ISO 9001:2015 standard is based on PDCA (Plan – Do – Check – Act) approach. Effivity also follows the same cycle. After planning phase wherein you define and establish your QMS & provide resources, it is time to act. Operations module of Effivity allows an organization to capture all documented information about products & services they deliver to the customer.
Operations module of Effivity ensures you meet various requirements across the standard applicable to product/service/projects in an effective, efficient and simple manner. Below steps demonstrate capabilities of this module and how you can comply with requirements with respect to operations related clause of the standard:-
An intelligent module level home page welcomes user to the module with all compliance options available in the module on left side menu. This home page shows quality objectives for the department, available / recently changed documents, real time graphical analysis on the basis of data / information captured in the system, alerts for pending tasks, quick links for common / regular tasks etc. Module level help is also given at appropriate places.
1. Define the raw materials / products / consumables / services you purchase so that you can control them effectively in purchase module. In quality module, you can define incoming inspection quality plan and incoming inspection quality records for these raw materials / products / consumables / services.
2. Define the product/services/projects for the organization. All of your project/service/production/execution planning will be for the products / services you define here. Effivity also allows you to define in process/final inspection quality plan and in process/final quality records in quality modules for these products / services / projects.
3. Users can raise internal work orders by providing details of work order and responsible person for work order execution.
4. Establish operation planning for each product/service/project by defining processes and resources required. This is important in capturing the product/service/project acceptance/performance criteria at a macro level. Looking at this for each product/service/project company delivers, a high level quality plan can be established.
5. One of the 7 quality management principles is Process Approach. The better we define and manage various processes in an organization, better are chances of deviation free output. This module allows user to determine and define process by defining input, Procedure / work flow, output, responsibility & accountability, resources required, process effectiveness measurement parameters and risks associated with the process. If any processes are outsourced, user can define them as outsourced process and further controls can be established to ensure performance of outsourced service providers is monitored effectively.
6. Risks / opportunities identified and associated with each process will be automatically shown in Risk and Opportunity module where user can take actions to address them effectively.
7. Some processes in the organization may be special processes wherein resultant output cannot be verified by subsequent monitoring & measurement until product is delivered or used. You can identify and control these kind of special processes which needs process validation in this module. All validation and revalidation information about special processes are addressed by this module.
8. On the basis of internal work order or customer work order, Effivity allows the user to plan for execution against work order. 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 Hassel free. Don’t miss any calibration dates as 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 capturing date, work done and uploading relevant calibration certificates if any for future traceability.
10. Maintenance of assets / equipment directly adds to profitability and timely delivery. Effivity allows an organization to capture all equipment used by the organization for effective asset management. Once equipment is created in the system, user can schedule the equipment for preventive maintenance by defining preventive maintenance plan. System will generate alerts for users so that you never miss any scheduled maintenance activity. On the basis of actual preventive maintenance, users can update and capture details for specific preventive maintenance completed. In case of any breakdown of equipment, you can capture all relevant details of breakdown, date, time, actions taken, root cause, corrective actions etc. System also allows you to calculate total time lost in the organization due to breakdown.
11. In case of damage to any physical / intellectual property owned by customer / supplier but currently in possession of the organization, can be captured as per the requirements of the standard. Further actions can be taken for these kind of deviation as per non conformity module of the software.
12. Performance evaluation of operations and processes is critical to identify improvement opportunities in an organization. Effivity allows an organization to monitoring and measure various parameters / indicators by defining what to monitor, how to monitor and when to monitor. It also allows to capture tracking against each parameters.
13. Procedures and forms related to Operation can be captured in documented information module.
14. Users can also define various quality objectives, add plan to achieve objectives and track objectives for achievement.
Comprehensive capabilities of this module enables all the requirements pertaining to operations of an organization to be addressed in a quick and simplified manner while ensuring 100% compliance to ISO 9001:2015 standard. Contact us at info at effivity.com for further information or visit www.effivity.com to subscribe to our award winning and one of its kind of ISO 9001 compliance software.