The visit of an auditor, especially from an external agency or regulatory body, can be quite stressful for businesses. They ask for documents, examine audit trails, inspect premises, and ask questions that can leave one scrambling for data and information that may be hidden away somewhere!
Sometimes, the company may be prepared with the documents, but the order may be wrong and spread out across folders. This may cause delays in accessing the right documents when needed. Then, there is the issue of multiple versions of the same document! Ugh! Once that happens, deciding which version is correct adds to the chaos.
Don’t we all want to avoid such situations? The need of the hour for any enterprise is to have a robust audit management solution that streamlines everything from audit planning and preparation to audit reports and closure. A well-defined document management system is a key part of any audit system as well.
Being “audit-ready” at all times will not only result in improved compliance, but also improve overall quality and business performance.
ComplianceQuest’s Enhanced Audit Management Software – What’s New?
ComplianceQuest, in its efforts to continuously improve its features and capabilities to help its customers, has introduced a few new features to the CQ Audit Management Software. These features help improve the quality of the audit, plan it better, and provide access to the relevant documents for better compliance. Some of the new features include:
- Standards Ready – It helps an auditor define which standards (ISO 9001, ISO 13485, etc.) they will be working on and make that available to the audit team.
- Audit Format – The auditor can choose how the audit will be conducted (i.e., Virtual, Onsite, For Cause, Assessment, Periodic Review, etc.).
- Look-up Location Field – Lookup a company location, and the value will auto-populate the record in Audit, Findings, CAPA, Nonconformance, and Risk.
- Audit Program Year – This will help specify the year for which the audit program will be scheduled.
- Multi-step Approvals – The audit program records whose status is not Closed or Void and is not already in Approval. This can be sent for approval multiple times.
- Intelligent Recommendations –
- To suggest Audit Finding Type based on the description of previous similar findings
- Identify similar Audit Findings to determine reoccurrence and show the resulting related Audit Finding records in the Related List
- Identify similar Nonconformance to determine reoccurrence and recommend escalation to CAPA
Of course, our Audit Management Solution seamlessly integrates with CAPA, Risk Management, Change and other key modules of our EQMS solution. It is designed to drive efficiency into the overall process of planning, scheduling and running an audit.
Need for Automating Audit Processes and Workflows
ISO 19011 defines auditing as a systematic, independent, and documented approach to obtaining objective evidence and determining the extent to which the audit criteria are fulfilled. Audit criteria could be a legal requirement, showing the compliance or non-compliance of the processes and products to the regulatory standards. The requirements encompass work instructions, policies, procedures, contractual obligations, etc.
Audits can be of two types:
- Internal or first-party audits conducted by, or on behalf of, the organization itself
- External audits include second-party audits conducted by stakeholders such as customers; or third-party audits conducted by independent auditing organizations, including governmental agencies and certification/registration of conformity agencies
While compliance is important, audit management also ensures improved quality management through greater collaboration between the different teams with a common goal. It ensures that the quality processes are well-understood and implemented.
Important Aspects of Robust Audit Management Process
Some of the key elements involved in audit management include:
Document Management: The audit process requires easy access to accurate and sufficient documentation of processes. It can become very complex for manufacturers with a wide range of products or ones with a wide supplier network.
Create an Audit Trail: Audit readiness requires manufacturers to have up-to-date, transparent, and traceable data for better monitoring, tracking changes, and quickly identifying deviations.
Data Accessibility: Access to complete and organized data is important as and when required to make informed decisions, improve communication, and enhance responsiveness to non-conformities. This will help improve quality across the organization.
Reduce Risk of Error: Manual and outdated systems, inadequate quality policies, and poor auditing processes can increase the risks of non-conformance. Automating workflows can improve collaboration and enhance efficiency, improving audit results.
Continuous Improvement: Consistency, effectiveness, and quality are three important aspects that auditors look for during the auditing process. Therefore, continuous improvement in various aspects such as waste reduction, time management, metrics monitoring, etc., is essential.
Improving Compliance: Periodic auditing helps assess the level of compliance and areas of improvement by identifying gaps and opportunities.
Your Enterprise Must Have an Audit Management Program that can be Trusted
A good audit management program helps businesses to ensure the adequacy of internal controls and implement best practices to improve compliance with regulations and standards.
It can help identify gaps and opportunities for improvement in operations and reduce waste.
Good audit management can ensure the efficient use of resources, improve managing cross-functional issues, and enhance cost savings.
A manufacturing audit also helps assess the supplier’s capability to meet the project requirements. Assessing their facilities can help evaluate their reliability as a potential partner.
Identifying any current and potential issues ahead of time can help take corrective and preventive action proactively – to mitigate risks.
Automating Audit Management Process with a Next-Generation EQMS like ComplianceQuest
Manual audit management processes can make it difficult to have visibility and transparency, making them ineffective and prone to errors. With automated audit management, businesses can simplify documentation, assigning responsibilities, and monitoring progress with access to real-time data. This can help improve process efficiency and compliance, initiate CAPA, and provide access to audit trails.
ComplianceQuest’s Audit Management software is cloud-based and so facilitates collaboration and communication with greater ease. It helps to digitally transform the audit management process. By automating the audit workflow, the CQ Audit Management Software empowers business and quality leaders to identify gaps and predict quality performance in the future by providing data at their fingertips. They can access documents and reports of past audits easily while capturing failure trends and take corrective and preventive action for continuous improvement. With this, businesses can improve performance, supplier management, compliance, customer satisfaction, and revenue growth.
ComplianceQuest’s Audit Management Software is part of its modular Enterprise-wide Quality Management System (EQMS) that automates quality assurance and management processes. It is integrated with:
- Document Management
- Management Review
Overall, it ensures greater effectiveness of the audit management process as it helps the organization at every level with audit findings and implements the necessary follow-up action.
For more about CQ Audit Management Software: https://www.compliancequest.com/audit-management-software-system/