Operations

The ISO 9001:2015 standard is based on a PDCA (Plan – Do – Check – Act) approach. Effivity follows the same cycle. After the planning phase wherein you define and establish your QMS and provide resources, it is time to act. The Operations module of Effivity allows an organisation to capture all documented information regarding products and services they deliver to the customer.

The Operations module of Effivity ensures you meet the various requirements across the standard applicable to products, services and projects in an effective, efficient and simple manner. The steps below demonstrate the capabilities of this module and show how you can comply with the requirements relevant to the operations related clauses of the standard.

1. Define the raw materials, products, consumables and services you purchase so you can control them effectively in the Purchasing module. In the Quality module, you can define incoming inspection quality plans and incoming inspection quality records for these raw materials, products, consumables and services.
2. Define the product, services and projects for the organisation. All of your project, service, production and execution planning will be for the products and services you define here. Effivity also allows you to define in process and final inspection quality plans, and in process and final quality records in the Quality modules for these products, services and projects.
3. Users can create internal work orders by providing details of the work order and the person responsible for work order execution.
4. Establish operation planning for each product, service and project by defining the processes and resources required. This is important when capturing the product, service, project acceptance and performance criteria at a macro level. Looking at this for each product, service or project provider ensures that a high-level quality plan can be established.
5. One of the 7 quality management principles is the Process Approach. The better we define and manage various processes in an organisation, the better our chances are of deviation-free output. This module allows users to determine and define a process by defining the input, procedure, workflow, output, responsibility and accountability, resources required, parameters used to measure process effectiveness and the risks associated with the process. If any processes are outsourced, users can define them as outsourced processes and further controls can be established to ensure the performance of outsourced service providers is monitored effectively.
6. Risks and opportunities identified and associated with each process will be automatically shown in the Risk and Opportunity module where a user can take action to address them effectively.
7. Some processes in the organisation may be special processes wherein resultant output cannot be verified by subsequent monitoring and measurement until the product is delivered or used. You can identify and control these types of special processes and implement process validation in this module. All validation and revalidation information regarding special processes are addressed in this module.
8. Based on an internal work order or a customer work order, Effivity allows the user to plan for process execution against the work order. The user can identify and capture process level planning here.
9. Effivity makes management of calibration or control of monitoring and measurement resources easy, flawless and hassle-free. Don’t miss any calibration dates as the software allows you to schedule the equipment for calibration and gives you alerts when it is due. You can update the calibration details of equipment after calibration by recording the date and work done and uploading relevant calibration certificates (if any) for future traceability.
10. Maintenance of assets and equipment directly adds to profitability and timely delivery. Effivity allows an organisation to capture all equipment used by the organisation for effective asset management. Once the equipment data is created in the system, users can schedule the equipment for preventive maintenance by defining a preventive maintenance plan. The system will generate alerts for users, so you never miss any scheduled maintenance activity. Based on actual preventive maintenance, users can update and capture details for the specific completed preventive maintenance. In case of any equipment breakdown, you can oversee all relevant details of the breakdown, date, time, actions taken, root cause, corrective actions, etc. The system also allows you to calculate total time lost in the organisation due to breakdowns.
11. In case of damage to any physical or intellectual property owned by a customer or supplier but currently in possession of the organisation, the details can be captured as per the requirements of the standard. Further action can be taken for this kind of deviation as per the Non-Conformance module of the software.
12. Performance evaluation of operations and processes is critical to identify improvement opportunities in an organisation. Effivity allows an organisation to monitor and measure various parameters and indicators by defining what to monitor, how to monitor and when to monitor. It also allows users to capture tracking against each parameter.
13. Procedures and forms relating to operations can be captured in the Documented Information module.
14. Users can also define various quality objectives, add plans to achieve objectives and track objectives for achievement.
15. Users can define KPIs – Key Performance Indicators for various business units, departments, processes and track achievement with the KPI sub module of the software.
16. Users can initiate a change using Change Management sub-module. Collaborate on the change, identify risks and opportunities related to the proposed change, impact on other processes, get it approved and execute the change in a controlled environment.

The comprehensive capabilities of this module enable all requirements pertaining to the operations of an organisation to be addressed in a quick and simplified manner while ensuring 100% compliance with the ISO 9001:2015 standard. Contact us at info@effivity.com for further information or visit ISOCertification/Register.htm to subscribe to our award winning and one of a kind QMS software.