Audit Management  >  Internal Audit Procedure for Manufacturing Company

Internal Audit Procedure for Manufacturing Company

internal audit procedure for manufacturing company

The internal audit focuses on improving process flows, cybersecurity, and the organization’s overall efficiency.

internal audit procedure for manufacturing company
quality-based approach for internal audits

Create a Quality-based Approach for Internal Audits

Any organization with a compliance management program must regularly conduct internal audits. These audits assure that the business operates at maximum efficiency across all departments.

Internal audits for the entire quality system are usually conducted annually. By establishing a disciplined, integrated approach to policies, regulations, cybersecurity, risks, controls, and issues, organizations can demonstrate a firm grasp of the regulatory compliance necessities and provide transparency into overall business risks.

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How to perform a quality control audit in a Manufacturing Business?

There are five critical steps to properly perform a manufacturing process audit. Here’s a checklist of everything one needs to do to learn how to audit the manufacturing business.

Select Audit Type:
Before starting the audit, identify the focus and goal that needs to be achieved. Once the goal is set, it is easy to ascertain which of the following audits must be performed.

  • System audits evaluate a company’s management systems and ensure that all elements and processes are effective. This audit also ensures that the development and implementation of the systems consistently meet specified requirements. For example, a QMS audit will review its existing quality system to comply with company policies and the required regulations.
  • Product audits examine a company’s services and products to ensure they’re compliant with government policies, performance standards, and company quality standards.
  • Process audits review all company processes to ensure efficiency within their established limits. This audit also checks operation time and responsiveness and the effectiveness of each procedure and process specifications.
  • A first-party audit is an internal audit designed to evaluate the performance of the organization’s objectives, identify problem areas and find processes that need continuous improvement. This audit is conducted by employees who take on the auditor’s role.
  • The second-party audit is an external audit conducted by auditors hired from outside the organization. These independent audits may impact the buying decisions of the customer.
  • A third-party audit is performed by an external organization. This is done to ensure there is no conflict of interest resulting in recognition, license approval, certification, or penalty being issued by the third-party organization.

List Tasks and Perform Audit:
Based on the audit that should be conducted, the auditor will have to perform specific tasks to accurately evaluate a particular area’s performance and effectiveness. When it’s time to perform the audit, preparing a checklist that has each task listed in a series of steps is recommended.

Record Findings in an Audit Report:
Once the audit is completed, the auditors must create an audit report to document all the findings. This report must be thoroughly reviewed before planning the next step.

Determine and Perform Corrective Action:
Based on the findings from the reports, determine and perform corrective actions to remedy the issues listed. It is advised to note everything that will be done to resolve each problem in a separate report. This will help keep track of the methods that have been tried and help choose suitable corrective actions in the future.

Schedule a Follow-Up Audit:
After corrective action is carried out, conduct another audit to measure changes instituted by the corrective action.

  • If system processes, performance, or products show improvement, record the findings in a separate audit report and discuss it before closing the audit.
  • If the findings indicate minimal or no changes in any processes, performance, or products, make a note in a separate audit report to determine the subsequent corrective action needed. Continue this pattern until there is an improvement.

Remote Audits of Quality and Safety Processes

A combination of remote and in-person internal audits can speed up the audit process and make life easier for quality and safety teams.

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Internal Audit Procedure for Manufacturing Companies

What is the Internal Audit Procedure for Manufacturing Companies?

Internal audits effectively act as a “pre-test” before the external auditors arrive. A successful and comprehensive internal audit in a manufacturing company can act as a “practice run” that allows organizations to remediate issues before the external audit and prevent official findings. Cybersecurity and manufacturing process audit can also be part of company internal audit. As automation and digitization enter manufacturing processes, cybersecurity becomes an integral part of audits.

An auditor performs company internal audits. An auditor is a person who has good knowledge of both business and industry standards. The auditor conducts the audit as per the standards. Quality auditors can be external or internal.

  • External auditor: the third party hired from an approved agency, customer, or client to evaluate the quality system or products
  • Internal auditor: an employee of the company

The following steps are part of company internal audit procedure for manufacturing companies:

  • Identifying Subject Matter Experts (SMEs)

    To perform an internal audit, the organization must involve stakeholders from across the organization. For example, SCADA experts and internal IT experts must collaborate to create a holistic security-first compliance approach.

  • Document Internal Control Procedures and Reasons for them

    Establish a risk analysis, procedures, policies, and processes. This document acts as the roadmap for the compliance program, which helps create the audit scope.

  • Continuously Monitor for Control Effectiveness

    Connected devices must interact seamlessly and have risk management controls in place. The organization must constantly monitor and remediate any potential weaknesses as soon as possible.

  • Continuously Document Your Monitoring

    Audits rely on documentation. Even when continuously monitored, the auditor may return findings without proper documentation. Documentation proves governance over the program, enabling the Board of Directors to oversee the program.

  • Create an Internal Audit Workflow

    Communication before, during, and after the audit helps maintain security and compliance. It is imperative to create a process for preparing, reviewing, and responding to the internal audit that ensures that all tasks are completed promptly.



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Costa Rican Medical Device Manufacturer Soars in the EQMS Cloud

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How can ComplianceQuest Audit Software help conduct internal audit in manufacturing businesses?

With the advent of technology, manufacturing processes and supply chain management is monitored, run, and maintained globally. As the industry is confined to strict regulations, organizations must conduct internal and external audits to ensure the safety of employees, quality of products, while staying competitive in a constantly changing world. With CQ Audit Management Software, planning and managing the entire audit cycle is effortless. The cloud-based scalable and flexible system helps players in the manufacturing industry with various audit requirements, from audit planning and scheduling to documenting findings to initiating CAPAs.

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

Appasamy Associates
Appasamy Associates

What is the role of ISO 9001 in an internal audit?

Clause 9.2 of ISO 9001:2015 states that “the organization should conduct internal audits at planned intervals to provide information on whether the quality management system conforms to the organization’s own requirements, the requirement of ISO 9001:2015 standards and is effectively implemented and maintained.” Essentially ISO recommends conducting an internal audit to ensure that the organization is compliant with regulatory requirements and take corrective action if necessary.

Streamline and Automate your end-to-end audit lifecycle with AI-enabled features in ComplianceQuest’s Audit Management Solution

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Frequently Asked Questions

  • To ensure the most significant benefit for an organization, audits are crucial for assessing the success of products, processes, and systems, whether it is existing or newly implemented. This is an essential component for:

    • Evaluating the conformity or nonconformity of the quality system based on specified requirements

    • Identifying whether the quality policies meet quality standards

    • Verifying objective evidence of processes

    • Ensuring the usage and sale of products based on regulation

    • Providing evidence to reduce and eliminate any problem areas

    • Taking corrective action for deficiencies

    • Recognizing improvement opportunities

  • Some of the benefits of using audit software in the manufacturing business include the following:

    • Faster and more efficient audit processing

    • Meet product quality requirements and overall manufacturing business goals

    • Improve manufacturing productivity and general business operations

  • Organizations implement the ISO 9000 group of standards to achieve compliance with their commitment to quality management. To ensure compliance, internal audits and audit planning play a key role. Some key advantages of implementing ComplianceQuest’s EQMS are:

    • Complete alignment to ISO 9001, ISO 13485, CGMP, and other regulations.

    • It is time-saving, cost-effective, paperless, and improves enterprise-wide data visibility

    • Serves as the single source of truth for all quality-related data and information

    • Documents and records are readily identifiable and traceable

    • Facilitates cloud-based storage of documents and records

    • Helps maintain data confidentiality and security

    • Provides easy-to-navigate dashboards and reports

    • Helps in risk identification, control, and monitoring

    • Ensures integration of the entire quality workflow across customer, supplier, and internal processes

    • The training management process is directly integrated with the EQMS workflow

    • New changes made in QMS can be easily communicated to the stakeholders

    • Employees are aware of the timelines and accountability


    ComplianceQuest’s Audit Management software is designed to drive efficiency into the audit management workflow. The software supports multiple stakeholders, including auditors, quality engineers, quality leaders, and senior management.

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