Modules

Document Control is the heart of any Quality Management System. Process traceability and record control are as critical for regulatory compliance as for internal compliance. Part of being compliant to international standards like ISO 9001, API Q1 and AS9100. The OEMS document control application lets you create add/ change document request, assign approval authority, attach files of any size or type, and create limitless workflows to route documents through the review and approval. The document will not be released to public unless it’s approved and signed off electronically by the approval authority, it also features a comprehensive change request workflow, to ensure that changes to documents follow proper change procedures. Document Control Application can be linked to the Training Application to maintain required objective evidence that the new document is communicated and understood. You will be surprised with the amount of data that you can navigate just from your document control application, as you know from document control, you can hit every single element in the management system, from the applicable location information, assets to employee’s competence and Qualifications. The OEMS also provide you with an option to maintain the library for customers, suppliers, and international standard specifications.

Critical Changes Always associated with potential risk, all risk-based industries and applicable international standard require you to identify mitigation plans associated with those risks to acceptable levels, not only that, but you also need to assess associated risks before and after implementing those changes. changes could be internal (QMS Change, EMS Change, OH&S Management System Change, Key Personnel Change, Design change, equipment change and change in Key Suppliers) or External Changes like (Legislation Change, and Economic Environment change). Our application is designed to manage these changes and eliminate/ reduce associated risks

• Manage the Change Management process from the beginning until the end
• Reduce cycle time for Managing Changes by making sure that all relevant information is sent to responsible individual(s) on scheduled times in a predetermined way
• Reduce cost of Change Management by running changes in parallel
• Contingency planning for any event that might affect your delivery and/or Quality
• Link quality activities to change management
• Provide workflows to assure collaboration of cross-functional teams
• Assess risks and opportunities for initiating certain changes through Risk Register application
• Link to other areas of the business to determine impact of changes
• Initiate action plans based on change type
• Integration with the Document Control application

The Training Management application is an essential Quality Solution that provides:

• Simplified Training Records
• Assign Training to individuals and groups
• Send reminder for expired training
• data collection and representation for the training data including assigned training hours
• paper-free records and forms consolidations
• electronic signatures
• connected to employee profile
• Quality-focused training management on specific policies, processes, and procedures to ensure compliance to international standards
• visibility for multiple-site and complex organization to identify training that is due, and training conducted as planned.

It’s important to have complete visibility and control over the auditing process, whether its an internal, supplier, process, compliance, and/or certification audit

while streamlining the scheduling, assigning, executing and reporting phases. Smart organizations are looking for ways to replace inefficient and error prone manual audit processes with automated audit management systems. Our system is connected to the CAPA application so you can navigate audit plan, audit results, CAPA assigned, status of those CAPA and prevent any undue delays for closure.

We automate the calibration and maintenance schedule and report all records electronically, you will have a visibility for your maintenance plans and calibration schedule for your multiple site/ complex organization, also the system will send an automated notifications for any upcoming activity that might be due.

• Manage the complete life cycle of calibration devices and monitoring and measurement equipment.
• Schedule calibrations and maintenance based on usage, time or other factors identified by the organization
• Define calibration plans with pass/fail criteria
• Define maintenance plans that track it by equipment, equipment family and/ or facility
• Report multiple maintenance records for various equipment on one single maintenance record
• Maintained asset maintenance log for each single asset in your organization
• Easily transfer asset from one location to another by your fingertip

Ensure finished product quality with automated control and visibility over all elements of your supply chain, from local manufacturers to global suppliers. The OEMS provide you with process for from, identification of supplier, identify specific criteria for evaluation and re-evaluation, not only that, we also provide a built-in KPI’s that track the supplier performance related to safety, Quality and delivery, It send notification to you and the supplier for any certifications that will be expired to ensure compliance all the time with the international standard requirement.

Our built-in dashboard keeps you track of supplier performance.

Thew system enhance your supply chain by:

• Measure, evaluate and improve supplier performance to enable companies to make informed future sourcing decisions
• Manage scorecards that contain both qualitative and quantitative elements each with its own percentage weight
• Maintain your Approved Supplier List, Scope of approval, approved product/ services, even supplier’s site specific
• Automatically update critical supplier metrics
• Integration with Suppliers, Materials and Chemicals, Receiving and Inspection, and Supplier Corrective Action (SCAR) and audits

Nonconformance Reporting manages the review and disposition of any production materials that do not conform to normal specifications.

• Provides a tool to effectively manage the assignment, timeliness, and history of the nonconforming materials process
• Ensures that any out of specification conditions are visible
• Enforce review and approval workflows, with timeliness tracking
• Integrates with Corrective Action (CAPA) and Supplier Corrective Action (SCAR) for investigation and resolution
• Integrates with Risk management tools to assess the risk of the non-conformance
• Integrates with Deviation Planning to track deviations from the standard process
• Integrates with 3rd party systems (e.g. SAP, Oracle)
• Provide you with Dashboard to show your organizational performance, identify your area weaknesses, nature of defects, immediate causes and root causes, this system is designed with highly hand-on and experienced personnel
• It tracks all returns that occur within a company. It allows users to identify the reason for return, material that needs to be returned, and quantities to be returned. Users can generate non-conformance and other workflows that link directly to the original return.
• Integrate with 3rd party systems (e.g. SAP, Oracle)

Invaluable customer feedback and complaints can be integrated into the CAPA handling process to enable a closed loop of continuous improvement.

Think about it, when you request a survey

• Manage customer profiles, investigate, and act on customer feedback including complaints
• Integrates with Corrective Action (CAPA) for investigation and resolution
• Integrates with risk management tools to surface risks along with identifying the actions needed to minimize the impact of a risk and prevent it from occurring
• Provide you with Dashboard about the data coming from customer survey and do the analysis for you
• Integrates with Complaint Handling for investigation, correction, and regulatory reporting
• Integrates with other ERP or business management systems

Accidents and Safety reporting provides a central location where all incidents and accidents are recorded and investigated, and actions are taken to reduce the chance of recurrence. It provides you with a complete dashboard about safety incidents. This system is wonderful for multi-site complex organization as it enhances your business by details analysis for safety incidents and appropriately link your CAPA application. It can generate safety reports that can be submitted to agencies like OSHA with ready templates for OSHA 300, 301 300A forms and more. The tool initiates incident reporting by recording incident details, including witness statements and external resources involved, creating reports to notify external agencies using MS Office templates, and automatically launching corrective actions.

• Set up records of all incidents/accidents and collect the required information to conduct investigations, including a risk analysis
• Report incidents by location, cost, nature, severity, location, cost, affected body parts, and lot more.
• Integrates with Corrective Action (CAPA) for investigation and resolution

Job Hazard Analysis (JHA) provides a proactive approach to job-related risk mitigation and controls. This tool breaks down a job into its various operational steps. JHA then analyzes each step for potential safety hazards, identifies any associated hazards, analyzes the risk of the hazard occurring, and determines preventive measures. Analyze and identify job hazards before they occur and eliminate or reduce risks to an acceptable level by putting the right controls into place.

• Performing workplace hazard identifications and assessments in a systematic manner for each individual occupational task
• Manage and reduce risks by defining risk assessment methodologies and assigning controls
• Use the Mobile App to complete assigned tasks, even disconnected from the network
• Report JHA status by location, area, and cell
• Dashboard for actions taken and actions that are still in progress.

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The OEMS – Designed to Amaze (c), AMG Quality Services LLC, and its affiliates, assigns, and licensors. All rights reserved. ASE Smart Solutions LLC is a sister company of AMG Quality Services LLC.

The OEMS – Designed to Amaze is a trademark of AMG Quality Services LLC. Trademarks may be registered in some jurisdictions. All other trademarks are the property of their respective owners. Portions (c) 2018, AMG Quality Services LLC. No claim to copyright is made for original U.S. Government Works.