Post By :- admin Date:- July 4, 2017
Enterprise Asset Management (EAM) software plays an important role to ensure consumer and workplace safety. Manufacturing companies must closely monitor and Calibrate their equipment and processes. This is particularly important in industriessuch as pharmaceuticals, oil & gas, nuclear, energy, and consumer products where failureto meet regulatory requirements can not only delay getting products to market, but canalso result in fines, plant closings, and lost revenue.
Calibration of the equipment, instruments, and processes used in manufacturing isessential in achieving the high-level of precision required by regulatory agencies like theFood and Drug Administration (FDA) and the International Organization for Standardization(ISO). The FDA’s submission guidelines for pre-market notifications require companies todocument how they perform, trace, and achieve consistency with equipment and instrumentcalibration. This documentation helps companies meet current good manufacturingpractices (cGMP) for quality and safety.
Calibration Tools Unmatched in the Industry
Customers no longer have to maintain two separate systems—one for EAM and anotherfor calibration—enabling them to save administrative and training costs.The Calibration module in EAM fully supports the highest level of compliance requirements forcalibration processes, reporting, and equipment. The module goes hand-in-hand with workmanagement, preventive maintenance, and other functions, as well as fully supports thesecurity of electronic records and signatures. The calibration module also offers the timesavingand convenience of mobile hand-held electronic devices. With easy-to-use screens andmenus, the EAM Calibration module enables customers to:
>Become more efficient
- Use a single system for both EAM and calibration
- Schedule and execute calibrations for processes, systems, and instruments,including instrument loops
- Standardize and manage calibration information and procedures
- Maintain Original Equipment Manufacturer (OEM) supplier data, tolerance levels,and current specifications
- Calibrate dual unit of measure devices
- Perform calibrations and log results remotely using handheld devices
>Anticipate, rather than react
- Enact remedial plans for out-of-tolerance equipment
- Integrate calibrations with asset, work management, and other enterprise systems
The Calibration module features unsurpassed capabilities, including:
Calibration Preventive Maintenance: With Enterprise asset management software, each piece of equipment can bedesignated as a unique asset that resides within an organization. Calibration preventivemaintenance (PM) can be established to generate calibration work orders for equipment.Each calibration PM contains instructions, approved procedures, OEM specifications, andprocess control limits for performing the calibration. Companies can set up calibration PMbased on calendar days, accumulated usage determined by best practices, ormanufacturer recommendations. EAM also includes acalendar tool to aid in future maintenance work order planningand resource needs. The Work Management modulehelps plan and organize employee work schedules.
Traceability:Traceability is critical for best practices in calibrationmanagement. If a calibration standard is found to be incorrect,EAM allows users to quickly determine which instrumentswere mis-calibrated. Identifying the standard’s last “good”calibration is critical to effectively segregating potentially affectedproducts. The Calibration module allows users toperform this reverse traceability.
Tracking Calibration Results Proper calibration procedures requiretracking calibration results and variances between actual conditionand standards established by the manufacturer, internationalstandards, or internal best practices. Calibration records must showproper resolution or degree of accuracy for the results. EAM can tracks results, including calibration sequences, test point data, tolerances, processcontrol limits, “As Found” results, “As Left” results, action taken, and calibrationstatus. The calibration work order is linked to a particular piece of equipment, allowingfor easy cost roll-up and historical tracking of all equipment information based onparent equipment, department, or organization. In EAM we can also tracks corrective actionprocedures and root-cause analysis related to out-of-tolerance work orders.
Calibration History and Reports:Each time a user performs a calibration, EAMautomatically stores the data. Users can search and view all calibrationresults for a selected piece of equipment by equipment class, department, or date range.Data can be directly exported to spread sheets or the Discoverer reporting tool forongoing analysis and reporting. EAM provides a wide array of standard calibrationreports, including frequency, date of last calibration, and the next scheduled calibration.Calibration records and reports prove that a company maintains procedures for performingcalibrations in a timely fashion. Regression analysis of results leads to a proactive approachto calibration, ensuring quality and consistency with critical business processes.
With the Calibration module, customers can:
>Maintain calibration histories to trace changes as well as audit for compliancewith strict quality guidelines set by the FDA, ISO and other agencies
>View and record calibration results and generate a wide range of advancedreports, including reverse traceability, to assist in determining the calibrationstandards used and increase consistency andaccuracy.
>Eliminate complex, manual reviews of paper calibration documentation andproviding quicker access to data through standard reports and the ability toeasily export data into Microsoft Excel
>Track changes to calibration records and be prepared for internal andgovernmental audits
>Maintain electronic records and signatures to track electronic updates and approvals