The Critical KPI to drive Manufacturing ProductivityJason Corder
A net reduction in cost of operations directly and positively affects the bottom line. Companies can boost revenue without sacrificing profitability by factoring in long-term debt-to capital ratio. Since finance puts a premium on a company’s ability to maximize productivity and use existing assets, you have to continually measure, analyze, and adjust your processes. This is accomplished by a rigorous practice of productivity gains, cost cutting with increased efficiencies, and maximizing returns on fixed assets.
Many manufactured products can have a significant impact on the well-being of consumers. As such, it stands to reason that stringent requirements and standards be set firmly in place for their manufacture.
Transition to online AMS reduces maintenance costs and improves operationsEmerson Exchange
Presented by David Rabon and Mike Ruhle
at the 2011 Emerson Exchange in Nashville.
Abstract: The utilities department at Pfizer Inc. in Groton, CT has leveraged an investment in SMART technologies to move from a failure/preventative maintenance process to a reliability based process. With a DeltaV upgrade, online AMS and Valvelink snap-on were installed. The software along with training/mentoring and a change in work practices have improved maintenance efficiency and costs. In the past work was performed when operations identified a process related alert only. Now the technicians help identify issues, generate work orders and resolve them before they become process issues.
The Critical KPI to drive Manufacturing ProductivityJason Corder
A net reduction in cost of operations directly and positively affects the bottom line. Companies can boost revenue without sacrificing profitability by factoring in long-term debt-to capital ratio. Since finance puts a premium on a company’s ability to maximize productivity and use existing assets, you have to continually measure, analyze, and adjust your processes. This is accomplished by a rigorous practice of productivity gains, cost cutting with increased efficiencies, and maximizing returns on fixed assets.
Many manufactured products can have a significant impact on the well-being of consumers. As such, it stands to reason that stringent requirements and standards be set firmly in place for their manufacture.
Transition to online AMS reduces maintenance costs and improves operationsEmerson Exchange
Presented by David Rabon and Mike Ruhle
at the 2011 Emerson Exchange in Nashville.
Abstract: The utilities department at Pfizer Inc. in Groton, CT has leveraged an investment in SMART technologies to move from a failure/preventative maintenance process to a reliability based process. With a DeltaV upgrade, online AMS and Valvelink snap-on were installed. The software along with training/mentoring and a change in work practices have improved maintenance efficiency and costs. In the past work was performed when operations identified a process related alert only. Now the technicians help identify issues, generate work orders and resolve them before they become process issues.
Development Of An Effective Industrial Maintenance Practice For Plant Optimum...IJERA Editor
Plant optimization is a sound fiscal decision and this is a key attribute of good operational management. The
decision to adhere strictly to the maintenance measurements, controls and efficiencies necessary for optimum
performance not only enhances the plant operations, it quite often produces a safer operating facility and
protects plant asset or investment. Plant operations rely on dependable acquired knowledge, skills, equipment
and maintenance programs for an assured performance whiles strategies are required to be in place for
equipment optimum availability to ensure system operational integrity in order to reduce costs which affect
production. This optimized system would ideally give meaning to effective maintenance practice of plant
equipment and accepted best maintenance management system. This paper presents a comprehensive review of
characteristics of plant equipment and maintenance strategies and proposes sustainable maintenance
management performance criteria. Thereby improving business, safety, equipment efficiency and sustain the
environment. The goal is to achieve optimum availability and optimum operating condition of the equipment
life cycle in a cost optimized approach.
John Day developed a proactive maintenance process in 1978 and manage maintenance and engineering at Alumax Mt. Holly and later at Alcoa Mt Holly for over 20 years. These are the slides he presented at the 1997 SMRP Conference. Great slides with great information. If you would like the slides and not PDF send me an email at rsmith@maintenancebestpractices.com. I worked for John Day back in the early 1980s which started my journey in Proactive Maintenance.
Streamlining Operations: The Role of Data Integration in the Manufacturing Wo...MileyJames
In today's rapidly evolving manufacturing landscape, data has become a valuable asset. The ability to collect, analyze, and utilize data effectively can significantly impact a manufacturer's ability to make informed decisions, improve processes, and remain competitive. Data integration plays a crucial role in this transformation, serving as the linchpin that connects disparate systems and empowers manufacturers to harness the full potential of their data. In this article, we will explore the importance of data integration in the manufacturing world and how it is revolutionizing the industry.
Development Of An Effective Industrial Maintenance Practice For Plant Optimum...IJERA Editor
Plant optimization is a sound fiscal decision and this is a key attribute of good operational management. The
decision to adhere strictly to the maintenance measurements, controls and efficiencies necessary for optimum
performance not only enhances the plant operations, it quite often produces a safer operating facility and
protects plant asset or investment. Plant operations rely on dependable acquired knowledge, skills, equipment
and maintenance programs for an assured performance whiles strategies are required to be in place for
equipment optimum availability to ensure system operational integrity in order to reduce costs which affect
production. This optimized system would ideally give meaning to effective maintenance practice of plant
equipment and accepted best maintenance management system. This paper presents a comprehensive review of
characteristics of plant equipment and maintenance strategies and proposes sustainable maintenance
management performance criteria. Thereby improving business, safety, equipment efficiency and sustain the
environment. The goal is to achieve optimum availability and optimum operating condition of the equipment
life cycle in a cost optimized approach.
John Day developed a proactive maintenance process in 1978 and manage maintenance and engineering at Alumax Mt. Holly and later at Alcoa Mt Holly for over 20 years. These are the slides he presented at the 1997 SMRP Conference. Great slides with great information. If you would like the slides and not PDF send me an email at rsmith@maintenancebestpractices.com. I worked for John Day back in the early 1980s which started my journey in Proactive Maintenance.
Streamlining Operations: The Role of Data Integration in the Manufacturing Wo...MileyJames
In today's rapidly evolving manufacturing landscape, data has become a valuable asset. The ability to collect, analyze, and utilize data effectively can significantly impact a manufacturer's ability to make informed decisions, improve processes, and remain competitive. Data integration plays a crucial role in this transformation, serving as the linchpin that connects disparate systems and empowers manufacturers to harness the full potential of their data. In this article, we will explore the importance of data integration in the manufacturing world and how it is revolutionizing the industry.
DAS manufacturing processes involve collecting, measuring, and analyzing the data collected from multiple sources. These systems work to provide a mean for signals sensing, analysis, and instruments, later turned into digital data for storage and further processing. Here's an overview of data acquisition systems and their importance in modern applications:
Providing a superior foundation for your corporate quality systemScott Reedy
Quality systems for companies regulated by the FDA must follow current good manufacturing practices (CGMPs) to comply with the FDA's 21 CFR part 820 regulations. This whitepaper discusses how Arena has expanded the traditional borders of QMS to manage product development and quality management processes in a single solution.
Data Quality Management: Cleaner Data, Better Reportingaccenture
In this new Accenture Finance & Risk presentation we explore a process to investigate, prioritize and resolve data quality issues, key to creating a more efficient and accurate reporting environment. View our presentation to learn more.
For more on regulatory reporting, see presentation on Financial Reporting Robotics: http://bit.ly/2qaLK9y
Visit our blog for latest Regulatory Insights: https://accntu.re/2qnXs1B
Technology Audit (TA) enables organization leaders understand the present IT utilization levels. The Audit process typically begins by understanding the vision, mission and the business goals of the customer. A high level mapping of the current IT deployment in relation to the business objectives is carried out, and possible gaps between the business objectives and IT deployment is observed and noted.
De-risking Life and Annuity Policy Admin System ConversionsCognizant
Highly effective policy administration system (PAS) conversions are those that address the involved people, processes and technologies. Life and annuity (L&A) insurance companies can improve success rates in PAS conversions when they emphasize these three dimensions as keys to the organizational change initiative.
Are you looking for a way to improve your quality management systems, help your teams be successful, satisfy industry quality standards, and meet customer expectations? If so, you are not alone. Many organizations face the challenge of managing quality in a complex and dynamic environment. That's why we created TQMSOptima, the ultimate quality management software solution for your business. TQMSOptima is a cloud-based platform that integrates all aspects of quality management, from planning and execution to monitoring and improvement. With TQMSOptima, you can:
- Streamline your workflows and processes with smart automation and collaboration tools.
- Enhance your visibility and control over your quality performance with real-time data and analytics.
- Reduce your risks and costs with proactive prevention and corrective actions.
- Boost your customer satisfaction and loyalty with consistent and reliable delivery of quality products and services.
TQMSOptima is designed to help you achieve excellence in quality management, no matter what industry you are in or what size your organization is. Whether you need to comply with ISO 9001, IATF 16949, ISO 14001, AIAG, or other quality standards, TQMSOptima can help you do it with ease and confidence. TQMSOptima is more than just a software, it's a partner in your quality journey.
If you want to learn more about how TQMSOptima can transform your quality management capabilities, watch this video to see it in action. You will discover how TQMSOptima can help you:
- Define your quality objectives and policies
- Manage your documents and records
- Document and Analyze audit results and inspection data
- Handle non-conformities and deviations
- Implement corrective and preventive actions
- Perform root cause analysis and risk assessment
- Generate timely and relevant data to assist in the decision making process
- Create unique user dashboards for monitoring responsibilities
- And much more!
Don't miss this opportunity to see how TQMSOptima can make your quality management easier, faster, and better. Watch the video now and get ready to take your quality management to the next level with TQMSOptima! 🚀
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Multidimensional Challenges and the Impact of Test Data ManagementCognizant
Test data management (TDM) is vital for quality assurance (QA) functions to best handle the many cha;l;enges associated with data security, release management, batch processing, data masking and fencing.
From Data to Insights: How IT Operations Data Can Boost QualityCognizant
By leveraging highly-analyzed operational data - the voice of customers, machines and tests - quality assurance (QA) and IT groups can derive major gains in quality of apps and in user experience.
Technology Audit | IT Audit | ERP Audit | Database Security Arish Roy
you are invited to utilize our services!
IT Infra Audit, Technology audit, penetration testing, Database security, We provides you to the best work finishing.
Top Key Factors for Seamless Yield Management in Fabless Start-ups.pptxyieldWerx Semiconductor
The semiconductor manufacturing industry is highly complex and requires efficient yield management system (YMS) to optimize production processes and maximize product yield. For fabless start-ups, selecting the right YMS is crucial to ensure data analysis, problem-solving, and scalability. This detailed technical content will explore the key areas to consider when choosing a YMS, providing insights and recommendations for the semiconductor manufacturing industry.
Inspace offers various IT services and provides applications for business needs and growth through specially designed IT audit and infrastructure services that helps the client explore the power of technology.
NUMERICAL SIMULATIONS OF HEAT AND MASS TRANSFER IN CONDENSING HEAT EXCHANGERS...ssuser7dcef0
Power plants release a large amount of water vapor into the
atmosphere through the stack. The flue gas can be a potential
source for obtaining much needed cooling water for a power
plant. If a power plant could recover and reuse a portion of this
moisture, it could reduce its total cooling water intake
requirement. One of the most practical way to recover water
from flue gas is to use a condensing heat exchanger. The power
plant could also recover latent heat due to condensation as well
as sensible heat due to lowering the flue gas exit temperature.
Additionally, harmful acids released from the stack can be
reduced in a condensing heat exchanger by acid condensation. reduced in a condensing heat exchanger by acid condensation.
Condensation of vapors in flue gas is a complicated
phenomenon since heat and mass transfer of water vapor and
various acids simultaneously occur in the presence of noncondensable
gases such as nitrogen and oxygen. Design of a
condenser depends on the knowledge and understanding of the
heat and mass transfer processes. A computer program for
numerical simulations of water (H2O) and sulfuric acid (H2SO4)
condensation in a flue gas condensing heat exchanger was
developed using MATLAB. Governing equations based on
mass and energy balances for the system were derived to
predict variables such as flue gas exit temperature, cooling
water outlet temperature, mole fraction and condensation rates
of water and sulfuric acid vapors. The equations were solved
using an iterative solution technique with calculations of heat
and mass transfer coefficients and physical properties.
We have compiled the most important slides from each speaker's presentation. This year’s compilation, available for free, captures the key insights and contributions shared during the DfMAy 2024 conference.
6th International Conference on Machine Learning & Applications (CMLA 2024)ClaraZara1
6th International Conference on Machine Learning & Applications (CMLA 2024) will provide an excellent international forum for sharing knowledge and results in theory, methodology and applications of on Machine Learning & Applications.
Hierarchical Digital Twin of a Naval Power SystemKerry Sado
A hierarchical digital twin of a Naval DC power system has been developed and experimentally verified. Similar to other state-of-the-art digital twins, this technology creates a digital replica of the physical system executed in real-time or faster, which can modify hardware controls. However, its advantage stems from distributing computational efforts by utilizing a hierarchical structure composed of lower-level digital twin blocks and a higher-level system digital twin. Each digital twin block is associated with a physical subsystem of the hardware and communicates with a singular system digital twin, which creates a system-level response. By extracting information from each level of the hierarchy, power system controls of the hardware were reconfigured autonomously. This hierarchical digital twin development offers several advantages over other digital twins, particularly in the field of naval power systems. The hierarchical structure allows for greater computational efficiency and scalability while the ability to autonomously reconfigure hardware controls offers increased flexibility and responsiveness. The hierarchical decomposition and models utilized were well aligned with the physical twin, as indicated by the maximum deviations between the developed digital twin hierarchy and the hardware.
Overview of the fundamental roles in Hydropower generation and the components involved in wider Electrical Engineering.
This paper presents the design and construction of hydroelectric dams from the hydrologist’s survey of the valley before construction, all aspects and involved disciplines, fluid dynamics, structural engineering, generation and mains frequency regulation to the very transmission of power through the network in the United Kingdom.
Author: Robbie Edward Sayers
Collaborators and co editors: Charlie Sims and Connor Healey.
(C) 2024 Robbie E. Sayers
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Effective Management of Electronic Batch Records
1. 180 N Riverview Drive No. 300
Anaheim, CA 92808
United States
+1 714 996 5302
marketing@parsec-corp.com
www.parsec-corp.com
TM
Effective Management
of Electronic Batch
Records
2. Examples of these industries include Pharmaceuticals,
Medical Devices, Diagnostics, Food & Beverage
(Nutritionals / Animal Nutrition), Cosmetics / Personal
Care products, and others.
Many manufactured products
can have a significant
impact on the well-being of
consumers. As such, it stands
to reason that stringent
requirements and standards
be set firmly in place for their
manufacture.
3. The US Food and Drug Administration (FDA)
has adopted a risk-based approach to establish
and enforce regulations for pharmaceutical
development, manufacturing, and quality
assurance. Mandatory regulations (e.g., Current
Good Manufacturing Practices or CGMP and 21
CFR Part 11), and voluntary frameworks, such as
Process Analytical Technology (PAT), are defined
to ensure final product quality through proper
design, analysis, and control of manufacturing
operations. To ensure product integrity and
quality, it is mandatory to have consistent
records of:
• Operations and procedures
• Process settings and variables
• Production events and conditions
• Quality and performance attributes of raw
and in-process materials
5. As with most manual operations
there were concerns with accuracy,
consistency, and repeatability.
The arrival of 21 CFR Part 11 and PAT brought a clearer regulatory
roadmap (and framework) for transitioning to Electronic Batch
Records (EBRs). There are many advantages to electronic record
keeping:
• Improved regulatory compliance
• Improved accuracy, consistency, and repeatability
• Improved information accessibility and real-time analysis
The challenge now lies in negotiating the various issues related
to infrastructure, existing systems, workflow, regulations,
training, and the availability of a flexible solution to effectively,
economically, and non-disruptively address these issues.
6. It is crucial to
understand
what constitutes
a compliant
electronic batch
record system.
Also, it raises considerable questions:
What level of electronic data
capture is required? How is this
data captured? How is it retrieved,
analyzed, and reported? How is the
integrity of data ensured? While these
questions sound simple, their not-so-
trivial answers are critical to having
the right solution in place.
TrakSYS™ real-time decision support
for manufacturing execution is
designed to help manage operational
complexities and improve quality
and productivity. In regulated
industries such as pharmaceutical
and food, electronic batch records
represent a significant opportunity for
improvement. TrakSYS™ effectively
paves the road for delivering
compliant, paperless, EBRs.
7. An Electronic Records based solution
with connection to the process via
MOM software can completely change
the complexity of the factory, not only
from a compliance viewpoint, but also
from a Continuous Improvement and
real-time analysis viewpoint.
8. Utilizing Electronic Records
TrakSYS™ provides a comprehensive
modeling and configuration engine
that allows the user to define data
sources, types, business rules,
conditions, and workflow. The
flexible configuration management
and dynamic change control
(keeping track of all modifications
to configuration, recorded data,
notes, and electronic signatures),
make it possible to meet the exact
data management and reporting
requirements of even the most
complex and demanding batch
applications.
Real-time Notifications
As great as it is to have a
comprehensive historical record
of the environmental and batch
process-specific variables, it is as
important to have to-the-point,
real-time notification of process
anomalies and deviations from
defined protocols.
TrakSYS™ makes it possible to
alert the responsible personnel
(as opposed to indiscriminate
broadcasting of process alarms)—
through their choice of delivery
mechanism (e.g., email, page,
SMS)—with specific messaging to
expedite proper decision-making and
corrective action in real-time. This
has a profound impact on improved
quality and productivity.
Procedures
Based on a validated product
manufacturing protocol, there are
standard operating procedures or
instructions in place that must be
carefully followed. All exceptions/
alterations must be clearly noted and
approved by authorized personnel.
For example, the instructions may
require a detailed and step-by-step
cleaning process that precedes
the start of any batch operation.
TrakSYS™ provides the option to
define the instruction steps (or to
retrieve them from other sources),
and then record the proper
completion of each instruction step.
Types of Data Sources
The electronic record requires
the inclusion of the designated
information that must be recorded
for each batch. Consistent, accurate,
and secure data is a fundamental
requirement of the batch record.
Such data must include but is not
limited to:
• Work order information
• Product information
• Production targets
• Operator information
• Environmental conditions
• Details of batch steps, stages,
and phases
• Batch process variables
• Operator observations and
comments
9. Historian
As both environmental conditions and batch-
specific process variables can affect the quality
and compliance of the product, it is required to
have a complete record of their values throughout
the process. TrakSYS™ satisfies this through its
performance historian functionality that will capture
the value of the required process variables—at
specification-defined intervals—and provide a
complete historical record to ensure operations
with specification limits (within which each process
variable must be controlled).
The TrakSYS™ historian functionality also makes
it possible to study the best settings for the most
consistent performance and yield. The historical
process variable trends may be studied versus other
process-relevant parameters and settings to gain
valuable insight for documented process and quality
improvement.
10. Notes and Observation
In order to provide in-depth context and contrast,
specifically for traceability and corrective actions,
clear and concise notes must be available. Such
notes and observation may play a critical role in root-
cause analysis and tracing of production anomalies.
TrakSYS™ offers comprehensive and multi-tiered
operator/user involvement tools to capture the
pertinent process-related observations that may
not otherwise be automatically captured by other
means. TrakSYS™ even allows for defining the rules
governing the recording of user observations (e.g.,
conditions, permissions, topics, events, areas).
11. Utilizing Electronic Records
asset, and other user-definable
filters.
Reporting
Collecting the necessary batch
process data is an important part
of developing effective electronic
batch records. Applying the correct
analytics and business rules to turn
raw data into actionable intelligence
is equally important. The actionable
intelligence is typically manifested in
the form of reports. The electronic
reports can offer significant benefits
if they are:
• Timely
• Accurate
• User configurable
(personalization)
• Flexible
• Accessible
• Secure
TrakSYS™ offers all these attributes
to effectively deliver the needed
information to satisfy both regulatory
and operational requirements.
With the delivery of accurate,
timely, and secure information,
TrakSYS™ empowers users—across
a wide spectrum of disciplines (e.g.,
production, maintenance, quality,
planning, IT, and regulatory)—to
work together to efficiently meet
operational excellence and quality-
by-design goals
Such meticulous and organized
management of the recorded data
(including observations/notes) makes
it possible to quickly and effectively
analyze batch records and decide
upon timely and proper response.
Electronic Signatures and Data
Management
Within regulated industries (and
for businesses interested in the
methodical management of their
manufacturing operations), it is
critical to establish a clear means of
monitoring and controlling changes
to:
• System configuration, settings,
and business rules
• Operational set points
• Pass/fail criteria
• Collected (actual) data
• Reported data
• Access rights
TrakSYS™ provides thorough
authoring and auditing capabilities—
based on the level of required
configuration control and
appropriate access privileges—
for all modification (i.e., changes,
deletions, additions) in various areas
of operation. Using the TrakSYS™
knowledge management portal, the
modifications can be sorted and
reported by type, personnel, date,
12. Taken together, utilizing Electronic
Records in regulated industries
with other tools available in
MES software to optimize value
streams, can have a dramatic
impact that provides substantial
rewards to the plant team by
reducing risk of violations,
improving processes, reducing
risk of recalls, improving
throughput and customer service
levels, and improving the bottom
line performance of the business.
13. TM
About Parsec
Parsec is the developer of TrakSYS™, a proven operations management software
application and solution platform designed to significantly improve manufacturing
processes. Parsec is committed to providing best-in-class products and solutions
to our worldwide community of clients to assist them in optimizing their
manufacturing operations. There are thousands of TrakSYS™ licenses in use
around the globe in a wide variety of Industries.
TrakSYS™ helps manufacturers to maximize asset utilization and efficiency,
increase capacity with no new capital equipment, reduce production costs,
decrease lead time, and improve profitability. For more information about Parsec
and TrakSYS™ please visit the corporate website at www.parsec-corp.com.
Copyright Parsec Automation Corp. 2016
All trademarks are the property of their respective owners