Functional Requirements of a Pharmaceutical Operations Intelligence Portal

The major tenant of a Pharmaceutical Operations Portal or Pharmaceutical Production Dashboard is that it meets the needs of users who want to have a broad visualization of manufacturing operations but then have the ability to carry out intensive data analysis by combining data from the many sources, without having to be ‘data extraction experts’ for each source system. The ability of the solution to provide the data to the user from disparate sources in a single integrated presentation is expected.

To enable this functionality, an operations intelligence architecture will become a core infrastructure component of a Pharmaceutical site’s Manufacturing Systems and is required to:

    • Centralize data presentation from disparate applications in the context of executed production
    • Provide a holistic view of all manufacturing systems to help to better understand the manufacturing process. Plant process data will be linked to other operations data such as LIMS sample results, maintenance work orders, calibration history, quality events and supply chain.
    • Track recipe execution and events and provide batch client tools to see from the start to end of process.
    • Allow user tools such as production status, lot trace reporting, spreadsheets and SPC analysis applications to ‘see’ across all buildings and plant sites.
    • Perform calculations across the disparate data sources and across batches so that operations KPIs can included in reports and analysis tools.

      o For example calculate process step yields such as weight yield, cumulative yield, and weight of product protein at each downstream purification step. Yields are calculated from batch volume (process data) and titer (lab data).
      o Then compare actual yields against target yields and with selected process parameters and lab results from previous batches to look for corollary effects.
    • Allow for linking raw material (and consumables) lot numbers to production lot numbers to track process fluctuations to raw material fluctuations. Organize the data in such a way to simplify the analysis required to answer operations questions such as root causes of process deviations.

      o A typical deviation investigation would be analyzing the reason for an out of process specification condition such as an atypical flow reading on a filtration skid which was identified through an alarm condition. As an example, an investigation scenario may require the following combination of data:

        • the batch id and operation step from a Manufacturing Execution System (MES) such as Emerson Syncade
        • the flow trend profile from the plant historian such as OSIsoft’s PI System
        • the flow meter asset id and work order and calibration history from the maintenance system such as Maximo
        • the filter lot number and vendor name from the ERP system such as SAP
        o Then run the same query with previous batches and allow the re-aggregation of results by any key parameter batch id, operation, vendor name etc.
      • Allow for linking time based environmental lab results to production lot numbers so that excursions which may affect batch disposition can be investigated:

        • Review recent work orders in the room from the maintenance system
        • Review room cleaning results from the Laboratory Information System (LIMS).
        • Review HVAC operation, pressures from the plant historian
        • Link to operations conducted in the room from the MES genealogy
        • Review historical environmental excursions for the same area from the LIMS system

    Implementing a Pharmaceutical Operational Intelligence Portal will provide ongoing improvement of process understanding and feed into an organization’s PAT initiative. The deployed architecture should be able to handle a variety of drug manufacturing plants including API sites, Biologics and Drug product sites including sterile, solid dosage and packaging facilities.

    Coming soon in the next blog post – how MIST and Associates has built a Pharmaceutical Production Portal using a middleware component SOA (Service Oriented Architecture) architecture including interfaces/adapters to manufacturing applications, HTML5 visualization web portal solutions, and a set of manufacturing data analysis and reporting tools.

    Building Information Monitoring Achieving Energy Sustainability with Portals

    While most Building Information Monitoring (BIM) solutions have traditionally focused on – energy visualization and energy analytics – the market is demanding the use of alternate distribution types for that energy as well, such as smart and micro-grids to their facilities.

    While monitoring of the central grid is still very important, the customer’s demands are shifting to a model of monitoring all energy available to the facility including its own micro grid. Predicting the impacts on sensitive equipment within buildings is paramount in BIM. Having a smart building or system be able to respond to the impacts helps ensure the existing grid can recover from its own upset without load-shedding its customers.

    Building managers have struggled for years with inflexible systems that monitor and manage internal HVAC, lighting, and energy systems using complex and mostly proprietary software. Today’s Portals have changed that by leveraging information contained in data historians and correlating aggregated data to BIM standards.

    We recognize that it is expensive to remodel existing buildings and infrastructure to smart building standards, but there are things that can be done with portals that can leverage the process data at your facility. In our research, we have benchmarked many facilities that have reduced operating costs related to: lighting, HVAC, utilities, parking garages, etc. without a total remodel of their facility.

    Having a better property management strategy for businesses today is more than the right thing to do, it’s the smart thing to do in this competitive market. Energy and sustainability is more feasible and can be reached by managing things like water reclamation or motorized shading without giving up the human comforts that we have all grown accustom to.

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube 

    Asset Optimization with Portals

    Lately, I have been receiving a lot of questions from our readers about best practices around reports, Portals and Dashboards. I will attempt to answer some of the common questions we are getting in this blog on the differences between a Dashboard and a Portal and why they are important.

    Today, Portals and Dashboards are a critical tools used for understanding at a glance what is going on within an organization. Delivering insight or Clear View to executives, managers, operations and maintenance across a company is paramount in today’s competitive market.

    First what is the differences between a Portal and a Dashboard? While they can be the same thing, for this discussion we will talk about the differences between the typical deployment and support of Portals and Dashboards.

    Most Dashboards are a thick client or application installed on a local machine or computer with in your organization usually installed by your ITT department. Dashboards are very dependent on the resources installed on user’s computer. Dashboards are a very effective way of seeing critical information at a plant or facility but are a little more expensive to maintain and administer.

    Portals are typically a thin client or web based visualization installed on a company’s server and accessed by the user through a URL. Like Dashboards offer a very effective way of seeing critical information at a plant or facility without the overhead cost and resources needed on a user’s computer. Most users can’t tell the difference between a Dashboard and Portal once the portal is configured by ITT or a consultant.

    So, why do I need a Portal? Most companies deploy a portal to leverage static and real time data from multiple systems into a single location for viewing by different groups within an organization. Executives view or profile would be more strategic in nature than a maintenance manager or production manager. Having a portal that can leverage asset centric data and correlate statistical data into a single screen is very powerful.

    Are all portals and Dashboards the same? The short answer is no. The old saying of you get what you pay for is true in the Dashboard and Portal development world as well. Here are a few things to consider when looking for a portal to purchase.

    1 Is your organization trying to reduce operating cost?
    2) Is your organization trying to reduce or mitigate shutdowns?
    3) Is your organization trying to maintain regulatory compliance?
    4) Does your organization need a Clear View into its daily operations?
    5) Does your organization need reporting functionality?
    6) Does your organization need an alarm management tool?

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube 

    Fleet Management with TELEMATICS

    Fleet Management is changing today with the advancements in Telematics and use of satellite links to data historians. Using portals to visualize the status and health of your assets is becoming an industry standard.

    The selection of telematics systems for legacy machines includes those of third-party suppliers as well as “all-makes” systems from OEMs, both of which report basic data that can usually be supplemented with added sensors, but the number of sensors may be limited. (Essentially, third-party and OEM all-makes systems can’t use the encrypted data stored in the machine’s ECU.)

    If you talk to telematics users, even those most advanced, you might be surprised at how little information is actually collected for use, but how powerful the information becomes when diligently applied to more efficient Fleet Intelligence management. The staple information seems to be hours and location, sometimes supplemented with fuel consumption.

    “Today, TELEMATICS solutions provide a vast amount of data that can easily become overwhelming to Fleet Managers if they try to take it all on at once,” says David Greenlee, worldwide Fleet specialist for MIST & Associates. “It’s better for them to focus on two or three pieces of data that they use on a consistent basis and integrate those into daily operations. When they’re comfortable with the operational flow, they can focus on another set of data that will further benefit the fleet.”

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube 

    Maintenance Key Performance Indicators (KPI’s)

    Key Performance Indicators (KPI’s) are an important management tool to measure operations performance, and are often used to measure maintenance. Unfortunately, unlike operations, there are only a few real measures of maintenance that adds value to the operations.

    The problem is some of the measurements that are used are often easy to manipulate and have no real value added. Key Performance Indicators (KPI’s) are a small number of agreed-upon measurements that reflect your organization’s critical goals for success — a numerical snapshot in time. For maintenance KPI’s to be really effective they must be aligned with operating KPI’s and there objectives.

    Remember, KPI’s should only be one measurement technique in your arsenal. They can be a quick and useful tool to diagnose strengths and weaknesses in your process, make strategic decisions, and ensure you are heading in the right direction. The real benefit is in the discussion of results with your team members, not the numbers themselves.

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube 

    Seven Steps to Alarm Management

    The Seven Steps to Alarm Management

    Step 1: Create and Adopt an Alarm Philosophy

    A comprehensive design and guideline document that makes it clear “exactly how to do alarms right.”

    Step 2: Alarm Performance Benchmarking

    Analyze the alarm system to determine its strengths and deficiencies, and effectively map out a practical solution to improve it.

    Step 3: “Bad Actor” Alarm Resolution

    From experience, it is known that around half of the entire alarm load usually comes from a relatively few alarms. The methods for making them work properly are documented, and can be applied with minimum effort and maximum performance improvement.

    Step 4: Alarm Documentation and Rationalization (D&R)

    A full overhaul of the alarm system to ensure that each alarm complies with the alarm philosophy and the principles of good alarm management.

    Step 5: Alarm System Audit and Enforcement

    DCS alarm systems are notoriously easy to change and generally lack proper security. Methods are needed to ensure that the alarm system does not drift from its rationalized state.

    Step 6: Real-Time Alarm Management

    More advanced alarm management techniques are often needed to ensure that the alarm system properly supports, rather than hinders, the operator in all operating scenarios. These include Alarm Shelving, State-Based Alarming, and Alarm Flood Suppression technologies.

    Step 7: Control and Maintain Alarm System Performance

    Proper management of change and longer term analysis and KPI monitoring are needed, to ensure that the gains that have been achieved from performing the steps above do not dwindle away over time. Otherwise they will; the principle of “entropy” definitely applies to an alarm system.

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube 

    Achieving Reliability Centered Maintenance with OSIsoft Data Historian PI

    Reliability Centered Maintenance is a great approach to optimizing equipment performance and reliability. Its conception came from tragedy in the aviation industry that resulted in loss of life. After decades of reliability research in aircraft safety and equipment failure, the RCM process was born. Today, RCM2 is used in other industries worldwide but not to the same extent. Why? One of the challenges for implementing an RCM process is the cost and time it takes to implement.

    The initial process requires lots of resources or subject matter experts (SME) from operations, engineering and maintenance to review the operating context of the equipment being analyzed. A complex RCM analysis takes weeks to define the functional failure modes and effects, write and implement the preventive maintenance (PM’s) after the analysis is complete. Unfortunately some organizations do not have sufficient resources at its disposal for this type of commitment.

    To aid the SME’s and minimize their time together as a collective group, you should assemble a package for each participant in the analysis. Some examples of what I include are: written operating context, data from your EAM/CMMS system (including maintenance plans and calendar or hourly based scheduled preventative maintenance (PM)), any known failure frequencies, location and equipment hierarchy, type taxonomies, maintenance history, P&ID, applicable drawings that show ancillary equipment which may need to be added to this RCM or have a standalone analysis.

    The net result of this analysis will provide an accurate failure frequency and failure codes that will greatly improve your organizations overall maintenance strategies. Where most companies fail is the implementation of the process. The reason for this is the process itself is intended to be dynamic not static. Any dynamic process needs to have some form of feedback. The RCM process is no exception and any change in the operating context or equipment change requires the SME’s to revisit the RCM analysis for changes. This feedback loop is difficult to monitor and requires notification to the RCM facilitator to ensure its long term success.

    A proactive maintenance management team would also consider some predictive analytics or condition based maintenance when implementing the RCM’s. I recommend utilizing an OSIsoft PI system in conjunction with a remote diagnostic center to mitigate intrusive maintenance. Utilizing a non-intrusive maintenance strategy for implementing the RCM process will greatly reduce unscheduled shut downs and equipment failures.

    So where should you apply Reliability Centered Maintenance in your organization? Well there is no short answer but the best rule of thumb or industry best practices are simply where you need it. A great example on where to start is meeting regulatory compliance. Most industries today are trying to comply with some level of regulatory compliance where the fines for a violation could be costly for their company.

    Another example could be simply what equipment in your plant or facility needs the highest amount of reliability? By starting with the lowest hanging fruit, your organization will see the return on investment (ROI) that will offset the time and resources it took to implement a sustainable RCM2 process.

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube 

    Deploying a Maintenance & Diagnostic Centers

    Remote operation and monitoring of equipment via an integrated SCADA or DCS system is a fundamental concept of remote diagnostics. Historically most companies utilize their Control Center to manage all alarms and diagnostics.

    Unfortunately, most control centers are not staffed with personnel knowledgeable in equipment diagnostics as they are typically staffed with operations centric personnel dedicated for command and control.

    New equipment today can produce large amounts of information about the health/condition of equipment. For many organizations and departments it is not clearly understood how this vast amount of data can be managed and who has the accountability to take action.

    This is why companies today are developing standalone Maintenance & Diagnostics Centers to fill this gap. This allows a small team of SME’s to fully leverage the telemetry from these automated systems and gain meaningful actionable insight into the health of their assets.

    Initially, most organizations quickly see returns on their investment by increasing the time between failures and mitigating unscheduled shutdowns of equipment. Where most organizations fail today is the politics around deploying a centralized diagnostic center. Typically, this happens by not clearly articulating the different roles and responsibilities of the control center and the diagnostic center.

    HostGator Promo Code

    While this seems very fundamental it is the leading contributor to diagnostic centers failure. Typically organizations are so focused on solving a technical issue or overcoming a resource gap that they miss the internal political aspects of deploying a diagnostic center.

    One of the rubs that operations and maintenance will have to overcome is alarm management. While both organizations need to share accountability on some events and alarms their actions are very different.

    While most Gas & Liquid pipelines have adopted an alarm management philosophy to meet regulatory requirements they are the exception to the rule. A common alarm strategy is called a Documentation and Rationalization or D&R. This process forces maintenance and operations to assign and prioritize alarms. Typically, alarms are assigned to operations and events are assigned to maintenance and/or engineering.

    In today’s regulatory environment companies need to move past traditional Alarm Management and evolve to true Data Management as its core concept in managing automated/remotely operated equipment. Having clarity on roles will help an organization transition effectively and operate a highly reliable system while maintenance & engineering actively monitoring equipment at facilities for potential failures or shutdowns.

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube 

    Condition Based Maintenance

    Today’s technologies have opened the door to better equipment performance with the advent of data historians, better networks, faster processor speeds, and advanced algorithms. By integrating these technologies any company can leverage and monitor data more efficiently from a centralized location while increasing reliability and system integrity.

    With the advent of these technologies traditional calendar or hourly-based maintenance can be a wasteful practice. Seldom does a device or equipment actually require maintenance during a scheduled PM, thus making scheduled maintenance a wasted practice in many cases. During intrusive preventative maintenance failure catalysts are often introduced into properly working equipment resulting in shut downs and equipment damage.

    Many companies have developed some of these tools to not only reduce this type of intrusive and costly maintenance, but to perform this type of maintenance in much more efficient and cost effective manner.

    Adding condition based maintenance to your strategy as a maintenance practices will free up resources for corrective maintenance, training, etc. Automating Preventative Maintenance PM’s has clear measureable return on investments. Monitoring CBM
    S from a centralized diagnostic center augments your engineering and maintenance work force by levering current and historical data remotely.

    Most maintenance teams start with a pilot program on what they consider to be the low hanging fruit. The next logical step for most companies is to develop a diagnostic center once the effectiveness of CBM’s has been validated.

    Here are a few things to consider when developing a CBM strategy:

    • Monitor and respond to maintenance type events or alarms.
    • Assist Maintenance teams in trouble shooting locally or in the field.
    • Perform initial equipment diagnostics for Operations, Engineering, Maintenance, or other SMEs as needed.
    • Free up resources
    • To assist with troubleshooting and validating corrective actions.
    • To identify issues which may lead unintended shutdowns or equipment outages
    • Perform post mortem or root cause analysis on equipment failures
    • Achieve Reliability Centered Maintenance
    • Ensure regulatory compliance.
    • To inform and support management decisions
    • Align with organizations objectives

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube 

    Predictive Analytics Software

    What are Predictive Analytic and predictive modeling and how can industries benefit from them today? While both of these techniques can be applied in many different types of analysis our discussion will be around the benefits for plant and facility maintenance uses. First, let’s talk about what the differences are.

    Predictive analytic portal uses a variety of statistical techniques from equipment modeling to data mining so that current and historical data can be analyzed to make predictions about future equipment events or failures.

    Predictive modeling leverages patterns found in current and historical data to identify risks and opportunities. Models capture relationships among many factors to allow assessment of risk or potential failure associated with a particular set of conditions. These could be as simple as a loss of efficiencies or as critical as mechanical failure.

    Today, many of the main stream software companies today use both of these techniques in their software suites to access a variety of data point’s sources and apply a variety of mathematical and statistical formulas to discover the best decision for a given situation.

    While most software developer’s offer advanced predictive-analytic software for identifying impending equipment problems and avoiding shutdowns or equipment failure. The difference in today’s predictive software’s can vary on how they leverages existing data, the modeling and infrastructure needed to provide early and actionable warnings of impending problems.

    I recommend defining a long term strategy before choosing the software to deploy at your organization. Here are some examples that you should consider; improve your operations, optimize maintenance resources and procedures, maximize equipment performance, and avoid unexpected shutdowns and catastrophic failures, increase availability, ensuring regulatory compliance, reliability, and efficiency.

    Also recognize that every piece of equipment is unique, your organization may be challenged with aging equipment, internal technical resources, limited budgets and most importantly lack of vision. Having a clear vision and organization support is critical to any long term sustainability. All of these questions need to be defined before purchasing your predictive analytic software.

    Now that have a plan you can refine short list of software by functionality. Some examples are, do they create empirical models, does the software utilize templates for distribution across like assets, and does the software write its notification back to a data historian, Prophecy, PDH or OSIsoft PI System.

    At the end of the day your Predictive analytic software integration should give your company a competitive edge and improve the ROI, substantially and ensure integrity. Predicative analytical software is becoming the science that removes guesswork out of the decision-making process and applies proven scientific guidelines to find right actions in the shortest time possible.

    Darryl has over 30 years of experience in the pipeline industry. His responsibilities have included operations management, facility management, planning and scheduling, regulatory compliance, process program development, budget administration, and development of product-integration strategies and long-range best business practices.
    Darryl Hammond

    Twitter YouTube