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Audit Management

Robust audit management helps organizations know the gaps, take action, and remain compliant

The Audit Management module in QMS helps drive efficiency and effectiveness into the audit management process.
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Companies conduct different types of audits to maintain checks and balances on different essential aspects of the organization. The important purpose of an audit is to ensure that each business area complies with applicable regulations and works within the confines of corporate policies. Audits are complex as they entail a careful examination of various business processes.

What is Audit Management?

Audit management forms the basis for a sound audit by offering straightforward, measurable steps for achieving specific audit objectives. Documentation of these audit management procedures allows auditors to remain well-informed about ongoing activities with minimal confusion. Audit management procedures are a guideline for auditors, employees, and other stakeholders.

Audit Management
ComplianceQuest Audit Management

How does Audit Management work?

Audit management is a quintessential process to ensure that all audit directives are correctly implemented and executed. It encourages any organization to:
  • Improve audit plans
  • Track and manage audit findings
  • Boost audit efficiency and cut costs
  • Gain deeper insights through detailed audit result

Implementation of Audit Management

Audits are an integral component of compliance and regulatory requirements. It is essential for analyzing the success of processes, products, and systems. Audit management is also essential for verifying objective evidence of processes and providing evidence for reducing and eliminating any problem areas.

Quality auditing management should highlight examples of good practice rather than simply identifying nonconformance, process issues, and corrective actions to ensure maximum benefit. With this practice in place, other departments can share information and adjust their working practices, delivering continuous improvement as a result.

Benefits of Audit Management

  • Keeping track of employees working from an office or remote location
  • Staying on top of the business’s progress
  • Management can easily monitor tasks while keeping track of their performances
  • Reducing the risk of fraud
  • Training employees and providing relevant documents
  • An effective method for overall evaluation
  • Checking for accuracy in financial statements
  • Identifying problems within the business to effectively address them

Layered Process Audits 101

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Features of CQ Audit Management

CQ’s Audit Management Software helps companies build a scalable, flexible, and configurable audit management workflow, depending on the specific needs. The audit management module offers the following features –

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Planning and Scheduling – Plan and schedule audit by site, department, suppliers
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Preparing for an Audit – Auditors are notified of upcoming audits, and they can prepare by reviewing past audits, open findings, critical findings, CAPAs
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Conducting Audits – Take notes, document findings, categorize relevant findings, anywhere, on any device
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Findings Documentation and Categorization – Document findings, attach evidence, and categorize them
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Audit Report Generation – Generate audit reports using pre-built audit templates
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Risk Assessment – Capture the risk profile during the audit planning phase and review as per audit findings
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Escalation to CAPA – Prioritize findings and initiate CAPA based on risk
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Supplier Portal and Interaction – Consolidate all quality data for suppliers to review, rectify, and respond to audit findings
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Audit Finding Response – Automatic generation of e-mail messages to the auditee
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Collaboration – Solicit feedback from the supply chain without giving up ownership of tasks
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Mobile Access – Access your CQ Audit Management solution on the go, anywhere, anytime, and on any device
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Reporting and Analytics – Utilize pre-developed best-practices-based reports and create additional reports and dashboards
Case study - Candelis
Customer Success

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Capabilities of ComplianceQuest Audit Management

Enable promptness and perfection in Audit performance

Enable promptness and perfection in Audit performance

CQ Audit Management Software allows businesses to plan internal and external audits. The software automates the entire audit workflow from audit planning scheduling to documenting findings and initiating CAPAs where required. Quality leaders can set up calendar views to alert all stakeholders about scheduled audits and prepare accordingly. It also empowers them to choose between complex, stringent, or streamlined audits flexibly.
Ensures effectiveness and continuous improvement of your QMS

Ensures effectiveness and continuous improvement of your QMS

Automate audit workflows with CQ Audit Management Software. The software enables business and quality leaders to identify gaps, predict quality performance in the future, capture failure trends, and take corrective and preventive action for continuous improvement.
Stay Compliant

Stay Compliant

With CQ Audit Management Software, businesses can plan audits for different regulatory standards such as ISO 13485, ISO 9001, FDA 21 CFR Part 11 to remain compliant.
Always remain Audit and Inspection ready

Always remain Audit and Inspection ready

The first step in risk management is to know the gaps. The CQ Audit Management Software helps in having a proactive risk management strategy, providing visibility and transparency across the entire process. The software allows businesses to plan, manage changes, learn from past audits, assign roles and responsibilities, create schedules, organize data, and conduct periodic internal audits.
Avoid Fines and Penalties

Avoid Fines and Penalties

Periodic and well-planned and executed audits can help mitigate non-compliance risks by identifying the gaps in a timely manner and reducing the impact on the business. The CQ Audit Management Software manages the entire audit cycle to ensure greater compliance and growth and avoid non-compliance penalties.

4 Phases of the Audit Process

The audit is carried out either by trained members of an organization’s staff (internal quality audit) or by auditors from outside the organization (external quality audit). The process of quality audits is divided into four phases as follows:
4 Phases of the Audit Process
Audit Initiation

Audit Initiation

The first step in the quality audit process is audit initiation. This involves a preliminary discussion between three parties – the client, the auditee, and the auditing organization. The discussion includes:
  • Setting the objective of the audit
  • Identifying the reference standards
  • Involving the auditors
  • The duration of the audit
Audit Planning

Audit Planning

Audit planning includes several activities by implying actions and reactions from the involved parties, including scheduling the audit, the number of resources needed, gathering audit, reporting the results, determining the sampling procedures, and following up on corrective and preventive actions.
Audit

Audit Execution

After audit initiation and planning, the auditor starts to perform various activities such as evaluation of process and system controls, employee interviews, on-site audit management, and regular communication with other relevant parties within the organization. Audit execution is often called ‘fieldwork’. It concludes with the final discussion between the auditor and the auditee.
Audit reporting and Follow-up

Audit reporting and Follow-up

The audit report includes the observation results, inspection or test results obtained, providing data on management, conformances and non-conformances found. It also includes recommended corrective actions that need to be taken.
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Simple and Easy to use QMS Software

We chose to implement CQ’s Non-Conformance Management, CAPA Management, Document Management and Related Training, Audit and Supplier Management. Works as shown. It is easy to configure, manage and use. We chose ComplianceQuest to address our ISO 9000 compliance, other regulatory requirements and Continuous Improvement needs. Our criteria was that the software should be cloud based, address the ISO 9000 requirements well, easy to implement, accessible from anywhere and also from any device. CQ has been by-far the easiest and Customer service is by far the best.
Venkatragavan Jayabalan,
Appasamy Associates

 

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Importance of Audit Management in Organization’s Growth

Audits are an integral component of compliance and regulatory requirements. They are essential for analyzing the success of processes, products, and systems. They are also a vital tool for verifying objective evidence of processes and providing evidence for reducing and eliminating any problem areas.

Audit management highlights areas of process issues and nonconformance that need corrective actions. This can help other departments to share information and adjust their working practices, delivering continuous improvement as a result. A robust audit management system supports the entire organization. ComplianceQuest Audit Management module helps –

  • Audit leaders schedule audits for internal operations, supply chain, and regulatory compliance
  • The audit coordinator assigns audits at a predefined frequency for key suppliers, R&D, manufacturing, testing
  • Auditors to complete the full audit process, access past audit data and have greater document control
  • Ensure operations/supply chain processes are being followed
  • Management review and analyze the effectiveness of the audit program and the state of compliance

Quality-centric companies rely on CQ QMS

Manage your entire audit lifecycle with ComplianceQuest’s audit management software for flexible, scalable and configurable workflow.

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Frequently Asked Questions

What are the three types of audit?
The three different types of quality audits are mentioned below:

  • Process audit – Specifies if a company’s processes are working within defined limits. It measures the conformance, effectiveness, and adequacy of the process controls established by procedures, work instructions, training, and process specifications.
  • Product audit – Inspects if a particular product or service complies with customer requirements, specifications, and performance standards.
  • System audit – Confirms that all management system elements are effective and appropriate while being developed, implemented, and documented as specified. A QMS audit measures an organization’s existing QMS to assure the conformance of the system with contract commitments, company policies, and regulatory requirements.
What are the principles of the audit?
An audit is considered an effective management tool to detect the problems and defects in the quality management system and helps improve and resolve them based on broad findings and recommendations. The principles of an audit are as follows:
  • Objectivity
  • Ethical standards
  • Accurate presentation
  • Collaboration
  • Independence
  • Professional support
  • Proficiency
  • Assessment based on evidence
  • Confidence

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