Automated Audit Management Solution for Medical Appliances Manufacturer

Customized QMS Software for Catering Services Company

customized qms software

Client

The client belongs to the fast growing food industry, who operates in the Middle East and is into the business of Catering and Support Services but is part of a big group of companies, with its Head Quarters situated in Saudi Arabia. They are handling a portfolio of clients who are unique and diverse. Their business encompasses major international blue-chip companies, military organizations, drilling contractors and private, high-profile individuals.

Business Requirement

Having vast experiences and wide operations the client is holding several certifications such as ISO 9001, ISO 22000:2018, ISO 22002-2, ISO 14001:2015, ISO 45001:2018, adhering to Saudi Aramco Food Codes and Saudi Aramco Guidelines. However, they need an integrated software to manage the complete QMS activities together and to consolidate their business efficiencies. It also required to adhere to documentation and regulation related to the food industry of the respective regions.

Solution offered

Since client was in need of a complete customized QMS software, Aura has taken this up as a new project development for developing new modules. Our solution is to customize the existing features as per the client’s requirements and industry specific needs such as – Enhancing the Dashboard with dynamic reports; enabling to view documents online instead of downloading any files; incorporating the Dynamic RCA module; Dynamic checklist types; Task creation based on each audit feedback instead of NCs alone; Observation based audit reports.

As a domain expert for more than 5 years, we at Aura analysed the optimal possibilities to go-live in the minimal timeline and planned the development of the customized QMS software.

Benefits

  • Holistic solution for ISO and other standard certifications
  • Streamlined the tasks and RCAs closure, with auto reminders and task allocation
  • Dynamic audit checklist with different parameters and checklist types
  • Simplified document management cycles
  • Mobile responsive, so can conduct audit anywhere

QMS System to Streamline Audit Management in Logistics Company

Client

The client is a leading logistics service provider with worldwide reach. The company is engaged in offering its valued customers a professional service and also provide flexible supply chain solutions that are tailored to meet the individual business needs of their customers.

Business Requirement

The client’s requirement was to develop a Quality Management software solution to handle their organization’s Complete Internal Audit Activities, handle the Document Management system requirements and to effectively manage their tasks on a day-to-day basis with the help of a software.

Solution offered

The client was given Aura’s Internal Audit Management module which covered key Audit Activities, such as Audit Scheduling, Audit Publishing, Pre-Audit Activities & Post-Audit Activities in real-time with related charts. This addressed the client’s pain point regarding internal audit activities management. An authorized user of the company will be given privilege access to create multiple Audit Checklists, to create and manage Audit Reports. The software system also provides the facility to do the Correction, Root Cause Analysis, Corrective Action, Effectiveness Review by Auditor & Auditee, all in a user-friendly manner.

To address the pain point of efficient document management AURA also provided the client the Article / Document Management System that enables an authorized user to create or update and publish documents / templates / articles quite effortlessly via the digitized system.

Access to specific documents can be restricted by assigning a security role with the proper access rights (common / a specific user group / individual user) in relation with Workflow Management. The software’s Dashboard feature actually facilitates the user to get to know the Daily, Weekly & Monthly tasks in a user-friendly manner. Such tasks can be the meetings, training’s, POA’s, Daily tasks and Audit tasks.

Benefits

  • Track RCAs with its relevant status, anytime & anywhere
  • Clarity in creating and managing various Audit Checklists
  • Document Management with revision history made easy
  • More personalized reminders on audits and events generated
  • Option to track non-audit related tasks also in the system

Audit & Document Management system for an E-commerce solution provider

aura-casestudy-ecommsolution

Client

Client is one of the Leading E-Commerce Business Store which has huge products coverage, this is their unique selling point.

Business Requirement

Client’s core requirement was the proposed solution, that should be able to effectively handle Comprehensive Audit &

Document management Solutions

for their ecommerce business. Also the system should be able to effectively import the existing Audit Checklist around 100 no’s. Proposed System should be able to handle Multiple level of Workflows with Document Version handling?

Solution offered

  • Client was provided with AURA QMS that facilitates Import option, where authorized users can create various Audit Checklists against various process in an easy manner which saves considerable time in the data entry & Saves time in Monthly Recurring tasks.
  • Auditor can share their Audit Observations as Conformities(O+), Non Conformities (O-) & Improvements (Oi) against Audit checklists, identified Non-Conformities will be moved to Post Audit tasks automatically, Auditee can update the necessary Correction, Root Cause & Corrective Actions.
  • System provides Auditor / Authorized user to do the effectiveness review of the Corrective Action POAs.
  • Aura facilitates the authorized users to configure the 1st level & 2nd level approval authorities as default for different document categories. If the Client needs multiple level more than 2 that is also possible.
  • Documents can be uploaded in various supporting formats such as Word, Excel, PDF, jpg, Tiff, bmp with document versions.
  • System provided the version handling facility to ease users
  • In addition to the above module Empowered Calendar view facilitates the individual users to view & track Daily, Weekly & Monthly Audit tasks, Article tasks, Meetings & Trainings in an effective manner.

Benefits

  • Comprehensive Audit Management Systems for complete audit activities
  • Effective Document management system with Approval workflow for better information tracking
  • Process based approach to improve Effectiveness
  • Reduces the manual work & Saves lot of time
  • Increased Visibility of Task status by Various filtering with respect to Audits & Documents

Quality and Audit Management solution for a steel manufacturing company

aura-casestudy-steelmanufact

Client

Client is one of the Leading Engineering Company experts in Steel fabrication works as a full service industrial contractor specializing in the design, fabrication, construction, and testing of field welded steel.

Business Requirement

Client’s core requirement was the proposed solution should be able to effectively handle Complete Internal Audit Activities & QMS users should track, Monitor Overall NCs improve the Compliance standards. Also the system should be able to support for Implementing the Client Satisfaction, Cost Reduction & Process Improvement OIs.

Solution offered

Client was provided with Aura QMS; our Quality solution facilitates Audit Management which simplifies the entire Audit Actives into 3 Major areas 1. Audit Scheduling & Publishing, 2. Pre Audit Activities, 3. Post Audit Activities.

  • In Aura QMS user will be able to configure the Auditors User Group, Supporting Auditors user group & CAR Auditor user group along with Pre Audit & Post Audit Activities, Based On this set Applicable configuration system works accordingly.
  • Aura facilitates the QMS user to create Process based parameter checklist & then multiple process wise parameter to Audit checklist mapping in a user friendly manner, similarly QMS user can create multiple Audit Check lists for various departments.
  • Aura provides the Internal Audit Report which gives the Overall status of NCs (Major NCs, Minor NCs), OIs with various filtering options of departments wise, Section wise, Executive wise. It gives the clear picture on where the NC raises with the appropriate next steps as RootCause & Corrective Action with POAs.
  • Facilitates Authorized user to Validate the OIs as Valid & Invalid with remarks. Valid OIs will be converted into POAs as Tasks with the category of Client Satisfaction, Cost Reduction & Process Improvement OIs. Further this POAs can be assigned to Responsible executives & QMS users can track the status of those OIs whenever required.

hence AURA automates the Complete Audit Activities with Task management in an easy way.

Benefits

  • Provides Complete Audit Management to avoid gaps in compliance, expose ineffective controls
  • Facilitates improvements in process requirements that lead customer satisfaction and new improvement initiatives
  • Reduces manual work & Saves lot of time
  • Increased Visibility of Audit Task status by Various filtering with respect Audit Status & NC Status.

QMS Software for a leading Products and Services providing company

aura-casestudy-servicespro

Client

Client is one of the Leading IT Company and a global provider of Consulting, Information Technology (IT) and Business Process Outsourcing (BPO) services. They mainly focus on delivering value through integrated solutions for data intensive business processes that help enterprises across the world overcome their business challenges.

Business Requirement

Client’s core requirement was the proposed solution should be able to effectively handle multiple Assessments such as ISO 9001 :2015 & ISO 27001 simultaneously. The Proposed system should handle those assessments and that leads to continual improvements to the Quality Management system & Information Security Management System (ISMS) requirements of the Organization in an effective manner.

Solution offered

As per the client’s requirement Proposed System should effectively handle multiple Assessments such as ISO 9001:2015 & ISO 27001 simultaneously. Aura QMS has been provided to the client, Aura provides the Flexibility to define, create Procedures & Internal Audit Activities tasks effectively.

AURA facilitates Assessment Management which allow users to create ISO 9001 :2015 as one Assessment, under that assessment Authorized user can create standard’s default clauses & Internal Audit activities as configurable one. Based on the set configuration respective audit tasks can be tracked. The system has the facility to assign the O+, O-, Oi against each notations & Track the audit finding reports to check compliance of the system. Similarly, ISO 27001 can also be created as a separate Assessment.

In addition to the above module Empowered Dash Board facilitates to view & Track the various Audit activities as graphical reports in a user friendly manner.

Benefits

  • Facilitates to handle various standards & configurable assessment management makes better visibility & helps to measure and track the tasks level progress
  • Driven process based approach to improve the process effectiveness
  • Reduces the manual work & saves lot of time
  • Increased visibility of task status by various filtering with respect to standards

Task Management for Oil and Gas Company

aura-casestudy-oilandgas

Client

Client is one of the Leading Company that provides products, services and solutions to Oil & Gas sector. They were successful in finding and developing new strategies and striking a new balance between risk and reward. These qualities have helped them to explore areas, where other companies thought that are too risky compared with potential rewards.

Business Requirement

Client’s core requirement was the proposed solution should be able to effectively handle New Initiatives and associated Tasks that has to be created with Tracking Mechanism, also the system should result in offering Tangible benefits that leads to continual improvements to the Quality Management system of the Organization.

Solution offered

Client was provided with Aura QMS software that help organizations to effectively monitor and manage their regulatory compliance activities. As per the client’s requirement, the system has been customized and made flexible to create ‘N’ no of New Initiatives & assign associated tasks. AURA facilitates Assessment Management which will allow to create New Initiative under that New Initiative management

Authorized user can create associated tasks & assign the responsible users for each tasks. Using the POA Module New Initiative Owner can track Completed %, Inprogress % & Yet to start % in a Graphical manner.

Document Management system in Aura helps to save all the documents in a secure, centralized web-based document control system with workflow mechanism (Forwarded, Approved & Published). It allows to upload Word, Excel, PPT & Image formats. System facilitates the Authorized user to Enable & Disable the Department Wise Document View privilege to the end users. This provides secured access of the Overall Document management system in an easy manner. It Leads to Reduce time, effort and costs associated with manual, paper-based document management processes in addition to the above Aura provides Meetings management & trainings management as add on module.

Benefits

  • Provides systematic, consistent workflows to capture, manage, review and track the entire Document management system effectively
  • Reduces the manual work & Saves lot of time
  • Configurable Assessment management makes better visibility & helps to measure the New Initiatives
  • Process based approach to improve Effectiveness

Audit management solution for a Pump manufacturing company

aura-casestudy-manufactpump

Client

Client is in Engineering Industry, vastly experienced in manufacturing Pumps & Valves, aimed at ensuring proper and timely services to their customers. As a trendsetter in the pumping field, the company have introduced innovations that have satisfied their customers.

Business Requirement

Client’s core requirement was the proposed solution should be able to effectively handle their Internal Audit Management Activities. Also the system should result in providing tangible benefits that leads to continual improvements to the Quality Management system of the Organization.

Solution offered

The Client was provided with Aura -Web based QMS software that helps organization to effectively monitor & manage their regulatory compliance activities & expose ineffectiveness in the existing system and help improvements in process requirements by using Comprehensive Assessment Management & Audit Management Module. Overall it leads to customer satisfaction and new improvement initiatives.

Aura QMS helped the client to effectively handle their Complete Assessment Management needs, also AURA provides the facility to create Assessments such as ISO 9001: 2015 as one assessment & ISO 27001 as another assessment.

AURA QMS also has the default clauses for ISO 9001:2008 & ISO 9001:2015. It saves time to the end users in data entry. In addition to that QMS users can add Assessments on their own & Track clauses, Internal Audit Activities such as Audit Scheduling, Audit Publishing, Pre Audit Activities & Post Audit Activities & Reports. Using this Assessment management, the QMS users will be able to create & maintain various standards.

QMS User will be able to generate the report of valid OIs from the system. This is the important Audit outcome. In this way QMS user can measure the tangible benefits.

Benefits

  • Reduces the manual work & Saves time
  • Configurable Assessment management makes better visibility
  • Helps to measure the Process Compliance
  • Avoid existing system gaps in running their Internal Audit activities
  • Process based approach to improve the Process Effectiveness

Audit Management Solution for Pump Manufacturer

aura-casestudy-auditpumpinc

Client

Client is one of the leading manufacturer of Pumps with three decades of experience, their service policy is aimed at ensuring quality and timely service to their customers across the country. Their quality of service and service accessibility is steadily improving with setting up of new branches and service centers.

Business Requirement

Client’s core requirement was the proposed solution should be able to effectively handle their Audit activities with Corrective Action for Nonconformities. Also the system should verify right tasks assigned to the appropriate stakeholders for handling & Tracking those tasks in an easy manner.

Solution offered

The Client was provided with Aura -Web based QMS software that helps them to effectively monitor & manage Internal audit activities and find ineffectiveness in the existing system. Also helps in bringing improvements in the existing process by using Comprehensive Audit Management Module. Overall it leads to customer satisfaction and new improvement initiatives.

Aura’s Comprehensive Audit Management module allows the QMS / Authorized user to create appropriate Audit checklists for each department in the organization.

Apart from audit management to address their core requirement ie., to effectively handle their Corrective Action for the Nonconformities Aura has been customized with the below given features:

The QMS user will be given flexibility to choose for a particular Department Audit what are all the applicable processes for this Department Audit. Auditor can raise their Observations as Conformities (0+) & Non Conformities (0-) through Audit Observation report. Based on the report the system creates & assigns this as Post Audit task to auditee.

Corrective Action in Aura includes 3 major steps (Correction, Root cause Analysis & Corrective Action). Once the correction & RootCause Analysis for the Non Conformities are reviewed & completed then the next important step is Corrective Action which can be done by following ways

Step 1: For the Root cause, the respective corrective action should be identified

Step 2: Mention the Identified Corrective Action with impact. The Impact can lead to Process Changes / Document changes / Audit checklist updation changes / Training related requirements / Other Checklist related changes)

Step 3: While defining the corrective actions, applicable departments should be mentioned for effective Implementation

Step 4: Corrective Action should be clearly specified with the types such as CAR POA type – Long Term & Short Term along with the TAT defined. CAR POA can be assigned to respective stake holders

Step 5: Once the above 4 steps are completed, Corrective Action Implementation Effectiveness Review can be done by CAR Auditor. CAR Auditor will be able to verify the Corrective action POA – Long Term & Short Term closure.

Preventive Action

AURA facilitates to log Preventive Action as POAs and assign those Preventive Action to respective stake holders using Tasks management. Completed on time, completed with Overdue, Inprogress and Yet to start POA’s can be tracked.

Benefits

  • Automation of Post Audit Activities
  • Mapping appropriate tasks to appropriate users (Auditor & Auditee)
  • Increased visibility on RootCause analysis current status between the various stake holders (QMS User, Auditor & Auditee)
  • Huge time saving & Avoid existing system gaps in running their Internal Audit activities
  • Process based approach to improve the Process Effectiveness

Quality Management Solution for a Knitted Garments Exporter

aura-casestudy-knittedgarments

Client

Client is one of the leading manufacturers and exporters of knitted garments with three decades of experience in the garment industry

Business Requirement

Client’s core requirement was to have a quality management solution that should be able to effectively handle their RootCause Analysis for the Nonconformities. Also the system should substantiate the right process involved by the appropriate stake holders in tasks handling & Tracking those tasks. The proposed system should offer tangible benefits that leads to continual improvements to the Quality Management System of the Organization.

Solution offered

Client was provided with Aura QMS, the best quality management software to manage, monitor and analyze their root cause and non-conformities. Aura’s Comprehensive Audit Management module allows QMS User / Authorized user to create appropriate Audit checklists for each departments which are all applicable to the organization such as Merchandising, Marketing, Exports, Finance, Materials, Production, Finishing and Sampling.

QMS user will have the flexibility to view a particular Department Audit and all the applicable processes. Auditor can raise their Observations as Conformities (0+) & Non Conformities (0-) through Audit Observation report. Based on the report the system creates & assigns this audit findings as Post Audit task to auditee.

RootCause Analysis:

Aura facilitates the Auditee to identify RootCause from the following steps

Step 1: Issue / Problem description (clearly breakdown the issues one by one & mention it below to find the Root causes considering the impact)

Step 2: Reason – (Clearly state the reason for each issue)

Step 3: Identifying the RootCause by doing Why-Why Analysis (5 times/ 6 times)

  1. While listing the possible causes, Include Cross Functional team
  2. List all the causes then do the Why, Why Analysis
  3. Each reason should have one Root cause
  4. One deviation / Nonconformance can have multiple Root cause

Once the Auditee has identified the RootCause, then the system creates & assigns RootCause verification as a task to auditor. Auditor & Auditee can track& know the RootCause Analysis current status (Completed & Inprogress status).

In this way, AURA’s Audit Management gives more clarity on Post Audit tasks & process related outcomes driven to end users that helps to improve process effectiveness within an organization.

Benefits

  • Automation of Post Audit Activities
  • Mapping appropriate tasks to appropriate users (Auditor & Auditee)
  • Increasing visibility on RootCause analysis current status between the various stake holders (QMS User, Auditor & Auditee)
  • Huge time saving & Avoid existing system gaps in running their Internal Audit activities
  • Process based approach to improve the Process Effectiveness.

Automated Audit Management Solution for Medical Appliances Manufacturer

aura-casestudy-medicalappmanufacture

Client

Client is one of the leading Manufacturer of medical appliances instruments. They manufacture appliances for measuring, checking, testing, navigating and all-purpose instruments except optical instruments.

Business Requirement

Client’s core requirement was to have a solution that should be effectively handle their multiple Audit checklist with minimal manual intervention. The proposed system should be time saving & should also provide tangible benefits that leads to continual improvements to their Quality Management system.

Solution offered

The Client was provided with Aura -Web based QMS software that helps them to effectively monitor & manage their regulatory compliance activities & expose ineffectiveness in the existing system. Also brings improvements in process by Specialized Assessment Management Module, which brings customer satisfaction and new improvement initiatives.

Client’s Core Requirement was the Audit Checklist creation; this can be done Process wise & the QMS user can select particular checklist for individual department audits too.

Aura’s Specialized Assessment Management module allows the QMS User / Authorized user to create all processes like Design & Development, Production, Assembly which are all applicable to the organization. Once the Process creation operation is completed then Process wise parameters can also be created in the same way.

QMS user will have flexibility to choose applicable processes for any particular department Audit. In the same way they can also create any no of department audits by choosing the Process wise parameters this will be one-time effort.

While scheduling audit the system facilitates the QMS user to choose Audit checklist name alone and facilitates in allocation of Audit by selecting the Auditor, Auditee & Audit schedule with the appropriate selection of Audit checklist in less timeframe.  Once the schedule is created and published, the system automatically allocates the task to Auditor & Auditee in their respective calendar view. This greatly helps in their planning & execution in an effective way. In this way, AURA saves lot of time in multiple audit checklists creation & allocation of audit schedule to QMS users.

Benefits

  • Automation of Process wise parameters and checklist creation
  • Mapping Department Wise Audit checklist with suitable process wise parameters leads to save huge time for QMS users in creating multiple department audit checklists.
  • System made Audit scheduling & schedule will be listed to Auditor & Auditee calendar view as notification
  • Increased visibility between the various stake holders (QMS User, Auditor & Auditee)
  • Huge time saving & Avoid paper based existing system gaps in running their Operational activities such as Process wise parameter creation, Multiple Audit checklist creation & Audit scheduling