirm the current timestamp to the PILOT: APS system.
Automatic rescheduling after production deviations appear.
Planning control on the basis on real time key data.
2.6.2 PILOT: APS Benefits
Integrated production planning for all production steps, including
maintenance.
Process steps are automatically created and planned from customer orders
from the ERP.
Production sequences can be prioritize by customer, resource, product,
etc.
Automatic rescheduling after production irregularities appear.
Planning control on the basis of real time key data.
No paper-based operations.
Shorter cycle times
Significant savings in both fixed and variable costs
Clear advantages on the synchronization of the entire production process.
Accelerates production process by using numerous Best Practice
parameters.
2.7 PILOT: Shift - Management
With this module, you can create an individually adjustable production
management layer with layer-specific and order-specific personnel time recording.
It offers the possibility to configure systematic and hierarchically arranged shift
plans with different shift times and different shift models. This not only simplifies
planning with less effort and, at the same time, improves the transparency of the
personnel use, but also important data can be collected and passed on to the ERP
system. This can be used, for example, to support personnel planning as well as
cost- and cost-related cost analyzes or further evaluations.
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2.8 PILOT:WMS Warehouse Management System
The economic requirements of production in themselves require that everything
needed to provide goods should be made available in the necessary quantity and
quality at the right time and in the right place. This can only be achieved using a
warehouse management system with a timely, location-based digital stock
management system which supports the goods-inwards and dispatch area
processes.
PILOT:WMS has been developed to meet this requirement for managing and
optimizing in-house storage systems. This configurable software ensures process
and cost optimization in storage locations and regions. It helps to manage the
inventory of storage locations and consumption, as well as transport requests for
raw materials or finished products.
For stock-holding, the system allows for an annual inventory using mobile- and
barcode-aided logging of all current stocks, to compare estimated and actual stock
levels. The actual stock levels can in turn be transmitted to compare with the
balances in an upstream ERP system. Moreover, checkable documentation for all
warehouse receipts and issues in the warehouse makes real-time stock control
possible. The PILOT:ERP Connector also supports integration by enabling the
automatic exchange of WMS-related data with the SAP/ERP system.
Image 10: PILOT: WMS KANBAN Monitor
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2.8.1 PILOT: WMS Features
storage locations and regions are freely configurable
manages the inventory of storage locations and consumption, as well as
transport requests for raw materials or finished products
mobile- and barcode-aided logging of all current stocks, in order to compare
estimated and actual stock levels in an annual inventory check
Where appropriate the actual stock levels can be transmitted to compare
with the balances in an upstream ERP system
material requirements and availability planning, based on actual material
consumption at the allocation and usage areas
Kanban strategies are included in the system (monitors, material
availability, etc.)
2.8.2 PILOT: WMS Benefits
accurate inventory data resulting from integrated systems (e.g. material
consumption booked during the weighing operation)
integrated data transfer & communication
logistics KPI monitoring & reporting
o inventory levels always up to date for material planning and
procurement
o automatic data exchange with ERP
stock levels controlled with the selected materials management strategy,
e.g. FIFO, Kanban
Material supplies to production according to current consumption (just-in-
time delivery)
cycle times are reduced by time savings in warehousing, relocations, and
the provisioning and availability of materials
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2.9 PILOT:LES Logistic Execution System
Productivity and efficiency in production are closely linked to well-functioning
internal logistics. Ultimately, incoming materials have to be received, stored and
registered: a task for which PILOT:LES has been created. This Logistics Execution
System provides a field-proven performance profile of all the necessary functions
for managing the internal and external goods receipts. This Logistics Execution
System provides a field-tested performance range of all the necessary functions
for goods-inwards management, both internal and external. The ERP-Connector
for LES thus allows the automatic exchange of LES-related data (such as material
master data, order data, postings in the ERP warehouse etc.) with the ERP system.
Thus production management has permanent maximum visibility of orders
including supplier, due date and status, as well as an overview of current transport
usage. In addition, the system offers reception control (laboratory, clearance of
raw materials, suppliers’ quality control, etc.) In addition, various add ons are
available to manage returns to suppliers, customer complaints and shipping.
PILOT also offers an add on for the digital management of the existing goods-
inwards and dispatch areas. A link to an external GPS-tracking system is also
available.
Image 11: PILOT:LES Receiving
2.9.1 PILOT: LES Features
Overview of orders including supplier, due date and status, as well as an
overview of your current transport use.
Reception control (laboratory, clearance of raw materials, suppliers’ quality
control, etc.)
supplier returns - management of returns to your suppliers
customer returns - management of returns from your customers
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Managing external and internal movements as well as in shipping control
(e .g. laboratory, material allocation, etc.)
Management of the existing goods-inwards and dispatch areas such as
gates, ramps, etc.
set of standard KPIs included
2.9.2 PILOT: LES Benefits
all information is available, using the integrated networking of all systems
no paper-based operations, transport orders are created automatically
pallets are automatically positioned in accordance with the guidelines
reduced time and space overheads from material warehousing and
repositioning
annual inventory-taking no longer necessary
material deliveries for production correspond to actual consumption (just-
in-time delivery)
cycle times are reduced by time savings in warehousing, relocations, and
the provisioning and availability of materials
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2.10 PILOT:QMS Quality Management
The increase in customer requirements and the need to provide information about
the measures taken to reach quality assurance require detailed test documents
with an inspection and test plan. PILOT: QMS has been developed for this special
requirement of automated test planning and test drawing generation.
One of the most important characteristic of this system is flexibility. E.g. it can be
used ideally as a tool in continuous processes improvement (KVP) or in in-process
controls.
For this purpose, different type of questions can be created and combined with a
different weighing. In addition, the information can be stored as to whether the
answer to the question is relevant for the overall test or not.
Surely, questions about the property type can also be flexible combined with test
plans. Test plans can also be inherited. The special features of PILOT: QMS
include the fact that a workflow is supported and every step is documented. The
test results can be evaluated with the PILOT: Report or exported to Excel.
Image 12: PILOT QMS LMS
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2.10.1 PILOT: QMS Features
Operators are guided and assisted through the process.
Continuous identification of out-of-specs states using define quality criteria
for all production steps, from the arrival of materials to the dispatch of
finished products.
Quality checks are configured individually according to specific times,
product groups, product categories, etc.
Systematic evaluation to all quality data through the system.
Efficient complain management.
Integrated data communication and transfer.
o Key data monitoring and quality.
o Standard quality reports.
o Automatic data exchange with ERP/SAP systems.
Digital management and documentation instead of paper base operations.
2.10.2 PILOT: QMS Benefits
All information is available for use, using the integrating networking of all
systems.
Automatic creation of lots for inspection.
Audit plans and checklists will be available where needed via desktop or
mobile device.
Automatic assignment of audit plans and checklists as appropriate to the
product in matter.
Connecting the measuring devices to the system allows automatic
comparison of the values measured with the specification and prevents
input errors.
Visual guidance using photos, instructions, notes (E.g. GHS Hazard
Symbols) can be provide at any time.
Cost and time savings through digital-supported quality-assurance
process.
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2.11 PILOT:CPO Control Plan Organizer
The increase of customer requirements and the need to provide information about
the measures taken to ensure quality assurance require detailed test documents
with an inspection plan and a test drawing. The Control Plan Organizer PILOT:
CPO was developed for this special requirement of automated test planning and
test drawing generation.
One of the most important characteristic of this system is flexibility. E.g. it can be
used ideally as a tool in continuous improvement processes (KVP) or in in-process
controls, for testing boiler temperatures or for testing calibration cycles of
measuring instruments. Other fields of application can be the sampling of the
samples in the laboratory information system (LIMS), checking of user rights or a
check of the professional profile of employees.
For this purpose, questions of different types can be created and combined with a
different weighting. In addition, the information can be stored as to whether the
answer to the question is relevant for the overall test result or not.
Of course, questions about the property type can also be combined in a flexible
manner with test plans. Test plans can also be inherited. Among the peculiarities
of PILOT: CPO also includes the fact that a workflow is supported and every step
is documented. The test results can be evaluated with the PILOT report or exported
for Excel.
Image 13: PILOT CPO Control Plan Organizer
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2.11.1 PILOT: CPO Features
Inspection plans can be assigned to a specific material, material class or
equipment.
Easy dialog-creation, assignment and clear presentation of all test points and
test details.
Simple way of changing status of a test plan.
Conclusion of several test points for test plans in relation to products or
materials.
Presentation of the complete test plan history including questions, test points
and testing procedures.
Evaluations / Analysis by product and material based on quality (by product
group, period, etc.).
Definition of escalation levels for active notification or critical test criteria.
Product Portfolio
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2.12 PILOT:Maintain
Maintenance processes are becoming more and more critical to production
because machine failures and inadequate availability of machine resources have
a major impact on productivity. Especially since is necessary to take into account
that requirements for maintenance management are increasing as a result of the
progressive automation and simultaneously growing complexity in the production
structures. This leaves substantial possibilities for optimization of productivity
unused.
PILOT: Maintain provides effective support for risk-based maintenance. This
solution has a connection to machines and diagnostic systems for the automatic
detection of defined states (temperature monitoring, runtime monitoring, vibration
measurements, etc.). It documents the results of the impact analyzes (FMEA),
base on which maintenance orders are defined. In addition, the system makes it
possible to plan the maintenance orders and to visualize the planning in a calendar.
Likewise, maintenance-specific analyzes are possible due to the complete
documentation of all maintenance activities. And also the SAP / ERP integration
for the automatic exchange of maintenance-related data is included. As a result,
there is less administrative effort, because replacement and spare parts are
checked and retrieved on the system.
Image 14: Maintenance steps
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2.12.1 PILOT: Maintain Features
Complete integration with ERP and other systems.
Maintenance stuff and activities automatically integrated into the production
planning and key data.
Maintenance planning and completion are linked to technical materials
stored.
Maintenance activities and technical materials stock are based on a risk
based assessment.
Integrated data transfer and communications.
Maintenance reporting and key data monitoring.
Automatic data exchange with ERP system.
Avoiding paper documentation by using mobile devices.
2.12.2 PILOT: Maintain Benefits
Fully digital and paper-free support for the creation and processing of work
orders in the system.
Activity durations will recorded automatically.
Less administrative effort because spare parts and consumables are
checked on the spot in the system inventory.
Parts are automatically allocated to the job and booked from stock.
Defining a minimum inventory level automatically initiates an order
requisition by mouse click.
Connections to machines and diagnostics systems to detect defined
conditions automatically (temperature monitoring, run-time monitoring,
vibration, measurements, etc.).
Visual guidance using photos, instructions, etc. for specific operations.
All information is made available using the integrated networking of all
systems involved.
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2.13 PILOT:EMS Energy Management System
Almost all production companies have to prove their energy efficiency for legal
reasons or they pursue strategies to reduce energy consumption, independently of
these requirements. PILOT:EMS is ideal for this. The solution meets the
requirements of the standards according to DIN EN 16247-1 or ISO 50001 and is
recognized as eligible energy management software by the competent Federal
Office for Economic Affairs and Export Control (BAFA).
PILOT:EMS is a comprehensive analysis of the energy demand and the CO
Balance, but above all the calculated consumption values can be systematically
optimized through an intelligent action management.
For a good reason, PILOT:EMS is based on the PILOT:APM solution, which is
used to determine operating and process data. It is designed in such a way that it
not only ensures a much more efficient production management, but at the same
time supports the requirements of modern energy management. The decisive
advantage is no additional investment for the technical infrastructure for the
specification of relevant data and identification of energy guzzlers as well as load
points and measures for their reduction for this easy-to-integrate and future-
oriented web technology.
Image 15: Examples EMS Diagram
Product Portfolio
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2.13.1 PILOT: EMS Features
Full support of DIN EN ISO 50001
Fully supports the PDCA cycle (Plan, Do, Check, Act).
Evaluation of Key Indicators according to DIN EN ISO 50001 and EMAS III.
Analysis and evaluation with the help of coaching views and trend outlooks.
Evaluation of key data using formula editor.
Integrated reporting system.
Quick and easy data connection using PILOT I/O Server.
Simple integration using forward-looking web technology.
All data available on mobile devices (Blackberry, IPhone, IPad).
2.13.2 PILOT: EMS Benefits
Transparent energy monitoring for efficient emission controls.
Production disruptions automatically trigger optimization measures.
Significant added-value, compared to conventional systems, by displaying
energy consumption in relation to production in a single system.
Modular system expanding flexibly with requirements.
Best Practices speed up systems implementation and support a minimal-
administration operation.
Sustainability guarantee by in-house systems.
High level of investment security by using a next generation intelligent
information system.
2.14 PILOT:ERP-Connector
PILOT: ERP connector provides the connection from MES to existing ERP
systems. It coordinates the data exchange between the two systems and supports
the transfer of orders and lists as well as master data.
Consumption data, production data, key figures, times as well as quality data are
reported back to the ERP.
2.15 PILOT:IO-Connector
PILOT: IO connector provides an interface to various systems, data transmission
from the OPC interface to the MDE / OEE application, and data buffering in case
of connection interruptions to the PILOT application
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3 Project Implementation Strategies
Felten leads their customers step by step in the optimization of their production.
Consulting:
Process Optimization
MES / ERP Integration
Production Controlling
Industry 4.0
PILOT Platform:
Best Practice Modules
Easy Scalable
Digital Orientation
Quick RoI
Project Management:
Experienced Teams
Best Practice Methods
Key User Concept / Train-the-Trainers
Budget / Timeline Controlling
Service & Support:
Workshops, Trainings
24/7, 365 days worldwide
Update Management
1st to 3rd Level Support
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3.1 IT-System Structure
Our hosting concept has been successively developed since 1997 in many projects
and rollouts with numerous satisfied customers. Depending on the existing
infrastructure, it consists of two main points: the central server and the local IO
connector (s).
Image 16: Overview PILOT System Landscape
PILOT: IO-Connector provides the interfaces to production. For simple handling of
the process communication it is normally located in the local environment. It
provides a variety of interfaces and also serves as a data buffer if the application
server should not be available.
The PILOT application server is usually located virtually together with regional or
local ERP hosting in a server room or data center.
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3.2 Data Collection
Data Collection in PILOT system is carried out in two different ways.
1. On Process Client /Touch-Terminal-PC
Manual Data entry on the process control during processing orders. For example:
- Correction of goods / Bad pieces counter
- Fault qualifications for non-automatic fault detection.
- Manual process input / Test Plans
2. PILOT:IO-Connector
The IO connector is used for automated data collection. The data can be
exchanged via different drivers (methods). Various versions are available as
standard. For example: OPC, OPC-UA, ODBC, Serial, Native Driver, etc.
- CSV, TAG-Lists, XML, File, etc.
Image 17: PILOT:IO-Connector
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3.3 Project Team
We are in close contact with our customers through the duration of the project and
will integrate the most important user groups into the project right from the start.
This allows us to ensure a high level of acceptance of our system as well as a fast
and easy implementation.
As the main contact partner, an experienced project manager is available as a
single contact person.
Image 18: Project Team Concept
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3.4 Support
In order to minimize interruptions in operation plants, support is a key element of
our strategy.
We provide worldwide support via remote access. Through individual Agreements
we guarantee a support up to 24/7.
Within the support management, all incidents and service requests are collected
centrally in a ticket system and forwarded to the responsible employees for the
first- and second-level support.
The service management also includes third-level support. This service also
includes research to develop solutions for the long-term elimination of faults.
On request, we provide local key users for first-level support. A local system
integrator can also perform this service.
3.4.1 Support Features
Workshops & Key User Training
Updates without Production stop
24/7 Support, 365 days worldwide
Support by diagnostic module
Documentation in a Ticket System
Covering of 1. - 3. Level Support
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3.5 Project Management
Project implementation is carried out according to the requirements of the QM
system based on the defined Project Life Cycle.
Image 19: Project Management
Established procedures, such as design specification, followed by the
implementation of the requirements and tests are join by our QA and an
experienced project management.
At an early stage, we integrate our customers into project implementation with
reviews and releases at defined milestones as well as tests.
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3.6 Implementation Management
We use the release management system to plan, define and control version tests
and their rollout into the production system.
This allows us to ensure that each new software or module version meets the
expected requirements, the customer's productive system is protected against
failures and only tested versions are executed.
In order to determine faulty processes at an early stage and to avoid software
accidents within production, we configure three different servers for each project:
One Development System for development and general test done by
Felten.
One Test System for training, testing of implementation results and system
extensions as well as analysis of our customer, but outside the production
area.
One Productive System for the real production areas.
Image 20: PILOT Integration Strategy
Our test processes and document templates meet the requirements for validation
according to GAMP 5.
For the definition and documentation of the tests, corresponding template
documents are available.
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3.7 Validation Strategy
In addition to the above-described implementation concepts, we offer validation
support for pharmaceutical systems. These refer to the entire validation as well as
to corresponding support.
The diagram illustrates the basic validation process of the Felten Group.
We follow the specifications of the MQP (Master Qualification Plan) of the customers as well as the dedicated specifications of a project-specific QPP (Quality and Project Plan).
For the validation documentation related document templates are available in the Felten Group. The templates follow exactly the specifications of GAMP 5. Possible adaptations of these templates depend on the customer's validation strategies.
On request, also available document templates of the customer can be used for the validation.
Image 21: Validation Process
In general, this results in individual work steps which can be represented as
follows.
Project realization Validation / Qualification
Creation of validation plan together with the
user, if necessary
Specification of the customer requirements in
the URS (User Requirements Specification) together with the user, if necessary
Creation of Quality and Project Plan
• Specification of functions in Functional Specification (FS) or Design Specification (DS)
Creation and actualization of the traceability matrix (TM) together with the project team, including required design reviews
Definition of software categories according to
GAMP5 with regard to risk analysis (PILOT modules are usually category 4)
Execution / supervision of the risk analysis for the evaluation of the risk filters. The template of the RA can be adapted to customer requirements
Project Realization, Customizing
Execution of Design Qualification
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Creation of Test Documentation FAT / SAT
Review Test Documentation (FAT, SAT) together with the Project team
Setup Test systeme
Creation of test documentation (IQ, OQ, PQ) according to standard templates Note: The tests are partly documented in the TM. Tests can also be carried out according to customer documents.
Internal Testing
FAT Accompanying the FAT, if necessary
Implementation, Training SAT Accompanying the SAT, if necessary
Execution and Documentation IQ, OQ, PQ
Creating Validation Report
The individual points are clearly documented in the traceability matrix (TM).
The general validation process is as follows:
- Setup & Customizing on the Test System
Execution of the FAT
- Transfer of the Application into the Q-System
Execution of the SAT and pre-validation (IQ / OQ).
If necessary, the target hardware can be connected.
- Transfer of the Application into the Productive System
Finalization of the SAT and IQ / OQ together with the target hardware
- Go-Live and PQ
In general, the PQ is carried out by the user himself.
This concept supports the realization strategies of core-systems followed by
rollouts (internal and additional sites supported by customer’s key users.
The core system can thus also be "pre-validated" at the other sites. The validation
effort will thereby be greatly reduced.
Image Register
Felten Group – PILOT:Suite V1.0 Page I of I
Image Register
Image 1: Felten Group - References ..................................................................................... 1
Image 2: Pilot Suite: Portfolio ................................................................................................ 2
Image 3: Pilot Suite: Connectivity .......................................................................................... 3
Image 4: Multifunctional Terminal User Interface ................................................................... 4
Image 5: Terminal Structure, Examples ................................................................................. 5
Image 6: Pilot Suite: Vertical Integration ................................................................................ 7
Image 7: Pilot WDS: Terminal Menus ...................................................................................10
Image 8: PILOT: APM Terminal ............................................................................................12
Image 9: PILOT: APS System ..............................................................................................14
Image 10: PILOT: WMS KANBAN Monitor ...........................................................................16
Image 11: PILOT:LES Receiving ..........................................................................................18
Image 12: PILOT QMS LMS .................................................................................................20
Image 13: PILOT CPO Control Plan Organizer.....................................................................22
Image 14: Maintenance steps ...............................................................................................24
Image 15: Examples EMS Diagram ......................................................................................26
Image 16: Overview PILOT System Landscape ...................................................................29
Image 17: PILOT:IO-Connector ............................................................................................30
Image 18: Project Team Concept .........................................................................................31
Image 19: Project Management ............................................................................................33
Image 20: PILOT Integration Strategy ..................................................................................34
Image 21: Validation Process ...............................................................................................35
FELTEN GmbH
In den Doerrwiesen 31
54455 Serrig
Tel: +49 6581 9169 – 0
www.felten-group.com