M&TE calibration has been historically the prerogative of the pharmaceutical industrial sector, due to the relevant pressure brought by regulatory constraints (FDA) and international recognized standard guidelines (GAMP, ISPE and others); such constraints and guidelines have forced all the Pharma organizations not only to adopt “systematic practices” (methods, rules and processes) but in many cases to adopt and implement dedicated information systems in order to support relevant operations scope, guarantee correct behaviors and certify the measurement accuracy.
In the last years, some other industrial sectors (primarily Petrochemical but also E&U and T&T) had to face the metrology scope with greater focus, answering to always growing efficiency targets, higher HSE pressure and, last but not least, the increasing technology digitalization of the assets they utilize on a daily basis. These organizations probably do not have the same tough and deep regulatory constraints typical of the Pharma sector, but they have the chance to inherit its experience, in order to achieve the objectives above mentioned, avoiding since the beginning the mistakes, the difficulties and the frictions that the Pharma world has had to endure:
-Standardization: the goal is to instill a “normalized” culture within the organization, to ensure that processes and methods are shared, accepted and put into practice by all. >How is it possible that in order to achieve the same goals, there is a tendency to think about, design, plan and deploy different processes, rules and protocols within the same organization (or within different organization which essentially do the same business) ?
-Inverse traceability: the goal is to be able to reliably trace back to the metrological standards adopted during the M&TE calibration procedures, in order to ensure a correct impact evaluation and the relative timely actions, if the measurements detected deviate from the standards.
>How is it possible that this concept, clear in theory to all, can be fully and correctly implemented by a few? -Referability chain: the goal is be able to correlate and above all contextualize all the production aspects about the assets where the M&TE is used, with all the relevant and consistent documentary elements (such as SOPs, operating range, tolerance, metrological standards, …) > Being understood the complexity of such a goal, how is it possible that very frequently the organizations trivialize the approach, simply limiting themselves to refer to generic “technical sheets” (often provided by the equipment or M&TE manufacturer or vendor) or, worst, even more generic “standard practices” (eventually reported in separate documents, somewhere, within the organization).
-Over-Compliance: this concept refers to the tendency to always equip with “top of technology” metrological tools, relying on the fact that their maximum precision and accuracy can somehow mitigate complexity and risks, even in the absence of exhaustive processes and methods. Unlikely, the more sophisticated the instruments are, the more complex and costly their calibration can be, often requiring interaction with specialized centers (not necessarily available at local level).
> How is it possible to accept (and suffer) truly stringent operational and economic constraints (directly coming from “top technology” approach), while not trying to approach the calibration scope in a more systemic and controlled way?
-Third Parties Involvement: very frequently, calibration services are outsourced to specialized third-party companies; such a situation adds a further “coordinate” in the complexity matrix above described, considering how management of data, processes fruition, contractual rules, SLAs or simply communications have to be consistently and timely guaranteed, and also taking into account how an increasing information spread leads risks in terms of data-privacy, security and integrity.
> How is it possible to accept unsecured and manual information flows between the organization and its service providers, with potential governance loss, technical incompliance, contractual inconsistency and data processing irregularities?
-Auditability: organizations plan and run periodic inspections/controls (internal driven or conducted by third parties), in order to verify the “goodness” of the entire calibration ecosystem (organizational aspects, as well as operational and logistical processes, end-to-end); such events bring about a pressing data demand.
>How is it possible that recovering and cross-referenced time-based historical data is always a nightmare, and that often forces you to take refuge in the preparation of dedicated electronic sheets, with all the risk of errors and inconsistency that this approach entails?
The answer
Maximo, with the depth of its functionalities, designed on the best practices of the market in 25+ years of presence and leadership in the O&G sector, and also thanks to its great flexibility, is able to help companies to meet the specific needs of the their sector, facilitating them to find adequate answers to the questions we have listed.
-the Workflow lets you design and implement every single process, complying with any specific requirement, facilitating the automation and the traceability of events, actions and behaviors (whether they refer to technical, regulatory, management or contractual aspects)
-the Asset & Item Calibration features let you to handle the registration, the configuration and the inventory of the metrological instruments (whether they are used in Production, as Standards or as Reference Standards)
-the Resource Qualification functions let you define specific rules for the involved resources assignment, to ensure that only trained and qualified technicians can operate on calibration aspects
-the Preventive Maintenance and Calibration DataSheet functions let you define and plan the calibration protocols and their instantiation rules
-the Calibration WorkOrders let you track the technical execution of all calibration activities, facilitating the protocols results collection and the final balance of activities from a management point of view
-the Escalation and Notification features let you regulate and automate rules, controls and communications between all the actors involved in the operations (whether internal or external)
-various Analytics and Reporting tools natively made available let you monitor in real-time the activities progress, notifying anomalies or findings, as well as facilitate data demand generation in case of inspections or audits.
Maximo is quite well known in the O&G market, since a long time and with a very significant market share, as certified by the analysts view, year over year. When facing incoming constraints, pressures and impacts due to the metrological scope, Maximo can nimbly extend its traditional Enterprise Asset Management perimeter, allowing higher efficiency, more clear ideas, overabundance of information protection, over-compliance risk and cost mitigation, with a complete but agile, consistent and effective approach, without coarse clustering….
with Maximo, it’s possible.
