Many organizations are currently facing increased pressure on IT spending. EHS compliance and Product Safety Stewardship processes are of necessary to maintain the compliance and regulatory needs. When companies are challenged by pressure to optimize spends how you can manage your EHS expenditure. What are the rules for identifying where to put your IT spend for meeting EHS requirements? The general guideline for IT spending for meeting EHS compliance programs include the regulatory framework which needs to be managed.

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Some of the regulations which are required to meet during current year include GHS implementation for Albania, Inventory program for Russia, in case of India, a draft safety rules have also been published. In Vietnam DG Road & In land waterways revision comes into force during the current year as well. Like that there are many regulations which are already published or in stages of feedback gathering stage. The other important regulatory implementation is in Europe for Poison center notification which requires products falling under the provision of Annexure VII required to be notified.  The due to date for Consumer and professional use fall on 1st Jan 2021. Similarly, SCIP database is another regulatory requirement which falls mid of year 2021. In this blog I would like to briefly summarize the IT requirements from these regulations and other compliance needs and how to achieve the business need to manage operational continuity.

Now coming to the IT requirements for meeting such regulatory needs, many compliance requirements needs Product Stewards in compiling the information from multiple sources and harmonizing the same if needed and amend the labels or chemical information as required. For Poison center notifications the information needs to be submitted to member state bodies. The format is XML based and defined by requirements laid out in annexure VIII of the CLP regulation. The regulation requires industry to submit Full chemical compositions, toxicological, intended use and Unique Formula identifier.  It is industry obligation to generate the UFI based on company VAT and mixture specific formulation number.

Though many companies already use internal numerical formulation numbers which might be used and if those are alphanumeric it needs adoption. Details about the regulation can be found in ECHA website. Now coming to the IT spend requirement, industries needs to invest in this regulation management like amending the existing label documents for UFI changes to generation of UFI via ECHA online bulk generation by csv upload and pulling of XML format data from existing systems for uploading to ECHA. Such System to System service functionality enables users to generate PSN dossier directly in own systems and exporting IUCLID compatible PCN format. An API specification is provided which can be used to generate the automation.

When it comes to SCIP, it requires companies supplying articles containing substances of very high concern on the candidate list in concentration above 0.1% weight by weight. The purpose of SCIP database is to ensure substance information to be available throughout the lifecycle of the products and materials. ECHA defined a XML schema for the submission and guidance as well. Now coming to System to system service it consumes REST services exposed by ECHA site. Details about the same is also defined in the ECHA guidance documents.

For both the scenarios of ECHA Poison Centre notification & SCIP, if you want to indigenously develop a tool internal to your organization, you might investigate similar processes provided by the software for some other requirement like ESDS XML shipment etc. There are also 3rd party organizations who provide these developed tools for pulling the information.

Other compliance programs which requires IT involvement include the validation or Change Management practices for Raw material changes. Though it seems like a normal practice of replacing the existing chemical supplier with a new supplier. The process about such Raw Material Introduction Procedures are quite complex and needs a careful assessment. They require different validations for managing the change. If such raw materials are of Active Pharmaceutical Ingredients, it is even more challenging in assessing the ingredient. Like those needed to be validated for many parameters like physical characteristics, purity levels and even dust generation capability etc.

Details about such requirements can be checked with FDA guidance documents on Management of Change of Chemicals for APIs.  With increased disruptions in the supply chains there are many requirements around the world to validate new sources and involvement of IT for creation of tool to support rapid changes are in high demand. Similarly notification change management or status evaluation is also of interest since new supply partners are sought.

Other Compliance requirement for meeting the Operational Compliance include the setup of personal monitoring devices for body temperature, violations of physical gatherings and screening of people in various locations. Such requirements need implementation of thermal scanners and logging of information for any deviations and other screening information. Though it might seem that manual monitoring would be sufficient for such screening, there are increased requirements from many sectors for development of tools which can automatically flag deviations and log the information and necessary communication set up.

The other kind of IT investment in this space is around the worker health monitoring devices and body measurement devices and corresponding analysis. It also needs a detailed analytical report development or dashboards.

The significant compliance requirement is around workplace sampling systems set up, health management tools. Many organizations around the world are working on setting up of Workplace sampling systems for measurement of chemicals and dust in their immediate vicinity. Increased awareness of such analysis of dust samplers is due to the hypothesis that COVID – 19 viruses can stick to dust particles and can travel in air and can impact the people health.

There is also heightened awareness around use of automation projects for compilation of manual tasks and it might be use of simple streamlining of processes or even setting up of RPA. Though business process reengineering type of process alignment are not considered for current scenario. Only automating and streamlining the existing processes with existing tools is what is being checked by industries around the world. Details about regulatory requirements and product compliance requirements and regulatory bodies directives can be checked by checking respective regulatory sites. The details about EHS requirements for meeting restarting the economy can be analyzed by looking at the playbooks published by major organizations. You can check even my previous blog on Recipe for Going digital in current scenario for EHS Digital Transformation for more on chemical investments industries are planning for EHS space.

To conclude you might find that many organizations work directly with consultants as an extended team member instead of generating a heavy budget projects to meet these kinds of projects which have regulatory or compliance needs. If you are skill full in one those areas or have an innovative software or technological product which suits to current requirement you might infact tap a great opportunity.

Thanks

Jayakumar

 

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