Activity

  • US FDA Quality Metrics Guidelines Update

    Jim Cahill
    Author: Eric Kuebler Since the Continued Process Verification (CPV) guidance in 2011, the U.S. Food and Drug Administration (FDA) has been talking quality and verifying process state of control. Now the FDA is getting around to defining what that looks like and what data they want to verify quality. However, the FDA’s push is leaving more questions than answers about what specific date they need, how they will…

  • Conference Room Pilots to Generate Involvement in MES Projects

    Jim Cahill
    Author: Jonathan Lustri As a Life Sciences consultant , I get involved in many different aspects of MES [manufacturing execution system] projects. In a recent project, I helped define the project execution plan. I knew Emerson’s biotech customer was highly concerned about the overall usability of the solution design as well as the acceptance of the solution by the operators. In this particular case, the Syncade…

  • Conference Room Pilots to Generate Involvement in MES Projects

    Jim Cahill
    Author: Jonathan Lustri As a Life Sciences consultant , I get involved in many different aspects of MES [manufacturing execution system] projects. In a recent project, I helped define the project execution plan. I knew Emerson’s biotech customer was highly concerned about the overall usability of the solution design as well as the acceptance of the solution by the operators. In this particular case, the Syncade…

  • Conference Room Pilots to Generate Involvement in MES Projects

    Jim Cahill
    Author: Jonathan Lustri As a Life Sciences consultant , I get involved in many different aspects of MES [manufacturing execution system] projects. In a recent project, I helped define the project execution plan. I knew Emerson’s biotech customer was highly concerned about the overall usability of the solution design as well as the acceptance of the solution by the operators. In this particular case, the Syncade…

  • Conference Room Pilots to Generate Involvement in MES Projects

    Jim Cahill
    Author: Jonathan Lustri As a Life Sciences consultant , I get involved in many different aspects of MES [manufacturing execution system] projects. In a recent project, I helped define the project execution plan. I knew Emerson’s biotech customer was highly concerned about the overall usability of the solution design as well as the acceptance of the solution by the operators. In this particular case, the Syncade…

  • Conference Room Pilots to Generate Involvement in MES Projects

    Jim Cahill
    Author: Jonathan Lustri As a Life Sciences consultant , I get involved in many different aspects of MES [manufacturing execution system] projects. In a recent project, I helped define the project execution plan. I knew Emerson’s biotech customer was highly concerned about the overall usability of the solution design as well as the acceptance of the solution by the operators. In this particular case, the Syncade…

  • Reducing Communications Problems during Shift Changeovers

    Jim Cahill
    Sources of unplanned downtime can be many including equipment failures and human error. For downtime resulting from operator interactions, one major source of errors is the communications breakdown that sometimes happens during a shift change. If not told or seen in captured notes and observations, the incoming operators may lack visibility to the key tasks and priorities to keep the process operating in a stable manner…

  • Reducing Communications Problems during Shift Changeovers

    Jim Cahill
    Sources of unplanned downtime can be many including equipment failures and human error. For downtime resulting from operator interactions, one major source of errors is the communications breakdown that sometimes happens during a shift change. If not told or seen in captured notes and observations, the incoming operators may lack visibility to the key tasks and priorities to keep the process operating in a stable manner…

  • Reducing Communications Problems during Shift Changeovers

    Jim Cahill
    Sources of unplanned downtime can be many including equipment failures and human error. For downtime resulting from operator interactions, one major source of errors is the communications breakdown that sometimes happens during a shift change. If not told or seen in captured notes and observations, the incoming operators may lack visibility to the key tasks and priorities to keep the process operating in a stable manner…

  • Reducing Communications Problems during Shift Changeovers

    Jim Cahill
    Sources of unplanned downtime can be many including equipment failures and human error. For downtime resulting from operator interactions, one major source of errors is the communications breakdown that sometimes happens during a shift change. If not told or seen in captured notes and observations, the incoming operators may lack visibility to the key tasks and priorities to keep the process operating in a stable manner…

  • Reducing Communications Problems during Shift Changeovers

    Jim Cahill
    Sources of unplanned downtime can be many including equipment failures and human error. For downtime resulting from operator interactions, one major source of errors is the communications breakdown that sometimes happens during a shift change. If not told or seen in captured notes and observations, the incoming operators may lack visibility to the key tasks and priorities to keep the process operating in a stable manner…

  • Prototype Manufacturing Operations Management Projects

    Jim Cahill
    The post Prototype Manufacturing Operations Management Projects appeared first on the Emerson Process Experts blog. The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and workflows. Click to enlarge . At the…

  • Prototype Manufacturing Operations Management Projects

    Jim Cahill
    The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and workflows. Click to enlarge . At the base, level 1 involves the instrumentation and final control elements that drive the process. Level 2 includes monitoring…

  • Prototype Manufacturing Operations Management Projects

    Jim Cahill
    The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and workflows. Click to enlarge . At the base, level 1 involves the instrumentation and final control elements that drive the process. Level 2 includes monitoring…

  • Prototype Manufacturing Operations Management Projects

    Jim Cahill
    The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and workflows. Click to enlarge . At the base, level 1 involves the instrumentation and final control elements that drive the process. Level 2 includes monitoring…

  • Prototype Manufacturing Operations Management Projects

    Jim Cahill
    The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and workflows. Click to enlarge . At the base, level 1 involves the instrumentation and final control elements that drive the process. Level 2 includes monitoring…

  • Continued Process Verification in the Process Validation Lifecycle

    Jim Cahill
    The post Continued Process Verification in the Process Validation Lifecycle appeared first on the Emerson Process Experts blog. In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices . It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state…

  • Continued Process Verification in the Process Validation Lifecycle

    Jim Cahill
    In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices . It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the…

  • Continued Process Verification in the Process Validation Lifecycle

    Jim Cahill
    In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices . It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the…

  • Continued Process Verification in the Process Validation Lifecycle

    Jim Cahill
    In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices . It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the…

  • Continued Process Verification in the Process Validation Lifecycle

    Jim Cahill
    In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices . It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the…

  • RFID Tagging for Materials Movements

    Jim Cahill
    Some of the technologies making the Internet of Things (IoT) possible include WirelessHART , radio-frequency identification (RFID) , near field communication , barcodes , QR codes and digital watermarking . I mention this because many process operations... Read the full text.

  • RFID Tagging for Materials Movements

    Jim Cahill
    Some of the technologies making the Internet of Things (IoT) possible include WirelessHART , radio-frequency identification (RFID) , near field communication , barcodes , QR codes and digital watermarking . I mention this because many process operations require material movements via truck, rail, ship and other discrete forms of transportation. The operations to track these movements have historically been done with…

  • RFID Tagging for Materials Movements

    Jim Cahill
    Some of the technologies making the Internet of Things (IoT) possible include WirelessHART , radio-frequency identification (RFID) , near field communication , barcodes , QR codes and digital watermarking . I mention this because many process operations require material movements via truck, rail, ship and other discrete forms of transportation. The operations to track these movements have historically been done with…

  • RFID Tagging for Materials Movements

    Jim Cahill
    Some of the technologies making the Internet of Things (IoT) possible include WirelessHART , radio-frequency identification (RFID) , near field communication , barcodes , QR codes and digital watermarking . I mention this because many process operations require material movements via truck, rail, ship and other discrete forms of transportation. The operations to track these movements have historically been done with…

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